Trial Outcomes & Findings for Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions (NCT NCT02059005)
NCT ID: NCT02059005
Last Updated: 2023-03-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
97 participants
Primary outcome timeframe
0, 3, 6 months
Results posted on
2023-03-29
Participant Flow
Participants were recruited at Temple University Hospital between November 2015 and June 2016.
Participants were screened for eligibility using the AUDIT, DAST, and Mini-International Neuropsychiatric Interview (MINI) for substance use disorders.
Participant milestones
| Measure |
Specialized Community Disease Management
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: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
48
|
|
Overall Study
3 Month Assessment
|
37
|
33
|
|
Overall Study
6 Month Assessment
|
29
|
24
|
|
Overall Study
COMPLETED
|
29
|
24
|
|
Overall Study
NOT COMPLETED
|
20
|
24
|
Reasons for withdrawal
| Measure |
Specialized Community Disease Management
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: 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.
|
|---|---|---|
|
Overall Study
Death
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
19
|
19
|
|
Overall Study
Incarceration
|
0
|
1
|
|
Overall Study
Inpatient
|
0
|
1
|
Baseline Characteristics
Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions
Baseline characteristics by cohort
| Measure |
Specialized Community Disease Management
n=49 Participants
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
n=48 Participants
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
n=97 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.84 years
STANDARD_DEVIATION 7.71 • n=5 Participants
|
48.65 years
STANDARD_DEVIATION 12.81 • n=7 Participants
|
50.26 years
STANDARD_DEVIATION 10.61 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
48 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Primary Substance of Use
Alcohol
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Primary Substance of Use
Marijuana
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Primary Substance of Use
Cocaine
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Primary Substance of Use
Opioids
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Primary Substance of Use
Other
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Index Medical Condition
Acute Myocardial Infarction
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Index Medical Condition
Congestive Heart Failure
|
21 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Index Medical Condition
Chronic Obstructive Pulmonary Disease
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Index Medical Condition
Diabetes
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Index Medical Condition
End Stage Renal Disease
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Index Medical Condition
Pneumonia
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Index Medical Condition
Rapid Rehospitalization
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0, 3, 6 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Treatment As Usual
n=48 Participants
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
n=49 Participants
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.
|
|---|---|---|
|
Change in Substance Use Rates From Baseline
Baseline
|
51.37 Days of Substance Use
Standard Deviation 34.31
|
51.38 Days of Substance Use
Standard Deviation 31.77
|
|
Change in Substance Use Rates From Baseline
3 Months
|
35.53 Days of Substance Use
Standard Deviation 34.74
|
26.65 Days of Substance Use
Standard Deviation 32.9
|
|
Change in Substance Use Rates From Baseline
6 Months
|
30.65 Days of Substance Use
Standard Deviation 33.72
|
30.47 Days of Substance Use
Standard Deviation 36.30
|
SECONDARY outcome
Timeframe: 0, 3, 6, monthsPopulation: 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.
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.
Outcome measures
| Measure |
Treatment As Usual
n=45 Participants
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
n=48 Participants
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.
|
|---|---|---|
|
Change in Treatment Session Attendance From Baseline
Baseline
|
11.36 Days of attending treatment sessions
Standard Deviation 24.78
|
4.75 Days of attending treatment sessions
Standard Deviation 15.47
|
|
Change in Treatment Session Attendance From Baseline
3 Months
|
9.34 Days of attending treatment sessions
Standard Deviation 22.75
|
5.93 Days of attending treatment sessions
Standard Deviation 17.81
|
|
Change in Treatment Session Attendance From Baseline
6 Months
|
6.17 Days of attending treatment sessions
Standard Deviation 19.48
|
3.27 Days of attending treatment sessions
Standard Deviation 7.03
|
SECONDARY outcome
Timeframe: 0, 3, 6, monthsPopulation: 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.
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.
Outcome measures
| Measure |
Treatment As Usual
n=45 Participants
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
n=42 Participants
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.
|
|---|---|---|
|
Number of Hospitalizations and Use of Emergency Services
Baseline
|
3.53 Days of ER or Hospital Utilization
Standard Deviation 4.79
|
5.5 Days of ER or Hospital Utilization
Standard Deviation 10.55
|
|
Number of Hospitalizations and Use of Emergency Services
3 Months
|
4.76 Days of ER or Hospital Utilization
Standard Deviation 8.81
|
4.91 Days of ER or Hospital Utilization
Standard Deviation 10.91
|
|
Number of Hospitalizations and Use of Emergency Services
6 Months
|
4.17 Days of ER or Hospital Utilization
Standard Deviation 4.86
|
3.55 Days of ER or Hospital Utilization
Standard Deviation 9.83
|
Adverse Events
Specialized Community Disease Management
Serious events: 23 serious events
Other events: 0 other events
Deaths: 1 deaths
Treatment As Usual
Serious events: 14 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Specialized Community Disease Management
n=49 participants at risk
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
n=48 participants at risk
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.
|
|---|---|---|
|
Cardiac disorders
Hospitalization for congestive heart failure
|
18.4%
9/49 • Number of events 23 • 6 months
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.
|
14.6%
7/48 • Number of events 15 • 6 months
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for COPD
|
12.2%
6/49 • Number of events 13 • 6 months
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.
|
8.3%
4/48 • Number of events 5 • 6 months
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.
|
|
Renal and urinary disorders
Hospitalization for Diabetes
|
4.1%
2/49 • Number of events 5 • 6 months
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.
|
4.2%
2/48 • Number of events 4 • 6 months
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.
|
|
Renal and urinary disorders
Hospitalization for end-stage renal disease
|
2.0%
1/49 • Number of events 1 • 6 months
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.
|
0.00%
0/48 • 6 months
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.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for pneumonia
|
4.1%
2/49 • Number of events 2 • 6 months
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.
|
0.00%
0/48 • 6 months
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.
|
|
Cardiac disorders
Hospitalization for cardiac arrest
|
2.0%
1/49 • Number of events 1 • 6 months
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.
|
0.00%
0/48 • 6 months
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.
|
|
Psychiatric disorders
Suicidal ideation/attempt
|
4.1%
2/49 • Number of events 2 • 6 months
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.
|
6.2%
3/48 • Number of events 3 • 6 months
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.
|
|
General disorders
Hospitalization for Syncope
|
2.0%
1/49 • Number of events 1 • 6 months
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.
|
0.00%
0/48 • 6 months
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.
|
|
Psychiatric disorders
Hospitalization for drug/alcohol use
|
2.0%
1/49 • Number of events 1 • 6 months
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.
|
0.00%
0/48 • 6 months
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.
|
|
Psychiatric disorders
Inpatient Drug/Alcohol
|
2.0%
1/49 • Number of events 1 • 6 months
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.
|
2.1%
1/48 • Number of events 1 • 6 months
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.
|
|
General disorders
Death, Cause Unknown
|
2.0%
1/49 • Number of events 1 • 6 months
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.
|
2.1%
1/48 • Number of events 1 • 6 months
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.
|
|
Cardiac disorders
Death related to congestive heart failure
|
0.00%
0/49 • 6 months
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.
|
4.2%
2/48 • Number of events 2 • 6 months
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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place