Supporting Treatment for Opioids and Recovery Capital (STORC) - R61 Phase (STORC R61)
Empowering Support Persons to Enhance the Recovery Capital of Postpartum Women With Opioid Use Disorder - R61 Phase
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The developmental R61 phase will focus on developing training materials and pilot testing STORC for feasibility and acceptability. This will be accomplished through three interrelated processes: 1) Developing materials to train support persons, including creating digital education content with expert consultants; 2) Pilot testing STORC recruitment procedures and training content to evaluate feasibility and acceptability; 3) Conducting qualitative interviews to gain diverse stakeholder input at the end of the pilot trial; and 4) Refining training materials into a final digital product with our media consultant.
Aim 1 (Months 2-12): We will develop and refine training materials to create a robust support person training. We will do this through an iterative process that first uses feedback from expert consultants with lived experience (two of whom are certified recovery specialists working in the PROUD clinic). These experts will develop scripts to communicate the training content to support persons, and we will work with our media production partner to produce the video content. After the pilot trial in Aim 2, we will refine the content and update any training portions that need improvement after qualitative interviews.
Aim 2: (Months 4-10) Pilot test STORC for feasibility and acceptability (N = 20 [10 patient/support person dyads]) and refine with feedback from the dyads at completion of the pilot. All participants will also view the training videos and provide feedback. The qualitative feedback and results of the pilot testing will inform the final STORC protocol used in the R33 phase.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Karen Alexander, PhD
- Numéro de téléphone: 9084510141
- E-mail: kalexander@friendsresearch.org
Sauvegarde des contacts de l'étude
- Nom: Rachel Woolworth, MSW
- Numéro de téléphone: 267-258-2067
- E-mail: rwoolworth@friendsresearch.org
Lieux d'étude
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19104
- University of Pennsylvania
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Contact:
- Sara Kornfield, PhD
- Numéro de téléphone: 215-746-1255
- E-mail: sarakorn@pennmedicine.upenn.edu
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Contact:
- Karen Alexander, PhD
- Numéro de téléphone: 9084510141
- E-mail: kalexander@friendsresearch.org
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Chercheur principal:
- Sara Kornfield, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- must be biological females
- must be currently within 6 weeks postpartum
- must be able to read, write, and speak English at a 6th-grade level
- must be diagnosed and receiving treatment for, or willing to receive treatment for opioid use disorder at the PROUD clinic
- must identify a support person who also consents to participate. Patient participants must identify prospective support persons in order to complete consent
Exclusion Criteria:
- pregnancy
- planned discharge to a long-term inpatient care facility (e.g., hospice)
- hospitalization for a suicide attempt
- major mental health disorder that requires treatment before OAT can be considered
- stillbirth or neonatal death of the index pregnancy/infant, as determined from the obstetric record.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: STORC
STORC is inclusive of patient navigation and support person training.
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STORC will operate as a service model integrating both designated support persons and specialized patient navigators to enhance recovery capital and improve secondary outcomes, including increased OAT retention.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Recruitment Feasibility
Délai: at study completion, up to 3 months
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Number of eligible participants recruited for the trial relative to the number screened.
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at study completion, up to 3 months
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Acceptability of the Intervention
Délai: At 3 month follow-up
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Intervention acceptability will be measured using the 4-item Acceptability of Intervention Measure (AIM), a valid and reliable self-report measure of the extent to which participant accepts the intervention as relevant to their experience.
The AIM is scored from 1 to 5, with higher scores indicating greater perceived acceptability of the intervention.
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At 3 month follow-up
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Appropriateness of the Intervention
Délai: at 3 month follow-up
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Intervention appropriateness will be measured using the 4-item Intervention Appropriateness Measure (IAM), a valid and reliable self-report measure of the extent to which participants see the intervention as appropriate for who they are and their experience.
The IAM is scored from 1 to 5, with higher scores indicating greater perceived appropriateness of the intervention.
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at 3 month follow-up
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Recovery Capital
Délai: Changes from baseline to 3 months follow-up
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Recovery Capital will be assessed using the Brief Assessment of Recovery Capital-10 (BARC-10).
The BARC-10 is scored from 10 to 60, with higher scores indicating greater recovery capital.
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Changes from baseline to 3 months follow-up
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Self-efficacy
Délai: Changes from baseline to 3 months
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The degree to which a person is confident they can make a change in health related behavior measured using the Patient Activation Measured (PAM).
The PAM-10 is scored from 0 to 100, with higher scores indicating greater patient activation, reflecting greater knowledge, skills, and confidence in managing one's health and healthcare.
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Changes from baseline to 3 months
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Substance use
Délai: The past 30 days
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Timeline follow-up of substance use in the past 30 days measured by number of days of substance use during the past 30 days, assessed at each follow-up visit.
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The past 30 days
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Karen Alexander, Friends Research Institute, Inc.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R61DA064704 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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