MBC2OTP Project (Measurement-Based Care Implementation in Community Opioid Treatment Programs)

NCT ID: NCT06345274

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-24
• Study Completion Date: 2026-02-28

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness and implementation of measurement-based care, which involves the systematic use of client self-report data to inform and enhance treatment, in opioid treatment programs using a pilot hybrid effectiveness-implementation study design. The main questions this study aims to answer are: 1) is measurement based care effective for improving patient treatment attendance and opioid abstinence, and 2) can measurement based care be implemented with fidelity in opioid treatment programs? Participants in this study will be opioid treatment program leaders and treatment providers. Leaders and treatment providers will participate in measurement-based care implementation strategies such as training and consultation to help them use measurement-based care with their patients. There is no comparison group for this study, however researchers will compare effectiveness outcomes prior to and post measurement-based care implementation and will evaluate changes in measurement-based care use with fidelity post implementation.

Detailed Description

Lethal drug overdoses have now become a leading cause of accidental death in the United States. The gold standard, evidence-based intervention for opioid use disorder (OUD) is pharmacotherapy, but abstinence rates following pharmacotherapy are sub-optimal. In fact, less than 40% of clients with OUD achieve abstinence in the first six months of treatment, highlighting the critical need to supplement pharmacotherapy with evidence-based psychosocial interventions. Unfortunately, very few community opioid treatment programs (OTPs) offer psychosocial interventions due to high patient volume and the need to identify behavioral treatments that can be flexibly delivered. Measurement-based care (MBC), the systematic use of client self-report data to inform treatment, is an evidence-based intervention that is uniquely well suited to complement OUD pharmacotherapy. Given the high lethality of opioid misuse, MBC provides an opportunity to identify early warning signs for poor treatment progress and enables treatment providers to intervene. Additionally, MBC may serve as a minimal intervention/intervention structure to increase the effectiveness of OUD treatment. Such structures have been proposed for implementation in community settings in lieu of full package evidence-based interventions to enhance feasibility and reduce barriers. The pressing need for flexible psychosocial interventions to complement pharmacotherapy, paired with the extensive evidence in support of MBC, makes it crucial to understand ways to implement and evaluate MBC's effectiveness in OTPs. This study involves a pilot type I hybrid effectiveness-implementation study with four OTPs.

Study Aim and Hypotheses are:

Aim: Pilot MBC effectiveness-implementation trial in community OTPs. Four OTPs will participate in a pilot hybrid type 1 effectiveness-implementation trial in which an MBC assessment protocol will be integrated into each OTP's electronic medical record (EMR). The pilot trial will gather data on MBC's effectiveness (outcomes: patient attendance and opioid abstinence) and implementation (outcomes: provider MBC exposure and fidelity). The study hypotheses are that post MBC EMR integration, patients will attend more treatment appointments (H1) and have more negative opioid urine screens per month (H2) compared to pre-EMR integration patients. Provider MBC exposure and fidelity will also be positively associated with higher attendance and abstinence across all sites (H3).

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Measurement Based Care Implementation

All participating opioid treatment programs will receive this arm.

Group Type: EXPERIMENTAL

Measurement Based Care Training and Monthly Consultation

Intervention Type: BEHAVIORAL

Participating opioid treatment program leaders and treatment providers will receive two measurement-based care implementation strategies: 1) didactic training including a total of four hours of workshop training led by a measurement-based care expert, and 2) monthly consultation calls led by a measurement-based care expert for 6 months.

Interventions

Measurement Based Care Training and Monthly Consultation

Participating opioid treatment program leaders and treatment providers will receive two measurement-based care implementation strategies: 1) didactic training including a total of four hours of workshop training led by a measurement-based care expert, and 2) monthly consultation calls led by a measurement-based care expert for 6 months.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Provide supervision or oversight to treatment providers or provide administrative oversight at the OTP
• Conduct supervision or oversight primarily in English

• Are considered a treatment provider at the OTP providing direct patient care
• Conduct treatment primarily in English

• Must be a new patient at the opioid treatment program in the 6 months pre or post measurement-based care implementation

Exclusion Criteria

• Younger than 18 years of age
• Does not have electronic medical records

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Kelli Scott

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Family Guidance Centers, Inc.

Aurora, Illinois, United States

Site Status: RECRUITING

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status: RECRUITING

Family Guidance Centers, Inc.

Chicago, Illinois, United States

Site Status: RECRUITING

Family Guidance Centers, Inc.

Des Plaines, Illinois, United States

Site Status: RECRUITING

Family Guidance Centers, Inc.

Joliet, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kelli Scott, PhD

Role: CONTACT

kelli.scott@northwestern.edu

312-503-0347

Facility Contacts

Kelli Scott, PhD

Role: primary

kelli.scott@northwestern.edu

312-503-0347

Kelli Scott, PhD

Role: primary

kelli.scott@northwestern.edu

312-503-0347

Kelli Scott, PhD

Role: primary

kelli.scott@northwestern.edu

312-503-0347

Kelli Scott, PhD

Role: primary

kelli.scott@northwestern.edu

312-503-0347

Kelli Scott, PhD

Role: primary

kelli.scott@northwestern.edu

312-503-0347

References

Scott K, Guigayoma J, Palinkas LA, Beaudoin FL, Clark MA, Becker SJ. The measurement-based care to opioid treatment programs project (MBC2OTP): a study protocol using rapid assessment procedure informed clinical ethnography. Addict Sci Clin Pract. 2022 Aug 19;17(1):44. doi: 10.1186/s13722-022-00327-0.

Reference Type: BACKGROUND

PMID: 35986380 (View on PubMed)

Other Identifiers

K23DA050729

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SP0077172

Identifier Type: -

Identifier Source: org_study_id