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NCT03931174: MIMIC

Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics)

Completed NA Results posted Last updated 19 March 2025
What this trial tests

NA trial testing Addiction Technology Transfer Center (ATTC) Training Strategy in Opioid-use Disorder in 780 participants. Completed in 31 July 2024.

Timeline
9 April 2019
Primary endpoint
31 August 2023
31 July 2024

Quick facts

Lead sponsorBrown University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposehealth services research
Enrollment780
Start date9 April 2019
Primary completion31 August 2023
Estimated completion31 July 2024
Sites29 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Brown University

Who can join

18 and older, any sex, with Opioid-use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

CM Exposure (Implementation Outcome) Primary · From baseline to 9 months post-baseline

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 (

GroupValue95% CI
Addiction Technology Transfer Center (ATTC) Training18
Enhanced ATTC (E-ATTC) Training Strategy31
Contingency Management Competence Scale for Reinforcing Attendance (Implementation Outcome) Primary · From baseline to 9 months post-baseline

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 a

GroupValue95% CI
Addiction Technology Transfer Center (ATTC) Training0.53± 1.66
Enhanced ATTC (E-ATTC) Training Strategy1.25± 2.14
CM Sustainment (Implementation Outcome) Primary · 6-month time interval following Implementation time period

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 t

GroupValue95% CI
Addiction Technology Transfer Center (ATTC) Training6
Enhanced ATTC (E-ATTC) Training Strategy6
Opioid Abstinence: Past Month (Patient Outcome) Secondary · Assessed at 3 and 6-months from patient baseline assessment

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.

3-months post baseline
GroupValue95% CI
Addiction Technology Transfer Center (ATTC) Training8.89± 13.12
Enhanced ATTC (E-ATTC) Training Strategy9.39± 14.00
6-months post baseline
GroupValue95% CI
Addiction Technology Transfer Center (ATTC) Training10.15± 16.33
Enhanced ATTC (E-ATTC) Training Strategy8.33± 14.70
Global Appraisal of Individual Needs Opioid-Related Problem Scale: Past Month (Patient Outcome) Secondary · Assessed at 3 and 6-months from patient baseline assessment

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 hig

3-months post baseline
GroupValue95% CI
Addiction Technology Transfer Center (ATTC) Training2.43± 3.51
Enhanced ATTC (E-ATTC) Training Strategy2.55± 3.67
6-months post baseline
GroupValue95% CI
Addiction Technology Transfer Center (ATTC) Training2.24± 3.47
Enhanced ATTC (E-ATTC) Training Strategy2.17± 3.69
Implementation Climate Scale Secondary · From baseline to 9 months post baseline

Implementation climate scale (Jacobs et al., 2014). This scale contains 6 items scored on a 1 to 5 scale. An average score across the 6 items will be calculated per provider. Possible scores on this outcome range from a minimum of 1 to a maximum of 6. Higher scores indicate a more positive implementation climate, which is a better outcome.

GroupValue95% CI
Addiction Technology Transfer Center (ATTC) Training3.77± 1.17
Enhanced ATTC (E-ATTC) Training Strategy4.27± 0.81
Leadership Engagement Scale Secondary · From baseline to 9 months post baseline

Measure of leadership engagement (Garner, unpublished data). The scale contains 4 items scored on a 1 to 5 scale. An average perceived leadership engagement scale will be calculated for each provider. Possible scores on this outcome range from a minimum score of 1 to a maximum score of 5. Higher scores indicate higher perceived leadership engagement, which is a better outcome.

GroupValue95% CI
Addiction Technology Transfer Center (ATTC) Training3.47± 1.27
Enhanced ATTC (E-ATTC) Training Strategy3.75± 1.17

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected as part of comprehensive follow-up assessments (twice over a 6-month period for patients and twice over a 9-month period for providers).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Addiction Technology Transfer Center (ATTC) Training
Serious: 1/381 (0%)
Deaths: 1/381
Enhanced ATTC (E-ATTC) Training Strategy
Serious: 1/399 (0%)
Deaths: 1/399

Serious adverse events (1 terms)

ReactionSystemAddiction Technology Trans…Enhanced ATTC (E-ATTC) Tra…
DeathInjury, poisoning and procedural complications

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT03931174 adverse events section.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): A cluster-randomized type 3 hybrid effectiveness-implementation trial.
    Becker SJ, Murphy CM, Hartzler B, Rash CJ, et al · · 2021 · cited 24× · PMID 34635178 · DOI 10.1186/s13722-021-00268-0
  2. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): results of a 28-site cluster-randomized type 3 hybrid trial.
    Becker SJ, Janssen T, Souza T, Hartzler B, et al · · 2025 · cited 1× · PMID 41361474 · DOI 10.1186/s13012-025-01473-0
  3. Early COVID-Related pandemic impacts and subsequent opioid outcomes among persons receiving medication for opioid use disorder: a secondary data analysis of a Type-3 hybrid trial.
    Janssen T, Garner BR, Yermash J, Yap KR, et al · · 2023 · cited 1× · PMID 37705105 · DOI 10.1186/s13722-023-00409-7
  4. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): preparation phase outcomes of a hybrid type 3 trial.
    Becker SJ, Janssen T, Murphy CM, Scott K, et al · · 2025 · PMID 41398966 · DOI 10.1186/s43058-025-00841-7
  5. Evaluating provider report of fidelity to contingency management in opioid treatment programs.
    Casline E, Scott K, Murphy CM, Garner BR, et al · · 2025 · PMID 39778506 · DOI 10.1016/j.drugalcdep.2024.112544
  6. Examining changes in pain interference via pandemic-induced isolation among patients receiving medication for opioid use disorder: a secondary data analysis.
    Frohe T, Janssen T, Garner BR, Becker SJ. · · 2024 · PMID 39334184 · DOI 10.1186/s12889-024-20077-9
  7. Examining Changes in Pain Interference via Pandemic-Induced Isolation Among Patients Receiving Medication for Opioid Use Disorder: A Secondary Data Analysis
    Frohe T, Janssen T, Garner BR, Becker SJ. · · 2023 · DOI 10.21203/rs.3.rs-3158420/v1

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