Improving Medication Use in Patients With Hypertension

• ClinicalTrials.gov Identifier: NCT00388817
• Recruitment Status: Completed
• First Posted: October 17, 2006
• Last Update Posted: October 17, 2006
• Sponsor: University of North Carolina
• 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: October 8, 2006
• First Posted Date: October 17, 2006
• Last Update Posted Date: October 17, 2006
• Study Start Date: January 2002
• Primary Completion Date: Not Provided

Current Primary Outcome Measures (submitted: October 16, 2006)

• Adherence to blood pressure medications
• Blood pressure control

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: October 16, 2006)

• Health-related quality of life
• Exacerbation of symptoms
• Patient satisfaction
• Direct costs

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Improving Medication Use in Patients With Hypertension
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Condition: Hypertension
• Intervention: Behavioral: Pharmacist intervention
• Study Arms: 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.

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: October 16, 2006): 492
• Original Enrollment: Same as current
• Study Completion Date: May 2005
• Primary Completion Date: Not Provided

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00388817
• Other Study ID Numbers: R01HL069399( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Not Provided
• Study Sponsor: University of North Carolina

Collaborators

• National Institutes of Health (NIH)
• Indiana University School of Medicine
• Wishard Health Services

Investigators

• Principal Investigator: Michael D Murray, PharmD, MPH; UNC-Chapel Hill

• PRS Account: University of North Carolina, Chapel Hill
• Verification Date: October 2006