High- and Low-risk Actinic Keratosis Referrals to Secondary Care

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05976061
Collaborator
Tergooi Hospital (Other)
3,379
1
37
91.3

Study Details

Study Description

Brief Summary

This study evaluates the implementation of the General Practitioners guidelines 'Suspicious Skin Lesions' and investigated whether their publication and implementation has led to a reduction in the proportion of referrals of low-risk patients with actinic keratosis to secondary care, after publication of the General Practitioners guidelines and implementation activities.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In the Dutch healthcare system, patients are first examined by the general practitioner who decides whether a referral to a dermatologist is indicated. Both general practitioners and dermatologists can diagnose and treat patients with actinic keratosis. Therefore, it is necessary to distinguish which patients the general practitioner should refer to a dermatologist and which patients are suitable to be treated by the general practitioner.

    This retrospective data study evaluates the proportion of low risk actinic keratosis patients in 2019 en 2018.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3379 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    High- and Low-risk Actinic Keratosis Referrals to Secondary Care. Implementation of the General Practitioners Guidelines for Actinic Keratosis Patients.
    Actual Study Start Date :
    Mar 1, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2023
    Anticipated Study Completion Date :
    Apr 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Low risk patients

    Low risk actinic keratosis patients referred by the general practitioner and diagnosed as actinic keratosis by the dermatologist in 2018 and 2019.

    High risk patients

    High risk actinic keratosis patients referred by the general practitioner and diagnosed as actinic keratosis by the dermatologist in 2018 and 2019.

    Outcome Measures

    Primary Outcome Measures

    1. Change in proportion of low-risk actinic keratosis patients among all actinic keratosis patients. [2018 compared to 2019 (2 years)]

      The change in proportion of low-risk actinic keratosis patients among all actinic keratosis patients referred by the general practitioner to the dermatologist. The definition of low-risk actinic keratosis patients was based on the General Practitioners guidelines 'Suspicious skin lesions' (published in 2017). Patients were defined as low-risk when they were not immunocompromised, did not have a cutaneous malignancy in their medical history, did not have previous treatment or if they did not have extensive lesions.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients of 18 years and older

    • referred to dermatologist for suspicion of actinic keratosis and diagnosed as actinic keratosis by the dermatologist

    • treated at MaastrichtUMC+ or TergooiHospital

    Exclusion Criteria:
    • different diagnosis than actinic keratosis

    • referred by a different specialist than the general practitioner

    • referred with multiple problems

    • referred for a second opinion

    • if the patients was treated as different diagnosis than actinic keratosis by general practitioner

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ellen Oyen Maastricht Netherlands

    Sponsors and Collaborators

    • Maastricht University Medical Center
    • Tergooi Hospital

    Investigators

    • Principal Investigator: Klara Mosterd, prof.dr., Maastricht UMC+
    • Principal Investigator: Maud Jansen, dr., Maastricht UMC+

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Maastricht University Medical Center
    ClinicalTrials.gov Identifier:
    NCT05976061
    Other Study ID Numbers:
    • 2020-2432
    First Posted:
    Aug 4, 2023
    Last Update Posted:
    Aug 4, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Maastricht University Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 4, 2023