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OpenTrials
Completed

NCT Number: NCT00848224

Improving Adherence to Pharmacological Treatment

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.

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Key information

Conditions

Medication Adherence Behavior Cardiovascular Diseases Coronary Disease Health Behavior Heart Diseases Myocardial Ischemia Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Memorial Medical Center

Worcester, Massachusetts, 01655, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

systems-based and pharmacist-mediated program

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.

Other names: Patient-centered counseling

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • National Institutes of Health (NIH)

Registry information

Acronym: PACT

Important dates

Study start
2000
Primary completion
2005
Study completion
2005
First posted
Feb 20, 2009
Registry last updated
Feb 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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