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. In the meantime, results have been published in peer-reviewed journals, as listed below.
What is the research about?
Clinical guidelines recommend that adults ages 50 to 75 receive screening for colorectal cancer, or CRC. For older adults, ages 76–85, guidelines recommend that clinicians, such as doctors and nurse practitioners, and patients work together to make decisions about CRC screening, because for some older adults, the harms of screening may outweigh its benefits.
Including shared decision making, or SDM, conversations in an office visit may help ensure that older adults are knowledgeable and involved in CRC screening decisions. SDM is a process where patients and clinicians make decisions together based on the patient’s individual needs. One way to support clinicians and patients to have SDM conversations is to send clinicians an alert when a patient may need screening. But an alert may not be enough by itself. Clinicians may also need training in SDM.
In this study, the research team is comparing two ways to help clinicians and patients ages 76–85 discuss CRC screening decisions. Both ways use a system that alerts clinicians that patients are eligible for a discussion about CRC screening. One way also trains clinicians in SDM.
Who can this research help?
Clinics and clinicians can use results from this study when looking for ways to improve CRC screening decision making with older patients.
What is the research team doing?
The research team is recruiting 50 clinicians to take part in the study and 500 patients receiving care from these clinicians. Patients are ages 76–85, have an upcoming office visit, and either have never had CRC screening or need a follow-up screening.
The research team is assigning clinicians by chance to one of two groups. In both groups, an alert notifies clinicians when one of their patients ages 76–85 with an upcoming visit is due for CRC screening. The alert also shows clinicians any past CRC screening results for that patient.
In one of the groups, clinicians also complete a two-hour online SDM training. The training includes lessons, case studies, and interactive exercises on SDM. For example, the training teaches clinicians how to communicate information about cancer risk and talk to patients about their goals and concerns.
The research team is using surveys of patients, clinicians, and caregivers, and reviewing patients’ medical records for both groups to compare
- Patient and caregiver perceptions of how much the clinician used SDM during the visit
- Patients’ CRC screening knowledge
- Patients’ screening preferences
- Whether patients received their preferred screening approach
- Clinicians’ attitudes toward SDM
- How satisfied clinicians were with the visit
- CRC screening rates
The research team is also assessing clinicians’ SDM skills. Clinicians in both groups are role playing a CRC screening visit by talking to a patient actor on the phone; the team is reviewing transcripts from these calls.
Patients and clinicians with expertise in primary care, geriatrics, and CRC screening and treatment are providing input at each stage of the study.
Research methods at a glance
| Design Elements | Description |
|---|---|
| Design | Randomized controlled trial |
| Population |
|
| Interventions/ Comparators |
|
| Outcomes |
Primary: patient perception of extent of SDM Secondary: patient CRC screening knowledge, receipt of preferred CRC screening approach, clinician SDM skills, CRC screening rates, clinician satisfaction with visit, caregiver perception of extent of SDM, clinician attitude toward SDM |
| Timeframe | 1-week follow-up for primary outcome |
COVID-19-Related Study
Testing a Shared Decision Making Program for Patients with a Canceled or Delayed Screening Colonoscopy during the COVID-19 Pandemic -- The PRIMED Study
Results Summary
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
What was this COVID-19 study about?
During the COVID-19 pandemic, clinics canceled or postponed services that were not urgent, like colonoscopies to screen for colorectal cancer, or CRC. A colonoscopy is a test where a doctor inserts a long, flexible tube with a camera into the colon to check for signs of CRC. When clinics resumed all services, some patients did not immediately reschedule their screening.
In this study, the research team compared two ways to help engage patients in CRC screening and increase CRC screening rates:
- A shared decision making, or SDM, program. Patients received a worksheet by mail. The worksheet described the benefits and risks of screening for CRC with colonoscopy or stool-based testing or delaying screening for one year. In stool-based testing, patients collect samples of their stool at home and mail them to a lab. The lab tests for blood in the stool, which can be an early sign of CRC. A trained decision coach called the patients once to review the worksheet with them. The coach could answer questions and help patients schedule screening and follow-up appointments.
- Usual care. A clinic staff member contacted patients by email, text message, phone call, or online portal to reschedule their screening. Patients could also call to reschedule.
What were the results?
Compared with patients who received usual care, patients in the SDM program:
- Had higher rates of CRC screening
- Completed screenings earlier
- Reported more shared decision making, where patients and healthcare staff work together to make decisions
- Felt more confident about their screening choice
Patients in the SDM program and patients who received usual care didn’t differ in their preference for the type of screening.
Who was in the study?
This study included 800 English- and Spanish-speaking adults ages 45–75 whose colonoscopy was canceled between March 2020 and May 2020. All received care at Massachusetts General Hospital in Boston. Of these, 74 percent were White, 5 percent were Black, 12 percent were Hispanic, 4 percent were Asian, 2 percent were more than one race or ethnicity, and 4 percent were unknown race or ethnicity. The average age was 60, and 53 percent were women.
What did the research team do?
The research team assigned patients by chance to SDM or usual care. The team chose 250 patients in each group by chance to complete a survey. The survey asked patients about shared decision making and how they felt about their screening decision. After six months, the team looked at patients’ health records to see which group had more patients who completed CRC screening.
Clinicians, advocacy organizations, and patients helped plan the study.
What were the limits of the study?
Patients in this study had already decided to receive a screening colonoscopy. Results may differ with patients who haven’t already made that decision. This study took place at a single hospital. Results may differ in other places.
How can people use the results?
Clinics can use these results when considering ways to help patients complete CRC screening.
Professional Abstract
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
Background
Thousands of colonoscopies were canceled or postponed during the onset of the COVID-19 pandemic. Some patients were hesitant to reschedule their colorectal cancer (CRC) screening.
Objective
To compare the effectiveness of a decision aid plus coaching using a shared decision making (SDM) approach versus usual care for increasing CRC screening rates
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 800 English- and Spanish-speaking patients ages 45–75 whose scheduled colonoscopy at Massachusetts General Hospital in Boston, Massachusetts, was canceled or postponed between March 2020 and May 2020 |
| Outcomes |
CRC screening uptake; SDM process; how much personal uncertainty or conflict patients felt about their screening decision, known as decisional conflict; screening preference |
| Data Collection Timeframe | September 2020–April 2021 |
This randomized controlled trial compared the effectiveness of an SDM approach versus usual care for patients with a canceled or delayed screening colonoscopy during the COVID-19 pandemic.
Researchers randomized patients to one of two groups:
- SDM. Patients received a worksheet by mail, which described the benefits and risks of screening for CRC with colonoscopy or stool-based testing or delaying screening for one year. A trained decision coach called the patient once to review the worksheet, answer questions, and help schedule screening and follow-up appointments.
- Usual care. Patients could call to reschedule their canceled screening, or a clinic staff member contacted patients to reschedule.
The study included 800 adults who had a canceled or delayed colonoscopy between March 2020 and May 2020, at the onset of the COVID-19 pandemic. Of these patients, 74% were White, 5% were Black, 12% were Hispanic, 4% were Asian, 2% reported more than one race, and 4% did not report a race or ethnicity. The average age was 60, and 53% were female.
In each group, researchers randomly surveyed 250 patients about shared decision making, decisional conflict, and their intentions to follow through with screening. Six months later, researchers looked at health records to determine who had completed CRC screening.
Clinicians, advocacy organizations, and patients gave input on the study design.
Results
Compared with patients in the usual care group, patients in the SDM group had higher CRC screening uptake (35% versus 23% at 6 months; p<0.001) and completed screenings earlier (median 46 days versus 55 days at 6 months; p<0.001).
Of those surveyed, patients in the SDM group reported more shared decision making than those in the usual care group (mean difference = 0.7 points; 95% confidence interval [CI]: 0.4, 0.9]; p<0.001). The proportion of adults who indicated that they had no decisional conflict was higher in the SDM group than in the usual care group (69% versus 48%; p=0.003). The usual care and SDM groups did not differ significantly in preference for type of screening.
Limitations
This study took place at a single treatment center and included only patients who already had decided to receive CRC screening. Results may not generalize to all patients eligible for CRC screening or to patients in other locations.
Conclusions and Relevance
Among patients whose screening colonoscopy was canceled or delayed due to the COVID-19 pandemic, those who received an SDM intervention were more likely to complete screening and reported more shared decision making than patients who received usual care.
Peer Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers asked whether all patients received the same shared decision making worksheet regarding scheduling a colonoscopy or stool test, or whether the worksheet was tailored so that patients who were at higher risk for colon cancer were given different pros and cons about taking a stool test rather than a colonoscopy. The researchers said that all patients received the same worksheet regardless of their risk for colon cancer and that the worksheet described pros and cons for both colonoscopy and stool testing. The researchers did indicate that the worksheet indicated that colonoscopy would be a better test for patients with a history of polyps or a family history of colon cancer.
- The reviewers noted that the second survey, sent after vaccines were available, seemed to have a different objective than originally planned. The population for the second survey was different from the population for the first survey and therefore could not be used to assess change in attitudes compared to the first survey. The researchers agreed that the use of the second survey was unclear. In fact, a change in the study protocol led to this second survey and it was not part of the original analyses. They moved the methods and results for this second survey to the appendix of the report to reduce confusion.
- The reviewers asked the researchers to provide documentation for all of the scales used in the study so the reader could understand what the scores mean on the scales. The researchers explained that the main outcome scale was designed for the study and that they provided references for the documentation for each of the other scales. They chose not to add the documentation directly to the report to avoid extending the report length.
Final Enhancement Report
This COVID-19 study's final enhancement report is expected to be available by August 2023.
Journal Citations
Article Highlight: For older adults, guidelines recommend clinicians and patients work together to make decisions about colorectal cancer screening (CRC). However, these conversations must consider several factors and can be challenging. This study compared two ways to help clinicians and older patients make colorectal cancer screening decisions. The objective of the study was to promote shared decision making for CRC testing decisions among older patients. In results appearing in an August 2022 issue of the Journal of General Internal Medicine, the research team found that physician training plus electronic reminders when patients are eligible for a discussion about screening increased shared decision making and frequency of colorectal cancer testing discussions in an age group where shared decision making is essential.