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

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

Sponsors

Lead Sponsor: Odense University Hospital

Source 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.

Overall Status Not yet recruiting
Start Date 2019-02-01
Completion Date 2021-04-01
Primary Completion Date 2020-12-31
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of days from symptom debut to beginning of antibiotic treatment for Lyme neuroborreliosis 0-90 days
Secondary Outcome
Measure Time Frame
Number of yearly referred Lyme patients Up to 4 years (1460 days).
Number of Borrelia antibody tests in peripheral blood ordered by primary care physicians Up to 4 years (1460 days).
Enrollment 60
Condition
Intervention

Intervention Type: Other

Intervention Name: Oral and written information on tick-bites and Lyme disease

Description: See under study arm descriptions

Arm Group Label: Teaching arm

Eligibility

Criteria:

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 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

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Fredrikke C Knudtzen, MD Principal Investigator Department of Infectious Diseases, Odense University Hospital
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Contact: Clinical Center for Emerging and Vectorborne Infections Sigurdur Skarphedinsson, MD, PhD
Location Countries

Denmark

Verification Date

2019-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Odense University Hospital

Investigator Full Name: Fredrikke Christie Knudtzen

Investigator Title: Speciality Registrar, Specialist in Infectious Diseases, Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Teaching arm

Type: Experimental

Description: The Primary Health Care physicians getting oral and written information on tick-bites and Lyme disease with focus on Lyme neuroborreliosis.

Label: Passive arm

Type: No Intervention

Description: The Primary Health Care physicians that does not get contacted with an offer to receive oral and written information.

Acronym NBdelay
Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Open label interventional study where primary Health care Physicians in areas on Funen Island, Denmark, are included if they have their practice in an area with Lyme Neuroborreliosis incidens > 4.6/100.000

Primary Purpose: Treatment

Masking: None (Open Label)

Masking Description: Open label study, due to the intervention (lectures) and the criteria for receiving the intervention (Lyme neuroborreliosis incidens > 4.6/100.000), the study cannot be blinded.

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