基于患者个体需求的原发性痴呆照护：DemStepCare 集群随机对照试验研究方案。
Primary dementia care based on the individual needs of the patient: study protocol of the cluster randomized controlled trial, DemStepCare.
机构信息
Institute of Medical Biometry and Statistics, Section of Health Care Research and Rehabilitation Research, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
Institute of Medical Biometry and Statistics, Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.
出版信息
BMC Geriatr. 2021 Apr 1;21(1):222. doi: 10.1186/s12877-021-02114-z.
BACKGROUND
Most people with dementia (PwD) are cared for at home, with general practitioners (GPs) playing a key part in the treatment. However, primary dementia care suffers from a number of shortcomings: Often, diagnoses are made too late and therapies by GPs do not follow the guidelines. In cases of acute crises, PwD are too often admitted to hospital with adverse effects on the further course of the disease. The aim of this study is to implement and evaluate a new GP-based, complex dementia care model, DemStepCare. DemStepCare aims to ensure demand-oriented, stepped care for PwD and their caregivers.
METHODS/DESIGN: In a cluster randomized controlled trial, the care of PwD receiving a complex intervention, where the GP is supported by a multi-professional team, is compared to (slightly expanded) usual care. GPs are clustered by GP practice, with 120 GP practices participating in total. GP practices are randomized to an intervention or a control group. 800 PwD are to be included per group. Recruitment takes place in Rhineland-Palatinate, Germany. In addition, a second control group with at least 800 PwD will be formed using aggregated routine data from German health insurance companies. The intervention comprises the training of GPs, case management including repeated risk assessment of the patients' care situation, the demand-oriented service of an outpatient clinic, an electronic case record, external medication analyses and a link to regional support services. The primary aims of the intervention are to positively influence the quality of life for PwD, to reduce the caregivers' burden, and to reduce the days spent in hospital. Secondary endpoints address medication adequacy and GPs' attitudes and sensitivity towards dementia, among others.
DISCUSSION
The GP-based dementia care model DemStepCare is intended to combine a number of promising interventions to provide a complex, stepped intervention that follows the individual needs of PwD and their caregivers. Its effectiveness and feasibility will be assessed in a formative and a summative evaluation.
TRIAL REGISTRATION
German Register of Clinical Trials (Deutsches Register Klinischer Studien, DRKS), DRKS00023560 . Registered 13 November 2020 - Retrospectively registered. HTML&TRIAL_ID=DRKS00023560.
背景
大多数痴呆症患者（PwD）在家中接受护理，全科医生（GPs）在治疗中起着关键作用。然而，初级痴呆症护理存在许多缺陷：通常，诊断太晚，GPs 的治疗方法不符合指南。在急性危机情况下，PwD 经常被送往医院，这对疾病的进一步发展产生不利影响。本研究的目的是实施和评估一种新的基于全科医生的复杂痴呆症护理模式，DemStepCare。DemStepCare 旨在确保为 PwD 及其照顾者提供需求导向的分阶段护理。
方法/设计：在一项集群随机对照试验中，将接受复杂干预的 PwD 的护理与（略有扩展的）常规护理进行比较，该干预由多专业团队支持全科医生。全科医生按全科医生实践进行分组，共有 120 个全科医生实践参与。全科医生实践随机分为干预组或对照组。每组将纳入 800 名 PwD。招募工作在德国莱茵兰-普法尔茨州进行。此外，将使用德国健康保险公司的汇总常规数据形成至少包含 800 名 PwD 的第二个对照组。干预措施包括全科医生培训、包括反复评估患者护理情况风险在内的病例管理、以需求为导向的门诊服务、电子病例记录、外部药物分析以及与区域支持服务的联系。干预的主要目的是积极影响 PwD 的生活质量，减轻照顾者的负担，并减少住院天数。次要终点包括药物适宜性和全科医生对痴呆症的态度和敏感性等。
讨论
基于全科医生的痴呆症护理模式 DemStepCare 旨在结合多种有前途的干预措施，提供一种复杂的、分阶段的干预措施，满足 PwD 和他们的照顾者的个体需求。它的有效性和可行性将通过形成性和总结性评估来评估。
试验注册
德国临床试验注册处（Deutsches Register Klinischer Studien，DRKS），DRKS00023560。于 2020 年 11 月 13 日注册-回顾性注册。HTML&TRIAL_ID=DRKS00023560。
Zotero 插件