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
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Karen Alexander, PhD
- Telefoonnummer: 9084510141
- E-mail: kalexander@friendsresearch.org
Studie Contact Back-up
- Naam: Rachel Woolworth, MSW
- Telefoonnummer: 267-258-2067
- E-mail: rwoolworth@friendsresearch.org
Studie Locaties
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- University of Pennsylvania
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Contact:
- Sara Kornfield, PhD
- Telefoonnummer: 215-746-1255
- E-mail: sarakorn@pennmedicine.upenn.edu
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Contact:
- Karen Alexander, PhD
- Telefoonnummer: 9084510141
- E-mail: kalexander@friendsresearch.org
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Hoofdonderzoeker:
- Sara Kornfield, PhD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Recruitment Feasibility
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Appropriateness of the Intervention
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Karen Alexander, Friends Research Institute, Inc.
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- R61DA064704 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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