Facilitating the Implementation of Interim Methadone to Increase Treatment Access
Primary Purpose
Opioid-use Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Practice
Implementation Facilitation
Sponsored by
About this trial
This is an interventional health services research trial for Opioid-use Disorder focused on measuring Implementation Facilitation, Interim methadone treatment, Opioid Treatment Program
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
Sites / Locations
- Robert Philip Schwartz, M.D.
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Usual Practice
Implementation Facilitation
Arm Description
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 (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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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
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
Full Information
NCT ID
NCT04188977
First Posted
November 12, 2019
Last Updated
July 27, 2022
Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT04188977
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
Keywords
Implementation Facilitation, Interim methadone treatment, Opioid Treatment Program
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Type 3 implementation-effectiveness type study using a modified stepped wedge design
Masking
Care Provider
Masking Description
OTPs are masked during their Pre-Implementation Phase.
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Practice
Arm Type
Other
Arm Description
OTPs are able to request from state and federal health department officials to utilize interim methadone treatment to address admission delays in their OTP.
Arm Title
Implementation Facilitation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Practice
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Implementation Facilitation
Intervention Description
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 Measure Information:
Title
Accessibility
Description
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.
Time Frame
Nine months
Secondary Outcome Measure Information:
Title
Uptake
Description
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.
Time Frame
Nine months
Title
Efficiency
Description
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.
Time Frame
Nine months
Title
Fidelity
Description
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.
Time Frame
Six months
Title
Uptake during the Sustainability Phase
Description
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
Time Frame
Six months
Title
Effectiveness: percentage of opioid positive tests
Description
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
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Schwartz, M.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Philip Schwartz, M.D.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Facilitating the Implementation of Interim Methadone to Increase Treatment Access
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