Educational and Feedback Interventions for Bronchiolitis

Recruiting at 43 trial locations

Overseen By Canita Brent, MPH

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Philadelphia

Disqualifiers: Apnea, Cardiac disease, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

32357 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to identify the optimal deimplementation strategies for an overused practice: continuous pulse oximetry monitoring of children hospitalized with bronchiolitis who are not receiving supplemental oxygen.

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

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Educational and Feedback Interventions for Bronchiolitis?

Research shows that using a clinical pathway, which is a structured plan of care, can reduce readmission rates for bronchiolitis and improve outcomes for other conditions like pneumonia. Integrated care pathways help reduce unnecessary treatments and continuously improve care quality by regularly updating practices based on the latest evidence. ^{1 2 3 4 5}

Is the educational and feedback intervention for bronchiolitis safe for humans?

The research articles reviewed do not provide specific safety data for educational and feedback interventions, but they focus on improving clinical practices and patient care, which suggests a focus on safety and quality improvement. ^{6 7 8 9 10}

How does the treatment 'Educational and Feedback Interventions for Bronchiolitis' differ from other treatments for bronchiolitis?

This treatment is unique because it focuses on educating healthcare providers and giving feedback to improve the management of bronchiolitis, rather than using medications. It aims to reduce unnecessary treatments and antibiotic overuse by standardizing care through evidence-based guidelines. ^{2 4 11 12 13}

Research Team

Rinad S Beidas, PhD

Principal Investigator

Northwestern University

Christopher P Bonafide, MD, MSCE

Principal Investigator

Children's Hospital of Philadelphia

Eligibility Criteria

The EMO Trial is for English-speaking nurses, physicians, and hospital administrators who have cared for bronchiolitis patients. It includes infants and children aged 2-23 months hospitalized with a primary diagnosis of bronchiolitis on non-ICU wards. Exclusions are extreme prematurity, cardiac disease, chronic lung conditions, immunodeficiency or current severe illness like COVID-19.

Inclusion Criteria

I last used supplemental oxygen more than an hour ago.

Their child had their oxygen levels monitored while breathing normal air during Aim 1 data collection.

Employed full-time by the hospital, affiliated practice, or affiliated university

Exclusion Criteria

I have a neuromuscular disease.

I have a weakened immune system.

I have or might have COVID-19 or its related severe complications.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Deimplementation Strategy Implementation

Implementation of deimplementation strategies including educational outreach, audit & feedback, and electronic health record-integrated clinical pathways

Up to 3 years

Sustainability Monitoring

Monitoring the sustainability of guideline-concordant deimplementation of continuous pulse oximetry monitoring

3 years

Follow-up

Participants are monitored for safety and effectiveness after deimplementation strategies

4 years

Treatment Details

Interventions

• Audit & Feedback (real time, individual-level)
• Audit & Feedback (unit level)
• Clinical Pathway Integrated into Electronic Health Record
• Educational Outreach

Trial Overview This study tests strategies to reduce unnecessary continuous pulse oximetry monitoring in children with bronchiolitis not needing supplemental oxygen. Interventions include educational outreach, audit & feedback at unit and individual levels, and integrating clinical pathways into electronic health records.

Participant Groups

Group I: Unlearning + Substitution Experimental Treatment 4 Interventions

Includes educational outreach, audit \& feedback, and an electronic health record-integrated clinical pathway to support appropriate use of pulse oximetry.

Group II: Unlearning Only Active Control 3 Interventions

Includes educational outreach and audit \& feedback.

Who Is Running the Clinical Trial?

Children's Hospital of Philadelphia

Lead Sponsor

Trials

749

Recruited

11,400,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Children's Hospital Medical Center, Cincinnati

Collaborator

Trials

844

Recruited

6,566,000+

Pediatric Research in Inpatient Settings (PRIS) Network

Collaborator

Trials

2

Recruited

33,000+

Findings from Research

Patients hospitalized for community-acquired pneumonia (CAP) who followed a specific clinical pathway had significantly lower in-hospital mortality rates compared to those who did not, particularly in four out of five severity levels.

The clinical pathway also improved the likelihood of receiving timely blood cultures and appropriate antibiotic therapy, and it notably reduced the odds of respiratory failure requiring mechanical ventilation by 80% in the least severe patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical pathway care improves outcomes among patients hospitalized for community-acquired pneumonia. Hauck, LD., Adler, LM., Mulla, ZD.[2019]

The implementation of an integrated care pathway in primary care and emergency departments significantly reduced the prescribing of salbutamol for acute bronchiolitis, dropping from 7.7% to 0% in the emergency department and from 14.1% to 5% in primary care centers.

Overall use of other medications, including epinephrine, corticosteroids, and antibiotics, also decreased significantly, indicating that the integrated care pathway effectively minimized unnecessary treatments without negatively impacting hospitalization or return rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Unnecessary Treatments for Acute Bronchiolitis Through an Integrated Care Pathway. Montejo, M., Paniagua, N., Saiz-Hernando, C., et al.[2022]

Integrated Care Pathways (ICPs) enhance patient care by providing structured guidelines and continuous evaluation of clinical practices, which helps improve the quality of care.

By documenting variations from the established pathways and analyzing their causes, ICPs serve as effective audit tools that minimize inconsistencies and facilitate rapid incorporation of improvements into routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated care pathways: effective tools for continuous evaluation of clinical practice. Kitchiner, D., Davidson, C., Bundred, P.[2022]

Implementing a clinical pathway for managing infants with acute viral bronchiolitis significantly reduced hospital readmissions and the use of unnecessary treatments like supplemental fluids and steroids, based on a study of 229 infants compared to 207 infants managed without the pathway.

The pathway did not affect the overall length of hospital stay or time spent on oxygen, indicating that while it improved certain aspects of care, it did not compromise the quality of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A clinical pathway for bronchiolitis is effective in reducing readmission rates. Cheney, J., Barber, S., Altamirano, L., et al.[2022]

A comprehensive care pathway for managing COPD exacerbations was developed, consisting of 38 evidence-based interventions and 39 indicators (24 process and 15 outcome), validated by nine multidisciplinary teams in Belgium.

The eight-step method used to create this care pathway can serve as a model for other healthcare teams to standardize clinical content for various patient populations, ensuring effective and evidence-based care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eight-step method to build the clinical content of an evidence-based care pathway: the case for COPD exacerbation. Lodewijckx, C., Decramer, M., Sermeus, W., et al.[2021]

The usability evaluation of the Performance Improvement plaN GeneratoR (PINGR) identified 47 usability issues, with the most significant problems related to 'Consistency and standards' and 'Match between system and real world', which could hinder effective use by clinicians.

The recommended actions component of PINGR had the highest number of usability issues, indicating that improvements in this area could enhance the overall effectiveness of computerized Audit and Feedback systems in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interface design recommendations for computerised clinical audit and feedback: Hybrid usability evidence from a research-led system. Brown, B., Balatsoukas, P., Williams, R., et al.[2022]

The effectiveness of electronic audit and feedback (e-A&F) interventions in improving quality of care is highly variable, as shown by a meta-analysis of seven studies involving 81,700 patients and 329 healthcare professionals, with many studies exhibiting medium to high risk of bias.

Most e-A&F interventions targeted theoretical domains like 'knowledge', 'social influences', and 'goals', but did not comprehensively address all relevant domains, indicating a need for future research to better understand which theoretical factors are crucial for enhancing the effectiveness of e-A&F interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of electronic audit and feedback: intervention effectiveness and use of behaviour change theory. Tuti, T., Nzinga, J., Njoroge, M., et al.[2023]

Audit and Feedback (A&F) can significantly improve patient care by providing actionable insights, but its effectiveness is often hindered by challenges in data validity, feedback interpretation, and the ability to implement changes.

Successful implementation of A&F requires a supportive culture, adequate leadership, and sometimes coaching to help healthcare teams translate feedback into practical actions for improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A&F: obstacles to implementing interventions in the health system.] Di Blasio, N., Acampora, A., Bonomi, A., et al.[2023]

A review of 140 trials on audit and feedback (A&F) interventions revealed significant gaps in reporting, with clarity ranging from 56% to 97%, indicating a need for improved standardization in how these interventions are documented.

The study identified 17 modifiable elements of A&F interventions, highlighting considerable variation in their design, with 51% targeting individual providers and 92% aimed at behavior change, which may affect the overall effectiveness of A&F in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting and design elements of audit and feedback interventions: a secondary review. Colquhoun, H., Michie, S., Sales, A., et al.[2018]

A new pediatric trigger tool was developed to identify adverse events (AEs) in hospitalized children, revealing that 34% of patients experienced a total of 563 AEs, with 442 of these being preventable.

The study found that AEs are common in pediatric patients, and the tool can help healthcare organizations improve patient safety by measuring and analyzing these events across different clinical specialties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of triggers and development of a pediatric trigger tool to identify adverse events. Unbeck, M., Lindemalm, S., Nydert, P., et al.[2018]

In a study of 181 children with bronchiolitis, the implementation of a clinical pathway significantly reduced antibiotic use from 27% in the non-pathway group to only 9% in the pathway group.

The clinical pathway not only decreased unnecessary antibiotic prescriptions but also maintained quality of care, as evidenced by no negative impacts on unplanned return visits, while also reducing costs and length of hospital stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evidence-based clinical pathway for bronchiolitis safely reduces antibiotic overuse. Wilson, SD., Dahl, BB., Wells, RD.[2019]

Both video-based and slide-based eLearning programs improved clinicians' management of bronchiolitis in infants, leading to fewer unnecessary investigations and treatments.

Video-based eLearning was particularly effective, resulting in significantly reduced hospital admissions and better discharge planning compared to slide-based learning, enhancing clinician confidence and patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is slide-based or video-based eLearning better at achieving behavioural change in bronchiolitis management? A cluster-based randomised control trial. Talati, R., Fonseca, B., Mallitt, KA., et al.[2023]

An educational intervention at a children's hospital led to a significant reduction in the use of unnecessary antibiotics and bronchodilators for infants hospitalized with bronchiolitis, indicating improved adherence to treatment guidelines.

While the intervention successfully decreased the duration of antibiotic use for children with confirmed RSV infections and reduced bronchodilator treatments, it did not affect the length of hospital stay or readmission rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardizing the care of bronchiolitis. Adcock, PM., Sanders, CL., Marshall, GS.[2019]

References

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

Clinical pathway care improves outcomes among patients hospitalized for community-acquired pneumonia. [2019]

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

Reducing Unnecessary Treatments for Acute Bronchiolitis Through an Integrated Care Pathway. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Integrated care pathways: effective tools for continuous evaluation of clinical practice. [2022]

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

A clinical pathway for bronchiolitis is effective in reducing readmission rates. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Eight-step method to build the clinical content of an evidence-based care pathway: the case for COPD exacerbation. [2021]

6. Ireland pubmed.ncbi.nlm.nih.gov

Interface design recommendations for computerised clinical audit and feedback: Hybrid usability evidence from a research-led system. [2022]

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

A systematic review of electronic audit and feedback: intervention effectiveness and use of behaviour change theory. [2023]

8. Italy pubmed.ncbi.nlm.nih.gov

[A&F: obstacles to implementing interventions in the health system.] [2023]

9. England pubmed.ncbi.nlm.nih.gov

Reporting and design elements of audit and feedback interventions: a secondary review. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Validation of triggers and development of a pediatric trigger tool to identify adverse events. [2018]

11. Netherlands pubmed.ncbi.nlm.nih.gov

An evidence-based clinical pathway for bronchiolitis safely reduces antibiotic overuse. [2019]

12. Australia pubmed.ncbi.nlm.nih.gov

Is slide-based or video-based eLearning better at achieving behavioural change in bronchiolitis management? A cluster-based randomised control trial. [2023]

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

Standardizing the care of bronchiolitis. [2019]