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Clinical Trials/NCT04921631
NCT04921631
Active, Not Recruiting
N/A

Randomized Trial of Specialty Palliative Care Integrated With Critical Care for Critically Ill Older Adults

University of Pittsburgh2 sites in 1 country1,400 target enrollmentJune 28, 2021

Overview

Phase
N/A
Intervention
Early Integration of Specialty Palliative Care with Critical Care
Conditions
Critical Illness
Sponsor
University of Pittsburgh
Enrollment
1400
Locations
2
Primary Endpoint
Patient and family centeredness of care
Status
Active, Not Recruiting
Last Updated
9 months ago

Overview

Brief Summary

The National Academy of Medicine and the National Institutes of Health have called for urgent action to improve the care delivered to the nearly 1,000,000 older Americans who die in intensive care units (ICUs) annually, or survive with substantial impairments. These patients often die with distressing symptoms and may receive more invasive, life-prolonging treatment than they would choose for themselves. Moreover, their family members acting as surrogate decision makers often experience lasting psychological distress from the ICU experience. The investigators will conduct a randomized trial among 500 patients and 750 surrogates and up to 150 clinicians to determine whether early integration of specialty palliative care with standard critical care can improve outcomes for critically ill older patients at high risk of death or severe functional impairments and their family members.

Registry
clinicaltrials.gov
Start Date
June 28, 2021
End Date
May 1, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Douglas White

Professor

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Intervention

The intervention arm will receive early specialty palliative care integrated with standard critical care.

Intervention: Early Integration of Specialty Palliative Care with Critical Care

No intervention

Usual ICU care; each study ICU has a policy for family meetings within 72 hours of admission and at least weekly thereafter.

Outcomes

Primary Outcomes

Patient and family centeredness of care

Time Frame: Measured at 3 months after hospital discharge

12-item Patient Perceived Patient-Centeredness of Care Scale (PPPC), previously modified for use by surrogates, completed at 3-month telephone follow-up of surrogates.

Secondary Outcomes

  • Unmet palliative care needs(Measured at day 5 post-randomization)
  • Surrogates' clarity about patient values and preferences(Measured on study day 5)
  • Duration of mechanical ventilation(Measured at 6 months)
  • Composite measure of goal-concordant care(Measured at 3 months)
  • Satisfaction with ICU care(Measured at 3 months)
  • Risk of post-traumatic stress disorder(Measured at 6 months)
  • Proportion of patients who received comfort-focused care during the index hospitalization and time to comfort-focused care during index hospitalization(Measured at 6 months)
  • Surrogates' prognostic awareness(Measured on study day 5)
  • Symptoms of anxiety and depression(Measured at 6 months)
  • Cost of index hospitalization(Measured at 6 months)
  • Proportion of patients with new DNR order during index hospitalization and time to first DNR order during index hospitalization(Measured at 6 months)
  • Proportion of patients enrolled in hospice during index hospitalization and time to hospice enrollment during index hospitalization(Measured at 6 months)
  • ICU and hospital length of stay(Measured at 6 months)
  • Resource utilization over 6-months follow-up(Measured at 3 months and 6 months)

Study Sites (2)

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