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Resuscitation Preference Discussion for Severe Illness (CHART Trial)

Phase 2 & 3

Waitlist Available

Led By Renee Stapleton, MD PhD

Research Sponsored by University of Vermont

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

>65 years old

Must not have

Unable to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months and 6 months post-randomization

Summary

This trial looks at whether it's better to have a conversation with a seriously ill hospitalized patient about whether or not they want cardiopulmonary resuscitation, or to just go with the usual care.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on communication methods rather than medical treatments, there are no direct physical side effects. However, discussions about end-of-life care can be emotionally impactful for patients and their families.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need help with more than four daily activities.

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I am older than 65.

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I have a chronic illness with a life expectancy of less than 2 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months and 6 months post-randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months and 6 months post-randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 6 months post-randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation

Secondary study objectives

5-question communication domain of the CANHELP Questionnaire, slightly modified to focus on communication about cardiopulmonary resuscitation

Cost of health care after initial hospitalization

Hospital Anxiety and Depression Survey (HADS)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: InterventionExperimental Treatment1 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 ControlPlacebo Group1 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.

0 / 4Eligibility criteria met