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Randomized Evaluation of Default Access to Palliative Services (REDAPS)

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ClinicalTrials.gov Identifier: NCT02505035
Recruitment Status : Recruiting
First Posted : July 22, 2015
Last Update Posted : March 4, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
COPD ESRD Dementia Behavioral: Default ordering of palliative consult Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Default Palliative Care Consultation for Seriously Ill Hospitalized Patients
Actual Study Start Date : March 2016
Actual Primary Completion Date : November 2018
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Default ordering of palliative consult
No Intervention: 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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Goals of care assessment [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Documented assessments of patients' goals of care within the electronic health record

  2. Pain assessment [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Documented assessments of patients' pain scores within the electronic health record

  3. Dyspnea assessment [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Documented assessments of patients' dyspnea within the electronic health record

  4. Code status [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Code status documented within the electronic health record

  5. Mechanical ventilation [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Documented orders for mechanical ventilation within the electronic health record

  6. Cardiopulmonary resuscitation [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Documented orders for cardiopulmonary resuscitation within the electronic health record

  7. Inpatient dialysis [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Documented orders for dialysis during inpatient stay within the electronic health record

  8. ICU admission [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Transferal to an intensive care unit documented within the electronic health record

  9. Hospital discharge status [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Hospital discharge disposition code documented within the electronic health record

  10. Discharge planning orders [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Discharge orders for home care services documented within the electronic health record

  11. Hospital readmission [ Time Frame: 30 days ]
    30-day hospital re-admissions documented within the Premier database

  12. Direct cost per day [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Direct cost per day documented within the Premier database

  13. Direct cost per hospitalization [ Time Frame: Duration of hospital stay, an expected average of 8 days ]
    Direct cost per hospitalization documented within the Premier database



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 65 years or older
  2. Current hospitalization of at least 3 calendar days
  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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505035


Contacts
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Contact: Vanessa Madden, BS 215-746-4923 vmadden@mail.med.upenn.edu
Contact: Sarah Hill, MA 314-733-8218 SEHill@ascensionhealth.org

Locations
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United States, Connecticut
St. Vincent's Medical Center Recruiting
Bridgeport, Connecticut, United States, 06606
United States, Florida
St. Vincent's Medical Center, Riverside Recruiting
Jacksonville, Florida, United States, 32204
St. Vincent's Medical Center, Southside Recruiting
Jacksonville, Florida, United States, 32216
United States, Kansas
Via Christi Hospital, St. Francis Recruiting
Wichita, Kansas, United States, 67214
Via Christi Hospital, St. Joseph Recruiting
Wichita, Kansas, United States, 67218
United States, Michigan
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49048
United States, New York
Our Lady of Lourdes Memorial Hospital Recruiting
Binghamton, New York, United States, 13905
United States, Tennessee
St. Thomas West Hospital Recruiting
Nashville, Tennessee, United States, 37205
United States, Texas
University Medical Center Brackenridge Recruiting
Austin, Texas, United States, 78701
United States, Wisconsin
Columbia St. Mary's, Ozaukee Recruiting
Mequon, Wisconsin, United States, 53097
Columbia St. Mary's, North Lake Recruiting
Milwaukee, Wisconsin, United States, 53211
Sponsors and Collaborators
University of Pennsylvania
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Scott D Halpern, PhD,MD University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02505035     History of Changes
Other Study ID Numbers: 822134
UH2AG050311 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: March 2019

Keywords provided by University of Pennsylvania:
Palliative care
Pragmatic trial