Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation

Sponsor

Indiana University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04683744

Collaborator

Patient-Centered Outcomes Research Institute (Other)

100

Enrollment

Location

29.6

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Screening	Other: Semi-structured interviews-Patients Other: Semi-structured interviews-Health system

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation

Actual Study Start Date :

Jan 11, 2021

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Healthcare system leadership, providers, and staff Leadership, providers, and staff at the study team's affiliated health systems.	Other: Semi-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.
Patients receiving primary care at the study team's affiliated health systems Patients who had a least one primary care visit during the past 24 months at the study team's affiliated health care systems.	Other: Semi-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.

Arm

Intervention/Treatment

Healthcare system leadership, providers, and staff

Leadership, providers, and staff at the study team's affiliated health systems.

Other: Semi-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.

Patients receiving primary care at the study team's affiliated health systems

Patients who had a least one primary care visit during the past 24 months at the study team's affiliated health care systems.

Other: Semi-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.

Outcome Measures

Primary Outcome Measures

Identify facilitators and barriers to implementing decision aids, provider notifications, and personal risk calculation using an electronic health record to promote colorectal cancer screening. [2 years]
Semi-structured interviews with health system leadership, providers and staff conducted every 3-4 months
Identify the 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
Identify patient knowledge, attitudes, and beliefs that influence decisions to engage in cancer screening and prevention during the COVID-19 pandemic, and barriers to uptake [1 day]
Semi-structured interviews with primary care patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.