Hypertension
Conditions
Keywords
Hypertension, Telemonitoring, Pharmacy management
Brief summary
In this project we develop and implement an intervention to improve hypertension control in a primary care setting that takes advantage of new technology (home blood pressure telemonitoring) and team models of care (pharmacist case management). The results of the project will have important implications for future efforts to improve care provided to many of the estimated 20 million Americans with uncontrolled hypertension.
Detailed description
Blood pressure (BP) is controlled to recommended levels in only 1 in 3 people with hypertension, and there has been little improvement since the late 1980s, despite advances in evidence to support aggressive hypertension control, and availability of many new and effective antihypertensive drugs. It is clear that meaningful and sustained improvement in hypertension control will likely require fundamental changes in the current physician-centered office-visit based model of caring for hypertension. In this project we develop and implement an intervention that takes advantage of new technology and team models of care to improve BP measurement and control, solving the problems that have limited the application of case management approaches to hypertension care improvement. The study will take place in a diverse population of adults with hypertension cared for in a real-world primary care setting. The Telemonitoring Intervention (TI) integrates 2 innovative components: First, home BP measures are done using state-of-the-art modem-enabled automated equipment that internally stores and electronically transmits BP data through a simple touch-tone telephone connection to a secure web site. Second, a pharmacist case manager integrated with the primary care team through a jointly used electronic medical record (EMR) and formulary adjusts antihypertensive therapy using an approved written protocol, under a collaborative practice agreement with physicians. Treatment decisions are based on home BP data and are discussed and communicated to patients in telephone visits with the pharmacist case manager. Two-way communication between the pharmacist case manager and the patient's primary care team is assured by using a shared EMR and by additional secure messaging of the results of every pharmacist encounter to the primary care team. To assess the impact of the TI on hypertension control, patient satisfaction, and costs of care, we will conduct a cluster-randomized trial, assigning 16 primary care clinics and 450 of their nested patients with uncontrolled hypertension to either a Usual Care (UC) control group or TI. Blood pressure outcomes in both groups will be determined at baseline, 6, 12, 18 and 54 months in an identical and blinded fashion in a research clinic separate from the clinical setting where patients received their medical care. We hypothesize that guideline BP control will be achieved at 6 months and maintained at 12 months in more than 60% of patients from TI clinics, compared to \< 40% in patients from UC clinics. We will compare satisfaction with care and costs in the TI and UC groups. The TI has the potential to improve hypertension control for millions of patients, and could be implemented widely in diverse and large patient populations based on performance in this randomized trial. The results of the project will have important implications for future efforts to improve care provided to many of the estimated 20 million Americans with uncontrolled hypertension.
Interventions
Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist.
Sponsors
Study design
Eligibility
Inclusion criteria
* Age 21 years or more * Linked using EMR data to a HealthPartners Medical Group primary care clinic * Within the 12-month period of time prior to screening have had at least 2 primary care outpatient encounters, in the two most recent of which the blood pressure was above Joint National Committee 7 (JNC7) goal (\<140/90 mmHg or \<130/80 for patients with diabetes or kidney disease). * Have a measured blood pressure at a research clinic screening visit above the JNC7 goal
Exclusion criteria
* Acute coronary syndrome or stroke within the past 3 months * Class III (marked limitation of physical activity) or IV (symptoms at rest) New York Heart Association heart failure, or known left ventricular ejection fraction (\<30%) * Severe renal dysfunction, with epidermal growth factor receptor (eGFR) ,30 ml/min/1.73 m2 using the abbreviated Modification of Diet in Renal Disease Study (MDRD) equation * Known secondary causes of hypertension such as coarctation of the aorta, pheochromocytoma, adrenal cortical hypertension or renal vascular hypertension * Unwillingness to be followed for a period of 18 months * Pregnancy or unwillingness to use reliable bith control for females of child-bearing age * Participation in another clinical trial * Requires an interpreter to communicate with health care providers * Dementia, mental illness or any condition that would limit ability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure Control | Baseline, 6 months, 12 months, 18 months | Percentage of patients with controlled blood pressure at each time point (less than 140/90 mmHg or 130/80 mmHg for patients with kidney disease or diabetes) |
| Mean Systolic Blood Pressure | Baseline, 6 months, 12 months, 18 months, 54 months | Systolic blood pressure at baseline and 4 time points |
| Mean Diastolic Blood Pressure | Baseline, 6 months, 12 months, 18 months, 54 months | Mean diastolic blood pressure at baseline and 4 time points |
Countries
United States
Participant flow
Recruitment details
Recruitment was between March 2009-April 2011. We identified adult patients with elevated BP (systolic BP \>140 or diastolic BP \>90 mm Hg) at the two most recent primary care visits in the past year using electronic medical records. Patients received up to two mailings followed by phone calls. Further screening occurred in research clinic.
Pre-assignment details
Participants were assigned to treatment group based on their primary care clinic location. Clinics were randomized to treatment or control (cluster randomization).
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics. | 222 |
| Telemonitoring Intervention The telemonitoring intervention (TI) patients will receive a home blood pressure telemonitor and will work with a clinical pharmacist case manager to control elevated blood pressure. Patients will use their home telemonitors to read and send their blood pressures to their Pharmacist case manager, who will use phone meetings with the patient to make medication adjustments.
Telemonitors and pharmacy management : Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist. | 228 |
| Total | 450 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did Not Attend Visit | 20 | 28 |
| Overall Study | Language barrier | 1 | 0 |
| Overall Study | Withdrawal by Subject | 13 | 8 |
Baseline characteristics
| Characteristic | Total | Usual Care | Telemonitoring Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 151 Participants | 70 Participants | 81 Participants |
| Age, Categorical Between 18 and 65 years | 299 Participants | 152 Participants | 147 Participants |
| Age, Continuous | 61.1 years STANDARD_DEVIATION 12 | 60.2 years STANDARD_DEVIATION 12.2 | 62.0 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 9 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 440 Participants | 213 Participants | 227 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 7 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized Black or African American | 53 participants | 29 participants | 24 participants |
| Race/Ethnicity, Customized Other | 22 participants | 13 participants | 9 participants |
| Race/Ethnicity, Customized White | 368 participants | 177 participants | 191 participants |
| Sex: Female, Male Female | 201 Participants | 98 Participants | 103 Participants |
| Sex: Female, Male Male | 249 Participants | 124 Participants | 125 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 8 / 222 | 5 / 228 |
| serious Total, serious adverse events | 37 / 222 | 30 / 228 |
Outcome results
Blood Pressure Control
Percentage of patients with controlled blood pressure at each time point (less than 140/90 mmHg or 130/80 mmHg for patients with kidney disease or diabetes)
Time frame: Baseline, 6 months, 12 months, 18 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Blood Pressure Control | Baseline | 0 percentage of participants |
| Usual Care | Blood Pressure Control | 6 Months | 45.2 percentage of participants |
| Usual Care | Blood Pressure Control | 12 Months | 52.8 percentage of participants |
| Usual Care | Blood Pressure Control | 18 Months | 57.1 percentage of participants |
| Telemonitoring Intervention | Blood Pressure Control | 18 Months | 71.8 percentage of participants |
| Telemonitoring Intervention | Blood Pressure Control | Baseline | 0 percentage of participants |
| Telemonitoring Intervention | Blood Pressure Control | 12 Months | 71.2 percentage of participants |
| Telemonitoring Intervention | Blood Pressure Control | 6 Months | 71.8 percentage of participants |
Mean Diastolic Blood Pressure
Mean diastolic blood pressure at baseline and 4 time points
Time frame: Baseline, 6 months, 12 months, 18 months, 54 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care | Mean Diastolic Blood Pressure | Baseline | 85.1 mm Hg |
| Usual Care | Mean Diastolic Blood Pressure | 12 Months | 80.8 mm Hg |
| Usual Care | Mean Diastolic Blood Pressure | 54 Months | 79.1 mm Hg |
| Usual Care | Mean Diastolic Blood Pressure | 18 Months | 78.7 mm Hg |
| Usual Care | Mean Diastolic Blood Pressure | 6 Months | 81.7 mm Hg |
| Telemonitoring Intervention | Mean Diastolic Blood Pressure | 54 Months | 77.8 mm Hg |
| Telemonitoring Intervention | Mean Diastolic Blood Pressure | Baseline | 84.4 mm Hg |
| Telemonitoring Intervention | Mean Diastolic Blood Pressure | 6 Months | 75.0 mm Hg |
| Telemonitoring Intervention | Mean Diastolic Blood Pressure | 12 Months | 75.1 mm Hg |
| Telemonitoring Intervention | Mean Diastolic Blood Pressure | 18 Months | 75.1 mm Hg |
Mean Systolic Blood Pressure
Systolic blood pressure at baseline and 4 time points
Time frame: Baseline, 6 months, 12 months, 18 months, 54 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Usual Care | Mean Systolic Blood Pressure | 6 Months | 136.9 mmHg |
| Usual Care | Mean Systolic Blood Pressure | 18 Months | 133.0 mmHg |
| Usual Care | Mean Systolic Blood Pressure | 12 Months | 134.8 mmHg |
| Usual Care | Mean Systolic Blood Pressure | 54 Months | 131.7 mmHg |
| Usual Care | Mean Systolic Blood Pressure | Baseline | 147.7 mmHg |
| Telemonitoring Intervention | Mean Systolic Blood Pressure | 54 Months | 131.2 mmHg |
| Telemonitoring Intervention | Mean Systolic Blood Pressure | Baseline | 148.2 mmHg |
| Telemonitoring Intervention | Mean Systolic Blood Pressure | 6 Months | 126.7 mmHg |
| Telemonitoring Intervention | Mean Systolic Blood Pressure | 12 Months | 125.7 mmHg |
| Telemonitoring Intervention | Mean Systolic Blood Pressure | 18 Months | 126.9 mmHg |