Educational and Feedback Interventions for Bronchiolitis

Recruiting at 46 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best ways to reduce unnecessary continuous pulse oximetry (a device that measures oxygen levels in the blood) monitoring in children with bronchiolitis who don't need extra oxygen. It involves strategies such as educational outreach and feedback to hospital staff. Eligible participants include nurses, doctors, and parents of children hospitalized with bronchiolitis, particularly those involved in the care and oversight of these young patients. The trial aims to improve hospital practices to ensure appropriate care without overusing monitoring. As an unphased trial, it offers participants the opportunity to contribute to optimizing care practices and reducing unnecessary interventions for children.

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 prior data suggests that these educational and feedback interventions are safe for children with bronchiolitis?

Research shows that educational programs and feedback systems are generally safe for participants. Studies have found that healthcare professionals receive these methods well, finding them practical and easy to use. No reports of negative effects have emerged from these approaches.

Past research suggests that adding clinical guidelines to electronic health records is safe. These guidelines aim to improve healthcare decisions and have been used without safety concerns.

Overall, these strategies enhance care without introducing new risks. No evidence of negative events has been found from using these methods. Participants can feel assured about the safety of these interventions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for bronchiolitis because they aim to revolutionize how care is delivered through innovative methods. Unlike traditional treatments that focus mainly on symptomatic relief, these interventions integrate real-time audit and feedback alongside educational outreach to healthcare providers, promoting best practices directly at the point of care. The "Unlearning + Substitution" approach further stands out by incorporating a clinical pathway directly into the electronic health record, helping guide appropriate use of pulse oximetry. This could lead to more efficient, evidence-based decision-making, potentially improving patient outcomes and reducing unnecessary interventions.

What evidence suggests that this trial's interventions could be effective for reducing unnecessary pulse oximetry in bronchiolitis?

Research has shown that educational programs and feedback can help reduce the use of continuous pulse oximetry in infants with stable bronchiolitis. In this trial, one group will receive educational outreach and audit & feedback to help healthcare providers adhere more closely to guidelines. Another group will receive these interventions along with a clinical pathway integrated into electronic health records. Studies have found that this integration can improve bronchiolitis management by giving healthcare workers easy access to guidelines, leading to better decision-making. Overall, these methods aim to reduce unnecessary monitoring, ensuring children receive appropriate care. ^{1 2 4 6 7}

Who Is on the Research Team?

Christopher P Bonafide, MD, MSCE

Principal Investigator

Children's Hospital of Philadelphia

Rinad S Beidas, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34473258/

Evaluation of an Educational Outreach and Audit ... - PubMed Objectives: To evaluate deimplementation outcomes of educational outreach and audit and feedback strategies aiming to reduce guideline- ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2783681

Evaluation of an Educational Outreach and Audit ... An educational outreach and audit and feedback program to reduce continuous pulse oximetry use in hospitalized infants with stable bronchiolitis.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8414187/

Evaluation of an Educational Outreach and Audit ... An educational outreach and audit and feedback program to reduce continuous pulse oximetry use in hospitalized infants with stable bronchiolitis.

4. caep.ca caep.ca/periodicals/Volume_22_Issue_5/Vol_22_Issue_5_Page_678_-_686_Dowling.pdf

Group-facilitated audit and feedback to improve bronchiolitis ... The primary outcome was the proportion of patients who received any low-value intervention and was ana- lysed using statistical process control charts. Results: ...

5. cambridge.org cambridge.org/core/journals/canadian-journal-of-emergency-medicine/article/groupfacilitated-audit-and-feedback-to-improve-bronchiolitis-care-in-the-emergency-department/E4C0BFD1C17CCB4767ECD2AA46860999

Group-facilitated audit and feedback to improve ... The primary outcome was the proportion of patients who received any low-value intervention and was analysed using statistical process control ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9093027/

Systematic review and narrative synthesis of computerized ... Audit and feedback (A&F) is widely used to improve care quality and health outcomes. Through summarizing clinical performance over time (audit), ...

7. researchgate.net researchgate.net/publication/341843793_Group-facilitated_audit_and_feedback_to_improve_bronchiolitis_care_in_the_emergency_department

Group-facilitated audit and feedback to improve ... Results Seventy-eight percent of emergency physicians consented to receive their audit and feedback reports. Patient characteristics were similar in the ...