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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier:
NCT00781365
First received: October 28, 2008
Last updated: June 12, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Hypertension
Other: Telemonitors and pharmacy management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Home Blood Pressure Telemonitoring and Case Management to Control Hypertension

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute for Education and Research:

Primary Outcome Measures:
  • Blood Pressure Control [ Time Frame: Baseline, 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Systolic blood pressure at baseline and 3 time points

  • Mean Diastolic Blood Pressure [ Time Frame: Baseline, 6 months, 12 months, 18 months ] [ Designated as safety issue: No ]
    Mean diastolic blood pressure at baseline and 3 time points


Enrollment: 450
Study Start Date: March 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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 and 18 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781365

Locations
United States, Minnesota
HealthPartners Research Foundation
Minneapolis, Minnesota, United States, 55440
Sponsors and Collaborators
HealthPartners Institute for Education and Research
Investigators
Principal Investigator: Karen L Margolis, MD, MPH HealthPartners Institute for Education and Research
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier: NCT00781365     History of Changes
Other Study ID Numbers: 07116, 1R01HL090965
Study First Received: October 28, 2008
Results First Received: February 27, 2014
Last Updated: June 12, 2014
Health Authority: United States: Federal Government

Keywords provided by HealthPartners Institute for Education and Research:
Hypertension
Telemonitoring
Pharmacy management

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014