- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02515344
Impact of the Distribution to Attending Physicians of a Nominative List of Their Patients Not Participating in the Organised Screening of Colorectal Cancer (IDLN)
Impact of the Distribution to Attending Physicians of a Nominative List of Their Patients Not Participating in the Organised Screening of Colorectal Cancer: Randomised Study Measuring the Impact on Participation
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Background:
Participation rate for colorectal cancer screening in France is 39%. In a Cochrane review, patient participation rates to colorectal cancer screening varies from 30 to 60%. Policy makers usually consider that these participation rates should be higher, based on the premise that the impact of the screening mainly depends on patient participation. In France, patients at average risk of colorectal cancer are eligible to the Faecal Occult Blood Test for colorectal cancer screening if: 1) they are older than 50 and younger than 74; 2) they have no personal history of colorectal cancer (or history of adenoma bigger than 1 cm) and no family history of colorectal cancer.
Objective:
To demonstrate that providing to GPs a list of their patients who are not compliant to colorectal cancer screening will 1) enhance patient participation to screening, and 2) decrease the proportion of cancer diagnosed outside the screening organisation. Design : Randomised controlled study, 3 parallel arms.
Design:
Randomized controlled study. 3 parallel arms.
Setting:
Primary care setting in France.
Enrollment:
In this study, the intervention will focus on the GP. The statistical unit for the results analysis will be the GP. GPs allocated in the 3 groups of the study will be all GPs 1) from the "Loire-Atlantique and Vendée" geographic area (1300 GPs on average) and 2) who have more than 100 patients in their patient list (based on data provided by the Healthcare Insurance System Services).
Intervention:
GPs allocated to the intervention group (A) will receive a list of the patients who are not compliant to colorectal cancer screening, while GPs allocated to the others groups will not receive the corresponding information.
Randomization:
3 groups : (A) GPs will receive a list of the patients who are not compliant to colorectal cancer screening, (B) GPs will receive a document providing general information on colorectal cancer screening, (C) GPs will not receive any specific document (they continue regular practice).
Primary outcome measure: Patient participation to colorectal cancer screening Secondary Outcome Measures: number of cancers screened in (versus diagnosed outside) the screening procedure.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
In this study, the statistical unit is the GP.
Inclusion Criteria:
GPs allocated in the 3 groups of the study will be all GPs
- 1) from the "Loire-Atlantique and Vendée" geographic area (1300 GPs on average)
- 2) who have more than 100 patients in their patient list (based on data provided by the Healthcare Insurance System Services).
Exclusion Criteria:
- GPs who have less than 100 patients in their patient list
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: A: nominative list
Providing a list of patients not compliant with CRC sreening General Practitioners allocated to the intervention group (A) will receive:
|
GPs allocated to the intervention group (A) will receive a list of the patients who are not compliant to colorectal cancer screening, while GPs allocated to the others groups will not receive this information.
|
|
Aktiver Komparator: B: general information
Providing general information about CRC screening General Practitioners allocated to group (B) will receive: - a document providing general information about colorectal cancer screening (but will not receive the nominative list of patients non compliant to colorectal cancer screening) |
|
|
Kein Eingriff: C: usual practice
General Practitioners allocated to group (C) will not receive any information (as in usual practice)
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Patient participation rate to colorectal cancer screening
Zeitfenster: 12 months after starting date of the study
|
12 months after starting date of the study
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Number of cancers screened in (versus diagnosed outside) the screening procedure.
Zeitfenster: 12 months after starting date of the study
|
12 months after starting date of the study
|
Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- RC12_0497
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