Daugherty Stacie L, Vupputuri Suma, Hanratty Rebecca, Steiner John F, Maertens Julie A, Blair Irene V, Dickinson L Miriam, Helmkamp Laura, Havranek Edward P
University of Colorado Denver, School of Medicine, Department of Medicine, Division of Cardiology, Adult and Child Consortium for Health Outcomes Research and Delivery Science, Aurora, CO, United States.
Kaiser Permanente Mid-Atlantic States, Mid-Atlantic Permanente Research Institute, Rockville, MD, United States.
JMIR Res Protoc. 2019 Mar 25;8(3):e12498. doi: 10.2196/12498.
Medication nonadherence 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.
The Hypertension and Values (HYVALUE) trial aims to examine whether a values-affirmation intervention improves medication adherence (primary outcome) by targeting racial stereotype threat.
The HYVALUE trial is a patient-level, blinded randomized controlled trial comparing a brief values-affirmation writing exercise with a control writing exercise among black and white patients with uncontrolled hypertension. We are recruiting patients from 3 large health systems in the United States. The primary outcome is patients' adherence to antihypertensive medications, with secondary outcomes of systolic and diastolic blood pressure over time, time for which blood pressure is under control, and treatment intensification. We are comparing the effects of the intervention among blacks and whites, exploring possible moderators (ie, patients' prior experiences of discrimination and clinician racial bias) and mediators (ie, patient activation) of intervention effects on outcomes.
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 1130 patients. On the basis of 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.
The HYVALUE study moves beyond documentation of race-based health disparities toward testing an intervention. We focus on a medical condition-hypertension, which is arguably the greatest contributor to mortality disparities for black patients. If successful, this study will be the first to provide evidence for a low-resource intervention that has the potential to substantially reduce health care disparities across a wide range of health care conditions and populations.
ClinicalTrials.gov NCT03028597; https://clinicaltrials.gov/ct2/show/NCT03028597 (Archived by WebCite at http://www.webcitation.org/72vcZMzAB).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/12498.
药物治疗依从性不佳是导致高血压控制不佳的一个重要且可改变的因素。刻板印象威胁可能会阻碍患者在临床诊疗过程中积极参与，从而导致依从性方面的种族差异，进而降低坚持遵医嘱治疗的积极性。
高血压与价值观（HYVALUE）试验旨在研究价值观肯定干预是否通过针对种族刻板印象威胁来提高药物治疗依从性（主要结局）。
HYVALUE试验是一项患者层面的、双盲随机对照试验，在患有未控制高血压的黑人和白人患者中，将简短的价值观肯定写作练习与对照写作练习进行比较。我们正在从美国3个大型医疗系统招募患者。主要结局是患者对抗高血压药物的依从性，次要结局包括随时间变化的收缩压和舒张压、血压得到控制的时间以及治疗强化情况。我们正在比较干预措施在黑人和白人中的效果，探索可能的调节因素（即患者先前的歧视经历和临床医生的种族偏见）以及干预效果对结局的中介因素（即患者积极性）。
本研究由美国国立心肺血液研究所资助。入组和随访正在进行中，数据分析预计于2020年末开始。计划入组1130名患者。基于支持价值观肯定在教育环境中的有效性的证据以及我们的试点工作表明改善了患者与临床医生的沟通，我们假设价值观肯定可消除刻板印象威胁对临床互动的负面影响，并可减少药物治疗依从性及后续健康结局方面的种族差异。
HYVALUE研究超越了对基于种族的健康差异的记录，转而测试一种干预措施。我们关注的是一种疾病——高血压，它可以说是导致黑人患者死亡率差异的最大因素。如果成功，本研究将首次为一种低资源干预措施提供证据，该措施有可能在广泛的医疗条件和人群中大幅减少医疗保健差异。
ClinicalTrials.gov NCT03028597；https://clinicaltrials.gov/ct2/show/NCT03028597（由WebCite存档于http://www.webcitation.org/72vcZMzAB）。
国际注册报告识别码（IRRID）：DERR1-10.2196/12498。
