- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05702021
Implementing Contingency Management for Stimulant Use in Specialty Addiction Treatment Organizations (MIMIC2)
Implementing Contingency Management for Stimulant Use in Specialty Addiction Treatment Organizations (Center for Dissemination and Implementation Science at Stanford, Research Component #2)
Stimulants constitute a new and deadly fourth wave of the opioid epidemic. Contingency management is the most effective intervention for stimulant use and is an evidence-based adjunct to medication for opioid use disorder. Yet, uptake of contingency management in opioid treatment programs that provide medication for opioid use disorder remains low; in fact, access to contingency management is arguably one of the greatest research-to-practice gaps in the addiction treatment services field. The goal of this study is to conduct a type III hybrid effectiveness-implementation trial to evaluate a multi-level implementation strategy, the Science of Service Laboratory, to install contingency management for stimulant use in opioid treatment programs. The Science of Service Laboratory has three core components: didactic training, performance feedback, and external facilitation.
Utilizing a stepped wedge design, a cohort of public sector addiction specialty treatment programs will be randomized to receive Science of Service Laboratory across four cohorts. Each of the programs will provide de-identified electronic medical record data from all available patient charts on contingency management delivery and patient outcomes. Staff from each program will provide feedback on contextual determinants influencing implementation. This study will rigorously evaluate whether a multi-level implementation strategy developed by one of the longest-standing national intermediary purveyor organizations-the SAMHSA Technology Transfer Centers, will improve both implementation and patient outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stimulant use among persons with opioid use disorder is associated with an array of serious consequences. Among those with opioid use disorder, stimulant use has been associated with more persistent opioid use; higher risk of HIV infection; higher levels of family, medical, legal, and vocational problems; and increased risk of fatal overdose. Contingency management is an evidence-based intervention for stimulant use and an evidence-based adjunct to medication for opioid use disorders. Medication for opioid use disorder is the first-line, evidence-based treatment for opioid use disorder, but does not specifically reduce stimulant use, and there are not yet efficacious medications for stimulant addiction. Moreover, individuals who continue to use stimulants while receiving medication for opioid use disorder have worse treatment response in terms of both retention and abstinence from opioids. Contingency management targets stimulant use via reinforcing incentives for attaining abstinence. Despite an abundance of research evidence, contingency management uptake in opioid treatment programs remains low due to barriers at both the provider- and organizational-levels. Effectively addressing the contingency management evidence-to-practice gap could advance both the field of implementation science and the quality of care in specialty addiction treatment settings. This project evaluates a multi-level implementation strategy, the Science to Service Laboratory, to install contingency management for stimulant use in opioid treatment programs. The Science of Service Laboratory employs three core components: didactic training; performance feedback; and external facilitation.
Utilizing a type III hybrid effectiveness-implementation trial with a stepped wedge design, we will enroll public sector addiction specialty programs across two states (Rhode Island and Illinois) to receive the Science of Service Laboratory. Data collection will leverage multiple sources. Programs will be enrolled across 4 cohorts - 1 in Rhode Island and 3 in Illinois. Each program will receive the multi-level Science to Service Laboratory and will extract de-identified electronic medical record data on contingency management implementation and patient outcomes. In addition, program staff will report on contextual determinants of implementation. Results will evaluate whether a multi-level implementation strategy initially developed by one of the longest-standing intermediary purveyor organizations (SAMHSA Technology Transfer Centers), will improve implementation and patient outcomes. In addition, the project will advance implementation science via specification and evaluation of contextual determinants.
The Specific Aims and corresponding hypotheses are:
Specific Aim 1: To test the effectiveness of the Science of Service Laboratory on implementation outcomes, including contingency management Reach, Adoption, and Implementation.
Specific Aim 2: To test the effectiveness of the Science of Service Laboratory on patient outcomes, including: Stimulant Abstinence and Treatment Retention.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara Becker
- Phone Number: 312-503-1709
- Email: Sara.becker@northwestern.edu
Study Contact Backup
- Name: Kira DiClemente-Bosco
Study Locations
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Illinois
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Chicago, Illinois, United States, 60609
- Recruiting
- ACCESS Community Health Networks
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Contact:
- Ashland Family Center
- Phone Number: 773-434-9216
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Chicago, Illinois, United States, 60623
- Completed
- Lawndale Christian Health Center
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Chicago, Illinois, United States, 60651
- Completed
- Healthcare Alternative Systems
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Chicago, Illinois, United States, 60654
- Recruiting
- Community Outreach Intervention Projects
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Contact:
- Mobile Outreach
- Phone Number: 312-785-7195
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Chicago, Illinois, United States, 60654
- Recruiting
- Family Guidance Centers
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Contact:
- Central Intake
- Phone Number: 844-834-2227
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Rockford, Illinois, United States, 61108
- Recruiting
- Rosecrance Health Network
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Contact:
- Rosecrance Harrison
- Phone Number: 815-335-9798
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Rhode Island
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Pawtucket, Rhode Island, United States, 02860
- Completed
- Addiction Recovery Institute
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Providence, Rhode Island, United States, 02905
- Completed
- Comprehensive Treatment Centers
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Providence, Rhode Island, United States, 02909
- Completed
- CODAC
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Opioid Treatment Program Counselors:
- Inclusion criteria: 1) provide ongoing psychosocial support to medication for opioid use disorder patients (e.g., intake sessions, individual counseling, and/or group counseling sessions), and 2) have an active caseload
- Exclusion criteria: Younger than 18 years of age, unable to provide informed consent
Persons on Medication for Opioid Use Disorder [Not recruited, via electronic medical records only]
- Inclusion criteria: must be newly initiated on medication for opioid use disorders (within the past 30 days) and have concurrent stimulant use (indicated by self-report of past 30-day stimulant use or positive toxicology screen within 30 days).
- Exclusion criteria: Younger than 18 years of age, Does not have electronic medical records
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Science of Service Laboratory implementation strategy
The Science of Service Laboratory implementation strategy consists of: didactic training (contingency management workshops; monthly contingency management coaching calls), performance feedback (practice sessions and electronic medical record feedback); and facilitation (monthly facilitation calls).
|
The Science of Service Laboratory implementation strategy consists of: didactic training (contingency management workshops; monthly contingency management coaching calls), performance feedback (practice sessions and electronic medical record feedback); and facilitation (monthly facilitation calls).
|
|
No Intervention: Stepped wedge comparator
Our hybrid trial uses a unidirectional crossover stepped wedge design.
All sites cross over in the same direction from usual care to intervention.
All sites therefore act as their own comparison prior to the sequential roll-out of the implementation strategy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in percent of patients receiving contingency management from pre-implementation to post-implementation
Time Frame: 10 months
|
This is an implementation outcome capturing Reach and is extracted from electronic medical records.
This is a patient-level measure of the change in the percent of newly inducted patients with a history of stimulant use who are documented as having received 1 or more contingency management sessions from pre-implementation to post-implementation.
|
10 months
|
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Change in percent of counselors delivering contingency management from pre-implementation to post-implementation
Time Frame: 10 months
|
This is an implementation outcome capturing Adoption and is extracted from electronic medical records.
This is a provider-level measure of the change in percent of counselors at each program who are documented as having delivered 1 or more contingency management sessions from pre-implementation to post-implementation.
|
10 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the percent of toxicology screens negative for stimulants
Time Frame: 10 months
|
This is a patient-level outcome measuring Stimulant Abstinence and is extracted from electronic medical records.
This measures the change in percent of toxicology screens that are negative for stimulants from pre-implementation to post-implementation.
|
10 months
|
|
Change in number of contingency management sessions
Time Frame: 10 months
|
This is a patient-level outcome measuring Contingency Management Treatment Retention and is extracted from electronic medical records.
This measures the change in the number of contingency management sessions received per patient from pre-implementation to post-implementation.
|
10 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara Becker, Northwestern University
Publications and helpful links
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
- STU00217287
- P50DA054072 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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