Results Summary
What was the research about?
For older adults ages 76–85, clinical guidelines note that the benefits of screening for colorectal cancer, or CRC, may not outweigh the harms. For this reason, the guidelines recommend that clinicians, such as doctors and nurse practitioners, work together with patients to make the screening decisions that work best for each patient. Shared decision making, or SDM, is a process in which patients and clinicians work together to make healthcare decisions.
In this study, the research team compared two approaches to improve SDM about CRC screening for older adults:
- Electronic alert alone. Clinicians received an email or alert in a patient's electronic health record two or three days before meeting with the patient. The alert encouraged clinicians to talk with their patients about CRC screening.
- Clinician training plus electronic alert. Along with an email or alert, clinicians took a two-hour online training. The training had examples of SDM and helped clinicians talk with their patients about CRC screening.
What were the results?
Compared with patients in the electronic alerts alone group, patients in the clinician training and electronic alerts group:
- Reported more SDM about CRC screening
- Were more likely to discuss CRC screening with their clinician
- Had more intention to follow through with their preferred type of CRC screening
- Received more CRC screenings after one year
The two groups didn’t differ in:
- How much patients knew about CRC screening
- How satisfied patients were with their visit
- How many patients received their preferred type of CRC screening
- How confident clinicians were in their ability to do SDM
- How often clinicians used SDM in practice sessions during training activities
Who was in the study?
The study included 466 patients ages 76–85 who were due or overdue for CRC screening. All received care from one of 67 primary care clinicians at 35 clinics in Massachusetts and Maine. Among patients, 93 percent were White, and 7 percent were non-White or Hispanic. The average age was 79, and 53 percent were women.
What did the research team do?
The research team assigned clinicians by chance to one of the two approaches.
Clinicians filled out an online survey about SDM at the start of the study and again after patient visits. Soon after their visit, patients filled out a survey about the level of SDM. The research team looked at health records to find the number of CRC screenings.
Patients, advocacy groups, and clinicians helped design the study.
What were the limits of the study?
Patient visits happened during the COVID-19 pandemic, which caused disruptions to care. Also, most patients in the study were White. Results may have differed if more patients from other racial backgrounds were part of the study.
Future research could look at ways to improve SDM with clinicians who provide care for patients from other racial backgrounds.
How can people use the results?
Health systems can use the results when considering ways to help older patients and their clinicians make decisions about CRC screening.
Professional Abstract
Objective
To compare the effect of clinician training to promote shared decision making (SDM) plus electronic reminders, versus electronic reminders alone, on patient-reported level of SDM with their clinician
Study Design
| Design Elements | Description |
|---|---|
| Design | Cluster randomized controlled trial |
| Population | 67 primary care clinicians with at least 20 patients ages 75–85 due for CRC screening; 466 patients ages 76–85 due or overdue for CRC screening |
| Interventions/ Comparators |
|
| Outcomes | Primary: patient-reported level of SDM about CRC screening during office visit with clinician Secondary: CRC screening discussion during visit with clinician, patients’ screening intention, number of patients screened for CRC, patient knowledge about CRC screening, patient satisfaction with clinician visit, patient receipt of preferred approach to CRC screening, clinician confidence in delivering SDM with patients, clinician demonstration of SDM in simulated interactions with patient actors |
| Timeframe | Immediate follow-up for primary outcome |
In this cluster randomized controlled trial, the research team randomly assigned clinicians to one of two groups:
- Electronic reminders alone. Clinicians received an email or electronic health record (EHR) notification two or three days before meeting with a patient. The alert encouraged clinicians to discuss with their patient whether to continue CRC screening.
- SDM skills training plus electronic reminders. Along with electronic reminders, clinicians received a two-hour, online SDM communication skills training course with case studies and interactive exercises that simulated conversations with patients about colorectal cancer (CRC) screening.
The study included 466 patients who were due or overdue for CRC screening and 67 primary care clinicians from 35 clinics within five hospital systems in Massachusetts and Maine. Among patients, 93% were White and 7% were non-White or Hispanic. The average age was 79, and 53% were female.
Clinicians completed an online survey at baseline about their attitudes toward SDM and their confidence in delivering SDM; they completed another survey after visits with patients. Patients completed a mail-in survey on their reported level of SDM about CRC screening shortly after their main visit with their clinician. Researchers collected data from EHRs on the number of patients screened for CRC and on patients’ discussions with their clinicians about CRC screenings.
Patients, advocacy organizations, and clinicians helped design the study.
Results
Compared with the patients whose clinicians received electronic reminders alone, patients whose clinicians received SDM skills training plus electronic reminders:
- Had higher patient-reported levels of SDM with their clinician about CRC screening (p=0.01)
- Were more likely to report having discussed CRC screening during a visit with their clinician (odds ratio [OR]=1.7; 95% confidence interval [CI]: 1.07, 2.91; p=0.03)
- Had a higher intention of following through with their preferred CRC screening approach (p=0.01)
- Received more CRC screenings after one year (39% versus 29%; p=0.03)
The two groups did not differ significantly in patients’ knowledge about CRC screening, satisfaction with their clinician office visit, receipt of their preferred approach to CRC screening, or in clinicians’ confidence in delivering SDM or clinicians’ demonstration of SDM in simulated interactions with patient actors.
Limitations
Study visits happened during the COVID-19 pandemic, which caused disruptions to care. Also, most of the patients in the study were White. Results may have differed if more patients from other racial backgrounds had participated in the study.
Conclusions and Relevance
In this study, the group that received SDM skills training plus electronic reminders had higher patient-reported levels of SDM with their clinician about CRC screening, compared with the group that received electronic reminders alone. Health systems can consider using SDM training to enhance the effectiveness of a reminder to have discussions with patients about CRC screening.
Future Research Needs
Future research could examine the effects of the SDM training with clinicians who provide care for patients from other racial backgrounds.
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
View this COVID-19 study's final enhancement report.
DOI - Digital Object Identifier: 10.25302.02.2023.CDR.2017C39270_C19
Final Research Report
View this project's final research report.
Implementation
Related PCORI Dissemination and Implementation Project
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.
Results of This Project
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 felt that the report overstated the effectiveness of their intervention on improving shared decision making (SDM) and asked researchers to be more conservative in their conclusions and suggest that their intervention shows only the promise of an effective approach to increasing SDM. The researchers agreed that the size of the intervention effect on SDM was modest but disagreed that the study results showed only a promise of effectiveness for their intervention, noting that patients in the intervention arm were more likely to hear about options in colorectal cancer screenings and patients felt more like they engaged in SDM with providers.
The reviewers requested more information about involvement of the study stakeholders, particularly during study implementation, analysis and interpretation. The researchers expanded their description of stakeholder engagement, explaining that the workgroups of patient and stakeholder partners were most active in the first year of the study when decisions were needed regarding study implementation. Once the study was underway these groups met less often as the focus changed to adherence to the intervention and study protocols.
The reviewers were unclear regarding blinding procedures in the study. The researchers explained that it was not possible to blind physicians to intervention assignment since they received the SDM training. Patients, however, were not told what interventions were being tested nor whether their physician was in the treatment or comparator arm.
The reviewers asked the researchers to comment on the high non-response rate, with almost 40% of the patients of the participating physicians not providing follow-up information and therefore not contributing to analyses. The researchers explained that they only considered patients study participants if they did provide follow-up information but acknowledged that patients who did respond could be different from patients who did not respond, creating the potential for a biased study sample. They added this concern to their limitations.