A Cluster Package Intervention to Promote an Evidence-based Use of PSA-tests in General Practice
NCT ID: NCT06748456
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-09-09
2026-01-01
Brief Summary
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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.
Detailed Description
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In Denmark the first examinations of a possible prostate cancer diagnosis take place in general practice. Every citizen in Denmark with a social security number has free and direct access to a general practitioner (GP) and works as a gatekeeper to the healthcare system. If the GP suspects prostate cancer in a patient the GP has the possibility to measure the level of prostate specific antigen (PSA) in a blood sample. If the level of PSA is high it may indicate the presence of prostate cancer.
However, according to the national clinical guidelines on detection and diagnostic investigation of prostate cancer the PSA-test is only recommended on a small patient group with very specific and rare symptoms. Furthermore they do not recommend neither systematic nor opportunistic screening with the PSA-test.
The reason for the rather restrictive guidelines for PSA-testing is to avoid overdiagnosis and overtreatment of prostate cancer. A high level of PSA in a blood sample is not necessarily due to prostate cancer but could also be elevated by other conditions such as cystitis or an enlarged benign prostate. Even if the further examinations at a urology department in a hospital finds prostate cancer in the patient it is potentially indolent cancer and not a clinically important tumor which is an prostate cancer overdiagnosis and could lead to unnecessary treatment which is overtreatment. The treatment of prostate cancer could cause harms such as impotence, incontinence and faecal incontinence.
Since 2018, GP's in Denmark has been encouraged to cluster in groups of other GP's from their local area to work with quality development and form so called quality clusters. The aim of these quality clusters was to create a medical professional forum where the GP's could meet 2-4 times a year and exchange experiences with each other in a specific clinically relevant area decided by the cluster itself. One of the main points of the quality cluster concept was that the quality development work should be based on descriptive data from their own GP clinics. At present 116 quality clusters exist in Denmark and includes 3.519 GP's in 1.542 GP clinics.
By the same time of the establishment of the quality cluster a national organization called KiAP (a Danish acronym for Quality in General Practice) was founded. The primary purpose was to support the quality clusters with their quality development work. One of the supportive initiatives by KiAP is the development of cluster packages which is meeting material for the quality clusters on their cluster meetings. A cluster packages has one specific clinically relevant theme and consists of data, expert videos, reflection questions among other things.
The investigators have chosen to develop a cluster package about PSA-tests in general practice with the purpose to promote an evidence-based practice. A pilot study will be conducted in the development process. The aim of the study is to evaluate the effectiveness of the cluster package. Since the study is a cluster randomized trial the investigators invited all the Danish quality clusters to agree to use the cluster package on one of their cluster meetings. The participating quality clusters are randomized to an intervention group and a control group.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
The control group will be offered the intervention at the end of the intervention period.
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Cluster package intervention group
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.
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
Standard care control group
The control group will be offered the intervention at the end of the intervention period.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Quality clusters willing to participate in a cluster meeting with PSA as a theme in 2025.
Exclusion Criteria
* Quality clusters unwilling to await allocation before planning their cluster meetings in 2025.
* Quality clusters participating in the pilot study
ALL
No
Sponsors
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Kvalitet i Almen Praksis (KiAP)
UNKNOWN
University of Copenhagen
OTHER
Responsible Party
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Principal Investigators
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Marius Brostrøm Kousgaard, Associate professor
Role: PRINCIPAL_INVESTIGATOR
Center of General Practice, Department of Public Health, University of Copenhagen
Locations
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Center of General Practice, Department of Public Health, University of Copenhagen
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Christian Leick, PhD student
Role: primary
Other Identifiers
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103342
Identifier Type: -
Identifier Source: org_study_id