评估慢性病患者中基于人群的数字化患者报告结局和体验的使用情况和获益：PROMchronic 研究方案。

Evaluating the Population-Based Usage and Benefit of Digitally Collected Patient-Reported Outcomes and Experiences in Patients With Chronic Diseases: The PROMchronic Study Protocol.

机构信息

Department of Healthcare Management, School of Economics and Management, Technical University Berlin, Berlin, Germany.

aQua Institute, Göttingen, Germany.

出版信息

JMIR Res Protoc. 2024 Aug 5;13:e56487. doi: 10.2196/56487.

DOI:10.2196/56487

PMID:39102279

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11333866/

Abstract

BACKGROUND

Chronic diseases are associated with a high disease burden. Under- and overprovision of care as well as quality variation between health care providers persists, while current quality indicators rarely capture the patients' perspective. Capturing patient-reported outcome measures (PROMs) as well as patient-reported experience measures (PREMs) is becoming more and more important to identify gaps in care provision, prioritize services most valuable to patients, and aid patients' self-management.

OBJECTIVE

This study aims to measure the potential benefits and effectiveness of using electronic patient-reported outcome measures (ePROMs) and electronic patient-reported experience measures in a structured and population-based manner to enhance health care for chronic disease patients in Germany.

METHODS

This prospective cohort study aims to evaluate the potential benefits of PROM usage in patients with chronic diseases. We evaluate whether (1) digitally collected PROMs and PREMs can be used for health system performance assessment by generating a representative response of chronically diseased individuals with asthma, chronic obstructive pulmonary disease, diabetes, and coronary artery disease across Germany, and (2) based on the PROMs and PREMs, low-value care can be identified. As patient-reported outcomes (PROs) are rarely presented back to patients, (3) this study also examines patients' reactions to their PROM scores in the form of digital PRO feedback. For these purposes, randomly selected patients from a nationwide German insurer are digitally surveyed with generic and disease-specific PROMs and PREMs, as well as additional questions on their health-related behavior, 4 times over 1 year. Individual PRO feedback is presented back to patients longitudinally and compared to a peer group after each survey period. Patient-reported data is linked with health insurance data. Response rates, changes in health and experience outcomes over time, self-reported changes in health behavior, and health care system usage will be analyzed.

RESULTS

The PROMchronic study explores the usage of PROMs in patients with chronic diseases. Data collection began in October 2023, after the initial invitation letter. All the 200,000 potential patients have been invited to participate in the study. Data have not yet been analyzed. Publication of the interim results is planned for the autumn of 2024, and the results are planned to be published in 2025.

CONCLUSIONS

We aim to fill the research gap on the population-based usage of PROMs and PREMs in patients with chronic diseases and add to the current understanding of PROM data-sharing with patients. The study's results can thereby inform whether a health care system-wide approach to collecting PROMs and PREMs can be used to identify low-value care, assess quality variation within and across chronic conditions, and determine whether PRO feedback is helpful and associated with any changes in patients' health behaviors.

TRIAL REGISTRATION

German Clinical Trials Register DRKS00031656; https://drks.de/search/en/trial/DRKS00031656.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56487.

摘要

背景

慢性病与高疾病负担相关。医疗服务的提供存在不足和过度，以及医疗服务提供者之间的质量差异，而当前的质量指标很少能捕捉到患者的视角。越来越重要的是要获取患者报告的结果测量（PROMs）和患者报告的体验测量（PREMs），以发现护理提供方面的差距，确定对患者最有价值的服务，并帮助患者进行自我管理。

目的

本研究旨在衡量以结构化和基于人群的方式使用电子患者报告的结果测量（ePROMs）和电子患者报告的体验测量（ePREMs）来增强德国慢性病患者医疗服务的潜在益处和效果。

方法

本前瞻性队列研究旨在评估慢性病患者使用 PROM 的潜在益处。我们评估了（1）通过在德国各地收集哮喘、慢性阻塞性肺疾病、糖尿病和冠状动脉疾病的慢性病患者的代表性反应，数字收集的 PROMs 和 PREMs 是否可用于评估卫生系统绩效；（2）是否可以基于 PROMs 和 PREMs 识别低价值的护理；（3）由于患者报告的结果（PROs）很少反馈给患者，本研究还研究了患者对数字 PRO 反馈中自身 PROM 分数的反应。为此，从一家全国性的德国保险公司中随机选择患者，在 1 年内进行 4 次针对一般和特定疾病的 PROMs 和 PREMs 以及关于其健康相关行为的其他问题的数字调查。个体 PRO 反馈会纵向呈现给患者，并在每次调查期后与同龄组进行比较。患者报告的数据与健康保险数据相关联。将分析响应率、随时间推移的健康和体验结果变化、自我报告的健康行为变化以及卫生保健系统的使用情况。

结果

PROMchronic 研究探讨了在慢性病患者中使用 PROMs 的情况。数据收集于 2023 年 10 月开始，在最初的邀请信之后。已经邀请了所有 20 万名潜在患者参与研究。目前尚未分析数据。计划于 2024 年秋季公布中期结果，并计划于 2025 年公布研究结果。

结论

我们旨在填补基于人群的慢性病患者使用 PROMs 和 PREMs 的研究空白，并增进对与患者共享 PROM 数据的现有理解。研究结果可以说明，是否可以采用收集 PROMs 和 PREMs 的全卫生系统方法来识别低价值护理，评估慢性病内部和之间的质量差异，并确定 PRO 反馈是否有用以及是否与患者健康行为的任何变化相关。