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The SOFIA pilot trial: a cluster-randomized trial of coordinated, co-produced care to reduce mortality and improve quality of life in people with severe mental illness in the general practice setting
Pilot and Feasibility Studies Pub Date : 2021-09-03 , DOI: 10.1186/s40814-021-00906-z
M P Rozing 1, 2 , A Jønsson 1 , R Køster-Rasmussen 1 , T D Due 1 , J Brodersen 1, 3 , K H Bissenbakker 1 , V Siersma 1 , S W Mercer 4 , A D Guassora 1 , J Kjellberg 5 , P K Kjellberg 5 , M H Nielsen 1 , I Christensen 1, 5 , J E Bardram 6 , F Martiny 1 , A Møller 1 , S Reventlow 1 ,
Affiliation  

People with severe mental illness (SMI) have an increased risk of premature mortality, predominantly due to somatic health conditions. Evidence indicates that primary and tertiary prevention and improved treatment of somatic conditions in patients with SMI could reduce this excess mortality. This paper reports a protocol designed to evaluate the feasibility of a coordinated co-produced care program (SOFIA model, a Danish acronym for Severe Mental Illness and Physical Health in General Practice) in the general practice setting to reduce mortality and improve quality of life in patients with severe mental illness. The SOFIA pilot trial is designed as a cluster randomized controlled trial targeting general practices in two regions in Denmark. We aim to include 12 practices, each of which is instructed to recruit up to 15 community-dwelling patients aged 18 and older with SMI. Practices will be randomized by a computer in a ratio of 2:1 to deliver a coordinated care program or usual care during a 6-month study period. A randomized algorithm is used to perform randomization. The coordinated care program includes educational training of general practitioners and their clinical staff educational training of general practitioners and their clinical staff, which covers clinical and diagnostic management and focus on patient-centered care of this patient group, after which general practitioners will provide a prolonged consultation focusing on individual needs and preferences of the patient with SMI and a follow-up plan if indicated. The outcomes will be parameters of the feasibility of the intervention and trial methods and will be assessed quantitatively and qualitatively. Assessments of the outcome parameters will be administered at baseline, throughout, and at end of the study period. If necessary the intervention will be revised based on results from this study. If delivery of the intervention, either in its current form or after revision, is considered feasible, a future, definitive trial to determine the effectiveness of the intervention in reducing mortality and improving quality of life in patients with SMI can take place. Successful implementation of the intervention would imply preliminary promise for addressing health inequities in patients with SMI. The trial was registered in Clinical Trials as of November 5, 2020, with registration number NCT04618250 . Protocol version: January 22, 2021; original version

中文翻译:

SOFIA 试点试验:一项在全科环境中协调、共同生产的护理以降低严重精神疾病患者的死亡率和提高生活质量的整群随机试验

患有严重精神疾病 (SMI) 的人过早死亡的风险增加,主要是由于躯体健康状况。有证据表明,对 SMI 患者进行一级和三级预防以及改善躯体疾病的治疗可以降低这种过高的死亡率。本文报告了一项协议,旨在评估在一般实践环境中协调联合生产的护理计划(SOFIA 模型,丹麦语中严重精神疾病和身体健康的首字母缩写词)在一般实践环境中降低死亡率和提高生活质量的可行性。患有严重精神疾病的患者。SOFIA 试点试验被设计为一项针对丹麦两个地区一般实践的集群随机对照试验。我们的目标是包括 12 个实践,每家公司都被指示招募多达 15 名 18 岁及以上患有 SMI 的社区居民。实践将由计算机以 2:1 的比例随机分配,以在 6 个月的研究期内提供协调护理计划或常规护理。随机算法用于执行随机化。协调护理计划包括全科医生及其临床人员的教育培训 全科医生及其临床人员的教育培训,涵盖临床和诊断管理,并专注于对该患者群体的以患者为中心的护理,之后全科医生将提供长期咨询侧重于 SMI 患者的个人需求和偏好,并在需要时制定后续计划。结果将是干预和试验方法可行性的参数,并将进行定量和定性评估。结果参数的评估将在研究期间的基线、整个期间和结束时进行。如有必要,将根据本研究的结果修改干预措施。如果认为以当前形式或修订后的干预措施是可行的,则可以在未来进行确定性试验,以确定干预措施在降低 SMI 患者死亡率和改善生活质量方面的有效性。干预的成功实施意味着解决 SMI 患者健康不公平问题的初步前景。该试验于2020年11月5日在Clinical Trials注册,注册号为NCT04618250。协议版本:2021 年 1 月 22 日;原版
更新日期:2021-09-03
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