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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Karen Alexander, PhD
- Telefonnummer: 9084510141
- E-post: kalexander@friendsresearch.org
Studera Kontakt Backup
- Namn: Rachel Woolworth, MSW
- Telefonnummer: 267-258-2067
- E-post: rwoolworth@friendsresearch.org
Studieorter
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19104
- University of Pennsylvania
-
Kontakt:
- Sara Kornfield, PhD
- Telefonnummer: 215-746-1255
- E-post: sarakorn@pennmedicine.upenn.edu
-
Kontakt:
- Karen Alexander, PhD
- Telefonnummer: 9084510141
- E-post: kalexander@friendsresearch.org
-
Huvudutredare:
- Sara Kornfield, PhD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: STORC
STORC is inclusive of patient navigation and support person training.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recruitment Feasibility
Tidsram: at study completion, up to 3 months
|
Number of eligible participants recruited for the trial relative to the number screened.
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at study completion, up to 3 months
|
|
Acceptability of the Intervention
Tidsram: At 3 month follow-up
|
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.
|
At 3 month follow-up
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Appropriateness of the Intervention
Tidsram: at 3 month follow-up
|
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.
|
at 3 month follow-up
|
|
Recovery Capital
Tidsram: Changes from baseline to 3 months follow-up
|
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.
|
Changes from baseline to 3 months follow-up
|
|
Self-efficacy
Tidsram: Changes from baseline to 3 months
|
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.
|
Changes from baseline to 3 months
|
|
Substance use
Tidsram: 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.
|
The past 30 days
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Karen Alexander, Friends Research Institute, Inc.
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R61DA064704 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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