Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Stepped-wedge trial
Primary Purpose
Health Services Research
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.

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Lawndale Christian Health Center
Chicago, Illinois 60623
Contact:
Brittany Buckner
brittanybuckner@lawndale.org

Healthcare Alternative Systems NEXA-MAR
Chicago, Illinois 60651
Contact:
Marian Jurewicz
MJurewicz@hascares.org

Community Outreach Intervention Projects Southside Mobile Van
Chicago, Illinois 60654
Contact:
Albert Murphy
amurph20@uic.edu

Family Guidance Centers Chicago Ave.
Chicago, Illinois 60654
Contact:
Sarah McHugh
smchugh@fgcinc.org

More Details

NCT ID
NCT05702021
Status
Recruiting
Sponsor
Northwestern University

Study Contact

Medical Director of Behavioral Health Chicago Department of Pu
312-742-0381
miao.hua@cityofchicago.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.