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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phone Calls to Promote Adherence With Inhaled Corticosteroids

Conditions
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Asthma

Intervention / Treatment
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* Behavioral: Automated Phone-Based Refill Reminders


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Automated Phone-Based Refill Reminders<br>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. | Behavioral: Automated Phone-Based Refill Reminders<br>* The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions.<br>* Other names: The BREATHE EASY Medication Reminder Program;|
| No Intervention: Usual Care<br>Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Medication Possession Ratio | 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. | Measured over 19 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Juniper Asthma Quality of Life Questionnaire (Global Score) | 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. | Measured at 19 months | 
| Rate of Acute Health Care Visits for Asthma | 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. | Measured over 19 months of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ICS, Inhaled Corticosteroids, Adherence