Roman Health Ventures Inc, 116 W 23Rd St, New York, NY, 10011, USA.
Two Sigma, New York, NY, USA.
BMC Health Serv Res. 2023 Nov 20;23(1):1277. doi: 10.1186/s12913-023-10231-1.
Incorporating patient-reported outcome measures into routine clinical care can improve the patient experience, increase engagement, and establish a structured method for gathering adverse event (AE) data. Systematically collecting this information on a large scale can also inform new solutions for removing treatment barriers like medication nonadherence. This study evaluated whether implementing a patient-reported outcome data collection and adverse event surveillance tool would result in greater treatment continuation for patients receiving care on a telehealth platform.
We used iterative plan-study-do-act cycles to evaluate how this data collection and surveillance tool-a short prompt for patients to provide information on treatment satisfaction and side effects-impacted treatment continuation, the outcome of interest. We tested two cycles in n = 2,000 patients receiving care for erectile dysfunction on a telehealth platform as a randomized controlled trial, and accounted for incidents where true randomization was not possible during implementation. The first cycle tested the tool alone, while the second cycle tested the tool in conjunction with a messaging template system that provided standardized side effect counseling.
Compared to patients in the control group, patients in the intervention group were more likely to refill their prescription over the duration of the study period (75% vs. 71%, Kaplan Meier log-rank test, p = 0.04). Receiving standardized counseling as part of the AE response system was positively associated with treatment continuation (p = 0.0005).
Prompting patients to report side effects and outcomes outside of routine clinical visits has the potential to improve quality of care in virtual treatment.
This trial has been retrospectively registered as a clinical trial (ClinicalTrials.gov Identifier: NCT05895539, registered June 8, 2023).
将患者报告的结果测量指标纳入常规临床护理中可以改善患者体验，提高参与度，并建立一种结构化的方法来收集不良事件（AE）数据。系统地大规模收集这些信息还可以为解决药物不依从等治疗障碍提供新的解决方案。本研究评估了在远程医疗平台上接受治疗的患者实施患者报告的结果数据收集和不良事件监测工具是否会导致更多的治疗延续。
我们使用迭代计划-研究-行动循环来评估这种数据收集和监测工具-一个简短的提示，让患者提供关于治疗满意度和副作用的信息-如何影响治疗延续，这是我们感兴趣的结果。我们在一项随机对照试验中对 n = 2000 名接受远程医疗平台治疗的勃起功能障碍患者进行了两轮测试，并考虑了在实施过程中无法进行真正随机化的情况。第一轮测试仅测试了该工具，而第二轮测试则测试了该工具与提供标准化副作用咨询的消息模板系统相结合的情况。
与对照组相比，干预组患者在研究期间更有可能续开处方（75% vs. 71%，Kaplan-Meier 对数秩检验，p = 0.04）。作为 AE 响应系统的一部分接受标准化咨询与治疗延续呈正相关（p = 0.0005）。
提示患者在常规临床就诊之外报告副作用和结果有可能改善虚拟治疗的护理质量。
该试验已作为临床试验进行了回顾性注册（ClinicalTrials.gov 标识符：NCT05895539，注册于 2023 年 6 月 8 日）。
