The objective of this study is to design, implement, and evaluate the impact of an adapted health information technology(IT)-enabled practice model for asthma symptom monitoring using patient-reported outcomes (PROs) in a primary care setting. Adults over 18 years of age with asthma will be recruited at primary care clinics and randomized to either 1) asthma symptom monitoring via the mobile health (mHealth) app; or 2) usual care. The investigators will collect data on patient-reported asthma quality of life and asthma-related healthcare utilization. We will also study barriers and facilitators to implementation of the mHealth app and health IT-enabled practice model.
The specific aims of this study are: 1. Adapt our existing health IT-enabled practice model for asthma symptom monitoring using PROs to a primary care population. The health IT-enabled practice model is comprised of the following: an mHealth app that can be installed on patients' smartphones that integrates into clinical workflow; and an asthma PRO dashboard in the electronic health record (EHR) for clinicians. 2. Implement the adapted health IT-enabled practice model in 7 primary care community clinics, identify a cohort of eligible asthma patients to participate, and train clinicians and clinical staff. 3. Rigorously evaluate the impact of this new health IT-enabled practice model using a randomized controlled trial study in which we enroll 500 asthma patients (250 intervention, 250 usual care) by primary care clinician. We will measure patient-reported asthma quality of life and asthma-related healthcare utilization (defined as urgent care and emergency room visits and hospitalizations) as our primary and secondary outcomes, respectively. We will use mixed methods to identify barriers and facilitators to implementation and factors that affect sustainable spread and scale as per the Non-adoption, Abandonment, Scale-up, Spread, and Sustainability (NASSS) framework.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Asthma symptom monitoring via a clinically integrated mobile health (mHealth) application installed on participants' smartphones.
Brigham & Women's Hospital
Boston, Massachusetts, United States
Change in Asthma-related Quality of Life (Mini AQLQ Score) - 12 Months
Mean change in asthma-related patient-reported quality of life from baseline to 12 months, assessed using the 15-item Mini Asthma Quality of Life Questionnaire (MiniAQLQ). MiniAQLQ scores range from 1 (worst quality of life) to 7 (best quality of life), with higher scores indicating better asthma-related quality of life. The MiniAQLQ score represents the mean of 15 items across four domains (symptoms, activity limitation, emotional function, and environmental stimuli).
Time frame: Baseline to 12 months
Change in Asthma-related Quality of Life (Mini AQLQ Score) - 6 Months
Mean change in asthma-related patient-reported quality of life from baseline to 6 months, assessed using the 15-item Mini Asthma Quality of Life Questionnaire (MiniAQLQ). MiniAQLQ scores range from 1 (worst quality of life) to 7 (best quality of life), with higher scores indicating better asthma-related quality of life. The MiniAQLQ score represents the mean of 15 items across four domains (symptoms, activity limitation, emotional function, and environmental stimuli).
Time frame: Baseline to 6 months
Asthma-related Healthcare Utilization
Mean number of asthma-related healthcare encounters per participant during the study period, including nonroutine asthma-related emergency department visits, urgent care visits, and hospitalizations (with asthma listed as the primary or secondary diagnosis) at MGB-affiliated institutions.
Time frame: Baseline to 12 months
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Enrollment
413