HomeVENT Decision Support Tool for Respiratory Insufficiency in Children

(HomeVENT Trial)

Recruiting at 3 trial locations

Overseen By Jennifer Shephard, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Non-English or Non-Spanish speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new decision-making support tool for families and doctors considering home ventilation (breathing assistance) for children. The goal is to determine if this tool helps families feel more prepared and improves collaborative decision-making between families and doctors. Participants will be divided into two groups: one will use the HomeVENT decision support tool with study staff, while the other will continue with usual care. Parents who speak English or Spanish and are deciding on home ventilation for their child within 30 days are suitable candidates for this trial. As an unphased trial, this study offers families an opportunity to contribute to research that could enhance decision-making for others in similar situations.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on decision-making support rather than medication changes.

What prior data suggests that the HomeVENT decision support tool is safe for use in decision-making about home ventilation for children?

Research has shown that the HomeVENT decision support tool aids families and doctors in making informed choices about home ventilation for children. Direct safety data on the tool itself is unavailable because it is not a medical treatment but an online guide for decision-making.

In past studies, families used similar tools without any reported safety issues. These tools simplify complex medical decisions, making them easier to understand and manage. As a digital tool, HomeVENT does not have physical side effects like a drug or device might.

Overall, families find the tool helpful and easy to use. While traditional safety data is lacking, experiences with similar tools suggest it is safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the HomeVENT decision support tool because it aims to revolutionize how families and clinicians manage respiratory insufficiency in children at home. Unlike traditional care, which often relies on in-person consultations and generalized guidelines, HomeVENT offers a personalized, web-based approach to decision-making. This tool allows for real-time adjustments and tailored guidance, potentially improving outcomes by empowering families with the information and support they need to make informed decisions from the comfort of their home.

What evidence suggests that the HomeVENT decision support tool is effective for improving decision-making in respiratory insufficiency in children?

Research has shown that the HomeVENT decision support tool, tested in this trial, aids families and doctors in making better choices about home ventilation for children. Available online, this tool helps families consider how their home life and values influence their decisions. Early results suggest that HomeVENT improves decision-making by providing a consistent and thorough support process. As a result, families feel more prepared and confident when making these important choices. Although the tool does not suggest a specific decision, it aims to clarify and support the process. Participants in this trial will either use the HomeVENT tool or receive usual care, allowing for a comparison of outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Renee D Boss, MD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for parents or primary caregivers over 18, who speak English or Spanish and are making decisions about home ventilation for their child. It's also for physicians involved in these decisions. Participants must be willing to follow the study procedures and be available throughout the study.

Inclusion Criteria

Provision of signed and dated informed consent form (parent) or completion of oral consent (physician)

I am the main caregiver deciding on home ventilation for a child within 30 days.

Physician of a child whose parents are enrolled in the study; physician must be engaged in the home ventilation decision

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Families in the intervention arm review a web-based decision-making tool and are interviewed about website topics

1 month

1 visit (in-person or virtual)

Usual Care

Families in the usual care arm receive standard care without intervention

1 month

1 visit (in-person or virtual)

Follow-up

Participants are monitored for preparedness and shared decision-making at 1, 6, and 12 months

12 months

3 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• HomeVENT decision support tool

Trial Overview The HomeVENT decision support tool is being tested to see if it helps families make better-informed choices regarding chronic home ventilation for a child. Families will either receive usual care or use the intervention with guidance, followed by interviews and surveys.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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 II: Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

A systematic review of 130 studies on muscle strengthening training (MST) in youth revealed that only 33.8% reported on adverse events (AEs), highlighting a significant gap in safety monitoring during these interventions.

Among the studies that did report AEs, 40.1% documented at least one adverse event, with over half of the reported events (59.1%) linked directly to the training or testing, indicating a need for better definitions and reporting practices in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of Adverse Events in Muscle Strengthening Interventions in Youth: A Systematic Review. Mack, DE., Anzovino, D., Sanderson, M., et al.[2023]

A study involving interviews with 38 families revealed that parents' decisions about pediatric home ventilation were influenced by their child's disease stage, with those in earlier stages viewing it as a hopeful option for improvement, while those in later stages saw it as less beneficial.

Most families found the decision-making process emotionally distressing but reported satisfaction with their final choice, highlighting the need for targeted counseling and support for families facing such decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Experiences Deciding For and Against Pediatric Home Ventilation. Boss, RD., Henderson, CM., Raisanen, JC., et al.[2021]

The Heart OBServation app, developed with input from parents of infants with congenital heart disease (CHD), showed good usability scores (82.3 at discharge and 81.7 after one month), indicating it is user-friendly and effective for its intended purpose.

Parents found the app helpful in understanding their child's normal condition and recognizing signs of deterioration, which can empower them to make informed decisions about when to seek medical help.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart OBServation app: development of a decision support tool for parents of infants with severe cardiac disease. Hjorth-Johansen, E., Børøsund, E., Moen, A., et al.[2023]

Decision-support tools, whether paper or electronic, can significantly enhance the quality of care for children requiring respiratory support in pediatric intensive care units by reducing errors and improving outcomes.

These tools help clinicians by standardizing procedures, performing calculations, and integrating complex patient data, leading to more consistent and evidence-based decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical Ventilation and Decision Support in Pediatric Intensive Care. Newth, CJL., Khemani, RG., Jouvet, PA., et al.[2018]

A new NICU-focused trigger tool was developed and tested, revealing a high incidence of adverse events in hospitalized children, with 554 unique adverse events identified across 749 charts, averaging 0.74 events per patient.

The study found that 56% of these adverse events were preventable, highlighting the need for improved safety measures, as only 8% were reported through traditional hospital reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-focused trigger tool to identify harm in North American NICUs. Sharek, PJ., Horbar, JD., Mason, W., et al.[2021]

The Family Reporting System (FRS) was developed to allow families of hospitalized children to report adverse events, addressing the limitations of standard clinician-initiated reporting systems that often miss many documented events.

The FRS demonstrated good face validity, excellent usability, and strong clinical utility, indicating it is an effective tool for enhancing patient safety by capturing valuable information from families about potential harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A human factors and survey methodology-based design of a web-based adverse event reporting system for families. Daniels, JP., King, AD., Cochrane, DD., et al.[2022]

The HomeVENT approach, which included a website, a Question Prompt List, and in-depth family interviews, was found to be feasible and acceptable for helping families and clinicians make informed decisions about pediatric home ventilation.

Families using HomeVENT were less likely to choose home ventilation compared to those receiving usual care, indicating that the intervention encouraged deeper consideration of how such decisions would impact their daily lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home values and experiences navigation track (HomeVENT): Supporting decisions about pediatric home ventilation. Boss, RD., Vo, HH., Jabre, NA., et al.[2023]

The Physician Parent Decision Support System (PPADS) is designed to enhance family-centered care in the NICU by providing clinical updates and outcome predictions, which may lead to earlier interventions and better resource allocation.

A usability study with 8 parents and 5 neonatologists indicated that both groups found the PPADS tool easy to use and beneficial for improving communication, suggesting its potential effectiveness in supporting decision-making for infant care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PPADS: Physician-PArent Decision-Support for Neonatal Intensive Care. Frize, M., Bariciak, E., Gilchrist, J.[2022]

The study highlights the variability among physicians in the use of postnatal steroids (PNS) for preterm infants, indicating a need for better decision-making tools.

A proposed model combines online clinical decision support tools, including a bronchopulmonary dysplasia estimator and an extubation success calculator, to assist physicians in making informed decisions about administering PNS to ventilated preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The possible role of artificial intelligence in deciding postnatal steroid management in extremely premature ventilated infants. Bottu, A., Manzar, S.[2023]

A study involving 38 parents, where 20 chose home ventilation for their child and 18 did not, highlighted the importance of clinician support in the decision-making process for pediatric home ventilation.

Key themes identified include the need for clinicians to show dedication to families, manage medical teams effectively, introduce home ventilation thoughtfully, facilitate meaningful discussions about options, and respect family decisions, all of which can enhance the quality of decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parent perspectives on facilitating decision-making around pediatric home ventilation. Jabre, NA., Raisanen, JC., Shipman, KJ., et al.[2022]

The PPADS tool is a computerized decision support system designed to help parents in the NICU make informed decisions about their infants' care, aiming to improve communication and satisfaction in decision-making processes.

Usability testing with parents of neonates who graduated from the NICU showed that the PPADS tool is both useful and easy to use, indicating its potential to enhance the decision-making experience in challenging situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and usability testing of a parent decision support tool for the neonatal intensive care unit. Weyand, SA., Frize, M., Bariciak, E., et al.[2020]

A systematic analysis of adverse events in home mechanical ventilation (HMV) identified key risk factors such as patient transportation, suction, and tracheostomy decannulation, which can jeopardize patient safety.

The study suggests implementing risk mitigation measures, including checklists and reminder functions for caregivers, to enhance safety and prevent errors associated with HMV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Causes of adverse events in home mechanical ventilation: a nursing perspective. Lipprandt, M., Liedtke, W., Langanke, M., et al.[2022]

In a South African pediatric intensive care unit (PICU), a retrospective audit identified a high rate of adverse events (50.8 per 100 patient days) among 80 patients, with catheter complications and hypoglycemia being the most common issues.

The study found that real-time registration during ward rounds reported a lower rate of adverse events (27.2 per 100 patient days) among 236 patients, highlighting that different registration methods can yield varying insights into patient safety and types of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient safety in South Africa: PICU adverse event registration*. Vermeulen, JM., van Dijk, M., van der Starre, C., et al.[2014]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10294038/

Home values and experiences navigation track (HomeVENT) The overarching goal of HomeVENT is to offer consistent and comprehensive decision supports for families and clinicians facing a choice about pediatric home ...

2. withpower.com withpower.com/trial/phase-respiratory-insufficiency-10-2023-c13ca

HomeVENT Decision Support Tool for Respiratory ... This is a multicenter study to test a decision-making support process for families and clinicians facing decisions about chronic home ventilation for a ...

3. reporter.nih.gov reporter.nih.gov/project-details/11174305

Project Details HomeVENT includes a novel, web-based tool to help families deliberate how their home life context and values affects decisions for or against home ventilation ...

4. researchgate.net researchgate.net/publication/353471060_Life_with_pediatric_home_ventilation_Expectations_versus_experience

Life with pediatric home ventilation: Expectations versus ... Objective: To pilot feasibility and acceptability of HomeVENT, a systematic approach to family-clinician decision-making about pediatric home ventilation.

5. researchgate.net researchgate.net/publication/350741104_Shared_Decision_Making_for_Children_With_Chronic_Respiratory_Failure-It_Takes_a_Village_And_a_Process

Shared Decision Making for Children With Chronic ... While the goal of HomeVENT is not to favor any one decision about home ventilation, but instead to improve the quality of the decision-making process, important ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S277262822500041X

Development and acceptability testing of a tracheostomy ... Parents found a video educating parents on the tracheostomy decision-making process acceptable and potentially helpful.