Phone Interview to Prevent Recurring Opioid Overdoses

Opioid-related Disorders Clinical Trial

— TTIP-PRO  

Official title:

Pilot Evaluation of the "Tailored Telephone Intervention Delivered by Peers to Prevent Recurring Opioid-Overdoses"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282306
• Other study ID #: 2014-2591
• Status: Completed
• Phase: N/A
• First received: October 30, 2014
• Last updated: May 27, 2015
• Start date: September 2014
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: University of Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria for participants (receiving the TTIP-PRO intervention):

• have been treated for an OOD by the UCMC ED within the prior 8 months

• have used heroin and/or abused prescription opioids in the prior 12 months

• be 18 years of age or older at time of enrollment

• be able to provide verbal consent to participate in English

Exclusion Criteria for participants (receiving the TTIP-PRO intervention):

• demonstrate difficulty understanding the study as assessed with four true-false questions (i.e., 1. This is a research study; 2. Your participation is entirely voluntary; 3. You will be asked questions about your risk of opioid overdose.; 4. Your participation will involve several phone calls).

Inclusion Criteria for Peer Interventionists:

• be 18 years of age or older at time of enrollment

• be enrolled in a methadone-maintenance or buprenorphine- maintenance treatment program for at least one year

• report being opioid-abstinent for at least one year

• meet at least one of the following: has experienced/witnessed/lost a family member or friend to an overdose

• be able to provide informed consent in English

Exclusion criteria for Peer Interventionists:

• have significant treatment/clinical concerns as determined by treatment program staff

The primary pool of potential Peer Interventionists will be patients enrolled in the UC Health (University of Cincinnati Physicians Company) methadone-maintenance or buprenorphine- maintenance treatment programs. Recruitment will be through clinic postings and word of mouth. It is estimated that 2-3 Peer Interventionists will be enrolled in the study.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Drug Abuse
• Drug Addiction
• Drug Overdose
• Opioid Dependence
• Opioid Use, Unspecified
• Opioid-related Disorders
• Overdose
• Substance Abuse

Intervention

Behavioral:
• TTIP-PRO
The peer-delivered TTIP-PRO intervention is designed to: 1). increase the patient's knowledge of risk factors for OOD, with a particular emphasis on the patient's personal risk factors. This aim is one of harm reduction and is intended to help patients who continue to abuse opioids to use in a safer manner and 2).For patients who are open to considering treatment, to encourage the patient to get treatment for his/her opioid use disorder. This goal is based on research findings that effective treatment reduces the risk of OOD.

Locations

Country	Name	City	State
United States	3131 Harvey Avenue, Suite 104	Cincinnati	Ohio
United States	UC Physicians Company, LLC Opioid Treatment Program	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	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).	6 months	No
Secondary	Impact of TTIP-PRO on knowledge about Opioid Overdose. (will be assessed with a paired difference test (e.g., paired t-test))	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.	6 months	No