Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics)

NCT03931174 | Completed Results DMC

• 2 other identifiers: #1811002260R01DA046941
• Study Type: interventional
• Target: 780
• Locations: 1 country
• Sites: 29

Brief Summary

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.

Conditions

Opioid-use Disorder

Keywords

implementation; opioid use

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  6-month time interval following Implementation time period

Secondary Outcomes (2)

• Opioid Abstinence: Past Month (Patient Outcome)

  Assessed at 3 and 6-months from patient baseline assessment

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

  Assessed at 3 and 6-months from patient baseline assessment

Other Outcomes (2)

• Implementation Climate Scale

  From baseline to 9 months post baseline

• Leadership Engagement Scale

  From baseline to 9 months post baseline

Study Arms (2)

Addiction Technology Transfer Center (ATTC) Training

ACTIVE COMPARATOR

Half of the opioid treatment centers will receive the ATTC training strategy.

Behavioral: Addiction Technology Transfer Center (ATTC) Training Strategy

Enhanced ATTC (E-ATTC) Training Strategy

EXPERIMENTAL

Half of the opioid treatment centers will receive the E-ATTC training strategy.

Behavioral: Enhanced Addiction Technology Transfer Center (E-ATTC) Training Strategy

Interventions

Addiction Technology Transfer Center (ATTC) Training Strategy BEHAVIORAL

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.

Also known as: ATTC

Addiction Technology Transfer Center (ATTC) Training

Enhanced Addiction Technology Transfer Center (E-ATTC) Training Strategy BEHAVIORAL

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.

Also known as: E-ATTC

Enhanced ATTC (E-ATTC) Training Strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• None
• 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
• None
• is responsible for supervising frontline CM Staff
• is willing to commit to 14 months of external leadership coaching
• None
• adult patients
• newly admitted to the opioid treatment center within the past 30 days
• prescribed any FDA-approved OUD medication
• 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

Sponsors & Collaborators

• Brown University: lead
• RTI International: collaborator
• University of Washington: collaborator
• UConn Health: collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Northwestern University: collaborator
• Ohio State University: collaborator

Study Sites (29)

Kinsella Treatment Center

Bridgeport, Connecticut, 06605, United States

Location

Liberation Programs Bridgeport

Bridgeport, Connecticut, 06610, United States

Location

Community Renewal Team

Hartford, Connecticut, 06120, United States

Location

Liberation Programs Stamford

Stamford, Connecticut, 06901, United States

Location

North Charles Institute for the Addictions

Cambridge, Massachusetts, 02140, United States

Location

Habit Opco East Wareham Comprehensive Treatment Center

East Wareham, Massachusetts, 02538, United States

Location

Habit Opco Fall River Comprehensive Treatment Center

Fall River, Massachusetts, 02721, United States

Location

Spectrum Health Systems Framingham

Framingham, Massachusetts, 01702, United States

Location

Spectrum Health Systems Haverhill

Haverhill, Massachusetts, 01830, United States

Location

Spectrum Health Systems Leominster

Leominster, Massachusetts, 01453, United States

Location

Spectrum Health Systems Milford

Milford, Massachusetts, 01757, United States

Location

Spectrum Health Systems Millbury

Millbury, Massachusetts, 01527, United States

Location

Gifford Street Comprehensive Treatment Center

New Bedford, Massachusetts, 02744, United States

Location

Spectrum Health Systems North Adams

North Adams, Massachusetts, 01247, United States

Location

Spectrum Health Systems Pittsfield

Pittsfield, Massachusetts, 01201, United States

Location

Spectrum Health Systems Southbridge

Southbridge, Massachusetts, 01550, United States

Location

Habit Opco Taunton Comprehensive Treatment Center

Taunton, Massachusetts, 02780, United States

Location

Spectrum Health Systems Waltham

Waltham, Massachusetts, 02451, United States

Location

Spectrum Health Systems Weymouth

Weymouth, Massachusetts, 02190, United States

Location

Spectrum Health Systems Worcester

Worcester, Massachusetts, 01605, United States

Location

Habit Opco West Lebanon Comprehensive Treatment Center

West Lebanon, New Hampshire, 03784, United States

Location

CODAC Behavioral Healthcare - Eleanor Slater

Cranston, Rhode Island, 02920, United States

Location

Lifespan Recovery Center

Providence, Rhode Island, 02904, United States

Location

Discovery House Comprehensive Treatment Center

Providence, Rhode Island, 02905, United States

Location

VICTA

Providence, Rhode Island, 02907, United States

Location

CODAC Providence

Providence, Rhode Island, 02909, United States

Location

Woonsocket Comprehensive Treatment Center

Woonsocket, Rhode Island, 02895, United States

Location

BAART Programs Berlin

Berlin Corners, Vermont, 05602, United States

Location

West Ridge Center

Rutland, Vermont, 05701, United States

Location

Related Publications (5)

• Becker SJ, Janssen T, Murphy CM, Scott K, DiClemente-Bosco K, Souza T, Garner BR. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): preparation phase outcomes of a hybrid type 3 trial. Implement Sci Commun. 2025 Dec 15. doi: 10.1186/s43058-025-00841-7. Online ahead of print.

  PMID: 41398966 DERIVED

• Becker SJ, Janssen T, Souza T, Hartzler B, Rash CJ, DiClemente-Bosco K, Garner BR. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): results of a 28-site cluster-randomized type 3 hybrid trial. Implement Sci. 2025 Dec 9. doi: 10.1186/s13012-025-01473-0. Online ahead of print.

  PMID: 41361474 DERIVED

• Frohe T, Janssen T, Garner BR, Becker SJ. Examining changes in pain interference via pandemic-induced isolation among patients receiving medication for opioid use disorder: a secondary data analysis. BMC Public Health. 2024 Sep 27;24(1):2581. doi: 10.1186/s12889-024-20077-9.

  PMID: 39334184 DERIVED

• Janssen T, Garner BR, Yermash J, Yap KR, Becker SJ. 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. Addict Sci Clin Pract. 2023 Sep 13;18(1):54. doi: 10.1186/s13722-023-00409-7.

  PMID: 37705105 DERIVED

• Becker SJ, Murphy CM, Hartzler B, Rash CJ, Janssen T, Roosa M, Madden LM, Garner BR. Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics): A cluster-randomized type 3 hybrid effectiveness-implementation trial. Addict Sci Clin Pract. 2021 Oct 12;16(1):61. doi: 10.1186/s13722-021-00268-0.

  PMID: 34635178 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Sara Becker
• Organization: Northwestern University

sara.becker@northwestern.edu

312-503-4203

Study Officials

• Sara J Becker, Ph.D.

  Brown University and Northwestern University

  PRINCIPAL INVESTIGATOR

• Bryan R Garner, Ph.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster Randomized Trial

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: April 30, 2019
• Study Start: April 9, 2019
• Primary Completion: August 31, 2023
• Study Completion: July 31, 2024
• Last Updated: March 19, 2025
• Results First Posted: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Protocol was published in 2021. Analytic code and participant-level data were made ready for distribution by July 30, 2024.
• Access Criteria: Data will only be shared with external investigators when a data use agreement (DUA) is executed between Brown University and the requester's institution. The DUA will specify the requested data elements (each of which must be justified), the specific research question, the timeline for the project, and schedule for data destruction.

Locations

US (29)