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Randomized Evaluation of Default Access to Palliative Services (REDAPS)

10 september 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

34239

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

65 jaar en ouder (Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Gedragsmatig: Default ordering of palliative consult
Geen tussenkomst: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Composite Measure: Length of Stay and In-Hospital Mortality
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Goals of care assessment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 30 days
30-day hospital re-admissions documented within the Premier database
30 days
Direct cost per day
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Pennsylvania

Medewerkers

National Institute on Aging (NIA)

Onderzoekers

  • Hoofdonderzoeker: Scott D Halpern, PhD,MD, University of Pennsylvania

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 maart 2016

Primaire voltooiing (Werkelijk)

1 november 2018

Studie voltooiing (Werkelijk)

1 september 2020

Studieregistratiedata

Eerst ingediend

16 juli 2015

Eerst ingediend dat voldeed aan de QC-criteria

20 juli 2015

Eerst geplaatst (Schatting)

22 juli 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 september 2020

Laatste update ingediend die voldeed aan QC-criteria

10 september 2020

Laatst geverifieerd

1 september 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 822134
  • UH2AG050311 (Subsidie/contract van de Amerikaanse NIH)

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