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The trial of Methadone Patient Access to Collaborative Treatment (MPACT) will establish the impact of the intervention on patient outcomes of methadone treatment retention and in treatment overdose.
It will also establish the impact of patient and staff trauma symptoms and clinic practice change on MPACT intervention implementation.
This MPACT trial will involve finalizing the refined MPACT intervention (materials, training) and conducting a Hybrid Type 1, 15-month cluster randomized controlled trial in 30 clinics with 600 patients (20/clinic) and 480 staff (18/clinic) to assess MPACT effect on patient outcomes and examine the relationship between staff trauma outcomes and MPACT implementation. R33 Specific AIMS:
AIM 1: Quantify the effects of MPACT on methadone treatment (MMT) practice change and opioid treatment program (OTP) culture.
AIM 2: Determine the efficacy of MPACT on MMT retention, in-MMT overdose and patient and staff post traumatic stress symptoms (PTSS) outcomes.
AIM 3: Evaluate the effect of patient and staff trauma symptoms on primary outcomes and staff MPACT implementation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MPACT Intervention | Experimental | Enrolled clinic staff will be exposed to the MPACT intervention components over the trial period. This includes accredited training, clinic self assessment, reflective supervision for counseling/peer/case management staff, and wellness education with navigation to trauma symptoms assessment and resources including trauma treatment. Periodic surveys of staff and patients will be conducted to assess outcome measures (primary and secondary) and patient chart reviews will verify patient outcomes. |
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| Control for MPACT | No Intervention | Enrolled clinic staff will not receive any portion of the intervention. Periodic surveys of staff and patients will be conducted to assess outcome measures (primary and secondary) and patient chart reviews will verify patient outcomes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MPACT | Other | Four components are part of this intervention: 1) accredited training about patient centered, trauma-informed care and the standard of care under the current federal regulation (42CFRpart8), 2) education about trauma and trauma symptoms including vicarious (work related) trauma and navigation to symptoms screening and resources including treatment, 3) reflective supervision for counseling, case management and peer staff, and 4) clinic self assessment for trauma-informed and patient centered care |
| Measure | Description | Time Frame |
|---|---|---|
| Days in Treatment to treatment interruption | Time (days) to treatment interruption | 18 months |
| Time to treatment cessation | Time to treatment cessation (tolerance of 30 days) | 18 months |
| In Treatment- Point in time | Point in time in treatment (0 day, 30 day, 60, day, 90 day) | 18 months |
| Number of patients reporting opioid overdoses while in methadone treatment | Reported overdoses by patients in methadone treatment during the trial period by survey measured at 5 points during the study period. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of staff experiencing vicarious (work related) stress | Post traumatic stress symptoms and vicarious (work related) trauma symptoms measured by the Vicarious Trauma Scale (VTS). Total scores can be grouped into three categories to represent low (8-28), moderate (29-42) and high (43-56) levels of vicarious trauma symptoms | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona College of Medicine | Tucson | Arizona | 85714 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40105313 | Derived | Meyerson BE, Davis A, Crosby RA, Linde-Krieger LB, Brady BR, Carter GA, Mahoney AN, Frank D, Rothers J, Coffee Z, Deuble E, Ebert J, Jablonsky MF, Juarez M, Lee B, Lorenz HM, Pava MD, Tinsely K, Yousaf S. Methadone Patient Access to Collaborative Treatment: Protocol for a Pilot and a Randomized Controlled Trial to Establish Feasibility of Adoption and Impact on Methadone Treatment Delivery and Patient Outcomes. JMIR Res Protoc. 2025 Apr 15;14:e69829. doi: 10.2196/69829. |
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A Data Management and Sharing Plan has been filed with the National Institute on Drug Abuse.
Within 2 years of study completion
See Data Management and Sharing Plan
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Hybrid Type 1, 18-month simultaneous cluster randomized controlled trial in 30 clinics
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| Number of patients and staff experiencing post traumatic stress symptoms |
Post traumatic stress symptoms measured by the 8-item PCL-5 measuring post traumatic stress symptoms. Scores range from 0-80, with higher scores representing greater levels of traumatic stress symptomatology. |
| 18 months |