Institute for Evidence in Medicine (for Cochrane Germany Foundation), Faculty of Medicine and Medical Center, University of Freiburg, Breisacher Str. 153, 79110, Freiburg, Germany.
Section of Health Care Research and Rehabilitation Research, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
BMC Fam Pract. 2019 Feb 25;20(1):33. doi: 10.1186/s12875-019-0925-8.
Back pain is one of the most frequent causes of health-related work absence. In Germany, more than 70% of adults suffer from at least one back pain episode per annum. It has strong impact on health care costs and patients' quality of life. Patients increasingly seek health information on the internet. However, judging its trustworthiness is difficult. In addition, physicians who are being confronted with this type of information often experience it to complicate the physician-patient interaction. The GAP trial aims to develop, implement and evaluate an evidence-based, easy-to-understand and trustworthy internet information portal on lower back pain to be used by general practitioners and patients during and after the consultation. Effectiveness of GAP portal use compared to routine consultation on improving communication and informedness of both physicians and patients will be assessed. In addition, effects on health care costs and patients' days of sick leave will be evaluated.
We will conduct a prospective multi-centre, cluster-randomized parallel group trial including 1500 patients and 150 recruiting general practitioners. The intervention group will have access to the GAP portal. The portal will contain brief guides for patients and physicians on how to improve the consultation as well as information on epidemiology, aetiology, symptoms, benefits and harms of treatment options for acute, sub-acute and chronic lower back pain. The GAP portal will be designed to be user-friendly and present information on back pain tailored for either patients or physicians in form of brief fact sheets, educative videos, info-graphics, animations and glossaries. Physicians and patients will assess their informedness and the physician-patient communication in consultations at baseline and at two time points after the consultations under investigation. Days of sick leave and health care costs related to back pain will be compared between control and intervention group using routine data of company health insurance funds.
The GAP-trial intends to improve the communication between physicians and their patients and the informedness of both groups. If proven beneficial, the evidence-based and user-friendly portal will be made accessible for all patients and health professionals in back pain care. Inclusion of further indications might be implemented and evaluated in the long term.
German Clinical Trials Register DRKS00014279 (registered 27th of April 2018).
背痛是导致与健康相关的缺勤最常见的原因之一。在德国，超过 70%的成年人每年至少会经历一次背痛。它对医疗保健成本和患者的生活质量有很大的影响。患者越来越多地在互联网上寻找健康信息。然而，判断其可信度是很困难的。此外，面对这种类型的信息，医生往往会觉得它使医患互动变得复杂。GAP 试验旨在开发、实施和评估一个基于证据的、易于理解和值得信赖的互联网下背痛信息门户，供全科医生和患者在咨询期间和之后使用。将评估 GAP 门户的使用与常规咨询相比，在改善医患双方的沟通和知情程度方面的效果。此外，还将评估对医疗保健成本和患者病假天数的影响。
我们将进行一项前瞻性的多中心、集群随机平行组试验，包括 1500 名患者和 150 名招募的全科医生。干预组将可以使用 GAP 门户。该门户将包含针对患者和医生的简要指南，介绍如何改善咨询，以及关于急性、亚急性和慢性下背痛的流行病学、病因、症状、治疗选择的益处和危害的信息。GAP 门户将设计为用户友好，并以简短的事实表、教育视频、信息图表、动画和词汇表的形式为患者或医生提供针对背痛的信息。医生和患者将在基线和调查咨询后的两个时间点评估他们在咨询中的知情程度和医患沟通。将使用公司健康保险基金的常规数据比较对照组和干预组的病假天数和与背痛相关的医疗保健费用。
GAP 试验旨在改善医生与其患者之间的沟通以及两组患者的知情程度。如果被证明是有益的，那么这个基于证据和用户友好的门户将可供所有背痛护理的患者和卫生专业人员使用。在长期内，可以纳入进一步的适应症并进行评估。
德国临床试验注册中心 DRKS00014279（2018 年 4 月 27 日注册）。
