Home Blood Pressure Telemonitoring and Case Management to Control Hypertension (Hyperlink)

• ClinicalTrials.gov Identifier: NCT00781365
• Recruitment Status: Completed
• First Posted: October 29, 2008
• Results First Posted: July 14, 2014
• Last Update Posted: April 13, 2017
• Sponsor: HealthPartners Institute
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): HealthPartners Institute

Tracking Information

• First Submitted Date: October 28, 2008
• First Posted Date: October 29, 2008
• Results First Submitted Date: February 27, 2014
• Results First Posted Date: July 14, 2014
• Last Update Posted Date: April 13, 2017
• Study Start Date: March 2009
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 15, 2017)

• Blood Pressure Control [ Time Frame: 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 [ Time Frame: Baseline, 6 months, 12 months, 18 months, 54 months ]
  Systolic blood pressure at baseline and 4 time points
• Mean Diastolic Blood Pressure [ Time Frame: Baseline, 6 months, 12 months, 18 months, 54 months ]
  Mean diastolic blood pressure at baseline and 4 time points

• Original Primary Outcome Measures (submitted: October 28, 2008): To test a robust, multi-modal intervention to achieve and maintain high levels of BP control (<140/90 mmHg, or <130/80 mmHg if diabetes or kidney disease is present) in primary care patients with uncontrolled blood pressure [ Time Frame: 18 months ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: October 28, 2008): To compare satisfaction with care and cost of care in the treatment intervention and usual care groups. [ Time Frame: 18 months ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Home Blood Pressure Telemonitoring and Case Management to Control Hypertension
• Official Title: Home Blood Pressure Telemonitoring and Case Management to Control Hypertension
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Hypertension

Intervention

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.

Study Arms

• No Intervention: Control
  Patients in the control group will receive usual care from their primary care physicians at HealthPartners Medical Group clinics.
• Experimental: Telemonitors and pharmacy management
  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.
  Intervention: Other: Telemonitors and pharmacy management

Publications *

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 28, 2008): 450
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 2012
• Actual Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00781365
• Other Study ID Numbers: 07116; 1R01HL090965 ( U.S. NIH Grant/Contract ); 2R01HL090965 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: HealthPartners Institute
• Study Sponsor: HealthPartners Institute
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Karen L Margolis, MD, MPH; HealthPartners Institute

• PRS Account: HealthPartners Institute
• Verification Date: March 2017