Colorectal Cancer Screening
Conditions
Keywords
decision aid, decision making, COVID-19, risk communication, colorectal neoplasm, electronic health records
Brief summary
The rate of screening for colorectal cancer (CRC) in the U.S. remains low (under 65%), meaning that thousands of people die of colorectal cancer unnecessarily. Colorectal cancer screening tests range from more invasive and very sensitive for polyps and cancer (colonoscopy) to less invasive and less sensitive (e.g., fecal immunochemical testing (FIT)). Screening rates go up when patients consider all these tests, not just colonoscopy. Informing patients about their options for CRC screening could produce higher quality decisions, improve the match between patient preferences and tests performed, and increase uptake of CRC screening. Decision aids (DAs) are a promising tool for accomplishing this goal. Also, precision CRC prevention - providing information about an individual's specific risk for CRC - has great promise to increase uptake and improve decision making. Unfortunately, the COVID-19 pandemic is causing severe challenges to providing CRC screening and other prevention services. Health systems are trying to adapt, but these efforts have only begun and are poorly understood. Moreover, patient perceptions of disease risk and risk from COVID-19 are unknown.
Detailed description
The study team will engage with the leadership, staff, and providers in the study team's partner healthcare systems, to identify facilitators and barriers to implementing patient decision aids and provider notifications as well as cancer risk assessment tools, for colorectal cancer screening, and for other evidence-based cancer screening during the COVID pandemic and, potentially, after the conclusion of the pandemic. At the conclusion of the study, the investigators will have extensive information regarding how best to provide decision aids through an electronic health record (EHR) portal, with or without personalized information, and to deliver provider notifications, which can guide broader implementation. The study will involve interviews with staff and providers at the study team's partner healthcare systems to identify facilitators and barriers to implementing decision aids and provider notifications for colorectal cancer screening. Also, the investigators will interview patients to identify perceptions of prevention during the COVID-19 pandemic including risk perception and barriers to screening, perceptions of risk from both the pandemic and disease, and patient cancer screening and risk prevention behaviors engaged in or postponed during the pandemic and patient rationales for their decisions. This part of the study will suggest potentially promising approaches for providing prevention and disease management during the COVID-19 pandemic.
Interventions
OTHERSemi-structured interviews-Patients
The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making.
OTHERSemi-structured interviews-Health system
The interview guide will consist of questions to elicit thoughts from health system leadership, providers, and staff about implementing decision aids, provider notifications, and cancer risk assessments in their health center or healthcare system. The questions may be specific to colorectal cancer screening or more generally about other cancer screenings. The investigators may also ask questions about cancer screening initiatives their health center or healthcare system engaged in during the COVID-19 pandemic.
Sponsors
Patient-Centered Outcomes Research Institute
Indiana University
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Health system participants will be eligible if: * they are employed by one of the study team's partner healthcare systems. Patient participants will be eligible if: * they have had a primary care visit during the past 24 months * they have completed cancer screening during the past 5 years prior to 2020 for breast, cervical or lung cancer as noted in the electronic health record (EHR) * age 50 years or older * speaks English * accessible by phone.
Exclusion criteria
Patients will be excluded if: * they did not complete any cancer screening for breast, colon, cervical, or lung cancer during the past 5 years prior to 2020 * did not complete a primary care visit at a partner healthcare system during the past 2 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Facilitators and Barriers to Implementing Decision Aids, Provider Notifications, and Personal Risk Calculation Using an Electronic Health Record (EHR) to Promote Colorectal Cancer Screening. | 2 years | Semi-structured interviews with health system leadership, providers and staff conducted every 3-4 months to discuss facilitators and barriers to implementing decision aids, provider notification, and personal risk calculation using an EHR to promote cancer screening. |
| Challenges and Facilitators of Effective Cancer Screening and Prevention in Primary Care During the COVID-19 Pandemic Among Leadership, Providers, and Staff. | 9 months | Semi-structured interviews with health system leadership, providers, and staff from the study team's affiliated health systems about their perceptions of the impact of COVID-19 on primary care and cancer screening. |
| Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic. | 6 months | Semi-structured interviews with primary care patients who were due for either breast, cervical, colorectal, or lung cancer screening between April-July 2020 at the study teams affiliate health systems. The interview guide contained questions to explore the patients' understanding, attitudes, and beliefs about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting preventive and other (non-screening) healthcare, and information needed for decision making. |
Countries
United States
Participant flow
Recruitment details
Healthcare system: we used snowball sampling to identify leadership, providers, and clinical staff involved in cancer screening, primary care and prevention. We interviewed 20 key informants in January-July 2021 and re-interviewed 11 of them in January-March 2022. Patients: we interviewed patients (screened and not screened) who were due for breast, cervical, colorectal, or lung cancer screening in April-July 2020. Interviews were conducted from August 2021 through February 2022.
Pre-assignment details
One patient that was consented, enrolled, and interviewed was removed from the study after review of data by PI and key research members concluded that the patient had undergone a diagnostic rather than screening procedure.
Participants by arm
| Arm | Count |
|---|---|
| Not Screened Patients Patients who were due for cancer screening (breast, cervical, colorectal or lung cancer) between April-July 2020, however had not completed the screening they were selected for at time of interview. | 29 |
| Screened Patients Patients who were due for cancer screening (breast, cervical, colorectal or lung cancer) between April-July 2020 and had completed the screening they were selected for at time of interview. | 32 |
| Health System Participants Leadership, providers, and clinical staff involved in cancer screening, primary care, and prevention at two affiliated health systems. | 20 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | withdrawn (determined not eligible after enrollment) | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Not Screened Patients | Total | Screened Patients | Health System Participants |
|---|---|---|---|---|
| Age, Continuous | 56.1 years STANDARD_DEVIATION 15.1 | 56.1 years STANDARD_DEVIATION 14.7 | 56.2 years STANDARD_DEVIATION 14.5 | — |
| Confidence Filling Out Medical Forms A little bit | 1 Participants | 2 Participants | 1 Participants | — |
| Confidence Filling Out Medical Forms Extremely | 15 Participants | 36 Participants | 21 Participants | — |
| Confidence Filling Out Medical Forms Not at all | 4 Participants | 5 Participants | 1 Participants | — |
| Confidence Filling Out Medical Forms Quite a bit | 5 Participants | 10 Participants | 5 Participants | — |
| Confidence Filling Out Medical Forms Somewhat | 4 Participants | 8 Participants | 4 Participants | — |
| Difficulty Understanding Written Information Always | 2 Participants | 2 Participants | 0 Participants | — |
| Difficulty Understanding Written Information Never | 13 Participants | 31 Participants | 18 Participants | — |
| Difficulty Understanding Written Information Occasionally | 7 Participants | 12 Participants | 5 Participants | — |
| Difficulty Understanding Written Information Often | 0 Participants | 1 Participants | 1 Participants | — |
| Difficulty Understanding Written Information Sometimes | 7 Participants | 15 Participants | 8 Participants | — |
| Employment Status Employed Full-time | 6 Participants | 15 Participants | 9 Participants | — |
| Employment Status Employed Part-time | 2 Participants | 8 Participants | 6 Participants | — |
| Employment Status Unemployed/retired | 21 Participants | 37 Participants | 16 Participants | — |
| Employment Status Unknown | 0 Participants | 1 Participants | 1 Participants | — |
| Have Help Reading Hospital Materials Always | 2 Participants | 2 Participants | 0 Participants | — |
| Have Help Reading Hospital Materials Never | 14 Participants | 34 Participants | 20 Participants | — |
| Have Help Reading Hospital Materials Occasionally | 7 Participants | 13 Participants | 6 Participants | — |
| Have Help Reading Hospital Materials Often | 2 Participants | 4 Participants | 2 Participants | — |
| Have Help Reading Hospital Materials Sometimes | 4 Participants | 8 Participants | 4 Participants | — |
| Health System Roles Clinical Support (MA, RN) | — | 6 Participants | — | 6 Participants |
| Health System Roles Leadership/Administration | — | 9 Participants | — | 9 Participants |
| Health System Roles Provider (MD, DO, APP) | — | 5 Participants | — | 5 Participants |
| Highest Level of Education Associate degree | 0 Participants | 4 Participants | 4 Participants | — |
| Highest Level of Education Bachelor's degree | 6 Participants | 13 Participants | 7 Participants | — |
| Highest Level of Education High school graduate/GED | 12 Participants | 19 Participants | 7 Participants | — |
| Highest Level of Education Less than high school diploma | 2 Participants | 5 Participants | 3 Participants | — |
| Highest Level of Education Professional or graduate degree | 2 Participants | 3 Participants | 1 Participants | — |
| Highest Level of Education Some college/technical or trade school | 7 Participants | 17 Participants | 10 Participants | — |
| Living Situation Divorced | 3 Participants | 7 Participants | 4 Participants | — |
| Living Situation Married/Living with a Partner | 14 Participants | 27 Participants | 13 Participants | — |
| Living Situation Never Married | 7 Participants | 16 Participants | 9 Participants | — |
| Living Situation Separated | 0 Participants | 1 Participants | 1 Participants | — |
| Living Situation Widowed | 5 Participants | 10 Participants | 5 Participants | — |
| Race/Ethnicity, Customized Black or African American | 11 Participants | 24 Participants | 13 Participants | — |
| Race/Ethnicity, Customized Hispanic/Latino | 0 Participants | 0 Participants | 0 Participants | — |
| Race/Ethnicity, Customized Other | 1 Participants | 4 Participants | 3 Participants | — |
| Race/Ethnicity, Customized White | 17 Participants | 33 Participants | 16 Participants | — |
| Sex/Gender, Customized Female | 24 Participants | 47 Participants | 23 Participants | — |
| Sex/Gender, Customized Male | 4 Participants | 13 Participants | 9 Participants | — |
| Sex/Gender, Customized Other | 1 Participants | 1 Participants | 0 Participants | — |
| Subjective Health Status Excellent | 1 Participants | 2 Participants | 1 Participants | — |
| Subjective Health Status Fair | 7 Participants | 14 Participants | 7 Participants | — |
| Subjective Health Status Good | 14 Participants | 30 Participants | 16 Participants | — |
| Subjective Health Status Poor | 4 Participants | 6 Participants | 2 Participants | — |
| Subjective Health Status Very good | 3 Participants | 9 Participants | 6 Participants | — |
| Subjective Income Are comfortable | 7 Participants | 22 Participants | 15 Participants | — |
| Subjective Income Do NOT have enough to make ends meet | 7 Participants | 10 Participants | 3 Participants | — |
| Subjective Income Have just enough to make ends meet | 14 Participants | 28 Participants | 14 Participants | — |
| Subjective Income Unknown | 1 Participants | 1 Participants | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 29 | 0 / 32 |
| other Total, other adverse events | 0 / 20 | 0 / 29 | 0 / 32 |
| serious Total, serious adverse events | 0 / 20 | 0 / 29 | 0 / 32 |
Outcome results
Primary
Challenges and Facilitators of Effective Cancer Screening and Prevention in Primary Care During the COVID-19 Pandemic Among Leadership, Providers, and Staff.
Semi-structured interviews with health system leadership, providers, and staff from the study team's affiliated health systems about their perceptions of the impact of COVID-19 on primary care and cancer screening.
Time frame: 9 months
Population: 20 leaders, managers, and providers were interviewed in January-July 2021, and 11 were re-interviewed in January-March 2022. We identified five emergent, overarching themes of the impact of COVID-19 pandemic on cancer screening and preventive care services across two healthcare organizations and across the time frame of the COVID-19 pandemic (2020-2022).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthcare System Leadership, Providers, and Staff | Challenges and Facilitators of Effective Cancer Screening and Prevention in Primary Care During the COVID-19 Pandemic Among Leadership, Providers, and Staff. | 5 Themes |
Primary
Facilitators and Barriers to Implementing Decision Aids, Provider Notifications, and Personal Risk Calculation Using an Electronic Health Record (EHR) to Promote Colorectal Cancer Screening.
Semi-structured interviews with health system leadership, providers and staff conducted every 3-4 months to discuss facilitators and barriers to implementing decision aids, provider notification, and personal risk calculation using an EHR to promote cancer screening.
Time frame: 2 years
Population: The initial sample of 8 interviewees identified 12 additional stakeholders, allowing us to snowball our sample to complete interviews with 20 participants including primary care providers, nurses, medical assistants, quality and clinic managers, and cancer screening program managers.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Healthcare System Leadership, Providers, and Staff | Facilitators and Barriers to Implementing Decision Aids, Provider Notifications, and Personal Risk Calculation Using an Electronic Health Record (EHR) to Promote Colorectal Cancer Screening. | Themes: Barriers identified | 8 Themes |
| Healthcare System Leadership, Providers, and Staff | Facilitators and Barriers to Implementing Decision Aids, Provider Notifications, and Personal Risk Calculation Using an Electronic Health Record (EHR) to Promote Colorectal Cancer Screening. | Themes: Facilitators identified | 6 Themes |
Primary
Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic.
Semi-structured interviews with primary care patients who were due for either breast, cervical, colorectal, or lung cancer screening between April-July 2020 at the study teams affiliate health systems. The interview guide contained questions to explore the patients' understanding, attitudes, and beliefs about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting preventive and other (non-screening) healthcare, and information needed for decision making.
Time frame: 6 months
Population: We interviewed 32 patients who completed screening in 2020 and 29 patients who did not complete the relevant screening test from April 2020 to the date of the interview.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Healthcare System Leadership, Providers, and Staff | Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic. | Cancer Screening | 3 Themes |
| Healthcare System Leadership, Providers, and Staff | Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic. | Other Healthcare Services (non-screening) | 4 Themes |
| Healthcare System Leadership, Providers, and Staff | Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic. | Health Information | 3 Themes |
| Screened Patients | Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic. | Cancer Screening | 3 Themes |
| Screened Patients | Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic. | Other Healthcare Services (non-screening) | 4 Themes |
| Screened Patients | Number of Themes Identified by Patients That Influenced Decisions to Engage in Cancer Screening and Other Healthcare Services, and What Information Was Needed for Making Healthcare Decisions During the COVID-19 Pandemic. | Health Information | 3 Themes |