Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Thousands of people in the United States die every year from colorectal cancer, or CRC, a condition that can be treated if found early through screening. One common screening method is colonoscopy, which uses a probe with a camera to view the colon from the inside. Another is stool testing, which looks for blood or changes in cells in a patient’s stool. Each test has different benefits and harms. For example, colonoscopy is an invasive test but it’s good at finding cancer and polyps that may turn into cancer. Stool tests are less invasive but not as good at finding polyps or cancer.

When patients know their risk of having cancer or a polyp that may turn into cancer, it can help them work with their providers to choose the screening test that’s right for them. For example, patients at high risk may prefer colonoscopy, which can remove polyps when they are found. Patients at low risk may prefer stool testing. Risk for cancer or polyps is based on factors such as the patient’s age and family history.

In this study, the research team is comparing ways of communicating with patients and clinicians about the patient’s risk of having cancer or a polyp that may turn into cancer. Each way uses a decision aid to present the patient’s risk. Decision aids help people choose between two or more options based on what is most important to them.

The research team wants to know how these approaches affect how patients make choices about CRC screening.

Who can this research help?

Results may help clinics considering ways to help doctors and patients make CRC screening decisions.

What is the research team doing?

The research team is recruiting 1,100 patients who are due for CRC screening. The team is dividing the patients into four groups at different clinics. They are assigning the groups by chance to receive information about CRC screening in one of four ways:

  • Patients view an online decision aid with general information about CRC and the benefits and harms of colonoscopy and stool tests.
  • Patients view the online decision aid plus a personalized message with an estimate of their risk for CRC.  
  • Patients view the online decision aid without the personalized message. Their provider receives an electronic health record, or EHR, message with an estimate of the patient’s risk.
  • Patients view the online decision aid with the personalized message. Their provider receives an EHR message with an estimate of the patient’s risk.

After six months, the research team is checking patients’ EHRs to see if they received CRC screening, what type of screening they received, and whether they received their screening of choice. The team is also talking to patients to see if they made an informed choice about screening, how patients perceive their CRC risk, and if they felt conflicted about their choice. Healthcare system leaders, providers, and patients are helping to design and carry out this study.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population 1,100 individuals ages 50–75 from primary care clinics in central Indiana who are due for screening and have no high-risk family or personal history
Interventions/
Comparators
  • Online patient decision aid with personalized risk estimate
  • Online patient decision aid without personalized risk estimate
  • Online patient decision aid with personalized risk estimate plus EHR message for provider
  • Online patient decision aid without personalized risk estimate plus EHR message for provider
Outcomes

Primary: screening uptake, decision quality

Secondary: perceived CRC risk, decision conflict

Timeframe 6-month follow-up for primary outcomes

Project Information

Peter H. Schwartz, MD, PhD, MA
Trustees of Indiana University
$3,015,693
Measuring the Impact of Providing Personalized Risk Information to Patients and their Providers

Key Dates

August 2019
November 2024
2019

Study Registration Information

Tags

Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022