Trial Outcomes & Findings for Evaluating a Preference-based Intervention for Increasing Colorectal Cancer Screening (NCT NCT00810771)
NCT ID: NCT00810771
Last Updated: 2015-06-02
Results Overview
The CRC Screening rate reports percentage of participant adherence with any Colorectal Cancer Screening test within 6 months of Decider Guider intervention. Decider Guider is a tool to help patients make an informed choice about colon cancer testing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
466 participants
Primary outcome timeframe
Within 6 months of Decider Guider intervention.
Results posted on
2015-06-02
Participant Flow
The Usual Care group is not counted toward the Enrollment total. See description of group below for additional details.
The Usual Care group is not counted toward the Enrollment total. See description of group below for additional details.
Participant milestones
| Measure |
Preference-tailored (PT) Intervention
Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
Preference-tailored Information: A preference elicitation exercise generated a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects were provided with a handout to take to their clinic appointment as were the Standard Information group, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
|
Standard Information (SI) Intervention
Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
|
Usual Care
Due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
|
|---|---|---|---|
|
Overall Study
STARTED
|
232
|
234
|
84
|
|
Overall Study
COMPLETED
|
232
|
234
|
84
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating a Preference-based Intervention for Increasing Colorectal Cancer Screening
Baseline characteristics by cohort
| Measure |
Preference-tailored (PT) Intervention
n=198 Participants
Preference-tailored Information: A preference elicitation exercise generated a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects were provided with a handout to take to their clinic appointment as were the Standard Information group, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
|
Standard Information (SI) Intervention
n=197 Participants
Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
|
Usual Care
n=84 Participants
Due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
|
Total
n=479 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
155 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
370 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
43 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
109 Participants
n=4 Participants
|
|
Age, Continuous
|
60.1 Years
n=5 Participants
|
60.6 Years
n=7 Participants
|
59.5 Years
n=5 Participants
|
60.35 Years
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
194 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
461 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
198 participants
n=5 Participants
|
197 participants
n=7 Participants
|
84 participants
n=5 Participants
|
479 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within 6 months of Decider Guider intervention.The CRC Screening rate reports percentage of participant adherence with any Colorectal Cancer Screening test within 6 months of Decider Guider intervention. Decider Guider is a tool to help patients make an informed choice about colon cancer testing.
Outcome measures
| Measure |
Preference-tailored (PT) Intervention
n=232 Participants
Preference-tailored (PT) intervention
Intervention:
Behavioral: Standard Information Behavioral: Preference-tailored Information
Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
|
Standard Information (SI) Intervention
n=234 Participants
Standard information (SI) intervention
Behavioral: Standard Information
Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
|
Usual Care
n=84 Participants
"Usual Care" - due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
|
|---|---|---|---|
|
Colorectal Cancer (CRC) Screening Rate.
|
40.1 percentage of participants
|
40.2 percentage of participants
|
19.3 percentage of participants
|
SECONDARY outcome
Timeframe: 3-5 days after Decider Guider interventionPopulation: Data was not collected for Usual Care arm.
Outcome measure using 6 items measuring degree of participation in IDM. Scaled and recategorized into Low, Moderate and High level of IDM. The range is from 1 (low level of IDM) to 6 (high level of IDM).
Outcome measures
| Measure |
Preference-tailored (PT) Intervention
n=198 Participants
Preference-tailored (PT) intervention
Intervention:
Behavioral: Standard Information Behavioral: Preference-tailored Information
Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
|
Standard Information (SI) Intervention
n=197 Participants
Standard information (SI) intervention
Behavioral: Standard Information
Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
|
Usual Care
"Usual Care" - due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
|
|---|---|---|---|
|
Number of Elements of Braddock's Informed Decision Making (IDM) Model Discussed With Provider
|
5.72 Degree of participation
Interval 1.0 to 6.0
|
5.70 Degree of participation
Interval 1.0 to 6.0
|
—
|
SECONDARY outcome
Timeframe: 3-5 days after Decider Guider intervention.Population: Data was not collected for Usual Care arm.
Outcome measure measuring knowledge of CRCS using 8-item knowledge measure (all true/false questions) developed for study, scaled and categorized into low/moderate/high knowledge, where low = low knowledge and high = high knowledge.
Outcome measures
| Measure |
Preference-tailored (PT) Intervention
n=198 Participants
Preference-tailored (PT) intervention
Intervention:
Behavioral: Standard Information Behavioral: Preference-tailored Information
Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
|
Standard Information (SI) Intervention
n=197 Participants
Standard information (SI) intervention
Behavioral: Standard Information
Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
|
Usual Care
"Usual Care" - due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
|
|---|---|---|---|
|
Colorectal Cancer Screening (CRCS) Knowledge and Attitudes.
High
|
20.7 percentage of participants
|
17.4 percentage of participants
|
—
|
|
Colorectal Cancer Screening (CRCS) Knowledge and Attitudes.
Low
|
13.1 percentage of participants
|
14.9 percentage of participants
|
—
|
|
Colorectal Cancer Screening (CRCS) Knowledge and Attitudes.
Moderate
|
66.2 percentage of participants
|
67.7 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 3-5 days after Decider Guider intervention.Population: Data was not collected for Usual Care arm.
Outcome measures measuring decisional satisfaction using 7-item scale categorized into low, moderate, high. Decisional satisfaction is a measure that was first developed by Margaret Holmes Rover and colleagues (Med Decis Making. 1996 Jan-Mar;16(1):58-64) to assess the perspective of a patient involved in a medical decision with the decision making process. The measure includes questions related to overall satisfaction, and satisfaction with the amount of information received, involvement in, degree of consistency with values, and time to make the decision. The measure includes 5 questions each on a 5 point scale where higher scores = higher satisfaction. When scaled into one overall measure of decision satisfaction, lower scores = lower satisfaction and higher scores = higher satisfaction.
Outcome measures
| Measure |
Preference-tailored (PT) Intervention
n=198 Participants
Preference-tailored (PT) intervention
Intervention:
Behavioral: Standard Information Behavioral: Preference-tailored Information
Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
|
Standard Information (SI) Intervention
n=197 Participants
Standard information (SI) intervention
Behavioral: Standard Information
Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
|
Usual Care
"Usual Care" - due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
|
|---|---|---|---|
|
Decisional Satisfaction
Moderate
|
35.4 Percentage of participants
|
22.8 Percentage of participants
|
—
|
|
Decisional Satisfaction
Low
|
16.6 Percentage of participants
|
29.4 Percentage of participants
|
—
|
|
Decisional Satisfaction
High
|
48 Percentage of participants
|
47.7 Percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 3-5 days after Decider Guider intervention.Population: Data was not collected for Usual Care arm.
Outcome measure measuring intent to get CRC screening using 5-item stage of readiness scale. Intent is measured by looking at the highest 2 items (I think I will get screened and I am committed to getting screened).
Outcome measures
| Measure |
Preference-tailored (PT) Intervention
n=198 Participants
Preference-tailored (PT) intervention
Intervention:
Behavioral: Standard Information Behavioral: Preference-tailored Information
Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
|
Standard Information (SI) Intervention
n=197 Participants
Standard information (SI) intervention
Behavioral: Standard Information
Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
|
Usual Care
"Usual Care" - due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
|
|---|---|---|---|
|
Intent to Get Colorectal Cancer Screening.
|
76.8 percentage of participants
|
72.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 3-5 days after Decider Guider intervention.Population: Data was not collected for Usual Care arm.
Outcome measure measuring self-efficacy using 5-item measure, dichotomized into low vs. high self-efficacy (confidence) in getting screened.
Outcome measures
| Measure |
Preference-tailored (PT) Intervention
n=198 Participants
Preference-tailored (PT) intervention
Intervention:
Behavioral: Standard Information Behavioral: Preference-tailored Information
Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
|
Standard Information (SI) Intervention
n=197 Participants
Standard information (SI) intervention
Behavioral: Standard Information
Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
|
Usual Care
"Usual Care" - due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
|
|---|---|---|---|
|
Self Efficacy.
Low
|
64.1 percentage of participants
|
61.4 percentage of participants
|
—
|
|
Self Efficacy.
High
|
35.9 percentage of participants
|
38.6 percentage of participants
|
—
|
SECONDARY outcome
Timeframe: 3-5 days after Decider Guider intervention.Population: Data was not collected for Usual Care arm.
Outcome measure measuring percentage of participants discussing CRCS with provider using single question (yes/no): "did you discuss Colorectal Cancer Screening with your provider?"
Outcome measures
| Measure |
Preference-tailored (PT) Intervention
n=198 Participants
Preference-tailored (PT) intervention
Intervention:
Behavioral: Standard Information Behavioral: Preference-tailored Information
Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
|
Standard Information (SI) Intervention
n=197 Participants
Standard information (SI) intervention
Behavioral: Standard Information
Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
|
Usual Care
"Usual Care" - due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
|
|---|---|---|---|
|
If Colorectal Cancer Screening Screening (CRCS) Discussed With Provider.
|
65.1 percentage of participants
|
67.4 percentage of participants
|
—
|
Adverse Events
Preference-tailored (PT) Intervention
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Information (SI) Intervention
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Preference-tailored (PT) Intervention
n=232 participants at risk
Preference-tailored (PT) intervention
|
Standard Information (SI) Intervention
n=234 participants at risk
Standard information (SI) intervention
|
Usual Care
n=84 participants at risk
"Usual Care" - due to budget and time constraints this group was not powered as a true study arm but was used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may occur during the study timeframe and impact rated of CRC screening. Data was not collected on every participant in this arm.
|
|---|---|---|---|
|
Vascular disorders
Hospitalization for Deep Venous Thrombus (DVT) and Abdominal Aortic Aneurysm (AAA)
|
0.00%
0/232 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
0.43%
1/234 • Number of events 1 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
0.00%
0/84 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
|
Renal and urinary disorders
Hospitalization for Acute Renal Failure and Diastolic Heart Failure.
|
0.43%
1/232 • Number of events 1 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
0.00%
0/234 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
0.00%
0/84 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
|
Cardiac disorders
Emergency room visit for atrial flutter; death 53 days later noted in chart, cause unknown
|
0.43%
1/232 • Number of events 1 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
0.00%
0/234 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
0.00%
0/84 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospitalization for esophageal cancer.
|
0.43%
1/232 • Number of events 1 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
0.00%
0/234 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
0.00%
0/84 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
|
Psychiatric disorders
Hospitalization for depression and alcohol intoxication
|
0.00%
0/232 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
0.43%
1/234 • Number of events 1 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
0.00%
0/84 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
|
Cardiac disorders
Death due to myocardial infarction.
|
0.00%
0/232 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
0.43%
1/234 • Number of events 1 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
0.00%
0/84 • 1 year
All Serious Adverse Events were determined by the IRB to be unrelated to study participation.
|
Other adverse events
Adverse event data not reported
Additional Information
Sarah Hawley, Ph.D.
VA Ann Arbor Healthcare System, Center for Clinical Management Research
Phone: 734-936-8816
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place