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- Klinische proef NCT00134589
CHOICE: Communicating Health Options Through Information and Cancer Education
Increasing CRC Screening in Health Plan Members
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Colorectal cancer is the second most common cause of cancer death in the United States. Early detection and intervention can significantly reduce morbidity and mortality from colorectal cancer (CRC), and current guidelines recommend that asymptomatic adults over age 50 periodically obtain screening by one of several modalities (FOBT, sigmoidoscopy, colonoscopy, or double contrast barium enema). However, CRC screening remains substantially underutilized in the U.S., and more than half of all adults do not adhere to these recommendations. This study was designed to increase CRC screening among health plan members, and involves the collaboration of a major health insurer.
We are conducting a cluster-randomized trial in health practices in Georgia and Florida, to test the effectiveness of a decision aid (video + brochures) for increasing adherence to CRC screening guidelines. Thirty-two large group practices were recruited and randomized to receive usual care (routine reminders) or an evidence-based decision aid intervention. In each practice, patients between the ages of 52 and 75, without current CRC screening history, were enrolled into the study.
In early 2007, we received a full HIPAA waiver that permitted us to send the decision aid intervention to long-term non-responders in the intervention group, and to access claims data for this group and the long-term non-responders in the usual care group. This procedure will make it possible for us to learn more about the real-world impact of the intervention.
The intervention will continue for up to 2 years for still-unscreened participants. The main outcome is receipt of an evidence-based modality of CRC screening according to the US Preventive Services Task Force Guidelines (FOBT, flexible sigmoidoscopy, colonoscopy, or double contrast barium enema).
Unique features of the proposed study include its potential to establish systems to increase screening uptake that will help fulfill HEDIS requirements; improving our understanding of how screening promotion interventions work in both White and Black populations; collaboration with a community partner of the Emory Prevention Research Center, and forging collaborative relationships between public health and health care researchers, and the affected communities of health plans and health care providers.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Emory University Rollins School of Public Health
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Ages 52-75
- Aetna Health Plan member
- Average risk for colorectal cancer
- Did not have colorectal cancer screening within guideline time frame (1 to 10 years, depending on individual's age and type of screening)
Exclusion Criteria:
- History of colorectal cancer, polyps, inflammatory bowel disease, upper or lower gastrointestinal bleeding, cirrhosis, chronic obstructive pulmonary disease, cancer, blindness, uncorrectable hearing loss, severe dementia, severe heart failure, severe coronary artery disease
- Family history of colorectal cancer/polyps
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Enkel
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
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Completion of colorectal cancer screening
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Secundaire uitkomstmaten
Uitkomstmaat |
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Patient's intention to ask/patient asking medical provider for colorectal cancer screening
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Karen Glanz, PhD, MPH, Emory University
Publicaties en nuttige links
Algemene publicaties
- Pignone M, Winquist A, Schild LA, Lewis C, Scott T, Hawley J, Rimer BK, Glanz K. Effectiveness of a patient and practice-level colorectal cancer screening intervention in health plan members: the CHOICE trial. Cancer. 2011 Aug 1;117(15):3352-62. doi: 10.1002/cncr.25924. Epub 2011 Feb 11.
- Pignone M, Scott TL, Schild LA, Lewis C, Vazquez R, Glanz K. Yield of claims data and surveys for determining colon cancer screening among health plan members. Cancer Epidemiol Biomarkers Prev. 2009 Mar;18(3):726-31. doi: 10.1158/1055-9965.EPI-08-0751.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CDC-NCCDPHP-R-01-PH-000018
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Academic Detailing (Medical Practices)+Decision Aids (Patients)
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