PCORI funds implementation projects to increase awareness and promote the use of PCORI-funded research findings to improve health care practices and health outcomes. This project is proposing to conduct implementation activities for the results of the research project: Using Numbers in a Decision Aid to Describe Risks and Benefits of Colorectal Cancer Screening Options

1. What were the results of the original PCORI-funded study?

In the original study, 688 people who were due for colorectal cancer (CRC) screening and had an upcoming appointment with a primary care provider viewed one of two short presentations on a computer (“decision aids”) that provide information about colorectal CRC and the most popular screening tests. CRC is the third most common cause of cancer mortality in the United States, with over 52,000 deaths expected in 2022. Screening is recommended for all people ages 45 to 75, but under 70 percent of eligible people in the United States are up to date with screening.

This means that many people get CRC or die from it unnecessarily, even though there are multiple approved tests, allowing patients to choose a test that is right for them. The two most widely utilized tests are colonoscopy and stool tests, both covered by health insurance. Colonoscopy is done every 10 years and is the best at finding polyps and cancer but is an invasive procedure that requires cleaning out the colon the day before and carries risks of its own. The main alternative is doing a stool testing with the Fecal Immunochemical Test (FIT) or FIT/DNA (Cologuard^®), which are non-invasive and performed at home. But these tests require handling stool, must be repeated every one to three years and can miss polyps and cancer, and any positive tests require a follow-up colonoscopy. Everybody between the ages of 45 to 75 should be screened, but each person can choose which test they prefer.

The patients in the study were randomized to view one of two decision aids. Both provided information about CRC and screening with colonoscopy and stool tests. Both also provided information about the risk of developing or dying of CRC, the protection that screening provides and the chance of negative outcomes from screening. One of the decision aids presented this information using numbers and figures (the Quantitative decision aid) while the other did so using words, such as “rare” or “common” (the Verbal decision aid). Participants answered a questionnaire before and after viewing the presentation (T0 and T1), and again six months later (T2). The primary outcome was whether participants got screened within six months. The study team also measured patients’ intent to be screened, their knowledge and how they felt about making a decision (their “decision conflict”).

Both decision aids were successful at increasing patients’ knowledge and how they felt about making a decision. Participants also said that they really liked viewing the decision aids and felt that they helped them make a good decision. The Quantitative decision aid did slightly better on some measures. About 29 percent of all patients who viewed the decision aids received CRC screening within six months.

The two health systems where the research took place now wish to make this decision aid available to all their patients who are due for screening. In the original study, patients viewed the decision aid on a laptop in their clinic. In other research, the study team has now come up with an easier method: patients view the decision aid by clicking on a link that is sent to them by email or through the patient portal of the electronic health record. In a later study funded by PCORI, the study team successfully used this method to send decision aids to over 900 patients due for CRC screening.

2. Why is this research finding(s) important?

This research finding shows that patients can be helped to learn about CRC screening and feel more confident about making a decision. This can help them make a shared decision with their provider about getting screened.

3. What is the goal of this project?

The primary objective of the implementation project is to improve shared decision making and increase uptake of CRC screening by facilitating the implementation of a decision aid for over 75,000 patients due for screening in two health care systems spanning Indiana. The study team will work with their two partner health care systems to help them achieve this goal. IU Health is the largest health care provider in Indiana, with more than 60 adult primary care centers throughout Indiana, including urban, suburban and rural areas. Eskenazi Health includes a safety-net hospital and 12 Federally Qualified Health Centers throughout Marian County, Indiana, serving many low- and middle-income residents and a significant representation of minoritized ethnic and racial groups.

4. What is the project team doing?

The project team will update the decision aid to reflect recent changes such as the lower starting age for screening (now 45 years old rather than 50) and create a Spanish-language version. The project team will work with both health care systems to help determine how to identify patients to receive the decision aid, and to whom to provide it first. The project team will work with leadership, staff and providers to plan the rollout throughout each system. The project team will help train clinic staff and providers on how to utilize the decision aid to support shared decision making about screening. During the “Active Implementation” phase in each clinic, team members will work with staff and providers to identify problems and solve them.

5. How is the team evaluating this project?

The study team will ask patients how they felt about their decision-making process with their provider using a well-known tool called the CollaboRATE scale. The study team expects that this score will increase significantly after the start of distribution of the decision aid to patients. The study team will also track how many links for the decision aid are sent to patients and how many links patients actually open and view. Finally, the study team will track how many patients get screened, both before and after the health systems start sending out the decision aid.

6. How is the team involving patients and others in this project?

Patients serving on an advisory board were integrally involved in creating this decision aid in the project team’s previous study and have been involved in their other studies involving decision aids. For the proposed project, five patient partners from the project team’s two partner health care systems will be members of the study team, attending all meetings and participating in all activities. The study team is also fortunate to have leaders in CRC screening, prevention, decision aids and shared decision making from across the country serving on their National Engagement and Dissemination Team. They will help plan and implement the project and then will help describe to others what happened in order to help other health care systems do similar things.

7. How will this project help ensure future uptake and use of PCORI-funded results?

PCORI has funded many studies of decision aids, with the goal of improving the understanding and ability of patients to participate in shared decision making with their providers. While many studies have confirmed the ability of decision aids to do this, decision aids are not part of normal medical care. One important barrier is the difficulty of getting decision aids to patients effectively in ways that do not require extra time or stress for providers or their staff and do not require additional expense. The method of providing a decision aid by sending the patient an electronic link through email, text or the patient portal of their electronic medical record is effective, easy and inexpensive. Still, it will take concerted effort for three years to fully implement the decision aid. Once that is done and the success can be shown and the barriers and ways of overcoming those barriers can be studied, other health care systems across the country can potentially copy this approach to make decision aids part of normal medical care. The decision aids that PCORI has funded and the information that PCORI has discovered which could help patients make informed choices can be disseminated widely and can help many patients make better decisions with their health care providers.