Evaluation of an Intervention to Increase Colorectal Cancer Screening in Primary Care Clinics
14 december 2012 bijgewerkt door: Centers for Disease Control and Prevention
This study is a three-arm randomized controlled trial to implement and evaluate the relative effects of: 1) clinic-focused intervention; 2) combined patient- and clinic-focused intervention, and 3) usual care on the provision of colorectal cancer (CRC) screening in primary care clinics.
The study will also examine the relative effects of the intervention conditions on secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening) and on intermediate outcome measures of attitudes, beliefs, opinions, and social influence surrounding CRC screening among patients, clinicians, and clinical staff.
The target population includes average-risk patients aged 50-75 years, clinicians, and clinical staff within the primary care setting.
The intervention will be implemented within primary care clinics in two managed care organizations (MCOs).
The intervention targets the following CRC screening modalities: fecal occult blood test (FOBT), flexible sigmoidoscopy, colonoscopy, and double contrast barium enema.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
5066
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Michigan
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Detroit, Michigan, Verenigde Staten, 48202
- Henry Ford Health System
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87106
- ABQ Health Partners/Lovelace Clinic Foundation
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Washington
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Seattle, Washington, Verenigde Staten, 98109
- Battelle Centers for Public Health Research and Evaluation
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
50 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
Inclusion Criteria for the Patient-focused Intervention
- Average risk
- Male or female
- 50-75 years
- Scheduled for non-acute ambulatory care visit at one of the study sites
- Due for CRC screening including no record of FOBT in the past year, no record of flexible sigmoidoscopy in the past 5 years, no record of colonoscopy in the past 10 years, and no record of double contrast barium enema in the past 5 years
Inclusion Criteria for the Clinic-focused Intervention
- Primary care clinicians, to include the following specialties: Family Practice/General Practice Physicians, General Internal Medicine Physicians, Nurse Practitioners in Family/General Practice, Physician Assistants who conduct non-acute ambulatory medical exams in study clinics
- Primary care clinical staff, to include nurses, medical assistants, and appointment schedulers
Exclusion Criteria (Patients):
- Prior diagnosis of CRC
- Prior diagnosis of colorectal polyps
- Prior diagnosis of ulcerative colitis
- Prior diagnosis of Crohn's Disease
- Prior diagnosis of hereditary nonpolyposis or polyposis
- Medical records contain an International Classification of Diseases (ICD-9) code for family history of CRC
- Younger than 50 years of age
- Older than 80 years of age.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: 1
Gebruikelijke zorg
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No intervention will be conducted in this arm of the study.
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Experimenteel: 2
Clinic-focused intervention: The clinicians and clinical staff in each of the clinics will be scheduled for training sessions.
The provider trainings will be designed for clinicians and clinical staff and will be conducted in at least two separate sessions of approximately 3 hours total duration.
The sessions will be scheduled to accommodate the clinic schedule, but will be held with no more than 1 month between them.
Participants in clinic training sessions will receive continuing education credit.
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The clinic-focused intervention consists of CRC screening training sessions for clinicians and clinical staff.
The provider training sessions will include the presentation of CRC screening statistics and information, and will be heavily interactive and skills-based.
The provider training sessions will also focus on the provision of tools for improving clinical staff- and clinician-patient interactions about CRC screening and for office system changes/improvements to identify eligible patients and to track screening.
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Experimenteel: 3
Clinic-focused and patient focused intervention: The clinic focused-intervention as described in Arm 2 will be combined with a patient-focused intervention. Patient focused intervention: CRC education packets, based upon previously developed CDC CRC patient education materials, have been adapted for each study site. These CRC educational packets will be mailed to average-risk patients aged 50-80 years who are due for CRC screening (based on electronic records) and who schedule a non-acute ambulatory care visit in clinics assigned to the patient-focused intervention. A cover letter signed by the patient's physician will be included with each packet. The packets will be mailed approximately 1 week before the medical appointment. |
This arm will combine the clinic-focused intervention and the patient-focused intervention.
The clinic-focused intervention consists of CRC screening training sessions for clinicians and clinical staff as described in Arm 2. The patient-focused intervention includes sending a CRC screening education packet (CDC-developed educational text tailored for use within the study sites), accompanied by a letter from the patient's physician, to patients meeting study inclusion criteria.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Changes in colorectal cancer screening rates (4 modalities)
Tijdsspanne: One year post initiation of intervention
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One year post initiation of intervention
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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Changes in the frequency of secondary behavioral outcomes (e.g., clinician-patient discussions about CRC screening)
Tijdsspanne: One year post initiation in intervention
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One year post initiation in intervention
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Changes in measures of attitudes, beliefs, opinions, and social influence surrounding CRC screening among patients, clinicians, and clinical staff.
Tijdsspanne: One year post initiation of intervention
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One year post initiation of intervention
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Judith Lee Smith, PhD, Centers for Disease Control and Prevention
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- Coughlin SS, Costanza ME, Fernandez ME, Glanz K, Lee JW, Smith SA, Stroud L, Tessaro I, Westfall JM, Weissfeld JL, Blumenthal DS. CDC-funded intervention research aimed at promoting colorectal cancer screening in communities. Cancer. 2006 Sep 1;107(5 Suppl):1196-204. doi: 10.1002/cncr.22017.
- Shires DA, Divine G, Schum M, Gunter MJ, Baumer DL, Kasprzyk D, Montano DE, Smith JL, Elston-Lafata J. Colorectal cancer screening use among insured primary care patients. Am J Manag Care. 2011;17(7):480-8.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juli 2009
Primaire voltooiing (Werkelijk)
1 juni 2010
Studie voltooiing (Werkelijk)
1 december 2011
Studieregistratiedata
Eerst ingediend
15 augustus 2008
Eerst ingediend dat voldeed aan de QC-criteria
18 augustus 2008
Eerst geplaatst (Schatting)
19 augustus 2008
Updates van studierecords
Laatste update geplaatst (Schatting)
17 december 2012
Laatste update ingediend die voldeed aan QC-criteria
14 december 2012
Laatst geverifieerd
1 december 2012
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CDC-NCCDPHP-4555
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