Four Conversations RCT
2018年12月12日 更新者：Duke University
Four Conversations Randomized Controlled Trial
The purpose of this study is to see whether patients with metastatic breast cancer, their caregivers, and their healthcare providers can improve in shared decision making (SDM) and preparedness around end of life (EOL) planning through participation in Reimagine's online Four Conversations™ program.
The goal is to close clinical practice gaps and enhance the quality of care for patients with metastatic breast cancer through increased competence and performance of healthcare providers and healthcare systems.
調査の概要
研究の種類
介入
入学 (実際)
357
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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North Carolina
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Durham、North Carolina、アメリカ、27710
- Duke University Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Diagnosed with metastatic breast cancer (MBC), caregiver to patient with MBC who is enrolled in this study, or MBC provider
- Age ≥ 18 years
- Internet access through a computer, laptop, tablet, or other mobile device
- Able/willing to have an online interaction with a Reimagine Pillar Guide
- Providing informed consent
- Able to read/write English
Exclusion Criteria:
- None
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ランダム化
- 介入モデル：並列代入
- 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：Four Conversations Intervention
Subjects in this arm will participate in Reimagine's online Four Conversations program during the initial study period of four weeks.
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The online Four Conversations program consists of tutorial videos, printable documents, and live sessions with a counselor to educate subjects on shared decision making and care planning for those with advanced disease.
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他の：Waitlisted Control
Subjects in this arm will continue to receive standard care from their healthcare providers during the initial study period (i.e.
no intervention).
After four weeks, subjects will then participate in Reimagine's online Four Conversations program.
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The online Four Conversations program consists of tutorial videos, printable documents, and live sessions with a counselor to educate subjects on shared decision making and care planning for those with advanced disease.
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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 |
|---|---|---|
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Change in patient/caregiver and provider preparedness for decision making as measured by the Preparation for Decision Making Scale
時間枠：Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
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The Preparation for Decision Making Scale is a reliable and validated self-reported measure of the patient/caregiver or provider's perception of how useful a decision support intervention is in preparing the respondent to communicate with others making a health decision.
Items are summed and scored, then divided by 10; scores can be converted to a 0-100 scale.
Higher scores indicate higher perceived level of preparation for decision making.
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Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
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Change in patient/caregiver decision making self-efficacy as measured by the Decision Self-efficacy Scale
時間枠：Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
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The Decision Self-efficacy Scale is a reliable and validated instrument that measures self-confidence or belief in one's abilities in decision making, including shared decision making (SDM).
Items are summed, divided by 11, and multiplied by 25.
Scores range from 0 to 100 (very confident).
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Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
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Change in patient self-conflict as measured by the Decisional Conflict Scale
時間枠：Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
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The Decisional Conflict scale is a reliable and validated measure of the state of uncertainty about a course of action.
Items are summed, divided by 16, and multiplied by 25.
Scores range from 0 to 100 (high decisional conflict).
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Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
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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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Change in provider end of life (EOL) care knowledge as measured by revised City of Hope EOL Knowledge Assessment
時間枠：Baseline, Post-Intervention (Week 4)
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The content of the City of Hope End of Life Knowledge Assessment was revised to reflect the program curriculum.
Correctly answered questions will be awarded one point, summed, and a total score generated.
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Baseline, Post-Intervention (Week 4)
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Change in patient and caregiver quality of life (QOL) as measured by the PROMIS Global Scale
時間枠：Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
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The PROMIS Global Scale is a reliable and validated measure of general perceptions of health.
Items are predictive of care utilization and mortality.
The scale produces two health scores: physical and mental.
Items are summed and converted to t-scores.
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Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
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Change in patient/caregiver and provider end of life (EOL) conversations as measured by EOL Conversations
時間枠：Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
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The EOL Conversations are author-developed questionnaires incorporating items from the Survey on Advanced Care Planning Conversations.
Points are totaled and summed.
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Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Feasibility as measured by completion of advance directive documents
時間枠：Post-Intervention (Week 4 or 8)
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Post-Intervention (Week 4 or 8)
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Feasibility as measured by the patient's completion of Reimagine's Worries to Wishes Treatment Plan
時間枠：Post-Intervention (Week 4 or 8)
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Post-Intervention (Week 4 or 8)
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Feasibility as measured by Reimagine's Four Conversations program usage, as measured by clickstream data from Reimagine's website and Reimagine staff report
時間枠：Intervention period (4 weeks)
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Clickstream data associated with viewing videos and other web content (e.g., social community) on the Reimagine website will be collected and analyzed through a web analytics software package.
Session attendance will be collected by the Reimagine staff (specially trained counselors called Pillar Guides) and sent to the study team for analysis following each of the online meetings.
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Intervention period (4 weeks)
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Feasibility as measured by satisfaction with Reimagine's Four Conversations program, as measured by the Program Satisfaction & Evaluation questionnaire
時間枠：Post-Intervention (Week 4 or 8)
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The Program Satisfaction & Evaluation questionnaire was developed by the study team to assess perceived helpfulness of the program in terms of outcomes and patient-provider communication.
Points are totaled and summed.
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Post-Intervention (Week 4 or 8)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Sophia K Smith, PhD、Duke University School of Nursing
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.
- Smith SK, Westbrook K, MacDermott K, Amarasekara S, LeBlanc M, Pan W. Four Conversations: A Randomized Controlled Trial of an Online, Personalized Coping and Decision Aid for Metastatic Breast Cancer Patients. J Palliat Med. 2020 Mar;23(3):353-358. doi: 10.1089/jpm.2019.0234. Epub 2019 Oct 22.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年12月15日
一次修了 (実際)
2018年10月21日
研究の完了 (実際)
2018年10月21日
試験登録日
最初に提出
2016年10月24日
QC基準を満たした最初の提出物
2016年10月24日
最初の投稿 (見積もり)
2016年10月25日
学習記録の更新
投稿された最後の更新 (実際)
2018年12月13日
QC基準を満たした最後の更新が送信されました
2018年12月12日
最終確認日
2018年12月1日
詳しくは
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