Drug UseNCT02059005
Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions
A study testing Specialized Community Disease Management and Treatment As Usual in people with Drug Use and Alcohol Use, run by Treatment Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Use, Alcohol Use, Congestive Heart Failure
- What is being tested?
- Specialized Community Disease Management and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2014to 28 Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient is 18 years or older
- alcohol and/or drug screening score that indicates at least mild problem severity
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
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.
Read the 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.
- Conditions
- Drug Use, Alcohol Use, Congestive Heart Failure, Pneumonia, Acute Myocardial Infarction, Diabetes Mellitus
- Being tested
- Specialized Community Disease Management, Treatment As Usual
- Keywords
- Addiction, Substance Use Disorder, Rehospitalization, Community Disease Management, Behavioral Health, Community Health Worker
- Medical subject headings
- Alcohol Drinking, Heart Failure, Pneumonia, Diabetes Mellitus, Pulmonary Disease, Chronic Obstructive, Kidney Failure, Chronic, Behavior, Addictive, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specialized Community Disease ManagementBehavioural
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 UsualBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Specialized Community Disease Management | Experimental | Specialized Community Disease Management Receives: Behavioral: Specialized Community Disease Management |
| Treatment As Usual | Active comparator | Treatment as Usual: standard post-hospital discharge with medical monitoring. Receives: Behavioral: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0, 3, 6 months
Secondary outcomes (2)
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.
Measured: 0, 3, 6, months
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.
Measured: 0, 3, 6, months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study start18 Nov 2014
- Primary completion16 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Drug UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Treatment Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Adam C Brooks, PhD, Principal investigator, Treatment Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059005
- Sponsor's protocol ID
- PCORI-1306-03482
- Status last verified
- Mar 2023
- First submitted
- 7 Feb 2014
- Last updated
- 29 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: in line with HIPAA protections, we will make our final dataset available to other researchers. Fully de-identified data will be available to any researcher. If a researcher should request a limited dataset then we will only share that data after obtaining an appropriate data use agreement which includes an agreement not to attempt to re-identify or contact participants. We will not share directly identifiable data with outside researchers per our HIPAA authorization for this study.
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specialized Community Disease Management to Reduce Substance Use and Hospital Readmissions
- ClinicalTrials.gov ID
- NCT02059005
- Acronym / sponsor ID
- PCORI-1306-03482
- Conditions
- Drug Use, Alcohol Use, Congestive Heart Failure, Pneumonia, Acute Myocardial Infarction, Diabetes Mellitus
- Keywords
- Addiction, Substance Use Disorder, Rehospitalization, Community Disease Management, Behavioral Health, Community Health Worker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Treatment Research InstituteUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 18 Nov 2014 (actual)
- Primary completion
- 16 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Posted 10 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specialized Community Disease Management | Experimental | Behavioral: Specialized Community Disease ManagementSpecialized Community Disease Management |
| Treatment As Usual | Active comparator | Behavioral: Treatment As UsualTreatment as Usual: standard post-hospital discharge with medical monitoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient is 18 years or older
- alcohol and/or drug screening score that indicates at least mild problem severity
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specialized Community Disease ManagementSpecialized 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. | Behavioural | Specialized Community Disease Management |
| Treatment As UsualTreatment 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. | Behavioural | Treatment As Usual |
Primary outcome
Change in Substance Use Rates From Baseline
Time frame: 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.
2 secondary outcomes
Change in Treatment Session Attendance From Baseline
Time frame: 0, 3, 6, months
Number of Hospitalizations and Use of Emergency Services
Time frame: 0, 3, 6, months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Patient-Centered Outcomes Research Institute Project AbstractLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. in line with HIPAA protections, we will make our final dataset available to other researchers. Fully de-identified data will be available to any researcher. If a researcher should request a limited dataset then we will only share that data after obtaining an appropriate data use agreement which includes an agreement not to attempt to re-identify or contact participants. We will not share directly identifiable data with outside researchers per our HIPAA authorization for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adam C Brooks, PhD principal investigator
Treatment Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specialized Community Disease Management and Treatment As Usual in people with Drug Use and Alcohol Use, run by Treatment Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Substance Use Rates From Baseline (time frame: 0, 3, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.