Holmen Heidi, Holm Are Martin, Kilvær Thomas Karsten, Ljoså Tone Marte, Granan Lars-Petter, Ekholdt Christopher, Larsen Lotte Sandberg, Fosse Erik
Intervention Centre, Division of Technology and Innovation, Oslo University Hospital, Oslo, Norway.
Department of Nursing and Health Promotion, Faculty of Health Sciences, Oslo Metropolitan University, Oslo, Norway.
JMIR Res Protoc. 2023 Jul 10;12:e46649. doi: 10.2196/46649.
Health care services are being challenged by an increasing number of patients and limited resources. Hence, research investigating options to reduce costs and increase effectiveness is warranted. Digital outpatient services can provide flexible and tailored follow-up, improve patients' health literacy, and facilitate the identification of adverse courses of disease. However, previous research largely focused on disease-specific contexts and outcomes. Therefore, research on digital services investigating generic outcomes such as health literacy is warranted.
This article aims to describe the "digital outpatient service" intervention and present the protocol for an ongoing multicenter, nonrandomized trial evaluating this intervention.
Based on previous experiences and evidence-based knowledge, we developed this intervention through patient-journey maps in collaboration with each clinical specialty. The patients gain access to a mobile app for self-monitoring and patient-reported outcomes and a chat for contact between the patients and health care workers. The health care workers' dashboard includes a traffic light system to draw attention to the most urgent patient reports. In this multicenter, non-randomized controlled trial, patients are allocated to the control group receiving standard care or the 6-month intervention. Eligible patients are aged 18 years or older who receive outpatient care at the neurology, lung, pain, or cancer departments at 2 university hospitals in Norway. Our evaluation will include patient-reported outcomes, qualitative interviews, and clinical measures. The primary outcome will be health literacy using the Health Literacy Questionnaire. A sample size of 165 participants is split into a 1:2 ratio in favor of the intervention. We will analyze quantitative data in SPSS (IBM Corp) using descriptive statistics and logistic regression, and qualitative data using thematic analysis.
This trial started in September 2021, and the intervention started in January 2022. Recruitment has ended, with 55 patients in the control group and 107 patients in the intervention group. Follow-up is expected to end in July 2023, with results expected to be obtained in December 2023.
This study will evaluate an intervention facilitated by an already certified digital multicomponent solution, with intervention content based on patient-reported outcomes, health literacy, and self-monitoring. The intervention is specifically tailored to each participating center and the needs of their patients using patient journey maps. The comprehensive and generic evaluation of this digital outpatient service intervention is a strength as it targets a heterogeneous sample of patients. Thus, this study will provide important knowledge about the applicability and effects of digital health care services. As a result, patients and health care workers will gain a new, evidence-based understanding of whether and how digital tools may be used in clinical care.
ClinicalTrials.gov NCT05068869; https://clinicaltrials.gov/ct2/show/NCT05068869.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/46649.
医疗保健服务正面临着患者数量不断增加和资源有限的挑战。因此，有必要开展研究来探索降低成本和提高效率的方法。数字门诊服务可以提供灵活且个性化的随访，提高患者的健康素养，并有助于识别疾病的不良病程。然而，以往的研究主要集中在特定疾病的背景和结果上。因此，有必要开展关于数字服务的研究，以调查诸如健康素养等一般性结果。
本文旨在描述“数字门诊服务”干预措施，并介绍一项正在进行的多中心、非随机试验的方案，该试验旨在评估这一干预措施。
基于以往的经验和循证知识，我们与各临床专科合作，通过患者旅程地图开发了这一干预措施。患者可以使用一款移动应用程序进行自我监测并报告患者相关结果，还可以通过聊天功能与医护人员进行联系。医护人员的仪表板包括一个交通信号灯系统，以提醒注意最紧急的患者报告。在这项多中心、非随机对照试验中，患者被分配到接受标准护理的对照组或接受为期6个月干预的试验组。符合条件的患者年龄在18岁及以上，他们在挪威的2所大学医院的神经科、肺部、疼痛科或癌症科接受门诊治疗。我们的评估将包括患者报告的结果、定性访谈和临床测量。主要结果将使用健康素养问卷来衡量健康素养。165名参与者的样本量按照1:2的比例分配，以支持干预组。我们将使用描述性统计和逻辑回归在SPSS（IBM公司）中分析定量数据，并使用主题分析分析定性数据。
该试验于2021年9月开始，干预措施于2022年1月开始。招募工作已经结束，对照组有55名患者，干预组有107名患者。随访预计于2023年7月结束，结果预计于2023年12月获得。
本研究将评估一种由已获认证的数字多组件解决方案推动的干预措施，其干预内容基于患者报告的结果、健康素养和自我监测。该干预措施通过患者旅程地图专门针对每个参与中心及其患者的需求进行了定制。对这种数字门诊服务干预措施进行全面和一般性评估是一项优势，因为它针对的是异质性患者样本。因此，本研究将提供关于数字医疗服务的适用性和效果的重要知识。结果，患者和医护人员将对数字工具是否以及如何用于临床护理获得新的、基于证据的理解。
ClinicalTrials.gov NCT05068869；https://clinicaltrials.gov/ct2/show/NCT05068869。
国际注册报告识别号（IRRID）：DERR1-10.2196/46649。
