Telephone-Based Program to Promote Inhaled Corticosteroid Adherence Among Individuals With Asthma

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Behavioral: Automated Phone-Based Refill Reminders

• Registration Number: NCT00414817
• Lead Sponsor: Kaiser Permanente

Brief Summary

Inhaled corticosteroids (ICS) are often prescribed as a treatment for asthma. However, many individuals who take these medications do not adhere to their prescribed treatment regimen. The purpose of this study is to evaluate the effectiveness of a telephone-based program at improving medication adherence among individuals with asthma.

Detailed Description

Asthma is a serious, chronic disease that affects lung function and impairs an individual's ability to breathe normally. ICS reduce airway inflammation and are often prescribed to treat these conditions. However, poor medication adherence is a common problem that can lead to treatment failure, hospitalization, or death. A telephone-based system that uses interactive voice recognition technology to remind individuals to follow their medication regimen may prove beneficial in promoting adherence. The purpose of this study is to evaluate the effectiveness of such a telephone-based intervention at improving adherence to inhaled corticosteroid regimens among individuals with asthma. If this study proves successful, telephone-based interventions may be developed to promote treatment adherence for other chronic medical conditions.

This 19-month study will enroll approximately 14,000 members of the Kaiser Permanente Northwest or Hawaii health system. Participants will be randomly assigned to either take part in the telephone intervention or receive usual medical care. Over the 19-month period, participants in the intervention group will receive between one and eight phone calls that will remind them to refill their prescriptions and offer education about ICS. If needed, the call may also offer a transfer to a pharmacy refill line or to speak with a pharmacist. Approximately 2,000 participants will complete questionnaires at study entry and at the end of the 19-month intervention period. The questionnaires will assess quality of life, respiratory health, asthma control, depression, inhaler use beliefs, and satisfaction with the intervention. Electronic medical record data and questionnaires will be used to determine adherence rates.

Study Timeline

• Study First Submitted: 2006-12-20
• Study First Submitted QC: 2006-12-20
• Study First Posted: 2006-12-22
• Study Start: 2007-06
• Primary Completion: 2009-04
• Study Completion: 2009-10
• Results First Submitted: 2015-07-23
• Status Verified: 2016-12
• Results First Submitted QC: 2016-12-06
• Last Update Submitted: 2016-12-06
• Results First Posted: 2017-01-30
• Last Update Posted: 2017-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14064

Inclusion Criteria

• Received treatment for asthma in the year prior to study entry
• Received at least one respiratory medication at a Kaiser Permanente Northwest (KPNW) or Kaiser Permanente Hawaii (KPH) outpatient pharmacy in the year prior to study entry
• Continuous Kaiser Permanente membership from the year prior to study entry through study entry
• Willing to participate in the study

Exclusion Criteria

• Excluded from primary analyses if fewer than three months of follow-up

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Automated Phone-Based Refill Reminders	Automated Phone-Based Refill Reminders	Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.

Primary Outcome Measures

Name	Time	Method
Modified Medication Possession Ratio	Measured over 19 months	We used a modification of the Medication Possession Ratio (MPR) as our primary outcome measure. The MPR is computed as the number of days' supply of medication dispensed during a given time window divided by the time between the first dispensing in the window and the end of the window. Our modified MPR (mMPR) also accounted for medication that was on hand at the start of the window and ignored any days' supply that would extend beyond the end of the window. The MPR, and by extension the mMPR, assumes that medications were used as directed and that a new inhaled corticosteroid canister was not started until any medication on hand was exhausted.

Secondary Outcome Measures

Name	Time	Method
Juniper Asthma Quality of Life Questionnaire (Global Score)	Measured at 19 months	Asthma specific quality of life measurement developed by Dr. Elizabeth Juniper. This is the overall summary score and ranges from 1=poorest quality of life to 7=best quality of life.
Rate of Acute Health Care Visits for Asthma	Measured over 19 months of follow-up	annualized rate of acute asthma health care utilization events (urgent care, emergency department use, hospitalization) based on data derived from the electronic medical record. Each type of event was given equal weight for this analysis.

Trial Locations

Locations (2)

Center for Health Research/KPH; 🇺🇸 Honolulu, Hawaii, United States

Center for Health Research-KPNW; 🇺🇸 Portland, Oregon, United States