Rationale and Design of the Randomized Evaluation of Default Access to Palliative Services (REDAPS) Trial

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 ICU patients. We hypothesize that patient-centered outcomes can be improved without raising 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 45 years or older are enrolled at 11 hospitals using an integrated electronic health record (EHR). As a pragmatic trial designed to enroll between 12,000 and 15,000 patients, eligibility is determined using a validated, EHR-based algorithm, and all outcomes are captured via the EHR 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. The REDAPS trial was registered with clinicaltrials.gov, NCT02505035 on July 16, 2015.

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