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Physicians face a challenge in promoting colorectal cancer screening (CRCS) in the face of multiple competing demands. A decision aid (DA) that clarifies patient preferences and improves decision quality could aid shared decision making (SDM) and be effective at increasing CRCS rates. However, exactly how such DA improves SDM is not clear. This 4-year R01 study funded by the National Cancer Institute seeks to provide detailed understanding of how an interactive DA affects patient-physician communication and SDM, and ultimately CRCS adherence.
This two-armed randomized controlled trial (300 patients/arm) will compare Colorectal Web (CW), the interactive DA, to a non-interactive control website in ten practices in Metro Detroit. Patients will be adults aged 50 years and over, not current on CRCS. In the clinic before the patient-physician encounter, participants will complete a Patient Baseline Survey. They will be randomized to CW or the control website. Data will be collected after the patient reviews the respective website (Post-Intervention Survey), during the patient-physician encounter (digital audio recording), and after it (Post-Encounter Survey). Chart audit will be performed six months after the encounter to determine whether the patient underwent CRCS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment. | |
| Intervention with Colorectal Website | Active Comparator | Intervention website includes an interactive component including preferences and risk assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colorectal Web | Behavioral | The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits | Chart audits were conducted 6 months after the participant's study visit to determine if screening had occurred and if the type of screen was the same as the participant's preferred type of screening. | 6 months following intervention a chart audit will be conducted to determine if CRCS was completed. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Masahito Jimbo, MD, PhD, MPH | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's and Family Medical Clinic | Allen Park | Michigan | 48101 | United States | ||
| Downriver Internists |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31128959 | Derived | Jimbo M, Sen A, Plegue MA, Hawley S, Kelly-Blake K, Rapai M, Zhang M, Zhang Y, Xie X, Ruffin MT 4th. Interactivity in a Decision Aid: Findings From a Decision Aid to Technologically Enhance Shared Decision Making RCT. Am J Prev Med. 2019 Jul;57(1):77-86. doi: 10.1016/j.amepre.2019.03.004. Epub 2019 May 23. | |
| 24216139 | Derived |
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Data is still being analyzed and papers written
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment. |
| FG001 | Intervention With Colorectal Website |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Allen Park |
| Michigan |
| 48101 |
| United States |
| University of Michigan Family Medicine at Domino's | Ann Arbor | Michigan | 48106 | United States |
| University of Michigan Briarwood Family Medicine | Ann Arbor | Michigan | 48108 | United States |
| Dua Family Practice | Canton | Michigan | 48187 | United States |
| George C. Hawrot, MD | Dearborn | Michigan | 48124 | United States |
| Andrew Thomas, MD | Detroit | Michigan | 48201 | United States |
| Morang Chester Clinic | Detroit | Michigan | 48224 | United States |
| Rice Lanzilote & Egan | Detroit | Michigan | 48227 | United States |
| David Williams, MD | Detroit | Michigan | 48235 | United States |
| IPC - Livonia Internal Medicine | Livonia | Michigan | 48152 | United States |
| Lonnie Joe Jr. MD | Southfield | Michigan | 48075 | United States |
| Mark W. Sawka, MD | Woodhaven | Michigan | 48183 | United States |
| University of Michigan Family Medicine at Corner Health Center | Ypsilanti | Michigan | 48197 | United States |
| Jimbo M, Kelly-Blake K, Sen A, Hawley ST, Ruffin MT 4th. Decision Aid to Technologically Enhance Shared decision making (DATES): study protocol for a randomized controlled trial. Trials. 2013 Nov 11;14:381. doi: 10.1186/1745-6215-14-381. |
Intervention website includes an interactive component including preferences and risk assessment.
Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment. |
| BG001 | Intervention With Colorectal Website | Intervention website includes an interactive component including preferences and risk assessment. Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Participants screened for colon cancer | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Reporting Preferred Screening Type as Reported by Chart Audits | Chart audits were conducted 6 months after the participant's study visit to determine if screening had occurred and if the type of screen was the same as the participant's preferred type of screening. | Posted | Number | participants | 6 months following intervention a chart audit will be conducted to determine if CRCS was completed. |
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During 2 year data collection period
No difference
This study involved participants looking at a website and completing questionnaires regarding colon cancer risks and screening. The risks of participating in these activities are no greater than participating in everyday activities. The participant who died after consenting died during knee surgery, totally unrelated to participating in the study. This was the only AE that study staff became aware of during the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Same information is presented in the control website as is found in the intervention website, but no interactive component: preferences and risk assessment. | 0 | 286 | 0 | 286 | 0 | 286 |
| EG001 | Intervention With Colorectal Website | Intervention website includes an interactive component including preferences and risk assessment. Colorectal Web: The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS | 1 | 284 | 1 | 284 | 0 | 284 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment | Participant's death occurred during surgery totally unrelated to participation in the study. Clinic site staff member just happened to mention to research study staff this happened. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Masahito Jimbo | UMichigan | 734-998-7120 | mjimbo@med.umich.edu |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| >=65 years |
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| Male |
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