Hospital-Based Contingency Management

Sponsor
Oregon Health and Science University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05515757
Collaborator
CareOregon (Other), Affect Therapeutics, Inc. (Industry)
90
1
23.3

Study Details

Study Description

Brief Summary

This study aims to adapt an outpatient mobile app-based contingency management intervention to the hospital setting to understand how we can use contingency management to improve health outcomes in hospitalized patients with stimulant use disorders.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mobile-app based contingency management
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Development of a Hospital-Based Contingency Management Intervention
Anticipated Study Start Date :
Aug 22, 2022
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

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.

Behavioral: Mobile-app based contingency management
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.

Outcome Measures

Primary Outcome Measures

  1. Intervention acceptability and feasibility [Week 0-8]

    Evaluated using semi-structured qualitative interviews with participants and staff

Secondary Outcome Measures

  1. Brief Addiction Monitor (BAM) [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.

  2. Participant engagement in the contingency management intervention [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.

  3. Participant drug test results [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Oregon Health and Science University
  • CareOregon
  • Affect Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT05515757
Other Study ID Numbers:
  • STUDY00023484
First Posted:
Aug 25, 2022
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Oregon Health and Science University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 25, 2022