Improving Patient and Family Health Using Family-Centered Outcomes and Shared Decision-Making

NCT04437069 | Active Not Recruiting

• 1 other identifier: IRB_00103194
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a randomized clinical trial where participants (parents of a fetus or neonate diagnosed with a life-threatening congenital heart disease (CHD)) will randomly be assigned to either receiving a web-based decision aid (DA) alone, or receiving the decision aid that includes a values clarification exercise. Because of the novel use of decision aids in CHD in an acute setting, we will also compare participants receiving the DA in a randomized control trial to a prospective observational population of families faced with similar decisions without a DA (control group). We have designated the Brief Symptom Inventory Global Severity Index of Global Distress 3 months post-birth or death/termination as our primary outcome measure.

Conditions

Patient Decision Aids; Congenital Heart Disease; Congenital Heart Defect

Keywords

values clarification exercise; shared decision making; patient education; patient decision aids; congenital heart disease; congenital heart defect

Outcome Measures

Primary Outcomes (1)

• Change in the Brief Symptom Inventory (BSI) Global Severity Index of Global Distress

  The BSI is a validated scale of 53 questions that indicate the degree of stress the participant has experienced within the previous seven days. Answers range in a 5 point Likert scale from 0=not at all to 4=extremely. The scale measures stress, so a lower score is better. Scores are obtained for nine primary symptom dimensions and three global indices of distress. The primary comparison is the baseline measurement versus 3 months post-decision measurement. We are looking at how those measurements changed.

  1 week post baseline & 3 months post-decision

Secondary Outcomes (4)

• Decision Quality - Values

  1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision

• Decision Quality - Knowledge

  1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision

• Perinatal Grief

  1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision

• Brief Symptom Inventory (BSI) Global Severity Index of Global Distress

  1 week Post-Decision Aid, 1 month post-decision

Other Outcomes (13)

• Combined Outcome Measure for Risk Communication and Treatment Decision Making Effectiveness (COMRADE)

  1 week Post-Decision Aid, 1 month post-decision, & 3 months post-decision

• Preference for Shared Decision Making

  1 week from Baseline, 1 week post-Decision Aid, & 1 month post-decision

• Preparation for Decision Making

  1 week Post-Decision Aid

Study Arms (3)

Standard Care (Control)

NO INTERVENTION

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

Decision Aid

EXPERIMENTAL

Participants view the Decision Aid only

Other: Decision Aid

Decision Aid & Values Clarification Exercise

EXPERIMENTAL

Participants view both the Decision Aid and the Values Clarification Exercise

Other: Decision Aid; Other: Values Clarification Exercise

Interventions

Decision Aid OTHER

Participants will view a Decision Aid (delivered as an app) that provides them with information regarding congenital heart disease, as described in the literature. The DA is tailored to the specific diagnosis of the fetus/neonate, so that participants are only viewing information about their baby's specific CHD diagnosis (and not other types of CHD). This is shown using videos and diagrams to clearly explain the defect, what their treatment options are (surgical intervention, comfort care, or termination), and personal stories from other parents who have dealt with the same diagnosis before (including both positive and negative outcomes). The DA was developed according to the International Patient Decision Aid Standards (see http://ipdas.ohri.ca/) (IRS# 14-13332).

Decision Aid; Decision Aid & Values Clarification Exercise

Values Clarification Exercise OTHER

The Values Clarification Exercise is a process that aids patients in clarifying their values and goals to improve alignment of their preferences with their chosen treatment. It was developed according to the International Patient Decision Aid Standards. It includes ten values that were chosen based on feedback from the parent investigators and clinicians. The ten values are: 1) discomfort to the child, 2) time in the hospital, 3) risk that the child will have impairments, 4) need to provide home medical care, 5) chronic medical care/decisions, 6) financial issues, 7) life in adulthood, 8) impact on the family, 9) beliefs about doing everything medically possible, \& 10) life expectancy. Each value has a sliding scale where the user can compare 2 treatment options at a time. They are asked which described situation feels better for them and their family.

Decision Aid & Values Clarification Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parents whose fetus/neonate was diagnosed with a life-threatening CHD that meets eligibility criteria below without restriction based on gender, race, age, or socioeconomic status.
• We will request participation from both parents but will not disqualify families if only one parent participates.
• Eligibility Criteria: Parents whose fetus/neonate was diagnosed with a life-threatening CHD that are offered the choice between intervention and comfort care (and in some cases termination). This is limited to the following diagnoses: Truncus Arteriosus, Pulmonary Atresia with Intact Ventricular Septum, Complex Single Ventricle, Complex Single Ventricle with Heterotaxy, Hypoplastic Left Heart Syndrome (HLHS), and Ebstein's Anomaly of the Tricuspid Valve.

You may not qualify if:

• Patients with other types of CHD that are not listed above are not eligible.
• Participants must be 18 years of age or older

Sponsors & Collaborators

• University of Utah: lead
• American Heart Association: collaborator

Study Sites (2)

Primary Children's Hospital Fetal and Pediatric Cardiology Clinics or Cardiac or Neonatal Intensive Care Units

Salt Lake City, Utah, 84108, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (20)

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• Delaney RK, Pinto NM, Ozanne EM, Stark LA, Pershing ML, Thorpe A, Witteman HO, Thokala P, Lambert LM, Hansen LM, Greene TH, Fagerlin A. Study protocol for a randomised clinical trial of a decision aid and values clarification method for parents of a fetus or neonate diagnosed with a life-threatening congenital heart defect. BMJ Open. 2021 Dec 10;11(12):e055455. doi: 10.1136/bmjopen-2021-055455.

  PMID: 34893487 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Angela Fagerlin, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chair, Department of Population Health Sciences

Model Details: Parents randomized using simple randomization into two conditions: one group receives the patient decision aid, and one group receives the patient decision aid and the values clarification exercise. There is no stratified randomization. There are 4 survey time points: 1) Baseline, 2) Post-Viewing of the Decision Aid (or Decision Aid and Values Clarification Exercise), 3) Post-Decision, and 4) Three Months Post-Decision.

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 18, 2020
• Study Start: October 1, 2020
• Primary Completion: November 30, 2025
• Study Completion (Estimated): July 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)