Clinical trial NCT04401332: A Randomized Controlled Trial of AppS to Home Monitor Your Asthma
Official title: Integrating Patient-Reported Outcomes Into Routine Primary Care: Monitoring Asthma Between Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: patient-reported outcomes (PROs)
mobile health (mHealth) apps
asthma
electronic health record (EHR)
health information technology
implementation research
mobile phone
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2020-05-26
Enrollment: 445
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Asthma-related patient-reported quality of life
timeFrame: 6 months from enrollment
measure: Asthma-related patient-reported quality of life
timeFrame: 12 months from enrollment
Secondary outcomes:
measure: Asthma-related healthcare utilization
timeFrame: 12 months from enrollment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
Study officials:
affiliation: RAND
name: Robert S Rudin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mass General Brigham
name: Anuj K Dalal, MD
role: PRINCIPAL_INVESTIGATOR
References: