A Pilot Study to Evaluate a Telepharmacy Intervention to Improve Inhaler Adherence in Veterans With COPD

Hypothesis: Can a counseling intervention, delivered by a pharmacist, increase inhaler adherence in veterans with COPD who have demonstrated poor inhaler adherence through pharmacy refill records?

Veterans who receive who receive daily maintenance inhalers from the William S Middleton Memorial Veterans Hospital Pharmacy and who have a medication possession ratio less than 80% over the previous six months will be invited to participate in the study. This study will randomize 100 participants to a usual care arm or a pharmacist counseling intervention. Final data collection will be six months after randomization to determine if both self-reported and refill record adherence has changed.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Behavioral: COPD Inhaler Counseling; Behavioral: Usual Pharmacy Care

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • UW-Madison School of Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female veterans established with the William S. Middleton Memorial Veterans Hospital and associated Community Based Outpatient Clinics
• Fill their inhaled COPD medications with the VHA
• A diagnosis of COPD and an active prescription for a twice daily long-acting beta-agonist and/or long-acting anticholinergic with or without a prescription for inhaled corticosteroids for at least 4 months.
• Non-adherence to at least one COPD medication, a medication possession ratio of less than 80% or over 120% via the pharmacy refill records.

Exclusion Criteria:

• Patients with a diagnosis or electronic medical record note regarding significant hearing impairment.
• Patients with a diagnosis regarding cognitive deficit and activated power of attorney.
• Patients who use daily nebulization instead of inhalers for maintenance medication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Usual Care	Behavioral: Usual Pharmacy Care; The usual care arm will receive standard care from the William S Middleton Memorial Veterans Hospital pharmacists.
Experimental: COPD Counseling Intervention; Pharmacist counseling intervention delivered via telephone.	Behavioral: COPD Inhaler Counseling; The counseling will be performed via telephone by a pharmacist at the William S Middleton Memorial Veterans Hospital. The counseling will include education about inhaled COPD medication, inhaler technique review, reminder tools, and motivational interviewing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to daily inhaled COPD medications	Adherence will be measured by pharmacy refill records and by participant self-report	Previous six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
COPD exacerbations	Participants will be asked how many episodes of worsening their COPD has required additional medical care and/or the use of an oral steroid or antibiotic.	Previous six months

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: American Society of Health-System Pharmacists; William S. Middleton Memorial Veterans Hospital
• Investigators: Principal Investigator: Arthur Schuna, RPh MS, William S. Middleton Memorial Veterans Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: January 3, 2011
• First Submitted That Met QC Criteria: January 3, 2011
• First Posted (Estimate): January 5, 2011

Study Record Updates

• Last Update Posted (Estimate): May 28, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: M-2010-1187