van Westrienen Paula Elisabeth, Pisters Martijn F, Toonders Suze Aj, Gerrits Marloes, Veenhof Cindy, de Wit Niek J
Department of Health Innovation and Technology, Fontys University of Applied Sciences, Eindhoven, Netherlands.
Center for Physical Therapy Research and Innovation in Primary Care, Utrecht, Netherlands.
JMIR Res Protoc. 2018 May 8;7(5):e120. doi: 10.2196/resprot.9404.
Medically unexplained physical symptoms are an important health problem in primary care, with a spectrum from mild to chronic. The burden of chronic medically unexplained physical symptoms is substantial for patients, health care professionals, and society. Therefore, early identification of patients with moderate medically unexplained physical symptoms is needed in order to prevent chronicity. The preventive screening of medically unexplained physical symptoms (PRESUME) screening method was developed using data from the electronic medical record of the patients' general practitioner and demonstrated its prognostic accuracy to identify patients with moderate medically unexplained physical symptoms. In the next step, we developed a proactive blended and integrated mental health and physical therapy intervention program (PARASOL) to reduce complaints of moderate medically unexplained physical symptoms, stimulate self-management, and prevent chronicity.
The primary objective of this study is to investigate the effectiveness of the blended PARASOL intervention on the impact of symptoms and quality of life in patients with moderate medically unexplained physical symptoms compared with usual care. Secondary objectives are to study the effect on severity of physical and psychosocial symptoms, general health, physical behavior, illness perception, and self-efficacy in patients with moderate medically unexplained physical symptoms as well as to determine the cost-effectiveness of the program.
This paper presents the study protocol of a multicenter cluster randomized clinical trial. Adult patients with moderate medically unexplained physical symptoms will be identified from electronic medical record data using the PRESUME screening method and proactively recruited for participation in the study. Cluster randomization will be performed at the level of the participating health care centers. In total 248 patients with moderate medically unexplained physical symptoms (124 patients per arm) are needed. The PARASOL intervention is a 12-week blended primary care program consisting of 4 face-to-face consultations with the mental health nurse and 5 physical therapy sessions, supplemented with a Web-based program. The Web-based program contains (1) information modules and videos on self-management and educative themes, (2) videos and instructions on prescribed home exercises, and (3) assignments to gradually increase the physical activity. The program is directed at patients' perception of symptoms as well as modifiable prognostic risk factors for chronicity using therapeutic neuroscience education. It encourages self-management, as well as an active lifestyle using a cognitive behavioral approach and graded activity. Primary outcomes are impact of symptoms and quality of life. Secondary outcomes are severity of physical and psychosocial symptoms, general health, physical behavior, illness perceptions, self-efficacy, and cost-effectiveness. All measurements will be performed at baseline, 3 and 12 months after baseline. Retrospective cost questionnaires will also be sent at 6 and 9 months after baseline and these will be used for the cost-effectiveness analysis.
The intervention has been developed, and the physical therapists and mental health nurses in the participating experimental health care centers have received two days of training on the content of the blended PARASOL intervention. The recruitment of health care centers started in June 2016 and inclusion of patients began in March 2017. Follow-up assessments of patients are expected to be completed in March 2019.
This study is the first randomized clinical trial to determine the effectiveness (including cost-effectiveness) of a proactive, blended, and integrated mental health and physical therapy care program for patients with moderate medically unexplained physical symptoms. The findings will help to improve the treatment for patients with moderate medically unexplained physical symptoms and prevent chronicity.
Netherlands Trial Register NTR6755; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6755 (Archived by WebCite at http://www.webcitation.org/6ywporY7u).
医学上无法解释的身体症状是初级保健中的一个重要健康问题，症状范围从轻度到慢性。慢性医学上无法解释的身体症状给患者、医护人员和社会带来了沉重负担。因此，需要早期识别中度医学上无法解释的身体症状患者，以预防慢性病。医学上无法解释的身体症状预防性筛查（PRESUME）筛查方法是利用患者全科医生电子病历中的数据开发的，并证明了其在识别中度医学上无法解释的身体症状患者方面的预后准确性。在下一步中，我们开发了一个积极的综合心理健康和物理治疗干预项目（PARASOL），以减少中度医学上无法解释的身体症状的主诉，促进自我管理，并预防慢性病。
本研究的主要目的是调查与常规护理相比，PARASOL综合干预对中度医学上无法解释的身体症状患者的症状影响和生活质量的有效性。次要目的是研究对中度医学上无法解释的身体症状患者的身体和心理社会症状严重程度、总体健康状况、身体行为、疾病认知和自我效能的影响，并确定该项目的成本效益。
本文介绍了一项多中心整群随机临床试验的研究方案。将使用PRESUME筛查方法从电子病历数据中识别出患有中度医学上无法解释的身体症状的成年患者，并积极招募他们参与研究。整群随机化将在参与的医疗保健中心层面进行。总共需要248名患有中度医学上无法解释的身体症状的患者（每组124名患者）。PARASOL干预是一个为期12周的综合初级保健项目，包括与心理健康护士进行4次面对面咨询和5次物理治疗课程，并辅以一个基于网络的项目。基于网络的项目包含：（1）关于自我管理和教育主题的信息模块和视频；（2）关于规定家庭锻炼的视频和说明；（3）逐步增加身体活动的任务。该项目针对患者对症状的认知以及使用治疗性神经科学教育对慢性病的可改变预后风险因素。它鼓励自我管理，以及采用认知行为方法和分级活动的积极生活方式。主要结局是症状影响和生活质量。次要结局是身体和心理社会症状的严重程度、总体健康状况、身体行为、疾病认知、自我效能和成本效益。所有测量将在基线、基线后3个月和12个月进行。回顾性成本问卷也将在基线后6个月和9个月发送，这些问卷将用于成本效益分析。
该干预措施已开发出来，参与实验的医疗保健中心的物理治疗师和心理健康护士已接受了为期两天的关于PARASOL综合干预内容的培训。医疗保健中心的招募工作于2016年6月开始，患者纳入工作于2017年3月开始。预计患者的随访评估将于2019年3月完成。
本研究是第一项随机临床试验，旨在确定针对中度医学上无法解释的身体症状患者的积极、综合的心理健康和物理治疗护理项目的有效性（包括成本效益）。研究结果将有助于改善中度医学上无法解释的身体症状患者的治疗，并预防慢性病。
荷兰试验注册NTR6755；http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6755（由WebCite存档于http://www.webcitation.org/6ywporY7u）。
