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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

Tracking Information
First Submitted Date December 20, 2020
First Posted Date December 24, 2020
Last Update Posted Date April 8, 2021
Actual Study Start Date January 11, 2021
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2020)
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation
Official Title Facilitators and Barriers to Cancer Screening: Stakeholder Perspectives on Implementation
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Colorectal Cancer Screening
Intervention
  • 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.
  • 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.
Study Groups/Cohorts
  • Healthcare system leadership, providers, and staff
    Leadership, providers, and staff at the study team's affiliated health systems.
    Intervention: Other: Semi-structured interviews-Health system
  • 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.
    Intervention: Other: Semi-structured interviews-Patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 20, 2020)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04683744
Other Study ID Numbers 2012926551
CDR-2018C3-14715 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Peter Schwartz, Indiana University
Study Sponsor Indiana University
Collaborators Patient-Centered Outcomes Research Institute
Investigators Not Provided
PRS Account Indiana University
Verification Date April 2021