Randomized Evaluation of Default Access to Palliative Services (REDAPS)
10 september 2020 uppdaterad 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.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
34239
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Connecticut
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Bridgeport, Connecticut, Förenta staterna, 06606
- St. Vincent's Medical Center
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Florida
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Jacksonville, Florida, Förenta staterna, 32204
- St. Vincent's Medical Center, Riverside
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Jacksonville, Florida, Förenta staterna, 32216
- St. Vincent's Medical Center, Southside
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Kansas
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Wichita, Kansas, Förenta staterna, 67214
- Via Christi Hospital, St. Francis
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Wichita, Kansas, Förenta staterna, 67218
- Via Christi Hospital, St. Joseph
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Michigan
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Kalamazoo, Michigan, Förenta staterna, 49048
- Borgess Medical Center
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New York
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Binghamton, New York, Förenta staterna, 13905
- Our Lady of Lourdes Memorial Hospital
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37205
- St. Thomas West Hospital
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Texas
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Austin, Texas, Förenta staterna, 78701
- University Medical Center Brackenridge
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Wisconsin
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Mequon, Wisconsin, Förenta staterna, 53097
- Columbia St. Mary's, Ozaukee
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Milwaukee, Wisconsin, Förenta staterna, 53211
- Columbia St. Mary's, North Lake
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
65 år och äldre (Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Composite Measure: Length of Stay and In-Hospital Mortality
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Goals of care assessment
Tidsram: Duration of hospital stay, an expected average of 8 days
|
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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Duration of hospital stay, an expected average of 8 days
|
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
Tidsram: 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
Tidsram: 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
|
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Discharge planning orders
Tidsram: Duration of hospital stay, an expected average of 8 days
|
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
Tidsram: 30 days
|
30-day hospital re-admissions documented within the Premier database
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30 days
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Direct cost per day
Tidsram: 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
Tidsram: Duration of hospital stay, an expected average of 8 days
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Direct cost per hospitalization documented within the Premier database
|
Duration of hospital stay, an expected average of 8 days
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Scott D Halpern, PhD,MD, University of Pennsylvania
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 mars 2016
Primärt slutförande (Faktisk)
1 november 2018
Avslutad studie (Faktisk)
1 september 2020
Studieregistreringsdatum
Först inskickad
16 juli 2015
Först inskickad som uppfyllde QC-kriterierna
20 juli 2015
Första postat (Uppskatta)
22 juli 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 september 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 september 2020
Senast verifierad
1 september 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 822134
- UH2AG050311 (U.S.S. NIH-anslag/kontrakt)
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