- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05515757
Hospital-Based Contingency Management
Development of a Hospital-Based Contingency Management Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Contingency management (CM), an evidence-based strategy that utilizes a reward-based system as positive reinforcement, has been most robustly studied in the outpatient setting, but also has the potential to improve hospital care for patients with stimulant use disorder. The hospital is a challenging environment for people who use drugs. Conflicts with staff often result from in-hospital substance use, prolonged time off the unit, and missing medications, leading to negative health outcomes and re-admissions. By relying on positive rewards to encourage positive health behaviors, CM has the potential to improve staff-patient relationships, healthcare engagement, and reduce substance use in the hospital. Stimulant use disorder is especially difficult to address in the hospital due to a lack of medications that can support cravings and withdrawal symptoms. However, little is known about CM implementation in hospitals and the hospital setting may introduce unique challenges.
The objective of this study is to adapt an outpatient mobile app-based CM intervention to the hospital setting to understand the feasibility and acceptability of a hospital-based CM intervention to improve health outcomes in hospitalized patients with substance use disorders. We'll achieve this objective through following specific aims: Aim 1: Identify adaptations needed to implement an evidence-based outpatient mobile-app based CM intervention to the hospital setting for hospitalized patients with substance use disorders. Aim 2: Determine the feasibility, including facilitators and barriers, of implementing a mobile app-based CM intervention in the hospital setting. Aim 3: Assess the acceptability of a mobile app-based hospital-based CM intervention to patients and staff.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oregon
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Portland, Oregon, United States, 97239
- Linda Peng
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Be 18 years of age or older
- Have moderate to severe stimulant use disorder, as diagnosed using DSM-5 criteria for stimulant use disorder by an addiction medicine provider
- Have an anticipated hospital length of stay greater than 2 weeks
- Be able to use a smartphone and agree to download and use the Affect app as part of study-related procedures
- Be English speaking and be able to understand explanations of study procedures and the informed consent to participate
Exclusion Criteria:
- Unable to engage in the intervention due to cognitive impairment or altered mental status
- Unable to engage in the intervention due to acute medical/mental health issues, per judgement of the research assistant
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Mobile app-based contingency management
All participants will be enrolled into an 8-week mobile app-based contingency management intervention starting during a prolonged hospitalization.
|
We are adapting an evidence-based outpatient mobile-app based CM intervention to the hospital setting for hospitalized patients with stimulant use disorders requiring prolonged hospitalization.
Participants will be enrolled into an 8-week mobile-app based contingency management intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention acceptability and feasibility
Time Frame: Week 0-8
|
Evaluated using semi-structured qualitative interviews with participants and staff
|
Week 0-8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brief Addiction Monitor (BAM)
Time Frame: Week 0-8
|
The Brief Addiction Monitor (BAM) is a 17-item, multidimensional, progress-monitoring instrument for patients with a substance use disorder.
The BAM includes items that assess risk factors for substance use, protective factors that support recovery, and drug and alcohol use.
This instrument will be used to monitor the progress of the participants substance use disorder.
Each functional domain of the survey (use, risk, protective) has an associated composite score which serves as a marker of clinical status.
For Use (Scores 0 to 12), higher scores mean more substance use.
For Risk (scores 0 to 24), higher sores mean more risk.
For Protective (scores 0 to 24), higher scores mean more protection.
|
Week 0-8
|
|
Participant engagement in the contingency management intervention
Time Frame: Week 0-8
|
Participation in the contingency management intervention will be tracked.
This includes number of counseling appointments attended and number of self-reflection activities attended.
This is an implementation outcome where we measure how often participants are engaging in this intervention.
|
Week 0-8
|
|
Participant drug test results
Time Frame: Week 0-8
|
Participants can complete twice weekly drug testing as part of the contingency management intervention.
We will measure the number of positive and negative drug tests as an objective measure of substance use.
|
Week 0-8
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00023484
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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