Asthma
Conditions
Keywords
patient-reported outcomes (PROs), mobile health (mHealth) apps, asthma, electronic health record (EHR), health information technology, implementation research, mobile phone
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: 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.
Interventions
OTHERMobile health app
Asthma symptom monitoring via a clinically integrated mobile health (mHealth) application installed on participants' smartphones.
Sponsors
RAND
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Asthma-related Quality of Life (Mini AQLQ Score) - 12 Months | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Asthma-related Healthcare Utilization | Baseline to 12 months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert S Rudin, PhD
RAND
PRINCIPAL_INVESTIGATORAnuj K Dalal, MD
Massachusetts General Hospital
Participant flow
Recruitment details
Adults with a diagnosis of asthma who had a primary care provider at one of seven participating primary care clinics affiliated with a large academic health center in Boston, MA were identified and recruited between July 2020 and March 2022. Eligible patients completed screening and baseline questionnaires prior to enrollment. Reported recruitment and pre-assignment details apply to patient participants only.
Pre-assignment details
Primary care clinicians participated in delivering usual clinical care and supporting the intervention but were not enrolled as research participants and are therefore not included in enrollment counts or study data reported in this record. After providing informed consent and completing baseline questionnaires, 413 eligible patients were randomized to the intervention group (n = 211) or the usual care control group (n = 202).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 52.2 Years STANDARD_DEVIATION 15.4 |
| Mini Asthma Quality of Life Questionnaire (MiniAQLQ) score | 5.04 Score on a scale STANDARD_DEVIATION 1.27 |
| Race/Ethnicity, Customized Black | 82 Participants |
| Race/Ethnicity, Customized Hispanic | 77 Participants |
| Race/Ethnicity, Customized Other or missing | 12 Participants |
| Race/Ethnicity, Customized White | 226 Participants |
| Sex: Female, Male Female | 164 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
None listed