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).

Keywords: behavioral economics; electronic health records; palliative care; pragmatic clinical trial.

Figure 1.

Schematic of the stepped-wedge randomized trial. Wedge intervals are 2.4 months, representing the average of eight hospitals having 2.7-month intervals between them and the other three electronic health record–linked hospitals having 1.5-month intervals.

Figure 2.

Consort diagram for the Randomized Evaluation of Default Palliative Care Services (REDAPS) trial. The presence of an eligible diagnosis is determined from electronic health record data mining. For reference, Day 0 equals the calendar day of admission. COPD = chronic obstructive pulmonary disease; EHR = electronic health record; ESRD = end-stage renal disease; ITT = intention to treat; LOS = length of stay; PC = palliative care; PCC = palliative care consult.

Figure 3.

Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2). This schematic represents the PRECIS-2 criteria developed to measure how the design of a trial will impact the applicability of the results. It depicts a nine-spoked wheel representing domains of trial design that affect where on the continuum a trial is pragmatic or explanatory. It is scored on a 5-point Likert scale for each domain, 1 being very explanatory and 5 being very pragmatic. The values in this figure represent the consensus scores of four raters (the principal investigator, two National Institutes of Health program officials, and a methodologist from Westat Inc.) who were convened at a National Institutes of Health–sponsored review of pragmatic trials in April 2015.