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

Trial Summary

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 data supports the effectiveness of the HomeVENT decision support tool treatment for respiratory insufficiency in children?

Research shows that decision-support tools, like HomeVENT, can improve medical care quality and outcomes by helping doctors make consistent, evidence-based decisions. Similar tools have been found useful in neonatal care, improving communication and decision-making between doctors and parents. ^{1 2 3 4 5}

Is the HomeVENT Decision Support Tool generally safe for use in children?

The safety of home mechanical ventilation, which involves using devices like ventilators at home, can be affected by human errors in handling these devices. Understanding and addressing these errors is important to prevent harm and ensure patient safety. ^{6 7 8 9 10}

How is the HomeVENT treatment different from other treatments for respiratory insufficiency in children?

The HomeVENT treatment is unique because it uses a decision support tool to help families and clinicians make informed decisions about pediatric home ventilation, focusing on personalized care and improving decision-making processes rather than just medical intervention. ^{1 2 11 12 13}

What is the purpose of this trial?

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.

Research Team

Renee D Boss, MD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Home values and experiences navigation track (HomeVENT): Supporting decisions about pediatric home ventilation. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Mechanical Ventilation and Decision Support in Pediatric Intensive Care. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

PPADS: Physician-PArent Decision-Support for Neonatal Intensive Care. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The possible role of artificial intelligence in deciding postnatal steroid management in extremely premature ventilated infants. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Development and usability testing of a parent decision support tool for the neonatal intensive care unit. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Reporting of Adverse Events in Muscle Strengthening Interventions in Youth: A Systematic Review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Causes of adverse events in home mechanical ventilation: a nursing perspective. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Patient safety in South Africa: PICU adverse event registration*. [2014]

9. United States 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. [2021]

10. Ireland pubmed.ncbi.nlm.nih.gov

A human factors and survey methodology-based design of a web-based adverse event reporting system for families. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Parent perspectives on facilitating decision-making around pediatric home ventilation. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Family Experiences Deciding For and Against Pediatric Home Ventilation. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Heart OBServation app: development of a decision support tool for parents of infants with severe cardiac disease. [2023]