JMIR Publications

ABSTRACT

Background:

Medication non-adherence is a significant, modifiable contributor to uncontrolled hypertension. Stereotype threat may contribute to racial disparities in adherence by hindering a patient’s ability to actively engage during a clinical encounter, resulting in reduced activation to adhere to prescribed therapies.

Objective:

The Hypertension and Values (HYVALUE) trial aims to examine whether a values affirmation intervention: 1) improves medication adherence, and 2) targets racial stereotype threat.

Methods:

The HYVALUE trial is a patient-level, blinded randomized controlled trial comparing a brief values-affirmation writing exercise to a control writing exercise among Black and White patients with uncontrolled hypertension. We are recruiting patients from three large health systems in the US. The primary outcome is patients’ adherence to antihypertensive medications, with secondary outcomes of systolic and diastolic blood pressure, time under blood pressure control, and treatment intensification. We are comparing effects of the intervention among Blacks and Whites, exploring possible moderators (i.e., patients’ prior experiences of discrimination and clinician racial bias) and mediators (i.e., patient activation) of intervention effects on outcomes.

Results:

This study was funded by the National Heart, Lung and Blood Institute. Enrollment and follow-up are ongoing, and data analysis is expected to begin in late 2020. Planned enrollment is 1,130 patients. Based on evidence supporting the effectiveness of values affirmation in educational settings and our pilot work demonstrating improved patient-clinician communication, we hypothesize that values affirmation disrupts the negative effects of stereotype threat on the clinical interaction and can reduce racial disparities in medication adherence and subsequent health outcomes.

Conclusions:

The HYVALUE study moves beyond documentation of race-based health disparities towards testing an intervention. We focus on a medical condition – hypertension – that is arguably the greatest contributor to mortality disparities for Blacks. If successful, this study will be the first to provide evidence for a low-resource intervention that has the potential to substantially reduce healthcare disparities across a wide range of health care conditions and populations. Clinical Trial: ClinicalTrials.gov NCT03028597; https://clinicaltrials.gov/ct2/show/NCT03028597 (Archived by WebCite at http://www.webcitation.org/72vcZMzAB).