CDS + HHFNC Weaning for Bronchiolitis

(REST EEC Trial)

Overseen By India Loar

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Immunocompromised, Immunosuppressed, Chronic lung disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 30 days

198 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve bronchiolitis treatment, a common lung infection in young children. It tests whether clinical decision support (CDS), which provides doctors with reminders to adjust treatment, can standardize and enhance the process of reducing heated high flow nasal cannula (HHFNC) therapy. The goal is to determine if this approach speeds up recovery and improves care. Children under two years old with bronchiolitis and notable breathing difficulties may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance future patient treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for pediatric patients with bronchiolitis?

Research has shown that Clinical Decision Support (CDS) tools are safe and effective. These tools help standardize care and improve outcomes, particularly in treating bronchiolitis. For example, one study found that using CDS enabled infants with bronchiolitis to leave intensive care more quickly.

Regarding High-Flow Nasal Cannula (HFNC) therapy, studies indicate it is generally well-tolerated. For infants with bronchiolitis, HFNC can improve oxygen levels more effectively than some other oxygen treatments. However, risks include difficulty protecting the airway and the possibility of inhaling food or liquid.

Overall, evidence supports the safe use of both CDS and HFNC, but like all treatments, they carry some risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to wean infants off high-flow nasal cannula (HHFNC) support in bronchiolitis cases. Unlike standard care, which might not include systematic guidance, the trial introduces Clinical Decision Support (CDS) as a significant feature. This system provides electronic reminders to healthcare teams, potentially leading to more efficient and timely weaning. By integrating technology with traditional weaning practices, the trial aims to optimize patient outcomes and enhance the current weaning process.

What evidence suggests that this trial's treatments could be effective for bronchiolitis?

Research has shown that many doctors prefer using heated high flow nasal cannula (HHFNC) therapy to treat bronchiolitis, often finding it as effective or even superior to other methods like CPAP, another type of breathing support. In this trial, one group will receive HHFNC therapy with Clinical Decision Support (CDS) systems. Studies suggest that CDS can help doctors adhere more closely to treatment guidelines, potentially leading to better patient outcomes. Another group will receive HHFNC therapy without CDS support. Historically, many treatments for bronchiolitis have not been very effective. Despite this, researchers are carefully studying the combination of CDS and HHFNC for its potential to improve care for children with bronchiolitis. Early results suggest that this approach might enhance consistency in care and improve recovery times. ^{4 6 7 8 9}

Who Is on the Research Team?

Christopher Horvat, MD

Principal Investigator

UPMC Children's Hospital of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for children under 2 years old with bronchiolitis and a work of breathing (WOB) score greater than 2. It's not suitable for kids with congenital heart disease affecting their breathing, those who have weakened immune systems, or chronic lung conditions.

Inclusion Criteria

My child is under 2 years old with a severe breathing difficulty score over 2.

Exclusion Criteria

I have a long-term lung condition.

I was born with a heart condition that affects my breathing and heart function.

My immune system is weak.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive heated high flow nasal cannula (HHFNC) with or without clinical decision support (CDS) for bronchiolitis

Up to 30 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including PICU and hospital length of stay, mortality, and respiratory support free days

Up to 90 days

What Are the Treatments Tested in This Trial?

Interventions

• Clinical Decision Support (CDS)
• HHFNC Weaning

Trial Overview The study tests if using Clinical Decision Support (CDS) can help doctors better follow guidelines when starting and adjusting heated high flow nasal cannula (HHFNC) therapy in young patients with bronchiolitis to improve recovery outcomes.

How Is the Trial Designed?

Group I: HHFNC + Clinical decision Support Experimental Treatment 2 Interventions

Standardized HHFNC weaning coupled with clinical decision support consisting of electronic record embedded reminders to the clinical team to wean HHFNC

Group II: HHFNC Weaning Active Control 2 Interventions

Team does not receive clinical decision support reminders to wean the HHFNC

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Christopher Horvat

Lead Sponsor

Trials

1

Recruited

200+

Beckwith Foundation

Collaborator

Trials

2

Recruited

210+

Published Research Related to This Trial

In a study of 506 clinical decision support (CDS) alerts over 14 months, 78% of prescribers modified their orders in response to alerts designed to prevent high-risk medication prescriptions, indicating a high overall action rate.

The study revealed that relying solely on override rates does not accurately reflect the effectiveness of CDS alerts, highlighting the importance of ongoing evaluation and improvement of these alerts to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an electronic health record alert on inappropriate prescribing of high-risk medications to patients with concurrent "do not give" orders. Smith, K., Durant, KM., Zimmerman, C.[2022]

The review highlights the need for better evaluation methods for clinical decision support (CDS) alerts, as current practices often overlook the appropriateness of alert overrides, which can negatively impact patient safety.

The proposed interactive dashboard for monitoring CDS alerts aims to streamline evaluations by providing comprehensive views of alert histories, potentially reducing alert fatigue and enhancing the effectiveness of CDS systems in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical decision support alert appropriateness: a review and proposal for improvement. McCoy, AB., Thomas, EJ., Krousel-Wood, M., et al.[2022]

A study identified nine cases of clinical decision support (CDS) malfunctions related to medication routes, highlighting that including non-systemically available routes (like eye drops and topical preparations) in value sets can lead to false alerts.

These value set errors are common across various healthcare organizations and can negatively impact the accuracy of CDS interventions, suggesting a need for improved knowledge management tools to audit and create appropriate value sets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical decision support malfunctions related to medication routes: a case series. Wright, A., Nelson, S., Rubins, D., et al.[2023]

A study of 1690 children with bronchiolitis showed that starting high-flow nasal cannula (HFNC) therapy at higher flow rates (2 L/kg/min) and providing clear weaning guidance reduced the duration of HFNC use without affecting overall hospital length of stay (LOS) or the need for escalated care.

The implementation of a standardized clinical pathway for HFNC management led to more efficient use of the therapy, suggesting that structured protocols can improve treatment outcomes in pediatric bronchiolitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is implementation of a hospital pathway for high-flow nasal cannula initiation and weaning associated with reduced high-flow duration in bronchiolitis? Tarantino, L., Goodrich, N., Kerns, E., et al.[2023]

A review of 12 studies on clinical decision support (CDS) systems for chronic obstructive pulmonary disease (COPD) revealed mixed effectiveness and low-to-medium adoption rates in hospital settings, indicating that while these systems are being developed, their impact is not yet fully realized.

There is a significant gap in understanding the barriers and facilitators to implementing CDS systems for COPD, with only one study reporting facilitators and none addressing barriers, highlighting the need for more comprehensive evaluations and strategies to enhance their use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical decision support systems for chronic obstructive pulmonary disease (COPD) in hospitals: A systematic review. Bamgboje-Ayodele, A., Borg, DN., McPhail, SM., et al.[2023]

A clinical decision support system (CDSS) was developed to assist clinicians in managing post-cardiac surgery patients by modeling decision-making strategies based on key cardiovascular parameters like blood pressure and cardiac output.

The CDSS successfully replicated expert anesthetists' therapeutic interventions in simulated patient scenarios, effectively controlling hemodynamic parameters to target values, demonstrating its potential efficacy in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A hybrid hierarchical decision support system for cardiac surgical intensive care patients. Part I: Physiological modelling and decision support system design. Denaï, MA., Mahfouf, M., Ross, JJ.[2015]

A cluster randomized clinical trial involving 33 primary care practices and over 100,000 patient visits found that an integrated clinical prediction rule (iCPR) tool did not significantly reduce antibiotic prescribing rates for acute respiratory infections, with 35% of intervention visits and 36% of control visits resulting in prescriptions.

The study highlights the challenges of implementing clinical decision support tools in diverse primary care settings, as the iCPR tool was used in only 6.9% of eligible visits and did not lead to changes in the rates of related diagnostic tests either.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Clinical Decision Support on Antibiotic Prescribing for Acute Respiratory Infections: a Cluster Randomized Implementation Trial. Mann, D., Hess, R., McGinn, T., et al.[2021]

A clinical decision support (CDS) system was developed to provide personalized pain management recommendations for dentists, aiming to reduce opioid prescriptions after dental extractions, and was implemented in a study involving patients from February 2020 to May 2021.

The CDS tool, which integrates with electronic health records and utilizes patient-specific data, showed variable provider engagement, with up to 87.4% of providers using it during extraction encounters, indicating its potential for improving pain management practices in dental settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Decision Support to Reduce Opioid Prescriptions for Dental Extractions using SMART on FHIR: Implementation Report. Rindal, DB., Pasumarthi, DP., Thirumalai, V., et al.[2023]

The use of Human-Centred Design (HCD) methods in developing a Clinical Decision Support System (CDSS) for pulmonary embolism significantly improved usability and functionality, ensuring that the system aligns with natural cognitive workflows of clinicians.

Iterative evaluations and usability testing revealed critical design adjustments, such as reordering information and clarifying interface elements, which enhanced the overall effectiveness of the CDSS in supporting clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human-centred design processes for clinical decision support: A pulmonary embolism case study. Babione, JN., Ocampo, W., Haubrich, S., et al.[2021]

A Clinical Decision Support (CDS) system using SNOMED CT terminology helps physicians quickly access important allergy and drug interaction information during prescriptions, improving treatment safety.

The CDS allows customization of alert preferences for physicians, reducing the risk of alert fatigue while providing clinically relevant information for better decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a SNOMED CT based national medication decision support system. Greibe, K.[2013]

In a study involving 6 infants with bronchiolitis, using a nebulizer integrated into high-flow nasal cannula (HFNC) therapy resulted in significantly higher comfort and satisfaction scores compared to a standard jet nebulizer.

The findings suggest that while the integrated nebulizer improves patient experience, further research is needed to assess its impact on the clinical outcomes of bronchiolitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incorporating a Nebulizer System Into High-Flow Nasal Cannula Improves Comfort in Infants With Bronchiolitis. Valencia-Ramos, J., Mirás, A., Cilla, A., et al.[2018]

In a study of 268 infants with moderate bronchiolitis, high-flow nasal cannula (HFNC) therapy did not significantly reduce the rate of treatment failure requiring escalation of care compared to standard oxygen therapy, with failure rates of 14% and 20% respectively.

Although HFNC showed some short-term benefits in respiratory status, it did not decrease the need for admission to the pediatric intensive care unit (PICU), and there were reports of three pneumothoraces in the HFNC group, indicating potential safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised trial of high-flow nasal cannula in infants with moderate bronchiolitis. Durand, P., Guiddir, T., Kyheng, C., et al.[2022]

In a study of a commercial electronic prescribing system at a UK pediatric hospital, 16,182 conflict alerts were generated over one year, with 89% of visible alerts being overridden by prescribers, indicating potential issues with alert specificity.

Drug-allergy conflict alerts were the most frequently accepted by users, while alerts for exact drug duplication were the least accepted, suggesting that the current alert algorithms may need improvement to enhance their effectiveness and reduce override rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of clinical decision support alert overrides in an electronic prescribing system at a tertiary care paediatric hospital. Jani, YH., Barber, N., Wong, IC.[2022]

In a study of 61 infants with bronchiolitis, high-flow nasal cannula (HFNC) treatment was found to be safe and significantly reduced the likelihood of needing pediatric intensive care unit (PICU) admission compared to standard low-flow oxygen treatment, with a fourfold decrease in risk.

HFNC responders showed a decrease in heart rate and respiratory rate within the first hour of treatment, allowing for early identification of non-responders who may require more intensive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-flow nasal cannula oxygen therapy for infants with bronchiolitis: pilot study. Mayfield, S., Bogossian, F., O'Malley, L., et al.[2022]

The implementation of a respiratory therapist (RT)-driven management protocol for high-flow nasal cannula (HFNC) therapy in pediatric patients with bronchiolitis significantly reduced the average duration of HFNC from 2.5 days to 1.8 days, indicating improved efficiency in treatment.

The protocol also led to a decrease in pediatric ICU length of stay from 2.6 days to 2.1 days and hospital length of stay from 5.7 days to 4.7 days, while maintaining safety as there were no significant changes in noninvasive ventilation use or intubation rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a High-Flow Nasal Cannula Management Protocol in the Pediatric ICU. Peterson, RJ., Hassumani, DO., Hole, AJ., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7059285/

A nationwide survey on the use of heated humidified high ... HHFNC was reported by nearly two-thirds (68%) of the practitioners who used it on the wards to be as effective or superior to CPAP (Continuous Positive Airway ...

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08327-y

A randomized, embedded, pragmatic, Bayesian clinical trial ... A randomized, embedded, pragmatic, Bayesian clinical trial examining clinical decision support for high flow nasal cannula management in children with ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1714855

A Randomized Trial of High-Flow Oxygen Therapy in ... Numerous studies have investigated the role of medical therapies in infants with bronchiolitis; none of these interventions have shown efficacy.

4. withpower.com withpower.com/trial/phase-bronchiolitis-5-2023-a8195

CDS + HHFNC Weaning for Bronchiolitis (REST EEC Trial) Trial Overview The study tests if using Clinical Decision Support (CDS) can help doctors better follow guidelines when starting and adjusting heated high flow ...

5. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD009609.pub3/abstract

High‐flow nasal cannula therapy for infants with bronchiolitis Outcome measures included the need for invasive respiratory support and time until discharge, clinical severity measures, oxygen saturation ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10965756/

Clinical Decision Support Principles for Quality ... If a QI team develops an order set aligned with bronchiolitis evidence-based practice, CDS use–implementation measures, such as order set use, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10191735/

Improving Pediatric Intensive Care Unit Discharge Timeliness ... Improving pediatric intensive care unit discharge timeliness of infants with bronchiolitis using clinical decision support.

8. publications.aap.org publications.aap.org/pediatrics/article/doi/10.1542/peds.2024-068136/204537/Improving-Management-of-Bronchiolitis-Across-a

Improving Management of Bronchiolitis Across a Primary ... EHR decision-support tools included a best practice advisory (BPA) and a smart set. Teams were educated through live and web-based training (52% ...

9. journals.lww.com journals.lww.com/pqs/fulltext/2024/01000/impact_of_a_bronchiolitis_clinical_pathway_on.3.aspx

Impact of a Bronchiolitis Clinical Pathway on Management... This study aims to measure the effect of a bronchiolitis pathway on management decisions by preferred language for care.