Substance AddictionNCT00993395
A Comprehensive Peer Mentor-based Disease Management Program for Medically Complex Substance Users
A study testing peer mentor-based disease management in people with Substance Addiction, run by Johns Hopkins University at 1 site in United States.
Trial summary
Substance-using adults are admitted to hospital for medical complication from their drug and alcohol use at very high rates; yet, their care is often defined by low rates of referral to addiction treatment programs and recidivism. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Substance Addiction
- What is being tested?
- peer mentor-based disease management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted to an intensive day hospital focused on medically complex substanse users are eligible for enrolment
Who cannot join
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Substance-using adults are admitted to hospital for medical complication from their drug and alcohol use at very high rates; yet, their care is often defined by low rates of referral to addiction treatment programs and recidivism. In 1997, we instituted an integrated medical-substance use treatment program at Johns Hopkins, the First Step Day Hospital, designed for intensive post-acute care of previously hospitalized substance using adults. We have shown that patients with dual diagnoses admitted to First Step more often complete their course of medical care and stay in recovery longer than patients not admitted to First Step.(1;2) On discharge from First Step, patients are medically stable and drug-free. Their substance abuse care is transferred to an out-patient substance abuse treatment facility and their medical care is transferred to their primary care provider. Unfortunately, many patients are lost to follow-up during this transition. We believe that a peer mentor-based disease management program (PM) can provide continuity of care that begins in First Step and continues after discharge thereby increasing the proportion of patients who remain in treatment for their addiction and medical conditions. Peer mentors are persons from the target community who have been in recovery for 5 or more years. In cooperation with patients and providers, peer mentors improve the integration of care, quality of care, and access to healthcare services. This pilot study will test the effectiveness of a peer mentor-based disease management program. The specific aims are to compare the impact of the PM intervention verses enhanced usual care on outcomes in three domains (1) medical/psychiatric health status, (2) addiction recovery, and (3) social resource acquisition. If successful, this study will provide evidence supporting a larger randomized controlled trial of the impact of field workers on post-acute care among patients with dual diagnoses.
- Conditions
- Substance Addiction
- Being tested
- peer mentor-based disease management
- Keywords
- addiction, peer mentor, adherence
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peer mentor-based disease managementBehavioural
peer mentor-based disease management focused on three domains: medical care, recovery, and social stabilization
| Study group | Role | What they receive |
|---|---|---|
| Peer Mentor Intervention | Experimental | peer mentor-based disease management focusing on three domains: medical care, recovery, and social stabilization Receives: Behavioral: peer mentor-based disease management |
What is being measured
The primary outcome is the main question the study is designed to answer.
adherence to first prescription refill after discharge
Measured: 60 days
Secondary outcomes (7)
Adherence to first medical appointment
Measured: 60 days
Rate of readmission and emergency department visits
Measured: 3 years
Length of stay in a recovery program
Measured: 1 year
Number of days without substance use
Measured: 3 years
Acquisition of medical insurance
Measured: 1 year
acquisition of long-term housing
Measured: 3 years
Acquisition of financial support
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AddictionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Healthways, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00993395
- Sponsor's protocol ID
- NA_00020931
- Status last verified
- Oct 2018
- First submitted
- 9 Oct 2009
- Last updated
- 10 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Peer Mentor-based Disease Management Program for Medically Complex Substance Users
- ClinicalTrials.gov ID
- NCT00993395
- Acronym / sponsor ID
- NA_00020931
- Conditions
- Substance Addiction
- Keywords
- addiction, peer mentor, adherence
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Healthways, Inc.
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Substance-using adults are admitted to hospital for medical complication from their drug and alcohol use at very high rates; yet, their care is often defined by low rates of referral to addiction treatment programs and recidivism. In 1997, we instituted an integrated medical-substance use treatment program at Johns Hopkins, the First Step Day Hospital, designed for intensive post-acute care of previously hospitalized substance using adults. We have shown that patients with dual diagnoses admitted to First Step more often complete their course of medical care and stay in recovery longer than patients not admitted to First Step.(1;2) On discharge from First Step, patients are medically stable and drug-free. Their substance abuse care is transferred to an out-patient substance abuse treatment facility and their medical care is transferred to their primary care provider. Unfortunately, many patients are lost to follow-up during this transition. We believe that a peer mentor-based disease management program (PM) can provide continuity of care that begins in First Step and continues after discharge thereby increasing the proportion of patients who remain in treatment for their addiction and medical conditions. Peer mentors are persons from the target community who have been in recovery for 5 or more years. In cooperation with patients and providers, peer mentors improve the integration of care, quality of care, and access to healthcare services. This pilot study will test the effectiveness of a peer mentor-based disease management program. The specific aims are to compare the impact of the PM intervention verses enhanced usual care on outcomes in three domains (1) medical/psychiatric health status, (2) addiction recovery, and (3) social resource acquisition. If successful, this study will provide evidence supporting a larger randomized controlled trial of the impact of field workers on post-acute care among patients with dual diagnoses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer Mentor Intervention | Experimental | Behavioral: peer mentor-based disease managementpeer mentor-based disease management focusing on three domains: medical care, recovery, and social stabilization |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to an intensive day hospital focused on medically complex substanse users are eligible for enrolment
Key exclusion criteria (1 listed)
- Inability to provide informed consent
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 |
|---|---|---|
| peer mentor-based disease managementpeer mentor-based disease management focused on three domains: medical care, recovery, and social stabilization | Behavioural | Peer Mentor Intervention |
Primary outcome
adherence to first prescription refill after discharge
Time frame: 60 days
7 secondary outcomes
Adherence to first medical appointment
Time frame: 60 days
Rate of readmission and emergency department visits
Time frame: 3 years
Length of stay in a recovery program
Time frame: 1 year
Number of days without substance use
Time frame: 3 years
Acquisition of medical insurance
Time frame: 1 year
acquisition of long-term housing
Time frame: 3 years
Acquisition of financial support
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peer mentor-based disease management in people with Substance Addiction, run by Johns Hopkins University 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 10 Oct 2018. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
adherence to first prescription refill after discharge (time frame: 60 days). 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 10 Oct 2018.