Multicenter HomeVENT: Home Values and Experiences Navigation Track

NCT ID: NCT06102330

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-06
• Study Completion Date: 2030-12-31

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.

Detailed Description

Across 4 centers, the investigators will recruit 150 English and/ or Spanish-speaking families (up to 2 parents per family) who are currently facing a decision about tracheostomy and home ventilation for the child. The investigators will also recruit up to 2 clinicians who are central to the decision for each child.

The first 50% of families will be assigned to "usual care" arm and the second 50% of families will be assigned to the "intervention" arm. Intervention families will view the study website with study staff and will answer questions related to website content in an interview that could last up to 2 hours. All families will be interviewed at 1, 6 and 12 months after enrollment (each interview lasts 15-30 minutes). Each family will designate 1-2 physician involved in the decision about home ventilation; each physician will be interviewed at 1 month interviews last ~15 minutes).

This is a controlled trial of a communication intervention and requires careful attention to words used. The investigators support the intention of being inclusive, and have invested considerable effort in creating a Spanish intervention and diversifying the team to include more native Spanish-speakers. However, as a communication randomized control trial (RCT), the investigators are concerned that one-off efforts to translate the website as well as using a translator, may confound the investigators interpretation of the data. Most significantly, the investigators risk not finding differences between the two arms if the investigators include those who do not speak English or Spanish.

Primary endpoints:

The investigators hypothesize that, compared to families who receive usual care related to decision-making about pediatric chronic home ventilation, families who receive the HomeVENT intervention will have increased preparedness for decision-making 1 month later.

The investigators hypothesize that, compared to families who receive usual care related to decision-making about pediatric chronic home ventilation, families who receive the HomeVENT intervention will perceive increased shared decision-making 1 month later.

The investigators hypothesize that, compared to physicians of families who receive usual care related to decision-making about pediatric chronic home ventilation, physicians of families who receive the HomeVENT intervention will perceive increased shared decision-making 1 month later.

Conditions

Pediatric ALL; Respiratory Insufficiency; Communication

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Usual Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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

Group Type: EXPERIMENTAL

HomeVENT decision support tool

Intervention Type: OTHER

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

Interventions

HomeVENT decision support tool

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Renee Boss, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Johns Hopkins All Childrens Hospital

Tampa, Florida, United States

Site Status: RECRUITING

Children's Hospital New Orleans

New Orleans, Louisiana, United States

Site Status: RECRUITING

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Site Status: RECRUITING

Seattle Childrens Hospital

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Renee D Boss, MD

Role: CONTACT

rboss1@jhu.edu

4106146444

Jennifer Shephard, RN

Role: CONTACT

jshepar1@jhmi.edu

410-955-5232

Facility Contacts

Nicholas Jabre, MD

Role: primary

njabre1@jhmi.edu

717-215-6522

Haley Sivilich

Role: backup

hsivili1@jhmi.edu

Carrie Henderson, MD

Role: primary

chend7@lsuhsc.edu

504-899-9511

Emily Moran

Role: backup

Emily.moran@lcmchealth.org

5048975377

Renee D Boss, MD

Role: primary

rboss1@jhu.edu

410-614-6444

Jennifer Shepard, RN

Role: backup

jshepar1@jhmi.edu

4109555232

Benjamin Wilfond, MD

Role: primary

benjamin.wilfond@seattlechildrens.org

206-884-8355

Abril Beretta

Role: backup

abril.beretta@seattlechildrens.org

Other Identifiers

1R01HD110414-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00395948

Identifier Type: -

Identifier Source: org_study_id