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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01270594
• Other study ID #: M-2010-1187
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2011
• Last updated: May 26, 2015
• Start date: January 2011
• Est. completion date: April 2012

Study information

• Verified date: May 2015
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: April 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• Usual Pharmacy Care
The usual care arm will receive standard care from the William S Middleton Memorial Veterans Hospital pharmacists.

Locations

Country	Name	City	State
United States	UW-Madison School of Pharmacy	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	American Society of Health-System Pharmacists, William S. Memorial Veterans Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to daily inhaled COPD medications	Adherence will be measured by pharmacy refill records and by participant self-report	Previous six months	No
Secondary	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	No