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

Opioid Use Disorder Clinical Trial

— MBC2OTP  

Official title:

Pilot Implementation of Measurement-Based Care in Community Opioid Treatment Programs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06345274
• Other study ID #: SP0077172
• Secondary ID: K23DA050729
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: February 2026

Study information

• Verified date: April 2024
• Source: Northwestern University
• Contact: Kelli Scott, PhD
• Phone: 312-503-0347
• Email: kelli.scott[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (Opioid Treatment Program Leaders):

• Provide supervision or oversight to treatment providers or provide administrative oversight at the OTP

• Conduct supervision or oversight primarily in English

Inclusion Criteria (Opioid Treatment Program Providers):

• Are considered a treatment provider at the OTP providing direct patient care

• Conduct treatment primarily in English

Exclusion Criteria (Opioid Treatment Program Leaders and Providers):

• Exclusion criteria are minimal to enhance generalizability and enable participation of all leaders and treatment providers overseeing or delivering care at each opioid treatment program. Providers and leaders will be excluded if they do not conduct treatment in English, as the measurement-based care assessment tool is written in the English language.

Inclusion Criteria (Persons receiving treatment at Opioid Treatment Programs [Not recruited, via electronic medical records only]):

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

Exclusion Criteria (Persons receiving treatment at Opioid Treatment Programs [Not recruited, via electronic medical records only]):

• Younger than 18 years of age

• Does not have electronic medical records

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Family Guidance Centers, Inc.	Aurora	Illinois
United States	Family Guidance Centers, Inc.	Chicago	Illinois
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Family Guidance Centers, Inc.	Des Plaines	Illinois
United States	Family Guidance Centers, Inc.	Joliet	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient treatment attendance (effectiveness outcome)	Treatment attendance will include both completion of medication for opioid use disorder (MOUD) dosing visits and attendance at treatment sessions. Data to be extracted from opioid treatment program electronic medical records include the number of treatment sessions/visits attended for each patient (e.g., MOUD dosing visits and individual/group counseling appointments) and the total number of treatment visits scheduled for each patient.	Assessed for 6 months for each patient both pre and post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Primary	Patient treatment attendance (effectiveness outcome)	Treatment attendance will include both completion of medication for opioid use disorder (MOUD) dosing visits and attendance at treatment sessions. Data to be extracted from opioid treatment program electronic medical records include the the total number of weeks each patient was retained in treatment after an initial intake appointment.	Assessed for 6 months for each patient both pre and post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Primary	Treatment provider measurement based care exposure (implementation outcome)	The total number of monthly completed counseling or treatment sessions delivered by treatment providers will be extracted from the opioid treatment program electronic medical record. The research team will compute monthly MBC exposure values by dividing the total number of sessions with MBC administration documentation by the total number of sessions completed for each patient.	Assessed for 6 months for each patient post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Secondary	Patient opioid abstinence (effectiveness outcome)	Data to be extracted from opioid treatment program electronic medical records include the number of positive and negative opioid use screens (e.g., urine screens and/or oral swabs) for each patient.	Assessed for 6 months for each patient both pre and post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Secondary	Treatment provider measurement based care fidelity (implementation outcome)	Treatment providers will report in the opioid treatment program electronic medical record if they administered, reviewed, discussed the MBC measure, and/or reevaluated the treatment plan at each counseling or treatment session. The research team will calculate categorical fidelity scores for each completed counseling or treatment session. MBC fidelity scores will be calculated on a researcher created MBC fidelity scale from "0" (no MBC administered) to "3" (full MBC fidelity) where higher scores indicate better MBC fidelity.	Assessed for 6 months for each patient post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.