Clinical trial NCT06345274: MBC2OTP Project (Measurement-Based Care Implementation in Community Opioid Treatment Programs)
Official title: Pilot Implementation of Measurement-Based Care in Community Opioid Treatment Programs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Opioid Use Disorder
Opioid Treatment Programs
Measurement-Based Care
Implementation Science
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-04-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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

Primary outcomes:
measure: Patient treatment attendance (effectiveness outcome)
timeFrame: 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.
measure: Patient treatment attendance (effectiveness outcome)
timeFrame: 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.
measure: Treatment provider measurement based care exposure (implementation outcome)
timeFrame: 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 outcomes:
measure: Patient opioid abstinence (effectiveness outcome)
timeFrame: 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.
measure: Treatment provider measurement based care fidelity (implementation outcome)
timeFrame: Assessed for 6 months for each patient post measurement based care implementation. Data will be extracted from the opioid treatment program electronic medical record.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Family Guidance Centers, Inc.
state: Illinois
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Chicago
country: United States
facility: Family Guidance Centers, Inc.
state: Illinois
city: Des Plaines
country: United States
facility: Family Guidance Centers, Inc.
state: Illinois
city: Joliet
country: United States
facility: Family Guidance Centers, Inc.
state: Illinois
Study officials:
References:
citation: 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.