Prescribe to Save Lives

Opioid-Related Disorders Clinical Trial

— PTSL  

Official title:

Implementation to Motivate Physician Response to Opioid Dependence in HIV Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175640
• Other study ID #: BH-15-259
• Secondary ID: R01DA038082
• Status: Completed
• Phase: N/A
• Start date: July 12, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2020
• Source: Baystate Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Opioid-Related Disorders

Intervention

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

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island
United States	University of Massachusetts Medical School - Baystate	Springfield	Massachusetts

Sponsors (5)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in naloxone prescribing behavior	Number of clinicians that prescribe naloxone. This information will be collected from electronic medical record (EMR) data.	baseline to 6 months
Secondary	Change in perception about pharmacotherapy for opioid use disorder; 6-month	Opinions About Medication Assisted Treatment (OAMAT) survey	baseline to 6 months
Secondary	Change in perception about pharmacotherapy for opioid use disorder; 12-month	Opinions About Medication Assisted Treatment (OAMAT) survey	baseline to 12 months
Secondary	Change in prescribing motivation; 6 months	Change in Motivation Scale	baseline to 6 months
Secondary	Change in prescribing motivation; 12 months	Change in Motivation Scale	baseline to 12 months
Secondary	Change in prescriber training	Number of prescribers that have completed buprenorphine training.	baseline to 12 months
Secondary	Change in buprenorphine prescribing behavior	Prevalence of buprenorphine prescription. This information will be collected from EMR data.	baseline to 12 months