- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00324753
Quality Improvement of Patient-Provider Communication For Colorectal Cancer Screening
27. november 2018 opdateret af: VA Office of Research and Development
Improving Patient-Provider Communication For Colorectal Cancer Screening
The immediate objective of this proposal is to assess the effectiveness of a multi-faceted intervention to improve patient-provider communication about colorectal cancer screening in improving patient adherence with colorectal cancer screening recommendations.
This intervention consists of: (1) guiding the communication process through patient activation to initiate a colorectal cancer screening discussion; (2) optimizing communication content through the use of a prompt sheet; and (3) cueing the provider to assess patient perception of the communication.
The long-term objective of our research program is to maximize colorectal cancer screening rates throughout the VA through widespread adoption of clinically feasible approaches to enhance patient-provider communication.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
In the United States, colorectal cancer is the third most common cancer and the second leading cause of cancer mortality with over 56,000 deaths in 2004).
Early detection through screening decreases the mortality associated with the disease.
However, adherence with current screening recommendations is low.
A survey of the general population indicates that only 53.1% of Americans, age 50 years and older for whom colorectal cancer screening is recommended, are up-to-date with this preventive service.
While colorectal cancer screening rates with the VA Healthcare System (VHA) are better than in the general population (75% in Fiscal Year (FY) 2005), they are lower than performance rates for other types of cancer screening (e.g., mammography) in VHA.
Further, numerous VA medical centers report colorectal cancer screening rates below the level considered satisfactory.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
454
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Illinois
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Chicago, Illinois, Forenede Stater, 60612
- Jesse Brown VA Medical Center, Chicago, IL
-
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15240
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
-
-
Texas
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Houston, Texas, Forenede Stater, 77030
- Michael E. DeBakey VA Medical Center, Houston, TX
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år til 74 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
Provider Eligibility:
- Primary care providers (MD, Certified Registered Nurse Practitioner (CRNP), or PA) at the study sites who see patients in the primary care setting at least 1 day per week and had no involvement in the design of the study are eligible for enrollment in the study.
Patient Eligibility:
- Primary care patients who are not "up-to-date" with colorectal cancer screening are the targeted population for study enrollment.
Up-to-date with colorectal cancer screening is defined as having completed one of the following:
- fecal occult blood testing within the past year
- sigmoidoscopy within the past 5 years
- colonoscopy within the past 10 years
- barium enema within the past 5 years.
Other patient eligibility criteria are:
- Primary Care Provider (PCP) enrolled in the study
- clinic visit scheduled with the enrolled PCP during the recruitment period
- English speaking
- no prior history of colorectal cancer or adenomatous polyps
- no prior history of inflammatory bowel disease
Exclusion Criteria:
- Patients who are deemed clinically not appropriate for colorectal cancer screening due to severe comorbidity and/or limited life expectancy as determined by the patient's primary care provider will be excluded from the study.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention
Communication sheet
|
Communication sheet
|
|
Andet: Control
Standard of care brochures
|
Standard of care brochures
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Completion of Colorectal Cancer Screening Tests
Tidsramme: 6-12 months
|
A survey collected data on patient demographic characteristics, family history of colorectal cancer or polyp, and provider recommendation for colorectal cancer screening, if any.
In addition, we asked patients whether colorectal cancer screening was discussed at the visit.
If the response was yes, we then asked patients how satisfied they were with the PCP communication during the visit in general using a 5-point Likert scale to a number of items describing the communication.
A medical record review was conducted to collect data on provider ordering and patient completion of the following colorectal cancer screening tests during the study period (i.e., 6 months from the time of the clinical encounter): fecal occult blood testing, sigmoidoscopy, or colonoscopy.
|
6-12 months
|
|
Quality of Communication
Tidsramme: immediate after the patient visit
|
Patient satisfaction with the discussion of Colorectal Cancer (CRC) screening with the primary care provider (PCP).
|
immediate after the patient visit
|
|
Communication Content
Tidsramme: immediately after the patient visit
|
PCP Explains CRC screening to my satisfaction
|
immediately after the patient visit
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Bruce S. Ling, MD MPH, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2007
Primær færdiggørelse (Faktiske)
1. juni 2010
Studieafslutning (Faktiske)
1. juni 2010
Datoer for studieregistrering
Først indsendt
9. maj 2006
Først indsendt, der opfyldte QC-kriterier
9. maj 2006
Først opslået (Skøn)
11. maj 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. november 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IIR 03-252
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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-
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