RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-10-01
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04437069

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * We will request participation from both parents but will not disqualify families if only one parent participates.
  3. * 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.
  1. * Patients with other types of CHD that are not listed above are not eligible.
  2. * Participants must be 18 years of age or older

Contacts and Locations

Study Contact

Kirstin Beck, BS
CONTACT
801-213-6543
kirstin.tanner@hsc.utah.edu

Principal Investigator

Angela Fagerlin, PhD
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

Primary Children's Hospital Fetal and Pediatric Cardiology Clinics or Cardiac or Neonatal Intensive Care Units
Salt Lake City, Utah, 84108
United States
University of Utah
Salt Lake City, Utah, 84108
United States

Collaborators and Investigators

Sponsor: University of Utah

  • Angela Fagerlin, PhD, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-01
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2020-10-01
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Patient Decision Aids
  • Congenital Heart Disease
  • Congenital Heart Defect