Pilot cluster randomized controlled trial of a complex intervention to improve management of vertigo in primary care (PRIMA-Vertigo): study protocol

Abstract

Objectives: 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.

Methods: 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.

Expected results: 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.

Conclusions: 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.

Keywords:

• Primary health care
• general practitioners
• vertigo
• dizziness
• guideline
• referral and consultation

Transparency

Declaration of funding

This manuscript was supported by the Federal Ministry of Education and Research, Germany under Grant BMBF FKZ 01EO1401.

Declaration of financial/other relationships

E.K., A.-J.S., A.P., J.S., R.S. and E.G. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

We would like to thank the professionals who dedicated their time to the preparation of the different training modules and provided support on elaborating data collection methods, intervention components and patient education materials, namely Dr. Klaus Jahn, Schön Klinik Bad Aibling, Deutsches Schwindel- und Gleichgewichtszentrum, Klinikum der Universität München, Dr. Sandra Becker-Bense, Neurologische Klinik und Poliklinik, Deutsches Schwindel- und Gleichgewichtszentrum, Klinikum der Universität München and Silvy Kellerer, physiotherapist, Deutsches Schwindel- und Gleichgewichtszentrum, Klinikum der Universität München.