Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT06102330

Conditions

Pediatric ALL

Respiratory Insufficiency

Communication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

HomeVENT decision support tool

Study Details

Brief summary:

This is a multicenter study to test a decision-making support process for families and clinicians facing decisions about chronic home ventilation for a child. The investigators hypothesize that the intervention will increase family preparedness for decision-making and will improve clinician-family shared-decision making. Half of families will be assigned to "usual care" arm and half to the "intervention" arm. Intervention families will view the study website with study staff and will answer questions related to website content. All families will be interviewed and surveyed at 1, 6 and 12 months after enrollment. Each family will designate 1-2 physician involved in the decision about home ventilation; each physician will be interviewed and surveyed at 1 month.

Conditions

Pediatric ALL

Respiratory Insufficiency

Communication

Study ID

NCT06102330

Start date

Feb 6, 2024

Status verified date

Jul, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

no intervention: Usual Care

No alteration in care. Will interview families and clinicians at 1 month, and families again at 6 and 12 months

experimental: Intervention

Will review a web-based decision-making tool with families and simultaneously interview family regarding website topics. Will interview families and clinicians at 1 month, and families again at 6 and 12 months

Interventions

HomeVENT decision support tool

Web-based decision support tool that describes diverse family experiences with making decisions about pediatric chronic home ventilation

Primary outcome measure

  • Preparedness for Decision Making among parents making decisions about home ventilation as assessed by the Preparedness for Decision Making scale. [ Time Frame: 1 month ]
  • Shared Decision Making among parents making decisions about home ventilation as assessed by the CollaboRATE-Parent version scale [ Time Frame: 1 month ]
  • Shared Decision Making among parents making decisions about home ventilation as assessed by the Consumer Assessment of Healthcare Providers and Systems (CAHPS-SDM) survey [ Time Frame: 1 month ]
  • Shared decision making about home ventilation for physicians as assessed by the Shared Decision Making Questionnaire - Physician (SDM-Q-DOC) version [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Renee D Boss, MD

4106146444rboss1@jhu.edu

Fiona Jardine, RN

410-955-5232fjardin1@jhu.edu

Locations

Johns Hopkins All Childrens Hospital

Recruiting

Tampa, Florida, United States, 33701

Contacts

Nicholas Jabre, MD

717-215-6522njabre1@jhmi.edu

Haley Sivilich

hsivili1@jhmi.edu

Children's Hospital New Orleans

Recruiting

New Orleans, Louisiana, United States, 70118

Contacts

Carrie Henderson, MD

504-899-9511chend7@lsuhsc.edu

Emily Moran

5048975377Emily.moran@lcmchealth.org

Johns Hopkins University School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Renee D Boss, MD

410-614-6444rboss1@jhu.edu

Fiona Jardine, RN

4109555232fjardin1@jhu.edu

Seattle Childrens Hospital

Recruiting

Seattle, Washington, United States, 98145

Contacts

Holly Vo, MD

206-884-8355Holly.vo@seattlechildrens.org

Devan Duenas

devan.duenas@seattlechildrens.org

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • chronic ventilation
  • decision-making

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-16.