Resuscitation Preference Discussion for Severe Illness

(CHART Trial)

Recruiting in Chapel Hill (>99 mi)

+3 other locations

Overseen By Shannon Carson, MD

Age: 65+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Vermont

Disqualifiers: DNR status, Transplant list, LVAD, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

182 Participants Needed

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Informed Assent Discussion, Usual Care with Attention Control for severe illness?

Research shows that informed assent discussions can help patients and families make better decisions about resuscitation by clearly explaining when CPR (cardiopulmonary resuscitation) is unlikely to be beneficial, thus reducing the burden of decision-making while allowing them to express their wishes. ^{1 2 3 4 5}

Is the Resuscitation Preference Discussion for Severe Illness safe for humans?

The research on informed assent discussions, which are similar to resuscitation preference discussions, focuses on communication and decision-making rather than a medical treatment, so there are no safety concerns for participants. ^{1 6 7 8 9}

How is the Informed Assent Discussion treatment different from other treatments for resuscitation preferences in severe illness?

The Informed Assent Discussion is unique because it provides a framework where patients who are unlikely to benefit from CPR are informed that CPR will not be performed unless they disagree, which reduces the decision-making burden on patients and families while still allowing them to express their wishes. ^{1 3 5 10 11}

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).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants engage in a discussion about CPR with a study doctor using the informed assent approach

During hospitalization

1 visit (in-person)

Usual Care with Attention Control

Participants receive a friendly visit in the hospital from research personnel to ask if they have any questions or concerns

During hospitalization

1 visit (in-person)

Follow-up

Participants are monitored for outcomes such as cost of health care, anxiety, depression, and quality of communication

6 months

Treatment Details

Interventions

• Informed Assent Discussion
• Usual Care with Attention Control

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+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Evolution of Investigating Informed Assent Discussions about CPR in Seriously Ill Patients. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Appropriate use of DNR orders: a practical approach. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of patient, physician, nurse, and family attitudes toward do not resuscitate orders. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Extremely premature birth, informed written consent, and the Greek ideal of sophrosyne. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Barriers to implementing a policy not to attempt resuscitation in acute medical admissions: prospective, cross sectional study of a successive cohort. [2018]

6. Brazil pubmed.ncbi.nlm.nih.gov

How to discuss about do-not-resuscitate in the intensive care unit? [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

"Do-not-resuscitate" preferences of the general Swiss population: Results from a national survey. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Preferences for resuscitation and intubation among patients with do-not-resuscitate/do-not-intubate orders. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Discordance of Patient-Reported and Clinician-Ordered Resuscitation Status in Patients Hospitalized With Acute Decompensated Heart Failure. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Surrogates' predictions of seriously ill patients' resuscitation preferences. [2019]

11. Ireland pubmed.ncbi.nlm.nih.gov

Discussing preferences for cardiopulmonary resuscitation: what do resident physicians and their hospitalized patients think was decided? [2015]