- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01257347
Measuring Adherence to Control Hypertension (MATCH)
Uncontrolled Hypertension: The Role of Medication Adherence and Clinical Inertia
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- Columbia University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: 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.
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(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 Names:
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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). |
(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 Names:
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Visits With Appropriate Hypertension Management
Time Frame: 1 month clinic visit
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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.
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1 month clinic visit
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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
Time Frame: 1 month clinic visit
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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.
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1 month clinic visit
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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
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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.
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1 month clinic visit
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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
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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.
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1 month clinic visit
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ian M Kronish, MD, MPH, Columbia University
Publications and helpful links
General Publications
- Moise N, Davidson KW, Chaplin W, Shea S, Kronish I. Depression and clinical inertia in patients with uncontrolled hypertension. JAMA Intern Med. 2014 May;174(5):818-9. doi: 10.1001/jamainternmed.2014.115. No abstract available.
- Kronish IM, Lin JJ, Cohen BE, Voils CI, Edmondson D. Posttraumatic stress disorder and medication nonadherence in patients with uncontrolled hypertension. JAMA Intern Med. 2014 Mar;174(3):468-70. doi: 10.1001/jamainternmed.2013.12881. No abstract available.
- Alcantara C, Edmondson D, Moise N, Oyola D, Hiti D, Kronish IM. Anxiety sensitivity and medication nonadherence in patients with uncontrolled hypertension. J Psychosom Res. 2014 Oct;77(4):283-6. doi: 10.1016/j.jpsychores.2014.07.009. Epub 2014 Jul 15.
- Moise N, Schwartz J, Bring R, Shimbo D, Kronish IM. Antihypertensive drug class and adherence: an electronic monitoring study. Am J Hypertens. 2015 Jun;28(6):717-21. doi: 10.1093/ajh/hpu199. Epub 2014 Oct 24.
- Gallagher BD, Muntner P, Moise N, Lin JJ, Kronish IM. Are two commonly used self-report questionnaires useful for identifying antihypertensive medication nonadherence? J Hypertens. 2015 May;33(5):1108-13. doi: 10.1097/HJH.0000000000000503.
- Kronish IM, Moise N, McGinn T, Quan Y, Chaplin W, Gallagher BD, Davidson KW. An Electronic Adherence Measurement Intervention to Reduce Clinical Inertia in the Treatment of Uncontrolled Hypertension: The MATCH Cluster Randomized Clinical Trial. J Gen Intern Med. 2016 Nov;31(11):1294-1300. doi: 10.1007/s11606-016-3757-4. Epub 2016 Jun 2.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAI1720
- K23HL098359 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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