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.

非医疗健康相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，此类社会问题也可能是由（慢性）疾病引起的。它们会带来相当大的经济成本，例如病假和长期缺勤。社会处方 (SP) 是一个潜在的解决方案：SP 是在英国开发的，近年来在 NHS 中得到广泛应用。在全球范围内，新加坡和加拿大等多个国家已实施社会处方计划。 SP 为全科医生 (GP) 提供非医疗转诊选项，可以配合现有治疗来改善健康和福祉。 SP 的实施是通过一名“联系工作人员”的参与，将具有非医疗健康相关社会需求的患者转介给该工作人员（= 开具“社会处方”）。第一步，链接工作人员评估需求，就目标达成一致，并与患者一起制定行动计划。行动计划包括转介社区中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。干预结束时，链接工作人员向开处方的全科医生提供反馈。链接工作人员和患者之间的联系通常涉及数周内的多次咨询。尽管在其他医疗机构中进行了许多评估 SP 的项目，但德国尚未进行 SP 的随机对照试验。因此，本试验的目的是测试在德国初级保健机构中进行 SP 随机对照试验 (RCT) 的可行性。该试验被设计为探索性、多中心、双臂、开放、随机对照、务实、可行性试验。 SP 与照常治疗加上一本小册子进行比较，其中包含有关当地社区提供的非临床支持和服务的信息。我们将在七个参与的 GP 诊所（研究中心）中招募约 300 名参与者（SP 与对照按 2:1 随机分配）。主要终点是通过以下指标衡量的可行性：(1) 与链接工作人员至少有过一次预约的参与者比例（仅限干预组），(2) 在 6 个月随访之前退出试验的参与者比例（双组）。次要终点包括可接受性、实用性和需求/利用，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验证性随机对照试验的设计提供信息，为德国社会处方的效果提供证据。