Randomized Evaluation of Default Access to Palliative Services (REDAPS)

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.

Study Overview

• Status: Completed
• Conditions: Dementia; ESRD; COPD
• Intervention / Treatment: Behavioral: Default ordering of palliative consult

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 34239
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Bridgeport, Connecticut, United States, 06606
      • St. Vincent's Medical Center
  • Florida
    • Jacksonville, Florida, United States, 32204
      • St. Vincent's Medical Center, Riverside
    • Jacksonville, Florida, United States, 32216
      • St. Vincent's Medical Center, Southside
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Via Christi Hospital, St. Francis
    • Wichita, Kansas, United States, 67218
      • Via Christi Hospital, St. Joseph
  • Michigan
    • Kalamazoo, Michigan, United States, 49048
      • Borgess Medical Center
  • New York
    • Binghamton, New York, United States, 13905
      • Our Lady of Lourdes Memorial Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37205
      • St. Thomas West Hospital
  • Texas
    • Austin, Texas, United States, 78701
      • University Medical Center Brackenridge
  • Wisconsin
    • Mequon, Wisconsin, United States, 53097
      • Columbia St. Mary's, Ozaukee
    • Milwaukee, Wisconsin, United States, 53211
      • Columbia St. Mary's, North Lake

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 65 years or older
2. Current hospitalization of at least 3 calendar days (modified ITT)

3. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Behavioral: Default ordering of palliative consult
No 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite Measure: Length of Stay and In-Hospital Mortality	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Goals of care assessment	Documented assessments of patients' goals of care within the electronic health record	Duration of hospital stay, an expected average of 8 days
Pain assessment	Documented assessments of patients' pain scores within the electronic health record	Duration of hospital stay, an expected average of 8 days
Dyspnea assessment	Documented assessments of patients' dyspnea within the electronic health record	Duration of hospital stay, an expected average of 8 days
Code status	Code status documented within the electronic health record	Duration of hospital stay, an expected average of 8 days
Mechanical ventilation	Documented orders for mechanical ventilation within the electronic health record	Duration of hospital stay, an expected average of 8 days
Cardiopulmonary resuscitation	Documented orders for cardiopulmonary resuscitation within the electronic health record	Duration of hospital stay, an expected average of 8 days
Inpatient dialysis	Documented orders for dialysis during inpatient stay within the electronic health record	Duration of hospital stay, an expected average of 8 days
ICU admission	Transferal to an intensive care unit documented within the electronic health record	Duration of hospital stay, an expected average of 8 days
Hospital discharge status	Hospital discharge disposition code documented within the electronic health record	Duration of hospital stay, an expected average of 8 days
Discharge planning orders	Discharge orders for home care services documented within the electronic health record	Duration of hospital stay, an expected average of 8 days
Hospital readmission	30-day hospital re-admissions documented within the Premier database	30 days
Direct cost per day	Direct cost per day documented within the Premier database	Duration of hospital stay, an expected average of 8 days
Direct cost per hospitalization	Direct cost per hospitalization documented within the Premier database	Duration of hospital stay, an expected average of 8 days

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Scott D Halpern, PhD,MD, University of Pennsylvania

Publications and helpful links

General Publications

• Courtright KR, Madden V, Gabler NB, Cooney E, Small DS, Troxel A, Casarett D, Ersek M, Cassel JB, Nicholas LH, Escobar G, Hill SH, O'Brien D, Vogel M, Halpern SD. Rationale and Design of the Randomized Evaluation of Default Access to Palliative Services (REDAPS) Trial. Ann Am Thorac Soc. 2016 Sep;13(9):1629-39. doi: 10.1513/AnnalsATS.201604-308OT.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: July 16, 2015
• First Submitted That Met QC Criteria: July 20, 2015
• First Posted (Estimate): July 22, 2015

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Palliative care; Pragmatic trial
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 822134; UH2AG050311 (U.S. NIH Grant/Contract)