Facilitating the Implementation of Interim Methadone to Increase Treatment Access

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

Detailed Description
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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.

Official Title
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Facilitating the Implementation of Interim Methadone to Increase Treatment Access: A Multi-Site Implementation Trial

Conditions
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Opioid-use Disorder

Intervention / Treatment
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* Other: Usual Practice
* Other: Implementation Facilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Type 3 implementation-effectiveness type study using a modified stepped wedge design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual Practice<br>OTPs are able to request from state and federal health department officials to utilize interim methadone treatment to address admission delays in their OTP. | Other: Usual Practice<br>* OTP Directors are able to ask their state health officials permission to use interim methadone treatment. The state officials are in turn able to ask officials from the Center of Substance Abuse Treatment for permission to provide interim methadone treatment.<br>|
| Experimental: Implementation Facilitation<br>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. | Other: Implementation Facilitation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accessibility | 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. | Nine months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake | 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. | Nine months | 
| Efficiency | 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. | Nine months | 
| Fidelity | 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. | Six months | 
| Uptake during the Sustainability Phase | 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 | Six months | 
| Effectiveness: percentage of opioid positive tests | 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 | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implementation Facilitation, Interim methadone treatment, Opioid Treatment Program