Integrating Patient-Reported Outcomes Into Routine Primary Care: Monitoring Asthma Between Visits
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- RAND
- Enrollment
- 413
- Locations
- 2
- Primary Endpoint
- Asthma-related patient-reported quality of life
Study Overview
Brief Summary
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.
Detailed Description
The specific aims of this study are:
- 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.
- 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.
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •English- or Spanish-speaking
- •18 years of age
- •Regularly uses (most days) a compatible smartphone (iOS or Android)
- •Able to provide consent
- •Seen for primary care within the last 12 months at one of the 7 outpatient primary care clinics that are part of the Brigham & Women's Hospital (BWH)/ Brigham & Women's Faulkner Hospital (BWFH) practice-based research network.
- •At least one visit coded for asthma within 12 months prior to screening, including inpatient, emergency department, urgent care/walk-in, and specialist visits.
Exclusion Criteria
- •Deemed inappropriate for study, per judgment of the BWH/ BWFH primary care provider
- •Unable to provide consent
Arms & Interventions
Intervention
All enrolled participants were assigned to a single study arm and received the intervention. The intervention consisted of a study smartphone application for asthma symptom monitoring (available in Spanish and English and downloadable for iOS and Android devices).
Intervention: Mobile health app (Other)
Usual Care
Usual care group patients received an email with general asthma advice
Outcomes
Primary Outcomes
Asthma-related patient-reported quality of life
Time Frame: 12 months from enrollment
Asthma-related patient-reported quality of life assessed using the 15-item Mini Asthma Quality of life Questionnaire (AQLQ)
Change in Asthma-related Quality of Life (Mini AQLQ Score) - 12 Months
Time Frame: Baseline to 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).
Change in Asthma-related Quality of Life (Mini AQLQ Score) - 6 Months
Time Frame: Baseline to 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).
Secondary Outcomes
- Asthma-related healthcare utilization(12 months from enrollment)
- Asthma-related Healthcare Utilization(Baseline to 12 months)