Colorectal Cancer Clinical Trial
Official title:
Improving Patient-Provider Communication For Colorectal Cancer Screening
| NCT number | NCT00324753 |
| Other study ID # | IIR 03-252 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | April 2007 |
| Est. completion date | June 2010 |
| Verified date | November 2018 |
| Source | VA Office of Research and Development |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 454 |
| Est. completion date | June 2010 |
| Est. primary completion date | June 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years to 74 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Jesse Brown VA Medical Center, Chicago, IL | Chicago | Illinois |
| United States | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas |
| United States | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| VA Office of Research and Development |
United States,
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: — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Completion of Colorectal Cancer Screening Tests | 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 | |
| Primary | Quality of Communication | Patient satisfaction with the discussion of Colorectal Cancer (CRC) screening with the primary care provider (PCP). | immediate after the patient visit | |
| Primary | Communication Content | PCP Explains CRC screening to my satisfaction | immediately after the patient visit |
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