Opioid Use DisorderNCT06965010
Measurement Based Care in Opioid Treatment Programs
A study testing Measurement-based care and Measurement As Usual in people with Opioid Use Disorder, run by University of Pittsburgh at 1 site in United States.
Trial summary
The goal of this HEAL Initiative study is to enhance the measurement, quality, and equity of care delivered in 20 community opioid treatment programs (OTPs) by creating and using measurement-based care (MBC) tools and systems. Patients will use MBC tools to track their symptoms and discuss with their providers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- Measurement-based care and Measurement As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,650 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 31 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OTP patients will be eligible to participate if they:
- are adults (aged 18 years or older);
- are initiating MOUD at the OTP, as a new patient (as defined by OTP guidelines); and
- speak primarily English or Spanish.
Who cannot join
- OTP patients will be excluded from participation if they:
- are under the age of 18;
- are not a new MOUD patient at the OTP
- do not speak primarily English or Spanish.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Hybrid Clinical Effectiveness Trial Type II of Measurement Based Care in Opioid Treatment Programs
The goal of this HEAL Initiative study is to enhance the measurement, quality, and equity of care delivered in 20 community opioid treatment programs (OTPs) by creating and using measurement-based care (MBC) tools and systems. Patients will use MBC tools to track their symptoms and discuss with their providers. This data will be collected over the course of the study to evaluate the effectiveness of MBC in improving patient care and treatment outcomes.
Read the detailed description
Opioid use disorder (OUD) remains a critical public health crisis in Pennsylvania. Measurement-based care (MBC) is the systematic use of client self-report data to inform treatment and is an evidence-based intervention that is uniquely well suited to complement opioid use disorder (OUD) pharmacotherapy that occurs within opioid treatment programs (OTPs). The study aims to enhance the measurement, quality, and equity of care delivered in 20 community OTPs by co-designing and implementing MBC tools and systems. Using a Hybrid Implementation Effectiveness Type II trial with a stepped-wedge design, MBC implementation (e.g., fidelity) and clinical (e.g., patient retention, improved quality of life) effectiveness will be evaluated simultaneously with quantitative and qualitative data. This study aims to provide: (1) preliminary evidence regarding the role and significance of capitalizing on MBC in opioid use disorder (OUD) treatments (including evidence on potential mechanisms underlying MBC's effects); (2) enhanced adoption of MBC via implementation strategies that are co-designed with stakeholders (policymaker, payer, and OTP); and (3) alternative avenues to potentially enhance symptom-related outcomes and treatment retention of OUD interventions with downstream societal, psychological, and public health benefits.
- Conditions
- Opioid Use Disorder
- Being tested
- Measurement-based care, Measurement As Usual
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement-based careBehavioural
Patients will complete MBC measures with their treatment provider and follow-up surveys conducted at baseline and monthly intervals. Both providers and patients will use the Greenspace Mental Health tools to regularly assess patient-reported symptoms, review results together, and collaboratively design individualized treatment plans. Providers will implement MBC to guide treatment adjustments based on these assessments.
Measurement As UsualBehavioural
Patients will participate in Measurement As Usual (MAU) via the existing processes available within treatment sites. Currently, patients are assessed and participate in semi-structured interviews at 6-month increments to assess progress and appropriateness of level of care.
| Study group | Role | What they receive |
|---|---|---|
| Measurement Based Care | Experimental | Monthly Use of Measurement-Based Care using Greenspace Mental Health tools Receives: Behavioral: Measurement-based care |
| Measurement As Usual followed by Measurement Based Care | Experimental | Participation in existing processes available within treatment sites including semi structured interviews followed by monthly use of Measurement-Based Care using Greenspace Mental Health tools Receives: Behavioral: Measurement-based care; Behavioral: Measurement As Usual |
| Measurement As Usual | Active comparator | Participation in existing processes available within treatment sites including semi structured interviews Receives: Behavioral: Measurement As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Treatment Retention - Clinical Effectiveness Outcome
Change in Patient Treatment Retention: clinic-level outcome measure that tracks the duration of OUD treatment based on medications, counseling and related services, as recorded in the claims data. Specific measures are the (1) % of patients still in treatment 6 months after initiating MOUD and (2) the average number of months new MOUD patients remain in treatment (12-month follow-up window).
Measured: Continuous following new MOUD patient intake events during the 9-month periods prior to and during MBC+/Implementation Phase in an OTP
Change in Patient's Perceived Recovery - Clinical Effectiveness Outcome
Change in Patient Recovery: patient-level outcome measure that evaluates progress in patient recovery obtained from survey data. The Brief Addiction Monitoring assessment question will be administered monthly to monitor substance use.
Measured: Monthly during the 9-month MBC+/Implementation Phase, sub-group of OTP sites during 9-month period pre-MBC+/Implementation Phase
Change in Patient Quality of Life - Clinical Effectiveness Outcome
Change in Patient Quality of Life: patient-level outcome measure that evaluates progress in patient quality of life. The Patient-Reported Outcomes Measurement Information System (PROMIS-29) Instrument will be administered at baseline and at every 3 months to evaluate and monitor physical, mental, and social health via The Greenspace Mental Health tool.
Measured: At baseline and every 3 months during the 9-month MBC+/Implementation Phase, sub-group of OTP sites during 9-month period pre-MBC+/Implementation Phase
Sustainment of Measurement-Based Care Implementation
The sustainment of MBC implementation is defined as the extent to which providers continue to use MBC tools with fidelity following the removal of active implementation support, based on data sourced from Greenspace and/or provider surveys. Each treatment session will continue to receive a score of "1" for documentation of MBC data collection, a "2" for documented data sharing, and a "3" for documented action informed by data. Sessions without MBC documentation will receive a "0." Sustainability is assessed by examining whether fidelity to core MBC components is maintained over time. Potential metrics include:
Percentage of sessions with completed MBC assessments during Sustainment Percentage of sessions where MBC results were reviewed with patients during Sustainment Percentage of sessions with documented action taken during Sustainment Percentage of providers meeting a predefined threshold for sustained fidelity (e.g., 80% of sessions scoring ≥2) during Sustainment
Measured: During the Sustainment Phase ~9 months post-Implementation
Fidelity of Measurement-Based Care Implementation
The Fidelity of MBC Implementation is defined as the extent to which providers administer and use MBC tools as intended based on data sourced from Greenspace and/or provider surveys during the Implementation Phase. MBC fidelity will be a single outcome measure that ranges from 0-3. Each treatment session will receive a "1" for documentation of MBC data collection, a "2" for documented data sharing, and a "3" for documented action informed by data. All attended appointments without MBC documentation will receive a "0."
Potential metrics include:
Percentage of sessions with completed MBC assessments Percentage of sessions where MBC results were reviewed with patients Percentage of sessions with documented action taken
Measured: Monthly during the 9-month MBC+/Implementation Phase
Adoption of Measurement-Based Care Implementation as Assessed by Patient Surveys - Measure Implementation Outcome
The adoption of MBC implementation will be assessed based on the percentage of OTP treatment providers who use MBC during and after active implementation. Adoption will be measured using patient surveys during the Implementation Phase.
Measured: Monthly during the 9-month MBC+/Implementation Phase
Adoption of Measurement-Based Care Implementation as Assessed by Greenspace Mental Health tools - Measure Implementation Outcome
The adoption of MBC implementation will be assessed based on the percentage of OTP treatment providers who use MBC during and after active implementation. Adoption will be measured using Greenspace Mental Health tools during the Implementation Phase.
Measured: Monthly during the 9-month MBC+/Implementation Phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start1 Oct 2025
- Primary completion1 Nov 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This study is a hybrid implementation effectiveness type II trial with a stepped wedge design. Each cohort of OTP sites (\~5 sites per cohort; 4 cohorts or 20 OTP sites total) will begin in the Measurement as Usual condition (MAU) and then cross over to a 9-month MBC+ Implementation Phase followed by a Sustainability Phase to monitor ongoing MBC implementation. Individual participant may experience one or the other or both interventions
- Masking
- None (open label)
- Enrolment
- 3,650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Renee Cloutier, University of Pittsburgh
- Investigators
- Renee Cloutier, PhD, Principal investigator, University of PittsburghKelli S Scott, PhD, Principal investigator, Northwestern UniversityArnie Aldridge, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965010
- Sponsor's protocol ID
- STUDY24080133
- Other IDs
- 1RM1DA059395-01
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Identifiable data will not be shared from this research project. HEAL-MBC will work with NIDA to develop a plan consistent with the HEAL Initiative Public Access and Data Sharing Policy to ensure that Harm Reduction Network Publications and, to the extent possible, the underlying primary data are immediately and broadly available to the public in a way that protects participant data in accordance with 45 C.F.R. 46 and other applicable laws. The data sharing plan will comply with the Health Insurance Portability and Accountability Act (HIPAA) of 1996 regulations and Institutional Review Board requirements. Data will be submitted to the NIDA-supported National Addiction \& HIV Data Archive Program (NAHDAP) repository for storage, archiving, and sharing for future studies.
Publications
Cloutier RM, Aldridge A, Lessley A, Loveland D, Sedlock R, Scott K. The HEALing Measurement Center: a stepped wedge cluster randomized study protocol to enhance opioid use disorder recovery through measurement based care. Implement Sci. 2026 Feb 21;21(1):25. doi: 10.1186/s13012-026-01492-5.
PubMed 41723468