NCT04188977

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 6, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

2.5 years

First QC Date

November 12, 2019

Last Update Submit

July 27, 2022

Conditions

Opioid-use Disorder

Keywords

Implementation FacilitationInterim methadone treatmentOpioid Treatment Program

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Uptake

    Nine months

  • Efficiency

    Nine months

  • Fidelity

    Six months

  • Uptake during the Sustainability Phase

    Six months

  • Effectiveness: percentage of opioid positive tests

    Six months

Study Arms (2)

Usual Practice

OTHER

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

Implementation Facilitation

EXPERIMENTAL

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

Interventions

Usual PracticeOTHER

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.

Usual Practice
Implementation FacilitationOTHER

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.

Implementation Facilitation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unwilling to be interviewed
  • requesting admission to OTP
  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Philip Schwartz, M.D.

Baltimore, Maryland, 21201, United States

Location

Related Publications (2)

  • Gryczynski J, Mitchell SG, Whitter M, Fuller D, Mitchell MM, Edelman EJ, Schwartz RP. A trial of implementation facilitation to increase timely admission to methadone treatment. J Subst Use Addict Treat. 2024 Jul;162:209375. doi: 10.1016/j.josat.2024.209375. Epub 2024 Apr 19.

    PMID: 38642889DERIVED

  • Mitchell SG, Jester J, Gryczynski J, Whitter M, Fuller D, Halsted C, Schwartz RP. Impact of COVID-19-related methadone regulatory flexibilities: views of state opioid treatment authorities and program staff. Addict Sci Clin Pract. 2023 Oct 17;18(1):61. doi: 10.1186/s13722-023-00417-7.

    PMID: 37848970DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Robert P Schwartz, M.D.

    Friends Research Institute, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
OTPs are masked during their Pre-Implementation Phase.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SEQUENTIAL
Model Details: Type 3 implementation-effectiveness type study using a modified stepped wedge design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2019

First Posted

December 6, 2019

Study Start

November 1, 2019

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

July 29, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)