Reducing Diagnostic Errors in Primary Care Pediatrics (Project RedDE)

• Sponsor: Montefiore Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02798354
• Collaborator: American Academy of Pediatrics (Other)
• Enrollment: 13,853
• Location: 1
• Arms: 3
• Actual Duration (Months): 29
• Patients Per Site Per Month: 477.5

Study Details

Study Description

Brief Summary

The proposal will focus on 3 specific, high-risk, pediatric ambulatory diagnostic errors each representing a unique dimension of diagnostic assessment: evaluation of symptoms, evaluation of signs and follow-up of diagnostic tests. Adolescent depression (i.e. symptoms) affects nearly 10% of teenagers, is misdiagnosed in almost 75% of adolescents and causes significant morbidity. Pediatric elevated blood pressure (signs) is misdiagnosed in 74-87% of patients, often due to inaccurate application of blood pressure parameters that change based on age, gender and height. Actionable pediatric laboratory values (diagnostic tests) are potentially delayed up to 26% of the time in preliminary investigations and 7-65% in adults, leading to harm and malpractice claims.

The investigators propose to conduct a multisite, prospective, stepped wedge cluster randomized trial testing a quality improvement collaborative (QIC) intervention within the American Academy of Pediatrics' Quality Improvement Innovation Networks (QuIIN) to reduce the incidence of pediatric primary care diagnostic errors. QuIIN is a national network of over 300 primary care practices, ranging from tertiary care academic medical centers to single practitioner private practices, interested in and experienced with QICs. Because many processes are likely to be common across diagnostic errors in outpatient settings, a multifaceted intervention, such as a QIC, has a high likelihood of success and broad applicability across populations. Preparatory inquiries to QuIIN primary care providers suggest high interest in reducing these 3 diagnostic errors and provider agreement with randomization to evaluate diagnostic error interventions. Practices will be randomized to one of three groups, with each group collecting retrospective baseline data on one error above, and then intervening to reduce that error during the first eight months. Each group will concurrently collect control data on an error they are not intervening on during those eight months. Following those eight months, the groups will continue intervening on their first error, begin intervening on the error they were a control site for, and begin collecting data on the third error for which they will be a control site for. Finally, in the final eight months, all groups will intervene on all three errors. A second wave of practices will be recruited to join the groups after eight months and will only intervene on two of the three errors.

Condition or Disease	Intervention/Treatment	Phase
Diagnostic Errors	Behavioral: Quality Improvement Collaborative	N/A

Detailed Description

Objectives:

Primary

• To determine whether a QIC consisting of evidence-based best-practice methodologies, mini-root cause analyses, data sharing, and behavior change techniques, is associated with a reduction in 3 specific diagnostic error rates in a national group of pediatric primary care practices.

• Hypothesis 1: Implementation of a QIC will lead to a 40% reduction in missed diagnosis of adolescent depression.

• Hypothesis 2: Implementation of a QIC will lead to a 30% reduction in missed diagnosis of pediatric elevated blood pressure.

• Hypothesis 3: Implementation of a QIC will lead to a 45% reduction in delayed diagnosis of actionable laboratory results.

Secondary

• To determine if a QIC's effect changes for wave 1 versus wave 2 participants, or for the second versus the first error a practice intervenes on.

• To further investigate the epidemiology of three ambulatory pediatric diagnostic errors: missed diagnosis of adolescent depression, missed diagnosis of pediatric elevated blood pressure, and delayed diagnosis of actionable laboratory results.

• To evaluate patient outcomes related to these diagnoses including outcomes after positive depression screening, missed elevated blood pressure screening and delayed diagnosis of actionable laboratory values.

Study Design

• Study Type: Interventional
• Actual Enrollment: 13853 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Reducing Diagnostic Errors in Primary Care Pediatrics
• Actual Study Start Date: Jun 1, 2015
• Actual Primary Completion Date: Oct 31, 2017
• Actual Study Completion Date: Oct 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reduce Elevated Blood Pressure Errors First Will provide baseline data on elevated blood pressure diagnosis and first intervene to reduce missed opportunities for elevated blood pressure diagnosis. Will then intervene to reduce missed opportunities for depression diagnosis and finally, intervene to reduce delayed diagnosis attributable to abnormal laboratory values. Quality Improvement Collaborative Intervention will consist of behavioral components, i.e., training, interactions with experts, root cause analyses of errors, idea sharing, best practices dissemination, etc.	Behavioral: Quality Improvement Collaborative; 1)Every 8 month 1-2 day interactive webinar learning sessions 2)Monthly webinars sharing best practices 3)Monthly team interactions with dedicated QI coach 4)Monthly data submission on both process and outcome measures 5)Monthly data feedback both at aggregate level with full inter-team transparency as well as at institutional level 6)Monthly mini root cause analyses performed on 1 error at each site 7)Multidisciplinary teams consisting of at least a physician, nurse, and office practice associate 8)Instruction on best practices from content area experts in QI, diagnostic errors, hypertension, mental health, leadership, behavior change, Model for Understanding Success in Quality (MUSIQ) and EHRs 9)Ongoing sharing of best ideas and barriers/issues among institutional teams
Experimental: Reduce Depression Errors First Will provide baseline data on depression diagnosis and first intervene to reduce missed opportunities for depression diagnosis. Will then intervene to reduce delayed diagnosis attributable to abnormal laboratory values and finally, intervene to reduce missed opportunities for elevated blood pressure diagnosis. Quality Improvement Collaborative Intervention will consist of behavioral components, i.e., training, interactions with experts, root cause analyses of errors, idea sharing, best practices dissemination, etc.	Behavioral: Quality Improvement Collaborative; 1)Every 8 month 1-2 day interactive webinar learning sessions 2)Monthly webinars sharing best practices 3)Monthly team interactions with dedicated QI coach 4)Monthly data submission on both process and outcome measures 5)Monthly data feedback both at aggregate level with full inter-team transparency as well as at institutional level 6)Monthly mini root cause analyses performed on 1 error at each site 7)Multidisciplinary teams consisting of at least a physician, nurse, and office practice associate 8)Instruction on best practices from content area experts in QI, diagnostic errors, hypertension, mental health, leadership, behavior change, Model for Understanding Success in Quality (MUSIQ) and EHRs 9)Ongoing sharing of best ideas and barriers/issues among institutional teams
Experimental: Reduce Lab Related Errors First Will provide baseline data on delayed diagnosis attributable to abnormal laboratory values and first intervene to reduce delayed diagnosis attributable to abnormal laboratory values. Will then intervene to reduce missed opportunities for elevated blood pressure diagnosis results and finally, to reduce missed opportunities for depression diagnosis. Quality Improvement Collaborative Intervention will consist of behavioral components, i.e., training, interactions with experts, root cause analyses of errors, idea sharing, best practices dissemination, etc.	Behavioral: Quality Improvement Collaborative; 1)Every 8 month 1-2 day interactive webinar learning sessions 2)Monthly webinars sharing best practices 3)Monthly team interactions with dedicated QI coach 4)Monthly data submission on both process and outcome measures 5)Monthly data feedback both at aggregate level with full inter-team transparency as well as at institutional level 6)Monthly mini root cause analyses performed on 1 error at each site 7)Multidisciplinary teams consisting of at least a physician, nurse, and office practice associate 8)Instruction on best practices from content area experts in QI, diagnostic errors, hypertension, mental health, leadership, behavior change, Model for Understanding Success in Quality (MUSIQ) and EHRs 9)Ongoing sharing of best ideas and barriers/issues among institutional teams

Outcome Measures

Primary Outcome Measures

1. Number of Adolescents Diagnosed With Depression Seen in Well Child Visits [Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)]

   Patients >=11 years old with documentation of major depression or subsyndromal depression diagnoses in the medical record

2. Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers [Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)]

   Systolic or Diastolic Blood Pressure >= 90th percentile for age, gender and height or >=120/80 in >=3 years old patients at well child visits and at least one of: 1) provider repeated blood pressure, 2) clinic note mentions elevated blood pressure/hypertension 3) plan included recheck or evaluation of blood pressure, or 4) ordering laboratory or other studies to evaluate elevated blood pressure

3. Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay [Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)]

   Documented action step for first positive within 30 days: Hemoglobin (Hgb) less than 11 and mean corpuscular volume (MCV) less than 75 in 1 or 2 year old without documentation of beginning iron, sending iron studies or family conversation Lead greater than 5 without documentation of family conversation on lead remediation or plan to retest Documented action step for first positive within 7 days: Positive Gonorrhea, Chlamydia, Syphilis or Human immunodeficiency virus (HIV) test without documentation of antibiotics begun or referral to HIV specialist Positive group A streptococcal throat culture with negative rapid group A streptococcal test without documentation of antibiotics begun or family conversation Thyroid stimulating hormone (TSH) less than 0.5 or greater than 4.5 in greater than 1 year old without plan to repeat lab values or referral to endocrinologist

Secondary Outcome Measures

1. Number of Adolescents With Mental Health Addressed During Their Well Child Visit [Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)]

   Provider screened for mental health concerns either with standard screening tool or clinical judgement and documented mental health concerns or no mental health concerns.

2. Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart [Collected Monthly (5-0 baseline months and 8-9 intervention months depending on the enrolled cohort)]

   Systolic or Diastolic Blood Pressure >= 90th percentile for age, gender and height or >=120/80 in >=3 years old patients at well child visits with blood pressure percentiles documented per the 4th Report.

3. Number of Patients With Elevated Blood Pressures Measured and Recognized by Provider [Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)]

   Systolic or Diastolic Blood Pressure >= 90th percentile for age, gender and height or >=120/80 in >=3 years old patients at well child visits with provider documentation of abnormal blood pressure or appropriate action taken

4. Number of Patients With Abnormal Laboratory Results Received and Recognized by Provider [Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)]

   Provider documentation of abnormal laboratory value, of appropriate diagnosis (e.g. iron deficiency anemia) or appropriate action taken without delay as defined above.

Other Outcome Measures

1. Percent of Clinics Reaching Pre-Determined Threshold for Providers With Laboratory Results Unread/Unacknowledged in Their Electronic Health Record (EHR) Inbox for More Than 72 Hrs [Collected at 4 months]

   Clinics reported percent of EHR inboxes with laboratory results unread/unacknowledged in their electronic health record (EHR) inbox for more than 72 hrs each month. They reported whether this percentage was equal to or less than 10%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months.

2. Percent of Clinics Reaching Pre-determined Threshold for Children Greater Than or Equal to 3 Yrs Old Receiving Blood Pressure Measurements at Triage for Well Child Visits [Collected until 2 months]

   Clinics reported percent of well child visit charts with blood pressure measurements at triage done each month. They reported whether this percentage was equal to or greater than 90%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months.

3. Percent of Clinics Reaching Predetermined Threshold for Adolescents Screened for Depression With Patient Health Questionnaire-9 Modified (PHQ-9M) During Well Child Visits [Collected monthly for 8 months when practice is intervening on this topic]

   Clinics reported percent of adolescent well child visit charts with depression screening done each month. They reported whether this percentage was equal to or greater than 90%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 26 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• The investigators will include 30 primary care pediatric practices that are part of the American Academy of Pediatrics' QuIIN (Quality Improvement Innovation Networks) organization. The second wave will recruit 15 additional practices.

• Practices must have sufficient volumes of adolescent well child visits (17 per month) and all well child visits (30 per month), and be able to query their EHR systems in order to be included in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	American Academy of Pediatrics	Elk Grove Village	Illinois	United States	60007

Sponsors and Collaborators

• Montefiore Medical Center
• American Academy of Pediatrics

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 21, 2016

More Information

Publications

None provided.

• Responsible Party: Michael Rinke, Associate Professor, Montefiore Medical Center
• ClinicalTrials.gov Identifier: NCT02798354
• Other Study ID Numbers: 2014-3980
• First Posted: Jun 14, 2016
• Last Update Posted: Dec 16, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Michael Rinke, Associate Professor, Montefiore Medical Center: Depression; Blood Pressure; Anemias, Iron-Deficiency; Streptococcal Infections; Sexually Transmitted Diseases; Lead Poisoning, Nervous System, Childhood; Thyrotropin

Study Results

Participant Flow

Pre-assignment Detail	Of note, initial control data were collected prior to the first Intervention Period

Arm/Group Title	Group 1: Blood Pressure, Depresion, Labs	Group 2: Depression, Labs, Blood Pressure	Group 3: Labs, Blood Pressure, Depression
Arm/Group Description	A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors.	A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors.	A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors.
Period Title: First Intervention Period
STARTED	1184	2176	990
Control Data Error 1	440	549	345
Intervention Data Error 1	744	1627	645
COMPLETED	1184	2176	990
NOT COMPLETED	0	0	0
Period Title: First Intervention Period
STARTED	2617	1047	1368
Control Data Error 2	1378	593	668
Intervention Data Error 2	1239	454	700
COMPLETED	2617	1047	1368
NOT COMPLETED	0	0	0
Period Title: First Intervention Period
STARTED	746	1010	2715
Control Data Error 3	419	620	1467
Intervention Data Error 3	327	390	1248
COMPLETED	746	1010	2715
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Reduce Elevated Blood Pressure Errors	Reduce Depression Errors	Reduce Lab Related Errors	Total
Arm/Group Description	A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. Data presented aggregates all control and intervention phase data respectively, from all three cohorts.	A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. Data presented aggregates all control and intervention phase data respectively, from all three cohorts.	A national cohort of pediatric practices enrolled in a Quality Improvement Collaborative intervention focused on reducing three errors of interest: blood pressure, labs and depression diagnoses. Each practice was cluster-randomized to collect control data on and then start working to reduce one of the three errors. During this first nine-month action phase, they also collected control data on a second error. Subsequently, practices worked to reduce this second error during an eight month action phase, while collecting control data on a third error. Finally, they worked to reduce this third error. During the second and third phases, they continued to collect data on the first and second errors. Data presented aggregates all control and intervention phase data respectively, from all three cohorts.	Total of all reporting groups
Overall Participants	3562	7508	2783	13853
Age (Count of Participants)
<=18 years	1805 50.7%	3967 52.8%	1332 47.9%	7104 51.3%
Between 18 and 65 years	29 0.8%	147 2%	94 3.4%	270 1.9%
>=65 years	0 0%	0 0%	0 0%	0 0%
<=18 years	1695 47.6%	3277 43.6%	1282 46.1%	6254 45.1%
Between 18 and 65 years	33 0.9%	117 1.6%	75 2.7%	225 1.6%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	880 24.7%	2094 27.9%	742 26.7%	3716 26.8%
Male	954 26.8%	2020 26.9%	684 24.6%	3658 26.4%
Female	836 23.5%	1677 22.3%	693 24.9%	3206 23.1%
Male	892 25%	1717 22.9%	664 23.9%	3273 23.6%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Insurance Status (Count of Participants)
Private Insurance	466 13.1%	1086 14.5%	322 11.6%	1874 13.5%
Non-private Insurance	1368 38.4%	3028 40.3%	1104 39.7%	5500 39.7%
Private Insurance	477 13.4%	1011 13.5%	322 11.6%	1810 13.1%
Non-private Insurance	1251 35.1%	2383 31.7%	1035 37.2%	4669 33.7%

Outcome Measures

1. Primary Outcome

Title	Number of Adolescents Diagnosed With Depression Seen in Well Child Visits
Description	Patients >=11 years old with documentation of major depression or subsyndromal depression diagnoses in the medical record
Time Frame	Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	Patients included at all practices during practices' depression control phase	Patients included at all practices during pratices' depression intervention phase
Measure Participants	3394	4114
Count of Participants [Participants]	233 6.5%	443 5.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	3.9
	Confidence Interval	(2-Sided) 95%; 2.4 to 5.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave

2. Primary Outcome

Title	Number of Patients With Elevated Blood Pressure Measured and Appropriately Acted on by Providers
Description	Systolic or Diastolic Blood Pressure >= 90th percentile for age, gender and height or >=120/80 in >=3 years old patients at well child visits and at least one of: 1) provider repeated blood pressure, 2) clinic note mentions elevated blood pressure/hypertension 3) plan included recheck or evaluation of blood pressure, or 4) ordering laboratory or other studies to evaluate elevated blood pressure
Time Frame	Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	Patients included at all practices during practices' BP control phase	Patients included at all practices during practices' BP intervention phase
Measure Participants	1728	1834
Count of Participants [Participants]	969 27.2%	1378 18.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	16
	Confidence Interval	(2-Sided) 95%; 12.3 to 20
	Parameter Dispersion	Type: Value:
	Estimation Comments	Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave

3. Primary Outcome

Title	Number of Patients With Abnormal Laboratory Results With Appropriate Actions Without Delay
Description	Documented action step for first positive within 30 days: Hemoglobin (Hgb) less than 11 and mean corpuscular volume (MCV) less than 75 in 1 or 2 year old without documentation of beginning iron, sending iron studies or family conversation Lead greater than 5 without documentation of family conversation on lead remediation or plan to retest Documented action step for first positive within 7 days: Positive Gonorrhea, Chlamydia, Syphilis or Human immunodeficiency virus (HIV) test without documentation of antibiotics begun or referral to HIV specialist Positive group A streptococcal throat culture with negative rapid group A streptococcal test without documentation of antibiotics begun or family conversation Thyroid stimulating hormone (TSH) less than 0.5 or greater than 4.5 in greater than 1 year old without plan to repeat lab values or referral to endocrinologist
Time Frame	Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	Patients included at all practices during practices' Labs control phase	Patients included at all practices during practices' Labs intervention phase
Measure Participants	1357	1426
Count of Participants [Participants]	1273 35.7%	1329 17.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.302
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; -1.0 to 3.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, lab test sent, and wave

4. Secondary Outcome

Title	Number of Adolescents With Mental Health Addressed During Their Well Child Visit
Description	Provider screened for mental health concerns either with standard screening tool or clinical judgement and documented mental health concerns or no mental health concerns.
Time Frame	Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	Patients included at all practices during practices' depression control phase	Patients included at all practices during pratices' depression intervention phase
Measure Participants	3394	4114
Count of Participants [Participants]	1782 50%	3075 41%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	26.6
	Confidence Interval	(2-Sided) 95%; 22.4 to 30.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave

5. Secondary Outcome

Title	Number of Patients With Elevated Blood Pressures Measured and Blood Pressure Percentiles Documented in the Chart
Description	Systolic or Diastolic Blood Pressure >= 90th percentile for age, gender and height or >=120/80 in >=3 years old patients at well child visits with blood pressure percentiles documented per the 4th Report.
Time Frame	Collected Monthly (5-0 baseline months and 8-9 intervention months depending on the enrolled cohort)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	Patients included at all practices during practices' BP control phase	Patients included at all practices during practices' BP intervention phase
Measure Participants	1728	1834
Count of Participants [Participants]	1233 34.6%	1681 22.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	20.1
	Confidence Interval	(2-Sided) 95%; 16.2 to 24.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave

6. Secondary Outcome

Title	Number of Patients With Elevated Blood Pressures Measured and Recognized by Provider
Description	Systolic or Diastolic Blood Pressure >= 90th percentile for age, gender and height or >=120/80 in >=3 years old patients at well child visits with provider documentation of abnormal blood pressure or appropriate action taken
Time Frame	Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	Patients included at all practices during practices' BP control phase	Patients included at all practices during practices' BP intervention phase
Measure Participants	1728	1834
Count of Participants [Participants]	1013 28.4%	1394 18.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	14
	Confidence Interval	(2-Sided) 95%; 10.3 to 17.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, and wave

7. Secondary Outcome

Title	Number of Patients With Abnormal Laboratory Results Received and Recognized by Provider
Description	Provider documentation of abnormal laboratory value, of appropriate diagnosis (e.g. iron deficiency anemia) or appropriate action taken without delay as defined above.
Time Frame	Collected Monthly (5-9 baseline months and 8-9 intervention months depending on the enrolled cohort)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control Group	Intervention Group
Arm/Group Description	Patients included at all practices during practices' Labs control phase	Patients included at all practices during practices' Labs intervention phase
Measure Participants	1357	1426
Count of Participants [Participants]	1292 36.3%	1339 17.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group, Intervention Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.922
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	0.1
	Confidence Interval	(2-Sided) 95%; -1.8 to 1.9
	Parameter Dispersion	Type: Value:
	Estimation Comments	Fitted by generalized mixed-effects model with potential clustering effects of practices and months taken into account; adjusted for age, sex, insurance, lab test sent, and wave

8. Other Pre-specified Outcome

Title	Percent of Clinics Reaching Pre-Determined Threshold for Providers With Laboratory Results Unread/Unacknowledged in Their Electronic Health Record (EHR) Inbox for More Than 72 Hrs
Description	Clinics reported percent of EHR inboxes with laboratory results unread/unacknowledged in their electronic health record (EHR) inbox for more than 72 hrs each month. They reported whether this percentage was equal to or less than 10%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months.
Time Frame	Collected at 4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group
Arm/Group Description	Patients included at all practices during practices' Labs intervention phase
Measure Participants	1426
Measure Clinics	30
Count of Units [Clinics]	27

9. Other Pre-specified Outcome

Title	Percent of Clinics Reaching Pre-determined Threshold for Children Greater Than or Equal to 3 Yrs Old Receiving Blood Pressure Measurements at Triage for Well Child Visits
Description	Clinics reported percent of well child visit charts with blood pressure measurements at triage done each month. They reported whether this percentage was equal to or greater than 90%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months.
Time Frame	Collected until 2 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group
Arm/Group Description	Patients included at all practices during practices' BP intervention phase
Measure Participants	1834
Measure Clinics	30
Count of Units [Clinics]	27

10. Other Pre-specified Outcome

Title	Percent of Clinics Reaching Predetermined Threshold for Adolescents Screened for Depression With Patient Health Questionnaire-9 Modified (PHQ-9M) During Well Child Visits
Description	Clinics reported percent of adolescent well child visit charts with depression screening done each month. They reported whether this percentage was equal to or greater than 90%, the pre-determined threshold. They only collected this process measure until they were compliant with the threshold for 2 consecutive months.
Time Frame	Collected monthly for 8 months when practice is intervening on this topic

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention Group
Arm/Group Description	Patients included at all practices during pratices' depression intervention phase
Measure Participants	4114
Measure Clinics	31
Percent of Clinics meeting threshold at 5 months	15
Percent of Clinics meeting threshold at 8 months	21

Adverse Events

Adverse Event Reporting Description	As this quality improvement research study was considered low risk, no adverse event data was collected.
Arm/Group Title	Reduce Elevated Blood Pressure Errors		Reduce Depression Errors		Reduce Lab Related Errors
Arm/Group Description	Will provide baseline data on elevated blood pressure diagnosis and first intervene to reduce missed opportunities for elevated blood pressure diagnosis. Will then intervene to reduce missed opportunities for depression diagnosis and finally, intervene to reduce delayed diagnosis attributable to abnormal laboratory values. Each group provides control data and intervention data on all 3 errors in different sequences. Three Wave 2 practices were recruited to increase power and they intervened on only 2 errors. Quality Improvement Collaborative: 1)Every 8 month 1-2 day interactive webinar learning sessions 2)Monthly webinars sharing best practices 3)Monthly team interactions with dedicated QI coach 4)Monthly data submission on both process and outcome measures 5)Monthly data feedback both at aggregate level with full inter-team transparency as well as at institutional level 6)Monthly mini root cause analyses performed on 1 error at each site 7)Multidisciplinar		Will provide baseline data on depression diagnosis and first intervene to reduce missed opportunities for depression diagnosis. Will then intervene to reduce delayed diagnosis attributable to abnormal laboratory values and finally, intervene to reduce missed opportunities for elevated blood pressure diagnosis. Each group provides control data and intervention data on all 3 errors in different sequences. Two Wave 2 practices were recruited to increase power and they intervened on only 2 errors. Quality Improvement Collaborative: 1)Every 8 month 1-2 day interactive webinar learning sessions 2)Monthly webinars sharing best practices 3)Monthly team interactions with dedicated QI coach 4)Monthly data submission on both process and outcome measures 5)Monthly data feedback both at aggregate level with full inter-team transparency as well as at institutional level 6)Monthly mini root cause analyses performed on 1 error at each site 7)Multidisciplinary teams cons		Will provide baseline data on delayed diagnosis attributable to abnormal laboratory values and first intervene to reduce delayed diagnosis attributable to abnormal laboratory values. Will then intervene to reduce missed opportunities for elevated blood pressure diagnosis results and finally, to reduce missed opportunities for depression diagnosis. Each group provides control data and intervention data on all 3 errors in different sequences. Four Wave 2 practices were recruited to increase power and they intervened on only 2 errors. Quality Improvement Collaborative: 1)Every 8 month 1-2 day interactive webinar learning sessions 2)Monthly webinars sharing best practices 3)Monthly team interactions with dedicated QI coach 4)Monthly data submission on both process and outcome measures 5)Monthly data feedback both at aggregate level with full inter-team transparency as well as at institutional level 6)Monthly mini root cause analyses performed on 1 error at ea
All Cause Mortality
	Reduce Elevated Blood Pressure Errors		Reduce Depression Errors		Reduce Lab Related Errors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Reduce Elevated Blood Pressure Errors		Reduce Depression Errors		Reduce Lab Related Errors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Reduce Elevated Blood Pressure Errors		Reduce Depression Errors		Reduce Lab Related Errors
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

Practices enrolled in a QIC are likely not representative of all practices. Appropriate actions broadly defined. No direct chart review verifications. No data on 11 practices who left the study. Quasi-random chart review strategy.

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.