Randomized Evaluation of Default Access to Palliative Services

Study Overview
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Brief Summary
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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
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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.

Official Title
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Default Palliative Care Consultation for Seriously Ill Hospitalized Patients

Conditions
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COPD, ESRD, Dementia

Intervention / Treatment
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* Behavioral: Default ordering of palliative consult


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Default ordering of palliative consult<br>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<br> <br> |
| No Intervention: Usual care<br>There will be no trial-driven approach to care. Inpatient palliative care consultative services will be actively requested by physicians as in usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Goals of care assessment | Documented assessments of patients' goals of care within the electronic health record | Duration of hospital stay, an expected average of 8 days | 
| Pain assessment | Documented assessments of patients' pain scores within the electronic health record | Duration of hospital stay, an expected average of 8 days | 
| Dyspnea assessment | Documented assessments of patients' dyspnea within the electronic health record | Duration of hospital stay, an expected average of 8 days | 
| Code status | Code status documented within the electronic health record | Duration of hospital stay, an expected average of 8 days | 
| Mechanical ventilation | Documented orders for mechanical ventilation within the electronic health record | Duration of hospital stay, an expected average of 8 days | 
| Cardiopulmonary resuscitation | Documented orders for cardiopulmonary resuscitation within the electronic health record | Duration of hospital stay, an expected average of 8 days | 
| Inpatient dialysis | Documented orders for dialysis during inpatient stay within the electronic health record | Duration of hospital stay, an expected average of 8 days | 
| ICU admission | Transferal to an intensive care unit documented within the electronic health record | Duration of hospital stay, an expected average of 8 days | 
| Hospital discharge status | Hospital discharge disposition code documented within the electronic health record | Duration of hospital stay, an expected average of 8 days | 
| Discharge planning orders | Discharge orders for home care services documented within the electronic health record | Duration of hospital stay, an expected average of 8 days | 
| Hospital readmission | 30-day hospital re-admissions documented within the Premier database | 30 days | 
| Direct cost per day | Direct cost per day documented within the Premier database | Duration of hospital stay, an expected average of 8 days | 
| Direct cost per hospitalization | Direct cost per hospitalization documented within the Premier database | Duration of hospital stay, an expected average of 8 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative care, Pragmatic trial