Hypertension
Conditions
Keywords
Medication adherence, clinical inertia, treatment intensification, quality of care
Brief 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 (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.
Interventions
BEHAVIORALDisclosure 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.
DEVICEMedSignals 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Visits With Appropriate Hypertension Management | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Visits With Regimen Intensification During 1-month Visit, Adherent in Week Prior to Outcome Visit, Only | 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 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Primary care providers (the cluster units) and patients were recruited from 2010 to 2014 from 2 hospital-based primary care clinics in New York City.
Pre-assignment details
200 patients were consented for the run-in and 100 were eligible for the trial and data analysis. 24 out of 49 primary care providers recruited had patients in the trial.
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Control: Physicians Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care. | 12 |
| Electronically-measuring Adherence Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm 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, and will list suggested clinical actions according to adherence status. 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. | 12 |
| Usual Care Control: Patients Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. | 35 |
| Electronically-Measuring Adherence Intervention: Patients Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. | 65 |
| Total | 124 |
Baseline characteristics
| Characteristic | Usual Care Control: Physicians | Electronically-measuring Adherence | Usual Care Control: Patients | Electronically-Measuring Adherence Intervention: Patients | Total |
|---|---|---|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 11 | 48 years STANDARD_DEVIATION 10 | 64 years STANDARD_DEVIATION 9 | 64 years STANDARD_DEVIATION 8 | 47 years STANDARD_DEVIATION 11 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 participants | 0 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Black or African American | 0 participants | 1 participants | 18 participants | 25 participants | 1 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 3 participants | 1 participants | 28 participants | 47 participants | 4 participants |
| Race/Ethnicity, Customized More than one race | 0 participants | 0 participants | 2 participants | 4 participants | 0 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 9 participants | 11 participants | 7 participants | 18 participants | 20 participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 2 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 10 participants | 9 participants | 8 participants | 17 participants | 19 participants |
| Region of Enrollment United States | 12 Participants | 12 Participants | 35 Participants | 65 Participants | 124 Participants |
| Sex/Gender, Customized Female | 6 participants | 7 participants | 22 participants | 50 participants | 13 participants |
| Sex/Gender, Customized Male | 6 participants | 5 participants | 13 participants | 15 participants | 11 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 12 | 0 / 12 | 0 / 35 | 0 / 65 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 0 / 35 | 0 / 65 |
Outcome results
Primary
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.
Time frame: 1 month clinic visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Control Group | Percentage of Visits With Appropriate Hypertension Management | 34 percentage of patient-clinician visits |
| Electronically-measuring Adherence | Percentage of Visits With Appropriate Hypertension Management | 69 percentage of patient-clinician visits |
Comparison: The sample size was calculated to have sufficient power to detect meaningful differences in appropriateness of clinician management between intervention and control groups. Each patient-clinician encounter was treated as independent and the sample size was inflated to account for the design effect (DE) of clustering of patients within clinician. GEE stands for generalized estimating equation.p-value: <=0.001GEE model
Secondary
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.
Time frame: 1 month clinic visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Control Group | Percentage of Visits With Counseling Performed During 1-month Visit, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period | 39 percentage of patient-clinician visits |
| Electronically-measuring Adherence | Percentage of Visits With Counseling Performed During 1-month Visit, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period | 84 percentage of patient-clinician visits |
Secondary
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.
Time frame: 1 month clinic visit
Population: patient-provider visits
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Control Group | Percentage of Visits With Hypertension Regimen Simplification, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period | 6 percentage of patient-clinician visits |
| Electronically-measuring Adherence | Percentage of Visits With Hypertension Regimen Simplification, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period | 9 percentage of patient-clinician visits |
Secondary
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.
Time frame: 1 month clinic visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care Control Group | Percentage of Visits With Regimen Intensification During 1-month Visit, Adherent in Week Prior to Outcome Visit, Only | 26 percentage of patient-clinician visits |
| Electronically-measuring Adherence | Percentage of Visits With Regimen Intensification During 1-month Visit, Adherent in Week Prior to Outcome Visit, Only | 56 percentage of patient-clinician visits |