Opioid Use Disorder
Conditions
Keywords
Patient Navigation
Brief summary
We are studying whether training an identified support person and providing patient navigation (i.e. a peer recovery specialist assisting you with finding the right support) after delivery can increase "recovery capital"-the resources that help people with opioid use disorder (OUD) stay in treatment and recover. This study will build upon the research team's prior work in conducting research among pregnant and parenting women with OUD. This project will be directed by the research team at Friends Research Institute in close collaboration with their research and clinical partners at the University of Pennsylvania in Philadelphia, PA. A two-phase study is proposed with an initial 1-year developmental phase (R61) that will develop and pilot test STORC to include support person training. A second 4-year phase (R33) will test STORC in a parallel, two-arm, randomized controlled trial design at two study sites.
Detailed description
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.
Interventions
BEHAVIORALSTORC
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.
Sponsors
Friends Research Institute, Inc.
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Support person training. Support persons will engage in online training. The training videos will be divided into three main modules. Module 1 will focus on building social and community capital, providing knowledge about OUD recovery, treatment, and processes of change. Module 2 will detail coping skills and emotional support resources for the support persons. Also included will be a discussion of healthy boundaries. In Module 3, a review of the skills learned will be included and effective communication skills will be further developed between support person and their loved one, and between support person and healthcare providers. Patient Navigation. The video training will be integrated alongside patient navigation, as an evidence-based intervention. Patient navigation addresses health beliefs, motivations, and barriers to engaging with services, including addressing social and material needs .
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Feasibility | at study completion, up to 3 months | Number of eligible participants recruited for the trial relative to the number screened. |
| Acceptability of the Intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Appropriateness of the Intervention | 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. |
| Recovery Capital | 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. |
| Self-efficacy | 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. |
| Substance use | The past 30 days | 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. |
Countries
United States
Contacts
CONTACTKaren Alexander, PhD
CONTACTRachel Woolworth, MSW
PRINCIPAL_INVESTIGATORKaren Alexander
Friends Research Institute, Inc.
Outcome results
None listed