CONtrolling Disease Using Inexpensive IT - Hypertension in Diabetes
Condition: Hypertension; Diabetes Mellitus
MeSH terms: Hypertension; Diabetes Mellitus
Study type: Interventional

Summary: 
      This project will develop and test a low-cost approach to using health information technology
      and home monitoring aimed at improving care for chronic conditions, with low barriers to
      adoption in a wide variety of settings - from large group practices using state-of-the-art
      electronic health records to small practices with no more than a computer with internet
      access. Success will lead to a cost-effective approach to improving control of hypertension,
      both among individuals with diabetes and among non-diabetics, which can make a substantial
      contribution to the health of the population of the United States as improving hypertension
      control is estimated to have a greater population health benefit than most other health
      interventions. Success will also set the stage for adaptation of this intervention to a
      variety of other chronic health conditions and further substantial improvements in the health
      of millions of Americans.
    

Detailed description: 
      This project will develop and test a low-cost approach to using health information technology
      (HIT), aimed at improving the effectiveness and cost-effectiveness of care for chronic health
      conditions that are amenable to home self-monitoring, that is easy to disseminate. In
      contrast to many other HIT-based interventions, the investigators will utilize commercial,
      off-the-shelf technology rather than custom, expensive HIT. The investigators are using
      hypertension control among persons with diabetes as our test case because there is documented
      need for improving control of hypertension in this high-risk population and studies estimate
      that improving hypertension control in diabetes is more cost-effective than most other
      medical interventions and possibly even cost-saving in direct health care dollars. This
      high-value return on investment is important for encouraging adoption, expansion, and
      dissemination of HIT innovations. Our intervention will involve recruiting 400 persons with
      diabetes and uncontrolled hypertension receiving care through Reliant Medical Group (RMG -
      formerly called Fallon Clinic). MODIFICATION (2/13) - Due smaller than anticipated numbers of
      eligible persons and low enrollment, we are expanding eligibility to include "prediabetics".
      Half of them will be randomly assigned to receive an automated blood pressure (BP) monitor
      capable of uploading readings through a computer, plus instruction on how to connect their
      monitors at home or in the clinic to upload their information into a popular and free
      commercial personal health record (PHR) system. These blood pressure data from the PHR will
      be transferred automatically into RMG's electronic health record (EHR) system and will alert
      RMG's existing team of care management nurses. Subjects whose blood pressure is uncontrolled
      will have their medication regimens intensified by these nurses according to protocols.
      Intervention subjects will receive regular outreach calls from the care management nurses if
      their blood pressure remains uncontrolled or they are not periodically uploading blood
      pressure readings. After one year, the investigators will compare outcomes between control
      and intervention subjects. Our primary outcomes will be change in mean blood pressure and
      proportion of subjects with controlled blood pressure. The investigators will also measure a
      range of secondary outcomes including costs of the intervention, medication utilization, and
      a variety of patient-reported outcomes. Furthermore, the investigators will interview and
      observe study subjects and care providers to gain a better understanding of factors affecting
      uptake and use of the intervention. The investigators will examine continued use of the
      intervention after formal study participation ends and will also measure uptake of the
      intervention by control subjects offered delayed entry at the end of the formal study.
      Lastly, the investigators will compare our study and findings to other, recent studies using
      HIT to improve hypertension control and develop a set of best practices and recommendations
      for future efforts in this area.
    

Intervention name(s): Self-monitoring-nurse-primary care provider feedback loop
Intervention type(s): Other
Intervention description(s): Intervention participants will receive an Omron BP monitor and assistance in setting it up to upload BP data to Reliant Medical Group from a home/work or clinic-based computer. They will be encouraged to upload readings at least once/month. Diabetes management nurses will receive the readings and, if a participant's mean BP is not at target, will follow protocols to address this, contacting PCPs as indicated by protocols.
Other intervention name(s): CONDUIT blood pressure intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Blood Pressure Monitors; Medical Informatics; Disease Management; Comparative Effectiveness Research