The HEALing Measurement Center: a stepped wedge cluster randomized study protocol to enhance opioid use disorder recovery through measurement based care

Abstract

Background

Opioid use disorder (OUD) remains a critical public health crisis across the United States. To address this challenge, the HEALing Measurement Center, funded by the National Institutes of Health (NIH) Helping to End Addiction Long-term (HEAL) Initiative, aims to enhance the quality, equity, and sustainment of care delivered in Pennsylvania opioid treatment programs (OTPs) through the implementation of measurement-based care (MBC). This initiative leverages interdisciplinary collaboration among academic researchers, state and community partners, payers, and OTP providers to address critical gaps in OUD treatment and implementation science.

Methods

Three research projects were designed to address immediate implementation support needs expressed by community partners while simultaneously meeting critical research gaps. Research Project 1 develops an MBC implementation blueprint co-designed with key constituents to address barriers such as paperwork burden and facilitate technical assistance and learning networks. Research Project 2 evaluates the effectiveness and implementation of an enhanced MBC implementation strategy (MBC +) compared to measurement implementation as usual (MAU) through a hybrid type 2 stepped-wedge effectiveness-implementation trial. Research Project 3 focuses on the clinical impact of MBC + on patients with OUD and co-occurring mental health conditions, exploring mechanisms underlying treatment success.

Discussion

This protocol provides an overview of the research design as well as the unique community partnerships leveraged to enhance MBC implementation. Overall, the projects within the HEALing Measurement Center aim to establish a foundation for future MBC scale-up and sustainment across Pennsylvania, provide learnings that can inform other implementation efforts, and enhance the quality of interventions for individuals with OUD.

Trial Registration

Clinicaltrials.gov, NCT06965010, Registered 11 May 2025, https://clinicaltrials.gov/study/NCT06965010.

Contributions to the Literature.

• The HEALing Measurement Center aims to improve care for opioid use disorder (OUD) through the implementation of measurement-based care (MBC), an intervention that helps patients and counselors monitor treatment progress.

• The Center will conduct three projects with 20 Pennsylvania opioid treatment programs (OTPs) to: 1) assess barriers and facilitators and design MBC implementation plans; 2) evaluate whether MBC is effective and if it is used across OTPs; and 3) assess whether MBC is effective for patients with OUD and other mental health conditions.

• These projects will identify what strategies are needed to get MBC used with all patients throughout Pennsylvania OTPs.

Introduction

Overdoses remain a leading cause of death in the United States, with rates further exacerbated by the COVID-19 pandemic [1]. Medications for opioid use disorder (MOUD), including oral methadone and sublingual buprenorphine, are among the most effective evidence-based interventions supporting OUD recovery. Meta analyses have found that both methadone and buprenorphine are associated with reductions in non-medical opioid use and increased periods of abstinence as well as reductions in risky substance use, blood-born viral infections, and overdose events [2–6]. Despite strong evidence, nearly 20% of MOUD patients discontinue treatment within the first month and 40–50% within three months [7–12]. Ongoing use of alcohol, stimulants, and other substances is common within the first year of MOUD initiation (ranging from 20 to 77%) and increases the risk of poor adherence and disengagement [13, 14]. These engagement challenges indicate that improved access to MOUD alone is insufficient for retaining patients in treatment. Adjunctive interventions are needed to support ongoing recovery, including tools to systematically monitor treatment response, detect non-response early, and intervene proactively to reduce the risk of treatment disengagement.

Measurement-based care (MBC) is an evidence-based intervention that involves systematically assessing patient treatment progress using measurement tools (i.e., a patient self-report or clinician administered questionnaire) at each treatment encounter [15, 16]. When applied with fidelity, MBC involves four key steps summarized as Collect, Share, Act, and Document: 1) Collect patient reported outcomes via measurement administration; 2) Share and discuss responses with the patient; 3) Act via shared decision-making with the patient to identify treatment plan changes and areas of focus for the current appointment/session; and an added step of 4) Documenting responses and treatment plan changes in the health record or other platform to facilitate progress tracking over time [16, 17]. MBC has been demonstrated to improve treatment outcomes and fidelity to treatment guidelines [18–20], patient communication and engagement [21, 22], and cost-effectiveness of both pharmacotherapy and psychotherapy treatments [18, 20, 23, 24]. MBC is theorized to exert its positive effects on treatment via at least three mechanisms: 1) providing a systematic process for collecting patient progress data and making rapid treatment changes for patients who are not improving [16, 19, 25]; 2) facilitating more collaborative care coordination among providers within and across organizations [16, 26]; and 3) enhancing patient insight and agency in their treatment process [22, 27].

Despite MBC’s potential for improving outcomes and treatment retention for patients receiving MOUD, MBC remains underutilized in behavioral healthcare generally, and in opioid treatment programs (OTPs) specifically [28]. MBC faces multi-level barriers when integrated into diverse treatment settings, including insufficient staff and provider training, burdensome or limited clinically meaningful measures, inefficient data informatics tools (e.g., data collection and management, actionable data output), limited time in patient sessions for assessments, and low agency capacity for innovations, specifically those that result in increased documentation burdens [23]. OTPs are the only federally certified entities outside of hospitals licensed to dispense methadone for the treatment of OUD. OTPs are critical settings for delivering effective MBC, considering that there are 2,117 locations serving approximately 600,000 adults annually in the United States, and with all required to provide comprehensive care (e.g., counseling, case management, collection of biometrics) [29–31]. OTPs are unique from other behavioral health settings due to extensive federal, state, and local regulations that exacerbate MBC barriers, including extensive paperwork and documentation practices, specific counseling regimens, and a 50-year legacy of dosing requirements and related payment strategies that continue to influence dosing regimens, even though it is no longer a SAMHSA requirement [32]. Together, these barriers and unique characteristics highlight a need for community co-designed MBC implementation strategies to enhance integration success in OTPs and improve clinical outcomes for patients with OUD.

The HEALing Measurement Center

The vision of the National Institute on Drug Abuse (NIDA) funded HEALing Measurement Center (RM1DA059395) is to enhance the measurement, quality, equity, and sustainment of OUD treatment. The HEALing Measurement Center (Center) brings together an expert team of researchers from University of Pittsburgh, Northwestern University Feinberg School of Medicine, and RTI International as well as an innovative research partnership with payers, policymakers, state agencies, and OTPs throughout Pennsylvania (PA). The Center is focused on conducting three interrelated projects to advance the implementation of MBC by co-designing implementation strategies to improve patient symptom data collection, analysis, monitoring, and reporting. Research Project 1 will focus on developing an MBC implementation blueprint that will include core (technical assistance [TA], learning network, and paperwork reduction strategies) and OTP-tailored de-implementation and implementation strategies. Research Project 2 will evaluate the clinical effectiveness and implementation of MBC via a hybrid type 2 stepped wedge effectiveness implementation trial that will test measurement implementation as usual (MAU) versus enhanced MBC implementation (MBC +). Finally, Research Project 3 will test the clinical effectiveness of MBC + relative to MAU for patients with co-occurring OUD and mental health diagnoses and will explore MBC mechanisms of action. Research Projects are further detailed below and summarized in Table 1; research timelines for each project can be found in Table 2.

Table 1.

Summary of HEALing Measurement Center Research Projects

Research Project	Objective	Key Activities	Outcomes
1 (Preparation)	Develop an MBC implementation blueprint tailored to PA OTPs	• Conduct mixed-methods organizational health assessments • Co-design implementation blueprint with stakeholders • Adapt MBC Measurement Tool	• Implementation blueprint tailored to OTPs • MBC Measurement Tool ready for deployment
2 (Implementation; Sustainment)	Evaluate the clinical and implementation effectiveness of MBC + versus MAU	• Conduct a hybrid stepped-wedge trial across 20 OTPs • Deliver enhanced technical assistance and learning networks • Implement paperwork reduction strategies	• MBC fidelity and adoption • Clinical effectiveness (e.g., treatment retention, symptom reduction) • Cost-effectiveness of MBC +
3 (Analysis & Dissemination)	Assess MBC + outcomes for patients with OUD and co-occurring mental health conditions (CO-MH)	• Analyze data from Research Project 2 • Examine mechanisms of action for MBC (e.g., service provision, patient-provider rapport)	• Effectiveness of MBC + for CO-MH patients • Identification of mechanisms driving MBC success

Table 2.

Study Timelines and Associated Activities

Pennsylvania OTP context

Pennsylvania is an ideal setting for studying MBC implementation at scale, with strong, bipartisan investment focused on combatting the opioid crisis [27]. In 2016, PA launched the Centers of Excellence (COE) program, which promotes integrated, patient-centered care by combining MOUD, mental health services, and care management across diverse settings, including OTPs. Since its inception, the COE network has expanded from 45 to 260 sites, supported by state agencies and managed care organizations (MCOs). Recent COE fidelity guidelines issued by the Pennsylvania Department of Human Services Office of Mental Health and Substance Abuse Services (OMHSAS) aim to standardize COE goals and streamline workflows, including documentation practices [33]. Twenty COE-designated OTPs will participate in the HEALing Measurement Center projects and are well-positioned to implement and evaluate MBC.

Guiding frameworks

The HEALing Measurement Center’s projects are guided by two implementation science frameworks: 1) The Exploration, Preparation, Implementation, and Sustainment (EPIS) framework which offers a phased structure to guide planning and implementation activities and assess key organizational factors; and 2) the Systems Transformation Framework (STF) which recognizes the implementation context as a complex adaptive system and offers dynamic strategies to prepare and implement organizational changes [34, 35]. Each of the Center’s Research Projects maps onto one or more EPIS Phases, with Research Project 1 focused on preparation, and Research Projects 2 and 3 centered on MBC implementation and sustainment. Note that the exploration stage was already completed prior to establishing the Center as part of the proposal development.

Manuscript objectives

The objectives of this protocol paper are to summarize the overarching goals and methods of the HEALing Measurement Center research projects. We present specific aims and methods for each Research Project below.

Methods

Research Project 1 (preparation)

Research Project 1 includes three specific aims to: 1) conduct an organizational health assessment to evaluate MBC barriers and facilitators; 2) develop an implementation blueprint; and 3) adapt the MBC Measurement Tool to meet the needs of participating OTPs. Results of a mixed methods assessment of barriers and facilitators will provide a starting point for the development of an implementation blueprint that will serve as a roadmap for MBC implementation in Research Project 2. Data collection will focus on a structure of quan + QUAL where quantitative and qualitative data will be collected simultaneously for the function of expansion (i.e., such that the qualitative data elaborates on the quantitative data) [36].

Site recruitment

Recruitment during the grant proposal (calendar year 2022) and post-funding re-engagement phases (calendar years 2023–2025) focused on recruiting 20 of 44 potential OTP sites with a COE designation; in addition to federal 42CFR and the PA Department of Drug and Alcohol Programs (DDAP) guidelines (e.g., standards for patient care, practitioner qualifications, licensure requirements) [29, 37, 38], these sites adhere to COE program guidelines overseen by OMHSAS and MCOs. Limiting recruitment to OTPs with a COE designation in the current projects provided additional consistency in programmatic structure and a standardized patient-level MAU assessment, while allowing the research team to leverage existing COE infrastructure for streamlined recruitment and integrated implementation. Recruitment activities were facilitated by partners and included presentations to OTP specific COE learning networks and email outreach and presentations to COE parent organization leadership. COE parent organization leadership interested in participating then reviewed and signed a Participation Letter that summarized project expectations and benefits. Once signed, leaders facilitated site visits, staff recruitment for key informant interviews and surveys, and completed formal research agreements/contracts.

Participants

For the Aim 1 organizational health assessment, OTP leadership, treatment providers, and staff will be invited to participate in OTP site visits (n = 20) and quantitative surveys (n = 5–10 per OTP). Leaders, providers, staff, and patients will be invited to engage in key informant interviews (n = 3–4 per OTP). Leaders will be eligible to participate if they: a) provide supervision or program oversight of providers delivering OUD counseling or medication management; and b) conduct supervision/oversight in English or Spanish. Providers will be eligible to participate in the mixed methods data collection if they: a) provide OUD counseling or medication management to patients; and b) conduct treatment in English or Spanish. Staff will be eligible to participate if they: a) have been employed at the organization for at least three months; and b) speak primarily English or Spanish. Patients will be eligible to participate if they: a) are adults (18 years or older); b) have initiated OTP treatment within the past 6 months; and c) speak primarily English or Spanish. Exclusion criteria are minimal to enhance generalizability and participation.

Initial site visits

Research and implementation staff will visit each OTP site to meet with OTP leaders and counselors as well as observe workflows. Specific objectives are to: 1) strengthen collaborative relationships with provider partners and create open channels for dialogue; 2) gain a comprehensive understanding of individual OTP’s operational processes; 3) conduct on-site observations and interact with key personnel to gather qualitative insights; and 4) identify barriers and facilitators to MBC implementation or paperwork reduction to incorporate into each site’s tailored implementation blueprint. Outputs included clinical workflows for intake and ongoing treatment, documented procedures, maps of physical OTP space, and key informant interview staff recruitment lists.

Key informant measures

Quantitative and qualitative data collection will be informed by the EPIS and STF frameworks to assess outer context, innovation, and inner context factors that may serve as barriers or facilitators to MBC implementation [35, 39]. Validated survey instruments (e.g., Implementation Climate Scale, Leadership Scale) and interview protocols will assess contextual factors influencing MBC implementation (see Table 3 for a full list of domains to be assessed). Sixty-minute interviews will be conducted by trained research team members and will assess feedback on the MBC tool and workflow. Transcripts will undergo directed content analysis guided by EPIS/STF.

Table 3.

Summary of Research Project 1 Organizational Health Assessment Measures Based on the EPIS and STF Frameworks

EPIS Factor Definition	EPIS Constructs	Measurement
Outer context- State and federal sociopolitical and economic contexts that influence the process of implement and delivery/use of the innovation	Service Environment/Policies	EBP-specific document review (i.e., regulations; annual reports; documented system-wide policies) – assess each treatment program’s required documentation practices (qualitative interview or leadership communication)
	Funding/Contracts	Qualitative interviews with providers on perceptions of funding contracts, inquire about current contracts/funding
	Patient/Client Characteristics	Demographics; Administrative Claims Data
Innovation factors – Feature or qualities of innovations to be implemented and fit with context Inner context—Structures or processes that take place and/or exist in organizations that may influence the process of implementation (e.g., individual characteristics culture, climate, readiness for change, capacity, competing priorities, fidelity support, continuous quality improvements)	Innovation/EBP Characteristics	Track and evaluate total cost of MBC intervention
	Innovation/EBP fit	Qualitative interviews with providers on perceptions of MBC intervention
	Organizational Climate	Implementation Climate Scale; Organizational Health Assessment
	Leadership	Implementation Leadership Scale; Organizational Health Assessment
	Readiness for Change	Organizational Readiness for Change; Organizational Health Assessment
	Provider Attitudes towards Innovation/EBP	Measurement Feedback Attitudes Scale
	Site Characteristics	Patient and Provider Demographics Survey
	Burnout	Stanford Personal Fulfillment Index

Statistical analysis and implementation blueprint development

Total and subscale scores will be calculated for each quantitative survey to identify average individual OTP and overall average scores on each domain of interest. Average OTP scores on measures and subscales will be compared to averages reported in the broader literature to identify which domains may serve as unique barriers or facilitators to MBC implementation in OTPs. Quantitative survey results will be connected to the qualitative key informant interviews via a directed content analysis approach to inform the implementation blueprint [40]. The directed content analysis will involve two independent coders engaging in four steps: 1) a priori development of a coding guide with both a priori codes guided by EPIS and STF and codes informed by the barriers and facilitators identified by the quantitative surveys; 2) application of the developed codebook to each of the interview transcripts using NVivo software; 3) weekly evaluation of inter-rater reliability and consensus on coding discrepancies; and 4) queries of the data to identify common themes.

The analyzed data will be used to inform the co-design of an implementation blueprint with the research team, policymaker, payer, and OTP constituents (Aim 2). This implementation blueprint will consist of a set of implementation and de-implementation strategies, including TA, learning networks, and paperwork reduction strategies, that will be deployed and tested in Research Project 2. The implementation blueprint co-design process will use a modified conjoint analysis approach, a procedure commonly employed in marketing to evaluate how consumers make decisions and tradeoffs when selecting products to purchase [41]. Conjoint analysis has previously been employed to inform implementation blueprint development [42] and is particularly beneficial for weighing the tradeoffs among the wide range of MBC implementation strategies available to OTPs. The strategies to be included in the final blueprint will be selected from the widely employed Expert Recommendations for Implementing Change (ERIC) taxonomy, a list of 73 implementation strategies compiled by implementation research experts [43].

Consistent with a modified conjoint analysis approach, we will convene a set of constituents that will include members of the research team (i.e., the implementation experts), policymaker and payer representatives, and key OTP leadership and treatment provider champion representatives [42]. Constituents will participate in three conjoint analysis workshop meetings with the research team. At the first meeting, constituents will be presented with a list of barriers to MBC implementation and asked to sort each identified barrier into a 2 × 2 table based on importance (i.e., whether the barrier is of high or low importance to address) and feasibility (i.e., high or low feasibility to address and/or change the barrier). Barriers with high importance and high feasibility will be reviewed by the research team, who will select an initial set of implementation strategies from ERIC to be reviewed in the next constituent meeting [43]. These strategies will at minimum include TA, learning networks, and paperwork reduction focused de-implementation strategies as they are key components of the COE implementation model and are core areas of focus for the HEALing Measurement Center.

During the second meeting, constituents will be presented with the list of preliminary implementation strategies selected by the research team and their definitions from the ERIC taxonomy. Constituents will be asked to rank each strategy on feasibility (high or low) based on available resources at the policy, payer, and OTP levels. Finally, the research team and constituents will come to consensus about the potential impact of each strategy on enhancing MBC fidelity on a scale from “1” – little to no impact to "3" – high impact. Strategies that are identified as high feasibility, high impact, or both will then be selected for inclusion in the final implementation blueprint. At the third meeting, the research team will work with constituents to operationalize the selected implementation strategies using the Strategies, Timeline, Activities, and Resources (STAR) log, an innovative and pragmatic tool that enables the specification and ongoing tracking of implementation strategies [44].

MBC measurement tool adaptation

Greenspace Mental Health is an MBC platform that enables electronic data capture (patients can complete measures on their personal devices or on an OTP owned device) and ongoing treatment progress monitoring through a treatment provider facing digital dashboard [45]. The HEALing Measurement Center will convene a separate constituent group with the Greenspace contractor, the research team, and OTP leaders and treatment providers. The MBC adaptation constituent group will engage in a two-step process that includes: 1) reviewing and selecting Greenspace measures to be included in the OTP MBC system; and 2) planning the MBC workflow to facilitate fidelity (i.e., Collect, Share, Act, and Document). MBC measures will at minimum include OUD symptoms and measures of co-occurring mental health disorders assessed on at least a monthly basis (see Table 4), however, OTP leaders may identify additional measures and establish site-specific workflows that will optimize the needs of their patient population.

Table 4.

Summary of Measurement as Usual (MAU) vs. Measurement-Based Care Plus (MBC +) Implementation Conditions

Domain	Opioid Treatment Program (OTP) MAU	COE Designated OTP MAU	MBC + Implementation
Patient Enrollment Criteria	• Aged 18 + OR provider has written parental consent • Enrolled in or eligible for Medicaid or other insurance • Meet OUD diagnostic criteria • No contraindications to MOUD • Meet OUD diagnostic criteria	• Aged 18 +  • Enrolled in or eligible for Medicaid • Meet OUD diagnostic criteria and not in sustained remission • Not currently or recently enrolled in a substance use treatment program (e.g., MOUD, OBOT, OTP) for more than 30 days	• Aged 18 +  • Enrolled in or eligible for Medicaid • Meet OUD diagnostic criteria • Newly enrolled per OTP criteria
Assessment Domains	• Standard assessments required, but not specified at the federal or state levels • Behavioral and physical health assessments, drug screening, etc. specified at the provider level	• Enrollment: Demographics • Enrollment & Monthly: Social Determinant of Health Needs, care management activities, referrals, MOUD delivery, physical and behavioral needs, referrals provided • Enrollment and Every 6 Months: Brief Assessment of Recovery Capital measure (BARC-10)	• MBC self-report tools via digital MBC platform including: o Generalized Anxiety Disorder-2 and 7 item (GAD-2; GAD-7) o Patient Health Questionnaire-2 and 8 item (PHQ-2; PHQ-8) o Columbia Suicide Severity Rating Scale (C-SSRS) o Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) o Substance Use Frequency Checklist o Short Opiate Withdrawal Scale (SOWS) o Opioid Craving Scale (OCS) o Brief Addiction Monitoring (BAM) Recovery Progress Item
Assessment Workflow	• Site-specific protocols	• Completed post-encounter by COE staff and entered into REDCap	• Administered to patients pre-clinical encounter • Reviewed and used in-session by providers
TA and Learning Networks	• DDAP Monthly TA Webinars	• COE Monthly TA and Learning Networks	• MBC Monthly TA with leaders and providers focused on: • MBC fidelity, • MBC clinical integration • Paperwork reduction
Provider Guidance on Measures	• Program and site-specific protocols informed by Federal, State, and licensure/certification requirements	• Focused on completion • No structured guidance on how to use data to inform clinical care	• Structured guidance on using MBC data in real-time for clinical decision-making
Data Reports	• Program and site-specific reports from EHR	• Monthly COE Reports	• Monthly MBC reports focused on enrollment and fidelity
Implementation Supports	• Program and site-specific protocols informed by Federal, State, and licensure/certification requirements	• COE-focused TA and learning network support only	• Additional implementation strategies tailored to MBC + needs: o Adapted workflows o Optional separate vs integrated TA delivery
Sustainment Phase	• Not applicable	• Not applicable	• Ongoing access to MBC tools and platform • COE TA continues, but MBC-specific supports are removed to assess sustainment

Note. TA = Technical Assistance; COE = Centers of Excellence for Opioid Use Disorder Treatment; EHR = electronic health record; MBC = Measurement Based Care; MCO = Managed Care Organizations

Research Project 2 (implementation, sustainment)

Research Project 2 is a hybrid type 2 effectiveness-implementation stepped-wedge cluster randomized trial that will compare OTP MAU to enhanced MBC Implementation (MBC +) across 20 OTPs (See Table 4). The hybrid type 2 study will have co-primary aims to evaluate the effectiveness and implementation of MBC across participating OTPs [46]. A stepped-wedge design was selected for Research Project 2 to increase the feasibility of project rollout and allow for all OTPs to eventually receive MBC + [47]. OTPs will engage in three project phases: pre-implementation (MAU), implementation (MBC +), and sustainment and will initiate the implementation phase in four cohorts with one cohort beginning every 6 months across the three-years of (see Fig. 1).

Fig. 1.

Research Project 2 timeline and stepped wedge design

Research Project 2 has three specific aims and associated hypotheses. Aim 1 is to evaluate MBC implementation outcomes including adoption, fidelity, sustainment and program implementation costs. We hypothesize that MBC + will result in improved MBC implementation outcomes, including greater adoption (H1a), fidelity (H1b), and sustainment (H1c). From a healthcare payer perspective, we will also estimate the cost-effectiveness of MBC + versus MAU for patient-month of retention in MOUD treatment. Second, we will estimate the difference in net costs to Medicaid per patient under MBC + versus MAU. We hypothesize that MBC + will be more cost effective than MAU for patient-month of retention and have reduced net costs to Medicaid per patient (H1d).

Aim 2 will compare the effect of MAU versus MBC + conditions on MOUD treatment retention, OUD symptoms, patient recovery progress, and patient quality of life. We hypothesize that MBC + will result in higher patient treatment retention as measured by the percentage of new patients still in treatment six months after initiating MOUD (H2a) and improvements in OUD symptoms (H2b), perceived recovery progress (H2c), and quality of life (H2d). Finally, Aim 3 will explore MBC implementation strategies’ theorized mechanisms of action linked to implementation outcomes of adoption, fidelity, and sustainment via mediational analyses. We hypothesize that increased provider self-efficacy and knowledge gain will mediate the association between the MAU and MBC + implementation strategies and implementation outcomes (H3a). We also anticipate that reduced provider burnout will mediate the association between MBC + and implementation outcomes given the addition of paperwork reduction focused de-implementation strategies (H3b).

Exploratory analyses

Among the sample of MBC + patients, we will examine the bi-directional relationships between (a) provider MBC fidelity over time and (b) within patient OUD symptoms, perceived recovery progress, and quality of life. We will test the extent to which severity of OUD symptoms and quality of life at time of initiating MOUD are associated with increased MBC use. We will also test the extent to which higher rates of MBC use over time are associated with improved patient treatment retention, OUD symptoms, recovery progress, and quality of life by the 6th month following MOUD initiation.

Participants

New MOUD patients (n = 3,650) will be enrolled from 20 PA OTPs described above in Site Recruitment. OTP leaders and treatment providers will be eligible to participate using the same eligibility criteria as in Research Project 1. OTP Patients will be eligible to enroll if they are: a) adults (aged 18 or older); b) initiating MOUD as a new patient (as defined by OTP guidelines) during either the OTP’s MAU or MBC + period; c) primarily English or Spanish speaking; and d) enrolled in Medicaid. As with Research Project 1, exclusion criteria are minimal to enhance generalizability and participation. While eligibility is not restricted to a specific MOUD class, most patients are expected to be receiving methadone (cf. buprenorphine, naltrexone). Consistent with ongoing procedures for MAU, comparison samples will be identified via claims and COE-related patient data.

MBC site-level intervention

The MBC program includes a digital platform (i.e., Greenspace Health), core delivery steps, and site-specific workflows that are utilized and executed by OTP counselors, care managers, or other clinicians. The digital MBC platform integrates eight validated measures for measuring ongoing mental health and substance use disorder symptoms (See Table 5 for list of measures). MBC core delivery steps align with the Collect, Share, Act model (with Document as an added step) and are presented in Fig. 2.

Table 5.

Study Assessments and Measures

Domain	Assessment	Month
		1 (Baseline)	2	3	4	5	6	7	8	9
Anxiety	GAD-2; GAD-7	X	X	X	X	X	X	X	X	X
Depression	PHQ-2; PHQ-8	X	X	X	X	X	X	X	X	X
Suicide	Columbia C-SSRS	X	X	X	X	X	X	X	X	X
PTSD	PC-PTSD 5	X	X	X	X	X	X	X	X	X
Other Substance Use	Checklist – Frequency of Use	X	X	X	X	X	X	X	X	X
Opioid Withdrawal	Short Opiate Withdrawal Scale (SOWS)	X	X	X	X	X	X	X	X	X
Opioid Craving	The Craving Scale	X	X	X	X	X	X	X	X	X
Recovery Progress	Brief Addiction Monitoring Item	X	X	X	X	X	X	X	X	X
Quality of Life	PROMIS-29 (v.2.1) PROPr	X		X			X			X
Social Determinants of Health	The Accountable Health Communities Health-Related Social Needs Screening Tool (CMS-HRSN)	X					X
Patient Agency	“Were you involved as much as you wanted in decisions about your treatment?”	X		X			X			X
Patient Satisfaction	“How satisfied are you with the care you received today?”	X		X			X			X
Patient Provider Rapport	Working Alliance Inventory -WAI-6 (Greenspace)	X		X			X			X
Treatment Retention	Medicaid Claims Data	Continuous
Costs to Medicaid	Medicaid Claims Data	Continuous
Implementation Costs	Document Review/Key Informant Interviews	Two times points per OTP

Fig. 2.

MBC collect, share, act, and document steps for use in opioid treatment programs

Consistent with current OTP practice, most new OTP patients will complete site-specific intakes and have daily in-person MOUD dosing visits. MBC enrollment for eligible patients will occur at the first individual counseling or care management session after they have received their first MOUD dose which may be one-30 days after intake. During enrollment, eligible patients will be informed about the purpose of MBC and, if interested, instructed on how to use the digital MBC platform. Thereafter, MBC assessments will be administered at least monthly for as long as the patient is in care during the study timeline (i.e., throughout each site’s implementation and sustainment phases). Patients will have the ability to complete assessments up to 72 h before scheduled appointments. During the appointment, the OTP provider will review responses with the patient using the digital platform’s data visualization tools; responses will then guide the counseling session agenda and/or be used to make treatment plan changes. Following each appointment, providers will document MBC responses, review, and discussion/treatment changes (i.e., MBC fidelity) in the Greenspace Health platform.

Randomization

Randomization will occur at the OTP/site level to enhance MBC implementation feasibility and due to the stepped-wedge cluster randomized trial design. OTPs will be randomized by the study statistician using procedures outlined by Brown and Lilford [47] and Chamberlain et al. [48] into one of four cohorts over time (4–6 OTPs per cohort, see Fig. 3) using computer-generated random numbers. In addition, randomization will be nested within two strata: by counties in metro areas of 1 million population or more (per 2023 Rural–Urban Continuum Codes) and whether the primary payer for the OTP is Community Care Behavioral Health Organization, UPMC Insurance Services Division (CCBHO).

Fig. 3.

CONSORT flow diagram of anticipated patient enrollment and cohort allocation for MAU and MBC + conditions

Implementation conditions

Each cohort will begin in the MAU condition and then cross over to a 9-month MBC + implementation phase followed by a sustainment phase to monitor ongoing MBC implementation. Details of the MAU and MBC + conditions are described below.

MAU

All 20 participating OTPs currently have existing assessment batteries and TA that are informed by federal, state, licensing, and organizational policies (see Table 4). As OTP designated COEs that serve Pennsylvania Medicaid enrollees, some measures are standardized across sites (e.g., claims data; Care Management REDCap); however there is substantial variability in patient measurement types, length, and workflows during and post-intake as OTPs vary in business structure (i.e., profit vs. non-profit), payer contracts, size (i.e., 1–14 sites), geographic location, and licensing/certification (e.g., Commission on Accreditation of Rehabilitation Facilities). None of the OTPs currently utilize MBC or receive MBC-related TA.

MBC + 

Once each cohort crosses over into the implementation phase (MBC +), they will receive monthly TA and learning community strategies focused on integrating MBC into clinical practice (e.g., using MBC with fidelity, making MBC-informed treatment decisions, troubleshooting MBC use with complex patients) and de-implementing paperwork burdens. MBC + implementation and de-implementation strategies will either be integrated with or provided separately to ongoing COE TA based on OTPs preferences assessed in Research Project 1. All TA will be delivered by master’s level implementation support specialists supervised by the research team and the University of Pittsburgh Program Evaluation and Research Unit. Once cohorts have completed the nine-month MBC +/Implementation Phase, they will enter an MBC sustainment phase. During sustainment, OTP cohorts will continue to have access to the MBC platform and technical support as well as the COE related TA from MCOs and the University of Pittsburgh Program Evaluation and Research Unit (funded and supported through state contracts) without the implementation supports provided during MBC +, thereby enabling ongoing evaluation of MBC sustainment in the absence of additional implementation strategies.

Measures

Table 5 provides an overview of all planned Research Project 2 outcomes and the project measurement timeline.

Statistical and power analyses

Descriptive statistics will be explored (means, standard deviations, ranges) for all implementation and effectiveness outcome variables for MBC + relative to MAU across all 20 OTPs. Due to the nested, non-independent nature of the data, multilevel modeling (MLM) will be conducted using the R package lme4 [49] to evaluate each MBC + implementation outcomes including adoption (Aim 1; H1a), fidelity (H1b), sustainment (H1c), and cost (H1d). Level 1 assessments (at each timepoint) will be nested within Level 2 OTPs. Restricted maximum likelihood (REML) will be used, which is a robust method to account for missing data that uses all information to estimate the model [50]. Intercepts will vary randomly across OTPs.

Generalized linear mixed models (GLMM) within the REML framework will be used for analyzing healthcare cost data to evaluate, using a log link function and a gamma family distribution to appropriately model left-skewed cost measures. Two health economic analyses will be conducted for Aim 1 following recommendations from the Second Panel for health economic analyses [51]. First, we will estimate the cost-effectiveness of MBC + for avoided overdose deaths. Second, a net cost-savings to Medicaid (a limited health system perspective) will be calculated using the programmatic costs in the implementation phase and the downstream costs of all-cause healthcare use by the patients.

For Aim 2 analyses, we will conduct MLM models to evaluate group differences between MAU versus MBC + on patient clinical effectiveness outcomes including treatment retention (H2a), OUD symptoms (H2b), perceived recovery progress (H2c), and quality of life (H2d). In these models, Level 1 patients will be nested within Level 2 OTPs. Intercepts and slopes will vary randomly across OTPs. At Level 1, all models will covary for age, sex, race/ethnicity, the current endorsement of any co-occurring mental health conditions (yes/no), and the ratio of treatment services indicated vs. services received in the past 12 months. At Level 2, all models will control for client caseloads and organizational health to rule out any differences in patient outcomes as a function of OTP capacity.

For Aim 3, mediation analyses will be conducted to evaluate the direct effects of the MAU and MBC + implementation strategies on the three implementation outcomes (adoption, implementation/MBC fidelity, and sustainment), as well as the indirect effects resulting from theorized mediator variables including provider self- efficacy, knowledge gain, and burnout. Mediation will be tested using a product of coefficients approach, which will separate the direct and indirect effects of the implementation strategies on implementation outcomes using the PROCESS macro for R (Version 4.2) [52].

Power considerations

Power analyses were run for Aim 2 using R packages simr102 and lme495 with pilot data from 33 COE designated OTPs (3,561 patients). Intraclass correlations coefficients (ICCs) indicated 82–94% of the variability in 90-day patient retention and treatment recovery was at the patient, within-treatment site level. We fixed the within-treatment site effects of 90-day patient retention-MBC implementation to b = −0.10 and treatment recovery-MBC implementation to b = −2.44 based on an approximation computed from the effect sizes reported by a recent meta-analysis [53], resulting in 99.63–100% power to detect effects depending on the model with six covariates included for each model. Power curve estimates showed that setting the N to 2,354 observations (OTPs*patients) would yield sufficient power (80%) to detect the smaller within-treatment site effect of 180-day (6 month) patient retention- MBC implementation. Assuming the fixed effects of Aim 1 are larger than the effect of 180-day patient retention-MBC implementation, a smaller sample is sufficient to yield sufficient power (80%) to detect effects.

For Aim 3, To achieve sufficient power (0.80) to detect the indirect effect (path c’) of the proposed mediation model using percentile bootstrapping with PROCESS macro for R (Version 4.2) [52, 54], recommend a sample size of 124–125 (OTP leaders/providers/staff) assuming the fixed effect sizes of path a and path b are either half-medium (b = 0.26) and medium (b = 0.39).

Research Project 3

Research Project 3 will include secondary analyses of Research Project 2 data to evaluate MBC’s effectiveness for improving outcomes and treatment service delivery for patients in OUD treatment with and without co-occurring mental health diagnoses. Consistent with Research Project 2, primary patient outcomes (OUD symptoms, treatment retention) will be assessed monthly and secondary outcomes (recovery progress, quality of life) will be assessed at 3-, 6-, and 9- months during Research Project 2’s active implementation periods. Primary treatment service outcomes will include claims of the number of distinct services provided across 12 months and the ratio of mental health services indicated vs. provided. Treatment mechanism variables, including number of services utilized, patient/provider rapport, and patient satisfaction will be assessed monthly during the active implementation phase. Covariates will include co-occurring conditions, co-occurring psychotropic medications, and demographics (age, sex, race/ethnicity).

Research Project 3 will evaluate three specific aims. Aim 1 will test the differential impact of MBC fidelity and treatment service delivery for patients with (CO-MH) and without a co-occurring MH disorder (i.e., OUD only) from Research Project 2. We hypothesize that CO-MH patients will have a greater number of treatment needs identified and provided (H1). Aim 2 will evaluate the relative clinical effectiveness of MBC + among CO-MH and OUD only patients across time, hypothesizing that CO-MH and OUD only patients enrolled in MBC + program will demonstrate improved retention rates relative to patients receiving MAU by nine months (H2). Finally, Aim 3 will explore MBC’s mechanisms of action among patients with CO-MH, hypothesizing that improvements in patient outcomes will be mediated by receiving indicated services, enhanced rapport, and higher patient satisfaction (H3).

Participants

Based on preliminary claims data analyses, 41% of the 3,560 participating patients are expected to have at least one CO-MH. At baseline, we expect to have an OUD only sample of n = 2,100 and CO-MH sample of n = 1,460. For the purposes of this project, CO-MH is broadly defined as the presence/absence of any clinically significant/diagnosed mental health condition assessed at baseline including anxiety, depression/mood, and PTSD.

Measures

Research Project 3 utilizes the same study measures as Project 2 delineated in Table 5. Theorized mechanisms of action to be explored are indicated services received, patient agency, patient-provider rapport, and patient satisfaction.

Statistical and power analyses

Research Project 3 is a secondary analysis of the hybrid type 2 effectiveness implementation trial described in Research Project 2 with similar planned statistical analyses, power, and missing data considerations.

Discussion

This study protocol outlines the HEALing Measurement Center’s innovative approach to enhancing OUD recovery through MBC implementation in PA OTPs. Our research builds on evidence that highlights MBC as an effective approach to improve treatment quality, patient engagement, and clinical effectiveness outcomes, while addressing the unique implementation barriers faced by OTPs. Our work represents one of the first comprehensive efforts to implement and evaluate MBC within OTPs, addressing critical gaps in the literature. Key contributions include:

1.  OTPs as an innovative and important implementation setting. This project will advance both recommendations of Dr. Volkow and colleagues and prior pilot efforts to systematically study MBC effectiveness and implementation in high-priority OTP settings [28, 55].

2. The integration of a patient reported MBC tool that can identify symptom severity provides an innovative solution to integrate patient centered care with high quality measurement into OTPs.

3. Paperwork Reduction as an innovative strategy to build capacity and improve MBC adoption. Co-designing an implementation blueprint incorporating paperwork reduction as a key de-implementation strategy in collaboration with policymakers and payers is novel given OTPs extensive documentation requirements and the need to integrate policymakers and payers to support sustained paperwork change.

4. Focus on co-occurring conditions: By evaluating the effectiveness of MBC for patients with both OUD and mental health conditions, our research addresses a high-need population often at risk for treatment discontinuation and poor outcomes [56, 57]. The study’s emphasis on personalized and systematic symptom monitoring holds potential to advance equitable care.

5. Scalability and sustainability: The hybrid stepped-wedge trial design and systematic exploration of implementation strategies allow us to assess not only effectiveness but also cost-effectiveness and long-term sustainment, providing actionable insights for future scale-up efforts.

Implications for practice and policy

The findings from this study will have significant implications for enhancing patient-centered OUD care. By systematically incorporating MBC into the treatment process, the study ensures that care is tailored to patient needs, fosters engagement and trust between patients and providers, and ultimately improves treatment outcomes. Patient-centered care is particularly crucial in OTPs, where treatment retention and addressing co-occurring mental health conditions remain critical challenges. The study’s collaborative design demonstrates the value of engaging state and local policymakers, payers, and OTP constituents in co-developing solutions that align clinical goals with policy incentives. By addressing administrative and financial barriers, policymakers can help create a more supportive environment for implementing and sustaining MBC.

Limitations and future directions

While this study introduces several innovations, it is not without limitations. Variability in resources and staffing across OTPs may influence MBC fidelity and the consistency of outcomes. Additionally, the findings may have limited generalizability to states with regulatory and funding environments that differ from Pennsylvania’s. Future research should focus on adapting MBC for other treatment settings, such as office-based opioid treatment programs or integrated care models, to determine its broader applicability as well as explore strategies for scaling to state- and nation-wide implementations. Additionally, identifying specific patient subgroups—such as those with particular co-occurring conditions—can help target interventions more effectively. Given evidence demonstrating that the average time to sustainable recovery is five years [58], longitudinal research that leverages patient-reported MBC data is also needed to describe the patient experience and identify emerging trends (e.g., novel substances) across time, geography, treatment episodes, and patient subgroups. Findings from this work can be used to identify and respond to existing and emerging treatment and service gaps.

Conclusion

The HEALing Measurement Center aims to improve OUD treatment through MBC implementation by addressing critical barriers to adoption, focusing on co-occurring mental health conditions, and integrating patient-centered care into OTP workflows. If the study hypotheses are supported, MBC + will emerge as an efficient and effective treatment option for OTP patients with OUD, including those with CO-MH conditions. Further, the proposed analyses test the specific mechanisms of action driving treatment success, offering valuable insights to guide future implementation efforts. These findings will not only contribute to the scientific understanding of MBC in OTPs but also provide actionable strategies for scaling and sustaining MBC. The collaborative nature of this initiative, coupled with its emphasis on scaling and sustaining MBC, has the potential to enhance recovery outcomes for individuals with OUD while informing broader efforts to address the ongoing opioid overdose crisis.

Abbreviations

MBC

Measurement Based Care

MBC + 

Enhanced Measurement Based Care Implementation

MAU

Measurement as Usual

OTP

Opioid Treatment Program

OUD

Opioid Use Disorder

MOUD

Medications for Opioid Use Disorder

COE

Centers of Excellence for OUD treatment

DDAP

Pennsylvania Department of Drug and Alcohol Programs

OMHSAS

Pennsylvania Department of Human Services Office of Mental Health and Substance Abuse Services

CCBHO

Community Care Behavioral Health Organization, UPMC Insurance Services Division

NIH

National Institutes of Health

EPIS

Exploration, Preparation, Implementation, and Sustainment Framework

STF

Systems Transformation Framework

NIDA

National Institute on Drug Abuse

MCO

Managed Care Organization

TA

Technical Assistance

Authors’ contributions

Authors RC, KS, and AA contributed to the design of the protocol. RC, KS, AA, and AL contributed to the conceptualization and writing of all manuscript sections. DL and RS contributed to manuscript review and editing. All authors approved the final manuscript.

Funding

This study protocol was supported by a grant award from the National Institute on Drug Abuse (RM1DA059395; MPIs: Cloutier, Scott, Aldridge).

Data availability

No datasets were generated or analysed during the current study.

Declarations

Ethics approval and consent to participate

Ethical approval was provided by the University of Pittsburgh Institutional Review Board (Research Project 1 Study #23090003: Research Project 2 Study #24080133). All participants consented to participate.

Consent for publication

Not applicable.

Competing interests

The authors declare no competing interests.