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
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Karen Alexander, PhD
- 电话号码：9084510141
- 邮箱：kalexander@friendsresearch.org
研究联系人备份
- 姓名：Rachel Woolworth, MSW
- 电话号码：267-258-2067
- 邮箱：rwoolworth@friendsresearch.org
学习地点
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
-
接触：
- Sara Kornfield, PhD
- 电话号码：215-746-1255
- 邮箱：sarakorn@pennmedicine.upenn.edu
-
接触：
- Karen Alexander, PhD
- 电话号码：9084510141
- 邮箱：kalexander@friendsresearch.org
-
首席研究员：
- Sara Kornfield, PhD
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：非随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Recruitment Feasibility
大体时间：at study completion, up to 3 months
|
Number of eligible participants recruited for the trial relative to the number screened.
|
at study completion, up to 3 months
|
|
Acceptability of the Intervention
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Appropriateness of the Intervention
大体时间：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
大体时间：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
大体时间：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
大体时间：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.
|
The past 30 days
|
合作者和调查者
调查人员
- 首席研究员：Karen Alexander、Friends Research Institute, Inc.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.