Clinical trial NCT06597955: Large-Scale Implementation of a Decision Aid About Colorectal Cancer Screening
Official title: Large-Scale Implementation of a Decision Aid About Colorectal Cancer Screening
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Colorectal Cancer Screening
Keywords: decision aid
implementation
colorectal cancer
shared decision making
electronic health record
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana University Health
name: Eskenazi Health
First posted: 2024-09-19
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants will be healthcare system primary care patients, and health system leadership, clinicians, and staff involved in primary care.

Brief summary: The goal of the project is to improve shared decision making and increase uptake of colorectal cancer (CRC) screening by facilitating the implementation of a decision aid about CRC and screening options in two healthcare systems in Indiana.

Detailed description: This implementation project is putting a shared decision making approach into routine practice to help patients make informed decisions about colorectal cancer(CRC) screening. Regular screening is recommended for adults ages 45 - 75 years old, and there are multiple approved tests for individuals at average risk for colorectal cancer. A video-based decision aid about CRC screening was developed and tested in a previous study by the project team. The study showed that viewing the decision aid had positive effects on measures directly related to shared decision making (knowledge, decision conflict) as well as intent to undergo CRC screening. The project team is working with two healthcare systems to provide patients who are eligible for CRC screening access to the decision aid, training staff and clinicians how to use the decision aid to support shared decision making for CRC screening, working with healthcare system leaders to support the staff and clinicians, and providing support for the ongoing use of the decision aid.

Eligibility criteria: Inclusion Criteria:

* Healthcare system participants will be eligible if they are employed by one of the project team's partner healthcare systems
* Patient participants will be eligible if they are considered due for colorectal cancer screening by the healthcare systems' criteria.

Exclusion Criteria:

Patient participants will be excluded if they:

* are not between ages of 45 - 75 years old
* self-report that they no longer receive primary care at either of the project team's partner healthcare systems
* self-report that they are not due for colorectal cancer screening (had colonoscopy within the past 10 years, sigmoidoscopy in the last 5 years, FIT in the past year, or Cologuard in the past 3 years)
* are unable to speak or read English or Spanish

Primary outcomes:
measure: Shared decision making
timeFrame: 18 months
measure: Implementation of decision aid
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Peter H. Schwartz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Teresa M. Damush, PhD
role: PRINCIPAL_INVESTIGATOR
References: