An interventional study of Telemonitors and pharmacy management in Hypertension, sponsored by HealthPartners Institute. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-13.
Sponsored by HealthPartners Institute · Not applicable, Interventional, and Prevention
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 450 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →HealthPartners Institute is the lead sponsor of 164 studies on the registry; 20 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
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.
Other: 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.
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
Mean Systolic Blood Pressure
Systolic blood pressure at baseline and 4 time points
Time frame: Baseline, 6 months, 12 months, 18 months, 54 months
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
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.
| Milestone | Telemonitoring Intervention | Usual Care |
|---|---|---|
| Started | 228 | 222 |
| Completed | 194 | 186 |
| Not completed | 34 | 36 |
| Withdrew: Withdrawal by subject | 13 | 8 |
| Withdrew: Did not attend visit | 20 | 28 |
| Withdrew: Language barrier | 1 | 0 |
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)
| percentage of participants | Usual Care | Telemonitoring Intervention |
|---|---|---|
| Baseline | 0 (0 to 0) | 0 (0 to 0) |
| 6 Months | 45.2 (39.2 to 51.3) | 71.8 (65.6 to 77.3) |
| 12 Months | 52.8 (45.4 to 60.2) | 71.2 (62.0 to 78.9) |
| 18 Months | 57.1 (51.5 to 62.6) | 71.8 (65.0 to 77.8) |
Systolic blood pressure at baseline and 4 time points
| mmHg | Usual Care | Telemonitoring Intervention |
|---|---|---|
| Baseline | 147.7 (145.8 to 149.5) | 148.2 (146.3 to 150.0) |
| 6 Months | 136.9 (134.6 to 139.2) | 126.7 (124.4 to 129.0) |
| 12 Months | 134.8 (132.5 to 137.2) | 125.7 (123.4 to 128.0) |
| 18 Months | 133.0 (130.4 to 135.5) | 126.9 (124.3 to 129.4) |
| 54 Months | 131.7 (128.8 to 134.6) | 131.2 (128.3 to 134.1) |
Mean diastolic blood pressure at baseline and 4 time points
| mm Hg | Usual Care | Telemonitoring Intervention |
|---|---|---|
| Baseline | 85.1 (82.9 to 87.3) | 84.4 (82.3 to 86.6) |
| 6 Months | 81.7 (79.5 to 84.0) | 75.0 (72.9 to 77.2) |
| 12 Months | 80.8 (78.5 to 83.2) | 75.1 (72.8 to 77.4) |
| 18 Months | 78.7 (76.6 to 80.9) | 75.1 (73.0 to 77.2) |
| 54 Months | 79.1 (76.8 to 81.4) | 77.8 (75.5 to 80.1) |
Collected over Events were reported at 6, 12, and 18 month clinic visits. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care | — | 37/222 (16.7%) | 8/222 (3.6%) |
| Telemonitoring Intervention | — | 30/228 (13.2%) | 5/228 (2.2%) |
| Event | Usual Care | Telemonitoring Intervention |
|---|---|---|
| Myocardial InfarctionCardiac disorders | 8/222 | 0/228 |
| Spinal decompression/fusionSurgical and medical procedures | 6/222 | 3/222 |
| Cerebrovascular accident (stroke)Vascular disorders | 5/222 | 2/228 |
| AnemiaBlood and lymphatic system disorders | 4/222 | 2/228 |
| Overdose, toxicity, or withdrawalInjury, poisoning and procedural complications | 4/222 | 1/228 |
| Chest pain, non-cardiac, non-specificGeneral disorders | 4/222 | 3/228 |
| Knee, hip, or shoulder arthroplastySurgical and medical procedures | 2/222 | 4/228 |
| Chest pain, atypicalCardiac disorders | 0/222 | 4/228 |
| Transient Ischemic AttackVascular disorders | 3/222 | 0/228 |
| Hypotension with syncopeVascular disorders | 0/222 | 3/228 |
| Event | Usual Care | Telemonitoring Intervention |
|---|---|---|
| Hypotension, dizziness, near syncopeCardiac disorders | 1/222 | 3/228 |
| Hypertensive crisisVascular disorders | 2/222 | 0/228 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/222 | 0/228 |
| Erythema nodosumSkin and subcutaneous tissue disorders | 1/222 | 0/228 |
| HypertensionVascular disorders | 1/222 | 0/228 |
| Allergic reactionInjury, poisoning and procedural complications | 1/222 | 0/228 |
| Allergic vasculitisVascular disorders | 1/222 | 0/228 |
| Uretral stent changeRenal and urinary disorders | 0/222 | 1/228 |
| Prostate CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/222 | 1/228 |
| Age, Categorical(Participants) | Usual Care | Telemonitoring Intervention | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 152 | 147 | 299 |
| >=65 years | 70 | 81 | 151 |
| Age, Continuous(years) | Usual Care | Telemonitoring Intervention | Total |
|---|---|---|---|
| Mean | 60.2 ± 12.2 | 62.0 ± 11.7 | 61.1 ± 12.0 |
| Sex: Female, Male(Participants) | Usual Care | Telemonitoring Intervention | Total |
|---|---|---|---|
| Female | 98 | 103 | 201 |
| Male | 124 | 125 | 249 |
| Ethnicity (NIH/OMB)(Participants) | Usual Care | Telemonitoring Intervention | Total |
|---|---|---|---|
| Hispanic or Latino | 9 | 1 | 10 |
| Not Hispanic or Latino | 213 | 227 | 440 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(participants) | Usual Care | Telemonitoring Intervention | Total |
|---|---|---|---|
| White | 177 | 191 | 368 |
| Black or African American | 29 | 24 | 53 |
| Asian | 3 | 4 | 7 |
| Other | 13 | 9 | 22 |
Plan to share: No
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