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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HL090965 | U.S. NIH Grant/Contract | View source | |
| 2R01HL090965 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics. | |
| Telemonitors and pharmacy management | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemonitors and pharmacy management | Other | Patients in the intervention arm will receive home blood pressure monitors, and will have individual hypertension case management from a medication therapy management pharmacist. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, 6 months, 12 months, 18 months |
| Mean Systolic Blood Pressure | Systolic blood pressure at baseline and 4 time points | Baseline, 6 months, 12 months, 18 months, 54 months |
| Mean Diastolic Blood Pressure | Mean diastolic blood pressure at baseline and 4 time points | Baseline, 6 months, 12 months, 18 months, 54 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen L Margolis, MD, MPH | HealthPartners Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Institute | Minneapolis | Minnesota | 55440 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22498720 | Background | Margolis KL, Kerby TJ, Asche SE, Bergdall AR, Maciosek MV, O'Connor PJ, Sperl-Hillen JM. Design and rationale for Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (HyperLink): a cluster randomized trial. Contemp Clin Trials. 2012 Jul;33(4):794-803. doi: 10.1016/j.cct.2012.03.014. Epub 2012 Apr 1. | |
| 25952653 | Background | Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Maciosek MV, Nyboer RA, O'Connor PJ, Pawloski PA, Sperl-Hillen JM, Trower NK, Tucker AD, Green BB. A Successful Multifaceted Trial to Improve Hypertension Control in Primary Care: Why Did it Work? J Gen Intern Med. 2015 Nov;30(11):1665-72. doi: 10.1007/s11606-015-3355-x. |
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Participants were assigned to treatment group based on their primary care clinic location. Clinics were randomized to treatment or control (cluster randomization).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Usual Care | Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics. |
| BG001 | Telemonitoring Intervention |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, 6 months, 12 months, 18 months |
|
Events were reported at 6, 12, and 18 month clinic visits
All events self-reported by participant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Knee, hip, or shoulder arthroplasty | Surgical and medical procedures | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Uretral stent change | Renal and urinary disorders | Non-systematic Assessment |
1) Response rate: 1 in 7 patients solicited by mail responded;of those screened, 1 in 4 eligible. 2) Participants were well-educated, had high income levels, 3) 1 integrated health care system, 4) study was not blinded.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Margolis, MD MPH | HealthPartners Institute for Education and Research | 952-967-7301 | karen.l.margolis@healthpartners.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 27363822 | Background | Pawloski PA, Asche SE, Trower NK, Bergdall AR, Dehmer SP, Maciosek MV, Nyboer RA, O'Connor PJ, Sperl-Hillen JM, Green BB, Margolis KL. A substudy evaluating treatment intensification on medication adherence among hypertensive patients receiving home blood pressure telemonitoring and pharmacist management. J Clin Pharm Ther. 2016 Oct;41(5):493-8. doi: 10.1111/jcpt.12414. Epub 2016 Jun 30. |
| 27720142 | Background | Asche SE, O'Connor PJ, Dehmer SP, Green BB, Bergdall AR, Maciosek MV, Nyboer RA, Pawloski PA, Sperl-Hillen JM, Trower NK, Margolis KL. Patient characteristics associated with greater blood pressure control in a randomized trial of home blood pressure telemonitoring and pharmacist management. J Am Soc Hypertens. 2016 Nov;10(11):873-880. doi: 10.1016/j.jash.2016.09.004. Epub 2016 Sep 25. |
| 23821088 | Result | Margolis KL, Asche SE, Bergdall AR, Dehmer SP, Groen SE, Kadrmas HM, Kerby TJ, Klotzle KJ, Maciosek MV, Michels RD, O'Connor PJ, Pritchard RA, Sekenski JL, Sperl-Hillen JM, Trower NK. Effect of home blood pressure telemonitoring and pharmacist management on blood pressure control: a cluster randomized clinical trial. JAMA. 2013 Jul 3;310(1):46-56. doi: 10.1001/jama.2013.6549. |
| 23031143 | Result | Kerby TJ, Asche SE, Maciosek MV, O'Connor PJ, Sperl-Hillen JM, Margolis KL. Adherence to blood pressure telemonitoring in a cluster-randomized clinical trial. J Clin Hypertens (Greenwich). 2012 Oct;14(10):668-74. doi: 10.1111/j.1751-7176.2012.00685.x. Epub 2012 Jul 26. |
| 35978336 | Derived | Margolis KL, Crain AL, Green BB, O'Connor PJ, Solberg LI, Beran M, Bergdall AR, Pawloski PA, Ziegenfuss JY, JaKa MM, Appana D, Sharma R, Kodet AJ, Trower NK, Rehrauer DJ, McKinney Z, Norton CK, Haugen P, Anderson JP, Crabtree BF, Norman SK, Sperl-Hillen JM. Comparison of explanatory and pragmatic design choices in a cluster-randomized hypertension trial: effects on enrollment, participant characteristics, and adherence. Trials. 2022 Aug 17;23(1):673. doi: 10.1186/s13063-022-06611-3. |
| 32862713 | Derived | Margolis KL, Dehmer SP, Sperl-Hillen J, O'Connor PJ, Asche SE, Bergdall AR, Green BB, Nyboer RA, Pawloski PA, Trower NK, Maciosek MV. Cardiovascular Events and Costs With Home Blood Pressure Telemonitoring and Pharmacist Management for Uncontrolled Hypertension. Hypertension. 2020 Oct;76(4):1097-1103. doi: 10.1161/HYPERTENSIONAHA.120.15492. Epub 2020 Aug 31. |
| 30646139 | Derived | Margolis KL, Asche SE, Dehmer SP, Bergdall AR, Green BB, Sperl-Hillen JM, Nyboer RA, Pawloski PA, Maciosek MV, Trower NK, O'Connor PJ. Long-term Outcomes of the Effects of Home Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure Among Adults With Uncontrolled Hypertension: Follow-up of a Cluster Randomized Clinical Trial. JAMA Netw Open. 2018 Sep 7;1(5):e181617. doi: 10.1001/jamanetworkopen.2018.1617. |
| 24368433 | Derived | Annuzzi G, Bozzetto L, Costabile G, Giacco R, Mangione A, Anniballi G, Vitale M, Vetrani C, Cipriano P, Della Corte G, Pasanisi F, Riccardi G, Rivellese AA. Diets naturally rich in polyphenols improve fasting and postprandial dyslipidemia and reduce oxidative stress: a randomized controlled trial. Am J Clin Nutr. 2014 Mar;99(3):463-71. doi: 10.3945/ajcn.113.073445. Epub 2013 Dec 24. |
| Language barrier |
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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.
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Primary | Mean Systolic Blood Pressure | Systolic blood pressure at baseline and 4 time points | Posted | Mean | 95% Confidence Interval | mmHg | Baseline, 6 months, 12 months, 18 months, 54 months |
|
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| Primary | Mean Diastolic Blood Pressure | Mean diastolic blood pressure at baseline and 4 time points | Posted | Mean | 95% Confidence Interval | mm Hg | Baseline, 6 months, 12 months, 18 months, 54 months |
|
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| 37 |
| 222 |
| 8 |
| 222 |
| EG001 | 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. | 30 | 228 | 5 | 228 |
| Acute pancreatitis | Gastrointestinal disorders | Non-systematic Assessment |
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| Small bowel obstruction | Gastrointestinal disorders | Non-systematic Assessment |
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| Spinal decompression/fusion | Surgical and medical procedures | Non-systematic Assessment |
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| Cellulitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Worsening Chronic Obstructive Pulmonary Disease (COPD) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment | Secondary to other conditions (renal failure, Chronic Obstructive Pulmonary Disease(COPD ), GI blood loss, anal fissure) |
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| Appendicitis | Infections and infestations | Non-systematic Assessment |
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| Acute back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Hashimoto's encephalopathy | Nervous system disorders | Non-systematic Assessment |
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| Fracture repair | Surgical and medical procedures | Non-systematic Assessment | Hospitalizations and surgery related to bone fracture |
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| Sepsis | Infections and infestations | Non-systematic Assessment |
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| Hernia repair | Surgical and medical procedures | Non-systematic Assessment |
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| Thyroidectomy | Surgical and medical procedures | Non-systematic Assessment |
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| Pyschiatric hospitalization | Psychiatric disorders | Non-systematic Assessment | Psychiatric hospital admissions: depression, alcohol abuse, psychosis, nonspecific altered mental state |
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| Overdose, toxicity, or withdrawal | Injury, poisoning and procedural complications | Non-systematic Assessment | Alcohol and narcotic overdose, toxicity, withdrawal |
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| Prostate resection | Reproductive system and breast disorders | Non-systematic Assessment |
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| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Hysterectomy | Surgical and medical procedures | Non-systematic Assessment |
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| Cholecystectomy | Surgical and medical procedures | Non-systematic Assessment |
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| Peri-operative wound infection | Infections and infestations | Non-systematic Assessment |
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| Dehydration | General disorders | Non-systematic Assessment |
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| Hemorrhoid surgery | Surgical and medical procedures | Non-systematic Assessment |
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| Gastrointestinal bleed | Gastrointestinal disorders | Non-systematic Assessment |
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| Bladder suspension | Surgical and medical procedures | Non-systematic Assessment |
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| Ascites | Hepatobiliary disorders | Non-systematic Assessment |
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| Acute abdominal pain | Hepatobiliary disorders | Non-systematic Assessment | Secondary to end stage liver disease |
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| Chest pain, non-cardiac, non-specific | General disorders | Non-systematic Assessment |
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| Chest pain, atypical | Cardiac disorders | Non-systematic Assessment | Cardiac cause not ruled out (history of cardiac disease, hypertensive crisis) |
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| Hypertensive crisis | Cardiac disorders | Non-systematic Assessment |
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| Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
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| Cerebrovascular accident (stroke) | Vascular disorders | Non-systematic Assessment |
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| Hypotension with syncope | Vascular disorders | Non-systematic Assessment | Hospitalization for hypotension with syncope |
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| Stable angina | Cardiac disorders | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
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| Transient Ischemic Attack | Vascular disorders | Non-systematic Assessment |
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| Peripheral artery disease | Vascular disorders | Non-systematic Assessment |
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| Coronary artery disease | Vascular disorders | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
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| Hypotension, dizziness, near syncope | Cardiac disorders | Non-systematic Assessment | ER or urgent care visit for low blood pressure, near syncope |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Hypertensive crisis | Vascular disorders | Non-systematic Assessment | ER or urgent care visit for high blood pressure |
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| Erythema nodosum | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hypertension | Vascular disorders | Non-systematic Assessment | New diagnosis |
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| Allergic reaction | Injury, poisoning and procedural complications | Non-systematic Assessment | ER visit for allergic reaction possibly related to antihypertensive drugs |
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| Allergic vasculitis | Vascular disorders | Non-systematic Assessment | Secondary to bladder infection treatment |
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| 12 Months |
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| 18 Months |
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| 54 Months |
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| 12 Months |
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| 18 Months |
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| 54 Months |
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