背景:在丹麦,慢性肾脏病(CKD)患者的门诊随访正从住院就诊转变为更远程的医疗服务.不使用远程患者报告结果(PRO)是一个众所周知的挑战,很难解释哪种干预机制会影响结果。过程评估可以,因此,用于回答有关干预措施如何以及为什么起作用的重要问题,旨在提高临床实践的意义。
目的:本研究旨在通过评估(1)研究人群的代表性来提供对干预过程的见解,(2)患者和医生的使用模式,(3)患者坚持干预,(4)临床参与。
方法:确定范围的过程评估,剂量,保真度,进行了临床参与,一项多中心随机对照试验(RCT)。我们开发并实施了一种使用PRO措施远程监测门诊患者的干预措施。从4个来源收集RCT中PRO干预组的数据:(1)来自参与者的PRO数据以确定个人因素,(2)基于Web的PRO系统识别关键使用干预模式,(3)病历,以确定与使用干预措施有关的临床因素,和(4)与相关医生进行的半结构化访谈。
结果:在邀请的320名患者中,152(47.5%)接受参加。研究人群反映了目标人群。PRO干预组的平均依从率为82%(95%CI76-87)。问卷回复率为539/544(99.1%)。101例患者中有13例(12.9%)需要协助完成研究程序。医生评估了477/539(88.5%)的问卷。在417/539(77.4%)的病例中建立了联系,和122/539(22.6%)的患者没有接触。医师开始288/417(69.1%),患者要求所有接触者中的129/417(30.9%)。接触的主要原因是临床数据(242/417,58%),PRO数据(92/417,22.1%),以及药物问题和预防原因(83/417,19.9%)。医生发现在远程随访中使用PRO措施有利于评估患者的健康状况。在问卷中纳入自我报告的临床数据促使医生评估患者的反应。然而,强调了一些障碍,例如与患者失去个人关系,以及在没有面对面评估的情况下错过重要症状的风险。
结论:本研究证明了远程监测在CKD患者中的重要性和实际应用。总的来说,干预措施按预期实施。我们观察到患者依从性高,医生管理了大多数问卷。一些医生担心与患者的距离使其无法使用“临床一瞥”,“存在忽视关键患者症状的潜在风险。这些发现强调了实施远程后续行动的关键考虑因素。引入一种结合远程和面对面协商的混合方法可以解决这些问题。
背景:ClinicalTrials.govNCT03847766;https://clinicaltrials.gov/study/NCT03847766。
BACKGROUND: In Denmark, outpatient follow-up for patients with chronic kidney disease (CKD) is changing from in-hospital visits toward more remote health care delivery. The nonuse of remote patient-reported outcomes (PROs) is a well-known challenge, and it can be difficult to explain which mechanisms of interventions influence the outcome. Process evaluation may, therefore, be used to answer important questions on how and why interventions work, aiming to enhance the implications for clinical practice.
OBJECTIVE: This study aimed to provide insight into the intervention process by evaluating (1) the representativity of the study population, (2) patient and physician use patterns, (3) patient adherence to the intervention, and (4) clinical engagement.
METHODS: A process evaluation determining the reach, dose, fidelity, and clinical engagement was carried out, alongside a multicenter randomized controlled trial (RCT). We developed and implemented an intervention using PRO measures to monitor outpatients remotely. Data were collected for the PRO intervention arms in the RCT from 4 sources: (1) PRO data from the participants to determine personal factors, (2) the web-based PRO system to identify key usage intervention patterns, (3) medical records to identify clinical factors relating to the use of the intervention, and (4) semistructured interviews conducted with involved physicians.
RESULTS: Of the 320 patients invited, 152 (47.5%) accepted to participate. The study population reflected the target population. The mean adherence rate to the PRO intervention arms was 82% (95% CI 76-87). The questionnaire response rate was 539/544 (99.1%). A minority of 13 (12.9%) of 101 patients needed assistance to complete study procedures. Physicians assessed 477/539 (88.5%) of the questionnaires. Contact was established in 417/539 (77.4%) of the cases, and 122/539 (22.6%) of the patients did not have contact. Physicians initiated 288/417 (69.1%) and patients requested 129/417 (30.9%) of all the contacts. The primary causes of contact were clinical data (242/417, 58%), PRO data (92/417, 22.1%), and medication concerns and precautionary reasons (83/417, 19.9%). Physicians found the use of PRO measures in remote follow-up beneficial for assessing the patient\'s health. The inclusion of self-reported clinical data in the questionnaire motivated physicians to assess patient responses. However, some barriers were emphasized, such as loss of a personal relationship with the patient and the risk of missing important symptoms in the absence of a face-to-face assessment.
CONCLUSIONS: This study demonstrates the importance and practical use of remote monitoring among patients with CKD. Overall, the intervention was implemented as intended. We observed high patient adherence rates, and the physicians managed most questionnaires. Some physicians worried that distance from the patients made it unfeasible to use their \"clinical glance,\" posing a potential risk of overlooking crucial patients\' symptoms. These findings underscore key considerations for the implementation of remote follow-up. Introducing a hybrid approach combining remote and face-to-face consultations may address these concerns.
BACKGROUND: ClinicalTrials.gov NCT03847766; https://clinicaltrials.gov/study/NCT03847766.