- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04349020
Patient Reported Outcomes for Acute Asthma Care Treatment (PROAACT)
April 15, 2024 updated by: Michelle Lin, Stanford University
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michelle Lin, MD, MPH, MS
- Phone Number: 212-824-8067
- Email: Michelle.Lin@mountsinai.org
Study Contact Backup
- Name: Lauren Gordon, MPH
- Phone Number: 212-824-8037
- Email: lauren.gordon@mountsinai.org
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Recruiting
- Icahn School of Medicine at Mount Sinai
-
Contact:
- Lynne Richardson, MD
- Email: Lynne.Richardson@mountsinai.org
-
Principal Investigator:
- Lynne Richardson, MD
-
New York, New York, United States, 10003
- Recruiting
- Mount Sinai Beth Israel
-
Contact:
- Lynne Richardson, MD
- Email: Lynne.Richardson@mountsinai.org
-
Principal Investigator:
- Lynne Richardson, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Patients being discharged from ED after an acute exacerbation.
Description
Inclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
within 7-10 days of enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between PROAACT scores and ED guideline adherence
Time Frame: within 7-10 days of enrollment
|
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.
|
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)
|
(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.
|
30 days and 180 days after index ED visit (day of enrollment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michelle Lin, MD, MPH, MS, Icahn School of Medicine at Mount Sinai
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 24, 2019
Primary Completion (Estimated)
July 31, 2024
Study Completion (Estimated)
July 31, 2024
Study Registration Dates
First Submitted
April 14, 2020
First Submitted That Met QC Criteria
April 14, 2020
First Posted (Actual)
April 16, 2020
Study Record Updates
Last Update Posted (Actual)
April 17, 2024
Last Update Submitted That Met QC Criteria
April 15, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCO 17-2036
- 1K23HL143042-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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