Measuring Adherence to Control Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to test whether accurately measuring patients' adherence to
      their blood pressure medications with electronic pillbox monitors and then providing
      clinicians with this information can improve the clinical management of uncontrolled
      hypertension.
    

Detailed description: 
      Despite the presence of numerous effective medications, one-half of the adults receiving
      treatment for hypertension in the United States have uncontrolled blood pressure. At least
      one-third of these hypertensive patients are not adherent to their blood pressure
      medications. Given this high rate of non-adherence, clinicians will ideally consider whether
      their patients are taking their pills before deciding whether to intensify a blood pressure
      regimen. Yet, in practice, clinicians are often unsure about their patients' level of
      adherence. This uncertainty limits clinicians' ability to optimally manage hypertension.
      Electronic medication monitors represent the gold-standard for objectively measuring
      day-to-day adherence. As a result, they have the potential to best reduce uncertainty
      regarding medication adherence. The goal of this study is to test whether providing
      clinicians with an objective measure of medication adherence obtained through electronic
      monitoring can improve clinician management of uncontrolled hypertension. When data from
      monitoring indicate poor adherence, it may motivate clinicians to counsel their patients on
      adherence. Conversely, when data from monitoring indicate good adherence among patients with
      uncontrolled hypertension, it may motivate clinicians to intensify treatment rather than
      presume patients were non-adherent.

      To test this hypothesis, this study will first enroll and randomize 30 primary care
      clinicians. Clinicians randomized to the intervention will be trained in the use of a
      quantitative report that summarizes their patients' adherence to blood pressure medications;
      they will receive these reports during visits with patients who later get enrolled in the
      study.

      The study will then enroll 300 patients with uncontrolled hypertension from the same clinic.
      These patients will then have their adherence to up to 4 blood pressure medications measured
      by an electronic pillbox. The MedSignals® pillbox (LIFETECHniques Inc., San Antonio, TX) is
      small (5"x3½"x1"), easily portable, and can simultaneous monitor adherence to up to four
      medications. The device records a pill as taken each time the individual pillbox lid is
      opened and closed. Data on adherence are easily uploaded (< 1 minute) by connecting the
      pillbox to a telephone line.

      Patients will return to the clinic after 1 month of taking their pills from the electronic
      pillbox for a visit with a research assistant and their clinician. At this time, data from
      the pillboxes will be downloaded and used to generate an adherence report. The report will
      summarize the percent of days that blood pressure medications were taken as prescribed during
      the monitoring period and will provide guidance on how to take action based on the data.
      After the report is generated (< 5 minutes), patients will attend visits with their
      clinicians. Clinicians in the intervention group will receive the adherence report at the
      time of this visit whereas clinicians in the control group will treat patients according to
      usual care (without report). Hypertension management during the 1-month clinic visit will be
      assessed after the visit by 1) reviewing the medical note to determine if clinicians
      intensified hypertension treatment and 2) surveying patients to determine if clinicians
      counseled them on adherence. Hypertension management will then be compared between groups.
    

Intervention name(s): Disclosure of adherence report to clinician; MedSignals pillbox
Intervention type(s): Behavioral; Device
Intervention description(s): During clinical visits with patients with uncontrolled hypertension, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.; (Non-experimental) Patients will be given an electronic pillbox. The device records the date and time when each compartment is opened. Adherence to each BP medication was calculated as the percent of doses taken as prescribed. Patients are informed that their adherence was recorded by the electronic pillbox and might be shared with their clinician depending on randomization.
Other intervention name(s): electronic pillbox
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Medication adherence; clinical inertia; treatment intensification; quality of care