Colorectal Cancer
Conditions
Keywords
cancer, screening, communication, 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.
Interventions
BEHAVIORALCommunication
Communication sheet
BEHAVIORALStandard of care
Standard of care brochures
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 74 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Colorectal Cancer Screening Tests | 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. |
| Quality of Communication | immediate after the patient visit | Patient satisfaction with the discussion of Colorectal Cancer (CRC) screening with the primary care provider (PCP). |
| Communication Content | immediately after the patient visit | PCP Explains CRC screening to my satisfaction |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Intervention arm- Prompting by prevention nurses and a communication sheet provided
A prevention nurse addressed the process of communication by activating the patient to initiate and conduct a discussion on colorectal cancer screening at the clinical encounter with their PCP. The prevention nurse also provided a talking guide to the patient which was a double-sided single sheet that contained specific communication content pertinent to colorectal cancer screening that should be addressed with the PCP during the clinical encounter and included specific information on fecal occult blood testing and colonoscopy. The patient and PCP could determine the depth at which the communication occurred depending on factors such as time and competing clinical demands. Included in this talking guide were items designed to assist the PCP in assessing the patient's perception of the communication that occurred during the clinical encounter. | 190 |
| Control Standard of care brochures
Standard of care: Standard of care brochures | 264 |
| Total | 454 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Customized Age (years) 50-59 | 114 Participants | 274 Participants | 160 Participants |
| Age, Customized Age (years) 60-69 | 67 Participants | 163 Participants | 96 Participants |
| Age, Customized Age (years) 70 and older | 9 Participants | 17 Participants | 8 Participants |
| Charlson Comorbidity Index 0 | 75 Participants | 212 Participants | 137 Participants |
| Charlson Comorbidity Index 1 | 62 Participants | 123 Participants | 61 Participants |
| Charlson Comorbidity Index 2 or more | 53 Participants | 119 Participants | 66 Participants |
| Education < High School Graduate | 16 Participants | 176 Participants | 160 Participants |
| Education High School Graduate | 52 Participants | 148 Participants | 96 Participants |
| Education Not Answered | 2 Participants | 2 Participants | 0 Participants |
| Education Post High School | 120 Participants | 128 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 33 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 172 Participants | 413 Participants | 241 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 8 Participants | 5 Participants |
| Family History of Colorectal Cancer or Polyps History of Colorectal Cancer | 20 Participants | 46 Participants | 26 Participants |
| Family History of Colorectal Cancer or Polyps History of Neither | 154 Participants | 374 Participants | 220 Participants |
| Family History of Colorectal Cancer or Polyps History of Polyps only | 16 Participants | 34 Participants | 18 Participants |
| Race/Ethnicity, Customized Race African American | 103 Participants | 269 Participants | 166 Participants |
| Race/Ethnicity, Customized Race Not Answered | 5 Participants | 12 Participants | 7 Participants |
| Race/Ethnicity, Customized Race Other | 14 Participants | 23 Participants | 9 Participants |
| Race/Ethnicity, Customized Race White | 68 Participants | 150 Participants | 82 Participants |
| Sex: Female, Male Female | 37 Participants | 59 Participants | 22 Participants |
| Sex: Female, Male Male | 153 Participants | 395 Participants | 242 Participants |
| Site Chicago | 72 Participants | 188 Participants | 116 Participants |
| Site Houston | 49 Participants | 110 Participants | 61 Participants |
| Site Pittsburgh | 69 Participants | 156 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 190 | 1 / 264 |
| other Total, other adverse events | 0 / 190 | 0 / 264 |
| serious Total, serious adverse events | 0 / 190 | 0 / 264 |
Outcome results
Primary
Communication Content
PCP Explains CRC screening to my satisfaction
Time frame: immediately after the patient visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Communication Content | Strongly Agree | 152 Participants |
| Intervention | Communication Content | Somewhat Agree/Neither | 30 Participants |
| Intervention | Communication Content | Missing/Unknown/Did not Discuss | 8 Participants |
| Control | Communication Content | Strongly Agree | 203 Participants |
| Control | Communication Content | Somewhat Agree/Neither | 50 Participants |
| Control | Communication Content | Missing/Unknown/Did not Discuss | 11 Participants |
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.
Time frame: 6-12 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Completion of Colorectal Cancer Screening Tests | CRC Test Completed | 102 Participants |
| Intervention | Completion of Colorectal Cancer Screening Tests | CRC Test Not Completed | 88 Participants |
| Control | Completion of Colorectal Cancer Screening Tests | CRC Test Completed | 142 Participants |
| Control | Completion of Colorectal Cancer Screening Tests | CRC Test Not Completed | 122 Participants |
p-value: 0.005Mixed Models Analysis
Primary
Quality of Communication
Patient satisfaction with the discussion of Colorectal Cancer (CRC) screening with the primary care provider (PCP).
Time frame: immediate after the patient visit
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Quality of Communication | Missing/Unknown/No Discussion | 11 Participants |
| Intervention | Quality of Communication | A lot of satisfaction | 149 Participants |
| Intervention | Quality of Communication | Some/Little Satisfaction | 30 Participants |
| Control | Quality of Communication | Missing/Unknown/No Discussion | 13 Participants |
| Control | Quality of Communication | A lot of satisfaction | 193 Participants |
| Control | Quality of Communication | Some/Little Satisfaction | 58 Participants |