AsthmaPIPANCT03736603
Implementing Pathways to Improve Pediatric Asthma Care
A study testing PIPA Intervention Bundle 1 and PIPA Intervention Bundle 2 in people with Asthma, run by University of California, San Francisco at 1 site in United States.
Trial summary
Background: Asthma affects nearly 10% of American children, and is a leading cause of pediatric emergency visits and hospitalizations. Clinical pathways are operational versions of practice guidelines aimed at the hospital management of common illnesses. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- PIPA Intervention Bundle 1 and PIPA Intervention Bundle 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2018to 30 Jun 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Working as a physician at the study site
- Age 2-17 years
- Primary diagnosis of asthma
Who cannot join
- None
- Patient/child eligibility criteria:
- Transferred in from another inpatient facility
- Presence of a chronic medical condition that precludes pathway use
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California
San Francisco, California, 94158
About this study
Official title: The PIPA Study (Pathways for Improving Pediatric Asthma Care): A Cluster Randomized Trial
Background:
Asthma affects nearly 10% of American children, and is a leading cause of pediatric emergency visits and hospitalizations. Clinical pathways are operational versions of practice guidelines aimed at the hospital management of common illnesses. Single-site studies of pediatric asthma pathways have shown significant improvements in quality of care.
Read more
Primary Objective:
To evaluate the effectiveness of clinical pathways for improving quality of care for children with asthma in a diverse, national sample of emergency department (ED) and hospital settings.
Primary Endpoints:
- Emergency Department: The proportion of eligible children who receive systemic steroids within 60 minutes of ED arrival
- Inpatient/Hospital: Mean length of hospital stay
Study Design:
This project will be implemented through an established quality improvement collaborative of hospitals across the United States, the Value in Inpatient Pediatrics Network (part of the American Academy of Pediatrics). A cluster randomized design will be employed. Group 1 hospitals will receive a multifaceted implementation strategy that includes: 1) a pathway implementation toolkit, 2) local multidisciplinary champions in the ED and inpatient settings, 3) audit and feedback, 4) educational seminars, and 5) practice facilitation (via teleconference). Group 2 will receive the same intervention with the addition of a mobile app pathway tool.
- Conditions
- Asthma
- Being tested
- PIPA Intervention Bundle 1, PIPA Intervention Bundle 2
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPA Intervention Bundle 1Behavioural
The PIPA intervention bundle 1 includes:
- Pathway Implementation Toolkit
- Local Multidisciplinary Champions
- Audit and Feedback
- Educational Seminars/Webinars
- Practice Facilitation
PIPA Intervention Bundle 2Behavioural
The PIPA intervention bundle 2 includes:
- Pathway Implementation Toolkit
- Local Multidisciplinary Champions
- Audit and Feedback
- Educational Seminars/Webinars
- Practice Facilitation
- Mobile App
| Study group | Role | What they receive |
|---|---|---|
| Pathway Intervention 1 | Experimental | Hospitals randomized to group 1 receive PIPA Intervention Bundle 1. Receives: Behavioral: PIPA Intervention Bundle 1 |
| Pathway Intervention 2 | Experimental | Hospitals randomized to group 2 receive PIPA Intervention Bundle 2, which adds a mobile app. Receives: Behavioral: PIPA Intervention Bundle 2 |
| Control | No intervention | Hospitals are in the control arm (usual care) after January 2017 until active implementation begins, which includes 3-6 months of implementation preparation (identifying local multidisciplinary champions, educational sessions/webinars for local champions, one teleconference with an external practice facilitator). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital/Inpatient: Mean length of hospital stay
Measured: 1 year
Emergency Department: Proportion of eligible children who receive systemic steroids within 60 minutes of ED arrival
Measured: 1 year
Secondary outcomes (11)
Hospital/Inpatient: Proportion of children with administration of bronchodilator via metered-dose inhaler early in hospitalization
Measured: 1 year
Hospital/Inpatient: Proportion of children screened for secondhand tobacco smoke exposure
Measured: 1 year
Hospital/Inpatient: Proportion of children who screen positive for secondhand tobacco smoke exposure whose caregivers are referred to smoking cessation resources
Measured: 1 year
Hospital/Inpatient: Proportion of children prescribed antibiotics at hospital discharge
Measured: 1 year
Hospital/Inpatient: Proportion of children with emergency department visits or readmissions to the hospital within 7 days
Measured: 1 year
Hospital/Inpatient: Proportion of children transferred to a higher level of care
Measured: 1 year
Emergency Department: Proportion of children who get an asthma exacerbation severity assessment at ED triage
Measured: 1 year
Emergency Department: Proportion of children who have chest radiographs performed
Measured: 1 year
Emergency Department: Proportion of children admitted to the hospital
Measured: 1 year
Emergency Department: Proportion of children transferred to a higher level of care
Measured: 1 year
Emergency Department: Mean length of emergency department stay
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start1 Jan 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
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
- Masking
- None (open label)
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Pediatrics
- Responsible party
- Sponsor
- Investigators
- Sunitha V Kaiser, MD MSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736603
- Sponsor's protocol ID
- 17 KA 01
- Acronym
- PIPA
- Status last verified
- Mar 2022
- First submitted
- 7 Nov 2018
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PIPA Study (Pathways for Improving Pediatric Asthma Care): A Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT03736603
- Acronym / sponsor ID
- PIPA / 17 KA 01
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- American Academy of Pediatrics
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 9 Nov 2018 (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.
Background:
Asthma affects nearly 10% of American children, and is a leading cause of pediatric emergency visits and hospitalizations. Clinical pathways are operational versions of practice guidelines aimed at the hospital management of common illnesses. Single-site studies of pediatric asthma pathways have shown significant improvements in quality of care.
Primary Objective:
To evaluate the effectiveness of clinical pathways for improving quality of care for children with asthma in a diverse, national sample of emergency department (ED) and hospital settings.
Primary Endpoints:
- Emergency Department: The proportion of eligible children who receive systemic steroids within 60 minutes of ED arrival
- Inpatient/Hospital: Mean length of hospital stay
Study Design:
This project will be implemented through an established quality improvement collaborative of hospitals across the United States, the Value in Inpatient Pediatrics Network (part of the American Academy of Pediatrics). A cluster randomized design will be employed. Group 1 hospitals will receive a multifaceted implementation strategy that includes: 1) a pathway implementation toolkit, 2) local multidisciplinary champions in the ED and inpatient settings, 3) audit and feedback, 4) educational seminars, and 5) practice facilitation (via teleconference). Group 2 will receive the same intervention with the addition of a mobile app pathway tool.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pathway Intervention 1 | Experimental | Behavioral: PIPA Intervention Bundle 1Hospitals randomized to group 1 receive PIPA Intervention Bundle 1. |
| Pathway Intervention 2 | Experimental | Behavioral: PIPA Intervention Bundle 2Hospitals randomized to group 2 receive PIPA Intervention Bundle 2, which adds a mobile app. |
| Control | No intervention | –Hospitals are in the control arm (usual care) after January 2017 until active implementation begins, which includes 3-6 months of implementation preparation (identifying local multidisciplinary champions, educational sessions/webinars for local champions, one teleconference with an external practice facilitator). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Working as a physician at the study site
- Age 2-17 years
- Primary diagnosis of asthma
Key exclusion criteria (4 listed)
- None
- Transferred in from another inpatient facility
- Presence of a chronic medical condition that precludes pathway use
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 |
|---|---|---|
| PIPA Intervention Bundle 1The PIPA intervention bundle 1 includes: 1. Pathway Implementation Toolkit 2. Local Multidisciplinary Champions 3. Audit and Feedback 4. Educational Seminars/Webinars 5. Practice Facilitation | Behavioural | Pathway Intervention 1 |
| PIPA Intervention Bundle 2The PIPA intervention bundle 2 includes: 1. Pathway Implementation Toolkit 2. Local Multidisciplinary Champions 3. Audit and Feedback 4. Educational Seminars/Webinars 5. Practice Facilitation 6. Mobile App | Behavioural | Pathway Intervention 2 |
Primary outcome
Hospital/Inpatient: Mean length of hospital stay
Time frame: 1 year
Emergency Department: Proportion of eligible children who receive systemic steroids within 60 minutes of ED arrival
Time frame: 1 year
11 secondary outcomes
Hospital/Inpatient: Proportion of children with administration of bronchodilator via metered-dose inhaler early in hospitalization
Time frame: 1 year
Hospital/Inpatient: Proportion of children screened for secondhand tobacco smoke exposure
Time frame: 1 year
Hospital/Inpatient: Proportion of children who screen positive for secondhand tobacco smoke exposure whose caregivers are referred to smoking cessation resources
Time frame: 1 year
Hospital/Inpatient: Proportion of children prescribed antibiotics at hospital discharge
Time frame: 1 year
Hospital/Inpatient: Proportion of children with emergency department visits or readmissions to the hospital within 7 days
Time frame: 1 year
Hospital/Inpatient: Proportion of children transferred to a higher level of care
Time frame: 1 year
Emergency Department: Proportion of children who get an asthma exacerbation severity assessment at ED triage
Time frame: 1 year
Emergency Department: Proportion of children who have chest radiographs performed
Time frame: 1 year
Emergency Department: Proportion of children admitted to the hospital
Time frame: 1 year
Emergency Department: Proportion of children transferred to a higher level of care
Time frame: 1 year
Emergency Department: Mean length of emergency department stay
Time frame: 1 year
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 21 Mar 2022.
- Individual participant dataSharing planned: No
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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 PIPA Intervention Bundle 1 and PIPA Intervention Bundle 2 in people with Asthma, 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 4 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 21 Mar 2022. 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?
Hospital/Inpatient: Mean length of hospital stay (time frame: 1 year). The study lists 2 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 21 Mar 2022.