Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-02-28 @ 5:34 AM
Study NCT ID:
NCT04349020
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2020-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Reported Outcomes for Acute Asthma Care Treatment
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Patient Reported Outcomes for Acute Asthma Care Treatment
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROAACT
Brief 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. 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1K23HL143042-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |