Randomized Evaluation of Default Access to Palliative Services (REDAPS)
10. September 2020 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
34239
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Connecticut
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Bridgeport, Connecticut, Vereinigte Staaten, 06606
- St. Vincent's Medical Center
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Florida
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Jacksonville, Florida, Vereinigte Staaten, 32204
- St. Vincent's Medical Center, Riverside
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Jacksonville, Florida, Vereinigte Staaten, 32216
- St. Vincent's Medical Center, Southside
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Kansas
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Wichita, Kansas, Vereinigte Staaten, 67214
- Via Christi Hospital, St. Francis
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Wichita, Kansas, Vereinigte Staaten, 67218
- Via Christi Hospital, St. Joseph
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Michigan
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Kalamazoo, Michigan, Vereinigte Staaten, 49048
- Borgess Medical Center
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New York
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Binghamton, New York, Vereinigte Staaten, 13905
- Our Lady of Lourdes Memorial Hospital
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Tennessee
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Nashville, Tennessee, Vereinigte Staaten, 37205
- St. Thomas West Hospital
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Texas
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Austin, Texas, Vereinigte Staaten, 78701
- University Medical Center Brackenridge
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Wisconsin
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Mequon, Wisconsin, Vereinigte Staaten, 53097
- Columbia St. Mary's, Ozaukee
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Milwaukee, Wisconsin, Vereinigte Staaten, 53211
- Columbia St. Mary's, North Lake
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
65 Jahre und älter (Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver 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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Kein Eingriff: 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Composite Measure: Length of Stay and In-Hospital Mortality
Zeitfenster: 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.
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Duration of hospital stay, an expected average of 8 days
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Goals of care assessment
Zeitfenster: 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
Zeitfenster: 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
|
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Dyspnea assessment
Zeitfenster: Duration of hospital stay, an expected average of 8 days
|
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
Zeitfenster: 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
Zeitfenster: 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
|
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Cardiopulmonary resuscitation
Zeitfenster: Duration of hospital stay, an expected average of 8 days
|
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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
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Hospital readmission
Zeitfenster: 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
Zeitfenster: Duration of hospital stay, an expected average of 8 days
|
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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Scott D Halpern, PhD,MD, University of Pennsylvania
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. März 2016
Primärer Abschluss (Tatsächlich)
1. November 2018
Studienabschluss (Tatsächlich)
1. September 2020
Studienanmeldedaten
Zuerst eingereicht
16. Juli 2015
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
20. Juli 2015
Zuerst gepostet (Schätzen)
22. Juli 2015
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
11. September 2020
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
10. September 2020
Zuletzt verifiziert
1. September 2020
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 822134
- UH2AG050311 (US NIH Stipendium/Vertrag)
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