Clinical Trials Directory

Trials / Completed

CompletedNCT03526380

The OPT-IN Project

Translation of Opiate Overdose Prevention Strategies

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
92 (actual)
Sponsor
University of Michigan · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Prescription opioid overdose represents a public health crisis. A number of efforts have been implemented to address opioid prescribing and opioid risk mitigation strategies for prescribers, but relatively few efforts have sought to address this problem directly with individuals who use opioids. This gap likely fails to fully address the inherent reinforcing nature of the medications that make it challenging to reduce use. The specific aim of this study is to pilot test a toolkit that pairs an intervention with the distribution of naloxone. External facilitation (supervision check-ins) will aid translation to delivery by non-research staff. Firstly, data will be collected from participants over time as a control group, prior to training site staff. Next, non-research staff will be trained on the intervention. Staff at the site will use the online "toolkit" developed in the beginning of this project to deliver the interventions and naloxone to their clients/patients as part of usual care. After staff at the site(s) are trained, additional data will be collected from participants during the intervention period and after 3-months.

Detailed description

Based on feedback from non-research site staff, the OPT-IN Project implementation package was tailored for optimal delivery in the site setting. The translation strategy will be evaluated using the RE-AIM framework, which includes Reach (e.g., number of individuals receiving intervention), Effectiveness (e.g., patient/client outcomes), Adoption (e.g., numbers trained), Implementation (e.g., fidelity of intervention delivery) and Maintenance (e.g., sustained in routine practice over time) with mixed qualitative and quantitative methods with intervention recipients.

Conditions

Interventions

TypeNameDescription
BEHAVIORALBehavioral: the OPT-IN InterventionA private one-on-one brief motivational interviewing intervention administered by non-research staff at community organizations. This will take up to 30 minutes to complete. The goal of the intervention is to improve opioid safety and reduce related overdoses among those who has a history of misusing opioids (prescription and illicit). The session will use techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This intervention will also seek to empower participants by providing content on bystander response as well as peer outreach, which emphasizes ways to discuss overdose risk with others at risk for overdose.

Timeline

Start date
2018-10-11
Primary completion
2020-06-30
Completion
2020-06-30
First posted
2018-05-16
Last updated
2020-08-13

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03526380. Inclusion in this directory is not an endorsement.