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Improving Medication Use in Patients With Hypertension

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ClinicalTrials.gov Identifier: NCT00388817
Recruitment Status : Completed
First Posted : October 17, 2006
Last Update Posted : October 17, 2006
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Indiana University School of Medicine
Wishard Health Services
Information provided by:
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE October 8, 2006
First Posted Date  ICMJE October 17, 2006
Last Update Posted Date October 17, 2006
Study Start Date  ICMJE January 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2006)
  • Adherence to blood pressure medications
  • Blood pressure control
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2006)
  • Health-related quality of life
  • Exacerbation of symptoms
  • Patient satisfaction
  • Direct costs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Medication Use in Patients With Hypertension
Official Title  ICMJE Improving Medication Use in Patients With Hypertension
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Hypertension
Intervention  ICMJE Behavioral: Pharmacist intervention
Study Arms  ICMJE Not Provided
Publications * 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. doi: 10.1001/archinternmed.2009.59. Erratum in: Arch Intern Med. 2009 Jul 13;169(13):1184.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: October 16, 2006)
492
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE May 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00388817
Other Study ID Numbers  ICMJE R01HL069399( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University of North Carolina
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • Indiana University School of Medicine
  • Wishard Health Services
Investigators  ICMJE
Principal Investigator: Michael D Murray, PharmD, MPH UNC-Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date October 2006

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