Clinical trial NCT02282306: Phone Interview to Prevent Recurring Opioid Overdoses
Official title: Pilot Evaluation of the "Tailored Telephone Intervention Delivered by Peers to Prevent Recurring Opioid-Overdoses"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overdose
Opioid-related Disorders
Drug Addiction
Drug Abuse
Substance Abuse
Opioid Use, Unspecified
Opioid Dependence
Drug Overdose
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2014-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.)
timeFrame: 6 months
Secondary outcomes:
measure: Impact of TTIP-PRO on knowledge about Opioid Overdose. (will be assessed with a paired difference test (e.g., paired t-test))
timeFrame: 6 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: 3131 Harvey Avenue, Suite 104
state: Ohio
city: Cincinnati
country: United States
facility: UC Physicians Company, LLC Opioid Treatment Program
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Theresa Winhusen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Winhusen T, Theobald J, Lewis D, Wilder CM, Lyons MS. Development and initial testing of a tailored telephone intervention delivered by peers to prevent recurring opioid-overdoses (TTIP-PRO). Health Educ Res. 2016 Apr;31(2):146-60. doi: 10.1093/her/cyw010.