- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00324753
Quality Improvement of Patient-Provider Communication For Colorectal Cancer Screening
November 27, 2018 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
454
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60612
- Jesse Brown VA Medical Center, Chicago, IL
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15240
- VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
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Texas
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Houston, Texas, United States, 77030
- Michael E. DeBakey VA Medical Center, Houston, TX
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 74 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Communication sheet
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Communication sheet
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Other: Control
Standard of care brochures
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Standard of care brochures
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completion of Colorectal Cancer Screening Tests
Time Frame: 6-12 months
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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.
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6-12 months
|
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Quality of Communication
Time Frame: immediate after the patient visit
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Patient satisfaction with the discussion of Colorectal Cancer (CRC) screening with the primary care provider (PCP).
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immediate after the patient visit
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Communication Content
Time Frame: immediately after the patient visit
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PCP Explains CRC screening to my satisfaction
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immediately after the patient visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bruce S. Ling, MD MPH, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
May 9, 2006
First Submitted That Met QC Criteria
May 9, 2006
First Posted (Estimate)
May 11, 2006
Study Record Updates
Last Update Posted (Actual)
November 29, 2018
Last Update Submitted That Met QC Criteria
November 27, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 03-252
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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