Clinical trial NCT00921401: Improving the Quality of Asthma Care Using the Internet
Official title: Improving the Quality of Asthma Care Using the Internet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Asthma
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Penn State University
First posted: 2009-06-16
Enrollment: 408
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: It is important for people with asthma to become involved in their asthma care and management. This study will evaluate an interactive Web site that provides tailored feedback and information to asthma patients and encourages them to ask their doctor specific questions about their asthma care.

Detailed description: Asthma is a common cause of illness and lost productivity, including missed days of work and school, in the United States. It is important for people with asthma to become involved in their treatment and care. Previous studies have shown that encouraging people to ask their doctor for various medical tests and treatments improves preventive care (e.g., cancer screenings), but more research is needed on the effect this can have on asthma management. This study will involve an interactive Web site that will ask patients questions about their asthma symptoms and medications and provide suggestions and feedback on the types of questions patients may want to ask their doctors. By asking questions about their asthma care and increasing communication with their doctor, patients may experience improved quality of asthma care and better asthma control. The purpose of this study is to evaluate the impact of the interactive Web site on asthma control and other measures of asthma management.

This 12-month study will enroll people with asthma. Participants will be randomly assigned to either the Asthma Feedback group or the Preventive Feedback (control) group. Both groups will log in to the study Web site at least once a month for 12 months and before all doctor visits. After logging in to the Web site, participants in the Asthma Feedback group will answer a series of questions about their asthma care. They will then receive information and feedback on the types of questions they should ask their asthma care provider during their next office visit. Participants in the Preventive Feedback group will answer questions and receive information and feedback regarding preventive services (e.g., cancer screening, cholesterol screening) that they should discuss with their primary care provider. At baseline and Months 6 and 12, all participants will complete online questionnaires regarding their asthma and overall health. Study researchers will review participants' medical records and insurance claims data at the end of the study.

Eligibility criteria: Inclusion Criteria:

Only individuals with persistent asthma will be considered for this study. These definitions are made based on definitions from the National Committee for Quality Assurance (NCQA) and include individuals who meet either criteria A or B:

* A: (Four or more prescription medications used for asthma treatment in 1 year) OR (One or more visits to the emergency room with a principal diagnosis of asthma in 1 year) OR (One or more inpatient hospital visits with a principal diagnosis of asthma in 1 year)
* B: (Four or more outpatient visits with any diagnosis of asthma) AND (two or more claims for a prescription drug used for asthma treatment in 1 year)

Other Inclusion Criteria:

* Speaks and reads English fluently
* Member of Highmark
* Has access to the Internet at home or at work
* Has a valid e-mail address
* No history of more than 20 pack-years of cigarette smoking
* Enrolled in a Highmark health plan offering that includes prescription drug coverage

Exclusion Criteria:

* Does not speak English
* Does not have Internet access at home or work
* Smoked more than 20 pack-years (to exclude possible chronic obstructive pulmonary disease \[COPD\])
* Does not currently have asthma
* Pregnant
* Unwilling to consent

Primary outcomes:
measure: Asthma control - as measured by the Asthma Control Test
timeFrame: Measured at Year 1
Secondary outcomes:
measure: Medication adherence, as measured by claims data
timeFrame: Measured at Year 1
measure: Outpatient provider visits, as measured by claims data
timeFrame: Measured at Year 1
measure: Asthma-related emergency department visits, as measured by claims data
timeFrame: Measured at Year 1
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center, Penn State College of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn State University
name: Christopher N Sciamanna, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pool AC, Kraschnewski JL, Poger JM, Smyth J, Stuckey HL, Craig TJ, Lehman EB, Yang C, Sciamanna CN. Impact of online patient reminders to improve asthma care: A randomized controlled trial. PLoS One. 2017 Feb 3;12(2):e0170447. doi: 10.1371/journal.pone.0170447. eCollection 2017.