Telecommunication Enhanced Asthma Management

Not Applicable

Completed

Conditions: Asthma

Interventions: Behavioral: Speech recognition

Registration Number: NCT00958932

Lead Sponsor: National Jewish Health

Brief Summary: The primary aim of this project is to conduct a randomized practical clinical trial within a large health maintenance organization to test a telephone intervention designed to improve adherence to daily asthma medications and thereby improve asthma outcomes. The investigators hypothesize that adherence with inhaled corticosteroid medications in the TEAM intervention group will be greater than in the usual care group.

Detailed Description: Asthma affects more than 15 million people in the United States. Inhaled corticosteroids (ICS), the ranking treatment-of-choice, are safe and highly efficacious in controlled trials, but adherence to ICS medications in real-world settings is poor in all patient groups, especially low-income and minority patients who experience the most morbidity from asthma. Children and adults with asthma take less than half of their prescribed ICS medication. One study found that only 44% of ICS prescriptions for children with asthma were filled. Even the most effective medications have little value if not taken as prescribed. Decreasing use of ICS has been repeatedly linked to poor asthma control and increasing health care utilization.

We will conduct a randomized, practical clinical trial to test the impact of a communication enhancement program for parents of 3-12 year old children with asthma in the largest health maintenance organization (HMO) within Colorado. Research in this setting has the significant advantage of not only establishing the utility of a behavior-changing strategy, but at the same time demonstrating that the strategy can be applied in a large healthcare system and sustained over time. The proposed intervention will be referred to here as the Telecommunication Enhanced Adherence Management (TEAM) program. This proposal builds upon ongoing efforts within Kaiser Permanente of Colorado (KPCO), the participating HMO, to use automated telecommunication technology to prevent diabetes, reduce cardiac risk, reduce calorie consumption, and increase exercise adherence, with the introduction of an intervention to increase adherence with daily ICS therapy. Speech Recognition (SR), the telecommunication technology used in this trial, has not previously been employed to promote adherence in a population of children treated for asthma within a large HMO. TEAM creates a theory-based enhanced communication program using SR with support from asthma care manager nurses. The Asthma Care Manager program already exists within KPCO, but with SR the frequency and quality of communication with parents is expected to improve significantly, resulting in more ICS medication refills, better persistence in ICS use, and improved asthma outcomes. Through SR calls, parents will be reminded and motivated about the importance of continued daily use of ICS medications, asked about their child's recent asthma symptoms, and given the opportunity to receive a call back from an asthma care manager or to place a request for a medication refill.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1187

Inclusion Criteria

3-12 year old children with asthma requiring daily corticosteroid

Exclusion Criteria

sibling already in study
physician excludes from participation
non English Speaking

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Speech recognition (TEAM intervention)	Speech recognition	Parents randomized to the intervention received speech recognition phone calls if their child's medication refill was overdue.

Primary Outcome Measures

Name	Time	Method
Medication Adherence	12 months	The primary outcome of this study, adherence, was expressed as a mean proportion of days covered (PDC) over 24 months. The PDC was calculated as the total number of ICS days supplied divided by the period for which the medication was prescribed. Calculation of the PDC was adjusted to account for the supply that would extend beyond the end of the study period. Comparisons were adjusted for baseline PDC, which was calculated as the ratio of number of days a patient had possession of medication divided by the number of days enrolled 1 year prior to randomization.

Secondary Outcome Measures

Name	Time	Method
Emergency Care Visits Per Person-Year	Per one year of person-time	Asthma-related emergency care events were compared between the two study groups. In health insurance data, individual records often do not cover the entire period of study because people may leave the insurance network seeking new coverage, or after moving, etc. However, this partial data is still usable when pooled to calculate numbers of events of interest per person-year. For example, one person may only be in the study for six months, and they may log an emergency room. Another person may be in the study for 18 months and log no visits. Put together, the two participants log two person years of data (6 months + 18 months = 24 months = 2 person-years in the study) and between the two of them they log one emergency room visit, which results in an outcome of 0.5 emergency care visits, on average, per person-year of data available. This measure of central tendency is calculated for the two study groups to permit comparison.