An Intervention in a Primary Healthcare Setting to Reduce Lyme Neuroborreliosis Treatment Delay

Not Applicable

• Conditions: Lyme Neuroborreliosis
• Interventions: Other: Oral and written information on tick-bites and Lyme disease

• Registration Number: NCT03820999
• Lead Sponsor: Odense University Hospital

Brief Summary

This study evaluates the effect of written and oral information in a primary health care setting on 1) patients referred to specialised examination for Lyme neuroborreliosis, 2) delay from patient symptom debut to treatment for Lyme neuroborreliosis, and 3) number of Borrelia serology tests from primary health care.

Detailed Description

Lyme neuroborreliosis is among the most common neuroinfections in northern Europe. Residual symptoms after treatment are a frequent problem in Lyme neuroborreliosis, and an association between the delay from symptom debut to antibiotic treatment has been established. In a previous study on Funen Island, Denmark, the delay from day of symptom debut to treatment for Lyme neuroborreliosis patients was 24 days. This considerable treatment delay did not change in the 20 years study period.

In the Danish health system, the general practitioners are the first medical professionals to see the majority of patients. They can refer patients to the hospital for further examination if indicated. Many general practitioners use Borrelia burgdorferi antibodies (igM/IgG) as a screening tool when they suspect Lyme disease or see patients with uncharacteristic symptoms. This is unfortunate, as the rash Erythema Migrans, the most common Borreliosis manifestation in Europe, is a clinical diagnosis. Only around 50% of patients have positive antibodies at time of Erythema Migrans diagnosis. Lyme neuroborreliosis is diagnosed based on symptoms and the results from the cerebrospinal fluid, and cannot be diagnosed based on serology, which only delays the time to diagnoses and treatment. The Danish guidelines on Lyme borreliosis therefore discourage general practitioners from using Borrelia serology.

In the before mentioned study from Funen Island, several patients described multiple contacts to their general practitioners, where the symptoms of Lyme neuroborreliosis were not recognized. The cardinal symptom of radicular pain was associated with a longer delay than many of the less common symptoms of Lyme neuroborreliosis.

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-01-28
• Study First Posted: 2019-01-29
• Last Update Submitted: 2019-01-29
• Last Update Posted: 2019-01-31
• Study Start: 2019-02
• Primary Completion: 2020-12-31
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Primary care physicians with a postal code in an area of Funen Island with a Lyme neuroborreliosis incidens of > 4.6/100.000
• Patients with a postal address on Funen and a positive Borrelia intrathecal antibody test (diagnostic for lyme neuroborreliosis) performed at the Department of Clinical Microbiology, Odense University Hospital from January 1st 2017 - December 31st 2020
• A Borrelia IgM/IgG serology ordered from Primary Health Care and performed at the Department of Clinical Microbiology, Odense University Hospital from January 1st 2017 - December 31st 2020

Read More

Exclusion Criteria

• Primary care physicians with a postal code in an area of Funen Island with a Lyme neuroborreliosis incidens of < 4.7/100.000

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teaching arm	Oral and written information on tick-bites and Lyme disease	The Primary Health Care physicians getting oral and written information on tick-bites and Lyme disease with focus on Lyme neuroborreliosis.

Primary Outcome Measures

Name	Time	Method
Number of days from symptom debut to beginning of antibiotic treatment for Lyme neuroborreliosis	0-90 days	Number of days from debut of neurological symptoms to beginning of antibiotic treatment for Lyme neuroborreliosis.

Secondary Outcome Measures

Name	Time	Method
Number of yearly referred Lyme patients	Up to 4 years (1460 days).	Number of yearly referred patients in the two study arms in the two years before the intervention (2017+2018) and after the intervention (2019+2020).
Number of Borrelia antibody tests in peripheral blood ordered by primary care physicians	Up to 4 years (1460 days).	Number of Borrelia antibody tests in peripheral blood ordered by primary Health care physicians in the two study arms in the two years before (2017+2018) and after (2019 + 2020) the intervention.

Trial Locations

Locations (1)

Clinical Center for Emerging and Vectorborne Infections; 🇩🇰 Odense, Funen, Denmark