Randomized Evaluation of Default Access to Palliative Services (REDAPS)
10 settembre 2020 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
34239
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Connecticut
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Bridgeport, Connecticut, Stati Uniti, 06606
- St. Vincent's Medical Center
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Florida
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Jacksonville, Florida, Stati Uniti, 32204
- St. Vincent's Medical Center, Riverside
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Jacksonville, Florida, Stati Uniti, 32216
- St. Vincent's Medical Center, Southside
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Kansas
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Wichita, Kansas, Stati Uniti, 67214
- Via Christi Hospital, St. Francis
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Wichita, Kansas, Stati Uniti, 67218
- Via Christi Hospital, St. Joseph
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Michigan
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Kalamazoo, Michigan, Stati Uniti, 49048
- Borgess Medical Center
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New York
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Binghamton, New York, Stati Uniti, 13905
- Our Lady of Lourdes Memorial Hospital
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Tennessee
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Nashville, Tennessee, Stati Uniti, 37205
- St. Thomas West Hospital
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Texas
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Austin, Texas, Stati Uniti, 78701
- University Medical Center Brackenridge
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Wisconsin
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Mequon, Wisconsin, Stati Uniti, 53097
- Columbia St. Mary's, Ozaukee
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Milwaukee, Wisconsin, Stati Uniti, 53211
- Columbia St. Mary's, North Lake
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
65 anni e precedenti (Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: 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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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Composite Measure: Length of Stay and In-Hospital Mortality
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Goals of care assessment
Lasso di tempo: 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
Lasso di tempo: Duration of hospital stay, an expected average of 8 days
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Duration of hospital stay, an expected average of 8 days
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Transferal to an intensive care unit 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 discharge status
Lasso di tempo: Duration of hospital stay, an expected average of 8 days
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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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Scott D Halpern, PhD,MD, University of Pennsylvania
Pubblicazioni e link utili
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 marzo 2016
Completamento primario (Effettivo)
1 novembre 2018
Completamento dello studio (Effettivo)
1 settembre 2020
Date di iscrizione allo studio
Primo inviato
16 luglio 2015
Primo inviato che soddisfa i criteri di controllo qualità
20 luglio 2015
Primo Inserito (Stima)
22 luglio 2015
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
11 settembre 2020
Ultimo aggiornamento inviato che soddisfa i criteri QC
10 settembre 2020
Ultimo verificato
1 settembre 2020
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 822134
- UH2AG050311 (Sovvenzione/contratto NIH degli Stati Uniti)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .