Four Conversations RCT
2018년 12월 12일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (실제)
357
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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North Carolina
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Durham, North Carolina, 미국, 27710
- Duke University Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in patient/caregiver and provider preparedness for decision making as measured by the Preparation for Decision Making Scale
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in provider end of life (EOL) care knowledge as measured by revised City of Hope EOL Knowledge Assessment
기간: 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
기간: 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
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility as measured by completion of advance directive documents
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Sophia K Smith, PhD, Duke University School of Nursing
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 12월 15일
기본 완료 (실제)
2018년 10월 21일
연구 완료 (실제)
2018년 10월 21일
연구 등록 날짜
최초 제출
2016년 10월 24일
QC 기준을 충족하는 최초 제출
2016년 10월 24일
처음 게시됨 (추정)
2016년 10월 25일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 12월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 12월 12일
마지막으로 확인됨
2018년 12월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .