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This multicenter RCT of 200 hospitalized patients and their family members evaluates an "informed assent" approach to discussing cardiopulmonary resuscitation, compared to usual care, in older seriously ill hospitalized patients with severe life-limiting illness or severe functional impairment.
Increasing evidence suggests that high quality palliative care in older patients improves quality of care, patient and family satisfaction, and costs of care. However, while some specific palliative care interventions have been investigated, exactly how we should provide this care remains unclear. One important component of high quality provider-patient communication is discussing cardiopulmonary resuscitation (CPR) within the context of the patient's values and goals of care. Unfortunately, these conversations are often rushed, focused only on the procedure rather than the patient's goals and values, and CPR is often offered as if a choice on a menu. Elderly hospitalized patients are unlikely to have made decisions about CPR prior to hospitalization, and these discussions often leave patients and families feeling burdened, stressed, and concerned. Outcomes after in-hospital CPR in chronically ill older patients continue to be very poor, despite decades of efforts toward improvement. The investigators aim to change the paradigm of CPR discussions with older adults unlikely to benefit from CPR. This study is a randomized controlled trial comparing an innovative "informed assent" approach to discussing CPR versus usual care with attention control for older hospitalized adults with life-limiting illness or severe functional impairment, enrolling patients and family members at three different study sites. Informed assent includes: 1) eliciting values and goals, 2) explaining CPR in the context of illness, and 3) a caring statement that the patient should not receive CPR if values include avoiding burdensome therapies unlikely to provide benefit. Thus, the provider can elicit values, convey information, and state an assessment, while allowing the patient or family to disagree. The investigators hypothesize that informed assent will improve quality of and satisfaction with communication about CPR; reduce the burden of potentially harmful CPR discussions, including reduced patient and family symptoms of depression and anxiety; and reduce intensity of care and health care utilization. The intervention builds on prior work investigating CPR outcomes in older adults and performing pilot studies of the informed assent intervention in both inpatients and outpatients.
Age
65 - No limit years
Sex
ALL
Healthy Volunteers
No
University of North Carolina
Chapel Hill, North Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
University of Vermont
Burlington, Vermont, United States
University of Washington
Seattle, Washington, United States
Start Date
December 1, 2016
Primary Completion Date
March 1, 2023
Completion Date
December 1, 2025
Last Updated
February 18, 2025
182
ACTUAL participants
Informed Assent Discussion
BEHAVIORAL
Usual Care with Attention Control
BEHAVIORAL
Lead Sponsor
University of Vermont
Collaborators
Data Source & Attribution
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