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Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions

Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02059005
Enrollment
97
Registered
2014-02-11
Start date
2014-11-18
Completion date
2017-02-28
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction, Alcohol Use, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, Diabetes Mellitus, Drug Use, End-Stage Renal Disease, Pneumonia

Keywords

Addiction, Substance Use Disorder, Rehospitalization, Community Disease Management, Behavioral Health, Community Health Worker

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.

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.

Interventions

BEHAVIORALSpecialized 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.

BEHAVIORALTreatment 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.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Treatment Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Substance Use Rates From Baseline0, 3, 6 monthsUrinalysis 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

MeasureTime frameDescription
Change in Treatment Session Attendance From Baseline0, 3, 6, monthsTreatment 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 Services0, 3, 6, monthsDays 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.

Countries

United States

Participant flow

Recruitment details

Participants were recruited at Temple University Hospital between November 2015 and June 2016.

Pre-assignment details

Participants were screened for eligibility using the AUDIT, DAST, and Mini-International Neuropsychiatric Interview (MINI) for substance use disorders.

Participants by arm

ArmCount
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.
49
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.
48
Total97

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath13
Overall StudyIncarceration01
Overall StudyInpatient01
Overall StudyLost to Follow-up1919

Baseline characteristics

CharacteristicTreatment As UsualTotalSpecialized Community Disease Management
Age, Continuous48.65 years
STANDARD_DEVIATION 12.81
50.26 years
STANDARD_DEVIATION 10.61
51.84 years
STANDARD_DEVIATION 7.71
Ethnicity (NIH/OMB)
Hispanic or Latino
10 Participants18 Participants8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
38 Participants79 Participants41 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Index Medical Condition
Acute Myocardial Infarction
4 Participants5 Participants1 Participants
Index Medical Condition
Chronic Obstructive Pulmonary Disease
8 Participants14 Participants6 Participants
Index Medical Condition
Congestive Heart Failure
18 Participants39 Participants21 Participants
Index Medical Condition
Diabetes
4 Participants9 Participants5 Participants
Index Medical Condition
End Stage Renal Disease
0 Participants1 Participants1 Participants
Index Medical Condition
Pneumonia
1 Participants5 Participants4 Participants
Index Medical Condition
Rapid Rehospitalization
13 Participants24 Participants11 Participants
Primary Substance of Use
Alcohol
18 Participants34 Participants16 Participants
Primary Substance of Use
Cocaine
14 Participants33 Participants19 Participants
Primary Substance of Use
Marijuana
6 Participants7 Participants1 Participants
Primary Substance of Use
Opioids
2 Participants7 Participants5 Participants
Primary Substance of Use
Other
6 Participants14 Participants8 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
32 Participants67 Participants35 Participants
Race (NIH/OMB)
More than one race
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
8 Participants14 Participants6 Participants
Race (NIH/OMB)
White
8 Participants14 Participants6 Participants
Region of Enrollment
United States
48 participants97 participants49 participants
Sex: Female, Male
Female
19 Participants40 Participants21 Participants
Sex: Female, Male
Male
29 Participants57 Participants28 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 493 / 48
other
Total, other adverse events
0 / 490 / 48
serious
Total, serious adverse events
23 / 4914 / 48

Outcome results

Primary

Change in Substance Use Rates From Baseline

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Treatment As UsualChange in Substance Use Rates From BaselineBaseline51.37 Days of Substance UseStandard Deviation 34.31
Treatment As UsualChange in Substance Use Rates From Baseline3 Months35.53 Days of Substance UseStandard Deviation 34.74
Treatment As UsualChange in Substance Use Rates From Baseline6 Months30.65 Days of Substance UseStandard Deviation 33.72
Specialized Community Disease ManagementChange in Substance Use Rates From BaselineBaseline51.38 Days of Substance UseStandard Deviation 31.77
Specialized Community Disease ManagementChange in Substance Use Rates From Baseline3 Months26.65 Days of Substance UseStandard Deviation 32.9
Specialized Community Disease ManagementChange in Substance Use Rates From Baseline6 Months30.47 Days of Substance UseStandard Deviation 36.3
Secondary

Change in Treatment Session Attendance From Baseline

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Treatment As UsualChange in Treatment Session Attendance From BaselineBaseline11.36 Days of attending treatment sessionsStandard Deviation 24.78
Treatment As UsualChange in Treatment Session Attendance From Baseline3 Months9.34 Days of attending treatment sessionsStandard Deviation 22.75
Treatment As UsualChange in Treatment Session Attendance From Baseline6 Months6.17 Days of attending treatment sessionsStandard Deviation 19.48
Specialized Community Disease ManagementChange in Treatment Session Attendance From BaselineBaseline4.75 Days of attending treatment sessionsStandard Deviation 15.47
Specialized Community Disease ManagementChange in Treatment Session Attendance From Baseline3 Months5.93 Days of attending treatment sessionsStandard Deviation 17.81
Specialized Community Disease ManagementChange in Treatment Session Attendance From Baseline6 Months3.27 Days of attending treatment sessionsStandard Deviation 7.03
Secondary

Number of Hospitalizations and Use of Emergency Services

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

Population: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Treatment As UsualNumber of Hospitalizations and Use of Emergency ServicesBaseline3.53 Days of ER or Hospital UtilizationStandard Deviation 4.79
Treatment As UsualNumber of Hospitalizations and Use of Emergency Services3 Months4.76 Days of ER or Hospital UtilizationStandard Deviation 8.81
Treatment As UsualNumber of Hospitalizations and Use of Emergency Services6 Months4.17 Days of ER or Hospital UtilizationStandard Deviation 4.86
Specialized Community Disease ManagementNumber of Hospitalizations and Use of Emergency ServicesBaseline5.5 Days of ER or Hospital UtilizationStandard Deviation 10.55
Specialized Community Disease ManagementNumber of Hospitalizations and Use of Emergency Services3 Months4.91 Days of ER or Hospital UtilizationStandard Deviation 10.91
Specialized Community Disease ManagementNumber of Hospitalizations and Use of Emergency Services6 Months3.55 Days of ER or Hospital UtilizationStandard Deviation 9.83

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026