Improving Adherence to Pharmacological Treatment

Not Applicable

Completed

• Conditions: Medication Adherence
• Interventions: Behavioral: systems-based and pharmacist-mediated program

• Registration Number: NCT00848224
• Lead Sponsor: University of Massachusetts, Worcester

Brief Summary

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

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.

Study Timeline

• Study Start: 2000-09
• Primary Completion: 2005-05
• Study Completion: 2005-05
• Status Verified: 2009-02
• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-19
• Last Update Submitted: 2009-02-19
• Study First Posted: 2009-02-20
• Last Update Posted: 2009-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 689

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	systems-based and pharmacist-mediated program	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

UMass Memorial Medical Center; 🇺🇸 Worcester, Massachusetts, United States