Measuring Adherence to Control Hypertension

Study Overview
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Brief Summary
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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
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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 (5x3½x1), 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.

Official Title
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Uncontrolled Hypertension: The Role of Medication Adherence and Clinical Inertia

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Disclosure of adherence report to clinician
* Device: MedSignals pillbox


Participation Criteria
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Eligibility Criteria
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Inclusion criteria established diagnosis of hypertension prescribed at least one blood pressure (BP) medication at least two consecutive clinic visits with elevated BP according to Joint National Committee (JNC-7) guidelines (i.e., BP ≥ 140/90 mmHg or ≥ 130/80 mmHg if diabetes or chronic kidney disease) 18 to 80 years old at least one prior visit with a clinician enrolled in the study Exclusion criteria severe mental illness resided in a long-term care facility unable to use the electronic adherence device due to physical or cognitive impairment non-English or non-Spanish speaking unavailable for follow-up

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Concealment (control)<br>Clinicians in the control arm will not receive any electronically-monitored medication adherence information (collected via MedSignals pillbox) at the 1-month visit and will be expected to manage hypertension according to their usual care. | Device: MedSignals pillbox<br>* (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.<br>* Other names: electronic pillbox;|
| Experimental: Disclosure (intervention)<br>Disclosure of adherence report to clinician: At clinic visits with patients with uncontrolled hypertension, clinicians in the intervention arm were provided with a quantitative summary of their patients' electronic adherence to antihypertensive medications (collected via MedSignals pillbox). | Behavioral: Disclosure of adherence report to clinician<br>* 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.<br>Device: MedSignals pillbox<br>* (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.<br>* Other names: electronic pillbox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Visits With Appropriate Hypertension Management | This is assessed using an algorithm in which patients are categorized as adherent or non-adherent based on electronic monitoring. If patients are adherent (summary measure of adherence to blood pressure medications in the week prior to visit is ≥ 80%), then hypertension management is appropriate if clinicians intensify the hypertension regimen or order testing for secondary hypertension. If patients are non-adherent (summary measure of adherence < 80%), then hypertension management is appropriate if clinicians take action to increase adherence through counseling or regimen simplification. | 1 month clinic visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Visits With Regimen Intensification During 1-month Visit, Adherent in Week Prior to Outcome Visit, Only | This will be determined based on abstracting information from the electronic medical record after the 1-month visit using a standardized instrument. An outcome assessor who is blinded to clinician and patient group assignment will assess whether, during the 1-month visit, the provider intensified the blood pressure regimen (added or increased dose of medications). All prescribing and test ordering at the recruitment clinic is recorded in the electronic medical record. | 1 month clinic visit | 
| Percentage of Visits With Counseling Performed During 1-month Visit, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period | This will be determined based on interviewing patients immediately after the 1-month visit using a standardized questionnaire. A research assistant who is blinded to group assignment will ask patients questions that assess whether clinicians counseled them about taking their blood pressure medications during that most recent visit. These questions are adapted from a validated questionnaire that assesses provider communication about blood pressure medications. | 1 month clinic visit | 
| Percentage of Visits With Hypertension Regimen Simplification, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period | This will be determined by abstracting data from the electronic medical record after the 1-month visit using a standardized instrument. An outcome assessor who is blinded to clinician and patient group assignment will assess whether, during the 1-month visit, the provider simplified the regimen by switching from a short-acting, multi-day dosing medication to a long-acting, once per day medication or switched two medication to a single combination pill. All prescribing and test ordering at the recruitment clinic is recorded in the electronic medical record. | 1 month clinic visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication adherence, clinical inertia, treatment intensification, quality of care