Multicenter HomeVENT: Home Values and Experiences Navigation Track (HomeVENT)

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Insufficiency; Communication; Pediatric ALL
• Intervention / Treatment: Other: HomeVENT decision support tool

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.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renee D Boss, MD; Phone Number: 4106146444; Email: rboss1@jhu.edu
• Study Contact Backup: Name: Jennifer Shephard, RN; Phone Number: 410-955-5232; Email: jshepar1@jhmi.edu

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33701
      • Recruiting
      • Johns Hopkins All Childrens Hospital
      • Contact: Nicholas Jabre, MD; Phone Number: 717-215-6522; Email: njabre1@jhmi.edu
      • Contact: Haley Sivilich; Email: hsivili1@jhmi.edu
      • Sub-Investigator: Joana Machry
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Recruiting
      • Children's Hospital New Orleans
      • Contact: Carrie Henderson, MD; Phone Number: 504-899-9511; Email: chend7@lsuhsc.edu
      • Contact: Emily Moran; Phone Number: 5048975377; Email: Emily.moran@lcmchealth.org
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University School of Medicine
      • Contact: Renee D Boss, MD; Phone Number: 410-614-6444; Email: rboss1@jhu.edu
      • Contact: Jennifer Shepard, RN; Phone Number: 4109555232; Email: jshepar1@jhmi.edu
      • Sub-Investigator: Emily Boss, MD
  • Washington
    • Seattle, Washington, United States, 98145
      • Recruiting
      • Seattle Childrens Hospital
      • Contact: Benjamin Wilfond, MD; Phone Number: 206-884-8355; Email: benjamin.wilfond@seattlechildrens.org
      • Contact: Abril Beretta; Email: abril.beretta@seattlechildrens.org
      • Sub-Investigator: Holly Vo, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Other: HomeVENT decision support tool; Web-based decision support tool that describes diverse family experiences with making decisions about pediatric chronic home ventilation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preparedness for Decision Making among parents making decisions about home ventilation as assessed by the Preparedness for Decision Making scale.	The Preparedness for Decision Making scale has a possible score range of 0-100. Higher score means more prepared.	1 month
Shared Decision Making among parents making decisions about home ventilation as assessed by the CollaboRATE-Parent version scale	The CollaboRATE-Parent version scale is a 3 item measure. Score range 0-27. Higher score means better shared decision making.	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	The Consumer Assessment of Healthcare Providers and Systems scale is an 8 item measure. Score range 0-23. Higher score means better shared decision making.	1 month
Shared decision making about home ventilation for physicians as assessed by the Shared Decision Making Questionnaire - Physician (SDM-Q-DOC) version	The Shared Decision Making Questionnaire - Physician questionnaire is a 9 item measure. Score range 0-54. Higher score meaning better shared decision making.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in decision making regret among parents who chose for or against home ventilation as assessed by the Decision Regret Scale	The Decision Regret Scale is a 5 item scale. Score range 1-25, with higher score meaning more regret.	6 months, 12 months
Change in Quality of Life expected vs. actual, among parents who faced choice about home ventilation as assessed by the Pediatric Quality of Life Family Impact Module (PEDSQL) scale	The Pediatric Quality of Life Family Impact Module (PEDSQL) Score range 0-100. Higher score better quality of life.	6 months, 12 months
Change in Impact of decision about home on daily life of child/ family as assessed by a qualitative interview		6 months, 12 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Renee Boss, MD, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 26, 2023

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: decision-making; chronic ventilation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: IRB00395948; 1R01HD110414-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only aggregate data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No