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Randomized Evaluation of Default Access to Palliative Services (REDAPS)

Primary Purpose

COPD, ESRD, Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Default ordering of palliative consult
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for COPD focused on measuring Palliative care, Pragmatic trial

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Vincent's Medical Center
  • St. Vincent's Medical Center, Riverside
  • St. Vincent's Medical Center, Southside
  • Via Christi Hospital, St. Francis
  • Via Christi Hospital, St. Joseph
  • Borgess Medical Center
  • Our Lady of Lourdes Memorial Hospital
  • St. Thomas West Hospital
  • University Medical Center Brackenridge
  • Columbia St. Mary's, Ozaukee
  • Columbia St. Mary's, North Lake

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Default ordering of palliative consult

Usual care

Arm Description

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.

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 Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
July 16, 2015
Last Updated
September 10, 2020
Sponsor
University of Pennsylvania
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT02505035
Brief Title
Randomized Evaluation of Default Access to Palliative Services
Acronym
REDAPS
Official Title
Default Palliative Care Consultation for Seriously Ill Hospitalized Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
September 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, ESRD, Dementia
Keywords
Palliative care, Pragmatic trial

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Default ordering of palliative consult
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
There will be no trial-driven approach to care. Inpatient palliative care consultative services will be actively requested by physicians as in usual care.
Intervention Type
Behavioral
Intervention Name(s)
Default ordering of palliative consult
Primary Outcome Measure Information:
Title
Composite Measure: Length of Stay and In-Hospital Mortality
Description
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.
Time Frame
Duration of hospital stay, an expected average of 8 days
Secondary Outcome Measure Information:
Title
Goals of care assessment
Description
Documented assessments of patients' goals of care within the electronic health record
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
Pain assessment
Description
Documented assessments of patients' pain scores within the electronic health record
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
Dyspnea assessment
Description
Documented assessments of patients' dyspnea within the electronic health record
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
Code status
Description
Code status documented within the electronic health record
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
Mechanical ventilation
Description
Documented orders for mechanical ventilation within the electronic health record
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
Cardiopulmonary resuscitation
Description
Documented orders for cardiopulmonary resuscitation within the electronic health record
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
Inpatient dialysis
Description
Documented orders for dialysis during inpatient stay within the electronic health record
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
ICU admission
Description
Transferal to an intensive care unit documented within the electronic health record
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
Hospital discharge status
Description
Hospital discharge disposition code documented within the electronic health record
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
Discharge planning orders
Description
Discharge orders for home care services documented within the electronic health record
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
Hospital readmission
Description
30-day hospital re-admissions documented within the Premier database
Time Frame
30 days
Title
Direct cost per day
Description
Direct cost per day documented within the Premier database
Time Frame
Duration of hospital stay, an expected average of 8 days
Title
Direct cost per hospitalization
Description
Direct cost per hospitalization documented within the Premier database
Time Frame
Duration of hospital stay, an expected average of 8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 1. Patients younger than 65 years old will not receive the intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott D Halpern, PhD,MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's Medical Center
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
St. Vincent's Medical Center, Riverside
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
St. Vincent's Medical Center, Southside
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Via Christi Hospital, St. Francis
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Hospital, St. Joseph
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67218
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Our Lady of Lourdes Memorial Hospital
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
Facility Name
St. Thomas West Hospital
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
University Medical Center Brackenridge
City
Austin
State/Province
Texas
ZIP/Postal Code
78701
Country
United States
Facility Name
Columbia St. Mary's, Ozaukee
City
Mequon
State/Province
Wisconsin
ZIP/Postal Code
53097
Country
United States
Facility Name
Columbia St. Mary's, North Lake
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53211
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27348271
Citation
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.
Results Reference
derived

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Randomized Evaluation of Default Access to Palliative Services

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