Decision Aid for Congenital Heart Disease

Recruiting at 1 trial location

Overseen By Kirstin Beck, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Other CHD, Under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

215 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist parents in making informed decisions when their unborn or newborn child is diagnosed with a life-threatening congenital heart disease (CHD). It evaluates a web-based tool called a decision aid, designed to support parents in choosing between medical intervention, comfort care, or, in some cases, termination. Some parents will use only the decision aid, while others will also engage in a Values Clarification Exercise to better understand their priorities. Parents of children diagnosed with specific conditions like Hypoplastic Left Heart Syndrome or Ebstein's Anomaly are eligible to participate. The trial seeks to assess how these tools impact stress levels three months after the birth or loss of the child. As an unphased trial, this study provides parents with a unique opportunity to contribute to research that could ease decision-making for future families facing similar challenges.

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 prior data suggests that this decision aid is safe for use in congenital heart disease?

Research has shown that decision aids, like the one used in this trial, are generally safe for participants. A decision aid provides information to help people make choices and does not involve any medical treatment or medication, so it causes no physical side effects.

Adding a values clarification exercise to a decision aid is also safe. This exercise helps participants consider what is most important to them when making a decision. Studies have found that these tools can improve decision-making without causing harm or distress.

Overall, both the decision aid and the values clarification exercise are well-tolerated by participants. No reports of negative effects have emerged from using these tools. Participants can feel confident in their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Decision Aid for Congenital Heart Disease because it empowers patients and families to make more informed medical choices. Unlike traditional treatments for congenital heart disease, which focus on surgical or medical interventions, this approach enhances decision-making by providing clear, accessible information tailored to the patient's specific situation. The Values Clarification Exercise adds another layer by helping participants align their healthcare decisions with their personal values and priorities. This could lead to more personalized care and improved satisfaction with treatment choices, setting it apart from standard care that may not fully address individual preferences.

What evidence suggests that this trial's decision aids could be effective for congenital heart disease?

Research shows that decision aids can help people make better health choices by providing clear information about their options. In this trial, participants may receive the Decision Aid alone, which has improved understanding and helped individuals make decisions aligned with their personal values in similar situations. This is particularly useful for complex medical choices, such as those involving congenital heart disease. Additionally, some participants will receive both the Decision Aid and a Values Clarification Exercise. Studies suggest that including an exercise to clarify personal values in a decision aid can further help people make choices that reflect what matters most to them, although results have varied. Overall, these tools may reduce stress and increase satisfaction with the decision-making process. ^{1 3 5 6 7}

Who Is on the Research Team?

Angela Fagerlin, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Decision Aid
• Values Clarification Exercise

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.

How Is the Trial Designed?

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+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

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An Evaluation a PrEP-Focused HIV Prevention Intervention ... This study aimed to test the efficacy of the 4-week Bio-behavioral Community-Friendly Health Recovery Program (CHRP-BB) at improving HIV prevention outcomes.

2. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-024-00534-x

Rationale and design of a randomized clinical trial of ... In a two parallel-arm randomized controlled trial, we are assessing an innovative eHealth delivery model that integrates PrEP with MOUD and is tailored to meet ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06684613

Study Details | NCT06684613 | Integrating PrEP Decision ... The purpose of this study is to expand and enhance a PrEP decision aid to include the full array of available formulation options and then integrate its ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39825419/

Rationale and design of a randomized clinical trial ... - PubMed In a two parallel-arm randomized controlled trial, we are assessing an innovative eHealth delivery model that integrates PrEP with MOUD.

5. formative.jmir.org formative.jmir.org/2024/1/e57348

Decision Support Tool to Improve Decision-Making for HIV Pre ... Our study aimed to develop a DST to improve PrEP decision-making for Black clients and to evaluate the tool's acceptability and usability.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06684613

Study Details | NCT06684613 | Integrating PrEP Decision ... The purpose of this study is to expand and enhance a PrEP decision aid to include the full array of available formulation options and then integrate its ...

7. withpower.com withpower.com/trial/phase-heart-defects-congenital-9-2020-615b0

Decision Aid for Congenital Heart Disease This trial tests a web-based tool to help parents of children with serious heart conditions make better treatment decisions. The tool provides information ...