Increasing Colorectal Cancer (CRC) Screening Among Hispanic Primary Care Patients

• Sponsor: Thomas Jefferson University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02272244
• Collaborator: Lehigh Valley Hospital (Other), Fox Chase Cancer Center (Other), Patient-Centered Outcomes Research Institute (Other)
• Enrollment: 400
• Locations: 3
• Arms: 2
• Duration (Months): 30
• Patients Per Site: 133.3
• Patients Per Site Per Month: 4.4

Study Details

Study Description

Brief Summary

This study is designed to test a standard mailed intervention (SI) versus a novel decision support and navigation intervention (DSNI). Working with patients and stakeholders, this randomized trial will include 400 Hispanic men and women who are 50 to 75 years of age, patients in community based primary care practices, and are eligible for CRC screening. We will consent, survey, and randomize participants either to the SI Group (n=200) or the DSNI Group (n=200). Study specific aims are to: (1) Assess intervention (DSNI versus SI) impact on overall CRC screening adherence; (2)Assess intervention (DNSI versus SI) impact on CRC screening decision stage; (3) Assess intervention (DNSI versus SI) impact on test-specific CRC screening adherence; and (4) Assess intervention (DNSI versus SI) impact on CRC and knowledge and perceptions.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Behavioral: Decision Support & Navigation; Behavioral: Standard	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Increasing Colorectal Cancer (CRC) Screening Among Hispanic Primary Care Patients
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Jan 20, 2017
• Actual Study Completion Date: Mar 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.	Behavioral: Standard
Experimental: Decision Support & Navigation DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.	Behavioral: Decision Support & Navigation

Outcome Measures

Primary Outcome Measures

1. Overall Screening Adherence [12 months]

   The two study groups will be compared in terms of the fraction of participants who undergo CRC screening (through SBT, colonoscopy, flexible sigmoidoscopy, etc.) within 12 months of the randomization date. Screening will be measured using data from the 6-month survey and the 12-month chart audit.

Secondary Outcome Measures

1. Change in Screening Decision Stage [6 months]

   At baseline and endpoint (6-month) survey, participants were asked about their decision stage regarding CRC screening. Possible decision stages are, ranked from lowest to highest stage: Decided not to do, Not considering, Haven't decided, Decided to Do and Done, with "Done" only possible at endpoint.

2. Test Specific Screening Adherence [12 Months]

   Test adherence (SBT or endoscopy) will be assessed using 6-month survey and 12-month medical records data. The two study groups will be compared in terms of the fraction of participants who have a screening test within 12 months.

3. Screening Knowledge and Perceptions [6 months]

   Knowledge and perceptions (Preventive Health Model scales) about CRC and screening will be assessed in a 6-month survey. Knowledge was measured by a set of 10 true-false statements about CRC and CRC screening. Knowledge was scored as the number of items correct with a possible range of 0 to 10. Perceptions about CRC and screening were measured using a 20-item scale based on the Preventive Health Model. Items were measured on a 5 point Likert scale ranging from 1 = Strongly Disagree to 5 = Strongly Agree. The total score and subscale scores were computed by taking the mean of component items resulting in scores that could range from 1 to 5, with higher scores indicating more favorable attitudes towards the CRC screening preventive health behavior.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Male or Female

• Self-identifies as being Hispanic or Latino

• 50 to 75 years of age

Exclusion Criteria:

• Previous diagnosis of CRC

• Up to date with CRC screening guidelines.

• Personal history of inflammatory bowel disease

• Personal history of polyps

• Family history of CRC diagnosed before the age of 60 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lehigh Valley Hospital	Allentown	Pennsylvania	United States	18105
2	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19012
3	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Thomas Jefferson University
• Lehigh Valley Hospital
• Fox Chase Cancer Center
• Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Ronald E Myers, PhD, Thomas Jefferson University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 14, 2016

More Information

Publications

None provided.

• Responsible Party: Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT02272244
• Other Study ID Numbers: AD-1306-01882
• First Posted: Oct 22, 2014
• Last Update Posted: Aug 12, 2019
• Last Verified: Aug 1, 2019

• 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 Thomas Jefferson University: Colorectal Cancer; Cancer Screening; Decision Support; Navigation
• Additional relevant MeSH terms: Colorectal Neoplasms

Study Results

Participant Flow

Recruitment Details	2,720 study invitation letters sent to subjects from 5 practices that appeared to meet eligibility criteria based on medical records.
Pre-assignment Detail	2,320 were excluded 98 contact not attempted (recruitment goals met or known ineligible) 504 were determined up to date on screening 182 were ineligible for other reasons 256 refused 717 were unable to be contacted 563 were wrong numbers

Arm/Group Title	Standard	Decision Support & Navigation
Arm/Group Description	SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.	DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.
Period Title: Overall Study
STARTED	203	197
COMPLETED	203	197
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Standard	Decision Support & Navigation	Total
Arm/Group Description	SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening. Standard	DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report. Decision Support & Navigation	Total of all reporting groups
Overall Participants	203	197	400
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.5 (6.5)	57.2 (6.4)	57.3 (6.5)
Age, Customized (Count of Participants)
50-59	140 69%	137 69.5%	277 69.3%
60-69	47 23.2%	48 24.4%	95 23.8%
70-79	16 7.9%	12 6.1%	28 7%
Sex: Female, Male (Count of Participants)
Female	118 58.1%	117 59.4%	235 58.8%
Male	85 41.9%	80 40.6%	165 41.3%
Race/Ethnicity, Customized (Count of Participants)
White/Caucasian	64 31.5%	69 35%	133 33.3%
Black/African American	61 30%	57 28.9%	118 29.5%
Other	42 20.7%	49 24.9%	91 22.8%
Unknown/Not Reported	36 17.7%	22 11.2%	58 14.5%
Marital Status (Count of Participants)
Married	94 46.3%	78 39.6%	172 43%
Living as marreid	10 4.9%	10 5.1%	20 5%
Divorced	25 12.3%	26 13.2%	51 12.8%
Separated	20 9.9%	13 6.6%	33 8.3%
Widowed	7 3.4%	17 8.6%	24 6%
Never married	47 23.2%	53 26.9%	100 25%
Education (Count of Participants)
Less than HS	90 44.3%	102 51.8%	192 48%
HS/GED	58 28.6%	51 25.9%	109 27.3%
Completed Non-College/Business/Trade/Tech	13 6.4%	8 4.1%	21 5.3%
2-yr Associates	16 7.9%	19 9.6%	35 8.8%
College Degree and above	26 12.8%	17 8.6%	43 10.8%
Employment Status (Count of Participants)
Working full-time	44 21.7%	41 20.8%	85 21.3%
Working part-time	41 20.2%	35 17.8%	76 19%
Keeping House	45 22.2%	45 22.8%	90 22.5%
Unable to Work/Disability	53 26.1%	62 31.5%	115 28.8%
Retired	20 9.9%	14 7.1%	34 8.5%
Family Income (Count of Participants)
Under $14,999	144 70.9%	136 69%	280 70%
$15,000-$29,000	37 18.2%	45 22.8%	82 20.5%
$30,000-$45,999	18 8.9%	12 6.1%	30 7.5%
$46,000-$59,999	3 1.5%	4 2%	7 1.8%
Unknown/Not Reported	1 0.5%	0 0%	1 0.3%
Insurance Status (Count of Participants)
Insured	140 69%	141 71.6%	281 70.3%
Uninsured	58 28.6%	53 26.9%	111 27.8%
Unknown/Not Reported	5 2.5%	3 1.5%	8 2%
Help Reading Materials from Doctor (Count of Participants)
Never	94 46.3%	96 48.7%	190 47.5%
Rarely	16 7.9%	15 7.6%	31 7.8%
Sometimes	45 22.2%	44 22.3%	89 22.3%
Often	11 5.4%	10 5.1%	21 5.3%
Always	37 18.2%	32 16.2%	69 17.3%
Practice (Count of Participants)
Centro de Salud	40 19.7%	43 21.8%	83 20.8%
Lehigh Valley Family Health Center	47 23.2%	45 22.8%	92 23%
Lehigh Valley Physician's Practice	76 37.4%	74 37.6%	150 37.5%
AIDS Activity Office	10 4.9%	10 5.1%	20 5%
Neighborhood Health Center of the Lehigh Valley	30 14.8%	25 12.7%	55 13.8%
Years in the US (Count of Participants)
Less than 1 year	1 0.5%	0 0%	1 0.3%
1-3	9 4.4%	12 6.1%	21 5.3%
4-6	12 5.9%	13 6.6%	25 6.3%
7-10	11 5.4%	18 9.1%	29 7.3%
More than 10	145 71.4%	132 67%	277 69.3%
Born in the US	24 11.8%	22 11.2%	46 11.5%
Unknown	1 0.5%	0 0%	1 0.3%
Region of Birth (Count of Participants)
United States	24 11.8%	22 11.2%	46 11.5%
Caribbean- Puerto Rico	81 39.9%	79 40.1%	160 40%
Caribbean- Dominican Republic and Cuba	65 32%	63 32%	128 32%
Central America/Mexico	19 9.4%	18 9.1%	37 9.3%
South America	14 6.9%	15 7.6%	29 7.3%
Language Most Spoken at Home (Count of Participants)
Spanish	163 80.3%	168 85.3%	331 82.8%
Both	26 12.8%	15 7.6%	41 10.3%
English	14 6.9%	14 7.1%	28 7%
Language Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	4.28 (1.05)	4.38 (1.00)	4.33 (1.02)
Preferred CRC screening test (Count of Participants)
Stool Blood Test	53 26.1%	33 16.8%	86 21.5%
Even	133 65.5%	142 72.1%	275 68.8%
Colonoscopy	17 8.4%	22 11.2%	39 9.8%
CRC screening decision stage (Count of Participants)
Decided not to do	2 1%	2 1%	4 1%
Not considering	7 3.4%	2 1%	9 2.3%
Haven't decided	20 9.9%	27 13.7%	47 11.8%
Decided to do	174 85.7%	166 84.3%	340 85%

Outcome Measures

1. Primary Outcome

Title	Overall Screening Adherence
Description	The two study groups will be compared in terms of the fraction of participants who undergo CRC screening (through SBT, colonoscopy, flexible sigmoidoscopy, etc.) within 12 months of the randomization date. Screening will be measured using data from the 6-month survey and the 12-month chart audit.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard	Decision Support & Navigation
Arm/Group Description	SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.	DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.
Measure Participants	203	197
Screened	88 43.3%	153 77.7%
Not Screened	115 56.7%	44 22.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard, Decision Support & Navigation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments	Model adjusted for age, sex, practice, baseline preferred test and baseline overall decision stage
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.83
	Confidence Interval	(2-Sided) 95%; 3.08 to 7.58
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Change in Screening Decision Stage
Description	At baseline and endpoint (6-month) survey, participants were asked about their decision stage regarding CRC screening. Possible decision stages are, ranked from lowest to highest stage: Decided not to do, Not considering, Haven't decided, Decided to Do and Done, with "Done" only possible at endpoint.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Participants with complete baseline and endpoint survey data

Arm/Group Title	Standard	Decision Support & Navigation
Arm/Group Description	SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.	DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.
Measure Participants	123	123
Forward Change	61 30%	97 49.2%
No Change	52 25.6%	23 11.7%
Backward Change	10 4.9%	3 1.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard, Decision Support & Navigation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments	Model compares Forward Change to No Change or Backwards Change and is adjusted for all baseline covariates.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.91
	Confidence Interval	(2-Sided) 95%; 2.55 to 9.47
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Test Specific Screening Adherence
Description	Test adherence (SBT or endoscopy) will be assessed using 6-month survey and 12-month medical records data. The two study groups will be compared in terms of the fraction of participants who have a screening test within 12 months.
Time Frame	12 Months

Outcome Measure Data

Analysis Population Description

All randomized participants.

Arm/Group Title	Standard	Decision Support & Navigation
Arm/Group Description	SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.	DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.
Measure Participants	203	197
None	115 56.7%	44 22.3%
Stool Blood Test	76 37.4%	113 57.4%
Colonoscopy	12 5.9%	40 20.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard, Decision Support & Navigation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Multinomial
	Comments	Model compared rates of SBT, CX and none; model is adjusted for age, sex, practice, baseline preferred test and baseline overall decision stage
Other Statistical Analysis		Reference for the outcome is No Screening; reference for the study group is the Standard Intervention group.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Standard, Decision Support & Navigation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Odds Ratio (OR)
	Comments	Stool Blood Test vs None
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	4.20
	Confidence Interval	(2-Sided) 95%; 2.63 to 6.70
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Standard, Decision Support & Navigation
	Comments
	Type of Statistical Test	Superiority
	Comments	Colonscopy vs None
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Odds Ratio (OR)
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	8.79
	Confidence Interval	(2-Sided) 95%; 4.13 to 18.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Screening Knowledge and Perceptions
Description	Knowledge and perceptions (Preventive Health Model scales) about CRC and screening will be assessed in a 6-month survey. Knowledge was measured by a set of 10 true-false statements about CRC and CRC screening. Knowledge was scored as the number of items correct with a possible range of 0 to 10. Perceptions about CRC and screening were measured using a 20-item scale based on the Preventive Health Model. Items were measured on a 5 point Likert scale ranging from 1 = Strongly Disagree to 5 = Strongly Agree. The total score and subscale scores were computed by taking the mean of component items resulting in scores that could range from 1 to 5, with higher scores indicating more favorable attitudes towards the CRC screening preventive health behavior.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Participants with complete baseline and 6-month survey data.

Arm/Group Title	Standard	Decision Support & Navigation
Arm/Group Description	SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening.	DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report.
Measure Participants	122	123
Preventive Health Model (PHM)	3.8 (0.5)	3.8 (0.6)
PHM: Salience	4.8 (0.5)	4.7 (0.6)
PHM: Response Efficacy	4.5 (0.7)	4.5 (0.7)
PHM: Susceptibility	2.6 (1.0)	2.8 (1.0)
PHM: Worries and Concerns	3.1 (1.1)	3.1 (1.1)
PHM: Social Support and Influence	4.4 (0.8)	4.4 (0.9)
Knowledge Test	4.7 (1.8)	4.6 (2.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Standard, Decision Support & Navigation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.862
	Comments
	Method	Regression, Linear
	Comments	Model of difference in Preventive Health Model (PHM) total score adjusts for all baseline covariates.
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 95%; -0.15 to 0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments	Model compares DSNI to SI.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Standard, Decision Support & Navigation
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.880
	Comments
	Method	Regression, Linear
	Comments	Model of knowledge test score adjusts for all baseline covariates
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; -.47 to .55
	Parameter Dispersion	Type: Value:
	Estimation Comments	Model compares DSNI to SI.

Adverse Events

Time Frame	1 Year from baseline
Arm/Group Title	Standard		Decision Support & Navigation
Arm/Group Description	SI Group participants will be mailed a set of standard materials. The materials will include a letter from the participant's primary care practice encouraging selection and performance of either (1) colonoscopy screening, or (2) stool blood test (SBT) screening. Accompanying the letter will be instructions for arranging a colonoscopy appointment and instructions for completing an enclosed immunochemical SBT kit. Print materials and contacts will be provided, in both English and Spanish, after the baseline survey. At 45 days following random assignment that encourages screening. Standard		DSNI Group will be mailed print materials, including a letter from the practice on CRC screening, an informational booklet, and instructions for arranging a colonoscopy appointment and for completing an enclosed immunochemical SBT kit. All materials will be provided in both English and Spanish. Within 7 days after this mailing, participants will receive a telephone call from a trained bilingual study navigator. Following the call, the navigator will enter the participant's screening plan into the participant's electronic medical record, send the participant a letter describing the screening plan, and send the participant's primary care provider a copy of that same letter. At 45 days following random assignment, research staff will send participants a reminder letter encouraging the participant's preferred test. At 6 months after randomization, the navigator will send the provider and their office manager a participant CRC screening status report. Decision Support & Navigation
All Cause Mortality
	Standard		Decision Support & Navigation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/203 (0%)		0/197 (0%)
Serious Adverse Events
	Standard		Decision Support & Navigation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/203 (0%)		0/197 (0%)
Other (Not Including Serious) Adverse Events
	Standard		Decision Support & Navigation
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/203 (0%)		0/197 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE 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.