## Protocol Section
### Identification Module
**NCT ID:** NCT01103479

**Brief Title:** Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

**Official Title:** Low-Literacy Physician-Patient Intervention Promoting Colorectal Cancer Screening

#### Organization Study ID Info
**ID:** R01CA140177-01
**Link:** https://reporter.nih.gov/quickSearch/R01CA140177-01
**Type:** NIH
#### Organization
**Class:** OTHER
**Full Name:** Northwestern University
#### Secondary ID Infos
**ID:** R01CA140177
**Link:** https://reporter.nih.gov/quickSearch/R01CA140177
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2013-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-05-06

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-04-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-07

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2014-09-09

**Type:** ESTIMATED

**Results First Submit Date:** 2014-08-28

**Results First Submit QC Date:** 2014-08-28

#### Start Date
**Date:** 2010-04

**Status Verified Date:** 2015-04

#### Study First Post Date
**Date:** 2010-04-14
**Type:** ESTIMATED
**Study First Submit Date:** 2010-04-12
**Study First Submit QC Date:** 2010-04-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Northwestern University

#### Responsible Party

**Investigator Affiliation:** Northwestern University

**Investigator Full Name:** Kenzie Cameron

**Investigator Title:** Research Associate Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this study is to evaluate the effectiveness of a low literacy, physician and patient-directed intervention to promote colorectal cancer (CRC) screening among the medically underserved.

**Detailed Description:** This study will test the separate and combined effect of two of these interventions: 1) a provider communication skills training using a continuous quality improvement (CQI) framework, and 2) a brief, multimedia Patient Education Program (PEP) that incorporates plain language, graphic design, and audio voice-over to overcome literacy limitations. Our provider intervention has demonstrated efficacy to significantly improve CRC screening recommendation rates. Our multimedia program has also been field tested among patients with limited literacy and was able to improve patient knowledge and intention to receive screening.

We will implement both provider-only and combined provider-patient strategies within a federally qualified health center network to determine the most effective and efficient approach to promote CRC screening in these settings. Results from the study, supplemented by cost analyses and the process evaluation will directly inform translational strategies for cancer prevention within difficult community-based healthcare settings.

### Conditions Module

**Conditions:**

- Colorectal Cancer

**Keywords:**

- Early Detection of Cancer

- Colorectal Cancer Screening

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** HEALTH_SERVICES_RESEARCH

#### Enrollment Info

**Count:** 569

**Type:** ACTUAL

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants will complete interviewer-administered pre- and post-test

**Label:** Control

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training

**Intervention Names:**

- Behavioral: Physician Intervention

**Label:** Physician Intervention

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening

**Intervention Names:**

- Behavioral: Physician and Patient Intervention

**Label:** Physician and Patient Intervention

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Physician Intervention

**Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training

**Name:** Physician Intervention

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Physician and Patient Intervention

**Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening

**Name:** Physician and Patient Intervention

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**Description:** CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy

**Measure:** Colorectal Cancer (CRC) Screening Completion

**Time Frame:** within 6 months of provider recommendation

**Description:** CRC screening completion via FOBT, FIT or Colonoscopy

**Measure:** Colorectal Cancer (CRC) Screening Completion

**Time Frame:** within 6 months of provider recommendation

#### Secondary Outcomes

**Description:** Provider recommendation of CRC Screening based on chart review

**Measure:** Provider Recommendation of CRC Screening

**Time Frame:** 6 months following patient enrollment into study

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients aged 50-75 years of age (in month 1 of the study)
* Patients have had two or more visits to the clinic during the past two years
* ACCESS Community Health Network patients
* University of Illinois Hospital \& Health Sciences System patients
* Patients ages 50 - 75 as of the start of the intervention study
* English or Spanish-Speaking

Exclusion Criteria:

* Patients \<50 or \> 75 years of age
* Patients who have had fewer than two or more visits to the clinic during the past two years
* Personal history of CRC or colorectal polyps, or of inflammatory bowel disease and a family history with a first-degree relative with CRC or colorectal polyps.
* Unable to speak English or Spanish
* Compliant with CRC screening (FOBT or FIT within the past year; flexible sigmoidoscopy within past 5 years; colonoscopy within past 10 years)

**Healthy Volunteers:** True

**Maximum Age:** 75 Years

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chicago

**Country:** United States

**Facility:** Access Community Health Network

**State:** Illinois

**Zip:** 60606

**Location 2:**

**City:** Chicago

**Country:** United States

**Facility:** University of Illinois Hospital & Health Sciences System

**State:** Illinois

**Zip:** 60612

#### Overall Officials

**Official 1:**

**Affiliation:** Northwestern University

**Name:** Kenzie A Cameron, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Cameron KA, Ramirez-Zohfeld V, Ferreira MR, Dolan NC, Radosta J, Galanter WL, Eder MM, Wolf MS, Rademaker AW. The Effects of a Multicomponent Colorectal Cancer Screening Intervention on Knowledge, Recommendation, and Screening among Underserved Populations. J Health Care Poor Underserved. 2020;31(4):1612-1633. doi: 10.1353/hpu.2020.0122.

**PMID:** 33416742

**Citation:** Ramirez-Zohfeld V, Rademaker AW, Dolan NC, Ferreira MR, Eder MM, Liu D, Wolf MS, Cameron KA. Comparing the Performance of the S-TOFHLA and NVS Among and Between English and Spanish Speakers. J Health Commun. 2015;20(12):1458-64. doi: 10.1080/10810730.2015.1018629. Epub 2015 Jul 6.

**PMID:** 26147770

**Citation:** Dolan NC, Ramirez-Zohfeld V, Rademaker AW, Ferreira MR, Galanter WL, Radosta J, Eder MM, Cameron KA. The Effectiveness of a Physician-Only and Physician-Patient Intervention on Colorectal Cancer Screening Discussions Between Providers and African American and Latino Patients. J Gen Intern Med. 2015 Dec;30(12):1780-7. doi: 10.1007/s11606-015-3381-8. Epub 2015 May 19.

**PMID:** 25986137

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Colorectal Cancer

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015179

- Term: Colorectal Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Control

**Description:** Participants will complete interviewer-administered pre- and post-test

**ID:** EG000

**Other Num at Risk:** 163

**Serious Number At Risk:** 163

**Title:** Control

**Group ID:** EG001

**Title:** Physician Training

**Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training

Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training

**ID:** EG001

**Other Num at Risk:** 201

**Serious Number At Risk:** 201

**Title:** Physician Training

**Group ID:** EG002

**Title:** Physician and Patient Intervention

**Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening

Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening

**ID:** EG002

**Other Num at Risk:** 174

**Serious Number At Risk:** 174

**Title:** Physician and Patient Intervention

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 163

**Group ID:** BG001

**Value:** 201

**Group ID:** BG002

**Value:** 174

**Group ID:** BG003

**Value:** 538

**Units:** Participants

### Group

**ID:** BG000

**Title:** Control

**Description:** Participants will complete interviewer-administered pre- and post-test

### Group

**ID:** BG001

**Title:** Physician Intervention

**Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training

Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training

### Group

**ID:** BG002

**Title:** Physician and Patient Intervention

**Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening

Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening

### Group

**ID:** BG003

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 6.07

**Value:** 57.46

#### Measurement

**Group ID:** BG001

**Spread:** 6.24

**Value:** 58.71

#### Measurement

**Group ID:** BG002

**Spread:** 6.09

**Value:** 57.03

#### Measurement

**Group ID:** BG003

**Spread:** 6.17

**Value:** 57.79

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 124

#### Measurement

**Group ID:** BG001

**Value:** 144

#### Measurement

**Group ID:** BG002

**Value:** 129

#### Measurement

**Group ID:** BG003

**Value:** 397

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 39

#### Measurement

**Group ID:** BG001

**Value:** 57

#### Measurement

**Group ID:** BG002

**Value:** 45

#### Measurement

**Group ID:** BG003

**Value:** 141

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 82

#### Measurement

**Group ID:** BG001

**Value:** 111

#### Measurement

**Group ID:** BG002

**Value:** 93

#### Measurement

**Group ID:** BG003

**Value:** 286

**Class Title:** Non-Hispanic Black

#### Measurement

**Group ID:** BG000

**Value:** 68

#### Measurement

**Group ID:** BG001

**Value:** 88

#### Measurement

**Group ID:** BG002

**Value:** 75

#### Measurement

**Group ID:** BG003

**Value:** 231

**Class Title:** Hispanic

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 6

#### Measurement

**Group ID:** BG003

**Value:** 21

**Class Title:** Other/Missing

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 163

#### Measurement

**Group ID:** BG001

**Value:** 201

#### Measurement

**Group ID:** BG002

**Value:** 174

#### Measurement

**Group ID:** BG003

**Value:** 538

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 100

#### Measurement

**Group ID:** BG001

**Value:** 118

#### Measurement

**Group ID:** BG002

**Value:** 106

#### Measurement

**Group ID:** BG003

**Value:** 324

**Class Title:** English

#### Measurement

**Group ID:** BG000

**Value:** 63

#### Measurement

**Group ID:** BG001

**Value:** 83

#### Measurement

**Group ID:** BG002

**Value:** 68

#### Measurement

**Group ID:** BG003

**Value:** 214

**Class Title:** Spanish

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 21

#### Measurement

**Group ID:** BG001

**Value:** 30

#### Measurement

**Group ID:** BG002

**Value:** 27

#### Measurement

**Group ID:** BG003

**Value:** 78

**Class Title:** Private

#### Measurement

**Group ID:** BG000

**Value:** 47

#### Measurement

**Group ID:** BG001

**Value:** 68

#### Measurement

**Group ID:** BG002

**Value:** 52

#### Measurement

**Group ID:** BG003

**Value:** 167

**Class Title:** Medicare

#### Measurement

**Group ID:** BG000

**Value:** 51

#### Measurement

**Group ID:** BG001

**Value:** 71

#### Measurement

**Group ID:** BG002

**Value:** 67

#### Measurement

**Group ID:** BG003

**Value:** 189

**Class Title:** Medicaid

#### Measurement

**Group ID:** BG000

**Value:** 66

#### Measurement

**Group ID:** BG001

**Value:** 52

#### Measurement

**Group ID:** BG002

**Value:** 42

#### Measurement

**Group ID:** BG003

**Value:** 160

**Class Title:** Uninsured

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 99

#### Measurement

**Group ID:** BG001

**Value:** 174

#### Measurement

**Group ID:** BG002

**Value:** 154

#### Measurement

**Group ID:** BG003

**Value:** 427

**Class Title:** Community FQHC

#### Measurement

**Group ID:** BG000

**Value:** 64

#### Measurement

**Group ID:** BG001

**Value:** 27

#### Measurement

**Group ID:** BG002

**Value:** 20

#### Measurement

**Group ID:** BG003

**Value:** 111

**Class Title:** Academic Health Center

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 44

#### Measurement

**Group ID:** BG001

**Value:** 38

#### Measurement

**Group ID:** BG002

**Value:** 35

#### Measurement

**Group ID:** BG003

**Value:** 117

**Class Title:** 0 - 6 years

#### Measurement

**Group ID:** BG000

**Value:** 41

#### Measurement

**Group ID:** BG001

**Value:** 64

#### Measurement

**Group ID:** BG002

**Value:** 52

#### Measurement

**Group ID:** BG003

**Value:** 157

**Class Title:** 7 - 12 years

#### Measurement

**Group ID:** BG000

**Value:** 76

#### Measurement

**Group ID:** BG001

**Value:** 98

#### Measurement

**Group ID:** BG002

**Value:** 86

#### Measurement

**Group ID:** BG003

**Value:** 260

**Class Title:** 13 or more years

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 4

**Class Title:** Missing data

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 101

#### Measurement

**Group ID:** BG001

**Value:** 137

#### Measurement

**Group ID:** BG002

**Value:** 111

#### Measurement

**Group ID:** BG003

**Value:** 349

**Class Title:** <$20,000/year

#### Measurement

**Group ID:** BG000

**Value:** 22

#### Measurement

**Group ID:** BG001

**Value:** 28

#### Measurement

**Group ID:** BG002

**Value:** 23

#### Measurement

**Group ID:** BG003

**Value:** 73

**Class Title:** $20,000 - $40,000/year

#### Measurement

**Group ID:** BG000

**Value:** 13

#### Measurement

**Group ID:** BG001

**Value:** 6

#### Measurement

**Group ID:** BG002

**Value:** 8

#### Measurement

**Group ID:** BG003

**Value:** 27

**Class Title:** $40,001 - $100,000/year

#### Measurement

**Group ID:** BG000

**Value:** 23

#### Measurement

**Group ID:** BG001

**Value:** 26

#### Measurement

**Group ID:** BG002

**Value:** 27

#### Measurement

**Group ID:** BG003

**Value:** 76

**Class Title:** Not sure/Don't know

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 5

#### Measurement

**Group ID:** BG003

**Value:** 13

**Class Title:** Refused/Missing

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 28

#### Measurement

**Group ID:** BG001

**Value:** 28

#### Measurement

**Group ID:** BG002

**Value:** 25

#### Measurement

**Group ID:** BG003

**Value:** 81

**Class Title:** Poor

#### Measurement

**Group ID:** BG000

**Value:** 75

#### Measurement

**Group ID:** BG001

**Value:** 107

#### Measurement

**Group ID:** BG002

**Value:** 88

#### Measurement

**Group ID:** BG003

**Value:** 270

**Class Title:** Fair

#### Measurement

**Group ID:** BG000

**Value:** 39

#### Measurement

**Group ID:** BG001

**Value:** 46

#### Measurement

**Group ID:** BG002

**Value:** 44

#### Measurement

**Group ID:** BG003

**Value:** 129

**Class Title:** Good

#### Measurement

**Group ID:** BG000

**Value:** 18

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 12

#### Measurement

**Group ID:** BG003

**Value:** 40

**Class Title:** Very Good

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 10

#### Measurement

**Group ID:** BG002

**Value:** 4

#### Measurement

**Group ID:** BG003

**Value:** 16

**Class Title:** Excellent

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 1

#### Measurement

**Group ID:** BG003

**Value:** 2

**Class Title:** Missing

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 51

#### Measurement

**Group ID:** BG001

**Value:** 86

#### Measurement

**Group ID:** BG002

**Value:** 67

#### Measurement

**Group ID:** BG003

**Value:** 204

**Class Title:** Inadequate

#### Measurement

**Group ID:** BG000

**Value:** 96

#### Measurement

**Group ID:** BG001

**Value:** 97

#### Measurement

**Group ID:** BG002

**Value:** 88

#### Measurement

**Group ID:** BG003

**Value:** 281

**Class Title:** Marginal/Adequate

#### Measurement

**Group ID:** BG000

**Value:** 16

#### Measurement

**Group ID:** BG001

**Value:** 18

#### Measurement

**Group ID:** BG002

**Value:** 19

#### Measurement

**Group ID:** BG003

**Value:** 53

**Class Title:** Missing

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**Unit of Measure:** participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 5
**Parameter Type:** NUMBER
**Title:** Survey Language
**Unit of Measure:** participants
### Measure 6
**Parameter Type:** NUMBER
**Title:** Insurance Status (more than one may apply)
**Unit of Measure:** participants
### Measure 7
**Parameter Type:** NUMBER
**Title:** Health Care System
**Unit of Measure:** participants
### Measure 8
**Parameter Type:** NUMBER
**Title:** Years of Education
**Unit of Measure:** participants
### Measure 9
**Parameter Type:** NUMBER
**Title:** Household Income
**Unit of Measure:** participants
### Measure 10
**Parameter Type:** NUMBER
**Title:** Health status
**Unit of Measure:** participants
### Measure 11
**Parameter Type:** NUMBER
**Title:** Health Literacy
**Unit of Measure:** participants
**Population Description:** Participants had to reach randomization, complete both pre and post-tests, and be eligible for colorectal cancer screening (verified by chart review).
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** k-cameron@northwestern.edu
**Organization:** Northwestern University
**Phone:** 312-503-3910
**Title:** Kenzie A. Cameron
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 0.62
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 4.38
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.32
**P-Value Comment:** Random effects model adjusting for clustering by clinic
**Parameter Type:** Risk Ratio (RR)
**Parameter Value:** 1.65
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 0.53
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.20
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.28
**P-Value Comment:** Linear model adjusting for stratification by clinic and participant age
**Parameter Type:** Risk Ratio (RR)
**Parameter Value:** 0.80
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 0.60
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 3.43
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.42
**P-Value Comment:** Random effects model adjusted for clustering by clinic
**Parameter Type:** Risk Ratio (RR)
**Parameter Value:** 1.43
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 0.94
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 95
**CI Upper Limit:** 1.18
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.38
**P-Value Comment:** Linear model adjusting for stratification by clinic and participant age
**Parameter Type:** Risk Ratio (RR)
**Parameter Value:** 1.05
**Statistical Comment:** 
**Statistical Method:** Mixed Models Analysis
**Tested Non-Inferiority:** False
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 17
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 69
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 41
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 28
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 70
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 216
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 113
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 103
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** CRC screening completion via Fecal Occult Blood Test (FOBT), Fecal Immunochemical Test (FIT) or Colonoscopy
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** within 6 months of provider recommendation
**Title:** Colorectal Cancer (CRC) Screening Completion
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** Participants will complete interviewer-administered pre- and post-test
**ID:** OG000
**Title:** Control
##### Group
**Description:** Participants in either the Physician Intervention or Physician and Patient Intervention Arms.

Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training

Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening

Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co
**ID:** OG001
**Title:** Intervention
#### Outcome Measure 2
**Description:** CRC screening completion via FOBT, FIT or Colonoscopy
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** within 6 months of provider recommendation
**Title:** Colorectal Cancer (CRC) Screening Completion
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training

Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training
**ID:** OG000
**Title:** Physician Intervention
##### Group
**Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening

Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening
**ID:** OG001
**Title:** Physician and Patient Intervention
#### Outcome Measure 3
**Description:** Provider recommendation of CRC Screening based on chart review
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months following patient enrollment into study
**Title:** Provider Recommendation of CRC Screening
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Participants will complete interviewer-administered pre- and post-test
**ID:** OG000
**Title:** Control
##### Group
**Description:** Participants in either the Physician Intervention or Physician and Patient Intervention Arms.

Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training

Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening

Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co
**ID:** OG001
**Title:** Intervention
#### Outcome Measure 4
**Description:** Provider recommendation of CRC Screening based on chart review
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 6 months following patient enrollment into study
**Title:** Provider Recommendation of CRC Screening
**Type:** SECONDARY
**Unit of Measure:** participants
##### Group
**Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training

Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training
**ID:** OG000
**Title:** Physician Intervention
##### Group
**Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening

Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening
**ID:** OG001
**Title:** Physician and Patient Intervention
### Participant Flow Module
#### Group
**Description:** Participants will complete interviewer-administered pre- and post-test
**ID:** FG000
**Title:** Control
#### Group
**Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training

Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training
**ID:** FG001
**Title:** Physician Intervention
#### Group
**Description:** Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening

Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening
**ID:** FG002
**Title:** Physician and Patient Intervention
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Up to date with CRC screening
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 9
###### Reason
**Group ID:** FG002
**Number of Subjects:** 12
##### Withdraw
**Type:** Family history of CRC
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 2
##### Withdraw
**Type:** Active cancer
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Withdraw
**Type:** Saw non-study physician
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
###### Reason
**Group ID:** FG002
**Number of Subjects:** 0
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 168
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 210
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 188
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 163
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 201
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 174
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 9
###### Achievement
**Group ID:** FG002
**Number of Subjects:** 14
**Pre-Assignment Details:** Enrolled participants were excluded from the trial before assignment to groups if they did not reach randomization (e.g. they did not reach the point in the pre-test survey where randomization took place. Therefore they were not assigned to groups. In this study, 3 of the 569 enrolled participants did not reach randomization.
**Recruitment Details:** Recruitment for this study took place between September 15, 2010 and January 30, 2013 across seven federally qualified health centers as well as one large academic health center.
**Has Results:** True