Health TrialsbyHealthPanel

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

ConditionsProstate CancerEvidence Based MedicineProstate Specific Antigen
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Copenhagen

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Quality clusters with a cluster coordinator

Quality clusters willing to participate in a cluster meeting with PSA as a theme in 2025.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Podcast

    Behavioral

    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

    Behavioral

    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

    Behavioral

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

  • Hand-out material 2

    Behavioral

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Cluster package intervention groupExperimental treatment 4 interventions
Group B: Standard care control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change of prostate specific antigen tests on unique men ≥40 taken by general practitioners

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.

Time frame
From cluster meeting to the end of intervention period at 6 months

Secondary outcomes

1

Pre/post intervention change

The prevalence of PSA test on unique men ≥40 taken at each GP clinic from pre- to post-intervention

Time frame
From cluster meeting to the end of intervention period at 6 months
2

High-user change

The change in the prevalence of PSA test on unique men ≥40 taken by the 10% highest users defined as all GP clinics

Time frame
From cluster meeting to the end of intervention period at 6 months
3

Variance between GPs

The homogeneity in the prevalence of PSA tests on unique men ≥40 within each cluster in the intervention group

Time frame
From cluster meeting to the end of intervention period at 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Copenhagen

Lead sponsor

Kvalitet i Almen Praksis (KiAP)

Collaborator

Source ClinicalTrials.gov
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