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Prescribe to Save Lives (PTSL)

Primary Purpose

Opioid-Related Disorders, Drug Overdose

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Implementation intervention

About this trial

This is an interventional health services research trial for Opioid-Related Disorders

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinicians and staff of HIV practice sites that:

Receive Ryan White Funding;
Treat adults with HIV;
Have 3 or more prescribing clinicians;
Have an electronic medical record (EMR) with an electronic medication list.

Exclusion Criteria:

Sites located in states with fewer than 500 Persons Living With HIV (PLWH) will be excluded

Sites / Locations

University of Massachusetts Medical School - Baystate
The Miriam Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Implementation intervention

Arm Description

Outcomes

Primary Outcome Measures

Change in naloxone prescribing behavior

Number of clinicians that prescribe naloxone. This information will be collected from electronic medical record (EMR) data.

Secondary Outcome Measures

Change in perception about pharmacotherapy for opioid use disorder; 6-month

Opinions About Medication Assisted Treatment (OAMAT) survey

Change in perception about pharmacotherapy for opioid use disorder; 12-month

Opinions About Medication Assisted Treatment (OAMAT) survey

Change in prescribing motivation; 6 months

Change in Motivation Scale

Change in prescribing motivation; 12 months

Change in Motivation Scale

Change in prescriber training

Number of prescribers that have completed buprenorphine training.

Change in buprenorphine prescribing behavior

Prevalence of buprenorphine prescription. This information will be collected from EMR data.

Full Information

NCT ID

NCT03175640

First Posted

May 18, 2017

Last Updated

December 17, 2020

Sponsor

Baystate Medical Center

Collaborators

National Institute on Drug Abuse (NIDA), The Miriam Hospital, Boston Medical Center, Rhode Island Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03175640

Brief Title

Prescribe to Save Lives

Acronym

PTSL

Official Title

Implementation to Motivate Physician Response to Opioid Dependence in HIV Settings

Study Type

Interventional

2. Study Status

Record Verification Date

December 2020

Overall Recruitment Status

Completed

Study Start Date

July 12, 2017 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Baystate Medical Center

Collaborators

National Institute on Drug Abuse (NIDA), The Miriam Hospital, Boston Medical Center, Rhode Island Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The U.S. is in the midst of an epidemic of opioid overdose deaths. The common use of opioids among persons living with HIV, along with their common use of benzodiazepines, has resulted in high rates of opioid overdose among this population. This study will test the implementation of evidence-based training, mentoring, technical support, and academic detailing to encourage HIV physicians to adopt evidence-based interventions to reduce overdose risk and treat opioid addiction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-Related Disorders, Drug Overdose

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

294 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Implementation intervention

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Implementation intervention

Intervention Description

The implementation intervention includes peer-to-peer training, post-training outreach, proactive expert support, and assistance with addressing environmental barriers.

Primary Outcome Measure Information:

Title

Change in naloxone prescribing behavior

Description

Number of clinicians that prescribe naloxone. This information will be collected from electronic medical record (EMR) data.

Time Frame

baseline to 6 months

Secondary Outcome Measure Information:

Title

Change in perception about pharmacotherapy for opioid use disorder; 6-month

Description

Opinions About Medication Assisted Treatment (OAMAT) survey

Time Frame

baseline to 6 months

Title

Change in perception about pharmacotherapy for opioid use disorder; 12-month

Description

Opinions About Medication Assisted Treatment (OAMAT) survey

Time Frame

baseline to 12 months

Title

Change in prescribing motivation; 6 months

Description

Change in Motivation Scale

Time Frame

baseline to 6 months

Title

Change in prescribing motivation; 12 months

Description

Change in Motivation Scale

Time Frame

baseline to 12 months

Title

Change in prescriber training

Description

Number of prescribers that have completed buprenorphine training.

Time Frame

baseline to 12 months

Title

Change in buprenorphine prescribing behavior

Description

Prevalence of buprenorphine prescription. This information will be collected from EMR data.

Time Frame

baseline to 12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinicians and staff of HIV practice sites that: Receive Ryan White Funding; Treat adults with HIV; Have 3 or more prescribing clinicians; Have an electronic medical record (EMR) with an electronic medication list. Exclusion Criteria: Sites located in states with fewer than 500 Persons Living With HIV (PLWH) will be excluded

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter D Friedmann, MD, MPH

Organizational Affiliation

University of Massachusetts Medical School - Baystate

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Josiah D Rich, MD, MPH

Organizational Affiliation

The Miriam Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Massachusetts Medical School - Baystate

City

Springfield

State/Province

Massachusetts

ZIP/Postal Code

01199

Country

United States

Facility Name

The Miriam Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

The investigators will make study data available to the community of scientists and the public in keeping with NIDA policies. After all data have been collected and the results of the major papers are in press, de-identified data will be made available to other qualified researchers on request. The request will be evaluated by Dr. Friedmann to ensure that it meets reasonable standards of scientific integrity. Ultimately, it is anticipated that de-identified data and codebooks will be warehoused and available through the ICPSR and SAMHDA websites. This data sharing plan will comply with the requirements of the privacy rule and federal regulations under HIPAA and 42 CFR Part 2 that govern the protection of individually identifiable information.

Citations:

PubMed Identifier

35587832

Citation

Jawa R, Walley AY, Wilson DJ, Green TC, McKenzie M, Hoskinson R Jr, Bratberg J, Ramsey S, Rich JD, Friedmann PD. Prescribe to Save Lives: Improving Buprenorphine Prescribing Among HIV Clinicians. J Acquir Immune Defic Syndr. 2022 Aug 15;90(5):546-552. doi: 10.1097/QAI.0000000000003001.

Results Reference

derived

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