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Recruiting Not applicable

A Cluster Package Intervention to Promote an Evidence-based Use of PSA-tests in General Practice

NCT06748456 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2024-09-09
Last updated
2024-12-27

Condition(s) studied

Prostate CancerEvidence Based MedicineProstate Specific Antigen

Investigational drug(s) / intervention(s)

PodcastCluster meetingHand-out material 1Hand-out material 2

Podcast: A pre-recorded podcast with a urologist and a GP discussing the theme to promote preparatory reflections among the GPs before the cluster meeting

Cluster meeting: A two-hour meeting facilitated by either the GPs cluster coordinator, another GP from the cluster or a facilitator outside the cluster chosen by the cluster itself with specific slides about PSA in general, guidelines, expert videos, data from the clinics, cases, and group discussions

Hand-out material 1: Hand-outs of the main take-home messages to facilitate further discussion in their respective GP offices

Hand-out material 2: Hand-outs to be used by GP and patients to facilitate communication about the relevance of taking a PSA-test

Study summary

It is widely acknowledged that prostate specific antigen (PSA) testing can lead to false-positives, overdiagnosis and overtreatment of prostate cancer. The current national clinical guidelines only recommend the test to a small group of patients and does not recommend neither systematic nor opportunistic screening for prostate cancer with the test.

The aim of this cluster randomized trial is to evaluate the effectiveness of a complex intervention aimed at improving the use of evidence based practice when using prostate specific antigen tests in general practice.

The complex intervention in this study is a so called cluster package which is meeting material to a quality cluster meeting as almost every general practitioner is a member of a quality cluster. Therefore, the investigators have developed a cluster package aimed at promoting an evidence-based use of the prostate specific antigen test to general practitioners.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Quality clusters with a cluster coordinator * Quality clusters willing to participate in a cluster meeting with PSA as a theme in 2025. Exclusion Criteria: * Quality clusters who already planned their cluster meetings in 2025. * Quality clusters unwilling to await allocation before planning their cluster meetings in 2025. * Quality clusters participating in the pilot study

Primary outcome measure(s)

  • Change of prostate specific antigen tests on unique men ≥40 taken by general practitioners — From cluster meeting to the end of intervention period at 6 months
    The primary outcome is a reduction in the prevalence of prostate specific antigen (PSA) test on unique men ≥40 taken at the level of the quality health cluster from six month pre-intervention until six months post-intervention, in the intervention group compared to the control group. The overall aim is to improve practice of evidence based medicine by general practitioners (GP's), therefore we do not attempt to remove all PSA-test taken, neither do we set a pre-defined number that needs to be achieved. However, when following Danish Guidelines for PSA-testing, only a very small proportion of males over 40 should have the test, and therefore we consider any reduction clinically relevant.

Trial sites (1)

FacilityCityRegionStatus
Center of General Practice, Department of Public Health, University of Copenhagen Copenhagen Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06748456 on ClinicalTrials.gov ↗ ← All trials in Denmark