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Improving Adherence to Pharmacological Treatment (PACT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00848224
First Posted: February 20, 2009
Last Update Posted: February 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Massachusetts, Worcester
  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: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Adherence to Pharmacological Treatment

Further study details as provided by University of Massachusetts, Worcester:

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 ]

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 ]

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
Experimental: 2 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.
Other Name: Patient-centered counseling

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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848224


Locations
United States, Massachusetts
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
University of Massachusetts, Worcester
National Institutes of Health (NIH)
Investigators
Principal Investigator: Ira S Ockene, MD University of Massachusetts, Worcester
  More Information

Responsible Party: Ira S. Ockene, M.D., University of Massachusetts Medical School
ClinicalTrials.gov Identifier: NCT00848224     History of Changes
Other Study ID Numbers: HL66786
First Submitted: February 18, 2009
First Posted: February 20, 2009
Last Update Posted: February 20, 2009
Last Verified: February 2009

Keywords provided by University of Massachusetts, Worcester:
coronary heart disease
lipid lowering medication
NCEP guidelines