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| ID | Type | Description | Link |
|---|---|---|---|
| OT2HL158287 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The goal of this pilot clinical trial is to determine feasibility and explore whether financial incentives paid to primary care patients for completing colorectal cancer screening increase completion of colorectal cancer screening. The main questions it aims to answer are:
Participants who are due for colorectal cancer screening will receive telephone outreach from primary care staff who will offer a stool-based colorectal cancer screening. Participants will be randomly assigned to either Group 1 or Group 2. Group 1 participants will be offered financial incentives for completing COVID-19 and flu shots within 2 months of enrollment. Group 2 participants will be offered financial incentives for completing a COVID-19 shot, a flu shot, and colorectal cancer screening within 2 months of enrollment.
Researchers will compare to see if completion of a COVID-19 shot, a flu shot, and colorectal cancer screening is different between the two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Full financial incentives | Experimental | $50/service patient financial incentive for completion of: COVID-19 shot, flu shot, colorectal cancer screening |
|
| Partial financial incentives | Active Comparator | $50/service patient financial incentive for completion of: COVID-19 shot, flu shot |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial incentive for colorectal cancer screening | Behavioral | $50 incentive paid to participant for completion of colorectal cancer screening within 2 months of enrollment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Percent of Participants Completing Colorectal Cancer Screening Between Study Arms | Completion of colonoscopy, sigmoidoscopy, CT colonography, or stool-based colorectal cancer screening test as documented in electronic health record within two months of study enrollment | Two months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Percent of Participants Completing COVID-19 Shot Between Study Arms | Completion of COVID-19 shot as documented in electronic health record within two months of study enrollment | Two months |
| Difference in Percent of Participants Completing Flu Shot Between Study Arms |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Reached for Recruitment | Number of patients reached for recruitment | Three months |
| Number of Patients Assessed for Eligibility | Number of patients assessed for eligibility |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marie A Krousel-Wood, MD, MSPH | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane University School of Medicine | New Orleans | Louisiana | 70112 | United States |
No IPD will be shared with other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Full Financial Incentives | $50/service patient financial incentive for completion of: COVID-19 shot, flu shot, colorectal cancer screening |
| FG001 | Partial Financial Incentives |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 11, 2024 | Mar 25, 2025 |
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Participants will be randomly assigned to a study arm for the duration of their two months in the study
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Primary care outreach staff will recruit and randomize participants and deliver the intervention. Group assignment will be documented in a separate study database not accessible by the primary care provider. Outcomes will be assessed in electronic health records data, which will be queried by primary care staff who do not have access to group assignment.
| Financial incentive for flu shot | Behavioral | $50 incentive paid to participant for completion of flu shot within 2 months of enrollment |
|
| Financial incentive for COVID-19 shot | Behavioral | $50 incentive paid to participant for completion of COVID-19 shot within 2 months of enrollment |
|
Completion of flu shot as documented in electronic health record within two months of study enrollment |
| Two months |
| Difference in Percent of Participants Completing at Least One of the Following Services Between Study Arms: Colorectal Cancer Screening, COVID-19 Shot, Flu Shot | Completion of colorectal cancer screening (colonoscopy, sigmoidoscopy, CT colonography, or stool-based colorectal cancer screening test), COVID-19 shot, *OR* flu shot as documented in electronic health record within two months of study enrollment | Two months |
| Difference in Percent of Participants Completing All Three Services Between Study Arms: Colorectal Cancer Screening, COVID-19 Shot, Flu Shot | Completion of colorectal cancer screening (colonoscopy, sigmoidoscopy, CT colonography, or stool-based colorectal cancer screening test), COVID-19 shot, *AND* flu shot as documented in electronic health record within two months of study enrollment | Two months |
| Three months |
| Number of Patients Consented and Randomized | Number of patients consented and randomized | Three months |
| Number of Patients Who Receive the Outreach Call Intervention | Number of patients who receive the outreach call intervention | Three months |
$50/service patient financial incentive for completion of: COVID-19 shot, flu shot
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Full Financial Incentives | $50/service patient financial incentive for completion of: COVID-19 shot, flu shot, colorectal cancer screening |
| BG001 | Partial Financial Incentives | $50/service patient financial incentive for completion of: COVID-19 shot, flu shot |
| 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, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | 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 | Difference in Percent of Participants Completing Colorectal Cancer Screening Between Study Arms | Completion of colonoscopy, sigmoidoscopy, CT colonography, or stool-based colorectal cancer screening test as documented in electronic health record within two months of study enrollment | Posted | Count of Participants | Participants | Two months |
|
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| ||||||||||||||||||||||||||||||
| Secondary | Difference in Percent of Participants Completing COVID-19 Shot Between Study Arms | Completion of COVID-19 shot as documented in electronic health record within two months of study enrollment | Posted | Count of Participants | Participants | Two months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Difference in Percent of Participants Completing Flu Shot Between Study Arms | Completion of flu shot as documented in electronic health record within two months of study enrollment | Posted | Count of Participants | Participants | Two months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Difference in Percent of Participants Completing at Least One of the Following Services Between Study Arms: Colorectal Cancer Screening, COVID-19 Shot, Flu Shot | Completion of colorectal cancer screening (colonoscopy, sigmoidoscopy, CT colonography, or stool-based colorectal cancer screening test), COVID-19 shot, *OR* flu shot as documented in electronic health record within two months of study enrollment | Posted | Count of Participants | Participants | Two months |
|
| |||||||||||||||||||||||||||||||
| Secondary | Difference in Percent of Participants Completing All Three Services Between Study Arms: Colorectal Cancer Screening, COVID-19 Shot, Flu Shot | Completion of colorectal cancer screening (colonoscopy, sigmoidoscopy, CT colonography, or stool-based colorectal cancer screening test), COVID-19 shot, *AND* flu shot as documented in electronic health record within two months of study enrollment | Posted | Count of Participants | Participants | Two months |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients Reached for Recruitment | Number of patients reached for recruitment | Overall Number of Participants Analyzed represents all patients who were approached and considered for recruitment. | Posted | Count of Participants | Participants | Three months |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients Assessed for Eligibility | Number of patients assessed for eligibility | Overall Number of Participants Analyzed represents all patients who were reached during recruitment | Posted | Count of Participants | Participants | Three months |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients Consented and Randomized | Number of patients consented and randomized | Overall Number of Participants Analyzed represents all patients who underwent eligibility screening and were eligible to participate. | Posted | Count of Participants | Participants | Three months |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients Who Receive the Outreach Call Intervention | Number of patients who receive the outreach call intervention | Posted | Count of Participants | Participants | Three months |
|
|
Two months
All-Cause Mortality was assessed/monitored using the primary care clinic electronic health record (EHR). Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed.
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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 | Full Financial Incentives | $50/service patient financial incentive for completion of: COVID-19 shot, flu shot, colorectal cancer screening Financial incentive for colorectal cancer screening: $50 incentive paid to participant for completion of colorectal cancer screening within 2 months of enrollment Financial incentive for flu shot: $50 incentive paid to participant for completion of flu shot within 2 months of enrollment Financial incentive for COVID-19 shot: $50 incentive paid to participant for completion of COVID-19 shot within 2 months of enrollment | 0 | 25 | 0 | 0 | 0 | 0 |
| EG001 | Partial Financial Incentives | $50/service patient financial incentive for completion of: COVID-19 shot, flu shot Financial incentive for flu shot: $50 incentive paid to participant for completion of flu shot within 2 months of enrollment Financial incentive for COVID-19 shot: $50 incentive paid to participant for completion of COVID-19 shot within 2 months of enrollment | 0 | 25 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laura Perry | Tulane University | 504-988-8906 | lperry5@tulane.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 11, 2024 | Apr 16, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D015179 | Colorectal Neoplasms |
| D007251 | Influenza, Human |
| D000086382 | COVID-19 |
| D000088823 | Vaccination Hesitancy |
| D000079263 | Vaccine-Preventable Diseases |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D001519 | Behavior |
| 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 |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D008171 | Lung Diseases |
| D000072758 | Vaccination Refusal |
| D016312 | Treatment Refusal |
| D000074822 | Treatment Adherence and Compliance |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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