Resuscitation Preference Discussion for Severe Illness

(CHART Trial)

Recruiting at 3 trial locations

Overseen by Renee Stapleton, MD PhD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: University of Vermont

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Renee Stapleton, MD PhD

Principal Investigator

University of Vermont

Eligibility Criteria

This trial is for English-speaking individuals over 65 with serious illnesses like advanced cancer, COPD needing oxygen, severe heart failure, late-stage cirrhosis or kidney disease requiring dialysis (if they're over 75), advanced lung diseases, or those highly dependent in daily activities. They must have a life expectancy under two years and be able to give consent.

Inclusion Criteria

English speaking

I need help with more than four daily activities.

I am older than 65.

Exclusion Criteria

Patient discharged from hospital prior to enrollment

Inappropriate for study enrollment per clinician

You have a left ventricular assist device (LVAD).

Treatment Details

Interventions

• Informed Assent Discussion (Behavioral Intervention)
• Usual Care with Attention Control (Behavioral Intervention)

Trial Overview The study compares an 'informed assent' method of discussing resuscitation options with the usual care given to seriously ill older patients in hospitals. It involves 200 patients and their families across multiple centers to see if this approach improves communication.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Participants (n= approximately 100 plus family members) who are randomized to the intervention arm of the study will participate in a discussion about CPR with a study doctor.

Group II: Usual Care with Attention Control Placebo Group 1 Intervention

Participants (n= approximately 100 plus family members) 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.

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+

Dr. Dragos Banu

University of Vermont

Chief Medical Officer

MD from Saba University School of Medicine

Dr. Richard Page

University of Vermont

Chief Executive Officer since 2018

MD from Duke University

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Dr. Timothy H. Dellit

University of Washington

Chief Executive Officer since 2023

MD from University of Washington

Dr. Anneliese Schleyer

University of Washington

Chief Medical Officer since 2023

MD, MHA

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Dr. Erik Summers

Medical University of South Carolina

Chief Medical Officer

MD from University of Alabama at Birmingham

Dr. Patrick J. Cawley

Medical University of South Carolina

Chief Executive Officer

MD, MBA

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC