Phone Interview to Prevent Recurring Opioid Overdoses (TTIP-PRO)
27 mai 2015 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Anticipé)
30
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Ohio
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Cincinnati, Ohio, États-Unis, 45229
- 3131 Harvey Avenue, Suite 104
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Cincinnati, Ohio, États-Unis, 45229
- UC Physicians Company, LLC Opioid Treatment Program
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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.)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Impact of TTIP-PRO on knowledge about Opioid Overdose. (will be assessed with a paired difference test (e.g., paired t-test))
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2014
Achèvement primaire (Réel)
1 février 2015
Achèvement de l'étude (Réel)
1 février 2015
Dates d'inscription aux études
Première soumission
30 octobre 2014
Première soumission répondant aux critères de contrôle qualité
3 novembre 2014
Première publication (Estimation)
4 novembre 2014
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
28 mai 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
27 mai 2015
Dernière vérification
1 mai 2015
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2014-2591
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .