Clinical trial NCT00414817: Telephone-Based Program to Promote Inhaled Corticosteroid Adherence Among Individuals With Asthma
Official title: Phone Calls to Promote Adherence With Inhaled Corticosteroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Inhaled Corticosteroids
ICS
Adherence
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2006-12-22
Enrollment: 14064
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Medication Possession Ratio
timeFrame: Measured over 19 months
Secondary outcomes:
measure: Juniper Asthma Quality of Life Questionnaire (Global Score)
timeFrame: Measured at 19 months
measure: Rate of Acute Health Care Visits for Asthma
timeFrame: Measured over 19 months of follow-up
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Center for Health Research/KPH
state: Hawaii
city: Portland
country: United States
facility: Center for Health Research-KPNW
state: Oregon
Study officials:
affiliation: Center for Health Research/KPNW
name: William M. Vollmer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Cynthia Rand, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Health Research/KPH
name: Joan Dubanoski, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Health Research/KPNW
name: Adrianne Feldstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Health Research/KPNW
name: David Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vollmer WM, Xu M, Feldstein A, Smith D, Waterbury A, Rand C. Comparison of pharmacy-based measures of medication adherence. BMC Health Serv Res. 2012 Jun 12;12:155. doi: 10.1186/1472-6963-12-155.
citation: Vollmer WM, Feldstein A, Smith DH, Dubanoski JP, Waterbury A, Schneider JL, Clark SA, Rand C. Use of health information technology to improve medication adherence. Am J Manag Care. 2011 Dec;17(12 Spec No.):SP79-87.
citation: Schneider J, Waterbury A, Feldstein A, Donovan J, Vollmer WM, Dubanoski J, Clark S, Rand C. Maximizing acceptability and usefulness of an automated telephone intervention: Lessons from a developmental mixed-methods approach. Health Informatics J. 2011 Mar;17(1):72-88. doi: 10.1177/1460458210391220.