Randomized Evaluation of Default Access to Palliative Services (REDAPS)
10 septembre 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
34239
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Connecticut
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Bridgeport, Connecticut, États-Unis, 06606
- St. Vincent's Medical Center
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Florida
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Jacksonville, Florida, États-Unis, 32204
- St. Vincent's Medical Center, Riverside
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Jacksonville, Florida, États-Unis, 32216
- St. Vincent's Medical Center, Southside
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Kansas
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Wichita, Kansas, États-Unis, 67214
- Via Christi Hospital, St. Francis
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Wichita, Kansas, États-Unis, 67218
- Via Christi Hospital, St. Joseph
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Michigan
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Kalamazoo, Michigan, États-Unis, 49048
- Borgess Medical Center
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New York
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Binghamton, New York, États-Unis, 13905
- Our Lady of Lourdes Memorial Hospital
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Tennessee
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Nashville, Tennessee, États-Unis, 37205
- St. Thomas West Hospital
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Texas
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Austin, Texas, États-Unis, 78701
- University Medical Center Brackenridge
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Wisconsin
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Mequon, Wisconsin, États-Unis, 53097
- Columbia St. Mary's, Ozaukee
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Milwaukee, Wisconsin, États-Unis, 53211
- Columbia St. Mary's, North Lake
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Composite Measure: Length of Stay and In-Hospital Mortality
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Goals of care assessment
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Scott D Halpern, PhD,MD, University of Pennsylvania
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 mars 2016
Achèvement primaire (Réel)
1 novembre 2018
Achèvement de l'étude (Réel)
1 septembre 2020
Dates d'inscription aux études
Première soumission
16 juillet 2015
Première soumission répondant aux critères de contrôle qualité
20 juillet 2015
Première publication (Estimation)
22 juillet 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 septembre 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 septembre 2020
Dernière vérification
1 septembre 2020
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 822134
- UH2AG050311 (Subvention/contrat des NIH des États-Unis)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .