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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Karen Alexander, PhD
- 電話番号：9084510141
- メール：kalexander@friendsresearch.org
研究連絡先のバックアップ
- 名前：Rachel Woolworth, MSW
- 電話番号：267-258-2067
- メール：rwoolworth@friendsresearch.org
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania
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コンタクト：
- Sara Kornfield, PhD
- 電話番号：215-746-1255
- メール：sarakorn@pennmedicine.upenn.edu
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コンタクト：
- Karen Alexander, PhD
- 電話番号：9084510141
- メール：kalexander@friendsresearch.org
-
主任研究者：
- Sara Kornfield, PhD
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recruitment Feasibility
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Appropriateness of the Intervention
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Karen Alexander、Friends Research Institute, Inc.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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