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Quality Improvement of Patient-Provider Communication For Colorectal Cancer Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00324753
Recruitment Status : Completed
First Posted : May 11, 2006
Results First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Communication Behavioral: Standard of care Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 454 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Improving Patient-Provider Communication For Colorectal Cancer Screening
Study Start Date : April 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention
Communication sheet
Behavioral: Communication
Communication sheet

Standard of care brochures
Behavioral: Standard of care
Standard of care brochures

Primary Outcome Measures :
  1. Completion of Colorectal Cancer Screening Tests [ Time Frame: 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.

  2. Quality of Communication [ Time Frame: immediate after the patient visit ]
    Patient satisfaction with the discussion of Colorectal Cancer (CRC) screening with the primary care provider (PCP).

  3. Communication Content [ Time Frame: immediately after the patient visit ]
    PCP Explains CRC screening to my satisfaction

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00324753

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United States, Illinois
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, United States, 60612
United States, Pennsylvania
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, United States, 15240
United States, Texas
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030
Sponsors and Collaborators
VA Office of Research and Development
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Principal Investigator: Bruce S. Ling, MD MPH VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Additional Information:
Publications of Results:
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Responsible Party: VA Office of Research and Development Identifier: NCT00324753    
Other Study ID Numbers: IIR 03-252
First Posted: May 11, 2006    Key Record Dates
Results First Posted: November 29, 2018
Last Update Posted: November 29, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VA Office of Research and Development:
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases