Patient Reported Outcomes for Acute Asthma Care Treatment

Asthma Clinical Trial

— PROAACT  

Official title:

Patient Reported Outcomes for Acute Asthma Care Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04349020
• Other study ID #: GCO 17-2036
• Secondary ID: 1K23HL143042-01A
• Status: Recruiting
• Start date: September 24, 2019
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: Michelle Lin, MD, MPH, MS
• Phone: 212-824-8067
• Email: Michelle.Lin[@]mountsinai.org
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Mount Sinai Beth Israel	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	within 7-10 days of enrollment
Secondary	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.	within 7-10 days of enrollment
Secondary	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.	30 days and 180 days after index ED visit (day of enrollment)