Phone Interview to Prevent Recurring Opioid Overdoses (TTIP-PRO)
2015년 5월 27일 업데이트: Theresa Winhusen, University of Cincinnati
Pilot Evaluation of the "Tailored Telephone Intervention Delivered by Peers to Prevent Recurring Opioid-Overdoses"
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.
연구 개요
상태
완전한
개입 / 치료
상세 설명
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.
연구 유형
중재적
등록 (예상)
30
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ohio
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Cincinnati, Ohio, 미국, 45229
- 3131 Harvey Avenue, Suite 104
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Cincinnati, Ohio, 미국, 45229
- UC Physicians Company, LLC Opioid Treatment Program
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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다른: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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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.)
기간: 6 months
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Impact of TTIP-PRO on knowledge about Opioid Overdose. (will be assessed with a paired difference test (e.g., paired t-test))
기간: 6 months
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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.
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6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 9월 1일
기본 완료 (실제)
2015년 2월 1일
연구 완료 (실제)
2015년 2월 1일
연구 등록 날짜
최초 제출
2014년 10월 30일
QC 기준을 충족하는 최초 제출
2014년 11월 3일
처음 게시됨 (추정)
2014년 11월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 5월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 5월 27일
마지막으로 확인됨
2015년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2014-2591
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .