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

NCT ID: NCT00414817

Last Updated: 2017-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14064 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-10-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Automated Phone-Based Refill Reminders

Intervention Type: BEHAVIORAL

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.

Usual Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Automated Phone-Based Refill Reminders

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

The BREATHE EASY Medication Reminder Program

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William M. Vollmer, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Health Research/KPNW

Cynthia Rand, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Joan Dubanoski, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Health Research/KPH

Adrianne Feldstein, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Health Research/KPNW

David Smith, PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Health Research/KPNW

Locations

Center for Health Research/KPH

Honolulu, Hawaii, United States

Center for Health Research-KPNW

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 22691240 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22216772 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25133772 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/22216772

main outcomes, Amer J Manag Care 2011

http://www.ncbi.nlm.nih.gov/pubmed/22691240

Vollmer et al, BMC Hlth Serv Res 2012. contains further details on computation of primary outcome measure and its performance characteristics

Other Identifiers

R01HL083433

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01HL083433-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

443

Identifier Type: -

Identifier Source: org_study_id