Impact of the COVID-19 Pandemic on the Implementation of Mobile Health to Improve the Uptake of Hydroxyurea in Patients With Sickle Cell Disease: Mixed Methods Study.
Impact of the COVID-19 Pandemic on the Implementation of Mobile Health to Improve the Uptake of Hydroxyurea in Patients With Sickle Cell Disease: Mixed Methods Study.
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DOI：
10.2196/41415
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发表时间：
2022-10-14
影响因子：
2.2
通讯作者：
Hankins, Jane S.
中科院分区：
文献类型：
--
作者：
Badawy, Sherif M.;DiMartino, Lisa;Brambilla, Donald;Klesges, Lisa;Baumann, Ana;Burns, Ebony;DeMartino, Terri;Jacobs, Sara;Khan, Hamda;Nwosu, Chinonyelum;Shah, Nirmish;Hankins, Jane S.
羟基脲疗法可有效减少镰状细胞病 (SCD) 相关并发症，并得到国家健康肺和血液研究所护理指南的推荐。然而，羟基脲并未得到充分利用，并且依从性也不佳。我们希望在多中心临床试验中测试多层次移动健康 (mHealth) 干预措施，以提高患者对羟基脲的依从性并改善提供者的处方。在前 2 个研究中心，参与者接触到了 COVID-19 大流行的早期阶段，其中包括他们的常规 SCD 护理受到干扰。我们的目的是描述 COVID-19 大流行对实施 mHealth 行为干预措施的影响，以提高 SCD 患者对羟基脲的依从性。前 2 个站点在大流行开始前 3 个月（2019 年 11 月至 2020 年 3 月）开始招募。实施期间，A地诊所关闭2个月，B地诊所关闭9个月。我们使用范围、有效性、采用、实施和维护 (RE-AIM) 框架来评估干预措施的实施和有效性。根据患者日常应用程序使用情况评估移动医疗实施情况。羟基脲的依从性计算为实施后前 12 周和 24 周内处方记录中覆盖天数 (PDC) 的比例。线性模型检查了应用程序使用情况和 PDC 更改之间的关系，并根据基线 PDC、锁定持续时间和站点进行了调整。我们对患者、医疗保健提供者、管理人员和研究人员进行了半结构化访谈，以确定与移动医疗实施和有效性相关的因素。我们使用混合方法来研究定性和定量研究结果的收敛性。 2020 年 3 月 15 日后，访问该应用程序的患者比例从 86% (n=55) 下降至 70% (n=45)。从基线到第 12 周，总体平均 PDC 增加为 4.5% (P=.32)，到第 24 周为 1.5% (P=.70)。 A 部位的平均 PDC 变化（12 周：20.9%；P=.003；24 周：16.7%；P=.01）比 B 部位（12 周：-8.2%；P=.14；24 周：-10.3%；P=.02）更大。调整后，2020 年 3 月 15 日之后应用程序使用量增加的患者的 PDC 变化增加了 13.8%。采访结果表明，B 站点在 COVID-19 期间关闭产生了更大的影响，但几乎所有患者都报告说，InCharge Health 应用程序有助于支持更一致的药物使用。我们发现早期诊所封锁产生了重大影响，这减少了移动医疗干预的实施，并导致患者对羟基脲的依从性降低。然而，在诊所封锁时间较短且羟基脲依从性较高的参与者中，中断程度较低。研究减轻重大紧急情况期间护理中断影响的附加策略（例如患者指导和健康导航）可能会“隔离”提高药物依从性的干预措施的实施。 ClinicalTrials.gov NCT04080167； https://clinicaltrials.gov/ct2/show/NCT04080167 RR2-10.2196/16319
Hydroxyurea therapy is effective for reducing complications related to sickle cell disease (SCD) and is recommended by National Health Lung and Blood Institute care guidelines. However, hydroxyurea is underutilized, and adherence is suboptimal. We wanted to test a multilevel mobile health (mHealth) intervention to increase hydroxyurea adherence among patients and improve prescribing among providers in a multicenter clinical trial. In the first 2 study sites, participants were exposed to the early phases of the COVID-19 pandemic, which included disruption to their regular SCD care. We aimed to describe the impact of the COVID-19 pandemic on the implementation of an mHealth behavioral intervention for improving hydroxyurea adherence among patients with SCD. The first 2 sites initiated enrollment 3 months prior to the start of the pandemic (November 2019 to March 2020). During implementation, site A clinics shut down for 2 months and site B clinics shut down for 9 months. We used the reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework to evaluate the implementation and effectiveness of the intervention. mHealth implementation was assessed based on patients’ daily app use. Adherence to hydroxyurea was calculated as the proportion of days covered (PDC) from prescription records over the first 12 and 24 weeks after implementation. A linear model examined the relationship between app usage and PDC change, adjusting for baseline PDC, lockdown duration, and site. We conducted semistructured interviews with patients, health care providers, administrators, and research staff to identify factors associated with mHealth implementation and effectiveness. We used a mixed methods approach to investigate the convergence of qualitative and quantitative findings. The percentage of patients accessing the app decreased after March 15, 2020 from 86% (n=55) to 70% (n=45). The overall mean PDC increase from baseline to week 12 was 4.5% (P=.32) and to week 24 was 1.5% (P=.70). The mean PDC change was greater at site A (12 weeks: 20.9%; P=.003; 24 weeks: 16.7%; P=.01) than site B (12 weeks: −8.2%; P=.14; 24 weeks: −10.3%; P=.02). After adjustment, PDC change was 13.8% greater in those with increased app use after March 15, 2020. Interview findings indicated that site B’s closure during COVID-19 had a greater impact, but almost all patients reported that the InCharge Health app helped support more consistent medication use. We found significant impacts of the early clinic lockdowns, which reduced implementation of the mHealth intervention and led to reduced patient adherence to hydroxyurea. However, disruptions were lower among participants who experienced shorter clinic lockdowns and were associated with higher hydroxyurea adherence. Investigation of added strategies to mitigate the effects of care interruptions during major emergencies (eg, patient coaching and health navigation) may “insulate” the implementation of interventions to increase medication adherence. ClinicalTrials.gov NCT04080167; https://clinicaltrials.gov/ct2/show/NCT04080167 RR2-10.2196/16319
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影响因子：
12.7
作者：
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