Four Conversations RCT
12. december 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
357
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
North Carolina
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Four Conversations Intervention
Subjects in this arm will participate in Reimagine's online Four Conversations program during the initial study period of four weeks.
|
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.
|
|
Andet: 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.
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in patient/caregiver and provider preparedness for decision making as measured by the Preparation for Decision Making Scale
Tidsramme: Baseline, Week 4 (waitlisted control only), Post-Intervention (Week 4 or 8)
|
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.
|
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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in provider end of life (EOL) care knowledge as measured by revised City of Hope EOL Knowledge Assessment
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility as measured by completion of advance directive documents
Tidsramme: Post-Intervention (Week 4 or 8)
|
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
Tidsramme: Post-Intervention (Week 4 or 8)
|
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
Tidsramme: 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
Tidsramme: 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.
|
Post-Intervention (Week 4 or 8)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Sophia K Smith, PhD, Duke University School of Nursing
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. december 2016
Primær færdiggørelse (Faktiske)
21. oktober 2018
Studieafslutning (Faktiske)
21. oktober 2018
Datoer for studieregistrering
Først indsendt
24. oktober 2016
Først indsendt, der opfyldte QC-kriterier
24. oktober 2016
Først opslået (Skøn)
25. oktober 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
13. december 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. december 2018
Sidst verificeret
1. december 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00070790
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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