Quality Improvement of Patient-Provider Communication For Colorectal Cancer Screening

• Sponsor: VA Office of Research and Development (U.S. Fed)
• Overall Status: Completed
• CT.gov ID: NCT00324753
• Collaborator: (none)
• Enrollment: 454
• Locations: 3
• Arms: 2
• Duration (Months): 38
• Patients Per Site: 151.3
• Patients Per Site Per Month: 4

Study Details

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	N/A

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
• 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: Apr 1, 2007
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Communication sheet	Behavioral: Communication; Communication sheet
Other: 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 [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 [immediate after the patient visit]

   Patient satisfaction with the discussion of Colorectal Cancer (CRC) screening with the primary care provider (PCP).

3. Communication Content [immediately after the patient visit]

   PCP Explains CRC screening to my satisfaction

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jesse Brown VA Medical Center, Chicago, IL	Chicago	Illinois	United States	60612
2	VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA	Pittsburgh	Pennsylvania	United States	15240
3	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00324753
• Other Study ID Numbers: IIR 03-252
• First Posted: May 11, 2006
• Last Update Posted: Nov 29, 2018
• Last Verified: Nov 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

Participant Flow

Arm/Group Title	Intervention	Control
Arm/Group Description	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.	Usual care arm which consisted of standard of care brochures available clinically. No communication prompts or guides provided for those in Arm 2.
Period Title: Overall Study
STARTED	190	264
COMPLETED	190	264
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Intervention	Control	Total
Arm/Group Description	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.	Standard of care brochures Standard of care: Standard of care brochures	Total of all reporting groups
Overall Participants	190	264	454
Age, Customized (Count of Participants)
50-59	114 60%	160 60.6%	274 60.4%
60-69	67 35.3%	96 36.4%	163 35.9%
70 and older	9 4.7%	8 3%	17 3.7%
Sex: Female, Male (Count of Participants)
Female	37 19.5%	22 8.3%	59 13%
Male	153 80.5%	242 91.7%	395 87%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	15 7.9%	18 6.8%	33 7.3%
Not Hispanic or Latino	172 90.5%	241 91.3%	413 91%
Unknown or Not Reported	3 1.6%	5 1.9%	8 1.8%
Race/Ethnicity, Customized (Count of Participants)
White	68 35.8%	82 31.1%	150 33%
African American	103 54.2%	166 62.9%	269 59.3%
Other	14 7.4%	9 3.4%	23 5.1%
Not Answered	5 2.6%	7 2.7%	12 2.6%
Charlson Comorbidity Index (Count of Participants)
0	75 39.5%	137 51.9%	212 46.7%
1	62 32.6%	61 23.1%	123 27.1%
2 or more	53 27.9%	66 25%	119 26.2%
Family History of Colorectal Cancer or Polyps (Count of Participants)
History of Colorectal Cancer	20 10.5%	26 9.8%	46 10.1%
History of Polyps only	16 8.4%	18 6.8%	34 7.5%
History of Neither	154 81.1%	220 83.3%	374 82.4%
Education (Count of Participants)
< High School Graduate	16 8.4%	160 60.6%	176 38.8%
High School Graduate	52 27.4%	96 36.4%	148 32.6%
Post High School	120 63.2%	8 3%	128 28.2%
Not Answered	2 1.1%	0 0%	2 0.4%
Site (Count of Participants)
Chicago	72 37.9%	116 43.9%	188 41.4%
Houston	49 25.8%	61 23.1%	110 24.2%
Pittsburgh	69 36.3%	87 33%	156 34.4%

Outcome Measures

1. Primary Outcome

Title	Completion of Colorectal Cancer Screening Tests
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	Communication sheet Communication: Communication sheet	Standard of care brochures Standard of care: Standard of care brochures
Measure Participants	190	264
CRC Test Completed	102 53.7%	142 53.8%
CRC Test Not Completed	88 46.3%	122 46.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.005
	Comments	p-value based on a test of any treatment difference by site.
	Method	Mixed Models Analysis
	Comments	The model was run using the xtlogit command in Stata and was adjusted for all of the reported baseline characteristics.

2. Primary Outcome

Title	Quality of Communication
Description	Patient satisfaction with the discussion of Colorectal Cancer (CRC) screening with the primary care provider (PCP).
Time Frame	immediate after the patient visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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.	Usual care arm which consisted of standard of care brochures available clinically. No communication prompts or guides provided for those in Arm 2.
Measure Participants	190	264
A lot of satisfaction	149 78.4%	193 73.1%
Some/Little Satisfaction	30 15.8%	58 22%
Missing/Unknown/No Discussion	11 5.8%	13 4.9%

3. Primary Outcome

Title	Communication Content
Description	PCP Explains CRC screening to my satisfaction
Time Frame	immediately after the patient visit

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention	Control
Arm/Group Description	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.	Usual care arm which consisted of standard of care brochures available clinically. No communication prompts or guides provided for those in Arm 2.
Measure Participants	190	264
Strongly Agree	152 80%	203 76.9%
Somewhat Agree/Neither	30 15.8%	50 18.9%
Missing/Unknown/Did not Discuss	8 4.2%	11 4.2%

Adverse Events

Arm/Group Title	Intervention		Control
Arm/Group Description	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.		Usual care arm which consisted of standard of care brochures available clinically. No communication prompts or guides provided for those in Arm 2.
All Cause Mortality
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/190 (0.5%)		1/264 (0.4%)
Serious Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/190 (0%)		0/264 (0%)
Other (Not Including Serious) Adverse Events
	Intervention		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/190 (0%)		0/264 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.