198 Participants Needed

CDS + HHFNC Weaning for Bronchiolitis

(REST EEC Trial)

CH
IL
Overseen ByIndia Loar
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Pittsburgh
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This project aims to answer the essential questions about the management of acute, pediatric respiratory illness, accelerate recovery from these all-too-common diseases, curb unnecessary costs of care, and demonstrate UPMC Children's Hospital of Pittsburgh's capabilities as the premier, world-class leader in the arena of pediatric learning healthcare systems. REST EEC will focus on the question of whether clinical decision support (CDS) facilitates the standardization of the initiation and weaning of heated high flow nasal cannula (HHFNC) for bronchiolitis.REST EEC will focus on whether the application of CDS improves adherence to a standardized guideline and leads to improved patient-centered outcomes.

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 data supports the effectiveness of the treatment Clinical Decision Support (CDS) for bronchiolitis?

Clinical Decision Support (CDS) systems have been shown to improve decision-making in various medical conditions, such as reducing unnecessary antibiotic prescriptions for respiratory infections and improving care efficiency in pulmonary embolism cases. This suggests that CDS could potentially enhance treatment strategies for bronchiolitis as well.12345

Is the CDS system generally safe for use in humans?

The research indicates that Clinical Decision Support (CDS) systems are designed to improve patient safety by minimizing medication errors through alerts about drug interactions and allergies. However, there is a high rate of alert overrides by users, suggesting that the system's alerts may not always be specific or useful, which could impact safety.678910

How is the CDS + HHFNC Weaning treatment for bronchiolitis different from other treatments?

The CDS + HHFNC Weaning treatment for bronchiolitis is unique because it involves a structured approach to gradually reduce the use of high-flow nasal cannula (HFNC) therapy, which is a method of providing oxygen through a tube in the nose. This approach aims to optimize the duration and effectiveness of HFNC therapy, which is not standardized in current treatments.1112131415

Research Team

CH

Christopher Horvat, MD

Principal Investigator

UPMC Children's Hospital of Pittsburgh

Eligibility Criteria

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.
See 1 more

Timeline

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

Treatment Details

Interventions

  • Clinical Decision Support (CDS)
  • HHFNC Weaning
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: HHFNC + Clinical decision SupportExperimental Treatment2 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 WeaningActive Control2 Interventions
Team does not receive clinical decision support reminders to wean the HHFNC

Find a Clinic Near You

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+

Findings from Research

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.
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.
A hybrid hierarchical decision support system for cardiac surgical intensive care patients. Part I: Physiological modelling and decision support system design.Denaรฏ, 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.
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]

References

Clinical decision support systems for chronic obstructive pulmonary disease (COPD) in hospitals: A systematic review. [2023]
A hybrid hierarchical decision support system for cardiac surgical intensive care patients. Part I: Physiological modelling and decision support system design. [2015]
Impact of Clinical Decision Support on Antibiotic Prescribing for Acute Respiratory Infections: a Cluster Randomized Implementation Trial. [2021]
Clinical Decision Support to Reduce Opioid Prescriptions for Dental Extractions using SMART on FHIR: Implementation Report. [2023]
Human-centred design processes for clinical decision support: A pulmonary embolism case study. [2021]
Impact of an electronic health record alert on inappropriate prescribing of high-risk medications to patients with concurrent "do not give" orders. [2022]
Characteristics of clinical decision support alert overrides in an electronic prescribing system at a tertiary care paediatric hospital. [2022]
Development of a SNOMED CT based national medication decision support system. [2013]
Clinical decision support alert appropriateness: a review and proposal for improvement. [2022]
Clinical decision support malfunctions related to medication routes: a case series. [2023]
11.United Statespubmed.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? [2023]
A randomised trial of high-flow nasal cannula in infants with moderate bronchiolitis. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Implementation of a High-Flow Nasal Cannula Management Protocol in the Pediatric ICU. [2023]
14.United Statespubmed.ncbi.nlm.nih.gov
Incorporating a Nebulizer System Into High-Flow Nasal Cannula Improves Comfort in Infants With Bronchiolitis. [2018]
High-flow nasal cannula oxygen therapy for infants with bronchiolitis: pilot study. [2022]