Quality Improvement of Patient-Provider Communication For Colorectal Cancer Screening

• ClinicalTrials.gov Identifier: NCT00324753
• Recruitment Status: Completed
• First Posted: May 11, 2006
• Results First Posted: November 29, 2018
• Last Update Posted: November 29, 2018
• Sponsor: VA Office of Research and Development
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; Communication sheet	Behavioral: Communication; Communication sheet
Control; Standard of care brochures	Behavioral: Standard of care; Standard of care brochures

Outcome Measures

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

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

Investigators

• Principal Investigator: Bruce S. Ling, MD MPH; VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

More Information

Additional Information:

Click here for more information about this study: Improving Patient-Provider Communication For Colorectal Cancer Screening 

Publications of Results:

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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00324753
• Other Study ID Numbers: IIR 03-252
• First Posted: May 11, 2006
• 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

• 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:

cancer; screening; communication; prevention

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases