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Project MIMIC (Maximizing Implementation of Motivational Incentives in Clinics) (MIMIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03931174
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
RTI International
University of Washington
UConn Health
Information provided by (Responsible Party):
Sara Becker, Brown University

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.


Condition or disease Intervention/treatment Phase
Opioid-use Disorder Behavioral: Addiction Technology Transfer Center (ATTC) Training Strategy Behavioral: Enhanced Addiction Technology Transfer Center (E-ATTC) Training Strategy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster Randomized Trial
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Implementing Contingency Management in Opioid Treatment Centers Across New England: A Type 3 Hybrid Trial
Actual Study Start Date : April 9, 2019
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : June 2024

Arm Intervention/treatment
Active Comparator: Addiction Technology Transfer Center (ATTC) Training
Half of the opioid treatment centers will receive the ATTC training strategy.
Behavioral: Addiction Technology Transfer Center (ATTC) Training Strategy
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.
Other Name: ATTC

Experimental: Enhanced ATTC (E-ATTC) Training Strategy
Half of the opioid treatment centers will receive the E-ATTC training strategy.
Behavioral: Enhanced Addiction Technology Transfer Center (E-ATTC) Training Strategy
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.
Other Name: E-ATTC




Primary Outcome Measures :
  1. CM exposure (implementation outcome) [ Time Frame: Calculated throughout the 9-month Implementation phase ]
    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.

  2. CM Competence (implementation outcome) [ Time Frame: Assessed monthly throughout the 9-month Implementation phase ]
    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.

  3. CM Sustainment (implementation outcome) [ Time Frame: Assessed at the end of the 12-month Sustainment phase ]
    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.


Secondary Outcome Measures :
  1. Opioid Abstinence: Past Month (patient outcome) [ Time Frame: Assessed at 3 and 6-months from patient baseline assessment ]
    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.

  2. Opioid-Related Problems: Past Month (patient outcome) [ Time Frame: 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 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.


Other Outcome Measures:
  1. Implementation Climate [ Time Frame: Assessed at start of Preparation phase (provider baseline assessment) and start of Implementation phase (5-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. Higher scores indicate a more positive implementation climate.

  2. Leadership Engagement [ Time Frame: Assessed at start of Preparation phase (provider baseline assessment) and start of Implementation phase (5-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. Higher scores indicate higher perceived leadership engagement.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03931174


Contacts
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Contact: Sara J Becker, Ph.D. (401) 863-6604 sara_becker@brown.edu
Contact: Bryan R Garner, Ph.D. (919) 597-5159 bgarner@rti.org

Locations
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United States, Massachusetts
North Charles Institute for the Addictions Recruiting
Cambridge, Massachusetts, United States, 02140
Contact: Eileen Rush    617-661-5770 ext 117    erush@northcharles.org   
Habit Opco Comprehensive Treatment Center Recruiting
E. Wareham, Massachusetts, United States, 02538
Contact: Susan Moitozo    508-295-7990 ext 200    susan.moitozo@ctcprograms.com   
Habit Opco Comprehensive Treatment Center Recruiting
Fall River, Massachusetts, United States, 02721
Contact: Enrico DiCenso Jr.    508-676-1307 ext 111    rick.dicensojr@ctcprograms.com   
Spectrum Health Systems Recruiting
Leominster, Massachusetts, United States, 01453
Contact: Colleen Ferrera    978-466-3820    colleen.ferrera@spectrumhealthsystems.org   
Spectrum Health Systems Recruiting
North Adams, Massachusetts, United States, 01247
Contact: Rebecca Polastri    413-281-7783    rebecca.polastri@spectrumhealthsystems.org   
Spectrum Health Systems Recruiting
Southbridge, Massachusetts, United States, 01550
Contact: Gabrielle Buschalla    508-762-1931    gabrielle.buschalla@spectrumhealthsystems.org   
United States, Rhode Island
CODAC Behavioral Healthcare Recruiting
Cranston, Rhode Island, United States, 02920
Contact: Farrell Carley    401-462-3530    fcarley@codacinc.org   
Discovery House Comprehensive Treatment Center Recruiting
Providence, Rhode Island, United States, 02905
Contact: Lisa Pontarelli    401-461-9110 ext 487    lisa.pontarelli@ctcprograms.com   
Sponsors and Collaborators
Brown University
RTI International
University of Washington
UConn Health
Investigators
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Principal Investigator: Sara J Becker, Ph.D. Brown University
Principal Investigator: Bryan R Garner, Ph.D. RTI International
  Study Documents (Full-Text)

Documents provided by Sara Becker, Brown University:
Informed Consent Form  [PDF] December 12, 2018

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Responsible Party: Sara Becker, Associate Professor, Brown University
ClinicalTrials.gov Identifier: NCT03931174    
Other Study ID Numbers: #1811002260
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sara Becker, Brown University:
implementation
opioid use