Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions
Study Details
Study Description
Brief Summary
This study will assess Specialized Community Disease Management (SCDM), an intervention which employs various evidence-based strategies to engage substance using co-morbid patients while in the hospital and follow them into the community via an empirically validated telephone approach as well as contact with a trained community health worker peer specialist. The investigators will first adapt and refine the core SCDM intervention with patient, provider, and stakeholder input through an active community advisory board. The investigators will then conduct a three-year, randomized controlled trial of 222 patients enrolled prior to hospital discharge who are diagnosed with congestive heart failure, pneumonia, acute myocardial infarction, chronic obstructive pulmonary disease, diabetes mellitus, or end-stage renal disease, and a substance use disorder (SUD). Patients will be randomized to either the SCDM intervention or Treatment as Usual (TAU), in which a team of nurse navigators and community health workers follow patients (primarily by telephone) for 90 days post-discharge, but do not address the specific needs of SUDs. The investigators will test the following four hypotheses: (1) patients randomized to SCDM will demonstrate larger reductions in substance use measured by urine-confirmed self-reported days using over the 6-month follow-up compared to patients randomized to TAU, (2) patients randomized to SCDM will attend more specialty substance abuse intervention and treatment sessions over the 6 month follow-up than patients randomized to TAU, (3) patients randomized to SCDM will demonstrate reduced HIV transmission risk behaviors and greater rates of HIV testing over the 6 month follow-up than patients randomized to TAU, and (4) patients randomized to SCDM will experience fewer days of rehospitalization and use of acute emergency services than patients randomized to TAU.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Hospitalized patients with substance use disorders (SUDs) face significant complications in their medical care. They are more likely to be discharged against medical advice, rehospitalized after discharge, and experience personal chaos and reduced family support. Hospital systems are moving to implement hospital-based and community disease management strategies to help patients transition post-discharge, however, few provide specialized follow-up for patients with SUDs. This proposal will test whether an extended, specialized community disease management program can improve outcomes over an existing nurse navigator disease management strategy for patients with co-morbid medical conditions and SUDs. The investigators will enroll 222 inpatients with co-occurring medical conditions and SUDs and will randomly assign them to either 1) Treatment as Usual - a 90-day, post-discharge program that consists of medical monitoring by workers who have no special training in working with SUD patients, or 2) the Specialized Community Disease Management program - a 90-day program that will employ specialized teams including a trained clinical social worker and a peer-specialist community health worker who will provide evidence-based telephone continuing care, home visits, and increased focus on patients' substance use. All participants will be followed at 3- and 6-months post-discharge. The investigators hypothesize that (1) patients randomized to SCDM will demonstrate larger reductions in substance use measured by urine-confirmed self-reported days using over the 6-month follow-up compared to patients randomized to TAU, (2) patients randomized to SCDM will attend more specialty substance abuse intervention and treatment sessions over the 6 month follow-up than patients randomized to TAU, (3) patients randomized to SCDM will demonstrate reduced HIV transmission risk behaviors and greater rates of HIV testing over the 6 month follow-up than patients randomized to TAU, and (4) patients randomized to SCDM will experience fewer days of rehospitalization and use of acute emergency services than patients randomized to TAU.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Specialized Community Disease Management Specialized Community Disease Management |
Behavioral: Specialized Community Disease Management
Specialized Community Disease Management is 90-day program that employs specialized teams including a trained clinical social worker and a peer-specialist community health worker who provide evidence-based telephone continuing care, home visits, and focus on patients' substance use following hospital discharge.
|
| Active Comparator: Treatment As Usual Treatment as Usual: standard post-hospital discharge with medical monitoring. |
Behavioral: Treatment As Usual
Treatment as Usual is a 90-day, post-discharge program that consists of medical monitoring by nurses and community health workers who have no special training in working with substance use disorder patients, and does not address substance use.
|
Outcome Measures
Primary Outcome Measures
- Change in Substance Use Rates From Baseline [0, 3, 6 months]
Urinalysis confirmed self-reported days of use for any substance, including alcohol, cocaine, marijuana, opiates, sedatives, and hallucinogens over time. Participants reported substance use for the 90 days prior to the assessment date.
Secondary Outcome Measures
- Change in Treatment Session Attendance From Baseline [0, 3, 6, months]
Treatment sessions attended for alcohol or drug use issues over time. Participants self-reported attendance for the 6 months prior to the baseline assessment. During follow-up assessments, participants self-reported attendance since the last assessment date.
- Number of Hospitalizations and Use of Emergency Services [0, 3, 6, months]
Days of hospitalization and days of use of acute emergency services after Baseline. Participants self-reported their service utilization for the 6 months prior to the baseline assessment. During follow-up assessments, participants self-reported their service utilization since the last assessment date.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
patient is 18 years or older
-
alcohol and/or drug screening score that indicates at least mild problem severity
Exclusion Criteria:
-
medical or psychiatric complications
-
patient was admitted to hospital directly from a drug and alcohol inpatient rehabilitation facility
-
patient reports plans to leave the area within the next 12 months
-
patient is unable to provide valid informed consent
-
patient is attending dialysis
-
patient is not English-speaking
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
Sponsors and Collaborators
- Treatment Research Institute
- Patient-Centered Outcomes Research Institute
Investigators
- Principal Investigator: Adam C Brooks, PhD, Treatment Research Institute
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- PCORI-1306-03482
Study Results
Participant Flow
| Recruitment Details | Participants were recruited at Temple University Hospital between November 2015 and June 2016. |
|---|---|
| Pre-assignment Detail | Participants were screened for eligibility using the AUDIT, DAST, and Mini-International Neuropsychiatric Interview (MINI) for substance use disorders. |
| Arm/Group Title | Specialized Community Disease Management | Treatment As Usual |
|---|---|---|
| Arm/Group Description | Specialized Community Disease Management: Specialized Community Disease Management is 90-day program that employs specialized teams including a trained clinical social worker and a peer-specialist community health worker who provide evidence-based telephone continuing care, home visits, and focus on patients' substance use following hospital discharge. | Treatment As Usual: Treatment as Usual is a 90-day, post-discharge program that consists of medical monitoring by nurses and community health workers who have no special training in working with substance use disorder patients, and does not address substance use. |
| Period Title: Overall Study | ||
| STARTED | 49 | 48 |
| 3 Month Assessment | 37 | 33 |
| 6 Month Assessment | 29 | 24 |
| COMPLETED | 29 | 24 |
| NOT COMPLETED | 20 | 24 |
Baseline Characteristics
| Arm/Group Title | Specialized Community Disease Management | Treatment As Usual | Total |
|---|---|---|---|
| Arm/Group Description | Specialized Community Disease Management: Specialized Community Disease Management is 90-day program that employs specialized teams including a trained clinical social worker and a peer-specialist community health worker who provide evidence-based telephone continuing care, home visits, and focus on patients' substance use following hospital discharge. | Treatment As Usual: Treatment as Usual is a 90-day, post-discharge program that consists of medical monitoring by nurses and community health workers who have no special training in working with substance use disorder patients, and does not address substance use. | Total of all reporting groups |
| Overall Participants | 49 | 48 | 97 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
51.84
(7.71)
|
48.65
(12.81)
|
50.26
(10.61)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
21
42.9%
|
19
39.6%
|
40
41.2%
|
| Male |
28
57.1%
|
29
60.4%
|
57
58.8%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
8
16.3%
|
10
20.8%
|
18
18.6%
|
| Not Hispanic or Latino |
41
83.7%
|
38
79.2%
|
79
81.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
35
71.4%
|
32
66.7%
|
67
69.1%
|
| White |
6
12.2%
|
8
16.7%
|
14
14.4%
|
| More than one race |
2
4.1%
|
0
0%
|
2
2.1%
|
| Unknown or Not Reported |
6
12.2%
|
8
16.7%
|
14
14.4%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
49
100%
|
48
100%
|
97
100%
|
| Primary Substance of Use (Count of Participants) | |||
| Alcohol |
16
32.7%
|
18
37.5%
|
34
35.1%
|
| Marijuana |
1
2%
|
6
12.5%
|
7
7.2%
|
| Cocaine |
19
38.8%
|
14
29.2%
|
33
34%
|
| Opioids |
5
10.2%
|
2
4.2%
|
7
7.2%
|
| Other |
8
16.3%
|
6
12.5%
|
14
14.4%
|
| Index Medical Condition (Count of Participants) | |||
| Acute Myocardial Infarction |
1
2%
|
4
8.3%
|
5
5.2%
|
| Congestive Heart Failure |
21
42.9%
|
18
37.5%
|
39
40.2%
|
| Chronic Obstructive Pulmonary Disease |
6
12.2%
|
8
16.7%
|
14
14.4%
|
| Diabetes |
5
10.2%
|
4
8.3%
|
9
9.3%
|
| End Stage Renal Disease |
1
2%
|
0
0%
|
1
1%
|
| Pneumonia |
4
8.2%
|
1
2.1%
|
5
5.2%
|
| Rapid Rehospitalization |
11
22.4%
|
13
27.1%
|
24
24.7%
|
Outcome Measures
| Title | Change in Substance Use Rates From Baseline |
|---|---|
| Description | Urinalysis confirmed self-reported days of use for any substance, including alcohol, cocaine, marijuana, opiates, sedatives, and hallucinogens over time. Participants reported substance use for the 90 days prior to the assessment date. |
| Time Frame | 0, 3, 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed in row differs from overall because the mixed-effects model analyses included participants who completed baseline and at least one follow-up. As a result, the number analyzed at each follow-up differed. |
| Arm/Group Title | Treatment As Usual | Specialized Community Disease Management |
|---|---|---|
| Arm/Group Description | Treatment As Usual: Treatment as Usual is a 90-day, post-discharge program that consists of medical monitoring by nurses and community health workers who have no special training in working with substance use disorder patients, and does not address substance use. | Specialized Community Disease Management: Specialized Community Disease Management is 90-day program that employs specialized teams including a trained clinical social worker and a peer-specialist community health worker who provide evidence-based telephone continuing care, home visits, and focus on patients' substance use following hospital discharge. |
| Measure Participants | 48 | 49 |
| Baseline |
51.37
(34.31)
|
51.38
(31.77)
|
| 3 Months |
35.53
(34.74)
|
26.65
(32.9)
|
| 6 Months |
30.65
(33.72)
|
30.47
(36.30)
|
| Title | Change in Treatment Session Attendance From Baseline |
|---|---|
| Description | Treatment sessions attended for alcohol or drug use issues over time. Participants self-reported attendance for the 6 months prior to the baseline assessment. During follow-up assessments, participants self-reported attendance since the last assessment date. |
| Time Frame | 0, 3, 6, months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed in row differs from overall because the mixed-effects model analyses included participants who completed baseline and at least one follow-up. As a result, the number analyzed at each follow-up differed. |
| Arm/Group Title | Specialized Community Disease Management | Treatment As Usual |
|---|---|---|
| Arm/Group Description | Specialized Community Disease Management: Specialized Community Disease Management is 90-day program that employs specialized teams including a trained clinical social worker and a peer-specialist community health worker who provide evidence-based telephone continuing care, home visits, and focus on patients' substance use following hospital discharge. | Treatment As Usual: Treatment as Usual is a 90-day, post-discharge program that consists of medical monitoring by nurses and community health workers who have no special training in working with substance use disorder patients, and does not address substance use. |
| Measure Participants | 45 | 48 |
| Baseline |
11.36
(24.78)
|
4.75
(15.47)
|
| 3 Months |
9.34
(22.75)
|
5.93
(17.81)
|
| 6 Months |
6.17
(19.48)
|
3.27
(7.03)
|
| Title | Number of Hospitalizations and Use of Emergency Services |
|---|---|
| Description | Days of hospitalization and days of use of acute emergency services after Baseline. Participants self-reported their service utilization for the 6 months prior to the baseline assessment. During follow-up assessments, participants self-reported their service utilization since the last assessment date. |
| Time Frame | 0, 3, 6, months |
Outcome Measure Data
| Analysis Population Description |
|---|
| The number analyzed in row differs from overall because the mixed-effects model analyses included participants who completed baseline and at least one follow-up. As a result, the number analyzed at each follow-up differed. |
| Arm/Group Title | Specialized Community Disease Management | Treatment As Usual |
|---|---|---|
| Arm/Group Description | Specialized Community Disease Management: Specialized Community Disease Management is 90-day program that employs specialized teams including a trained clinical social worker and a peer-specialist community health worker who provide evidence-based telephone continuing care, home visits, and focus on patients' substance use following hospital discharge. | Treatment As Usual: Treatment as Usual is a 90-day, post-discharge program that consists of medical monitoring by nurses and community health workers who have no special training in working with substance use disorder patients, and does not address substance use. |
| Measure Participants | 45 | 42 |
| Baseline |
3.53
(4.79)
|
5.5
(10.55)
|
| 3 Months |
4.76
(8.81)
|
4.91
(10.91)
|
| 6 Months |
4.17
(4.86)
|
3.55
(9.83)
|
Adverse Events
| Time Frame | 6 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Serious Adverse Events were defined as death; a life threatening event such as suicidal ideation/attempt or inpatient rehospitalization related to the index medical condition, suicidal behavior, psychiatric distress, or drug/alcohol complications/overdose. Unrelated medical events that did not require hospitalization were not be considered SAEs. | |||
| Arm/Group Title | Specialized Community Disease Management | Treatment As Usual | ||
| Arm/Group Description | Specialized Community Disease Management: Specialized Community Disease Management is 90-day program that employs specialized teams including a trained clinical social worker and a peer-specialist community health worker who provide evidence-based telephone continuing care, home visits, and focus on patients' substance use following hospital discharge. | Treatment As Usual: Treatment as Usual is a 90-day, post-discharge program that consists of medical monitoring by nurses and community health workers who have no special training in working with substance use disorder patients, and does not address substance use. | ||
All Cause Mortality |
||||
| Specialized Community Disease Management | Treatment As Usual | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/49 (2%) | 3/48 (6.3%) | ||
Serious Adverse Events |
||||
| Specialized Community Disease Management | Treatment As Usual | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 23/49 (46.9%) | 14/48 (29.2%) | ||
| Cardiac disorders | ||||
| Hospitalization for congestive heart failure | 9/49 (18.4%) | 23 | 7/48 (14.6%) | 15 |
| Hospitalization for cardiac arrest | 1/49 (2%) | 1 | 0/48 (0%) | 0 |
| Death related to congestive heart failure | 0/49 (0%) | 0 | 2/48 (4.2%) | 2 |
| General disorders | ||||
| Hospitalization for Syncope | 1/49 (2%) | 1 | 0/48 (0%) | 0 |
| Death, Cause Unknown | 1/49 (2%) | 1 | 1/48 (2.1%) | 1 |
| Psychiatric disorders | ||||
| Suicidal ideation/attempt | 2/49 (4.1%) | 2 | 3/48 (6.3%) | 3 |
| Hospitalization for drug/alcohol use | 1/49 (2%) | 1 | 0/48 (0%) | 0 |
| Inpatient Drug/Alcohol | 1/49 (2%) | 1 | 1/48 (2.1%) | 1 |
| Renal and urinary disorders | ||||
| Hospitalization for Diabetes | 2/49 (4.1%) | 5 | 2/48 (4.2%) | 4 |
| Hospitalization for end-stage renal disease | 1/49 (2%) | 1 | 0/48 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Hospitalization for COPD | 6/49 (12.2%) | 13 | 4/48 (8.3%) | 5 |
| Hospitalization for pneumonia | 2/49 (4.1%) | 2 | 0/48 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Specialized Community Disease Management | Treatment As Usual | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/49 (0%) | 0/48 (0%) | ||
Limitations/Caveats
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 | Adam Brooks, PhD |
|---|---|
| Organization | Treatment Research Institute |
| Phone | 215-399-0980 ext 128 |
| abrooks@tresearch.org |
- PCORI-1306-03482