Hypertension Clinical Trial
Official title:
A Mixed Methods Approach to the Development and Testing of the Measure of Drug Self-Management (MeDS), an Assessment for Use in Clinical Settings Among English and Spanish-speaking Patients With Hypertension and Diabetes.
The study objective is to develop and test a Measure of Drug Self-Management for use in
clinical settings among patients with hypertension and diabetes.
While medication non-adherence is a highly recognized public health and patient safety
concern, it is rarely assessed in a routine and consistent manner in clinical settings. With
the aging of the US population and rising rates of chronic disease, an increasing number of
adults are being prescribed multi-drug regimens that require greater self-management skills.
Despite the complexity of medication use, adherence has most commonly been measured as a
limited set of behaviors (i.e., filling a prescription, taking doses). This emphasis has,
over time, simplified how we think of prescription (Rx) medication use and directed
attention away from the full range of tasks associated with effective Rx self-management.
The field of health literacy research has deconstructed these tasks in considerable detail
in recent years, and can offer insight into a more comprehensive measurement of patients'
outpatient Rx use.
There is a clear need for a brief, yet inclusive, measure of adherence that can be used in
clinical settings to routinely assess patients' use of complex Rx regimens. Such an
assessment could be used to guide clinicians in addressing specific patient challenges to
safe and appropriate medication use. In response to this need, our study proposes to develop
a new assessment of medication self-management. This unique measure will utilize health
literacy best practices to promote patient comprehension and ease-of-use; it will also be
tailored to patients' actual regimens via electronic health record (EHR) data. Finally, the
tool will be available in both English and Spanish to support use among diverse patient
populations. Our study aims are to:
1. Develop and refine a Measure of Drug Self-Management (MeDS) prototype.
2. Inform the content, structure and delivery of the MeDS through targeted discussions
with patients, providers and information technology specialists.
3. Test the reliability and validity of the MeDS among patients with diabetes and
hypertension
H1: The MeDS will strongly correlate with other self-report adherence measures.
n/a
Observational Model: Cohort, Time Perspective: Cross-Sectional
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