NCT02505035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34,239

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

2.7 years

First QC Date

July 16, 2015

Last Update Submit

September 10, 2020

Conditions

COPDESRDDementia

Keywords

Palliative carePragmatic trial

Outcome Measures

Primary Outcomes (1)

  • Composite Measure: Length of Stay and In-Hospital Mortality

    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.

    Duration of hospital stay, an expected average of 8 days

Secondary Outcomes (13)

  • 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

  • Code status

    Duration of hospital stay, an expected average of 8 days

  • Mechanical ventilation

    Duration of hospital stay, an expected average of 8 days

  • +8 more secondary outcomes

Study Arms (2)

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.

Behavioral: Default ordering of palliative consult

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.

Interventions

Default ordering of palliative consultBEHAVIORAL
Default ordering of palliative consult

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

St. Vincent's Medical Center

Bridgeport, Connecticut, 06606, United States

Location

St. Vincent's Medical Center, Riverside

Jacksonville, Florida, 32204, United States

Location

St. Vincent's Medical Center, Southside

Jacksonville, Florida, 32216, United States

Location

Via Christi Hospital, St. Francis

Wichita, Kansas, 67214, United States

Location

Via Christi Hospital, St. Joseph

Wichita, Kansas, 67218, United States

Location

Borgess Medical Center

Kalamazoo, Michigan, 49048, United States

Location

Our Lady of Lourdes Memorial Hospital

Binghamton, New York, 13905, United States

Location

St. Thomas West Hospital

Nashville, Tennessee, 37205, United States

Location

University Medical Center Brackenridge

Austin, Texas, 78701, United States

Location

Columbia St. Mary's, Ozaukee

Mequon, Wisconsin, 53097, United States

Location

Columbia St. Mary's, North Lake

Milwaukee, Wisconsin, 53211, United States

Location

Related Publications (2)

  • 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.

    PMID: 38227032DERIVED

  • 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.

    PMID: 27348271DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveKidney Failure, ChronicDementia

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRenal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Scott D Halpern, PhD,MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2015

First Posted

July 22, 2015

Study Start

March 1, 2016

Primary Completion

November 1, 2018

Study Completion

September 1, 2020

Last Updated

September 11, 2020

Record last verified: 2020-09

Locations

US(11)