Comparing Optimized Models of Primary And Specialist Services for Palliative Care
- Conditions
- Seriously Ill Hospitalized Patients
- Registration Number
- NCT07224594
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
Palliative care (PC) seeks to reduce suffering and improve quality of life for patients with serious illnesses and their families. National guidelines recommend that clinicians either provide palliative care themselves (generalist PC) or consult experts (specialist PC) as a standard part of serious illness care. This pragmatic clinical trial will be conducted with 48 hospitals at two large U.S. health systems and enroll more than 78,000 seriously ill hospitalized patients. Eligibility is determined by a mortality prediction score where enrolled patients have at least a 70% risk of dying within 1 year. Enrollment assessment occurs as close as possible to 36 hours post admission. The 48 hospitals will be randomized to 3 arms: (1) standardized usual care, (2) trained generalist PC, or (3) specialist PC. Generalist clinicians are trained using the Center to Advance Palliative Care (CAPC) online trainings. This pragmatic, hybrid effectiveness-implementation parallel-cluster RCT will assess the comparative effectiveness of triggering generalist PC and specialist PC on several patient-centered outcome measures, and follows a pilot feasibility study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 78302
- Age 18 years of age or older; AND Predicted 1-year mortality risk of 70% or greater; AND Admitted to a study hospital.
- Patients who die or have an active or completed discharge order prior to enrollment time OR
- Readmission within 182 days of an eligible encounter OR
- Ineligible service line, with current admission status labeled as: hospice, acute rehabilitation, skilled nursing facility, long-term acute care, psychiatry, obstetrics
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Hospital free days Enrollment- 182 days. Count of days from enrollment spent alive outside of an acute care hospital through 182 days.
- Secondary Outcome Measures
Name Time Method Patient quality of life 1-month, 3-months, and 6-months post-enrollment Patient or caregiver report of the patient's quality of life using the 15-item McGill Quality of Life survey instrument.
Clinician communication 1-month post-enrollment Patient or caregiver report of how much patients feel heard and understood, using the 4-item CMS-MACRA survey instrument
Pain management 1-month post-enrollment Patient or caregiver report of whether patients receive desired help for pain, using the 3-item CMS-MACRA survey instrument.
Goal concordant care 1-month post-enrollment Patient or caregiver report of the patient's preferences for either extending life or ensuring comfort and the patient's perception of treatment.
Social interaction 1-month post-enrollment Patient or caregiver report of patient's social support using the 4-item Duke Social Support Index's Social Interaction Sub-scale
Loneliness 1-month post-enrollment Patient or caregiver report of patient's loneliness using the 3-item Duke UCLA loneliness scale.
Hospital free days at 3 months Enrollment - 3-months post-enrollment Count of days from enrollment spent alive and not in an acute care hospital through 3 months.
Institution free days at 3 months Enrollment - 3-months post-enrollment Count of days from enrollment spent alive and not in any care facility through 3 months.
Institution free days at 6 months Enrollment - 6-months post-enrollment Count of days from enrollment spent alive and not in any care facility through 6 months.
30-day hospital readmissions Enrollment - 30 days post-enrollment Count of readmissions
90-day hospital readmissions Enrollment - 90 days post-enrollment Count of readmissions.
Community-based palliative care use Enrollment - 6-months post-enrollment Binary variable indicating any use (use/no use) captured through EHR and claims data and count of days of PC visits.
Hospice use Enrollment - 6-months post-enrollment Binary variable indicating any use (use/no use) captured through EHR and claims data and count of days of hospice.
Change in code status Enrollment- Discharge from hospital (an average of 7 days) Binary indicator of whether code status changed from enrollment.
Trial Locations
- Locations (2)
Kaiser Permanente Southern California
🇺🇸Pasadena, California, United States
Trinity Health
🇺🇸Livonia, Michigan, United States
Kaiser Permanente Southern California🇺🇸Pasadena, California, United States