Colorectal Cancer, COVID-19, Health Behavior, Healthcare Patient Acceptance, Influenza, Vaccine Hesitancy, Vaccine-Preventable Diseases
Conditions
Keywords
Cancer screening, Preventive healthcare, Vaccine uptake, Patient financial incentives, Federally qualified health center, Health services
Brief summary
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: * Do patient financial incentives for completing colorectal cancer screening increase screening completion? * Does a patient financial incentive for colorectal cancer screening offered alongside patient financial incentives for COVID-19 and flu shots increase completion of those shots? 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.
Interventions
BEHAVIORALFinancial incentive for colorectal cancer screening
$50 incentive paid to participant for completion of colorectal cancer screening within 2 months of enrollment
BEHAVIORALFinancial incentive for flu shot
$50 incentive paid to participant for completion of flu shot within 2 months of enrollment
BEHAVIORALFinancial incentive for COVID-19 shot
$50 incentive paid to participant for completion of COVID-19 shot within 2 months of enrollment
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Tulane University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
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.
Intervention model description
Participants will be randomly assigned to a study arm for the duration of their two months in the study
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 45 to 75 * Receive care at participating primary care clinic * Due for colorectal cancer screening * Ability to understand and speak English
Exclusion criteria
* Currently participating in another clinical trial or research study on colorectal cancer screening * Unable or unwilling to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Percent of Participants Completing Colorectal Cancer Screening Between Study Arms | Two months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Percent of Participants Completing COVID-19 Shot Between Study Arms | Two months | Completion of COVID-19 shot as documented in electronic health record within two months of study enrollment |
| Difference in Percent of Participants Completing Flu Shot Between Study Arms | Two months | Completion of flu shot as documented in electronic health record within two months of study enrollment |
| Difference in Percent of Participants Completing at Least One of the Following Services Between Study Arms: Colorectal Cancer Screening, COVID-19 Shot, Flu Shot | Two months | 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 |
| Difference in Percent of Participants Completing All Three Services Between Study Arms: Colorectal Cancer Screening, COVID-19 Shot, Flu Shot | Two months | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Assessed for Eligibility | Three months | Number of patients assessed for eligibility |
| Number of Patients Consented and Randomized | Three months | Number of patients consented and randomized |
| Number of Patients Who Receive the Outreach Call Intervention | Three months | Number of patients who receive the outreach call intervention |
| Number of Patients Reached for Recruitment | Three months | Number of patients reached for recruitment |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Full Financial Incentives $50/service patient financial incentive for completion of: COVID-19 shot, flu shot, colorectal cancer screening | 25 |
| Partial Financial Incentives $50/service patient financial incentive for completion of: COVID-19 shot, flu shot | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Total | Full Financial Incentives | Partial Financial Incentives |
|---|---|---|---|
| Age, Continuous | 52.40 Years STANDARD_DEVIATION 6.61 | 52.48 Years STANDARD_DEVIATION 6.63 | 52.32 Years STANDARD_DEVIATION 6.74 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants | 24 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 10 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 14 Participants | 14 Participants |
| Region of Enrollment United States | 50 Participants | 25 Participants | 25 Participants |
| Sex: Female, Male Female | 35 Participants | 15 Participants | 20 Participants |
| Sex: Female, Male Male | 15 Participants | 10 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: Two months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Financial Incentives | Difference in Percent of Participants Completing Colorectal Cancer Screening Between Study Arms | 17 Participants |
| Partial Financial Incentives | Difference in Percent of Participants Completing Colorectal Cancer Screening Between Study Arms | 8 Participants |
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
Time frame: Two months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Financial Incentives | Difference in Percent of Participants Completing All Three Services Between Study Arms: Colorectal Cancer Screening, COVID-19 Shot, Flu Shot | 1 Participants |
| Partial Financial Incentives | Difference in Percent of Participants Completing All Three Services Between Study Arms: Colorectal Cancer Screening, COVID-19 Shot, Flu Shot | 0 Participants |
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
Time frame: Two months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Financial Incentives | Difference in Percent of Participants Completing at Least One of the Following Services Between Study Arms: Colorectal Cancer Screening, COVID-19 Shot, Flu Shot | 20 Participants |
| Partial Financial Incentives | Difference in Percent of Participants Completing at Least One of the Following Services Between Study Arms: Colorectal Cancer Screening, COVID-19 Shot, Flu Shot | 13 Participants |
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
Time frame: Two months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Financial Incentives | Difference in Percent of Participants Completing COVID-19 Shot Between Study Arms | 1 Participants |
| Partial Financial Incentives | Difference in Percent of Participants Completing COVID-19 Shot Between Study Arms | 0 Participants |
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
Time frame: Two months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Financial Incentives | Difference in Percent of Participants Completing Flu Shot Between Study Arms | 9 Participants |
| Partial Financial Incentives | Difference in Percent of Participants Completing Flu Shot Between Study Arms | 10 Participants |
Other Pre-specified
Number of Patients Assessed for Eligibility
Number of patients assessed for eligibility
Time frame: Three months
Population: Overall Number of Participants Analyzed represents all patients who were reached during recruitment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Financial Incentives | Number of Patients Assessed for Eligibility | 93 Participants |
Other Pre-specified
Number of Patients Consented and Randomized
Number of patients consented and randomized
Time frame: Three months
Population: Overall Number of Participants Analyzed represents all patients who underwent eligibility screening and were eligible to participate.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Financial Incentives | Number of Patients Consented and Randomized | 50 Participants |
Other Pre-specified
Number of Patients Reached for Recruitment
Number of patients reached for recruitment
Time frame: Three months
Population: Overall Number of Participants Analyzed represents all patients who were approached and considered for recruitment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Financial Incentives | Number of Patients Reached for Recruitment | 107 Participants |
Other Pre-specified
Number of Patients Who Receive the Outreach Call Intervention
Number of patients who receive the outreach call intervention
Time frame: Three months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Full Financial Incentives | Number of Patients Who Receive the Outreach Call Intervention | 25 Participants |
| Partial Financial Incentives | Number of Patients Who Receive the Outreach Call Intervention | 25 Participants |