Stroke Clinical Trial
Official title:
A Personalized Dashboard to Educate Veterans at Risk of Stroke
Personalized risk communication methods have been used to educate patients that are at a
high risk of developing cardiovascular disease. These methods include personalized
counseling, printed brochures and individualized graphs describing the status of the risk
factors. Very few studies have provided an interactive tool for patients to self-manage
their risk factors and observe the changes in risk by making lifestyle changes and modifying
other risk factors by seeking medical advice.
This Rapid Response Project (RRP) builds upon these methods of communication by presenting
the modifiable risk factors in the form of a personalized dashboard that highlights the
contribution of these risk factors on the risk of developing a cardiovascular event. The
modifiable risk factors that will be addressed in this study will include medical and
lifestyle risk factors. The medical risk factors are hypertension, atrial fibrillation,
diabetes mellitus and hyperlipidemia whereas the lifestyle risk factor is tobacco use.
Our primary goal is to develop a prototype of the dashboard to educate patients and help
them make informed decisions in modifying their risk factors to reduce the probability of a
cardiovascular event or stroke. We will also evaluate the effectiveness of this tool by
asking these patients to return after 6 months to determine if they have made any lifestyle
changes or pursued medical intervention to reduce their cardiovascular risk. We will make
qualitative observations on the knowledge retention of these patients while using the
interactive dashboard.
Background:
Personalized risk communication methods have been used to educate patients who are at high
risk of developing a cardiovascular event. These methods include personalized counseling,
printed brochures and individualized graphs describing the status of the risk factors. Very
few studies have provided an interactive tool for patients to use to compare the relative
change in risk that might result from modifying their risk factors.
Objectives:
The goals of this pilot study were to: (a) develop a prototype of a personalized dynamic
dashboard to educate veterans and help them make informed decisions about modifying their
vascular risk factors (hypertension, diabetes mellitus, hyperlipidemia, and tobacco use) to
reduce the probability of a vascular event; (b) test the usability of this tool from the
patient's perspective; and (c) provide preliminary data regarding the effectiveness of this
tool in terms of changes in lifestyle or risk factor control compared with nurse-education.
Methods:
This was a three-arm randomized controlled study. Veterans from the panel of one experienced
general internist were randomly assigned to one of three groups: (1) dashboard with
nurse-education, (2) nurse-education alone, (3) usual care. To be eligible, patients must
have had at least two of the following: body mass index >30 kg/m2; current tobacco use;
systolic blood pressure >140 mm Hg or diastolic >90 mm Hg; LDL-cholesterol >130 mg/dL, or
hemoglobin Hb1Ac >8%. We developed the dashboard in our Human Computer Interface/Information
Technology laboratory. Patients in the dashboard group received two in-person counseling
sessions regarding methods for controlling risk factors, and were asked to use the dashboard
tool to enter values for their own risk factors and to observe the relative effects of
varying their risk factor control on their overall vascular risk. The nurse-education
consisted of two in-person counseling sessions regarding methods for controlling risk
factors. Both intervention sessions lasted approximately 30 minutes; therefore, the majority
of the time was used to interact with the tool in the dashboard group whereas the entire
time was used for personalized risk factor discussion in the nurse-education group. For the
usual care group, data were retrospectively collected about the primary care visits and
laboratory tests which took place during the same period as the visits for intervention
patients.
Status:
Completed.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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