An ICU Intervention to Improve End-of-Life Care
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University of Washington
- Enrollment
- 3,498
- Locations
- 30
- Primary Endpoint
- Total Score on a survey: the Quality of Dying and Death (QODD) as assessed by family members.
Study Overview
Brief Summary
The purpose of this research study is to evaluate an intervention to improve the care given to patients who are dying in the intensive care unit (ICU) and their families. This study is a multi-center randomized trial of a multi-faceted quality improvement intervention designed to improve the quality of palliative and end-of-life care in the ICU setting. The intervention targets the hospital and the outcome evaluation occurs at the level of the individual patient and family with surveys completed by family members and nurses as well as standardized medical record review.
Detailed Description
Because of the severity of illness, the intensive care unit (ICU) is a setting where death is prevalent and where the majority of deaths involve decisions to withhold or withdraw life-sustaining therapies. There is substantial data to suggest that the quality of end-of-life care in the ICU is poor. Many patients die with moderate to severe pain, physicians are often unaware of patients' wishes regarding end-of-life care, and the care patients' receive is often not consistent with their treatment preferences. Our study aims to evaluate the effectiveness of a multi-faceted intervention to improve the quality of care for patients dying in, or shortly after a stay in, the ICU using a randomized controlled study of 12 hospitals. In addition we plan to examine the variability in, and predictors of, the quality of dying and end-of-life care in community hospital ICUs with the purpose of identifying the current quality of end-of-life care and the institutional, clinician, and patient factors associated with the quality of this care. We will evaluate the successful and unsuccessful components of the intervention and describe the institutional and clinician facilitators and barriers to the intervention's implementation, with a focus on identifying interventions to improve care for the dying at other sites.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients, family members, nurses, and clinician evaluators
- •Patients are eligible if they are:
- •in the ICU for a minimum of 6 hours AND,
- •if they die in an ICU or within 24 hours of transfer out of the ICU.
- •Family members or significant others are eligible if:
- •they were involved with the patient who has died.
- •Nurses are eligible if:
- •they cared for an eligible patient on either the shift during which the patient died or the shift preceding the death.
- •Clinicians are eligible to evaluate the intervention components if they:
- •work in a study ICU AND
- •participate in any of the intervention components.
Exclusion Criteria
- •Inability to read English well enough to complete the surveys
- •Under 18 years of age.
Outcomes
Primary Outcomes
Total Score on a survey: the Quality of Dying and Death (QODD) as assessed by family members.
Time Frame: 5 years
Secondary Outcomes
- Total score of the QODD, as assessed by nurses(5 years)
- Satisfaction with care, as assessed by a survey called Family Satisfaction with the ICU (FS-ICU) as assessed by family members(5 years)
- Indicators of quality of end-of-life care as assessed by standardized medical record review.(5 years)
Investigators
J. Randall Curtis
Professor of Medicine
University of Washington