Quality Improvement Tools for Opioid Use Disorder

(PROMOTE-QI Trial)

TL
EC
Overseen ByEmily C Costilow, MA, PMP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: RTI International
Must be taking: Methadone, Buprenorphine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to find better ways to keep people in opioid treatment programs (OTPs) longer, potentially leading to improved recovery outcomes. It compares three groups: one using a quality improvement (QI) toolkit, another using the QI toolkit with additional support from external QI facilitators, and a third receiving regular care. Participants come exclusively from BayMark OTPs, focusing on existing clinics. The study will measure how long patients remain in treatment and examine other health impacts, such as hospital visits and overdoses. The goal is to identify strategies that can help clinics effectively improve patient retention.

As an unphased trial, this study provides an opportunity to contribute to research that could enhance treatment strategies and improve patient outcomes.

Do I need to stop my current medications to join the trial?

The trial focuses on improving retention in opioid treatment programs and does not specify if participants need to stop their current medications. It seems likely that staying on methadone or buprenorphine is encouraged, as the study aims to keep patients in care.

What prior data suggests that these quality improvement tools are safe for opioid treatment programs?

Research has shown that the Quality Improvement (QI) Toolkit and External QI Facilitation used in this study are generally safe and well-tolerated. The QI Toolkit aids clinics in enhancing care for patients with opioid use disorder by organizing tasks and providing useful tools. No safety concerns have been reported from using the toolkit, as it focuses on improving clinic practices rather than directly treating patients.

Similarly, External QI Facilitation supports clinics in making improvements with the help of facilitators. This involves coaching teams to implement changes that enhance patient care. This method has been used in other healthcare settings without any reported harm. It focuses on supporting staff rather than directly affecting patients, posing minimal risk. Overall, both tools aim to improve clinic operations and keep patients in treatment, making them safe options for participating clinics.12345

Why are researchers excited about this trial?

Researchers are excited about these quality improvement tools for opioid use disorder because they offer innovative strategies to enhance treatment retention compared to traditional methods. Unlike usual care, which often lacks structured guidance, the QI toolkit provides clinics with evidence-based resources and templates to drive meaningful change. Additionally, the external QI facilitation arm introduces expert coaching through structured frameworks like the NIATx model, aiming to guide clinics in implementing effective retention strategies. This hands-on support and data-driven feedback could significantly improve patient outcomes by fostering a more responsive and adaptive treatment environment.

What evidence suggests that this trial's quality improvement tools could be effective for opioid use disorder?

Research has shown that quality improvement (QI) toolkits can enhance opioid treatment programs by helping retain patients. In one study, 76% of participants reported that their QI project improved their management of opioid treatment. Participants in this trial may receive a QI toolkit to monitor each step of treatment, potentially improving the program's overall performance and saving lives.

For clinics in this trial using external QI facilitation, evidence indicates that structured guidance can further improve patient retention. This method includes coaching and regular data reviews to implement effective changes. Overall, these strategies offer practical ways to keep patients in care longer, which is crucial for successful treatment.16789

Who Is on the Research Team?

TL

Tami L Mark, PhD

Principal Investigator

RTI International

Are You a Good Fit for This Trial?

This trial is for BayMark opioid treatment programs (OTPs) looking to improve patient retention. It aims to help patients stay on methadone or buprenorphine, which leads to better outcomes. Only BayMark OTPs can participate; there are no specific exclusion criteria mentioned.

Inclusion Criteria

Only BayMark OTPs are eligible for participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

OTPs are provided with quality measures and a QI toolkit, with or without external facilitation, to improve patient retention

12 months

Follow-up

Participants are monitored for retention and secondary outcomes such as ED visits and hospitalizations

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • External QI Facilitation
  • Quality Improvement (QI) Toolkit
  • Quality Measures (Audit and Feedback)
Trial Overview The study compares two methods against usual care in helping OTPs keep patients in treatment: one with quality measures and a QI toolkit, the other adds external facilitation to these tools. Forty-five clinics will be randomly placed into three groups to see which method works best.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2 - Title: Quality Measures + QI Toolkit + External QI FacilitationExperimental Treatment3 Interventions
Group II: Arm 1 - Title: Quality Measures + QI ToolkitExperimental Treatment2 Interventions
Group III: Arm 3 - Title: No Intervention: Usual CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

RTI International

Lead Sponsor

Trials
201
Recruited
942,000+

University of California, Los Angeles

Collaborator

Trials
1,594
Recruited
10,430,000+

BayMark Health Services

Collaborator

Los Angeles County Department of Public Health - Substance Abuse Prevention and Control (SAPC)

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Citations

A facilitation model for implementing quality improvement ...Data from 2018 shows that 128 people in the USA died every day from opioid overdoses and approximately 2 million people had opioid use disorder ...
PRoducing Outcome Measures for OTP Quality ImprovementA self-guided QI toolkit for OTPs with step-by-step change packages, PDSA templates, training materials, and case examples to improve retention.
Healthcare Expenditures Associated With Implementing an ...We evaluated the downstream costs of implementing an external facilitation approach to increase the adoption of medications for opioid use ...
Multifaceted Quality Improvement Initiative ...There may have been some external influences on retention and return rates apart from the QI interventions in this initiative. Within the MATA ...
Augmenting project ECHO for opioid use disorder with data ...This project sought to explore the feasibility of training clinics to collect performance data and initiate QI alongside clinics' participation in a Project ...
Virtual practice facilitation as an implementation strategy for ...OSC implementation was one part of a larger QI initiative to reduce high-dose opioid prescribing and improve care for patients with pain.
Association between different modalities of opioid use ...This study assessed the impact of different modalities of delivery of opioid use disorder (OUD)-related care on several patient outcomes.
Multifaceted Quality Improvement Initiative Improves...Our data demonstrate that following MI staff training, reduced initial clinic requirements, transportation support, and utilization of an incentive program, the ...
Engaging healthcare teams to increase access ...Using aggregate facility-level data from October 2015 to September 2022, we analyzed changes in patients receiving MOUD using hierarchical ...
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