Clinical trial NCT04188977: Facilitating the Implementation of Interim Methadone to Increase Treatment Access
Official title: Facilitating the Implementation of Interim Methadone to Increase Treatment Access: A Multi-Site Implementation Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-use Disorder
Keywords: Implementation Facilitation
Interim methadone treatment
Opioid Treatment Program
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-12-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Type 3 implementation-effectiveness type study using a modified stepped wedge design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria (Staff):

* OTP staff
* State health department staff responsible for OTP oversight

Exclusion Criteria:

* Unwilling to be interviewed

Inclusion Criteria (OTP applicants):

* requesting admission to OTP

Exclusion Criteria:

* None

Primary outcomes:
measure: Accessibility
timeFrame: Nine months
Secondary outcomes:
measure: Uptake
timeFrame: Nine months
measure: Efficiency
timeFrame: Nine months
measure: Fidelity
timeFrame: Six months
measure: Uptake during the Sustainability Phase
timeFrame: Six months
measure: Effectiveness: percentage of opioid positive tests
timeFrame: Six months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Robert Philip Schwartz, M.D.
state: Maryland
Study officials:
affiliation: Friends Research Institute, Inc.
name: Robert P Schwartz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: