Clinical trial · Interventional
A Cluster Package Intervention to Promote an Evidence-based Use of PSA-tests in General Practice
Development and Evaluation of a Cluster Package Intervention to Promote an Evidence-based Use of PSA-tests in General Practice: A Cluster Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Evidence Based Medicine | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Prostate Specific Antigen | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cluster meeting | Behavioral | — | UNRESOLVED |
| Hand-out material 1 | Behavioral | — | UNRESOLVED |
| Hand-out material 2 | Behavioral | — | UNRESOLVED |
| Podcast | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cluster package intervention group
- description
- 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.
- interventionNames
- Behavioral: Podcast
- Behavioral: Cluster meeting
- Behavioral: Hand-out material 1
- Behavioral: Hand-out material 2
- type
- NO_INTERVENTION
- label
- Standard care control group
- description
- The control group will be offered the intervention at the end of the intervention period.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHolmkjaer P, Leick C, Drivsholm T, Siersma V, Bro F, Kousgaard MB. A cluster randomized trial to evaluate the effects of a quality cluster-based intervention on the use of prostate-specific antigen test in general practice-a study protocol. Trials. 2026 Jun 29. doi: 10.1186/s13063-026-09867-1. Online ahead of print. PMID 42374596