Pediatric ALLHomeVENTNCT06102330
Multicenter HomeVENT: Home Values and Experiences Navigation Track
A study testing HomeVENT decision support tool in people with Pediatric ALL and Respiratory Insufficiency, run by Johns Hopkins University at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric ALL, Respiratory Insufficiency, Communication
- What is being tested?
- HomeVENT decision support tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 4 sitesUnited States
- Study dates
- 6 Feb 2024to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
Renee D Boss, MD, 410-614-6444, rboss1@jhu.edu
Fiona Jardine, RN, 4109555232, fjardin1@jhu.edu
- Recruiting
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Carrie Henderson, MD, 504-899-9511, chend7@lsuhsc.edu
Emily Moran, 5048975377, Emily.moran@lcmchealth.org
- Recruiting
Seattle Childrens Hospital
Seattle, Washington, 98145
Holly Vo, MD, 206-884-8355, Holly.vo@seattlechildrens.org
Devan Duenas, devan.duenas@seattlechildrens.org
- Recruiting
Johns Hopkins All Childrens Hospital
Tampa, Florida, 33701
Nicholas Jabre, MD, 717-215-6522, njabre1@jhmi.edu
Haley Sivilich, hsivili1@jhmi.edu
About this study
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.
Read the 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
- Being tested
- HomeVENT decision support tool
- Keywords
- chronic ventilation, decision-making
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Respiratory Insufficiency, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HomeVENT decision support toolOther
Web-based decision support tool that describes diverse family experiences with making decisions about pediatric chronic home ventilation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: HomeVENT decision support tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
The Decision Regret Scale is a 5 item scale. Score range 1-25, with higher score meaning more regret.
Measured: 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.
Measured: 6 months, 12 months
Change in Impact of decision about home on daily life of child/ family as assessed by a qualitative interview
Measured: 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start6 Feb 2024
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ALLStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The first half of families at each site will be enrolled in the 'usual care' arm, the second half enrolled in the 'intervention' arm
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Renee Boss, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102330
- Sponsor's protocol ID
- IRB00395948
- Other IDs
- 1R01HD110414-01A1
- Acronym
- HomeVENT
- Status last verified
- Jul 2026
- First submitted
- 19 Oct 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregate data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter HomeVENT: Home Values and Experiences Navigation Track
- ClinicalTrials.gov ID
- NCT06102330
- Acronym / sponsor ID
- HomeVENT / IRB00395948
- Conditions
- Pediatric ALL, Respiratory Insufficiency, Communication
- Keywords
- chronic ventilation, decision-making
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first half of families at each site will be enrolled in the 'usual care' arm, the second half enrolled in the 'intervention' arm
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: HomeVENT decision support toolWill 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HomeVENT decision support toolWeb-based decision support tool that describes diverse family experiences with making decisions about pediatric chronic home ventilation | Other | Intervention |
Primary outcome
Preparedness for Decision Making among parents making decisions about home ventilation as assessed by the Preparedness for Decision Making scale.
Time frame: 1 month
The Preparedness for Decision Making scale has a possible score range of 0-100. Higher score means more prepared.
Shared Decision Making among parents making decisions about home ventilation as assessed by the CollaboRATE-Parent version scale
Time frame: 1 month
The CollaboRATE-Parent version scale is a 3 item measure. Score range 0-27. Higher score means better shared decision making.
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
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.
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
The Shared Decision Making Questionnaire - Physician questionnaire is a 9 item measure. Score range 0-54. Higher score meaning better shared decision making.
3 secondary outcomes
Change in decision making regret among parents who chose for or against home ventilation as assessed by the Decision Regret Scale
Time frame: 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
Time frame: 6 months, 12 months
Change in Impact of decision about home on daily life of child/ family as assessed by a qualitative interview
Time frame: 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No. Only aggregate data will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Renee Boss, MD principal investigator
Johns Hopkins School of Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HomeVENT decision support tool in people with Pediatric ALL and Respiratory Insufficiency, run by Johns Hopkins University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renee D Boss, MD (4106146444, rboss1@jhu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.