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

NCT00414817 | Completed Results

• 3 other identifiers: 443R01HL083433R01HL083433-01A1
• Study Type: interventional
• Target: 14,064
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Keywords

Inhaled Corticosteroids; ICS; Adherence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Juniper Asthma Quality of Life Questionnaire (Global Score)

  Measured at 19 months

• Rate of Acute Health Care Visits for Asthma

  Measured over 19 months of follow-up

Study Arms (2)

Automated Phone-Based Refill Reminders

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Automated Phone-Based Refill Reminders 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.

Also known as: The BREATHE EASY Medication Reminder Program

Automated Phone-Based Refill Reminders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Center for Health Research/KPH

Honolulu, Hawaii, 96817, United States

Location

Center for Health Research-KPNW

Portland, Oregon, 97227, United States

Location

Related Publications (3)

• 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.

  PMID: 22691240 BACKGROUND

• 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.

  PMID: 22216772 RESULT

• 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.

  PMID: 25133772 RESULT

Related Links

• main outcomes, Amer J Manag Care 2011
• Vollmer et al, BMC Hlth Serv Res 2012. contains further details on computation of primary outcome measure and its performance characteristics

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. William Vollmer, Senior Investigator
• Organization: Kaiser Permanente, Center for Health Research

503-335-6755

Study Officials

• William M. Vollmer, PhD

  Center for Health Research/KPNW

  PRINCIPAL INVESTIGATOR

• Cynthia Rand, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Joan Dubanoski, PhD

  Center for Health Research/KPH

  PRINCIPAL INVESTIGATOR

• Adrianne Feldstein, MD

  Center for Health Research/KPNW

  PRINCIPAL INVESTIGATOR

• David Smith, PhD

  Center for Health Research/KPNW

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2006
• First Posted: December 22, 2006
• Study Start: June 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: October 1, 2009
• Last Updated: January 30, 2017
• Results First Posted: January 30, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)