Social prescribing to improve health and well-being of patients presenting with non-medical health related social needs in primary care: a multi-center randomized controlled pragmatic feasibility trial

社会处方可改善初级保健中具有非医疗健康相关社会需求的患者的健康和福祉：多中心随机对照实用可行性试验

• 批准号: 530364906
• 负责人: Professor Dr. Wolfram Joachim Herrmann
• 金额: --
• 依托单位: Institut für Allgemeinmedizin
• 依托单位国家: 德国
• 项目类别: Clinical Trials
• 资助国家: 德国
• 项目状态: 未结题
• 来源: https://gepris.dfg.de/gepris/projekt/530364906?language=en
• 关键词: Social; prescribing; improve; health; well

Non-medical health related social problems are highly prevalent in primary care. They can have a considerable impact on the development and course of mental and physical health. Such social problems can, however, also be caused by (chronic) disease. They are associated with considerable economic costs, such as sick leave and long-term absence from work. Social Prescribing (SP) is a potential solution: SP was developed in the UK and has become widely established in the NHS in recent years. Globally, social prescribing schemes have been implemented in several countries, such as Singapore and Canada. SP equips General Practitioners (GPs) with a non-medical referral option, which can accompany existing treatments to improve health and well-being. SP is implemented by involving a “link worker” to whom patients with non-medical health-related social needs are referred to (= issued a “social prescription”). In a first step, the link worker assesses needs, agrees on a goal and develops an action plan together with the patient. The action plans includes referrals to existing non-clinical support and services in the community. The link worker supports the patient to access these services. At the end of the intervention, the link worker gives feedback to the prescribing GP. The contact between link worker and patient usually involves several consultations over the course of several weeks. Although numerous projects evaluating SP in other healthcare settings have been conducted, no RCTs on SP have been performed in Germany. Thus, the goal of this trial is to test the feasibility of a randomized controlled trial (RCT) on SP in the primary care setting in Germany. The trial is designed as an exploratory, multi-center, two-armed, open, randomized controlled, pragmatic, feasibility trial. SP is compared with treatment-as-usual plus a brochure with information about local offers for non-clinical support and services in the community. We will recruit about 300 participants (2:1 randomization into SP vs. control) in seven participating GP practices (study centers). The primary endpoint is the feasibility measured by (1) proportion of participants who have at least one appointment with the link worker (intervention arm only), (2) proportion of participants that drop out of the trial before the 6-month follow-up (, both arms). Secondary endpoints include acceptability, practicality, and demand/utilization, as well as clinical endpoints for health status, well-being, and community connection. The results of this feasibility trial will inform the design of a confirmatory randomized controlled trial providing evidence on the effect of social prescribing in Germany.

非医学与健康相关的社会问题在初级保健中非常普遍。他们可以考虑对身心健康的发展和进程。但是，这种社会问题也可能是由于（慢性）疾病引起的。它们与考虑经济成本有关，例如病假和长期工作。社会处方（SP）是一个潜在的解决方案：SP是在英国开发的，近年来已在NHS中广泛建立。在全球范围内，已经在新加坡和加拿大等多个国家实施了社会处方计划。具有非医学推荐选项的SP当量全科医生（GPS），可以适应现有的治疗方法以改善健康和福祉。 SP是通过涉及一个“链接工作者”来实施的，该“链接工作者”与该链接相关的社会需求（=发出“社会处方”）。第一步，链接工作者评估的需求，同意目标，并与患者一起制定行动计划。行动计划包括转介到社区中现有的非临床支持和服务。链接工作者支持患者访问这些服务。在干预结束时，链接工作人员向开处方GP提供了反馈。链接工作者与患者之间的接触通常涉及几周的几次咨询。尽管已经在其他医疗保健环境中评估了SP的许多项目，但在德国尚未进行SP的RCT。这是该试验的目的是测试德国初级保健环境中SP的随机对照试验（RCT）的可行性。该试验被设计为探索性，多中心，两臂，开放，随机对照，务实，可行性试验。将SP与惯常的治疗和小册子进行了比较，并提供了有关社区中非临床支持和服务的当地报价的信息。我们将在七个参与的GP实践（研究中心）中招募约300名参与者（2：1随机化为SP与对照）。主要终点是通过（1）与链接工作者任命至少一项任命（仅干预部门）的参与者的比例，（2）在6个月的随访之前退出试验的参与者的比例（均为两臂）。次要终点包括可接受性，实用性和需求/利用率，以及健康状况，福祉和社区联系的临床终点。这项可行性试验的结果将为设计提供确认随机对照试验的设计，该试验提供了有关德国社会处方作用的证据。