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Choice Sets for Advance Directives

5. januar 2016 opdateret af: University of Pennsylvania

A Randomized Trial of Expanded Choice Sets to Increase Completion of Advance Directives

There is a large gap between the care seriously ill patients want and the care they receive. Advance directives (ADs) offer an opportunity for patients to express specific end-of-life preferences to avoid unwanted care. As promising as ADs may be for improving the quality of care near the end of life, rates of AD completion remain low and previous efforts to encourage their completion have had limited success. Principles of behavioral economics, such as the effects of defaults and other framing effects, may offer a novel approach to bridge the gap in end-of-life care. The goal of this study is to test whether the framing effect of expanding choice sets can increase the completion of and specification of choices within advance directives.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This study has been designed as two sequential randomized trials to test two separate expanded choice set interventions, with the second randomization enrollment being contingent on results from the first. All enrolled subjects will be asked if they would like to complete an advance directive and will have been randomized to receive either an expanded answer choice set or a standard answer choice, as described in detail elsewhere. Only those subjects who express a desire to complete an advance directive from both arms will then be randomized again in a stratified fashion to receive either a standard advance directive or one with an expanded choice set for the decisions regarding life-sustaining therapy, as described in detail elsewhere.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

321

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New Jersey
      • Camden, New Jersey, Forenede Stater, 08103
        • Lourdes-Camden
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Market Street DaVita
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Philadelphia 42nd Street DaVita
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Philadelphia PMC-Lombard DaVita
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University City DaVita
      • Philadelphia, Pennsylvania, Forenede Stater, 19106
        • Franklin DaVita
      • Philadelphia, Pennsylvania, Forenede Stater, 19107
        • PDI Walnut Tower DaVita
      • Philadelphia, Pennsylvania, Forenede Stater, 19123
        • Callowhill DaVita
      • Philadelphia, Pennsylvania, Forenede Stater, 19131
        • City Line DaVita
      • Philadelphia, Pennsylvania, Forenede Stater, 19146
        • South Broad Street
      • Philadelphia, Pennsylvania, Forenede Stater, 19149
        • Cottman DaVita
      • Philadelphia, Pennsylvania, Forenede Stater
        • South Philadelphia DaVita
      • Radnor, Pennsylvania, Forenede Stater, 19087
        • Radnor DaVita
      • Willow Grove, Pennsylvania, Forenede Stater, 19090
        • Abington DaVita
      • Willow Grove, Pennsylvania, Forenede Stater, 19090
        • Willow Grove DaVita

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:

  • Age 18 or older
  • Proficient in English
  • Chronic hemodialysis for minimum 90 days
  • Does not currently have a living will

Exclusion Criteria:

  • Blindness
  • Cognitive impairment that prohibits subject's provision of informed consent

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Expanded AD Choice

"Would you like to complete an advance directive with the assistance of any person(s) you choose?"

4 answer choices:

  • Yes, I would like to complete a comprehensive version of an advance directive.
  • Yes, I would like to complete an expanded version of an advance directive.
  • Yes, I would like to complete a brief version of an advance directive.
  • No, I do not wish to complete an advance directive.
Adfærdsmæssigt: Expanded AD Choice
Ingen indgriben: Standard AD Choice

"Would you like to complete an advance directive with the assistance of any person(s) you choose?"

2 answer choices:

  • Yes, I would like to complete an AD.
  • No, I do not wish to complete an advance directive.
Eksperimentel: Expanded Life-sustaining therapy Choice

For each hypothetical illness state described in the living will:

4 answer choices:

  • No, I would not want life support.
  • Yes, I would want life support.
  • I would want life support if my doctor believes it could help, but I want to stop receiving life support if at any time my doctor believes it is only delaying the moment of my death.
  • I do not wish to specify a preference at this time.
Adfærdsmæssigt: Expanded Life-sustaining Therapy Choice
Ingen indgriben: Standard Life-sustaining Therapy Choice

For each hypothetical illness state described in the living will:

3 answer choices:

  • No, I would not want life support.
  • Yes, I would want life support.
  • I do not wish to specify a preference at this time.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
advance directive
Tidsramme: up to 4 weeks
return of a completed and signed advance directive
up to 4 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Medical Outcomes Study Short Form-12v2
Tidsramme: baseline and 3 months
change from baseline in Short Form-12v2 score at 3 months
baseline and 3 months
McGill Quality of Life Questionnaire
Tidsramme: baseline and 3 months
change from baseline in McGill Quality of Life Questionnaire at 3 months
baseline and 3 months
Satisfaction with Decision Scale
Tidsramme: baseline
satisfaction with decision scale measured at baseline after decision to complete an advance directive is made
baseline
Decisional Conflict Scale
Tidsramme: up to 4 weeks
Decisional Conflict Scale measured immediately after completion of an advance directive
up to 4 weeks
no life-sustaining therapy preference specified
Tidsramme: up to 4 weeks
among all patients who complete an AD, the proportion of subjects who choose not to specify a preference for life-sustaining therapy on at least 1 clinical scenario within the AD
up to 4 weeks

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
hospital admissions
Tidsramme: up to 4 years
number of hospital admissions from enrollment to study completion
up to 4 years
ICU admissions
Tidsramme: up to 4 years
number of ICU admissions from enrollment to study completion
up to 4 years
Hospice admission
Tidsramme: up to 4 years
up to 4 years
death
Tidsramme: up to 4 years
up to 4 years
demographics of patients (ineligible) whom already completed a living will
Tidsramme: enrollment
enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pennsylvania

Efterforskere

  • Ledende efterforsker: Scott D Halpern, MD, PhD, University of Pennsylvania
  • Studieleder: Katherine R Courtright, MD, University of Pennsylvania

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

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

1. juli 2014

Primær færdiggørelse (Faktiske)

1. juli 2015

Studieafslutning (Faktiske)

1. oktober 2015

Datoer for studieregistrering

Først indsendt

16. juli 2014

Først indsendt, der opfyldte QC-kriterier

4. august 2014

Først opslået (Skøn)

5. august 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. januar 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. januar 2016

Sidst verificeret

1. januar 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 820002

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Slutstadie nyresygdom

Kliniske forsøg med Expanded AD Choice

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Denmark

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner