Improving Adherence to Pharmacological Treatment

Medication Adherence Clinical Trial

— PACT  

Official title:

Improving Adherence to Pharmacological Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00848224
• Other study ID #: HL66786
• Status: Completed
• Phase: N/A
• First received: February 18, 2009
• Last updated: February 19, 2009
• Start date: September 2000
• Est. completion date: May 2005

Study information

• Verified date: February 2009
• Source: University of Massachusetts, Worcester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 689
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Medication Adherence

Intervention

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.

Locations

Country	Name	City	State
United States	UMass Memorial Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome evaluated is the percentage of patients with a serum low-density lipoprotein cholesterol (LDL-C) level <70 mg/dl.		One year	No
Secondary	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	No