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Clinical Trials/NCT02505035
NCT02505035CompletedNot Applicable

Default Palliative Care Consultation for Seriously Ill Hospitalized Patients

University of Pennsylvania11 sites in 1 country34,239 target enrollmentStarted: March 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
34,239
Locations
11
Primary Endpoint
Composite Measure: Length of Stay and In-Hospital Mortality

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Health Services Research
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • •Patients younger than 65 years old will not receive the intervention

Arms & Interventions

Default ordering of palliative consult

Active Comparator

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.

Intervention: Default ordering of palliative consult (Behavioral)

Usual care

No Intervention

There will be no trial-driven approach to care. Inpatient palliative care consultative services will be actively requested by physicians as in usual care.

Outcomes

Primary Outcomes

Composite Measure: Length of Stay and In-Hospital Mortality

Time Frame: Duration of hospital stay, an expected average of 8 days

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.

Secondary Outcomes

  • Code status(Duration of hospital stay, an expected average of 8 days)
  • Mechanical ventilation(Duration of hospital stay, an expected average of 8 days)
  • Cardiopulmonary resuscitation(Duration of hospital stay, an expected average of 8 days)
  • Inpatient dialysis(Duration of hospital stay, an expected average of 8 days)
  • ICU admission(Duration of hospital stay, an expected average of 8 days)
  • Hospital discharge status(Duration of hospital stay, an expected average of 8 days)
  • Discharge planning orders(Duration of hospital stay, an expected average of 8 days)
  • Goals of care assessment(Duration of hospital stay, an expected average of 8 days)
  • Pain assessment(Duration of hospital stay, an expected average of 8 days)
  • Dyspnea assessment(Duration of hospital stay, an expected average of 8 days)
  • Hospital readmission(30 days)
  • Direct cost per day(Duration of hospital stay, an expected average of 8 days)
  • Direct cost per hospitalization(Duration of hospital stay, an expected average of 8 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (11)

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