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

与医疗卫生无关的社会问题在初级保健中非常普遍。它们可以对身心健康的发展和进程产生相当大的影响。然而，这些社会问题也可能是由（慢性）疾病引起的。这涉及相当大的经济成本，如病假和长期缺勤。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，新加坡和加拿大等几个国家已经实施了社会处方计划。SP为全科医生（GP）提供了非医疗转诊选择，可以与现有治疗一起改善健康和福祉。通过一名“联系工作人员”的参与，实施社会服务方案，向有非医疗健康相关社会需求的患者提供转诊服务（=开具“社会处方”）。在第一步中，链接工作者评估需求，商定目标，并与患者一起制定行动计划。这些行动计划包括转介社区现有的非临床支持和服务。链接工作人员支持患者访问这些服务。在干预结束时，链接工作人员向处方GP提供反馈。链接工作人员和患者之间的接触通常需要在几周内进行多次咨询。尽管在其他医疗环境中进行了许多评价SP的项目，但在德国尚未进行SP的RCT。因此，本试验的目的是检验在德国初级保健环境中进行SP随机对照试验（RCT）的可行性。本试验设计为探索性、多中心、双臂、开放性、随机对照、实用性、可行性试验。将SP与常规治疗进行比较，并提供一本小册子，介绍当地社区提供的非临床支持和服务。我们将在7个参与的GP实践（研究中心）招募约300名参与者（2：1随机分配至SP组与对照组）。主要终点是可行性，通过（1）与链接工作人员至少有一次预约的受试者比例（仅干预组），（2）在6个月随访前退出试验的受试者比例（，两组）。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。该可行性试验的结果将为设计一项验证性随机对照试验提供信息，该试验为德国社会处方的影响提供证据。

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.