Randomized Evaluation of Default Access to Palliative Services

Not Applicable

Completed

• Conditions: Dementia; ESRD; COPD
• Interventions: Behavioral: Default ordering of palliative consult

• Registration Number: NCT02505035
• Lead Sponsor: University of Pennsylvania

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 Timeline

• Study First Submitted: 2015-07-16
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-22
• Study Start: 2016-03
• Primary Completion: 2018-11
• Status Verified: 2020-09
• Study Completion: 2020-09
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34239

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Default ordering of palliative consult	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.

Primary Outcome Measures

Name	Time	Method
Composite Measure: Length of Stay and In-Hospital Mortality	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 Outcome Measures

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

Trial Locations

Locations (11)

St. Vincent's Medical Center, Riverside; 🇺🇸 Jacksonville, Florida, United States

Borgess Medical Center; 🇺🇸 Kalamazoo, Michigan, United States

Columbia St. Mary's, North Lake; 🇺🇸 Milwaukee, Wisconsin, United States

Columbia St. Mary's, Ozaukee; 🇺🇸 Mequon, Wisconsin, United States

St. Vincent's Medical Center; 🇺🇸 Bridgeport, Connecticut, United States

St. Vincent's Medical Center, Southside; 🇺🇸 Jacksonville, Florida, United States

University Medical Center Brackenridge; 🇺🇸 Austin, Texas, United States

St. Thomas West Hospital; 🇺🇸 Nashville, Tennessee, United States

Via Christi Hospital, St. Joseph; 🇺🇸 Wichita, Kansas, United States

Our Lady of Lourdes Memorial Hospital; 🇺🇸 Binghamton, New York, United States

Via Christi Hospital, St. Francis; 🇺🇸 Wichita, Kansas, United States