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Randomized Evaluation of Default Access to Palliative Services (REDAPS)

10. september 2020 opdateret af: University of Pennsylvania

Default Palliative Care Consultation for Seriously Ill Hospitalized Patients

This is a large pragmatic, randomized controlled trial to test the real-world effectiveness of inpatient palliative care consultative services in improving a number of patient- and family-centered processes and outcomes of care among seriously ill hospitalized patients. The investigators hypothesize that improved patient-centered outcomes can be achieved without higher costs by simply changing the default option for inpatient palliative care consultation for eligible patients from an opt-in to an opt-out system. To test this hypothesis the investigators will conduct a clinical trial at 11 hospitals using the same electronic health record within Ascension Health, the largest non-profit health system in the U.S.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The REDAPS trial aims to generate large-scale, experimental evidence regarding the real-world effectiveness of inpatient palliative consultative services (IPCS) and to test the incremental effectiveness and costs of a simple, scalable method to increase IPCS utilization among properly selected patients. The REDAPS trial will also compare the effectiveness of different palliative care team structures and services and identify patient subgroups most likely to benefit from IPCS. To achieve these goals, the investigators will conduct a clinical trial at 11 Ascension Health hospitals using the same electronic health record. Participating hospitals first contribute a minimum of 4 months of data under the control paradigm (opt-in model), where physicians must identify patients who may benefit from palliative care consultation and actively order such services. Then, using a stepped-wedge design, the hospitals are randomly assigned to begin the intervention in intervals spaced approximately 2.7 months apart. During the intervention, patients meeting consensus criteria for eligibility for palliative care consultation are identified by the electronic health record, a consultation is ordered by default, physicians may cancel the order after being alerted to it, and patients or family members may decline such services. By the end of the trial, all hospitals will have utilized the intervention paradigm of palliative care consultation for at least 4 months. The REDAPS trial will compare outcomes (clinical, economic, and process measures) before and after implementation within hospitals, as well as comparisons among hospitals at given time points.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

34239

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
    • Connecticut
      • Bridgeport, Connecticut, Forenede Stater, 06606
        • St. Vincent's Medical Center
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32204
        • St. Vincent's Medical Center, Riverside
      • Jacksonville, Florida, Forenede Stater, 32216
        • St. Vincent's Medical Center, Southside
    • Kansas
      • Wichita, Kansas, Forenede Stater, 67214
        • Via Christi Hospital, St. Francis
      • Wichita, Kansas, Forenede Stater, 67218
        • Via Christi Hospital, St. Joseph
    • Michigan
      • Kalamazoo, Michigan, Forenede Stater, 49048
        • Borgess Medical Center
    • New York
      • Binghamton, New York, Forenede Stater, 13905
        • Our Lady of Lourdes Memorial Hospital
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37205
        • St. Thomas West Hospital
    • Texas
      • Austin, Texas, Forenede Stater, 78701
        • University Medical Center Brackenridge
    • Wisconsin
      • Mequon, Wisconsin, Forenede Stater, 53097
        • Columbia St. Mary's, Ozaukee
      • Milwaukee, Wisconsin, Forenede Stater, 53211
        • Columbia St. Mary's, North Lake

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

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age 65 years or older
  2. Current hospitalization of at least 3 calendar days (modified ITT)

  3. Diagnosis of one or more of the following:

    • End-stage renal disease (ESRD) on dialysis
    • Chronic obstructive pulmonary disease (COPD) with home oxygen dependence or 2 or more hospitalizations in the past 12 months
    • Dementia admitted from a long-term care facility or prior placement of a surgical feeding tube or 2 or more additional hospitalizations in the past 12 months

Exclusion criteria:

1. Patients younger than 65 years old will not receive the intervention

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: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Default ordering of palliative consult
Hospitals randomized to the intervention arm will adopt a system whereby eligible patients are identified by the electronic health record, a consultation is ordered by default, and physicians may cancel the order after being alerted to it, and patients or family members may decline such services.
Adfærdsmæssigt: Default ordering of palliative consult
Ingen indgriben: Usual care
There will be no trial-driven approach to care. Inpatient palliative care consultative services will be actively requested by physicians as in usual care.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Composite Measure: Length of Stay and In-Hospital Mortality
Tidsramme: Duration of hospital stay, an expected average of 8 days
The primary outcome is a composite measure of in-hospital mortality and hospital length-of-stay that ranks deaths along the length-of-stay distribution. Data is extracted from the electronic health record.
Duration of hospital stay, an expected average of 8 days

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Goals of care assessment
Tidsramme: Duration of hospital stay, an expected average of 8 days
Documented assessments of patients' goals of care within the electronic health record
Duration of hospital stay, an expected average of 8 days
Pain assessment
Tidsramme: Duration of hospital stay, an expected average of 8 days
Documented assessments of patients' pain scores within the electronic health record
Duration of hospital stay, an expected average of 8 days
Dyspnea assessment
Tidsramme: Duration of hospital stay, an expected average of 8 days
Documented assessments of patients' dyspnea within the electronic health record
Duration of hospital stay, an expected average of 8 days
Code status
Tidsramme: Duration of hospital stay, an expected average of 8 days
Code status documented within the electronic health record
Duration of hospital stay, an expected average of 8 days
Mechanical ventilation
Tidsramme: Duration of hospital stay, an expected average of 8 days
Documented orders for mechanical ventilation within the electronic health record
Duration of hospital stay, an expected average of 8 days
Cardiopulmonary resuscitation
Tidsramme: Duration of hospital stay, an expected average of 8 days
Documented orders for cardiopulmonary resuscitation within the electronic health record
Duration of hospital stay, an expected average of 8 days
Inpatient dialysis
Tidsramme: Duration of hospital stay, an expected average of 8 days
Documented orders for dialysis during inpatient stay within the electronic health record
Duration of hospital stay, an expected average of 8 days
ICU admission
Tidsramme: Duration of hospital stay, an expected average of 8 days
Transferal to an intensive care unit documented within the electronic health record
Duration of hospital stay, an expected average of 8 days
Hospital discharge status
Tidsramme: Duration of hospital stay, an expected average of 8 days
Hospital discharge disposition code documented within the electronic health record
Duration of hospital stay, an expected average of 8 days
Discharge planning orders
Tidsramme: Duration of hospital stay, an expected average of 8 days
Discharge orders for home care services documented within the electronic health record
Duration of hospital stay, an expected average of 8 days
Hospital readmission
Tidsramme: 30 days
30-day hospital re-admissions documented within the Premier database
30 days
Direct cost per day
Tidsramme: Duration of hospital stay, an expected average of 8 days
Direct cost per day documented within the Premier database
Duration of hospital stay, an expected average of 8 days
Direct cost per hospitalization
Tidsramme: Duration of hospital stay, an expected average of 8 days
Direct cost per hospitalization documented within the Premier database
Duration of hospital stay, an expected average of 8 days

Samarbejdspartnere og efterforskere

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

Sponsor

University of Pennsylvania

Samarbejdspartnere

National Institute on Aging (NIA)

Efterforskere

  • Ledende efterforsker: Scott D Halpern, PhD,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 (Faktiske)

1. marts 2016

Primær færdiggørelse (Faktiske)

1. november 2018

Studieafslutning (Faktiske)

1. september 2020

Datoer for studieregistrering

Først indsendt

16. juli 2015

Først indsendt, der opfyldte QC-kriterier

20. juli 2015

Først opslået (Skøn)

22. juli 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. september 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. september 2020

Sidst verificeret

1. september 2020

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 822134
  • UH2AG050311 (U.S. NIH-bevilling/kontrakt)

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 Demens

Kliniske forsøg med Default ordering of palliative consult

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