Clinical trial NCT01416766: CONtrolling Disease Using Inexpensive IT - Hypertension in Diabetes
Official title: CONtrolling Disease Using Inexpensive IT - Hypertension in Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Diabetes Mellitus
Keywords: Blood Pressure Monitors
Medical Informatics
Disease Management
Comparative Effectiveness Research
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Reliant Medical Group
name: University of Massachusetts, Amherst
First posted: 2011-08-15
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion Criteria:

* diagnoses of both diabetes mellitus (MODIFICATION 2/13: prediabetes) and hypertension
* uncontrolled hypertension (mean of up to most recent 3 clinic BPs in previous 6 months with SBP\>=145 and/or DBP\>=85) AND mean of 3 readings taken at intake visit meeting same criterion

Exclusion Criteria:

* end-stage renal disease
* management of blood pressure by provider other than primary care provider (PCP)
* pregnancy/gestational diabetes
* terminal illness
* diagnosed or probable (based on screen) dementia
* active psychosis
* moderate-severe mental retardation
* indication by PCP that patient would be inappropriate for study
* planning to leave Reliant Medical Group (formerly Fallon Clinic) during the coming year

MODIFICATIONS: due to a smaller pool of eligible participants and lower enrollment than anticipated, eligibility for the study has been expanded as of February 2013 to include persons with "prediabetes," defined by either a coded diagnosis of abnormal glucose (International Classification of Diseases \[ICD\] 9-CM codes 790.2x) or a hemoglobin A1c laboratory value from 6.0%-6.4%. For this group, the DBP eligibility criterion will be a mean, as defined above, of \>=95, as target BP for this group is 140/90, not 140/80.

Primary outcomes:
measure: Change in blood pressure (BP)
timeFrame: At entry (day 1) and 1 year later; secondarily, electronic health record (EHR)-based readings prior to entry and one year later
Secondary outcomes:
measure: Refill adherence
timeFrame: 6 months prior to study entry and 6 months prior to study exit
measure: Self-reported medication adherence
timeFrame: At entry (day 1) and 1 year later, at exit
measure: Technology use
timeFrame: Continuous over course of study; final measurement at exit interview for intervention subjects & 6 mos. after exit for controls
measure: Health care utilization
timeFrame: Enrollment through exit 1 year later
measure: Satisfaction
timeFrame: At entry (day 1) and 1 year later, at exit
Other outcomes:
Locations:
city: Worcester
country: United States
facility: Reliant Medical Group
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Barry G Saver, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marquard JL, Garber L, Saver B, Amster B, Kelleher M, Preusse P. Overcoming challenges integrating patient-generated data into the clinical EHR: lessons from the CONtrolling Disease Using Inexpensive IT--Hypertension in Diabetes (CONDUIT-HID) Project. Int J Med Inform. 2013 Oct;82(10):903-10. doi: 10.1016/j.ijmedinf.2013.04.009. Epub 2013 Jun 22.