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Measuring Adherence to Control Hypertension (MATCH)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Ian Kronish, Columbia University
ClinicalTrials.gov Identifier:
NCT01257347
First received: December 8, 2010
Last updated: February 15, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Hypertension Behavioral: Disclosure of adherence report to clinician Device: MedSignals pillbox

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Prevention
Official Title: Uncontrolled Hypertension: The Role of Medication Adherence and Clinical Inertia

Further study details as provided by Ian Kronish, Columbia University:

Primary Outcome Measures:
  • Percentage of Visits With Appropriate Hypertension Management [ Time Frame: 1 month clinic visit ]
    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.


Secondary Outcome Measures:
  • Percentage of Visits With Regimen Intensification During 1-month Visit, Adherent in Week Prior to Outcome Visit, Only [ Time Frame: 1 month clinic visit ]
    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.

  • Percentage of Visits With Counseling Performed During 1-month Visit, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period [ Time Frame: 1 month clinic visit ]
    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.

  • Percentage of Visits With Hypertension Regimen Simplification, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period [ Time Frame: 1 month clinic visit ]
    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.


Enrollment: 124
Study Start Date: January 2011
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Concealment (control)
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
(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 Name: electronic pillbox
Experimental: Disclosure (intervention)

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
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.
Device: MedSignals pillbox
(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 Name: electronic pillbox

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01257347

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Ian M Kronish, MD, MPH Columbia University
  More Information

Publications:
Responsible Party: Ian Kronish, Assistant Professor of Medicine, Columbia University
ClinicalTrials.gov Identifier: NCT01257347     History of Changes
Other Study ID Numbers: AAAI1720
K23HL098359 ( U.S. NIH Grant/Contract )
Study First Received: December 8, 2010
Results First Received: July 25, 2016
Last Updated: February 15, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Ian Kronish, Columbia University:
Medication adherence
clinical inertia
treatment intensification
quality of care

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 28, 2017