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

<p><b>Objectives:</b> 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.</p> <p><b>Methods:</b> 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.</p> <p><b>Expected results:</b> 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.</p> <p><b>Conclusions:</b> 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.</p

Atmospheric pressure parameters in hPa for Augsburg and Munich.

<p>Atmospheric pressure parameters in hPa for Augsburg and Munich.</p

Additional file 1: of Outcome measures in older persons with acquired joint contractures: a systematic review and content analysis using the ICF (International Classification of Functioning, Disability and Health) as a reference

Structure of the International Classification of Functioning, Disability and Health (ICF). (DOC 67 kb

Trend of prevalence of vertigo.

<p>The prevalence of MD episodes is illustrated over the first 365 days after inclusion in the study. The black line corresponds to the loess smoother with k = 0.75. The dotted line displays the pointwise 95%-confidence intervals of the smoother. We observed a decrease in MD episode prevalence over the first 240 days and an increase thereafter.</p

Additional file 2: of RECAPDOC - a questionnaire for the documentation of rehabilitation care utilization in individuals with disorders of consciousness in long-term care in Germany: development and pretesting

Interview guide for the expert interviews with physicians. (DOCX 13 kb

Change in atmospheric pressure versus prevalence of MD episodes.

<p>Scatter plot of change in atmospheric pressure <i>DiffPressure</i> in hPa versus prevalence of MD episodes. The black line corresponds to the loess smoother with k = 0.75. No relationship between prevalence of MD episodes and change in air pressure could be observed for air pressure values on day zero, two and three, but a roughly linear increasing relationship was found between the onset of an MD episode and change in air pressure one day before the event.</p

Additional file 3: of RECAPDOC - a questionnaire for the documentation of rehabilitation care utilization in individuals with disorders of consciousness in long-term care in Germany: development and pretesting

German version of the REACPDOC questionnaire. (PDF 684 kb

Baseline characteristics of the study population (n = 56).

<p>Baseline characteristics of the study population (n = 56).</p

Additional file 1: of RECAPDOC - a questionnaire for the documentation of rehabilitation care utilization in individuals with disorders of consciousness in long-term care in Germany: development and pretesting

Questionnaires of the Delphi survey (round 1 & 2). (DOCX 15 kb

Change in air pressure over time.

<p>Station Augsburg.</p