Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer Screening
• Intervention / Treatment: Other: Semi-structured interviews-Health system; Other: Semi-structured interviews-Patients

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 462020
      • Recruiting
      • Indiana University
      • Contact: Karen K Schmidt, MSN; Phone Number: 317-278-4049; Email: schmidtk@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The participants will be health system primary care patients, and health system leadership, providers, or staff involved in primary care.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify facilitators and barriers to implementing decision aids, provider notifications, and personal risk calculation using an electronic health record to promote colorectal cancer screening.	Semi-structured interviews with health system leadership, providers and staff conducted every 3-4 months	2 years
Identify the 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	9 months
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	Semi-structured interviews with primary care patients	1 day

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Patient-Centered Outcomes Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: December 20, 2020
• First Submitted That Met QC Criteria: December 20, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 3, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: COVID-19; decision making; decision aid; electronic health records; colorectal neoplasm; risk communication
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2012926551; CDR-2018C3-14715 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No