Communication During Hospitalization About Resuscitation Trial



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:65 - Any
Updated:10/13/2018
Start Date:December 2016
End Date:December 2021
Contact:Sara Ardren, PA
Email:sara.ardren@uvmhealth.org
Phone:802-656-7953

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This multicenter RCT of 180 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.

Inclusion Criteria:

1. >65 years old

2. English speaking

3. N=180 patients (primary outcome) with decisional capacity who have life limiting
illness or severe functional impairment. Must have one or more of the following:

1. Chronic life-limiting illness with median survival <2 years defined as: 1)
metastatic cancer or inoperable lung cancer; 2) COPD requiring oxygen; 3) New
York Heart Association Class III or IV heart failure; or 4) Child's Class C
cirrhosis or MELD score of >20

2. Severe functional impairment defined as dependence with >4 activities of daily
living (ADLs) on Katz Index of Independence in ADLs.100,101

4. NOT being cared for on an ICU service

Exclusion Criteria:

1. Has already definitively chosen DNR status

2. Unable to provide informed consent

3. Refused consent

4. Currently listed on a transplant list (awaiting transplant)

5. Inappropriate for study enrollment per clinician

6. Has been hospitalized >96 hours
We found this trial at
3
sites
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Seattle, WA
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85 S Prospect St
Burlington, Vermont 5405
(802) 656-3131
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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Burlington, VT
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charleston, SC
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