Effect of Values Affirmation on Reducing Racial Differences in Adherence to Hypertension Medication: The HYVALUE Randomized Clinical Trial

Abstract

Importance: Stereotype threat, or the fear of confirming a negative stereotype about one's social group, may contribute to racial differences in adherence to medications by decreasing patient activation to manage chronic conditions.

Objective: To examine whether a values affirmation writing exercise improves medication adherence and whether the effect differs by patient race.

Design, setting, and participants: The Hypertension and Values trial, a patient-level, blinded randomized clinical trial, compared an intervention and a control writing exercise delivered immediately prior to a clinic appointment. Of 20 777 eligible, self-identified non-Hispanic Black and White patients with uncontrolled hypertension who were taking blood pressure (BP) medications, 3891 were approached and 960 enrolled. Block randomization by self-identified race ensured balanced randomization. Patients enrolled between February 1, 2017, and December 31, 2019, at 11 US safety-net and community primary care clinics, with outcomes assessed at 3 and 6 months. Analysis was performed on an intention-to-treat basis.

Interventions: From a list of 11 values, intervention patients wrote about their most important values and control patients wrote about their least important values.

Main outcomes and measures: The primary outcome of adherence to BP medications was measured using pharmacy fill data (proportion of days covered >90%) at baseline, 3 months, and 6 months. The secondary outcome was systolic and diastolic BP. Patient activation to manage their health was also measured.

Results: Of 960 patients, 474 (286 women [60.3%]; 256 Black patients [54.0%]; mean [SD] age, 63.4 [11.9] years) were randomly assigned to the intervention group and 486 (288 women [59.3%]; 272 Black patients [56.0%]; mean [SD] age, 62.8 [12.0] years) to the control group. Baseline medication adherence was lower (318 of 482 [66.0%] vs 331 of 412 [80.3%]) and mean (SE) BP higher among Black patients compared with White patients (systolic BP, 140.6 [18.5] vs 137.3 [17.8] mm Hg; diastolic BP, 83.9 [12.6] vs 79.7 [11.3] mm Hg). Compared with baseline, pharmacy fill adherence did not differ between intervention and control groups at 3 months (odds ratio [OR], 0.91 [95% CI, 0.57-1.43]) or at 6 months (OR, 0.86 [95% CI, 0.53-1.38]). There were also no treatment effect differences in pharmacy fill adherence by patient race (Black patients at 3 months: OR, 1.08 [95% CI, 0.61-1.92]; at 6 months: OR, 1.04 [95% CI, 0.58-1.87]; White patients at 3 months: OR, 0.68 [95% CI, 0.33-1.44]; at 6 months: OR, 0.55 [95% CI, 0.24-1.27]). Immediately after the intervention, the median patient activation was higher in intervention patients than in control patients, but this difference was not statistically significant in an unadjusted comparison (75.0 [IQR, 65.5-84.8] vs 72.5 [IQR, 63.1-80.9]; P = .06). In adjusted models, the Patient Activation Measure score immediately after the intervention was significantly higher in the intervention patients than in control patients (mean difference, 2.3 [95% CI, 0.1-4.5]).

Conclusions and relevance: A values affirmation intervention was associated with higher patient activation overall but did not improve adherence or blood pressure among Black and White patients with hypertension.

Trial registration: ClinicalTrials.gov Identifier: NCT03028597.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Daugherty reported receiving grants from the National Institutes of Health (NIH) during the conduct of the study; and grants from the Patient-Centered Outcomes Research Institute (PCORI), the NIH, and the American Heart Association outside the submitted work. Dr Vupputuri reported receiving grants from Kaiser Permanente, Sanofi, and the NIH during the conduct of the study. Dr Hanratty reported receiving grants from the NIH/National Heart, Lung, and Blood Institute (NHLBI) during the conduct of the study. Dr Steiner reported receiving grants from Kaiser Permanente, the NIH, and the American Heart Association outside the submitted work. Dr Dickinson reported receiving grants from the NIH during the conduct of the study. Dr Maertens reported receiving grants from the NIH/NHLBI during the conduct of the study; and grants from PCORI outside the submitted work. Dr Havranek reported receiving grants from the NIH during the conduct of the study; and grants from the NIH and the American Heart Association outside the submitted work. No other disclosures were reported.

Figures

Figure.. The Hypertension and Values (HYVALUE) Trial CONSORT Diagram

Assessed for eligibility: Those who met all inclusion criteria over the study period based on electronic health record data. Eligible but not called: Lists of eligible patients exceeded study team ability to screen and call all patients. Received allocated intervention: Patient consented, completed written exercise, and saw primary care provider after intervention delivery. Did not receive allocated intervention: A total of 9 patients across the 2 study groups were enrolled on the day of a scheduled primary care visit, and the visit was canceled by the clinic after the patient was randomized. The visit was not able to be rescheduled within 1 week of randomization. Lost to all follow-up: Patient moved or otherwise relocated out of the health system and had no electronic follow-up data after study enrollment. Lost to all in-person follow-up: Patient had no in-person or telephone follow-up data. Patient relocated, did not want to schedule follow-up visit at that time, did not return messages, withdrew from further contact, or was unreachable for follow-up scheduling. Patient was unreachable for follow-up scheduling.