search
Back to results

Quality Improvement of Patient-Provider Communication For Colorectal Cancer Screening

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communication
Standard of care
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Cancer focused on measuring cancer, screening, communication, prevention

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jesse Brown VA Medical Center, Chicago, IL
  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
  • Michael E. DeBakey VA Medical Center, Houston, TX

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Control

Arm Description

Communication sheet

Standard of care brochures

Outcomes

Primary Outcome Measures

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.
Quality of Communication
Patient satisfaction with the discussion of Colorectal Cancer (CRC) screening with the primary care provider (PCP).
Communication Content
PCP Explains CRC screening to my satisfaction

Secondary Outcome Measures

Full Information

First Posted
May 9, 2006
Last Updated
November 27, 2018
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT00324753
Brief Title
Quality Improvement of Patient-Provider Communication For Colorectal Cancer Screening
Official Title
Improving Patient-Provider Communication For Colorectal Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
cancer, screening, communication, prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
454 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Communication sheet
Arm Title
Control
Arm Type
Other
Arm Description
Standard of care brochures
Intervention Type
Behavioral
Intervention Name(s)
Communication
Intervention Description
Communication sheet
Intervention Type
Behavioral
Intervention Name(s)
Standard of care
Intervention Description
Standard of care brochures
Primary Outcome Measure Information:
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
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
Title
Communication Content
Description
PCP Explains CRC screening to my satisfaction
Time Frame
immediately after the patient visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce S. Ling, MD MPH
Organizational Affiliation
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jesse Brown VA Medical Center, Chicago, IL
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18725829
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.
Results Reference
result
Links:
URL
http://www.pittsburgh.va.gov/docs/quics_booklet.pdf
Description
Click here for more information about this study: Improving Patient-Provider Communication For Colorectal Cancer Screening

Learn more about this trial

Quality Improvement of Patient-Provider Communication For Colorectal Cancer Screening

We'll reach out to this number within 24 hrs