- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00397969
Improving the Frequency of Colonoscopy in Patients With a Previous Colorectal Polyp
Improving Surveillance for Colorectal Polyps
RATIONALE: Receiving a reminder letter from their doctor may increase the frequency of colonoscopy in patients who have had a colorectal polyp removed.
PURPOSE: This randomized clinical trial is studying how well a reminder letter from their doctor improves the frequency of colonoscopy in patients who have had a colorectal polyp removed.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- Determine whether rates of surveillance colonoscopy can be substantially increased by linking computerized data on endoscopic screening procedures to computerized pathology data to identify patients with prior adenomatous polyps who are due for repeat colonoscopy.
- Evaluate whether the impact of the intervention varies by patient characteristics, including age, sex, or site of primary care.
OUTLINE: This is a randomized, controlled, crossover study. Patients are stratified according to age (≤ 65 years of age vs > 65 years of age), gender, time elapsed since last colonoscopy, and primary care physician's (PCP) membership in Harvard Vanguard Medical Associates (yes vs no). Patients are randomized to 1 of 2 arms.
- Arm I: PCPs are mailed response forms (regarding the disposition of their eligible patients [e.g. patient letter mailed, patient called, scheduled for colonoscopy, colonoscopy completed elsewhere, patient refused procedure, clinical contraindication, patient deceased]) and letters reminding them that their patients are due for a follow-up colonoscopy. PCPs who do not return response forms within 4 weeks are sent a second set of reminders and patient letters.
- Arm II: Six months after the beginning of the study, PCPs are mailed response forms and patient letters once. A second set of reminders and patient letters are not sent.
PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Dana-Farber/Brigham and Women's Cancer Center
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Boston, Massachusetts, Forente stater, 02115
- Harvard Medical School
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
- Prior diagnosis of adenomatous polyp
Underwent prior colonoscopy with polypectomy at Brigham and Women's Hospital
- Due for repeat colonoscopy according to current national guidelines of the American Gastroenterology Association (no colonoscopy within the past 5 years)
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
Hva måler studien?
Primære resultatmål
Resultatmål |
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Successful completion of follow-up colonoscopy
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Number of patients completing colonoscopy during the study period
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: John Ayanian, MD, MPP, Harvard Medical School (HMS and HSDM)
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDR0000492752
- HMS-M11837-103
- BWH-2005-P-000371/3
- HPHC-1705
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