ADHD-Link: Communication to Improve Shared Decision-Making in ADHD
Sponsor
Children's Hospital of Philadelphia (Other)
Overall Status
Completed
CT.gov ID
NCT02716324
Collaborator
Patient-Centered Outcomes Research Institute (Other)
303
1
2
31.1
9.7
Study Details
Study Description
Brief Summary
The purpose of this study was to explore whether using an online patient portal plus a Care Manager is more effective than using an online portal alone in managing care for children with ADHD. Doctors at The Children's Hospital of Philadelphia currently use the online patient portal to help gather information from parents and teachers on ADHD symptoms, treatment, and medication side effects. The Care Manager is a person who meets with participants during the study to discuss their child's ADHD care. The Care Manager communicates with the child's doctor and teacher to communicate a parent's goals and preferences for their child's ADHD care.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Fragmentation in health care and poor communication across systems adversely impact engagement and adherence to treatment by children with ADHD and their families. Fragmentation of services for ADHD impairs communication and collaboration between families and primary care providers, mental health providers, and educators, and leads to suboptimal outcomes for children. Prior studies have documented that little communication and coordination exist among providers across different systems despite calls for better system integration.
Fragmentation in communication between providers has the potential to impair shared decision-making. To promote shared decision-making, we developed an electronic health record (EHR)-linked portal to collect information from parents, teachers and clinicians on children's ADHD symptoms and treatment-related preferences and goals. This has become standard of care at our institution. We also developed and pilot tested a ADHD Care Manager intervention which will be employed in this comparative effectiveness study.
303 participants were recruited from 11 primary care pediatric practices. Participants were randomly assigned to either the EHR portal alone, or the EHR portal plus a Care Manager. For those assigned to the EHR portal plus Care Manager, the Care Manager met with families at the beginning of the study to confirm their treatment preferences and goals, provide additional education on ADHD treatment, and distribute handouts on common concerns among ADHD patients and families. The Care Manager contacted families every 3 months or more frequently if needed by phone, email, or in-person to assess treatment use, identify new concerns, and assist families with problem-solving. The Care Manager also communicated with primary care clinicians, mental health providers, and teachers to clarify family treatment preferences and goals and address emerging treatment issues. Participants completed surveys that assessed ADHD symptoms, goal attainment, patient-reported outcomes, patient and family engagement, and treatment initiation and adherence.
Study Design
Study Type:
Interventional
Actual Enrollment
:
303 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Communication to Improve Shared Decision-Making in Attention-Deficit/Hyperactivity Disorder
Actual Study Start Date
:
Mar 10, 2016
Actual Primary Completion Date
:
May 9, 2018
Actual Study Completion Date
:
Oct 14, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: ADHD Portal In this arm, the ADHD Portal was used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents. |
Other: ADHD Portal
The ADHD portal was a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment were measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents were encouraged to consult with their children when completing the tool.
|
| Experimental: ADHD Portal plus Care Manager (CM) In this arm, the ADHD Portal was combined with the CM. Clinicians, teachers, and parents used the ADHD Portal as standard of care. In addition, clinicians, teachers, parents, and any external mental health providers interacted with a CM, who had access to information contained in the ADHD Portal. |
Behavioral: Care Manager CM)
The CM was an individual responsible for communicating and coordinating ADHD care. The CM established rapport with families and communicated with them every 3 months or more frequently if needed to assess treatment use, identify new concerns, and help problem-solve. The CM also communicated with the patient's ADHD care team (pediatrician, teacher, mental health providers) to clarify family goals, communicate information, and coordinate treatment.
Other: ADHD Portal
The ADHD portal was a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment were measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents were encouraged to consult with their children when completing the tool.
|
Outcome Measures
Primary Outcome Measures
- Change in Vanderbilt Parent Rating Scales (VPRS) [Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)]
The VPRS is a public domain tool that consists of forms completed by the child's parent and includes 18 items corresponding to the DSM-5 ADHD symptom criteria, 8 performance items, and 12 items assessing side effects. The VPRS items are scaled on a 4-point Likert rating ("never" to "very often"), and the scales used in this study were restricted to the 18 ADHD symptom items. Total scores were used to measure ADHD Symptoms. Higher scores indicated worse outcome. VPRS were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value. The VPRS measures ADHD symptoms and is scaled on a 4-point Likert rating ("never" to "very often"). The scale includes 18 ADHD symptom items with total scores ranges from 0-54.
Secondary Outcome Measures
- Mean Goal Attainment Scale (GAS) Score by Timepoint [Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)]
The GAS is a 5-point likert scale that assesses the degree to which parents' goals (obtained from the ADHD Preferences and Goals Instrument) are attained from none to completely. The GAS response categories are ordered from 0 ("no change") to 6 ("goal completely met"). Higher scores indicate greater goal attainment. The GAS was measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
- Treatment Initiation and Use of Services [9-12 months (Visit 4)]
Using responses from the Services Assessment for Children and Adolescents (SACA), a well-validated client-reported tool and provides information on any mental health services use, ambulatory services use, and inpatient service use, we determined (yes/no) whether participants ever received educational services, mental health services, or medications for ADHD. Parents reported whether their children used services ever or within the last nine months. Treatment initiation was measured by use of services ever. Categorizations include any service use, ambulatory service use (any community mental health or outpatient clinic, private professional, or in-home provider), and overnight stay (psychiatric or medical unit, residential treatment center, group home, or foster home). The time range of 9-12 given for Visit 4 reflects the time range counted as a single value.
- Treatment Adherence and Use of Services [9-12 months (Visit 4)]
Using responses from the Services Assessment for Children and Adolescents (SACA), a well-validated client-reported tool and provides information on any mental health services use, ambulatory services use, and inpatient service use, we determined (yes/no) whether participants ever received educational services, mental health services, or medications for ADHD. Parents reported whether their children used services ever or within the last nine months. Treatment adherence was measured by use of services in the past nine months. Categorizations include any service use, ambulatory service use (any community mental health or outpatient clinic, private professional, or in-home provider), and overnight stay (psychiatric or medical unit, residential treatment center, group home, or foster home). The time range of 9-12 given for Visit 4 reflects the time range counted as a single value.
- School Performance [Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)]
School Performance is a 5-item domain (minimum score=1, maximum score=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the School Performance domain is 5 and the maximum total score is 25 (total scores are not shown below). Values in the table below are reported as mean scores at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. School performance PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
- Student Engagement [Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)]
Student Engagement is a 4-item domain (minimum score=1, maximum score=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the Student Engagement domain is 4 and the maximum total score is 20 (total scores are not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Student Engagement PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
- Teacher Connectedness [Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)]
Teacher Connectedness is a 9-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the Teacher Connectedness domain is 9 and the maximum total score is 45 (total scores not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Teacher Connectedness PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
- Peer Relationships [Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)]
Peer Relationships is a 6-item domain (minimum=1, maximum=5, on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and a 7-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score is 6 and the maximum total score is 30 on the Child PROs. The minimum total score for the Peer Relationships domain is 7 and the maximum total score is 35 on the Parent PROs. Total scores not shown below. Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Higher scores indicate better outcomes. Peer Relationships PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
- Family Relationships [Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)]
Family Relationships is a 6-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the 30-item Child- (age 8-12) Patient Reported Outcomes Measures of relationships with other family members over the past 4 weeks. The minimum total score for the Family Relationships domain is 6 and the maximum total score is 30 (total scores not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Child-reported PRO measures were averaged for each domain for each time point. Higher scores indicate better outcomes. Family Relationships PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
- Engagement Measure Scores [Visit 4 (9-12 months)]
The Engagement Measure is a 28-item parent self-report measure comprised of four domains: Access (5-items, total score range 5-25), Patient Family Centered Care or PFCC (6-items, total score range 6-30), Communication (3-items, total score range 3-15), and Understanding (5-items, total score range 5-25). Total scores are not reported below. Scores for each individual item and therefore the mean for each domain (means reported in the table below) ranged from 1-5 with higher scores indicating greater engagement. The time range given for Visit 4 reflects the time range counted as a single value.
Eligibility Criteria
Criteria
Ages Eligible for Study:
5 Years
to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Aged 5 through12 years old
-
Receiving Attention-Deficit/Hyperactivity Disorder (ADHD) treatment from participating practices
-
ADHD or Attention Deficit Disorder (ADD) diagnosis code, International Classification of Diseases (ICD) code ICD-10-CM F90.9 or F90.0, listed in the problem list or recorded at an ambulatory visit in the past year.
-
Parental/guardian permission (informed consent) and if appropriate, child assent.
Exclusion Criteria:
-
Autism spectrum disorder, ICD-10-CM F84.0
-
Conduct disorder, ICD-10-CM F91.1
-
Psychosis, ICD-10-CM F29
-
Bipolar disorder, ICD-10-CM F31.9
-
Suicide attempt, ICD-10-CM T14.91, or suicide ideation, ICD-10-CM R45.85
-
Children and/or their parents/caregivers non-English speaking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Children's Hospital of Philadelphia
- Patient-Centered Outcomes Research Institute
Investigators
- Principal Investigator: James Guevara, MD MPH, Children's Hospital of Philadelphia
Study Documents (Full-Text)
More Information
Publications
- Forrest CB, Glade GB, Baker AE, Bocian AB, Kang M, Starfield B. The pediatric primary-specialty care interface: how pediatricians refer children and adolescents to specialty care. Arch Pediatr Adolesc Med. 1999 Jul;153(7):705-14.
- Guevara JP, Feudtner C, Romer D, Power T, Eiraldi R, Nihtianova S, Rosales A, Ohene-Frempong J, Schwarz DF. Fragmented care for inner-city minority children with attention-deficit/hyperactivity disorder. Pediatrics. 2005 Oct;116(4):e512-7.
- Guevara JP, Rothbard A, Shera D, Zhao H, Forrest CB, Kelleher K, Schwarz D. Correlates of behavioral care management strategies used by primary care pediatric providers. Ambul Pediatr. 2007 Mar-Apr;7(2):160-6.
- Homonoff EE, Maltz PF. Developing and maintaining a coordinated system of community-based services to children. Community Ment Health J. 1991 Oct;27(5):347-58.
- Wolraich ML, Bickman L, Lambert EW, Simmons T, Doffing MA. Intervening to improve communication between parents, teachers, and primary care providers of children with ADHD or at high risk for ADHD. J Atten Disord. 2005 Aug;9(1):354-68.
Responsible Party:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT02716324
Other Study ID Numbers:
- 15-012456
First Posted:
Mar 23, 2016
Last Update Posted:
Nov 25, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Children's Hospital of Philadelphia
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | From 3/2016-7/2017, primary care clinicians at participating pediatric practices nominated eligible patients for recruitment. Eligible patients were contacted by phone and then underwent in-person informed consent. Participants were stratified by practice, age group (5-7 or 8-12 years old), and sex and randomized 1:1 to the two study arms. |
|---|---|
| Pre-assignment Detail | Eligible participants were excluded prior to enrollment if they had history of suicide, bipolar disorder, schizophrenia, autism, or conduct disorder. |
| Arm/Group Title | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Arm/Group Description | In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents. ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool. | In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal. Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment. ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment. |
| Period Title: Overall Study | ||
| STARTED | 149 | 154 |
| COMPLETED | 130 | 143 |
| NOT COMPLETED | 19 | 11 |
Baseline Characteristics
| Arm/Group Title | ADHD Portal | ADHD Portal Plus Care Manager | Total |
|---|---|---|---|
| Arm/Group Description | In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents. ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool. | In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal. Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment. ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment. | Total of all reporting groups |
| Overall Participants | 149 | 154 | 303 |
| Age (Count of Participants) | |||
| <=18 years |
149
100%
|
154
100%
|
303
100%
|
| Between 18 and 65 years |
0
0%
|
0
0%
|
0
0%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
47
31.5%
|
47
30.5%
|
94
31%
|
| Male |
102
68.5%
|
106
68.8%
|
208
68.6%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White |
58
38.9%
|
62
40.3%
|
120
39.6%
|
| Black/African American |
69
46.3%
|
70
45.5%
|
139
45.9%
|
| Hispanic |
7
4.7%
|
8
5.2%
|
15
5%
|
| Other |
15
10.1%
|
13
8.4%
|
28
9.2%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
149
100%
|
154
100%
|
303
100%
|
| Baseline Vanderbilt Parent Rating Scale Scores (Vanderbilt Parent Rating Scale Score) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Vanderbilt Parent Rating Scale Score] |
32.6
(11.8)
|
31.3
(10.8)
|
31.9
(11.3)
|
Outcome Measures
| Title | Change in Vanderbilt Parent Rating Scales (VPRS) |
|---|---|
| Description | The VPRS is a public domain tool that consists of forms completed by the child's parent and includes 18 items corresponding to the DSM-5 ADHD symptom criteria, 8 performance items, and 12 items assessing side effects. The VPRS items are scaled on a 4-point Likert rating ("never" to "very often"), and the scales used in this study were restricted to the 18 ADHD symptom items. Total scores were used to measure ADHD Symptoms. Higher scores indicated worse outcome. VPRS were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value. The VPRS measures ADHD symptoms and is scaled on a 4-point Likert rating ("never" to "very often"). The scale includes 18 ADHD symptom items with total scores ranges from 0-54. |
| Time Frame | Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Row differs from the overall number due to missing data. |
| Arm/Group Title | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Arm/Group Description | In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents. ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool. | In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal. Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment. ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment. |
| Measure Participants | 149 | 154 |
| Visit 1 |
32.6
(11.8)
|
31.3
(10.8)
|
| Visit 2 |
28.7
(12.2)
|
29.0
(11.4)
|
| Visit 3 |
28.1
(12.1)
|
26.3
(11.6)
|
| Visit 4 |
27.2
(12.1)
|
25.7
(11.1)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Random effects models regressed VPRS scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. We examined intervention X time interaction term for statistical significance. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | .871 |
| Comments | ||
| Method | GLS random-effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Beta Coefficient |
| Estimated Value | 0.001 | |
| Confidence Interval |
(2-Sided) 95% -0.010 to 0.012 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Mean Goal Attainment Scale (GAS) Score by Timepoint |
|---|---|
| Description | The GAS is a 5-point likert scale that assesses the degree to which parents' goals (obtained from the ADHD Preferences and Goals Instrument) are attained from none to completely. The GAS response categories are ordered from 0 ("no change") to 6 ("goal completely met"). Higher scores indicate greater goal attainment. The GAS was measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value. |
| Time Frame | Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Arm/Group Description | In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents. ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool. | In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal. Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment. ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment. |
| Measure Participants | 114 | 127 |
| Visit 2 |
2.92
(1.82)
|
2.67
(1.68)
|
| Visit 3 |
2.93
(1.89)
|
3.01
(1.68)
|
| Visit 4 |
3.03
(1.66)
|
2.86
(1.75)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Random effects models regressed GAS scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. We examined intervention X time interaction term for statistical significance. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.499 |
| Comments | ||
| Method | Random effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Beta coefficient |
| Estimated Value | 0.001 | |
| Confidence Interval |
(2-Sided) 95% -0.002 to 0.004 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Treatment Initiation and Use of Services |
|---|---|
| Description | Using responses from the Services Assessment for Children and Adolescents (SACA), a well-validated client-reported tool and provides information on any mental health services use, ambulatory services use, and inpatient service use, we determined (yes/no) whether participants ever received educational services, mental health services, or medications for ADHD. Parents reported whether their children used services ever or within the last nine months. Treatment initiation was measured by use of services ever. Categorizations include any service use, ambulatory service use (any community mental health or outpatient clinic, private professional, or in-home provider), and overnight stay (psychiatric or medical unit, residential treatment center, group home, or foster home). The time range of 9-12 given for Visit 4 reflects the time range counted as a single value. |
| Time Frame | 9-12 months (Visit 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Numbers may not add to column totals due to missing data. Values and percentages for Ambulatory and Overnight services do not add up to the over n listed for the column due to missing data and logic structure of the Service Assessment for Children and Adolescents (SACA). |
| Arm/Group Title | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Arm/Group Description | In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents. ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool. | In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal. Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment. ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment. |
| Measure Participants | 119 | 137 |
| Yes |
79
53%
|
88
57.1%
|
| No |
40
26.8%
|
49
31.8%
|
| Yes |
77
51.7%
|
87
56.5%
|
| No |
42
28.2%
|
49
31.8%
|
| Yes |
5
3.4%
|
6
3.9%
|
| No |
92
61.7%
|
118
76.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Differences in proportions between the two groups in use of any services were assessed using the Chi-square Test. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.718 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Differences in proportions between the two groups in use of ambulatory mental health services were assessed using the Chi-square Test. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.903 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Differences in proportions between the two groups in use of any inpatient mental health services were assessed using the Chi-square Test. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.915 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | Treatment Adherence and Use of Services |
|---|---|
| Description | Using responses from the Services Assessment for Children and Adolescents (SACA), a well-validated client-reported tool and provides information on any mental health services use, ambulatory services use, and inpatient service use, we determined (yes/no) whether participants ever received educational services, mental health services, or medications for ADHD. Parents reported whether their children used services ever or within the last nine months. Treatment adherence was measured by use of services in the past nine months. Categorizations include any service use, ambulatory service use (any community mental health or outpatient clinic, private professional, or in-home provider), and overnight stay (psychiatric or medical unit, residential treatment center, group home, or foster home). The time range of 9-12 given for Visit 4 reflects the time range counted as a single value. |
| Time Frame | 9-12 months (Visit 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Rows may differ from overall umber analyzed due to missing data. Values and percentages for Ambulatory and Overnight services do not add up to the over n listed for the column due to missing data and logic structure of the Service Assessment for Children and Adolescents (SACA). |
| Arm/Group Title | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Arm/Group Description | In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents. ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool. | In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal. Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment. ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment. |
| Measure Participants | 67 | 80 |
| Yes |
48
32.2%
|
51
33.1%
|
| No |
19
12.8%
|
29
18.8%
|
| Yes |
47
31.5%
|
50
32.5%
|
| No |
18
12.1%
|
29
18.8%
|
| Yes |
1
0.7%
|
2
1.3%
|
| No |
3
2%
|
4
2.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Differences in proportions between the two groups in use of any mental health services during the study period were assessed using the Chi-square Test. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.310 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Differences in proportions between the two groups in use of ambulatory mental health services during the study period were assessed using the Chi-square Test. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.251 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Differences in proportions between the two groups in use of inpatient mental health services during the study period were assessed using the Chi-square Test. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 1.00 |
| Comments | ||
| Method | Chi-squared | |
| Comments | ||
| Title | School Performance |
|---|---|
| Description | School Performance is a 5-item domain (minimum score=1, maximum score=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the School Performance domain is 5 and the maximum total score is 25 (total scores are not shown below). Values in the table below are reported as mean scores at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. School performance PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value. |
| Time Frame | Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Row values may differ from overall values due to missing data and due to child measures being completed only by children 8-12 years old. |
| Arm/Group Title | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Arm/Group Description | In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents. ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool. | In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal. Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment. ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment. |
| Measure Participants | 148 | 150 |
| Parent PROS : Visit 1 |
2.82
(1.00)
|
2.77
(0.80)
|
| Parent PROS : Visit 2 |
3.00
(1.01)
|
2.91
(0.80)
|
| Parent PROS : Visit 3 |
3.03
(0.89)
|
3.04
(0.92)
|
| Parent PROS : Visit 4 |
3.08
(0.96)
|
3.03
(0.90)
|
| Child PROS : Visit 1 |
3.53
(0.77)
|
3.42
(0.79)
|
| Child PROS : Visit 2 |
3.22
(0.93)
|
3.30
(0.81)
|
| Child PROS : Visit 3 |
3.29
(0.85)
|
3.27
(0.77)
|
| Child PROS : Visit 4 |
3.23
(0.83)
|
3.41
(0.86)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Random effects models regressed Parent-reported PRO School Performance Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.662 |
| Comments | ||
| Method | Random effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Beta coefficient |
| Estimated Value | 0.000 | |
| Confidence Interval |
(2-Sided) 95% -0.001 to 0.001 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Random effects models regressed Child PRO School Performance Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.075 |
| Comments | ||
| Method | Random effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Beta coefficient |
| Estimated Value | 0.001 | |
| Confidence Interval |
(2-Sided) 95% 0.000 to 0.002 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Student Engagement |
|---|---|
| Description | Student Engagement is a 4-item domain (minimum score=1, maximum score=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the Student Engagement domain is 4 and the maximum total score is 20 (total scores are not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Student Engagement PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value. |
| Time Frame | Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Row values may differ from overall values due to missing data and due to child measures being completed only by children 8-12 years old. |
| Arm/Group Title | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Arm/Group Description | In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents. ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool. | In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal. Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment. ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment. |
| Measure Participants | 148 | 152 |
| Parent PROS : Visit 1 |
2.98
(0.79)
|
2.93
(0.80)
|
| Parent PROS : Visit 2 |
3.18
(0.85)
|
3.08
(0.80)
|
| Parent PROS : Visit 3 |
3.18
(0.78)
|
3.09
(0.70)
|
| Parent PROS : Visit 4 |
3.24
(0.82)
|
3.13
(0.80)
|
| Child PROS : Visit 1 |
3.11
(0.82)
|
3.04
(0.80)
|
| Child PROS : Visit 2 |
3.09
(0.09)
|
3.06
(0.73)
|
| Child PROS : Visit 3 |
3.15
(0.94)
|
3.01
(0.78)
|
| Child PROS : Visit 4 |
3.08
(0.83)
|
2.95
(0.79)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Random effects models regressed Parent-reported PRO Student Engagement Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.707 |
| Comments | ||
| Method | Random effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Beta coefficient |
| Estimated Value | 0.000 | |
| Confidence Interval |
(2-Sided) 95% -0.001 to 0.001 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Random effects models regressed Child PRO Student Engagement Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.735 |
| Comments | ||
| Method | Random effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Beta coefficient |
| Estimated Value | 0.000 | |
| Confidence Interval |
(2-Sided) 95% -0.001 to 0.001 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Teacher Connectedness |
|---|---|
| Description | Teacher Connectedness is a 9-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the Teacher Connectedness domain is 9 and the maximum total score is 45 (total scores not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Teacher Connectedness PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value. |
| Time Frame | Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Row values may differ from overall number analyzed due to missing data. |
| Arm/Group Title | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Arm/Group Description | In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents. ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool. | In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal. Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment. ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment. |
| Measure Participants | 120 | 121 |
| Child PROS : Visit 1 |
3.81
(0.80)
|
3.75
(0.76)
|
| Child PROS : Visit 2 |
3.85
(0.76)
|
3.82
(0.77)
|
| Child PROS : Visit 3 |
3.86
(0.86)
|
3.77
(0.83)
|
| Child PROS : Visit 4 |
3.75
(0.87)
|
3.72
(0.84)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Random effects models regressed Child PRO Teacher Connectedness Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.735 |
| Comments | Random effects models regressed Child Patient Reported Outcomes Teacher Connectedness Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p<0.05. | |
| Method | Random effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Beta coefficient |
| Estimated Value | 0.000 | |
| Confidence Interval |
(2-Sided) 95% -0.001 to 0.001 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Peer Relationships |
|---|---|
| Description | Peer Relationships is a 6-item domain (minimum=1, maximum=5, on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and a 7-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score is 6 and the maximum total score is 30 on the Child PROs. The minimum total score for the Peer Relationships domain is 7 and the maximum total score is 35 on the Parent PROs. Total scores not shown below. Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Higher scores indicate better outcomes. Peer Relationships PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value. |
| Time Frame | Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Row values may differ from overall values due to missing data and due to child measures being completed only by children 8-12 years old. |
| Arm/Group Title | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Arm/Group Description | In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents. ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool. | In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal. Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment. ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment. |
| Measure Participants | 148 | 152 |
| Parent PROS : Visit 1 |
3.56
(0.82)
|
3.54
(0.74)
|
| Parent PROS : Visit 2 |
3.63
(0.75)
|
3.56
(0.75)
|
| Parent PROS : Visit 3 |
3.61
(0.79)
|
3.63
(0.74)
|
| Parent PROS : Visit 4 |
3.72
(0.80)
|
3.66
(0.72)
|
| Child PROS : Visit 1 |
4.03
(0.74)
|
4.07
(0.71)
|
| Child PROS : Visit 2 |
3.79
(0.75)
|
3.93
(0.84)
|
| Child PROS : Visit 3 |
3.84
(0.74)
|
3.99
(0.72)
|
| Child PROS : Visit 4 |
3.91
(0.83)
|
3.94
(0.79)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Random effects models regressed Parent-reported PRO Peer Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.873 |
| Comments | Random effects models regressed Parent Patient Reported Outcomes Peer Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p<0.05. | |
| Method | Random effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Beta coefficient |
| Estimated Value | 0.000 | |
| Confidence Interval |
(2-Sided) 95% -0.001 to 0.001 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Random effects models regressed Child-reported PRO Peer Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.888 |
| Comments | Random effects models regressed Child Patient Reported Outcomes Peer Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p<0.05. | |
| Method | Random effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Beta coefficient |
| Estimated Value | 0.000 | |
| Confidence Interval |
(2-Sided) 95% -0.001 to 0.001 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Family Relationships |
|---|---|
| Description | Family Relationships is a 6-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the 30-item Child- (age 8-12) Patient Reported Outcomes Measures of relationships with other family members over the past 4 weeks. The minimum total score for the Family Relationships domain is 6 and the maximum total score is 30 (total scores not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Child-reported PRO measures were averaged for each domain for each time point. Higher scores indicate better outcomes. Family Relationships PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value. |
| Time Frame | Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Row values may differ from overall number for analysis due to missing data. |
| Arm/Group Title | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Arm/Group Description | In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents. ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool. | In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal. Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment. ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment. |
| Measure Participants | 120 | 121 |
| Child PROS : Visit 1 |
3.81
(0.77)
|
3.82
(0.68)
|
| Child PROS : Visit 2 |
3.83
(0.69)
|
3.80
(0.65)
|
| Child PROS : Visit 3 |
3.96
(0.67)
|
3.72
(0.72)
|
| Child PROS : Visit 4 |
3.81
(0.77)
|
3.79
(076)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Random effects models regressed Child-reported PRO Family Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.679 |
| Comments | Random effects models regressed Child Patient Reported Outcomes Family Relationships Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. The threshold for statistical significance was p<0.05. | |
| Method | Random effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Beta coefficient |
| Estimated Value | 0.000 | |
| Confidence Interval |
(2-Sided) 95% -0.001 to 0.001 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Engagement Measure Scores |
|---|---|
| Description | The Engagement Measure is a 28-item parent self-report measure comprised of four domains: Access (5-items, total score range 5-25), Patient Family Centered Care or PFCC (6-items, total score range 6-30), Communication (3-items, total score range 3-15), and Understanding (5-items, total score range 5-25). Total scores are not reported below. Scores for each individual item and therefore the mean for each domain (means reported in the table below) ranged from 1-5 with higher scores indicating greater engagement. The time range given for Visit 4 reflects the time range counted as a single value. |
| Time Frame | Visit 4 (9-12 months) |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | ADHD Portal | ADHD Portal Plus Care Manager |
|---|---|---|
| Arm/Group Description | In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents. ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool. | In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal. Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment. ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment. |
| Measure Participants | 123 | 139 |
| Access |
3.43
(0.7)
|
3.52
(0.6)
|
| PFCC |
3.45
(0.7)
|
3.44
(0.7)
|
| Communication |
2.50
(1.1)
|
2.64
(1.0)
|
| Understanding |
2.89
(0.8)
|
3.02
(0.8)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Random effects models regressed Access Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.495 |
| Comments | ||
| Method | Random effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Beta coefficient |
| Estimated Value | 0.074 | |
| Confidence Interval |
(2-Sided) 95% -0.164 to 0.311 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Random effects models regressed Patient Family Centered Care Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.885 |
| Comments | ||
| Method | Random effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Beta coefficient |
| Estimated Value | -0.013 | |
| Confidence Interval |
(2-Sided) 95% -0.217 to 0.191 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Random effects models regressed Communication Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.527 |
| Comments | ||
| Method | Random effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Beta coefficient |
| Estimated Value | 0.073 | |
| Confidence Interval |
(2-Sided) 95% -0.182 to 0.328 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | ADHD Portal, ADHD Portal Plus Care Manager |
|---|---|---|
| Comments | Random effects models regressed Understanding Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.285 |
| Comments | ||
| Method | Random effects model | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Beta coefficient |
| Estimated Value | 0.136 | |
| Confidence Interval |
(2-Sided) 95% -0.138 to 0.410 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | 9-12 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Since the study procedures were not greater than minimal risk, SAEs were not expected. | |||
| Arm/Group Title | ADHD Portal | ADHD Portal Plus Care Manager | ||
| Arm/Group Description | In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents. ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool. | In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal. Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment. ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment. | ||
All Cause Mortality |
||||
| ADHD Portal | ADHD Portal Plus Care Manager | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/149 (0%) | 0/154 (0%) | ||
Serious Adverse Events |
||||
| ADHD Portal | ADHD Portal Plus Care Manager | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/149 (0%) | 0/154 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| ADHD Portal | ADHD Portal Plus Care Manager | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/149 (0%) | 0/154 (0%) | ||
Limitations/Caveats
Study was conducted within a single integrated health care system in the Philadelphia metropolitan area and results may not be generalizable to other health systems or geographic areas.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | James Guevara, MD MPH |
|---|---|
| Organization | The Children's Hospital of Philadelphia |
| Phone | 2155901130 |
| guevara@email.chop.edu |
Responsible Party:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT02716324
Other Study ID Numbers:
- 15-012456
First Posted:
Mar 23, 2016
Last Update Posted:
Nov 25, 2019
Last Verified:
Nov 1, 2019