Improving Medication Use in Patients With Hypertension

This study has been completed.
Sponsor:
Collaborators:
Indiana University School of Medicine
Wishard Health Services
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00388817
First received: October 8, 2006
Last updated: October 16, 2006
Last verified: October 2006

October 8, 2006
October 16, 2006
January 2002
Not Provided
  • Adherence to blood pressure medications
  • Blood pressure control
Same as current
Complete list of historical versions of study NCT00388817 on ClinicalTrials.gov Archive Site
  • Health-related quality of life
  • Exacerbation of symptoms
  • Patient satisfaction
  • Direct costs
Same as current
Not Provided
Not Provided
 
Improving Medication Use in Patients With Hypertension
Improving Medication Use in Patients With Hypertension

The purpose of this trial is to determine whether minority and low-income patients with high blood pressure take their medications better when they are helped by a pharmacist and provided with special medication packaging and information aimed at persons with low health literacy.

Optimal use of medications in patients with hypertension prevents adverse outcomes. When their blood pressure is carefully controlled, patients with uncomplicated hypertension are spared primary events including myocardial infarction, stroke, cognitive impairment, and renal insufficiency. Patients who have already experienced complications are spared the suffering of subsequent events. Because hypertension is asymptomatic and antihypertensive drugs have adverse effects, patients often feel better when they are not taking their medication as opposed to when they carefully adhere to their physician’s prescribed regimen. Therefore, innovative strategies are needed to educate patients and improve patient adherence to a complicated regimen often involving many drugs. Doing so can to reduce morbidity, mortality, and the costs of patient care. Minority patients often do not have access to the resources needed to assist them with their medications and as such they are especially vulnerable. Recent studies suggest that blood pressure control of patients with hypertension improves when pharmacists provide patients with education and monitoring. However, studies of clinical endpoints have not been conducted. This study aims to develop and test, in a randomized controlled trial, a multileveled pharmacy-based program to improve adherence in minority patients. This program incorporates patient education materials and medication packaging designed for patients with low-literacy. A study pharmacist accessed a computer database that is integrated into an electronic medical database called the Regenstrief Medical Record System (RMRS).

Patients from Wishard Health Services with uncomplicated or complicated hypertension were randomly assigned to a pharmacist intervention or usual care group. Patients in the intervention group received verbal education, written education materials, icon-based labeling of medication containers, and therapeutic monitoring. The pharmacist educated patients about their medications, identified barriers to appropriate drug use, coached patients to overcome drug use barriers, and coordinated drug use for these patients in conjunction with their primary care providers. Patients in the usual care (control) group did not receive pharmacist intervention.

To objectively measure medication compliance, Medication Event Monitor System (MEMS) lids (electronic monitors) were used for all antihypertensive medications. MEMS lids contain a computer chip that electronically imprints a time/date stamp each time an opening and closure occurs. Such data reveal the temporal pattern of medication adherence. Data concerning clinical endpoints, comorbidities, and healthcare costs were extracted from the RMRS. Other data included blood pressure measurements, health related quality of life, cognitive function, health literacy, and satisfaction with care.

Study participation for the patients in the intervention group concluded after 12 months of active intervention, which be followed by six months of post-intervention follow-up. Primary endpoints included medication adherence and systolic and diastolic blood pressures. Secondary outcomes included health-related quality of life, symptoms, patient satisfaction, and direct healthcare costs.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Hypertension
Behavioral: Pharmacist intervention
Not Provided
Murray MD, Ritchey ME, Wu J, Tu W. Effect of a pharmacist on adverse drug events and medication errors in outpatients with cardiovascular disease. Arch Intern Med. 2009 Apr 27;169(8):757-63.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
492
May 2005
Not Provided

Inclusion Criteria:

  • 18 years of age and older
  • plan to receive health care and prescriptions at study facility
  • prescribed at least one blood pressure medication
  • English-speaking
  • access to a telephone
  • no hearing impairments in the normal range of conversation

Exclusion Criteria:

  • dementia
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00388817
R01-HL69399
Not Provided
Not Provided
University of North Carolina
  • National Institutes of Health (NIH)
  • Indiana University School of Medicine
  • Wishard Health Services
Principal Investigator: Michael D Murray, PharmD, MPH UNC-Chapel Hill
University of North Carolina, Chapel Hill
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP