SIP: Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT05206695
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH), Society of Hospital Medicine (Other)
16,800
1
2
44
381.9

Study Details

Study Description

Brief Summary

This study's objective is to identify and test pragmatic and sustainable strategies for implementing a multi-condition clinical pathway intervention for children hospitalized with asthma, pneumonia, or bronchiolitis in community hospitals. The hypothesis is that the multi-condition pathway intervention will be associated with significantly greater increases in clinicians' adoption of evidence-based practices compared to control. The study is a pragmatic, cluster-randomized trial in US community hospitals. The primary outcome will be adoption of evidence-based practices over a sustained period of 2 years. Secondary outcomes include length of hospital stay, intensive care unit transfer, and hospital readmission/emergency department revisit.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Multi-condition Pathway Intervention
N/A

Detailed Description

Asthma, pneumonia, and bronchiolitis are the top causes of childhood hospitalization in the US, leading to approximately 350,000 hospitalizations and $2 billion in costs annually. Poor guideline adoption by clinicians contributes to poor health outcomes for children hospitalized with these respiratory illnesses, including longer recovery time/hospital stay, higher rates of transfer to intensive care units, and increased risk of hospital readmission.

Pathways can improve clinicians' adoption of evidence-based practices/guidelines in both children's and community hospital settings. Pathways are simple, visual diagrams that guide clinicians step-by-step through the evidence-based care of a specific medical condition (accessed via paper or electronically). Most hospitals implement pathways for a single medical condition at a time (e.g., asthma). But Seattle Children's Hospital developed an intervention for simultaneously implementing pathways for multiple conditions. This intervention led to sustained guideline adoption, decreased length of stay, and decreased costs; and, these effects were comparable to those shown with single-condition pathway implementation. This multi-condition pathway intervention has not yet been studied in community hospitals, which face unique implementation barriers.

The study's objective is to identify and test pragmatic and sustainable strategies for implementing a multi-condition pathway intervention for children hospitalized with asthma, pneumonia, or bronchiolitis in community hospitals. The study is a pragmatic, cluster-randomized trial in US community hospitals. The pathway intervention will be implemented using the key implementation strategies defined for this intervention (audit and feedback, electronic health record integration, plan-do-study-act cycles). The primary outcome will be adoption of evidence-based practices over a sustained period of 2 years. Secondary outcomes include length of hospital stay, intensive care unit transfer, and hospital readmission/emergency department revisit.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
16800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participating hospitals will be randomized into either an intervention group (will test simultaneous implementation of 3 clinical pathways) or control (will continue to provide standard care)Participating hospitals will be randomized into either an intervention group (will test simultaneous implementation of 3 clinical pathways) or control (will continue to provide standard care)
Masking:
Single (Outcomes Assessor)
Masking Description:
Participants, care providers, and investigators cannot be masked due to the nature of the intervention. However, outcomes assessors will be masked.
Primary Purpose:
Health Services Research
Official Title:
The SIP Study: Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Oct 31, 2024
Anticipated Study Completion Date :
Nov 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Multi-condition Pathway 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.

Behavioral: Multi-condition Pathway Intervention
See Experimental/Arm 1 description

No Intervention: Standard of Care

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.

Outcome Measures

Primary Outcome Measures

  1. Pneumonia Evidence Based Practice 1 [During a hospitalization, approximately 2 days]

    Administration of narrow spectrum antibiotic

  2. Pneumonia Evidence Based Practice 2 [During a hospitalization, approximately 2 days]

    No prescription of macrolide antibiotics

  3. Asthma Evidence Based Practice 1 [During a hospitalization, approximately 2 days]

    Prescription of inhaled corticosteroids for children greater than or equal to 5 years-old

  4. Asthma Evidence Based Practice 2 [During a hospitalization, approximately 2 days]

    Use of metered-dose inhalers

  5. Asthma Evidence Based Practice 3 [During a hospitalization, approximately 2 days]

    Use of an asthma pathway/bronchodilator weaning protocol

  6. Bronchiolitis Evidence Based Practice 1 [During a hospitalization, approximately 2 days]

    No administration of bronchodilators

  7. Bronchiolitis Evidence Based Practice 2 [During a hospitalization, approximately 2 days]

    No chest radiographs

Secondary Outcome Measures

  1. Length of Hospital Stay [During a hospitalization, approximately 2 days]

    Length Hospital Stay

  2. Transfer to Intensive Care [During a hospitalization, approximately 2 days]

    The event of patient being transferred to an ICU

  3. 30-day Hospital Readmission or Emergency Department Revisit [30 days after hospital discharge]

    Event of a patient being readmitted to hospital or having an emergency department visit within 30 days of hospital discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Primary diagnosis of asthma AND age >2 to <18 years-old at time of admission to the hospital OR

  • Primary diagnosis of pneumonia AND age >2 months and <18 years at time of admission to the hospital OR

  • Primary diagnosis of bronchiolitis AND age <2 years at time of admission to the hospital

Exclusion Criteria:
  • Diagnosis of SARS-CoV-2

  • Transfer in from another inpatient facility

  • Pre-existing chronic illnesses (e.g., lung disease, cardiovascular disease, neurologic disorders)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, San Francisco San Francisco California United States 94153

Sponsors and Collaborators

  • University of California, San Francisco
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Society of Hospital Medicine

Investigators

  • Principal Investigator: Sunitha V Kaiser, MD, MSc, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT05206695
Other Study ID Numbers:
  • R61HL157804
  • R61HL157804
First Posted:
Jan 25, 2022
Last Update Posted:
May 27, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of California, San Francisco
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 27, 2022