Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345274
Status:
RECRUITING
Last Update Posted:
2024-04-22
First Post:
2024-03-21
Brief Title:
MBC2OTP Project Measurement-Based Care Implementation in Community Opioid Treatment Programs
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Pilot Implementation of Measurement-Based Care in Community Opioid Treatment Programs
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MBC2OTP
Brief Summary:
The goal of this clinical trial is to evaluate the effectiveness and implementation of measurement-based care which involves the systematic use of client self-report data to inform and enhance treatment in opioid treatment programs using a pilot hybrid effectiveness-implementation study design The main questions this study aims to answer are 1 is measurement based care effective for improving patient treatment attendance and opioid abstinence and 2 can measurement based care be implemented with fidelity in opioid treatment programs Participants in this study will be opioid treatment program leaders and treatment providers Leaders and treatment providers will participate in measurement-based care implementation strategies such as training and consultation to help them use measurement-based care with their patients There is no comparison group for this study however researchers will compare effectiveness outcomes prior to and post measurement-based care implementation and will evaluate changes in measurement-based care use with fidelity post implementation
Detailed Description:
Lethal drug overdoses have now become a leading cause of accidental death in the United States The gold standard evidence-based intervention for opioid use disorder OUD is pharmacotherapy but abstinence rates following pharmacotherapy are sub-optimal In fact less than 40 of clients with OUD achieve abstinence in the first six months of treatment highlighting the critical need to supplement pharmacotherapy with evidence-based psychosocial interventions Unfortunately very few community opioid treatment programs OTPs offer psychosocial interventions due to high patient volume and the need to identify behavioral treatments that can be flexibly delivered Measurement-based care MBC the systematic use of client self-report data to inform treatment is an evidence-based intervention that is uniquely well suited to complement OUD pharmacotherapy Given the high lethality of opioid misuse MBC provides an opportunity to identify early warning signs for poor treatment progress and enables treatment providers to intervene Additionally MBC may serve as a minimal interventionintervention structure to increase the effectiveness of OUD treatment Such structures have been proposed for implementation in community settings in lieu of full package evidence-based interventions to enhance feasibility and reduce barriers The pressing need for flexible psychosocial interventions to complement pharmacotherapy paired with the extensive evidence in support of MBC makes it crucial to understand ways to implement and evaluate MBCs effectiveness in OTPs This study involves a pilot type I hybrid effectiveness-implementation study with four OTPs
Study Aim and Hypotheses are
Aim Pilot MBC effectiveness-implementation trial in community OTPs Four OTPs will participate in a pilot hybrid type 1 effectiveness-implementation trial in which an MBC assessment protocol will be integrated into each OTPs electronic medical record EMR The pilot trial will gather data on MBCs effectiveness outcomes patient attendance and opioid abstinence and implementation outcomes provider MBC exposure and fidelity The study hypotheses are that post MBC EMR integration patients will attend more treatment appointments H1 and have more negative opioid urine screens per month H2 compared to pre-EMR integration patients Provider MBC exposure and fidelity will also be positively associated with higher attendance and abstinence across all sites H3
Study Aim and Hypotheses are
Aim Pilot MBC effectiveness-implementation trial in community OTPs Four OTPs will participate in a pilot hybrid type 1 effectiveness-implementation trial in which an MBC assessment protocol will be integrated into each OTPs electronic medical record EMR The pilot trial will gather data on MBCs effectiveness outcomes patient attendance and opioid abstinence and implementation outcomes provider MBC exposure and fidelity The study hypotheses are that post MBC EMR integration patients will attend more treatment appointments H1 and have more negative opioid urine screens per month H2 compared to pre-EMR integration patients Provider MBC exposure and fidelity will also be positively associated with higher attendance and abstinence across all sites H3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23DA050729 | NIH | None | httpsreporternihgovquickSearchK23DA050729 |