Resuscitation Preference Discussion for Severe Illness

(CHART Trial)

Not currently recruiting at 3 trial 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for discussing resuscitation preferences with seriously ill, hospitalized patients. The researchers aim to determine if an "informed assent" discussion about CPR (cardiopulmonary resuscitation) helps patients make better decisions compared to usual care. Participants will either engage in a detailed conversation with a doctor or receive a friendly visit to ask questions. The trial seeks individuals over 65 who speak English and have a severe illness that limits life expectancy or affects daily activities. It may suit those hospitalized with serious conditions like advanced heart failure or cancer.

As a Phase 2, Phase 3 trial, this study evaluates the approach's effectiveness in an initial group and represents the final step before FDA approval, offering a chance to contribute to significant advancements in patient care.

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 prior data suggests that the informed assent discussion is safe for discussing resuscitation preferences?

Research has shown that the "informed assent" approach has been studied for about 10 years in conversations about CPR with patients who have serious illnesses. This method aims to ensure that patients and their families understand what to expect from CPR. It is well-received because it provides clear information, aiding informed decision-making. As a communication method rather than a treatment or procedure, it has no physical side effects. Instead, studies have found that it enhances understanding and decision-making for patients and their families. While no negative effects have been reported from these discussions, evidence suggests they offer a safe and supportive way to discuss CPR options. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Resuscitation Preference Discussion for Severe Illness trial because it aims to improve the way doctors talk with patients about CPR in serious health situations. Unlike the standard approach, which often lacks detailed conversation, this method involves an informed assent discussion where patients and their families engage in a thorough dialogue with a study doctor. This approach could lead to more personalized care, ensuring that patients' wishes are clearly understood and respected. By potentially enhancing communication and decision-making, it could transform how end-of-life care decisions are made, making it a significant advancement in patient-centered care.

What evidence suggests that the informed assent discussion is effective for resuscitation preference in severe illness?

This trial will compare two approaches: an informed assent discussion and usual care with attention control. Research has shown that open communication with patients and families can improve decision-making about CPR. Participants in the intervention arm will discuss CPR with a study doctor, who will explain why it might not be performed unless the patient desires it, particularly when CPR is unlikely to be beneficial. This approach, studied for over 10 years, promotes clear communication. It helps ensure that patients understand their options and make informed choices about their care. ^{1 2 6 7 8}

Who Is on the Research Team?

Renee Stapleton, MD PhD

Principal Investigator

University of Vermont

Are You a Good Fit for This Trial?

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 are waiting for an organ transplant.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9179950/

Evolution of Investigating Informed Assent Discussions ... Outcomes after cardiopulmonary resuscitation (CPR) remain poor. We have spent 10 years investigating an “informed assent” (IA) approach to discussing CPR ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35595375/

Evolution of Investigating Informed Assent Discussions ... IA is a discussion framework whereby patients extremely unlikely to benefit from CPR are informed that unless they disagree, CPR will not be performed because ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2839326

Checklist-Guided Code Status Discussions in Patients for ... This training provided structured guidance for code status discussions with patients in whom CPR was considered futile, using a checklist to ...

4. withpower.com withpower.com/trial/phase-2-and-3-heart-failure-11-2016-11c7f

Resuscitation Preference Discussion for Severe Illness Research shows that informed assent discussions can help patients and families make better decisions about resuscitation by clearly explaining when CPR ( ...

5. shmpublications.onlinelibrary.wiley.com shmpublications.onlinelibrary.wiley.com/doi/abs/10.1002/jhm.2497

Uninformed consent: Do medicine residents lack the proper ... Conversations eliciting patient preferences about cardiopulmonary resuscitation (CPR) are among the most common examples of informed consent.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01878968

Does Detailed Informed Consent for Cardiopulmonary ... This study will examine whether evidence-based informed consent impacts patients choices and healthcare outcomes compared to routine care.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/acem.12613

The Association of Health Status and Providing Consent to ... This investigation was an analysis of data collected during a multisite, randomized, controlled, out-of-hospital cardiac arrest clinical trial ...

8. researchgate.net researchgate.net/publication/360656279_Evolution_of_Investigating_Informed_Assent_Discussions_about_CPR_in_Seriously_Ill_Patients

Evolution of Investigating Informed Assent Discussions ... IA is a discussion framework whereby patients extremely unlikely to benefit from CPR are informed that unless they disagree, CPR will not be performed because ...