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ACTIVE NOT RECRUITING
NCT02984124
PHASE2/PHASE3

Communication During Hospitalization About Resuscitation Trial

Sponsor: University of Vermont

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

182

Start Date

2016-12

Completion Date

2025-12

Last Updated

2025-02-18

Healthy Volunteers

No

Interventions

BEHAVIORAL

Informed Assent Discussion

Participants randomized to the intervention arm will participate in a discussion about CPR with a study doctor that follows these steps: 1. Patient's values and preferences for therapies and outcomes elicited from patient and family; overall therapeutic goals formulated 2. Description of CPR and dying process provided 3. Personalized explanation provided about probable lack of achieving any reasonable therapeutic goal with CPR (i.e. why s/he is a poor candidate for CPR due to underlying illness) 4. Patient and family informed that due to severe underlying illness and high likelihood that CPR will be burdensome/harmful and will not provide benefit, CPR will not be offered unless they disagree (except in rare circumstance where overall therapeutic goals from step 1 are to preserve life regardless of quality of that life) Assessment of patient's and family's understanding of issues discussed; patients may actively disagree and request CPR be performed, but CPR not explicitly offered

BEHAVIORAL

Usual Care with Attention Control

Participants who are randomized to the usual care arm will receive a friendly visit in the hospital from research personnel to ask if they have any questions or concerns. Follow up assessments and time windows will be explained. Importance of their participation in the study will be emphasized.

Locations (4)

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