Improving Adherence to Pharmacological Treatment - Full Text View

Sponsors and Collaborators:	University of Massachusetts National Institutes of Health (NIH)
Information provided by:	University of Massachusetts
ClinicalTrials.gov Identifier:	NCT00848224

Purpose

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.

Condition	Intervention
Medication Adherence	Behavioral: systems-based and pharmacist-mediated program

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Improving Adherence to Pharmacological Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol Heart Diseases

U.S. FDA Resources

Further study details as provided by University of Massachusetts:

Primary Outcome Measures:

The primary outcome evaluated is the percentage of patients with a serum low-density lipoprotein cholesterol (LDL-C) level <70 mg/dl. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment:	689
Study Start Date:	September 2000
Study Completion Date:	May 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental	Behavioral: 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.

Arms

Assigned Interventions

2: Experimental

Behavioral: 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.

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.

Eligibility

Ages Eligible for Study:	30 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848224

Locations

United States, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655

Sponsors and Collaborators

University of Massachusetts

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Ira S Ockene, MD

University of Massachusetts Medical School

More Information

No publications provided

Responsible Party:	University of Massachusetts Medical School ( Ira S. Ockene, M.D. )
Study ID Numbers:	HL66786
Study First Received:	February 18, 2009
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00848224 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Massachusetts:

coronary heart disease
lipid lowering medication
NCEP guidelines

Study placed in the following topic categories:

Coronary Disease
Heart Diseases
Coronary Artery Disease

ClinicalTrials.gov processed this record on August 30, 2009