MIMIC2: Implementing Contingency Management for Stimulant Use in Specialty Addiction Treatment Organizations

Sponsor

Northwestern University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05702021

Collaborator

National Institute on Drug Abuse (NIDA) (NIH), Stanford University (Other), Ohio State University (Other)

Enrollment

Locations

Arms

53.9

Anticipated Duration (Months)

7.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 regional cohort of 10 public sector opioid treatment programs will be randomized to receive Science of Service Laboratory at five distinct time points. At six intervals, each of the 10 opioid treatment programs will provide de-identified electronic medical record data from all available patient charts on contingency management delivery and patient outcomes. Staff from each opioid treatment 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.

Condition or Disease	Intervention/Treatment	Phase
Stimulant Use (Diagnosis)	Behavioral: Science to Service Laboratory	N/A

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 fully powered type III hybrid effectiveness-implementation trial with a stepped wedge design, we will randomize a cohort of 10 public sector opioid treatment programs in New England to receive the Science of Service Laboratory at five time points. Data collection will leverage multiple sources. At six intervals, each of the 10 opioid treatment programs will extract de-identified electronic medical record data on contingency management implementation and patient outcomes. In addition, opioid treatment 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 ensure equitable service provision to diverse, high-risk patients while advancing 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 Design

Study Type:

Interventional

Anticipated Enrollment :

76 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Stepped-wedge trialStepped-wedge trial

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcomes will be exported from electronic medical records. Data analysts will not know who was receiving the intervention at what time point.

Primary Purpose:

Health Services Research

Official Title:

Implementing Contingency Management for Stimulant Use in Specialty Addiction Treatment Organizations (Center for Dissemination and Implementation Science at Stanford, Research Component #2)

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2027

Anticipated Study Completion Date :

Aug 1, 2027

Arms and Interventions

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).	Behavioral: Science to Service Laboratory 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.

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).

Behavioral: Science to Service Laboratory

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.

Outcome Measures

Primary Outcome Measures

Change in percent of patients receiving contingency management from pre-implementation to post-implementation [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.
Change in percent of counselors delivering contingency management from pre-implementation to post-implementation [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.

Secondary Outcome Measures

Change in the percent of toxicology screens negative for stimulants [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.
Change in number of contingency management sessions [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Root Center for Advanced Recovery- Bristol Clinic	Bristol	Connecticut	United States	06010
2	Root Center for Advanced Recovery: Doctors Clinic	Hartford	Connecticut	United States	06106
3	Root Center for Advanced Recovery: Henderson/Johnson Clinic	Hartford	Connecticut	United States	06120
4	Root Center for Advanced Recovery: Manchester	Manchester	Connecticut	United States	06040
5	Root Center for Advanced Recovery: Middletown Clinic	Middletown	Connecticut	United States	06457
6	Root Center for Advanced Recovery: New Britain	New Britain	Connecticut	United States	06051
7	Root Center for Advanced Recovery: New London Clinic	New London	Connecticut	United States	06320
8	Root Center for Advanced Recovery: Norwich Clinic	Norwich	Connecticut	United States	06360
9	Root Center for Advanced Recovery: Torrington Clinic	Torrington	Connecticut	United States	06790
10	Root Center for Advanced Recovery: Willimantic Clinic	Willimantic	Connecticut	United States	06226