Community Pharmacy Assisting in Total Cardiovascular Health

Study Overview
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Brief Summary
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Despite proven benefits in reducing morbidity and mortality, many patients become nonadherent to statin therapy within the first year of starting. Due to their accessibility and frequent patient contact, pharmacists are well-positioned to improve medication adherence. The purpose of this study is to determine whether a simple intervention by community pharmacists can improve statin adherence in new statin users.

Conditions
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Statin Therapy, Adherence

Intervention / Treatment
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* Behavioral: CPATCH intervention to support statin adherence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pharmacies must fill at least 85 statin prescriptions in a six-week period CPATCH intervention was given priority over other study initiatives offered by the pharmacy All members of pharmacy staff provided informed consent
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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacy Intervention Arm<br>All patients receiving statins from pharmacies allocated to the pharmacist intervention arm of the study | Behavioral: CPATCH intervention to support statin adherence<br>* Routine identification of new statin users (first year of therapy), consistent assessment of barriers to adherence at every dispensation for these patients, reassurance about efficacy and safety, and proactive response to identified adherence barriers.<br>|
| No Intervention: Usual Care<br>Pharmacies not allocated to the intervention arm will serve as the control. They received no training on the CPATCH intervention and provide usual care to patients at their pharmacy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean statin adherence among all eligible new users of statin medications with at least 6 months of follow-up from index prescription | All statin dispensations are captured by the prescription drug plan database. Mean adherence will be measured using the proportion of days covered (sum of days supply for statin prescriptions during study period divided by the number of days of observation). PDC will be adjusted for any days subject was hospitalized during study period., | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of new statin users with adherence greater than or equal to 80% |  | 6 months | 
| Persistence with statin use among patients with a minimum of 12 months of follow-up |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Statins, Adherence, Pharmacists