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Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation

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ClinicalTrials.gov Identifier: NCT04683744
Recruitment Status : Recruiting
First Posted : December 24, 2020
Last Update Posted : April 8, 2021
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Peter Schwartz, Indiana University

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
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.

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Study Type : Observational
Estimated 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 : January 11, 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

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.




Primary Outcome Measures :
  1. Identify facilitators and barriers to implementing decision aids, provider notifications, and personal risk calculation using an electronic health record to promote colorectal cancer screening. [ Time Frame: 2 years ]
    Semi-structured interviews with health system leadership, providers and staff conducted every 3-4 months

  2. Identify the challenges and facilitators of effective cancer screening and prevention in primary care during the COVID-19 pandemic among leadership, providers, and staff. [ Time Frame: 9 months ]
    Semi-structured interviews with health system leadership, providers, and staff

  3. 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 [ Time Frame: 1 day ]
    Semi-structured interviews with primary care patients



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04683744


Locations
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United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 462020
Contact: Karen K Schmidt, MSN    317-278-4049    schmidtk@iu.edu   
Sponsors and Collaborators
Indiana University
Patient-Centered Outcomes Research Institute
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Responsible Party: Peter Schwartz, Principal Investigator, Indiana University
ClinicalTrials.gov Identifier: NCT04683744    
Other Study ID Numbers: 2012926551
CDR-2018C3-14715 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
First Posted: December 24, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Schwartz, Indiana University:
decision aid
decision making
COVID-19
risk communication
colorectal neoplasm
electronic health records
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases