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Trial record 75 of 482 for:    colon cancer | ( Map: Texas, United States )

Quality Improvement of Patient-Provider Communication For Colorectal Cancer Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Condition Colorectal Cancer
Interventions Behavioral: Communication
Behavioral: Standard of care
Enrollment 454
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Control
Hide 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
Arm/Group Title Intervention Control Total
Hide 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 Number of Baseline Participants 190 264 454
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Age (years) Number Analyzed 190 participants 264 participants 454 participants
50-59
114
  60.0%
160
  60.6%
274
  60.4%
60-69
67
  35.3%
96
  36.4%
163
  35.9%
70 and older
9
   4.7%
8
   3.0%
17
   3.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 264 participants 454 participants
Female
37
  19.5%
22
   8.3%
59
  13.0%
Male
153
  80.5%
242
  91.7%
395
  87.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 264 participants 454 participants
Hispanic or Latino
15
   7.9%
18
   6.8%
33
   7.3%
Not Hispanic or Latino
172
  90.5%
241
  91.3%
413
  91.0%
Unknown or Not Reported
3
   1.6%
5
   1.9%
8
   1.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 190 participants 264 participants 454 participants
White
68
  35.8%
82
  31.1%
150
  33.0%
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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 264 participants 454 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
  25.0%
119
  26.2%
[1]
Measure Description: The Charlson Comorbidity Index is a measure of comorbid burden. The index is a weighted sum of the presence of up to 22 comorbid conditions, which are each provided a weight of 1, 2, 3, or 6 as originally derived based on the contribution of each comorbid condition to one-year mortality. A score of 0, indicates the absence of the measured comorbidities, and higher scores indicate a higher level of comorbid burden, with a higher predicted risk of death.
Family History of Colorectal Cancer or Polyps  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 264 participants 454 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 264 participants 454 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
   3.0%
128
  28.2%
Not Answered
2
   1.1%
0
   0.0%
2
   0.4%
Site  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 190 participants 264 participants 454 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
  33.0%
156
  34.4%
1.Primary Outcome
Title Completion of Colorectal Cancer Screening Tests
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:

Communication sheet

Communication: Communication sheet

Standard of care brochures

Standard of care: Standard of care brochures

Overall Number of Participants Analyzed 190 264
Measure Type: Count of Participants
Unit of Measure: Participants
CRC Test Completed
102
  53.7%
142
  53.8%
CRC Test Not Completed
88
  46.3%
122
  46.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
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
Hide Description Patient satisfaction with the discussion of Colorectal Cancer (CRC) screening with the primary care provider (PCP).
Time Frame immediate after the patient visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide 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.
Overall Number of Participants Analyzed 190 264
Measure Type: Count of Participants
Unit of Measure: Participants
A lot of satisfaction
149
  78.4%
193
  73.1%
Some/Little Satisfaction
30
  15.8%
58
  22.0%
Missing/Unknown/No Discussion
11
   5.8%
13
   4.9%
3.Primary Outcome
Title Communication Content
Hide Description PCP Explains CRC screening to my satisfaction
Time Frame immediately after the patient visit
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide 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.
Overall Number of Participants Analyzed 190 264
Measure Type: Count of Participants
Unit of Measure: Participants
Strongly Agree
152
  80.0%
203
  76.9%
Somewhat Agree/Neither
30
  15.8%
50
  18.9%
Missing/Unknown/Did not Discuss
8
   4.2%
11
   4.2%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Control
Hide 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 (%) Affected / at Risk (%)
Total   1/190 (0.53%)   1/264 (0.38%) 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/190 (0.00%)   0/264 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/190 (0.00%)   0/264 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Maria K. Mor
Organization: Center for Health Equity Research and Promotion (VAPHS)
Phone: (412) 360-2240
EMail: maria.mor@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00324753     History of Changes
Other Study ID Numbers: IIR 03-252
First Submitted: May 9, 2006
First Posted: May 11, 2006
Results First Submitted: June 19, 2017
Results First Posted: November 29, 2018
Last Update Posted: November 29, 2018