Decision-making support for families considering home ventilation for children
Multicenter HomeVENT: Home Values and Experiences Navigation Track
This study is testing a new website to help families and doctors make better decisions about home ventilation for children with chronic breathing issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 4 sites (Tampa, Florida and 3 other locations) |
| Trial ID | NCT06102330 on ClinicalTrials.gov |
What this trial studies
This multicenter study aims to evaluate a decision-making support process for families and clinicians involved in chronic home ventilation decisions for pediatric patients. Families will be randomly assigned to either a usual care group or an intervention group that utilizes a dedicated website to facilitate discussions and decision-making. The study will involve interviews and surveys conducted at 1, 6, and 12 months post-enrollment to assess family preparedness and shared decision-making outcomes. The intervention is designed to enhance communication between families and healthcare providers, particularly focusing on Spanish-speaking participants.
Who should consider this trial
Good fit: Ideal candidates include English or Spanish-speaking parents of children who are facing a decision about home ventilation within the next 30 days.
Not a fit: Patients who do not speak English or Spanish, or those who are not parents or primary caregivers of a child facing these decisions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the decision-making experience for families facing complex choices about home ventilation for their children.
How similar studies have performed: Previous studies have shown promise in using decision support tools for similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. English- or Spanish-speaking 2. Males and females; Age 18 and over. 3. Parent of a child facing a decision about home ventilation within 30 days. A "parent" will be defined as any self-identified primary caregiver (parents, grandparents, etc). or Physician of a child whose parents are enrolled in the study; physician must be engaged in the home ventilation decision. 4. Provision of signed and dated informed consent form (parent) or completion of oral consent (physician) 5. Stated willingness to comply with all study procedures and availability for the duration of the study 6. Access to necessary resources if choose to participate via internet or telephone Exclusion Criteria: 1. Excluding children as they cannot be legal decision-makers 2. Non-English or Non-Spanish speaking parents, as the intervention website/ videos are only available in those two languages.
Where this trial is running
Tampa, Florida and 3 other locations
- Johns Hopkins All Childrens Hospital — Tampa, Florida, United States (Recruiting)
- Children's Hospital New Orleans — New Orleans, Louisiana, United States (Recruiting)
- Johns Hopkins University School of Medicine — Baltimore, Maryland, United States (Recruiting)
- Seattle Childrens Hospital — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Renee Boss, MD — Johns Hopkins School of Medicine
- Study coordinator: Renee D Boss, MD
- Email: rboss1@jhu.edu
- Phone: 4106146444
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.