Improving Adherence to Pharmacological Treatment

Study Overview
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Brief Summary
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The overall goal of this study was to implement and evaluate the effects of a systems-based and pharmacist-mediated program designed to improve adherence for patients with known coronary heart disease (CHD) to lipid-lowering pharmacologic therapy and of their physicians/nurse practitioners to the National Cholesterol Education Program Guidelines.

Detailed Description
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Patients were randomly assigned to a usual care condition which consisted of patients provided with usual care only, or to the Special Intervention (SI) condition. The intervention was implemented and coordinated by pharmacists, who utilized for tracking and communication the Lotus Notes®-based system that was developed for the project.

Official Title
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Improving Adherence to Pharmacological Treatment

Conditions
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Medication Adherence

Intervention / Treatment
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* Behavioral: systems-based and pharmacist-mediated program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: was between 30 and 85 years of age; had known CHD, defined as the presence of at least one coronary lesion at coronary angiography of >50%. Exclusion Criteria: was unable or unwilling to give informed consent; had a history of intolerance to two or more statin drugs; planned to move out of the area within one year of recruitment; had a poor prognosis such that life expectancy was thought to be <5 years; had a psychiatric illness which limited ability to participate; or had no telephone.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br> | Behavioral: systems-based and pharmacist-mediated program<br>* Patients in the SI were seen by a study pharmacists prior to discharge to establish a relationship with the patient, explain the pharmacist's role in the study, provide education about all discharge medications and a medication card listing all medications and their manner of use, and set the framework for the follow-up telephone calls. Patients received pharmacist-delivered adherence counseling telephone contacts that took place at two weeks following discharge, and at months 1, 3, 6, and 9 oriented towards assisting patients to remain adherent to prescribed lipid-lowering and other medications, and also towards ensuring that all patients were either documented to be at the LDL-C goal, or were assisted to reach the goal by facilitating the scheduling of repeat lipid measurement as needed and providing information, guidelines and prompts to the patient's physician or nurse practitioner.<br>* Other names: Patient-centered counseling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome evaluated is the percentage of patients with a serum low-density lipoprotein cholesterol (LDL-C) level <70 mg/dl. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of prescribed lipid-lowering medication taken by patients as measured by a continuous multiple-interval (CMA) measure of medication availability based on pharmacy records. |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary heart disease, lipid lowering medication, NCEP guidelines