a Ludwig-Maximilians-Universität München, University Hospital - German Center for Vertigo and Balance Disorders , Germany.
b Ludwig-Maximilians-Universität München - Institute for Medical Information Processing, Biometrics and Epidemiology , Germany.
Curr Med Res Opin. 2018 Oct;34(10):1819-1828. doi: 10.1080/03007995.2018.1456413. Epub 2018 Apr 23.
Vertigo and dizziness are highly prevalent symptoms in primary care, frequently misdiagnosed. Based on a thorough need assessment, INDICORE (INform, DIagnose, COmmunicate, REfer), an evidence-based complex intervention has been developed to transfer knowledge of specialized tertiary clinics to primary care providers (PCPs), improve the referral process and, ultimately, improve the functioning and quality of life of patients with vertigo/dizziness. The main objective of the PRIMA-Vertigo pilot study is to examine whether the INDICORE intervention is feasible and sufficiently promising to warrant a larger trial.
We plan to perform a single-blind, pragmatic cluster-randomized controlled pilot study with an accompanying process evaluation. PCPs will be the cluster units of randomization. Patients who consult these PCPs because of vertigo/dizziness symptoms will be included consecutively and considered the units of analysis. The intervention will be multi-faceted training on diagnostics targeted at the PCPs, supported by patient education material and a newly developed tool to structure the referral process. To balance the influence of non-specific effects, all clusters will receive generic communication training.
The process evaluation aims to provide results on the acceptability and feasibility of the INDICORE intervention components to PCPs and patients. Additionally, this study will provide a first estimate of the likely effectiveness of the intervention on patients' quality of life, functioning and participation.
The PRIMA-Vertigo pilot study will allow further tailoring of the INDICORE intervention to stakeholder needs before its effectiveness is evaluated in a large-scale main study.
眩晕和头晕是初级保健中非常普遍的症状，经常被误诊。基于全面的需求评估，INDICORE（INform、DIagnose、COmmunicate、REfer），一种基于证据的复杂干预措施已经被开发出来，旨在将专业三级诊所的知识转移到初级保健提供者（PCP）手中，改善转诊流程，最终提高眩晕/头晕患者的功能和生活质量。PRIMA-Vertigo 试点研究的主要目的是检验 INDICORE 干预措施是否可行且有足够的前景，值得进行更大规模的试验。
我们计划进行一项单盲、实用的集群随机对照试点研究，并进行伴随的过程评估。PCP 将是随机分组的集群单位。因眩晕/头晕症状咨询这些 PCP 的患者将被连续纳入并视为分析单位。干预措施将是针对 PCP 的有针对性的诊断多方面培训，辅以患者教育材料和新开发的工具来结构化转诊流程。为了平衡非特异性影响，所有集群都将接受通用沟通培训。
过程评估旨在为 PCP 和患者提供 INDICORE 干预措施的可接受性和可行性的结果。此外，本研究还将初步估计该干预措施对患者生活质量、功能和参与度的可能效果。
PRIMA-Vertigo 试点研究将允许进一步调整 INDICORE 干预措施，以满足利益相关者的需求，然后在大规模的主要研究中评估其有效性。
