CONtrolling Disease Using Inexpensive IT - Hypertension in Diabetes (CONDUIT-HID)
|ClinicalTrials.gov Identifier: NCT01416766|
Recruitment Status : Completed
First Posted : August 15, 2011
Last Update Posted : September 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hypertension Diabetes Mellitus||Other: Self-monitoring-nurse-primary care provider feedback loop||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||CONtrolling Disease Using Inexpensive IT - Hypertension in Diabetes|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||July 2015|
No Intervention: Control
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.
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).
Other: Self-monitoring-nurse-primary care provider feedback loop
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 Name: CONDUIT blood pressure intervention
- Change in blood pressure (BP) [ Time Frame: At entry (day 1) and 1 year later; secondarily, electronic health record (EHR)-based readings prior to entry and one year later ]We will assess differences in changes in systolic BP (SBP) and diastolic BP (DBP) measured at study intake and 1 year later at exit. We will also evaluate changes in mean EHR BP readings prior to study entry and in the 3 months before study exit. We will also assess the primary outcome in terms of % of intervention vs. control participants achieving control (originally proposed as mean of 3 exit readings <130 SBP and 80 DBP but now revised to 140 SBP and 80 DBP due to new evidence and change in the Healthcare Effectiveness Data and Information Set (HEDIS) measure for 2011). NOTE: For eligible participant group added 2/13, "prediabetic" patients, DBP control will be judged as mean <90mmHg as target BP for these groups is 140/90.
- Refill adherence [ Time Frame: 6 months prior to study entry and 6 months prior to study exit ]We will compare changes in the Medication Possession Ratio for antihypertensive medications for the 6 months prior to study entry and the 6 months prior to study exit for the subset of participants for whom insurance claims give us complete data on prescription fills.
- Self-reported medication adherence [ Time Frame: At entry (day 1) and 1 year later, at exit ]Change in self-reported medication adherence, based on: 1) the modified Morisky scale and 2) a visual analog scale (Walsh).
- Technology use [ Time Frame: Continuous over course of study; final measurement at exit interview for intervention subjects & 6 mos. after exit for controls ]We will measure use of home/office/other personal computers to upload BP readings over the internet vs. bringing BP monitor to clinic and uploading data vs. calling/mailing/faxing readings (offered to those not doing either of the first 2 after 2-3 months). We intend to offer delayed entry after the exit to control subjects and will assess their use over the next 3-6 months.
- Health care utilization [ Time Frame: Enrollment through exit 1 year later ]We will measure counts of Reliant Medical Group visits and hospitalizations. Number of antihypertensive medications and post/pre change will be compared for control vs. intervention participants. We will also compare health care costs, as represented by billed charges; complete charges are expected to be available for ~70% of participants; clinic-only charges will be compared for the remainder.
- Satisfaction [ Time Frame: At entry (day 1) and 1 year later, at exit ]Participant satisfaction with care will be measured using Consumer Assessment of Healthcare Providers and Systems (CAHPS) clinician and group survey questions.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01416766
|United States, Massachusetts|
|Reliant Medical Group|
|Worcester, Massachusetts, United States, 01605|
|Principal Investigator:||Barry G Saver, MD, MPH||University of Massachusetts, Worcester|