Communication During Hospitalization About Resuscitation Trial

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.

Conditions

• Severe Life-limiting COPD
• Severe Life-limiting Heart Failure
• Severe Life-limiting Cirrhosis
• Severe Life-limiting Malignancy
• Severe Functional Impairment
• End Stage Renal Disease

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.

Sponsors & Collaborators

• University of Washington

  collaborator OTHER

• Medical University of South Carolina

  collaborator OTHER

• University of North Carolina, Chapel Hill

  collaborator OTHER

• University of Vermont

  lead OTHER

Principal Investigators

• Renee Stapleton, MD PhD · University of Vermont

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-31

Primary Completion

2023-03-31

Completion

2025-12-31

Countries

• United States

Study Locations