RecruitingNot Applicable

Multicenter HomeVENT: Home Values and Experiences Navigation Track

United States600 participantsStarted 2024-02-06

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).
. 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

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Preparedness for Decision Making among parents making decisions about home ventilation as assessed by the Preparedness for Decision Making scale.

Timeframe: 1 month

Shared Decision Making among parents making decisions about home ventilation as assessed by the CollaboRATE-Parent version scale

Timeframe: 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

Timeframe: 1 month

Shared decision making about home ventilation for physicians as assessed by the Shared Decision Making Questionnaire - Physician (SDM-Q-DOC) version

Timeframe: 1 month

Trial details

NCT IDNCT06102330

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12

Contact for this trial

Renee D Boss, MD

4106146444 rboss1@jhu.edu

View on ClinicalTrials.gov More Pediatric ALL trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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).
. 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

Exclusion criteria

What they're measuring

Preparedness for Decision Making among parents making decisions about home ventilation as assessed by the Preparedness for Decision Making scale.

Timeframe: 1 month

Shared Decision Making among parents making decisions about home ventilation as assessed by the CollaboRATE-Parent version scale

Timeframe: 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

Timeframe: 1 month

Shared decision making about home ventilation for physicians as assessed by the Shared Decision Making Questionnaire - Physician (SDM-Q-DOC) version

Timeframe: 1 month