REDAPS: Randomized Evaluation of Default Access to Palliative Services
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| 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. |
Outcome Measures
Primary Outcome Measures
- Composite Measure: Length of Stay and In-Hospital Mortality [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
- Goals of care assessment [Duration of hospital stay, an expected average of 8 days]
Documented assessments of patients' goals of care within the electronic health record
- Pain assessment [Duration of hospital stay, an expected average of 8 days]
Documented assessments of patients' pain scores within the electronic health record
- Dyspnea assessment [Duration of hospital stay, an expected average of 8 days]
Documented assessments of patients' dyspnea within the electronic health record
- Code status [Duration of hospital stay, an expected average of 8 days]
Code status documented within the electronic health record
- Mechanical ventilation [Duration of hospital stay, an expected average of 8 days]
Documented orders for mechanical ventilation within the electronic health record
- Cardiopulmonary resuscitation [Duration of hospital stay, an expected average of 8 days]
Documented orders for cardiopulmonary resuscitation within the electronic health record
- Inpatient dialysis [Duration of hospital stay, an expected average of 8 days]
Documented orders for dialysis during inpatient stay within the electronic health record
- ICU admission [Duration of hospital stay, an expected average of 8 days]
Transferal to an intensive care unit documented within the electronic health record
- Hospital discharge status [Duration of hospital stay, an expected average of 8 days]
Hospital discharge disposition code documented within the electronic health record
- Discharge planning orders [Duration of hospital stay, an expected average of 8 days]
Discharge orders for home care services documented within the electronic health record
- Hospital readmission [30 days]
30-day hospital re-admissions documented within the Premier database
- Direct cost per day [Duration of hospital stay, an expected average of 8 days]
Direct cost per day documented within the Premier database
- Direct cost per hospitalization [Duration of hospital stay, an expected average of 8 days]
Direct cost per hospitalization documented within the Premier database
Eligibility Criteria
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:
- Patients younger than 65 years old will not receive the intervention
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Vincent's Medical Center | Bridgeport | Connecticut | United States | 06606 |
| 2 | St. Vincent's Medical Center, Riverside | Jacksonville | Florida | United States | 32204 |
| 3 | St. Vincent's Medical Center, Southside | Jacksonville | Florida | United States | 32216 |
| 4 | Via Christi Hospital, St. Francis | Wichita | Kansas | United States | 67214 |
| 5 | Via Christi Hospital, St. Joseph | Wichita | Kansas | United States | 67218 |
| 6 | Borgess Medical Center | Kalamazoo | Michigan | United States | 49048 |
| 7 | Our Lady of Lourdes Memorial Hospital | Binghamton | New York | United States | 13905 |
| 8 | St. Thomas West Hospital | Nashville | Tennessee | United States | 37205 |
| 9 | University Medical Center Brackenridge | Austin | Texas | United States | 78701 |
| 10 | Columbia St. Mary's, Ozaukee | Mequon | Wisconsin | United States | 53097 |
| 11 | Columbia St. Mary's, North Lake | Milwaukee | Wisconsin | United States | 53211 |
Sponsors and Collaborators
- University of Pennsylvania
- National Institute on Aging (NIA)
Investigators
- Principal Investigator: Scott D Halpern, PhD,MD, University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 822134
- UH2AG050311