Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics)

Study Overview
=================
Brief Summary
-----------------
There is an urgent need for effective treatments for patients with opioid use disorder (OUD). This study will train opioid treatment centers 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 OUD treatment centers 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 OUD centers. 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 OUD treatment centers 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 OUD treatment center, 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.

Detailed Description
-----------------
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 OUD treatment centers remains low. The primary purpose of this study is to experimentally evaluate two different comprehensive training models to train opioid treatment centers in CM. A Type 3 Hybrid Trial will be conducted collecting data on both implementation and patient outcomes. Using a cluster randomized design, 30 OUD treatment centers 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 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 (patient-level measure of number of CM sessions received during 9-month Implementation phase) CM Competence (provider-level measure of CM quality during month Implementation phase), and CM Sustainment (patient-level measure of number of CM sessions received during 12-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 organization-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.

Official Title
-----------------
Implementing Contingency Management in Opioid Treatment Centers Across New England: A Type 3 Hybrid Trial

Conditions
-----------------
Opioid-use Disorder

Intervention / Treatment
-----------------
* Behavioral: Addiction Technology Transfer Center (ATTC) Training Strategy
* Behavioral: Enhanced Addiction Technology Transfer Center (E-ATTC) Training Strategy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria for community-based OUD treatment centers (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 center staff or observed by research staff

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster Randomized Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Addiction Technology Transfer Center (ATTC) Training<br>Half of the opioid treatment centers will receive the ATTC training strategy. | Behavioral: Addiction Technology Transfer Center (ATTC) Training Strategy<br>* Participating organizations will receive training consisting of 3 components: 1) didactic workshop - full-day workshop led by a contingency management (CM) expert for both CM staff and leaders, 2) performance feedback - submission of CM session recordings for review and performance feedback at least monthly for 9 months for CM staff, and 3) staff coaching - monthly provider coaching calls led by a CM expert for 9 months for both CM staff and leaders.<br>* Other names: ATTC;|
| Experimental: Enhanced ATTC (E-ATTC) Training Strategy<br>Half of the opioid treatment centers will receive the E-ATTC training strategy. | Behavioral: Enhanced Addiction Technology Transfer Center (E-ATTC) Training Strategy<br>* Participating organizations will receive all of the elements of the ATTC control condition. In addition, organizations will receive two additional elements: 1) Implementation Sustainment Facilitation - monthly coaching calls for CM leaders and staff focused on sustainment, 2) Pay for Performance - participating CM staff will have the opportunity to earn monthly monetary bonuses for achieving pre-defined implementation goals for 9 months.<br>* Other names: E-ATTC;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CM exposure (implementation outcome) | Proportion of target CM sessions received per recruited patient (25 patients per site X 30 sites = 750 patients) based on electronic medical record review and data entered into a study-specific CM tracker tool. 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. Proportion of target CM sessions (target number = 12 over a 14 week period) will be calculated per patient. | Calculated throughout the 9-month Implementation phase | 
| CM Competence (implementation outcome) | Provider scores on the Contingency Management Competence Scale for Reinforcing Attendance (CMCS; Petry & Ledgerwood, 2010). Raters blind to treatment condition will code audio recorded CM sessions and rate them using the CMCS, which measures provider skill in CM delivery. CMCS contains 6 CM-specific skill items and 3 general practice skill items that are scored on a scale from 1 to 7, with higher scores indicating higher levels of provider skill. An average score across the 6 CM-specific skill items will be calculated for each provider. Providers will submit one audio recording per month for the duration of the 9-month Implementation phase. | Assessed monthly throughout the 9-month Implementation phase | 
| CM Sustainment (implementation outcome) | Proportion of target CM sessions received per patient based on electronic medical record review of 25 randomly selected charts per site (25 charts * 30 sites = 750 charts). Providers will report on patient encounters in the electronic medical record, and for each encounter will report if CM was provided. Proportion of target CM sessions (target number = 12 over a 14 week period) will be calculated per patient record. | Assessed at the end of the 12-month Sustainment phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Abstinence: Past Month (patient outcome) | Days of abstinence as reported using calendar-based recall based on theTimeline 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.This will be calculated for all patients who complete follow-up. | Assessed at 3 and 6-months from patient baseline assessment | 
| Opioid-Related Problems: 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 received 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 (possible range from 0 to 16), with higher scores indicating higher problems. This will be calculated for all patients who complete follow-up. | Assessed at 3 and 6-months from patient baseline assessment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
implementation, opioid use