The OPT-IN Project

University of Michigan

Status: Completed

Conditions: Opioid-Related Disorders

Treatments: Behavioral: Behavioral: the OPT-IN Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03526380

R49CE002099

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Speaks English Fluently
• Receiving services at one of the investigator's partner sites
• History of opioid use

Exclusion criteria

• Medically unstable
• Prisoners
• Inability to speak and understand English
• Inability to give informed, voluntary, written consent for any reason

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Treatment

Experimental group

Description:

Participants receive the OPT-IN Brief Intervention.

Treatment:

Behavioral: Behavioral: the OPT-IN Intervention

Control

No Intervention group

Description:

Participants will only complete the baseline and follow-up surveys.