Randomized Evaluation of Default Access to Palliative Services

NCT ID: NCT02505035

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34239 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2020-09-30

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.

Conditions

COPD; ESRD; Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Default ordering of palliative consult

Intervention Type: BEHAVIORAL

Usual care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Default ordering of palliative consult

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott D Halpern, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

St. Vincent's Medical Center

Bridgeport, Connecticut, United States

St. Vincent's Medical Center, Riverside

Jacksonville, Florida, United States

St. Vincent's Medical Center, Southside

Jacksonville, Florida, United States

Via Christi Hospital, St. Francis

Wichita, Kansas, United States

Via Christi Hospital, St. Joseph

Wichita, Kansas, United States

Borgess Medical Center

Kalamazoo, Michigan, United States

Our Lady of Lourdes Memorial Hospital

Binghamton, New York, United States

St. Thomas West Hospital

Nashville, Tennessee, United States

University Medical Center Brackenridge

Austin, Texas, United States

Columbia St. Mary's, Ozaukee

Mequon, Wisconsin, United States

Columbia St. Mary's, North Lake

Milwaukee, Wisconsin, United States

Countries

United States

References

Courtright KR, Madden V, Bayes B, Chowdhury M, Whitman C, Small DS, Harhay MO, Parra S, Cooney-Zingman E, Ersek M, Escobar GJ, Hill SH, Halpern SD. Default Palliative Care Consultation for Seriously Ill Hospitalized Patients: A Pragmatic Cluster Randomized Trial. JAMA. 2024 Jan 16;331(3):224-232. doi: 10.1001/jama.2023.25092.

Reference Type: DERIVED

PMID: 38227032 (View on PubMed)

Courtright KR, Madden V, Gabler NB, Cooney E, Small DS, Troxel A, Casarett D, Ersek M, Cassel JB, Nicholas LH, Escobar G, Hill SH, O'Brien D, Vogel M, Halpern SD. Rationale and Design of the Randomized Evaluation of Default Access to Palliative Services (REDAPS) Trial. Ann Am Thorac Soc. 2016 Sep;13(9):1629-39. doi: 10.1513/AnnalsATS.201604-308OT.

Reference Type: DERIVED

PMID: 27348271 (View on PubMed)

Other Identifiers

UH2AG050311

Identifier Type: NIH

Identifier Source: secondary_id

View Link

822134

Identifier Type: -

Identifier Source: org_study_id