Trial Outcomes & Findings for Risk Stratification to Promote Effective Shared Decision-Making for Colorectal Cancer Screening (NCT NCT01596582)

Last Updated: 2017-03-21

Results Overview

Concordance is a measure of the agreement between the patient's test preference and actual test ordered for standard care vs. risk assessment patients. It is defined as the number of patients who had their preferred test ordered.

Recruitment status

COMPLETED

Study phase

Target enrollment

352 participants

Primary outcome timeframe

3 months

Results posted on

2017-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Care Subjects randomized to the control arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled visit with their provider.	Risk Assessment Subjects randomized to the experimental arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) and the ACNI risk assessment tool just prior to a scheduled office visit with their provider. Risk Assessment: Patients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid The ACNI uses a point based system to stratify patients into low (mean rate of ACN \~3%)versus intermediate/high (\~ 8%) risk groups based on responses to 6 items: age 50-59,60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic black, other), smoking history (never, \<20 years, \>20 years), daily alcohol intake (\< 2 vs. \>/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never).
Overall Study STARTED	172	180
Overall Study COMPLETED	168	173
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Care Subjects randomized to the control arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled visit with their provider.	Risk Assessment Subjects randomized to the experimental arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) and the ACNI risk assessment tool just prior to a scheduled office visit with their provider. Risk Assessment: Patients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid The ACNI uses a point based system to stratify patients into low (mean rate of ACN \~3%)versus intermediate/high (\~ 8%) risk groups based on responses to 6 items: age 50-59,60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic black, other), smoking history (never, \<20 years, \>20 years), daily alcohol intake (\< 2 vs. \>/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never).
Overall Study Deemed ineligible after study visit	3	6
Overall Study Missing all outcome data	1	1

Baseline Characteristics

Risk Stratification to Promote Effective Shared Decision-Making for Colorectal Cancer Screening

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Care n=168 Participants Subjects randomized to the control arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled visit with their provider.	Risk Assessment n=173 Participants Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider. Risk Assessment: Patients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid The ACNI uses a point based system to stratify patients into low (mean rate of ACN \~3%)versus intermediate/high (\~ 8%) risk groups based on responses to 6 items: age 50-59,60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic black, other), smoking history (never, \<20 years, \>20 years), daily alcohol intake (\< 2 vs. \>/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never).	Total n=341 Participants Total of all reporting groups
Age, Continuous	56.0 years STANDARD_DEVIATION 5.9 • n=5 Participants	56.8 years STANDARD_DEVIATION 6.8 • n=7 Participants	56.4 years STANDARD_DEVIATION 6.3 • n=5 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	92 Participants n=7 Participants	180 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	81 Participants n=7 Participants	161 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity : Hispanic	13 Participants n=5 Participants	10 Participants n=7 Participants	23 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity : Non-Hispanic	154 Participants n=5 Participants	163 Participants n=7 Participants	317 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity : Refused	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race : White	33 Participants n=5 Participants	42 Participants n=7 Participants	75 Participants n=5 Participants
Race/Ethnicity, Customized Race : Black	104 Participants n=5 Participants	104 Participants n=7 Participants	208 Participants n=5 Participants
Race/Ethnicity, Customized Race : Other	31 Participants n=5 Participants	27 Participants n=7 Participants	58 Participants n=5 Participants
Education High school or less	98 Participants n=5 Participants	114 Participants n=7 Participants	212 Participants n=5 Participants
Education Greater than high school	70 Participants n=5 Participants	59 Participants n=7 Participants	129 Participants n=5 Participants
Marital status Married/living with partner	49 Participants n=5 Participants	47 Participants n=7 Participants	96 Participants n=5 Participants
Marital status Single/separated/divorced/widowed	119 Participants n=5 Participants	125 Participants n=7 Participants	244 Participants n=5 Participants
Marital status Refused	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Insurance Private/HMO	55 Participants n=5 Participants	38 Participants n=7 Participants	93 Participants n=5 Participants
Insurance Medicare	46 Participants n=5 Participants	54 Participants n=7 Participants	100 Participants n=5 Participants
Insurance Medicaid	37 Participants n=5 Participants	49 Participants n=7 Participants	86 Participants n=5 Participants
Insurance Free care	21 Participants n=5 Participants	20 Participants n=7 Participants	41 Participants n=5 Participants
Insurance Other	6 Participants n=5 Participants	11 Participants n=7 Participants	17 Participants n=5 Participants
Insurance None	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Desired role in decision-making Mostly patient	58 Participants n=5 Participants	53 Participants n=7 Participants	111 Participants n=5 Participants
Desired role in decision-making Shared	88 Participants n=5 Participants	88 Participants n=7 Participants	176 Participants n=5 Participants
Desired role in decision-making Mostly provider	22 Participants n=5 Participants	32 Participants n=7 Participants	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Standard Care n=168 Participants Subjects randomized to the standard care arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.	Risk Assessment n=173 Participants Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
Concordance Between Patient Preference and Test Ordered	148 Participants	147 Participants

SECONDARY outcome

Timeframe: 3 months

Population: Patients with cumulative ACNI scores of 5 to 12 were classified as intermediate/high risk (hereafter referred to as high risk), with a mean ACN rate of 8.3% (95% CI, 7.1% - 29.6%). Patients with cumulative scores of less than 5 were classified as low risk, with a mean ACN rate of 3.1% (95% confidence interval \[CI\], 2.4% - 24.1%).

Concordance between patient preference and test ordered for high versus low risk patients. It is defined as the number of patients who had their preferred test ordered.

Outcome measures

Outcome measures
Measure	Standard Care n=103 Participants Subjects randomized to the standard care arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.	Risk Assessment n=70 Participants Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
Concordance Between Patient Preference and Test Ordered for High vs. Low Risk Patients	86 Participants	61 Participants

SECONDARY outcome

Timeframe: One month

Population: The subgroup of patients who had their preferred test ordered, regardless of study arm or risk-category. The subgroup of patients who had a non-preferred test ordered, regardless of study arm or risk-category.

SDMP was assessed on the posttest using the validated 12-item Satisfaction with the Decision-Making Process scale. Individual items are assigned a point value ranging from 1 for ''strongly disagree'' (or ''poor'') to 5 for ''strongly agree'' (or ''excellent''). A cumulative score is then calculated based on the summed response scores for each item (maximum score = 60). Data was missing for 11 patients in the concordant group and 6 patients in the discordant group

Outcome measures

Outcome measures
Measure	Standard Care n=284 Participants Subjects randomized to the standard care arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.	Risk Assessment n=40 Participants Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
Satisfaction With Decision-making Process (SDMP)	52.0 units on a scale Standard Deviation 5.3	48.9 units on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: 3 months

Screening intentions were assessed on the posttest. Patients were asked how sure they were that they would complete the screening test that got scheduled Scores ranged from 5 = ''completely'' to 1 = ''not at all sure.'' Data was missing for 11 patients in the concordant group and 6 patients in the discordant group.

Outcome measures

Outcome measures
Measure	Standard Care n=284 Participants Subjects randomized to the standard care arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.	Risk Assessment n=40 Participants Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
Screening Intentions	4.6 units on a scale Standard Deviation 0.7	4.0 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 6 months

Test completion rates were tracked using BMC's electronic medical record, which captures results for all endoscopic procedures, imaging studies, and stool blood tests.

Outcome measures

Outcome measures
Measure	Standard Care n=295 Participants Subjects randomized to the standard care arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.	Risk Assessment n=46 Participants Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
Screening Test Completion	109 Participants	7 Participants

SECONDARY outcome

Timeframe: Two years

Population: The difference in the number of providers reflect provider attrition during the 2-year study period.

Provider satisfaction was assessed based on responses to a 3-item pretest administered prior to commencement of the study and the same 3-item posttest. The 3 items assessed to the extent to which providers felt that personalized risk assessment would be useful for: (1) selecting an appropriate screening test for their average risk patients \[test selection\]; (2) reduce time to decide on an appropriate screening modality \[save time\]; and (3) make them more receptive to patient preferences and possibly order a screening test other than colonoscopy \[receptive to patient preferences\]. Responses were assigned a point value ranging from 5= "strongly agree" and 1 = "strongly disagree".

Outcome measures

Outcome measures
Measure	Standard Care n=42 Participants Subjects randomized to the standard care arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.	Risk Assessment n=32 Participants Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
Provider Satisfaction Test selection	4.0 units on a scale Standard Deviation 0.7	3.9 units on a scale Standard Deviation 0.9
Provider Satisfaction Save time	3.2 units on a scale Standard Deviation 1.0	3.6 units on a scale Standard Deviation 1.0
Provider Satisfaction Receptive to patient preferences	3.8 units on a scale Standard Deviation 0.7	3.8 units on a scale Standard Deviation 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Test-specific concordance between patient preference for colonoscopy and test ordered for standard care versus risk assessment groups. It is defined as the number of patients who had their preferred test ordered.

Outcome measures

Outcome measures
Measure	Standard Care n=131 Participants Subjects randomized to the standard care arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.	Risk Assessment n=117 Participants Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
Concordance Between Patient Preference for Colonoscopy and Test Ordered	125 Participants	114 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Test-specific concordance between patient preference for a screening test other than colonoscopy (fecal occult blood testing, flexible sigmoidoscopy, double-contrast barium enema, CT colonography and stool DNA) and test ordered for standard care versus risk assessment arms. It is defined as the number of patients who had their preferred test ordered.

Outcome measures

Outcome measures
Measure	Standard Care n=37 Participants Subjects randomized to the standard care arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.	Risk Assessment n=51 Participants Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
Concordance Between Patient Preferences for Screening Tests Other Than Colonoscopy and Test Ordered	23 Participants	29 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Test-specific concordance between patient preference for colonoscopy and test ordered for high versus low risk patients. It is defined as the number of patients who had their preferred test ordered.

Outcome measures

Outcome measures
Measure	Standard Care n=71 Participants Subjects randomized to the standard care arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.	Risk Assessment n=46 Participants Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
Concordance Between Patient Preference for Colonoscopy and Test Ordered for High Versus Low Risk Patients	69 Participants	45 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 months

Test-specific concordance between patient preference for a screening test other than colonoscopy (fecal occult blood testing, flexible sigmoidoscopy, double-contrast barium enema, CT colonography and stool DNA) and test ordered for high versus low risk patients. It is defined as the number of patients who had their preferred test ordered.

Outcome measures

Outcome measures
Measure	Standard Care n=28 Participants Subjects randomized to the standard care arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.	Risk Assessment n=23 Participants Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
Concordance Between Patient Preferences for a Screening Tests Other Than Colonoscopy and Test Ordered for High Versus Low Risk Patients	14 Participants	15 Participants

Adverse Events

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Risk Assessment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul C. Schroy III, MD, MPH

Boston Medical Center

Phone: 671-638-8335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place