Clinical Pathway Intervention for Pediatric Respiratory Conditions

(SIP Trial)

Overseen By Sunitha V Kaiser, MD, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: SARS-CoV-2, Chronic illnesses, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve care for children admitted to hospitals with asthma, pneumonia, or bronchiolitis by testing a new approach for doctors and nurses called the Multi-condition Pathway Intervention. The goal is to determine if this method helps healthcare workers use proven treatments more effectively than regular care. Children hospitalized with asthma, pneumonia, or bronchiolitis may be eligible to participate. The study will also examine the length of hospital stays and the need for return visits or emergency room visits. As an unphased trial, this study offers a unique opportunity to contribute to enhancing hospital care for children with these conditions.

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 clinical pathway intervention is safe for pediatric respiratory conditions?

Research has shown that clinical pathways can improve care and outcomes for children with breathing problems like asthma, pneumonia, and bronchiolitis. These pathways are step-by-step plans that guide doctors and nurses in treating patients. Specifically, studies have demonstrated that using pathways for asthma helps children recover faster and reduces their hospital stay.

Regarding safety, clinical pathways do not introduce new drugs or treatments. Instead, they organize existing, proven methods more effectively. This approach means no new safety risks arise from the pathways themselves. They are designed to ensure children receive the best care based on current medical knowledge. Parents can feel confident that these pathways aim to enhance their child's care without adding new risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Multi-condition Pathway Intervention because it offers a more structured approach to managing pediatric respiratory conditions like asthma, pneumonia, and bronchiolitis. Unlike standard treatments that vary by hospital and might not use a unified strategy, this intervention provides clinicians with specific pathways to guide care. Key features include the use of audit and feedback loops, plan-do-study-act cycles, and electronic order sets, which aim to enhance decision-making and improve patient outcomes. By standardizing care, this intervention has the potential to ensure that children receive the best possible treatment consistently across different settings.

What evidence suggests that this multi-condition pathway intervention is effective for pediatric respiratory conditions?

This trial will compare a multi-condition pathway intervention with standard care for pediatric respiratory conditions. Studies have shown that a special treatment plan, like the multi-condition pathway intervention, helps healthcare providers follow proven methods when treating children with asthma, pneumonia, or bronchiolitis. This provides doctors and nurses with a clearer guide on effective treatments for these conditions. Research indicates that these plans can shorten hospital stays and reduce the need for intensive care or readmission soon after discharge. For example, one study found that using these plans improved the overall quality of care for children with these conditions in community hospitals. This approach aims to ensure children receive the best care possible based on the latest research. ^{1 2 4 5 6}

Who Is on the Research Team?

Sunitha Kaiser, MD, MSc

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for children hospitalized with asthma (ages 2-18), pneumonia (ages 2 months to <18 years), or bronchiolitis (<2 years old) in community hospitals. It excludes those with COVID-19, chronic illnesses like lung or heart disease, neurologic disorders, or transfers from other inpatient facilities.

Inclusion Criteria

My child was diagnosed with bronchiolitis and is under 2 years old.

Exclusion Criteria

I have been diagnosed with COVID-19.

I have a long-term illness like heart, lung, or nerve problems.

Transfer in from another inpatient facility

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of multi-condition pathway intervention using strategies like audit and feedback, electronic health record integration, and plan-do-study-act cycles

2 years

Follow-up

Participants are monitored for adoption of evidence-based practices and secondary outcomes such as hospital readmission and emergency department revisit

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Multi-condition Pathway Intervention

Trial Overview The study tests a multi-condition clinical pathway intervention aimed at increasing clinicians' use of evidence-based practices for treating asthma, pneumonia, and bronchiolitis over two years. The trial randomly assigns hospitals to either the new pathway or control group.

How Is the Trial Designed?

Group I: Multi-condition Pathway Intervention Experimental Treatment 1 Intervention

The multi-condition pathway intervention consists of pathways clinicians select from to guide the care of children with asthma, pneumonia, or bronchiolitis. Key implementation strategies include audit and feedback, plan-do-study-act cycles, and electronic order sets.

Group II: Standard of Care Active Control 1 Intervention

Hospitals randomized to the control arm will not receive the multi-condition pathway intervention or any external supports for implementation. They will continue to provide current standards of care.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Society of Hospital Medicine

Collaborator

Trials

6

Recruited

24,200+

Published Research Related to This Trial

In a study involving 3106 hospitalized children, the Patient and Family Centered I-PASS intervention significantly reduced adverse events (AEs) in children with complex chronic conditions (CCCs) by 50%.

However, the intervention did not show a statistically significant impact on AE rates for children without CCCs, indicating that the benefits of PFC I-PASS may be more pronounced in those with more complex health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Patient and Family Centered I-PASS on adverse event rates in hospitalized children with complex chronic conditions. Kuzma, N., Khan, A., Rickey, L., et al.[2023]

Medication administration clinical decision support systems (MACDSSs) can significantly reduce adverse drug events (ADE) in neonates and children, which are particularly vulnerable during medication management.

Despite the development of various MACDSSs, only a few have been tested in real-world settings, highlighting the need for more practical evaluations to enhance their effectiveness and safety in pediatric care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying the data elements and functionalities of clinical decision support systems to administer medication for neonates and pediatrics: a systematic literature review. Norouzi, S., Galavi, Z., Ahmadian, L.[2023]

This study aims to assess the frequency and types of adverse events in Australian pediatric care by reviewing 6000-8000 medical records of children under 16 years from various healthcare settings during 2012 and 2013.

The research will utilize a modified version of the Global Trigger Tool for data collection, which is a systematic approach to identifying potential safety issues in healthcare, highlighting the importance of improving patient safety in children's healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CareTrack Kids-part 3. Adverse events in children's healthcare in Australia: study protocol for a retrospective medical record review. Hibbert, PD., Hallahan, AR., Muething, SE., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12118519/

Simultaneously implementing pathways for improving asthma ... Our objective is to study the implementation and effectiveness of a multicondition pathway intervention for children hospitalized with asthma, pneumonia, or ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05206695

Study Details | NCT05206695 | Simultaneously ... The multi-condition pathway intervention consists of pathways clinicians select from to guide the care of children with asthma, pneumonia, or bronchiolitis. Key ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12180955/

Barriers, Facilitators, and Time Costs of Implementing a ... The trial seeks to determine the effectiveness of the multicondition pathway intervention on clinicians' guideline adherence in a national sample of general ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/95/NCT05206695/Prot_SAP_ICF_001.pdf

Simultaneously Implementing Pathways for Improving Asthma, ... multi-condition pathway intervention for children hospitalized with asthma, pneumonia, or bronchiolitis in community hospitals. In Aim 1, we will conduct a ...

5. researchgate.net researchgate.net/publication/383116296_Simultaneously_implementing_pathways_for_improving_asthma_pneumonia_and_bronchiolitis_care_for_hospitalized_children_Protocol_for_a_hybrid_effectiveness-implementation_cluster-randomized_trial

Protocol for a hybrid effectiveness-implementation, cluster ... Objective To study the implementation and effectiveness of a multicondition pathway intervention for children hospitalized with asthma, ...

6. withpower.com withpower.com/trial/phase-bronchiolitis-3-2022-42d0e

Clinical Pathway Intervention for Pediatric Respiratory ... Research shows that using clinical pathways for asthma in children can lead to faster recovery and shorter hospital stays, suggesting that similar structured ...