AsthmaSIPNCT05206695
Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children
A study testing Multi-condition Pathway Intervention in people with Asthma and Pneumonia, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Asthma, Pneumonia, Bronchiolitis
- What is being tested?
- Multi-condition Pathway Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11,760 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2022to 21 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Diagnosis of SARS-CoV-2
- Transfer in from another inpatient facility
- Pre-existing chronic illnesses (e.g., lung disease, cardiovascular disease, neurologic disorders)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94153
About this study
Official title: The SIP Study: Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children
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.
Read the 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.
- Conditions
- Asthma, Pneumonia, Bronchiolitis
- Being tested
- Multi-condition Pathway Intervention
- Keywords
- Children, Clinical pathways, Hospital
- Medical subject headings
- Asthma, Pneumonia, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-condition Pathway InterventionBehavioural
See Experimental/Arm 1 description
| Study group | Role | What they receive |
|---|---|---|
| Multi-condition Pathway Intervention | Experimental | 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, electronic order sets, and mentoring/facilitation. Receives: Behavioral: Multi-condition Pathway Intervention |
| Standard of Care | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumonia Evidence Based Practice 1
Administration of narrow spectrum antibiotic
Measured: During a hospitalization, approximately 2 days
Pneumonia Evidence Based Practice 2
No prescription of macrolide antibiotics
Measured: During a hospitalization, approximately 2 days
Asthma Evidence Based Practice 1
Prescription of inhaled corticosteroids for children greater than or equal to 5 years-old
Measured: During a hospitalization, approximately 2 days
Asthma Evidence Based Practice 2
Use of metered-dose inhalers
Measured: During a hospitalization, approximately 2 days
Asthma Evidence Based Practice 3
Use of an asthma pathway/bronchodilator weaning protocol
Measured: During a hospitalization, approximately 2 days
Bronchiolitis Evidence Based Practice 1
No administration of albuterol
Measured: During a hospitalization, approximately 2 days
Bronchiolitis Evidence Based Practice 2
No chest radiographs
Measured: During a hospitalization, approximately 2 days
Secondary outcomes (3)
Length of Hospital Stay
Length Hospital Stay
Measured: During a hospitalization, approximately 2 days
Transfer to Intensive Care
The event of patient being transferred to an ICU
Measured: During a hospitalization, approximately 2 days
30-day Hospital Readmission or Emergency Department Revisit
Event of a patient being readmitted to hospital or having an emergency department visit within 30 days of hospital discharge
Measured: 30 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start13 May 2022
- Primary completion21 Oct 2025
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 11,760 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Society of Hospital Medicine
- Responsible party
- Sponsor
- Investigators
- Sunitha V Kaiser, MD, MSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206695
- Sponsor's protocol ID
- R33HL157804
- Other IDs
- R33HL157804
- Acronym
- SIP
- Status last verified
- Apr 2026
- First submitted
- 11 Jan 2022
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data generated under this project will be administered in accordance with the policies of the University of California San Francisco (UCSF) and NIH/NHLBI. The Final Research Data (the dataset necessary to document and support research findings) will be made available for sharing after the main research findings from the final data set have been accepted for publication in a peer-reviewed journal. Prior to sharing, data will be redacted to strip all direct identifiers of hospitals (no identifiers of patients/individuals will be collected).
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SIP Study: Simultaneously Implementing Pathways for Improving Asthma, Pneumonia, and Bronchiolitis Care for Hospitalized Children
- ClinicalTrials.gov ID
- NCT05206695
- Acronym / sponsor ID
- SIP / R33HL157804
- Conditions
- Asthma, Pneumonia, Bronchiolitis
- Keywords
- Children, Clinical pathways, Hospital
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11,760 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Society of Hospital Medicine
- Study start
- 13 May 2022 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Multi-condition Pathway Intervention | Experimental | Behavioral: Multi-condition Pathway InterventionThe 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, electronic order sets, and mentoring/facilitation. |
| Standard of Care | No 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 may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Diagnosis of SARS-CoV-2
- Transfer in from another inpatient facility
- Pre-existing chronic illnesses (e.g., lung disease, cardiovascular disease, neurologic disorders)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-condition Pathway InterventionSee Experimental/Arm 1 description | Behavioural | Multi-condition Pathway Intervention |
Primary outcome
Pneumonia Evidence Based Practice 1
Time frame: During a hospitalization, approximately 2 days
Administration of narrow spectrum antibiotic
Pneumonia Evidence Based Practice 2
Time frame: During a hospitalization, approximately 2 days
No prescription of macrolide antibiotics
Asthma Evidence Based Practice 1
Time frame: During a hospitalization, approximately 2 days
Prescription of inhaled corticosteroids for children greater than or equal to 5 years-old
Asthma Evidence Based Practice 2
Time frame: During a hospitalization, approximately 2 days
Use of metered-dose inhalers
Asthma Evidence Based Practice 3
Time frame: During a hospitalization, approximately 2 days
Use of an asthma pathway/bronchodilator weaning protocol
Bronchiolitis Evidence Based Practice 1
Time frame: During a hospitalization, approximately 2 days
No administration of albuterol
Bronchiolitis Evidence Based Practice 2
Time frame: During a hospitalization, approximately 2 days
No chest radiographs
3 secondary outcomes
Length of Hospital Stay
Time frame: During a hospitalization, approximately 2 days
Transfer to Intensive Care
Time frame: During a hospitalization, approximately 2 days
30-day Hospital Readmission or Emergency Department Revisit
Time frame: 30 days after hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: Yes. Data generated under this project will be administered in accordance with the policies of the University of California San Francisco (UCSF) and NIH/NHLBI. The Final Research Data (the dataset necessary to document and support research findings) will be made available for sharing after the main research findings from the final data set have been accepted for publication in a peer-reviewed journal. Prior to sharing, data will be redacted to strip all direct identifiers of hospitals (no identifiers of patients/individuals will be collected).
Related trials for Asthma
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma
Asthma
RecruitingObservational study
A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice
Asthma
RecruitingPhase 3
A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
Asthma
Not yet recruitingPhase 4
Novel Method for Removal of Orally Deposited Inhaled Fluticasone Propionate
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunitha V Kaiser, MD, MSc principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-condition Pathway Intervention in people with Asthma and Pneumonia, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumonia Evidence Based Practice 1 (time frame: During a hospitalization, approximately 2 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.