CONtrolling Disease Using Inexpensive IT - Hypertension in Diabetes (CONDUIT-HID)

University of Massachusetts, Worcester

Status: Completed

Conditions: Hypertension; Diabetes Mellitus

Treatments: Other: Self-monitoring-nurse-primary care provider feedback loop

Study type: Interventional

Funder types: Other

Identifiers

NCT01416766

R18HS018461 (U.S. AHRQ Grant/Contract)

CONDUIT-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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196 participants in 2 patient groups

Control

No Intervention group

Description:

Control participants will receive usual care during their year of enrollment. At enrollment, prior to randomization, they will be informed that, if randomized to control status, they will be offered a free BP monitor and the opportunity to receive the study intervention after completing the exit interview in 1 year.

Intervention

Experimental group

Description:

Self-monitoring-nurse-primary care provider feedback loop After randomization, intervention participants will receive the intervention (free home BP monitor, assistance setting up to upload BP readings from home/work or clinic computer; feedback loop with nurse-driven protocols to manage uncontrolled hypertension and maintain control once attained).

Treatment:

Other: Self-monitoring-nurse-primary care provider feedback loop