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Information about ongoing health services research and public health projects
|Measuring the impact of providing personalized risk information to patients and their providers|
|Investigator (PI):||Schwartz, Peter H|
|Performing Organization (PO):||
(Current): Indiana University, School of Medicine, Department of Medicine, Division of General Internal Medicine and Geriatrics / (317) 274-8438
|Supporting Agency (SA):||Patient-Centered Outcomes Research Institute (PCORI)|
|Record Source/Award ID:||PCORI/ CDR-2018C3-14715|
|Funding:||Total Award Amount: $3,015,693|
|Award Information:||PCORI: More information and project results (when completed)|
|Abstract:||Does Personalized Risk Information Help Patients and Doctors Make Informed Decisions about Colorectal Cancer Screening? 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 Element 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.|
The rate of screening for colorectal cancer 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. An individual's chance of having an advanced colorectal neoplasm (ACN), a cancer or precancerous polyp, has direct implications for selecting a test. Colonoscopy is more effective for individuals with a higher chance of having an ACN, due to the increased chance that colonoscopy will find and/or remove one. For patients with low risk of having an ACN, non-invasive tests such as FIT are more attractive. Our research team has developed a decision aid and provider message that discloses the patient's current risk of ACN, based on a newly developed and validated prediction rule, and explains links to selecting a screening test. In pilot testing, personalized messages including ACN risk increased patients' intent to be screened and influenced their test choice. Out of 57 patients who saw an estimate of their risk of current ACN, all 57 (100%) agreed or strongly agreed that "the information is important to me" and 55 (95%) agreed or strongly agreed that "I would recommend this information to other people." Providers also support using this information in making screening decisions. Working with our partner health care systems, we have piloted a system that can deliver decision aids to patients effectively and affordably, through the patient portal of an electronic health record. The main objective of this application is to test whether providing patients and their providers with personalized messages about ACN risk results in higher screening uptake and higher decision quality, compared to an approach that does not utilize ACN risk. All participants in the study will be due for colorectal cancer screening and will have average risk, and all will view a decision aid that provides information about colorectal cancer screening. Half will also see information about their ACN risk. Half of these patients' providers will receive a notification about their patient's ACN risk. Our study will identify the impact on how many patients get screened within six months, and whether they make an informed choice. We will collect information to guide implementation of the system that uses the electronic health record to deliver decision aids to patients and notifications to providers. Leadership, providers, and staff at our partner health care systems will work with our team to design and implement the study. Patient-consultants have worked with our team on developing this study and will be integrally involved in carrying it out. Local, regional, and national partners from organizations that work on cancer and screening have been involved in designing the study and will be involved in carrying it out and disseminating and implementing the results.
|Record History:||('2021: Abstract archived and replaced.',)|