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Phone Interview to Prevent Recurring Opioid Overdoses (TTIP-PRO)

Primary Purpose

Overdose, Opioid-related Disorders, Drug Addiction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TTIP-PRO
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overdose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 3131 Harvey Avenue, Suite 104
  • UC Physicians Company, LLC Opioid Treatment Program

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

TTIP-PRO

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
October 30, 2014
Last Updated
May 27, 2015
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT02282306
Brief Title
Phone Interview to Prevent Recurring Opioid Overdoses
Acronym
TTIP-PRO
Official Title
Pilot Evaluation of the "Tailored Telephone Intervention Delivered by Peers to Prevent Recurring Opioid-Overdoses"
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overdose, Opioid-related Disorders, Drug Addiction, Drug Abuse, Substance Abuse, Opioid Use, Unspecified, Opioid Dependence, Drug Overdose

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TTIP-PRO
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TTIP-PRO
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.)
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Impact of TTIP-PRO on knowledge about Opioid Overdose. (will be assessed with a paired difference test (e.g., paired t-test))
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Theresa Winhusen, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
3131 Harvey Avenue, Suite 104
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
UC Physicians Company, LLC Opioid Treatment Program
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27004905
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.
Results Reference
derived

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