AsthmaPROAACTNCT04349020
Patient Reported Outcomes for Acute Asthma Care Treatment
An observational study of Asthma, run by Stanford University at 2 sites in United States.
Trial summary
Asthma affects 1 in every 12 persons in the U.S., resulting in 1.9 million ED visits annually; however, the impact of ED care on patient-reported outcomes after acute exacerbations is unknown. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Sep 2019to 31 Jul 2024
- Phase
- Observational
- 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
Study population: Patients being discharged from ED after an acute exacerbation.
Who may be able to join
- Age 18 or older
- English-speaking
- Prior diagnosis of asthma per the electronic health record
- Experiencing an ED visit for asthma as per ED clinician
- Medically appropriate for survey study as determined by treating ED clinician
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Mount Sinai Beth Israel
New York, New York, 10003
Lynne Richardson, MD, Lynne.Richardson@mountsinai.org
Lynne Richardson, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Lynne Richardson, MD, Lynne.Richardson@mountsinai.org
Lynne Richardson, MD
About this study
Asthma affects 1 in every 12 persons in the U.S., resulting in 1.9 million ED visits annually; however, the impact of ED care on patient-reported outcomes after acute exacerbations is unknown. The proposed research will train a physician-scientist to develop a novel instrument to assess patient-reported outcomes after adult ED asthma visits, evaluate the association between ED clinical processes and patient-reported outcomes, and test the association between patient-reported outcomes and subsequent acute care utilization. The candidate will acquire skills in patient-centered research, instrument development and validation, and risk adjusted outcome measurement that will enable her transition to independence.
Read the detailed description
This K23 award will enable the candidate, Michelle Lin, MD, MPH, MS, to become an independent physician scientist focused on developing, measuring and improving patient-reported outcomes for emergency department (ED) care of asthma and other acute cardiopulmonary conditions. Asthma affects 1 in every 12 persons in the U.S., resulting in 1.9 million ED visits annually; however, the impact of ED care on patient-reported outcomes after acute exacerbations is unknown-a gap which limits the evaluation of interventions to improve ED asthma care. Dr. Lin's proposed study aims to develop a patient-reported outcomes measure (PROM) for adult asthma patients seeking care in the ED, test the association between the quality of ED clinical care and patient-reported outcomes, and measure the association between patient-reported outcomes and subsequent acute care utilization. To achieve these goals, this proposal includes an integrated curriculum consisting of intensive mentorship and didactic coursework in patient-centered research, instrument development and validation including psychometric methods, geospatial techniques, outcome measurement, and risk adjustment. Her development and training activities also include building a research network of peers and collaborators, engaging with asthma patients in local communities, and participating in national scientific meetings. Dr. Lin has assembled a mentorship team of national leaders with expertise in patient-oriented asthma and emergency medicine research, patient engagement, instrument development, health care quality measurement, and outcome assessment. In her preliminary work, Dr. Lin has developed and pilot-tested candidate items for the novel Patient-Reported Outcomes for Acute Asthma Care and Treatment (PROAACT) instrument. During this K23, Dr. Lin will 1) evaluate the validity and reliability of the PROAACT instrument; 2) determine whether receiving more guideline-concordant ED care is associated with improved PROAACT responses; and 3) test the predictive validity of PROAACT responses with respect to subsequent ED visits and hospitalizations. Completion of this proposed project will result in a novel PROM for adult ED asthma patients and advance the understanding of how ED care impacts patient-reported outcomes, which will enable interventions to improve the quality of up to 1.9 million annual ED encounters for asthma. The proposed research and didactic plan will also facilitate Dr. Lin's transition to an independent clinical investigator focused on improving patient-reported outcomes for asthma and other cardiopulmonary conditions treated in ED settings.
- Conditions
- Asthma
- Keywords
- Patient Reported Outcomes
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported outcomes as measured by the PROAACT instrument
The study team will calculate patients' PROAACT scores and assess validity and reliability as a measure of quality after an ED visit asthma. the study team will compare PROAACT scores at the index visit (time of enrollment) and 7 days after enrollment. . Scale will be normalize on a Z-scale to produce a numeric value from 1-100 if validation is successful. A higher PROAACT score indicates improvement in patient-reported outcomes since the ED visit.
Measured: within 7-10 days of enrollment
Secondary outcomes (2)
Association between PROAACT scores and ED guideline adherence
The study team will assess ED clinician adherence to published guidelines for acute asthma care, and measure the association between guideline adherence and change in PROAACT scores. The study team hypothesizes patients receiving more guideline-concordant ED care will have greater improvement PROAACT scores at 7 days after the index ED visit.
Measured: within 7-10 days of enrollment
Rate of acute care encounters
(All-cause ED visit and/or hospitalization) Within 30 and 180 days after the index ED discharge. ED visits resulting in admission will count as one event.
Measured: 30 days and 180 days after index ED visit (day of enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start24 Sep 2019
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Michelle Lin, Stanford University
- Investigators
- Michelle Lin, MD, MPH, MS, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349020
- Sponsor's protocol ID
- GCO 17-2036
- Other IDs
- 1K23HL143042-01A1
- Acronym
- PROAACT
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2020
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin MP, Vargas-Torres C, Schuur JD, Shi D, Wisnivesky J, Richardson LD. Trends and predictors of hospitalization after emergency department asthma visits among U.S. Adults, 2006-2014. J Asthma. 2020 Aug;57(8):811-819. doi: 10.1080/02770903.2019.1621889. Epub 2019 Jun 12.
PubMed 31112431Lin MP, Gordon L, Richardson LD. Validating a Patient-Reported Outcome Measure to Improve Emergency Department Asthma Care: Protocol for an Observational Study. JMIR Res Protoc. 2025 May 29;14:e67195. doi: 10.2196/67195.
PubMed 40440691
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Reported Outcomes for Acute Asthma Care Treatment
- ClinicalTrials.gov ID
- NCT04349020
- Acronym / sponsor ID
- PROAACT / GCO 17-2036
- Conditions
- Asthma
- Keywords
- Patient Reported Outcomes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 24 Sep 2019 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 16 Apr 2020 (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.
Asthma affects 1 in every 12 persons in the U.S., resulting in 1.9 million ED visits annually; however, the impact of ED care on patient-reported outcomes after acute exacerbations is unknown. The proposed research will train a physician-scientist to develop a novel instrument to assess patient-reported outcomes after adult ED asthma visits, evaluate the association between ED clinical processes and patient-reported outcomes, and test the association between patient-reported outcomes and subsequent acute care utilization. The candidate will acquire skills in patient-centered research, instrument development and validation, and risk adjusted outcome measurement that will enable her transition to independence.
Detailed description
This K23 award will enable the candidate, Michelle Lin, MD, MPH, MS, to become an independent physician scientist focused on developing, measuring and improving patient-reported outcomes for emergency department (ED) care of asthma and other acute cardiopulmonary conditions. Asthma affects 1 in every 12 persons in the U.S., resulting in 1.9 million ED visits annually; however, the impact of ED care on patient-reported outcomes after acute exacerbations is unknown-a gap which limits the evaluation of interventions to improve ED asthma care. Dr. Lin's proposed study aims to develop a patient-reported outcomes measure (PROM) for adult asthma patients seeking care in the ED, test the association between the quality of ED clinical care and patient-reported outcomes, and measure the association between patient-reported outcomes and subsequent acute care utilization. To achieve these goals, this proposal includes an integrated curriculum consisting of intensive mentorship and didactic coursework in patient-centered research, instrument development and validation including psychometric methods, geospatial techniques, outcome measurement, and risk adjustment. Her development and training activities also include building a research network of peers and collaborators, engaging with asthma patients in local communities, and participating in national scientific meetings. Dr. Lin has assembled a mentorship team of national leaders with expertise in patient-oriented asthma and emergency medicine research, patient engagement, instrument development, health care quality measurement, and outcome assessment. In her preliminary work, Dr. Lin has developed and pilot-tested candidate items for the novel Patient-Reported Outcomes for Acute Asthma Care and Treatment (PROAACT) instrument. During this K23, Dr. Lin will 1) evaluate the validity and reliability of the PROAACT instrument; 2) determine whether receiving more guideline-concordant ED care is associated with improved PROAACT responses; and 3) test the predictive validity of PROAACT responses with respect to subsequent ED visits and hospitalizations. Completion of this proposed project will result in a novel PROM for adult ED asthma patients and advance the understanding of how ED care impacts patient-reported outcomes, which will enable interventions to improve the quality of up to 1.9 million annual ED encounters for asthma. The proposed research and didactic plan will also facilitate Dr. Lin's transition to an independent clinical investigator focused on improving patient-reported outcomes for asthma and other cardiopulmonary conditions treated in ED settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being discharged from ED after an acute exacerbation.
Key inclusion criteria (5 listed)
- Age 18 or older
- English-speaking
- Prior diagnosis of asthma per the electronic health record
- Experiencing an ED visit for asthma as per ED clinician
- Medically appropriate for survey study as determined by treating ED clinician
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient-reported outcomes as measured by the PROAACT instrument
Time frame: within 7-10 days of enrollment
The study team will calculate patients' PROAACT scores and assess validity and reliability as a measure of quality after an ED visit asthma. the study team will compare PROAACT scores at the index visit (time of enrollment) and 7 days after enrollment. . Scale will be normalize on a Z-scale to produce a numeric value from 1-100 if validation is successful. A higher PROAACT score indicates improvement in patient-reported outcomes since the ED visit.
2 secondary outcomes
Association between PROAACT scores and ED guideline adherence
Time frame: within 7-10 days of enrollment
Rate of acute care encounters
Time frame: 30 days and 180 days after index ED visit (day of enrollment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Background: PubMed 31112431Lin MP, Vargas-Torres C, Schuur JD, Shi D, Wisnivesky J, Richardson LD. Trends and predictors of hospitalization after emergency department asthma visits among U.S. Adults, 2006-2014. J Asthma. 2020 Aug;57(8):811-819. doi: 10.1080/02770903.2019.1621889. Epub 2019 Jun 12.
- Derived from this study: PubMed 40440691Lin MP, Gordon L, Richardson LD. Validating a Patient-Reported Outcome Measure to Improve Emergency Department Asthma Care: Protocol for an Observational Study. JMIR Res Protoc. 2025 May 29;14:e67195. doi: 10.2196/67195.
- Individual participant dataSharing planned: No
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
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.
Michelle Lin, MD, MPH, MS principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Stanford University at 2 sites 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 5 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michelle Lin, MD, MPH, MS (212-824-8067, Michelle.Lin@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported outcomes as measured by the PROAACT instrument (time frame: within 7-10 days of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04349020, which also lists 2 linked publications.
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 17 Apr 2024.