Phone Interview to Prevent Recurring Opioid Overdoses

Not Applicable

Completed

• Conditions: Drug Abuse; Substance Abuse; Drug Overdose; Overdose; Drug Addiction; Opioid Dependence; Opioid Use, Unspecified; Opioid-related Disorders
• Interventions: Behavioral: TTIP-PRO

• Registration Number: NCT02282306
• Lead Sponsor: University of Cincinnati

Brief Summary

There has been a dramatic rise in opioid overdose (OOD) deaths in recent years. Attempts to ameliorate the problem have largely focused on increasing the accessibility of naloxone, an opioid antagonist that is effective in OOD reversal. Individuals who have experienced a non-fatal OOD are at risk for additional overdoses and yet there are no interventions that specifically target this high-risk population. To address this gap, the investigators have developed the "Tailored Telephone Intervention delivered by Peers to Prevent Recurring Opioid Overdoses" (TTIP-PRO). The overall goal of the present study is to conduct a pilot evaluation of the TTIP-PRO. The research literature suggests the need for an intervention targeting patients experiencing a non-fatal OOD.

Detailed Description

This is a single-group, unblinded pilot study of the TTIP-PRO, which will be completed with approximately 30 participants. Potential participants will be identified by querying the University of Cincinnati Medical Center (UCMC) Emergency Department (ED) Electronic Health Record (EHR) for patients treated for an OOD (e.g., opioid poisoning). Patients who have experienced an OOD in the past 8 months will be eligible to receive the TTIP-PRO. A letter about the study will be sent to those patients. Interested patients will call the UC Health staff working on this study. A UC Health staff member will inform potential participants about the study, confirm eligibility, collect enrollment measures, and schedule a time for the TTIP-PRO to be completed with the Peer Interventionist. The participant will be instructed to contact the Peer Interventionist at the scheduled time. After the peer-delivered TTIP-PRO intervention has been completed, a UC Health employee will contact the participant to administer the follow-up measures. The UC Health employee will then send a mailing to the participant that will include a copy of the participant's "Personal Risks for Overdose" report, general information about overdose prevention, and information about treatment for opioid use disorder (see section 2.6 for additional information). The mailing will also include a gift card (which is a standard part of the TTIP-PRO) and an additional gift card to compensate the participant for his/her time as a study participant.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-11-03
• Study First Posted: 2014-11-04
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TTIP-PRO	TTIP-PRO	Patients who have experienced an OOD in the past 8 months will be eligible to receive TTIP-PRO. A letter about the study will be sent to those patients. Interested patients will call the UC Health staff working on this study. The intervention entails administering the Personal Opioid-Overdose Risk Survey and the Opioid Overdose and Treatment Awareness Survey to the patient. The TTIP-PRO computer program uses the information to generate the "Personal Feedback Report", which is used by the Peer Interventionist to provide the intervention. The TTIP-PRO computer program also creates the "Personal Risk Factors Report" which is mailed to the participant with some other helpful information.

Primary Outcome Measures

Name	Time	Method
Study Acceptability (proportion of patients who: a). call about the study and b). agree to participate in the study and c). who complete the study.)	6 months	Acceptability of the study will be assessed based on the proportion of patients who: a). call about the study and b). agree to participate in the study and c). who complete the study.; Acceptability of the study will be further assessed by peer interventionists who: a). complete the training and b). complete the study (i.e. continue to successfully provide intervention to assigned participants through the end of the study).

Secondary Outcome Measures

Name	Time	Method
Impact of TTIP-PRO on knowledge about Opioid Overdose. (will be assessed with a paired difference test (e.g., paired t-test))	6 months	The impact of the TTIP-PRO on knowledge about OOD will be assessed with a paired difference test (e.g., paired t-test). Finally, summary statistics for the proportion of participants willing to be contacted by a MAT staff member after receiving the TTIP-PRO intervention will be calculated.

Trial Locations

Locations (2)

3131 Harvey Avenue, Suite 104; 🇺🇸 Cincinnati, Ohio, United States

UC Physicians Company, LLC Opioid Treatment Program; 🇺🇸 Cincinnati, Ohio, United States