title: Rationale and Design of the Randomized Evaluation of Default Access to Palliative Services (REDAPS) Trial.
abstract: The substantial nationwide investment in inpatient palliative care services stems from their great promise to improve patient-centered outcomes and reduce costs. However, robust experimental evidence of these benefits is lacking. The Randomized Evaluation of Default Access to Palliative Services (REDAPS) study is a pragmatic, stepped-wedge, cluster randomized trial designed to test the efficacy and costs of specialized palliative care consultative services for hospitalized patients with advanced chronic obstructive pulmonary disease, dementia, or end-stage renal disease, as well as the overall effectiveness of ordering such services by default. Additional aims are to identify the types of services that are most beneficial and the types of patients most likely to benefit, including comparisons between ward and intensive care unit patients. We hypothesize that patient-centered outcomes can be improved without increasing costs by simply changing the default option for palliative care consultation from opt-in to opt-out for patients with life-limiting illnesses. Patients aged 65 years or older are enrolled at 11 hospitals using an integrated electronic health record. As a pragmatic trial designed to enroll between 12,000 and 15,000 patients, eligibility is determined using a validated, electronic health record-based algorithm, and all outcomes are captured via the electronic health record and billing systems data. The time at which each hospital transitions from control, opt-in palliative care consultation to intervention, opt-out consultation is randomly assigned. The primary outcome is a composite measure of in-hospital mortality and length of stay. Secondary outcomes include palliative care process measures and clinical and economic outcomes. Clinical trial registered with www.clinicaltrials.gov (NCT02505035).
authors.affiliation: 1 Pulmonary, Allergy, and Critical Care Medicine Division, Department of Medicine.|2 Center for Health Incentives and Behavioral Economics.|3 Fostering Improvements in End-of-Life Decision Science Program.
authors.forename: Katherine R
authors.initials: KR
authors.lastname: Courtright
authors.affiliation: 2 Center for Health Incentives and Behavioral Economics.|3 Fostering Improvements in End-of-Life Decision Science Program.|4 Center for Clinical Epidemiology and Biostatistics.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Madden
authors.affiliation: 2 Center for Health Incentives and Behavioral Economics.|3 Fostering Improvements in End-of-Life Decision Science Program.|4 Center for Clinical Epidemiology and Biostatistics.
authors.forename: Nicole B
authors.initials: NB
authors.lastname: Gabler
authors.affiliation: 2 Center for Health Incentives and Behavioral Economics.|3 Fostering Improvements in End-of-Life Decision Science Program.|4 Center for Clinical Epidemiology and Biostatistics.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Cooney
authors.affiliation: 4 Center for Clinical Epidemiology and Biostatistics.|5 Department of Statistics, Wharton School.
authors.forename: Dylan S
authors.initials: DS
authors.lastname: Small
authors.affiliation: 2 Center for Health Incentives and Behavioral Economics.|4 Center for Clinical Epidemiology and Biostatistics.
authors.forename: Andrea
authors.initials: A
authors.lastname: Troxel
authors.affiliation: 6 Department of Medical Ethics and Health Policy.|7 Department of Medicine, and.
authors.forename: David
authors.initials: D
authors.lastname: Casarett
authors.affiliation: 8 School of Nursing, University of Pennsylvania, Philadelphia, Pennsylvania.|9 Department of Veterans Affairs, Philadelphia, Pennsylvania.
authors.forename: Mary
authors.initials: M
authors.lastname: Ersek
authors.affiliation: 10 Division of Hematology/Oncology, Virginia Commonwealth University, Richmond, Virginia.
authors.forename: J Brian
authors.initials: JB
authors.lastname: Cassel
authors.affiliation: 11 Department of Health Policy and Management, Johns Hopkins University, Baltimore, Maryland.
authors.forename: Lauren Hersch
authors.initials: LH
authors.lastname: Nicholas
authors.affiliation: 12 Division of Research, Kaiser Permanente Northern California, Oakland, California.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Escobar
authors.affiliation: 13 Ascension Health, St. Louis, Missouri; and.
authors.forename: Sarah H
authors.initials: SH
authors.lastname: Hill
authors.affiliation: 13 Ascension Health, St. Louis, Missouri; and.
authors.forename: Dan
authors.initials: D
authors.lastname: O'Brien
authors.affiliation: 13 Ascension Health, St. Louis, Missouri; and.|14 Department of Family Medicine, Michigan State University, East Lansing, Michigan.
authors.forename: Mark
authors.initials: M
authors.lastname: Vogel
authors.affiliation: 1 Pulmonary, Allergy, and Critical Care Medicine Division, Department of Medicine.|2 Center for Health Incentives and Behavioral Economics.|3 Fostering Improvements in End-of-Life Decision Science Program.|4 Center for Clinical Epidemiology and Biostatistics.|6 Department of Medical Ethics and Health Policy.
authors.forename: Scott D
authors.initials: SD
authors.lastname: Halpern
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D003362:Cost-Benefit Analysis; D003422:Critical Care; D018592:Cross-Over Studies; D057286:Electronic Health Records; D005260:Female; D017052:Hospital Mortality; D006801:Humans; D007297:Inpatients / Q000706:statistics & numerical data*; D007902:Length of Stay; D008297:Male; D017063:Outcome Assessment, Health Care; D010166:Palliative Care / Q000191:economics* / Q000592:standards*; D011788:Quality of Life; D012107:Research Design; D014481:United States
keywords: behavioral economics; electronic health records; palliative care; pragmatic clinical trial