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

16800 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new way to help doctors treat children with asthma, pneumonia, or bronchiolitis in community hospitals. The method uses simple visual guides to ensure doctors follow the best care practices. The goal is to improve health outcomes and reduce hospital stays and costs.

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 Multi-condition Pathway Intervention for pediatric respiratory conditions?

Research shows that using clinical pathways for asthma in children can lead to faster recovery and shorter hospital stays, suggesting that similar structured approaches might be effective for other pediatric respiratory conditions. ^{1 2 3 4 5}

Is the Clinical Pathway Intervention for Pediatric Respiratory Conditions safe for children?

The research highlights that children are at a higher risk of adverse drug events (unintended and harmful effects from medications) during treatment, especially in the medication administration stage. Using clinical decision support systems can help reduce these risks and improve safety in pediatric care. ^{6 7 8 9 10}

How is the Multi-condition Pathway Intervention treatment different from other treatments for pediatric respiratory conditions?

The Multi-condition Pathway Intervention is unique because it uses a standardized clinical pathway approach, which involves a coordinated plan developed by a team of healthcare professionals to improve the quality and efficiency of care for pediatric respiratory conditions. This approach aims to reduce variability in treatment and improve outcomes, such as shorter hospital stays, without increasing readmission rates. ^{1 2 4 11 12}

Research Team

Sunitha Kaiser, MD, MSc

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

I have asthma and am between 2 and 18 years old.

I was diagnosed with pneumonia and am between 2 months and 18 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

One-year experience with an inpatient asthma clinical pathway. [2022]

2. China pubmed.ncbi.nlm.nih.gov

[Effect of clinical pathway management on pediatric pneumonia]. [2016]

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

A Clinical Pathway for the Care of Critically Ill Patients With Asthma in the Community Hospital Setting. [2020]

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

Improving Inpatient Asthma Management: The Implementation and Evaluation of a Pediatric Asthma Clinical Pathway. [2022]

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

Effectiveness of Pediatric Asthma Pathways for Hospitalized Children: A Multicenter, National Analysis. [2019]

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

Quality Improvement Project to Evaluate Discharge Prescriptions in Children With Cystic Fibrosis. [2022]

7. England 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. [2019]

8. England 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. [2023]

9. France pubmed.ncbi.nlm.nih.gov

[Assessing and making safe the medicine use pathway in paediatrics]. [2016]

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

Effect of Patient and Family Centered I-PASS on adverse event rates in hospitalized children with complex chronic conditions. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Implementing pediatric inpatient asthma pathways. [2022]

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

Asthma clinical pathway: an interdisciplinary approach to implementation in the inpatient setting. [2004]