The Magnitude of Effect of PCP Counseling on Participation Rate and Sedation Rate in Colonoscopy-based Screening Program
The Magnitude of Effect of Physician's Counseling on Participation Rate and Utilization of Sedation in Colonoscopy-based Colorectal Cancer Screening Program
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
Participation rate is one of the major factors influencing the effectiveness of screening programs. Participation rates in CRC screening, including primary colonoscopy programs, remain suboptimal. It is known that one of the strongest predictors of CRC screening participation rate is a physician, especially primary care physician (PCP), recommendation. Engaging a PCP tends to improve participation rate in organized and opportunistic cancer screening programs.
To our best knowledge there are no randomized controlled trials, dedicated specifically to assess the effect of physician's counseling on participation rate in primary colonoscopy CRC screening programs. There is also no data on the impact of physician's counseling on patient's decision to choose unsedated (not in sedation) or sedated colonoscopy.
In this study we aimed to quantitatively estimate the impact of a PCP's counseling on screening participation rate and utilization of sedation in the opportunistic primary CRC screening program when compared to the effect obtained by using a standardized information leaflet only.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- 50-65 years of age
Exclusion Criteria:
- colonoscopy within last 10 years
- change in bowel habits in the previous six months
- a visible blood in stool (unless related to known hemorrhoids)
- anemia or weight loss of unknown cause
- severe comorbid conditions making subject ineligible for screening colonoscopy
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 |
|---|---|
|
Sonstiges: Physician's counseling
|
Colorectal cancer (CRC) screening was recommended to a patient personally by a PCP.
The issue was discussed during a routine medical visit according to a standardized scheme.
PCP provided a patient with a rationale for CRC screening in asymptomatic individuals and benefits of early treatment of the disease.
A patient was told about colonoscopy-based screening program.
A PCP provided patient with information on how colonoscopy is performed and how to prepare a bowel for the examination, and informed a patient about possible adverse events related to the procedure including post-polypectomy bleeding and bowel perforation.
According to the scheme of the discussion screening modalities other than colonoscopy were not debated, unless a patient specifically asked about them.
|
|
Aktiver Komparator: Information leaflet
|
Patients were given leaflet on primary colonoscopy colorectal cancer screening program.
A leaflet provided rationale for colorectal cancer screening and information on colonoscopy-based colorectal cancer screening program.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Effect of primary care physician's (PCP) counseling on participation rate in primary colonoscopy screening program
Zeitfenster: Six months after intervention
|
Six months after intervention
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Effect of primary care physician's (PCP) counseling on a patient's decision to choose unsedated colonoscopy (not in sedation).
Zeitfenster: Six months after intervention
|
Six months after intervention
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Studienleiter: Jaroslaw Regula, MD, PhD, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
- Studienstuhl: Michal F. Kaminski, MD, PhD, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
- Hauptermittler: Michal Wiszniewski, MD, The Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland
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
- CMKP-2008
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