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

NCT ID: NCT03820999

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2021-04-01

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.

Conditions

Lyme Neuroborreliosis

Keywords

treatment delay; primary health care

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Teaching arm

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

Group Type: EXPERIMENTAL

Oral and written information on tick-bites and Lyme disease

Intervention Type: OTHER

See under study arm descriptions

Passive arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oral and written information on tick-bites and Lyme disease

See under study arm descriptions

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fredrikke Christie Knudtzen

Speciality Registrar, Specialist in Infectious Diseases, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fredrikke C Knudtzen, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Infectious Diseases, Odense University Hospital

Locations

Clinical Center for Emerging and Vectorborne Infections

Odense, Funen, Denmark

Countries

Denmark

Central Contacts

Fredrikke C Knudtzen, MD

Role: CONTACT

Phone: 004529178083

Email: fredrikke.christie.knudtzen@rsyd.dk

Sigurdur Skarphédinsson, MD, PhD

Role: CONTACT

Phone: 004565414280

Email: s.skarphedinsson@rsyd.dk

Facility Contacts

Sigurdur Skarphedinsson, MD, PhD

Role: primary

References

Knudtzen FC, Andersen NS, Jensen TG, Skarphedinsson S. Characteristics and Clinical Outcome of Lyme Neuroborreliosis in a High Endemic Area, 1995-2014: A Retrospective Cohort Study in Denmark. Clin Infect Dis. 2017 Oct 16;65(9):1489-1495. doi: 10.1093/cid/cix568.

Reference Type: RESULT

PMID: 29048514 (View on PubMed)

Knudtzen FC, Jensen TG, Andersen NS, Johansen IS, Hovius JW, Skarphedinsson S. An intervention in general practice to improve the management of Lyme borreliosis in Denmark. Eur J Public Health. 2022 Jun 1;32(3):436-442. doi: 10.1093/eurpub/ckac013.

Reference Type: DERIVED

PMID: 35323885 (View on PubMed)

Other Identifiers

FCKPhDProject4

Identifier Type: -

Identifier Source: org_study_id