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| Name | Class |
|---|---|
| University of New Mexico | OTHER |
| Wake Forest University Health Sciences | OTHER |
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This study is a multi-site randomized, controlled trial testing the effect of a combined intervention that includes a colorectal cancer (CRC) screening decision aid plus patient navigation in a diverse, primary care patient population in clinical sites in North Carolina and New Mexico.
Our primary aim is to determine the effect of the intervention on CRC screening completion six months after the index visit among all enrolled participants and among Latinos. Secondarily, we will determine how this intervention affects screening-related knowledge, self-efficacy, intent, and clinical communication, and examine whether these factors mediate the effect of the intervention on screening test completion. Lastly, we will explore whether insurance status, ethnicity, and patient language preference moderate the effect of the intervention on screening.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Usual care. | |
| Intervention group | Experimental | Decision aid and navigation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decision aid and navigation | Behavioral | Patients in the intervention group will receive a combined intervention consisting of a CRC screening decision aid and assistance from a trained patient navigator. |
| Measure | Description | Time Frame |
|---|---|---|
| Colorectal cancer screening completion | A blinded medical record review will be used to determine the primary outcome of 6 month Colorectal cancer screening status. To ensure optimal capturing of screening test completion, we will ask participants whose medical record does not contain evidence of screening to verify non-completion during the 6 month phone survey. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Colorectal cancer screening knowledge | Following the provider encounter, we will administer the post-encounter survey to measure intermediate screening related knowledge. | Post-encounter measure |
| Colorectal cancer screening related self-efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Reuland, MD, MPH | University of North Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States | ||
| University of North Carolina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28505217 | Derived | Reuland DS, Brenner AT, Hoffman R, McWilliams A, Rhyne RL, Getrich C, Tapp H, Weaver MA, Callan D, Cubillos L, Urquieta de Hernandez B, Pignone MP. Effect of Combined Patient Decision Aid and Patient Navigation vs Usual Care for Colorectal Cancer Screening in a Vulnerable Patient Population: A Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;177(7):967-974. doi: 10.1001/jamainternmed.2017.1294. | |
| 27242081 |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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The Colorectal cancer screening self-efficacy will be measured by the post-encounter survey.
| 6 months |
| Colorectal cancer screening related intent | The post-encounter survey will be used to measure the Colorectal cancer screening related intent. | 6 months |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| Carolinas Healthcare Systems | Charlotte | North Carolina | 28203 | United States |
| Derived |
| Brenner AT, Hoffman R, McWilliams A, Pignone MP, Rhyne RL, Tapp H, Weaver MA, Callan D, de Hernandez BU, Harbi K, Reuland DS. Colorectal Cancer Screening in Vulnerable Patients: Promoting Informed and Shared Decisions. Am J Prev Med. 2016 Oct;51(4):454-62. doi: 10.1016/j.amepre.2016.03.025. Epub 2016 May 27. |
| 25004983 | Derived | Brenner AT, Getrich CM, Pignone M, Rhyne RL, Hoffman RM, McWilliams A, de Hernandez BU, Weaver MA, Tapp H, Harbi K, Reuland D. Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial. Trials. 2014 Jul 8;15:275. doi: 10.1186/1745-6215-15-275. |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |