Facilitating the Implementation of Interim Methadone to Increase Treatment Access

Not Applicable

Completed

• Conditions: Opioid-use Disorder
• Interventions: Other: Usual Practice; Other: Implementation Facilitation

• Registration Number: NCT04188977
• Lead Sponsor: Friends Research Institute, Inc.

Brief Summary

The primary aim of this study is to evaluate the effectiveness of Implementation Facilitation (IF) in promoting increased accessibility to methadone treatment.

Detailed Description

This is a Type 3 implementation-effectiveness type study using a modified stepped wedge design. The study's purpose is to examine the effectiveness of Implementation Facilitation (IF) to prompt participating Opioid Treatment Programs (OTPs) to utilize interim methadone treatment and other approaches to reduce OTP admission delays. Interim methadone treamtent is an evidence-based practice permitted under federal OTP regulations to provide methadone treatment without routine counseling for individuals requesting methadone treatment who otherwise would not be able to be admitted to such treatment within 14 days of request. The study will be conducted at six OTPs in the US that are unable to admit individuals within 14 days of their request for methadone treatment. The OTPs will participate in a baseline Pre-Implementation Phase, an Implementation Phase, followed by a Sustainability Phase. OTPs will be randomly assigned in groups of two to the order in which they will initiate the Implementation Phase. IF will be delivered at the level of the OTP staff and their state health department official responsible for OTP oversight. OTP staff and state health department officials will be interviewed regarding facilitators and barriers to implementing interim methadone and other approaches to reduce admission delays. De-identified data will be gathered from the OTPs on the effectiveness of IF in prompting the implementation of interim methadone and reducing admission delays.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2019-11-12
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-06
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

• Unwilling to be interviewed

Inclusion Criteria (OTP applicants):

• requesting admission to OTP

Exclusion Criteria:

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Usual Practice	Usual Practice	OTPs are able to request from state and federal health department officials to utilize interim methadone treatment to address admission delays in their OTP.
Implementation Facilitation	Implementation Facilitation	Implementation Facilitation (IF) will consist of educational outreach to OTP staff, identification of local champions, training, performance feedback, and learning collaborative for OTP staff and state health department officials.

Primary Outcome Measures

Name	Time	Method
Accessibility	Nine months	Accessibility will be assessed from de-identified OTP records as the proportion of individuals requesting methadone treatment who receive at least one dose of methadone through either interim methadone (IM) or standard methadone within 14 days, divided by the number of individuals requesting methadone treatment.

Secondary Outcome Measures

Name	Time	Method
Uptake	Nine months	Uptake will be assessed from de-identified OTP records as the proportion of individuals unable to gain admission within 14 days who receive at least one interim methadone dose divided by the number of individuals who were unable to be admitted within 14 days.
Fidelity	Six months	Fidelity will be assessed from de-identified OTP records as the proportion of interim methadone patients transferred to standard methadone treatment within the permitted time limit from starting interim methadone treatment.
Uptake during the Sustainability Phase	Six months	Sustainability will be assessed from de-identified OTP records as the proportion of interim methadone patients admitted within 14 days of request during the Sustainability Phase
Effectiveness: percentage of opioid positive tests	Six months	Effectiveness will be assessed from de-identified OTP records as the percentage of opioid-positive urine tests of interim methadone patients at the time of transfer to standard methadone treatment
Efficiency	Nine months	Efficiency will be assessed from de-identified OTP records as the number of days from the request for OTP admission prior to receiving a first methadone dose.

Trial Locations

Locations (1)

Robert Philip Schwartz, M.D.; 🇺🇸 Baltimore, Maryland, United States