Clinical trial NCT04349020: Patient Reported Outcomes for Acute Asthma Care Treatment
Official title: Patient Reported Outcomes for Acute Asthma Care Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma
Keywords: Patient Reported Outcomes
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-04-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients being discharged from ED after an acute exacerbation.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-reported outcomes as measured by the PROAACT instrument
timeFrame: within 7-10 days of enrollment
Secondary outcomes:
measure: Association between PROAACT scores and ED guideline adherence
timeFrame: within 7-10 days of enrollment
measure: Rate of acute care encounters
timeFrame: 30 days and 180 days after index ED visit (day of enrollment)
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Michelle Lin, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.