Decision Aid for Congenital Heart Disease

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Angela Fagerlin, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Utah

Disqualifiers: Other CHD, Under 18

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a web-based tool to help parents of children with serious heart conditions make better treatment decisions. The tool provides information and helps clarify what is important to the parents. Researchers will see if this tool improves parents' mental health and decision-making quality.

Do I need to stop my current medications to join the trial?

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

What data supports the effectiveness of the Decision Aid for Congenital Heart Disease treatment?

Research shows that decision aids can improve shared decision-making in heart-related treatments, such as prosthetic heart valve selection and advanced heart failure therapies. These aids help patients and caregivers understand their options and align treatment choices with their personal values and goals. ^{1 2 3 4 5}

How does the Decision Aid for Congenital Heart Disease treatment differ from other treatments for this condition?

The Decision Aid for Congenital Heart Disease is unique because it focuses on shared decision-making, helping patients and caregivers understand and deliberate their treatment options. This approach is different from traditional treatments as it emphasizes aligning medical decisions with the patient's personal goals and values, rather than solely relying on clinical guidelines. ^{1 3 5 6 7}

Research Team

Angela Fagerlin, PhD

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for parents of a fetus or neonate diagnosed with specific life-threatening congenital heart diseases (CHD), such as Truncus Arteriosus and Hypoplastic Left Heart Syndrome. Both parents are invited to participate, but one parent can join if the other cannot. Participants must be adults over 18 years old without restrictions on gender, race, or socioeconomic status.

Inclusion Criteria

Both my partner and I are invited to participate, but it's okay if only one of us does.

My unborn baby or newborn has a serious heart defect and we're deciding on treatment options.

My unborn baby or newborn has a serious heart defect.

Exclusion Criteria

I am 18 years old or older.

My heart condition is not listed as an eligible type for this trial.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Decision Aid Intervention

Participants receive a web-based decision aid, with or without a values clarification exercise, to assist in shared decision-making regarding treatment options for congenital heart disease.

1 week

1 visit (virtual)

Follow-up

Participants are monitored for mental health outcomes, decision quality, and perceptions of patient-provider communication.

3 months

3 visits (virtual)

Treatment Details

Interventions

• Decision Aid (Behavioural Intervention)
• Values Clarification Exercise (Behavioural Intervention)

Trial Overview The study tests a web-based decision aid designed to help parents make informed choices about their child's CHD treatment. Some will use the decision aid alone; others will have an added values clarification exercise. Their effectiveness is compared against families making decisions without any aids.

Participant Groups

Group I: Decision Aid & Values Clarification Exercise Experimental Treatment 2 Interventions

Participants view both the Decision Aid and the Values Clarification Exercise

Group II: Decision Aid Experimental Treatment 1 Intervention

Participants view the Decision Aid only

Group III: Standard Care (Control) Active Control 1 Intervention

Participants will receive standard care and will not view either the Decision Aid or the Values Clarification Exercise

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Eduardo Sanchez

American Heart Association

Chief Medical Officer since 2013

MD from University of Texas Southwestern Medical School, MPH from UT Health Science Center at Houston, MS in Biomedical Engineering from Duke University

Katrina McGhee

American Heart Association

Chief Executive Officer since 2020

MBA from the University of Texas at Arlington

Findings from Research

The use of a patient decision aid in selecting prosthetic heart valves did not reduce preoperative decisional conflict among patients, but it significantly improved their knowledge and feelings of being informed about their options.

Patients using the decision aid experienced lower levels of anxiety and depression, and reported better mental well-being, indicating that while decisional conflict remained unchanged, the overall patient experience was enhanced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the Use of a Decision Aid Improve Decision Making in Prosthetic Heart Valve Selection? A Multicenter Randomized Trial. Korteland, NM., Ahmed, Y., Koolbergen, DR., et al.[2020]

Patient decision aids (PDAs) are effective tools designed to help patients make informed treatment choices in cardiology, particularly for conditions like coronary artery disease and heart failure, by considering the unique needs of diverse populations.

Implementing PDAs can enhance patient engagement and promote equitable healthcare delivery, especially for underrepresented racial and ethnic groups, although challenges remain in their widespread adoption and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Patient Decision Aids for Cardiology Care in Diverse Populations. Masterson Creber, R., Benda, N., Dimagli, A., et al.[2023]

The DECIDE-LVAD study is a multicenter, randomized trial involving 168 patient-caregiver dyads aimed at evaluating the effectiveness of decision aids (pamphlets and videos) for patients considering destination therapy left ventricular assist devices (DT LVAD) in end-stage heart failure.

The study will assess primary outcomes such as patient knowledge and alignment of treatment options with their values, which is crucial for ensuring that patients make informed decisions about invasive therapies that significantly impact their quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for Advanced Heart Failure: DECIDE-LVAD: Rationale, Design, and Pilot Data. McIlvennan, CK., Thompson, JS., Matlock, DD., et al.[2018]

A computer program can accurately estimate the risks and benefits of coronary artery revascularization procedures for individual patients using their medical history and exercise test results, providing a more personalized approach to treatment decisions.

This program challenges traditional clinical intuition by clearly defining treatment risks and benefits, encouraging both physicians and patients to critically evaluate their decision-making process regarding coronary artery disease treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining the need for coronary revascularization by an exercise test assessment computer program (ETAP). Kellett, J.[2019]

The decision aid significantly improved patients' knowledge of effective coronary heart disease (CHD) prevention strategies by 21 percentage points and increased the accuracy of their perceived CHD risk by 33 percentage points, indicating its efficacy in enhancing patient understanding.

Participants using the decision aid reported a 31 percentage point increase in discussions about CHD prevention with their healthcare providers and a 21 percentage point increase in their intent to adopt effective CHD risk-reducing strategies, demonstrating its potential to facilitate better patient-provider communication and decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a decision aid intervention on decision making about coronary heart disease risk reduction: secondary analyses of a randomized trial. Sheridan, SL., Draeger, LB., Pignone, MP., et al.[2022]

Decision-making in congenital cardiac care is complex and often uncertain, even for seemingly simple conditions, due to a lack of data and potential biases.

To improve decision-making, strategies such as using evidence-based medicine, larger datasets, standardized protocols, and incorporating artificial intelligence are recommended to reduce uncertainty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing uncertainty in decision-making of common congenital cardiac defects. McMahon, CJ., Sendžikaitė, S., Jegatheeswaran, A., et al.[2023]

An online contraceptive decision aid was developed through a qualitative study involving 17 female students in the Netherlands, which included a needs assessment and field testing to ensure it met user preferences.

Participants reported that the decision aid increased their knowledge and awareness of various contraceptive methods, suggesting it could enhance informed decision-making and consultation preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

End-user involvement in developing and field testing an online contraceptive decision aid. Hooiveld, T., Molenaar, JM., van der Heijde, CM., et al.[2023]

References

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

Does the Use of a Decision Aid Improve Decision Making in Prosthetic Heart Valve Selection? A Multicenter Randomized Trial. [2020]

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

Using Patient Decision Aids for Cardiology Care in Diverse Populations. [2023]

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

A Multicenter Trial of a Shared Decision Support Intervention for Patients and Their Caregivers Offered Destination Therapy for Advanced Heart Failure: DECIDE-LVAD: Rationale, Design, and Pilot Data. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Determining the need for coronary revascularization by an exercise test assessment computer program (ETAP). [2019]

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

The effect of a decision aid intervention on decision making about coronary heart disease risk reduction: secondary analyses of a randomized trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Managing uncertainty in decision-making of common congenital cardiac defects. [2023]

7. England pubmed.ncbi.nlm.nih.gov

End-user involvement in developing and field testing an online contraceptive decision aid. [2023]