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

NCT06748456 | Recruiting

• 1 other identifier: 103342
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Evidence Based Medicine; Prostate Specific Antigen

Keywords

PSA-test; Prostate Cancer; Evidence based medicine; Quality clusters; General practice

Outcome Measures

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.

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

Secondary Outcomes (3)

• Pre/post intervention change

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

• High-user change

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

• Variance between GPs

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

Study Arms (2)

Cluster package intervention group

EXPERIMENTAL

The intervention consists of: * A pre-recorded podcast to be heard by the GP's prior to the cluster meeting. * A two-hour meeting with a specific slideshow about PSA, data from the clinics within the cluster, current guidelines, cases and group discussions. * Two sets of hand-outs for the GP's to use in their own clinics. The intervention group will be offered the intervention during the intervention period of six months.

Behavioral: Podcast; Behavioral: Cluster meeting; Behavioral: Hand-out material 1; Behavioral: Hand-out material 2

Standard care control group

NO INTERVENTION

The control group will be offered the intervention at the end of the intervention period.

Interventions

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 package intervention group

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

Cluster package intervention group

Hand-out material 1 BEHAVIORAL

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

Cluster package intervention group

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

Cluster package intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• Kvalitet i Almen Praksis (KiAP): collaborator

Study Sites (1)

Center of General Practice, Department of Public Health, University of Copenhagen

Copenhagen, Denmark

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Marius Brostrøm Kousgaard, Associate professor

  Center of General Practice, Department of Public Health, University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Leick, PhD student

CONTACT

004560898397; christian.leick@sund.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, it will not be possible to blind the GP's or members of the research team after the allocation. The primary outcome is blinded to the statistician and data manager is blinded until outcomes are analyzed
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is a cluster randomized trial. The quality clusters are the participants (clusters) and randomization will take place at quality cluster level. Each cluster includes on average 13 GP clinics. The control group will be offered the intervention at the end of the intervention period.

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: December 27, 2024
• Study Start: September 9, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 27, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)