Multicenter HomeVENT: Home Values and Experiences Navigation Track

NCT06102330 | Recruiting

• 2 other identifiers: IRB003959481R01HD110414-01A1
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 4

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

Keywords

chronic ventilation; decision-making

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Change in decision making regret among parents who chose for or against home ventilation as assessed by the Decision Regret Scale

  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

  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

Study Arms (2)

Usual Care

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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

Interventions

HomeVENT decision support tool OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English- or Spanish-speaking
• Males and females; Age 18 and over.
• 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.
• Provision of signed and dated informed consent form (parent) or completion of oral consent (physician)
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Access to necessary resources if choose to participate via internet or telephone

You may not qualify if:

• Excluding children as they cannot be legal decision-makers
• Non-English or Non-Spanish speaking parents, as the intervention website/ videos are only available in those two languages.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (4)

Johns Hopkins All Childrens Hospital

Tampa, Florida, 33701, United States

RECRUITING

Children's Hospital New Orleans

New Orleans, Louisiana, 70118, United States

RECRUITING

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

Seattle Childrens Hospital

Seattle, Washington, 98145, United States

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Respiratory Insufficiency; Communication

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Respiration Disorders; Respiratory Tract Diseases; Behavior

Study Officials

• Renee Boss, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renee D Boss, MD

CONTACT

4106146444; rboss1@jhu.edu

Jennifer Shephard, RN

CONTACT

410-955-5232; jshepar1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The first half of families at each site will be enrolled in the 'usual care' arm, the second half enrolled in the 'intervention' arm

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 26, 2023
• Study Start: February 6, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)