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NCT Number: NCT02505035

Randomized Evaluation of Default Access to Palliative Services

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.

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Key information

Conditions

COPD Brain Diseases Central Nervous System Diseases Chronic Disease Dementia Disease Attributes ESRD Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Lung Diseases Lung Diseases, Obstructive Male Urogenital Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Renal Insufficiency Renal Insufficiency, Chronic Respiratory Tract Diseases Urogenital Diseases Urologic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Default ordering of palliative consult

Behavioral

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Default Palliative Care Consultation for Seriously Ill Hospitalized Patients

Acronym: REDAPS

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Jul 22, 2015
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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