Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics)

Brown University780 enrolled

Overview

There is an urgent need for effective treatments for patients with opioid use disorder (OUD). This study will train opioid treatment programs in an evidence-based behavioral treatment called contingency management (CM). Contingency management (i.e., motivational incentives for achieving pre-defined treatment goals) is one of the only behavioral interventions shown to improve patient treatment outcomes when combined with FDA-approved pharmacotherapy. Unfortunately, however, uptake of CM in opioid treatment programs remains low. In response to the urgent need for evidence-based behavioral OUD treatments, the investigators propose a large-scale type 3 hybrid trial comparing two comprehensive strategies to promote CM implementation as an adjunct to pharmacotherapy within opioid treatment programs. The control condition is the staff training strategy used by the New England Addiction Technology Transfer Center, which consists of didactic workshop, performance feedback, and staff coaching. The experimental condition is the ATTC strategy enhanced by external leadership coaching (using a model called Implementation Sustainment Facilitation; ISF) and provider incentives (using a model called Pay for Performance; P4P). A cluster randomized design trial will be conducted with 30 opioid treatment programs across New England. Centers will be randomized to one of the two implementation conditions (ATTC vs. enhanced-ATTC) over the 5 year project. At each opioid treatment program, data will be collected at multiple intervals from CM treatment providers, organizational leaders, and newly admitted patients. Additionally, patient charts will be randomly selected for review to examine sustainment. Data collection will include electronic medical record review, ratings of audio recordings by staff blind to condition, well-validated measures, and provider weekly report of patient encounter data. Specific Aims of the study are to experimentally compare the effect of the two conditions on implementation outcomes (Primary Aim) and on patient outcomes (Secondary Aim). An Exploratory Aim is to test whether two organization-level variables (i.e., implementation climate, leadership engagement) partially mediate the relationship between implementation condition and the key study outcomes.

Overdoses and deaths due to opioid use disorders (OUDs) have been declared a public health emergency in the United States, bringing to light an urgent need for highly effective OUD treatments. There are currently five FDA-approved medication formulations, which relative to placebo have demonstrated effectiveness in helping patients attain abstinence from opioids. Nonetheless, patients' opioid abstinence rates are sub-optimal: even when treated with the newest extended-release formulations only about 40% of patients maintain abstinence during the first 6-months of treatment. Contingency management (CM; i.e., motivational incentives for achieving pre-defined treatment goals) is one of the only behavioral interventions shown to improve patient abstinence from opioids when combined with FDA-approved pharmacotherapy. Unfortunately, however, uptake of CM in opioid treatment programs remains low. The primary purpose of this study is to experimentally evaluate two different comprehensive training models to train opioid treatment programs in CM. A Type 3 Hybrid Trial will be conducted collecting data on both implementation and patient outcomes. Using a cluster randomized design, 30 opioid treatment programs across New England will be randomized to one of two comprehensive training conditions over a 5 year period. The control condition is the staff training strategy used by the Substance Abuse and Mental Health Services Administration (SAMHSA)-funded network of Addiction Technology Transfer Centers (ATTC; i.e., didactic workshop + performance feedback + staff coaching). The experimental condition is the ATTC strategy enhanced by external leadership coaching (using a model called Implementation Sustainment Facilitation \[ISF\], i.e., leadership coaching focused on sustainment planning) and provider incentives (using a model called Pay for Performance \[P4P\]; i.e., monetary bonuses for achieving pre-defined implementation goals), hereafter referred to as E-ATTC. Elements of the E-ATTC condition were informed by our team's prior NIH-funded work evaluating organization-level implementation strategies. At each OUD treatment center, data will be collected at multiple intervals from up to 2-5 CM treatment providers (n=60-150 providers), 1-2 organizational leaders (n=30-60 leaders), and 25 newly admitted patients (n=750 patients). Additionally, 25 patient charts per center (n=750 charts) will be randomly selected for review to examine sustainment. Data collection will include electronic medical record review, ratings of audio recordings by staff blind to condition, well-validated measures, and biological verification of abstinence. The Primary Aim of the study is to experimentally compare the effect of the two training strategies on implementation outcomes. Focal implementation outcomes include: CM Exposure (provider-level measure of the proportion of providers delivering the target number of CM sessions to at least one patient during 9-month Implementation phase), CM Competence (provider-level measure of CM quality during month Implementation phase), and CM Sustainment (organization-level measure of the proportion of programs continuing to deliver CM sessions during 6-month Sustainment phase). The Secondary Aim of the study is to experimentally compare the effect of the two training strategies on patient outcomes. Focal patient outcomes include abstinence from opioids and opioid-related problems. An Exploratory Aim is to test whether two provider-level variables (i.e., implementation climate, leadership engagement) partially mediate the relationship between implementation condition and the key study outcomes. Pursuit of these aims is significant given the potential to improve the treatment of OUDs in community settings, which is one of the greatest public health challenges currently facing our nation. Major strengths of the approach include the study's experimental design (cluster randomized trial), novel implementation strategy based on mixed-methods pilot data by the investigative team, large sample of organizations (N = 30), partnership with a SAMHSA-funded national training center, and rigorously measured implementation and patient outcomes.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria for community-based opioid treatment programs (n = 30): * prescribes FDA-approved medication to treat adult patients with OUDs * enrolls 5+ new patients per month * has at least 2 staff who provide psychosocial support to OUD patients Exclusion criteria: • None Inclusion criteria for CM Providers (n = 60-150, range of 2-5 per center): * has been involved in providing psychosocial support to OUD patients on pharmacotherapy * has an active caseload * is willing to commit to 14 months of CM training and support Exclusion criteria: • None Inclusion Criteria for CM Leaders (n = 30-60, range of 1-2 per center): * is responsible for supervising frontline CM Staff * is willing to commit to 14 months of external leadership coaching Exclusion criteria: • None Inclusion criteria for patients (n = 750): * adult patients * newly admitted to the opioid treatment center within the past 30 days * prescribed any FDA-approved OUD medication Exclusion criteria: • issues that could interfere with the ability to complete a brief intake interview including acute intoxication, acute psychosis, acute mania, or cognitive impairment (prohibiting comprehension of the consent process), as reported by opioid treatment program staff or observed by research staff

Outcomes

Primary Outcomes

CM Exposure (Implementation Outcome)

Provider-level measure of whether the provider delivered the target number of CM sessions (at least 10 sessions) to at least one patient based on based on electronic medical record review and data entered into a study-specific CM tracker tool for up to 25 charts per site (25 charts\*30 sites = 750 charts). Providers will report on patient encounters in the electronic medical record and the study-specific CM tracker tool, and for each encounter will report if CM was provided. Using patient level data, providers will be classified as 1 (delivered 10 or more sessions to at least 1 patient) or 0 (did not deliver 10 or more CM sessions to any patients). \*This measure was initially defined as a patient-level outcome. We altered the level at which CM Exposure was assessed because our initial approach excluded providers who were trained but never delivered CM. To follow intent-to-treat principles, we aggregate CM Exposure data at the provider-level in a manner that uses all available data.

Time frame: From baseline to 9 months post-baseline

Contingency Management Competence Scale for Reinforcing Attendance (Implementation Outcome)

Provider scores on the Contingency Management Competence Scale for Reinforcing Attendance (CMCS; Petry \& Ledgerwood, 2010). Coders blind to treatment condition rate audio recorded CM sessions using the CMCS, which measures provider skill in CM delivery. CMCS contains 6 CM-specific skill items and 3 general skill items that are scored on a scale from 0 to 7. For each item, a score of 0 indicates an audio recording was not submitted, a score of 1 indicates the lowest possible skill and a score of 7 indicates the highest possible skill. Possible scale scores range from a minimum of 0 to 63. An average score will be calculated for each provider, with a minimum of 0 and maximum of 7. Providers will submit one audio recording per month for the duration of the 9-month Implementation phase. Each provider's highest CMCS score will be used in analysis. Higher scores indicate higher skill, which is a better outcome.

Time frame: From baseline to 9 months post-baseline

CM Sustainment (Implementation Outcome)

Proportion of programs delivering any CM after removal of active support. This is calculated based on review of all patient charts over a 6-month interval. Providers report on patient encounters in the medical record, and for each encounter report if CM was provided. Programs are classified as 1 (reported delivering CM to at least 1 patient) or 0 (did not deliver CM to any patients). The proportion of programs delivering CM is then calculated; a higher proportion is a better outcome. \*The level at which CM Sustainment was assessed was altered from provider-level to program-level because of the frequency of programs failing to report applying CM among any patients, across any of its providers. In addition, there was such high staff turnover we could not assess at the provider-level using original provider IDs. To be able to use all available data from all programs' medical records, we report on the proportion of any programs delivering CM after removal of active support.

Time frame: 6-month time interval following Implementation time period

Secondary Outcomes

Opioid Abstinence: Past Month (Patient Outcome)

Days of abstinence as reported using calendar-based recall based on the Timeline Followback Interview method (Sobell \& Sobell, 1992). Days of opioid abstinence will be calculated from 0 to 30 for each patient, with higher numbers indicating more days of abstinence (which is a better outcome). This will be calculated for all patients who complete follow-up.

Time frame: Assessed at 3 and 6-months from patient baseline assessment

Global Appraisal of Individual Needs Opioid-Related Problem Scale: Past Month (Patient Outcome)

Count of problems as reported using an adapted version of the Global Appraisal of Needs Substance Problems Scale (Dennis et al., 2002), which has been adapted to focus specifically on problems related to opioids. The scale contains 16 items that correspond to problems related to opioid use. Patients are asked the last time they had each problem with responses including past month, past year, lifetime, or never. A count of problems experienced over the past month will be calculated for each patient. The minimum possible score is 0 and the maximum possible score is 16. Higher scores indicate higher problems, which is a worse outcome. This will be calculated for all patients who complete follow-up.