METHODS: This is a planned secondary analysis of a RCT conducted among postpartum patients with HDP who were enrolled into our remote SMBP program, in which they obtain SMBP and then manually enter the SMBP value into a patient portal for individual provider response. In the parent trial, consenting patients were randomized to continued manual blood pressure entry of SMBP or use of a Bluetooth-enabled blood pressure cuff synched to a smartphone application utilizing artificial intelligence to respond to each obtained blood pressure or symptom for six weeks and to flag abnormalities for providers. Both SMBP programs were available in Spanish and English. For this study, women who self-reported their ethnicity were stratified into two ethnic groups - Hispanic and non-Hispanic - regardless of randomization group. Those who did not self-report ethnicity but completed all study procedures in Spanish were also categorized as Hispanic. Outcomes were the same in the parent study and this secondary analysis. The primary outcome was ≥1 SMBP assessment within 10 days postpartum. Secondary outcomes included number of blood pressure assessments and healthcare utilization outcomes (remote antihypertensive medication initiation or dose-increase and presentation to the Emergency Department or readmission for hypertension within 30 days of discharge). Participants rated their experience with SMBP via a scale from 0 (worst possible) to 10 (best possible) and the Decision Regret Scale, which assessed their regret in SMBP program participation (0=no regret; 100=high regret)).5 Outcomes were compared between groups. Risk differences (RD) were calculated for categorical and regression coefficients for continuous outcomes. The parent RCT was IRB-approved and published on clinicaltrials.gov (NCT05595629) before enrollment.
RESULTS: Among 119 women in the parent study, 83 (70%) self-reported ethnicity and the proportion of Hispanic people was similar in both treatment groups. This study compared 23 Hispanic (19% monolingual in Spanish) to 62 non-Hispanic women. Rates of SMBP assessment within 10 days postpartum was similar (Hispanic 64% vs non-Hispanic 79%; RD -0.1 (95% Confidence Interval (CI) -0.4, 0.1). There were no differences in mean number of remote SMBP assessments or rates of remote antihypertensive medication initiation or dose titration. The rates of hypertension-related presentations to the Emergency Department or hospital readmission were also similar between groups. Lastly, regardless of ethnicity, participants had low scores on the Decision Regret Scale and rated their experience with their remote SMBP program highly favorably. (See Table 1.) Conclusion: Hispanic and non-Hispanic postpartum patients with HDP had similar outcomes and favorable patient perceptions. The small sample size in this study may have produced inadequate power to detect a difference between study groups, thereby leading to Type II error. Thus, more research on Hispanic participants in remote SMBP programs is needed. However, the effect of remote SMBP programs on perinatal equity may not be limited to race-based disparities.
方法:这是对纳入我们远程SMBP计划的产后HDP患者进行RCT的计划二次分析,在其中,他们获得SMBP,然后手动将SMBP值输入患者门户,以获得个别提供者的响应。在家长审判中,同意的患者被随机分组,分别接受SMBP的持续手动血压输入,或使用与智能手机应用程序同步的蓝牙血压袖带,以在6周内对每个获得的血压或症状做出反应,并为提供者标记异常.两个SMBP程序都有西班牙语和英语版本。对于这项研究,自我报告种族的女性被分为两个种族-西班牙裔和非西班牙裔-不考虑随机分组.那些没有自我报告种族但以西班牙语完成所有研究程序的人也被归类为西班牙裔。结果在母体研究和此二次分析中是相同的。主要结局为产后10天内SMBP评估≥1次。次要结果包括血压评估次数和医疗保健利用结果(远程抗高血压药物开始或剂量增加,并在出院后30天内向急诊科就诊或高血压再入院)。参与者通过从0(最坏的可能)到10(最好的可能)和决策后悔量表对他们的SMBP经验进行评分。评估了他们在SMBP计划参与中的遗憾(0=无遗憾;100=高遗憾)。5组间比较结果。计算连续结局的分类和回归系数的风险差异(RD)。父母RCT获得IRB批准,并在招募前在clinicaltrials.gov(NCT05595629)上发布。
结果:在家长研究的119名女性中,83(70%)自我报告的种族和西班牙裔人的比例在两个治疗组中相似。这项研究比较了23名西班牙裔(19%的西班牙语单语)和62名非西班牙裔女性。产后10天内的SMBP评估率相似(西班牙裔64%与非西班牙裔79%;RD-0.1(95%置信区间(CI)-0.4,0.1)。远程SMBP评估的平均数量或远程抗高血压药物起始或剂量滴定率没有差异。两组之间与高血压相关的急诊或再入院率也相似。最后,不管种族,参与者的“决策后悔量表”得分较低,对他们在远程SMBP项目中的经历给予了很高的评价.(见表1。)结论:西班牙裔和非西班牙裔产后HDP患者具有相似的结局和良好的患者认知。这项研究中的小样本量可能不足以检测研究组之间的差异,从而导致类型II错误。因此,需要对远程SMBP计划中的西班牙裔参与者进行更多研究。然而,远程SMBP计划对围产期公平性的影响可能不仅限于基于种族的差异.