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

NCT05976061 | Active Not Recruiting

• 1 other identifier: 2020-2432
• Study Type: observational
• Target: 3,379
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratoses

Keywords

General Practitioners guidelines; actinic keratosis; general physician; dermatology; low-risk patients; referrals

Outcome Measures

Primary Outcomes (1)

• Change in proportion of low-risk actinic keratosis patients among all actinic keratosis patients.

  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.

  2018 compared to 2019 (2 years)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data from patients are collected retrospectively using the Electronic health records. Patients were selected based on the diagnosis-treatment-combination (DTC) 17 (premalignant lesion) and DTC 14 (cutaneous malignancy) that was registered from January 2018 to December 2019 by the dermatologist.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Tergooi Hospital: collaborator

Study Sites (1)

Ellen Oyen

Maastricht, Netherlands

Location

Related Links

• the Dutch College of General Practitioners guidelines 'Suspicious Skin lesions'. \[updated 2020\].

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Klara Mosterd, prof.dr.

  Maastricht UMC+

  PRINCIPAL INVESTIGATOR

• Maud Jansen, dr.

  Maastricht UMC+

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 4, 2023
• Study Start: March 1, 2021
• Primary Completion: September 1, 2023
• Study Completion: December 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

NL (1)