Four Conversations RCT
12. Dezember 2018 aktualisiert von: 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.
Studienübersicht
Studientyp
Interventionell
Einschreibung (Tatsächlich)
357
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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North Carolina
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Durham, North Carolina, Vereinigte Staaten, 27710
- Duke University Medical Center
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Sonstiges: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in patient/caregiver and provider preparedness for decision making as measured by the Preparation for Decision Making Scale
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Change in provider end of life (EOL) care knowledge as measured by revised City of Hope EOL Knowledge Assessment
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Feasibility as measured by completion of advance directive documents
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Sophia K Smith, PhD, Duke University School of Nursing
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
15. Dezember 2016
Primärer Abschluss (Tatsächlich)
21. Oktober 2018
Studienabschluss (Tatsächlich)
21. Oktober 2018
Studienanmeldedaten
Zuerst eingereicht
24. Oktober 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
24. Oktober 2016
Zuerst gepostet (Schätzen)
25. Oktober 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
13. Dezember 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
12. Dezember 2018
Zuletzt verifiziert
1. Dezember 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Pro00070790
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
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