Improving Adherence to Pharmacological Treatment

NCT ID: NCT00848224

Last Updated: 2009-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 689 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2005-05-31

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.

Conditions

Medication Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

2

Group Type: EXPERIMENTAL

systems-based and pharmacist-mediated program

Intervention Type: BEHAVIORAL

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.

Interventions

systems-based and pharmacist-mediated program

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Patient-centered counseling

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

University of Massachusetts Medical School

Principal Investigators

Ira S Ockene, MD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

HL66786

Identifier Type: -

Identifier Source: org_study_id