Clinical trial NCT00324753: Quality Improvement of Patient-Provider Communication For Colorectal Cancer Screening
Official title: Improving Patient-Provider Communication For Colorectal Cancer Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: cancer
screening
communication
prevention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2006-05-11
Enrollment: 454
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Completion of Colorectal Cancer Screening Tests
timeFrame: 6-12 months
measure: Quality of Communication
timeFrame: immediate after the patient visit
measure: Communication Content
timeFrame: immediately after the patient visit
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center, Chicago, IL
state: Illinois
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Bruce S. Ling, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ling BS, Trauth JM, Fine MJ, Mor MK, Resnick A, Braddock CH, Bereknyei S, Weissfeld JL, Schoen RE, Ricci EM, Whittle J. Informed decision-making and colorectal cancer screening: is it occurring in primary care? Med Care. 2008 Sep;46(9 Suppl 1):S23-9. doi: 10.1097/MLR.0b013e31817dc496.