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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: COPD Inhaler Counseling
* Behavioral: Usual Pharmacy Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COPD Counseling Intervention<br>Pharmacist counseling intervention delivered via telephone. | Behavioral: COPD Inhaler Counseling<br>* 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.<br>|
| Other: Usual Care<br> | Behavioral: Usual Pharmacy Care<br>* The usual care arm will receive standard care from the William S Middleton Memorial Veterans Hospital pharmacists.<br>|

What is the study measuring?
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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 |