Randomized Evaluation of Default Access to Palliative Services (REDAPS)
10. september 2020 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
34239
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Connecticut
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Bridgeport, Connecticut, Forente stater, 06606
- St. Vincent's Medical Center
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Florida
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Jacksonville, Florida, Forente stater, 32204
- St. Vincent's Medical Center, Riverside
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Jacksonville, Florida, Forente stater, 32216
- St. Vincent's Medical Center, Southside
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Kansas
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Wichita, Kansas, Forente stater, 67214
- Via Christi Hospital, St. Francis
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Wichita, Kansas, Forente stater, 67218
- Via Christi Hospital, St. Joseph
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Michigan
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Kalamazoo, Michigan, Forente stater, 49048
- Borgess Medical Center
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New York
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Binghamton, New York, Forente stater, 13905
- Our Lady of Lourdes Memorial Hospital
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Tennessee
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Nashville, Tennessee, Forente stater, 37205
- St. Thomas West Hospital
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Texas
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Austin, Texas, Forente stater, 78701
- University Medical Center Brackenridge
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Wisconsin
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Mequon, Wisconsin, Forente stater, 53097
- Columbia St. Mary's, Ozaukee
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Milwaukee, Wisconsin, Forente stater, 53211
- Columbia St. Mary's, North Lake
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
65 år og eldre (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Age 65 years or older
- Current hospitalization of at least 3 calendar days (modified ITT)
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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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.
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Ingen inngripen: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Composite Measure: Length of Stay and In-Hospital Mortality
Tidsramme: Duration of hospital stay, an expected average of 8 days
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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.
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Duration of hospital stay, an expected average of 8 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Goals of care assessment
Tidsramme: Duration of hospital stay, an expected average of 8 days
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Documented assessments of patients' goals of care within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Pain assessment
Tidsramme: Duration of hospital stay, an expected average of 8 days
|
Documented assessments of patients' pain scores within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Dyspnea assessment
Tidsramme: Duration of hospital stay, an expected average of 8 days
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Documented assessments of patients' dyspnea within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Code status
Tidsramme: Duration of hospital stay, an expected average of 8 days
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Code status documented within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Mechanical ventilation
Tidsramme: Duration of hospital stay, an expected average of 8 days
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Documented orders for mechanical ventilation within the electronic health record
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Duration of hospital stay, an expected average of 8 days
|
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Cardiopulmonary resuscitation
Tidsramme: Duration of hospital stay, an expected average of 8 days
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Documented orders for cardiopulmonary resuscitation within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Inpatient dialysis
Tidsramme: Duration of hospital stay, an expected average of 8 days
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Documented orders for dialysis during inpatient stay within the electronic health record
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Duration of hospital stay, an expected average of 8 days
|
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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
|
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Hospital discharge status
Tidsramme: Duration of hospital stay, an expected average of 8 days
|
Hospital discharge disposition code documented within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Discharge planning orders
Tidsramme: Duration of hospital stay, an expected average of 8 days
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Discharge orders for home care services documented within the electronic health record
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Duration of hospital stay, an expected average of 8 days
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Hospital readmission
Tidsramme: 30 days
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30-day hospital re-admissions documented within the Premier database
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30 days
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Direct cost per day
Tidsramme: Duration of hospital stay, an expected average of 8 days
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Direct cost per day documented within the Premier database
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Duration of hospital stay, an expected average of 8 days
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Direct cost per hospitalization
Tidsramme: Duration of hospital stay, an expected average of 8 days
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Direct cost per hospitalization documented within the Premier database
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Duration of hospital stay, an expected average of 8 days
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Scott D Halpern, PhD,MD, University of Pennsylvania
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2016
Primær fullføring (Faktiske)
1. november 2018
Studiet fullført (Faktiske)
1. september 2020
Datoer for studieregistrering
Først innsendt
16. juli 2015
Først innsendt som oppfylte QC-kriteriene
20. juli 2015
Først lagt ut (Anslag)
22. juli 2015
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. september 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. september 2020
Sist bekreftet
1. september 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 822134
- UH2AG050311 (U.S. NIH-stipend/kontrakt)
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