Colorectal Cancer Screening
Conditions
Keywords
Shared Decision Making, Patient Reported Outcomes, Continuing Medical Education, early detection of cancer, colonoscopy, colorectal cancer
Brief summary
This project aims to examine the impact of different interventions designed to help individualize colorectal cancer (CRC) screening decisions in adults aged 76-85. Clinicians will be assigned by chance to one of two arms. In the Intervention arm, clinician participants will complete a training course and will also be notified of patients in the target age group who are due for a discussion about CRC screening. In the Comparator arm, clinician participants will be notified of their patients in the target age group with an upcoming visit who are due for a discussion about CRC screening. The investigators expect that patients seen by clinicians in the intervention arm will report more involvement in the decision making process, be more knowledgeable about the risks and benefits of CRC screening, and will have better quality decisions. Further, the investigators expect that the physicians in the intervention arm will have greater confidence in and demonstrate more skills for conducting shared decision making conversations as compared to those in the control arm.
Detailed description
This study will advance understanding of how to engage and inform older adults in decisions about whether to continue or stop colorectal cancer (CRC) screening. The study will randomly assign about 50 primary care clinicians from 5 different sites to one of two different arms. In the Intervention arm, clinician participants will complete a training course and will also be notified of patients aged 76-85 with an upcoming visit who are due for a discussion about CRC screening. In the Comparator arm, clinician participants will be notified of their patients in the target age group with an upcoming visit who are due for a discussion about CRC screening. The study staff will collect surveys from about 500 eligible patients of participating physicians shortly after their visit to determine the impact of the intervention on patient-reported measures including the amount of shared decision making, knowledge, and preferences for cancer screening. Study staff will follow patients to track colorectal cancer screening tests in the 12 months following the visit and will survey some patients again at 12 months to examine any barriers to follow through with their preferred approach. The study will also assess physician's ability to demonstrate shared decision making skills for cancer screening decisions in simulated patient interactions. Caregivers, if identified by a patient participant, will also complete a short survey evaluating the visit.
Interventions
BEHAVIORALNotification
Clinicians will be notified of their patients aged 76-85 with an upcoming, non urgent visit who are due for colorectal cancer screening.
BEHAVIORALTraining
The 2-hour continuing medical education course in shared decision making, simulated patient interaction to practice skills, and monthly calls for a year to review difficult cases with clinical and shared decision making experts.
Sponsors
MaineHealth
Brigham and Women's Hospital
Newton-Wellesley Hospital
North Shore Medical Center
Patient-Centered Outcomes Research Institute
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
Physician participants will not be blinded to the study arm. Patients will not be given any information on their physician's assigned arm. Statistician will be blinded to the assignment when analyzing the results.
Intervention model description
Two-arm, multi-site cluster randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For Clinicians, eligibility will not be decided by sex, gender, or age Inclusion Criteria for clinicians: * Primary Care Physician (MD or NP) * Manages a panel of patients * Has ≥20 potentially eligible patients (age 76-85 and due for colorectal cancer screening) in their panel * Practices at participating site
Exclusion criteria
for clinicians: * Residents, medical students * Does not manage panel of patients (e.g. urgent care clinician) Patients of participating clinicians will be enrolled to evaluate the impact of the interventions. Inclusion Criteria for patients: * Adults, age 76-85 at the time of the scheduled visit * Scheduled for non-urgent office visit with a participating clinician during the study period * Due or overdue for colorectal cancer screening (e.g. never been screened, 1 year or less to follow-up interval indicated on previous test).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shared Decision Making Process (SDMP) Scale Score | About 1 week after the physician visit | The SDMP scale is a short, patient-reported scale that asks patients about discussion of options, pros and cons of colonoscopy and discussion of patients' preferences. Total scores range from 0-4, with higher scores indicating more shared decision making. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' Colorectal Cancer Screening Knowledge Score | 1 week after physician visit | Colorectal Cancer (CRC) Screening Knowledge will be assessed with multiple choice knowledge items adapted from the CRC Decision Quality Instrument. A total score from 0-100% will be calculated based on the number of correct answers, with higher scores indicating higher knowledge. |
| Percentage of Patients Who Received Preferred Approach to Colorectal Cancer Testing | 1 week after physician visit (preference); 12 months after physician visit (testing) | Colorectal Cancer Screening Preference assessed with 1 item adapted from the CRC Decision Quality Instrument will be compared with the screening approach followed (assessed via chart review and patient report) to determine the percentage of patients who received preferred approach to testing. |
| Physician's Shared Decision Making Skills | Baseline | The transcripts from the simulated patient interactions will be scored by two coders using Braddock's Informed Decision Making framework. Total scores range from 0-9 with higher scores indicating more shared decision making elements in the interaction. |
| Colorectal Cancer Screening Rates | 1 year | The chart review results of cancer screening rates for patients enrolled in the study. |
| Clinician Satisfaction With the Visit | 1 week post visit | The percentage of study patient visits where the clinicians' reported that they were 'extremely or very satisfied' will be compared across arms. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Companion SDM Process Scale Score | About a week after physician visit | Companions will complete an adapted version of the SDM Process survey to provide a different perspective on the conversation and involvement of the patient. A total score will range from 0-4, with higher scores indicating more shared decision making. |
| Clinician Attitude Toward Shared Decision Making | Baseline | The investigators will use five items to assess clinicians' confidence in Shared Decision Making Skills and Barriers to SDM. A total confidence score (0-20) with higher scores indicating higher confidence and a barrier score (0-8) higher scores indicating more barriers will be calculated. |
Countries
United States
Participant flow
Recruitment details
From May - August 2019, physicians enrolled onto the study from Internal Medicine and Family Medicine practices affiliated with five hospital networks-three academic medical centers and two community hospitals in the Northeast US. We targeted about 10 patients per physician from October 2019-April 2021. We anticipated enrolling 500 patients. Enrolled patients were able to invite a companion, if applicable
Participants by arm
| Arm | Count |
|---|---|
| Notification Only Arm/Providers Clinician participants will be notified of their patients aged 76-85 with an upcoming visit who are due for colorectal cancer screening.
Notification: Clinicians will be notified of their patients aged 76-85 with an upcoming, non urgent visit who are due for colorectal cancer screening. | 31 |
| Notification Only Arm/Patients Eligible patients who completed a visit with a participating physician in the 'notification only' arm.
Clinician participants will be notified of their patients aged 76-85 with an upcoming visit who are due for colorectal cancer screening.
Notification: Clinicians will be notified of their patients aged 76-85 with an upcoming, non urgent visit who are due for colorectal cancer screening. | 230 |
| Training and Notification Arm/Providers Clinician participants will be notified of their patients aged 76-85 with an upcoming visit who are due for colorectal cancer screening and will complete a two-hour shared decision making communication skills training course that includes case studies, interactive exercises, and lecture content.
Notification: Clinicians will be notified of their patients aged 76-85 with an upcoming, non urgent visit who are due for colorectal cancer screening.
Training: The 2-hour continuing medical education course in shared decision making, simulated patient interaction to practice skills, and monthly calls for a year to review difficult cases with clinical and shared decision making experts. | 28 |
| Training and Notification Only Arm/Patients Eligible patients who completed a visit with a participating physician in the 'training and notification' arm.
Clinician participants will be notified of their patients aged 76-85 with an upcoming visit who are due for colorectal cancer screening and will complete a two-hour shared decision making communication skills training course that includes case studies, interactive exercises, and lecture content.
Notification: Clinicians will be notified of their patients aged 76-85 with an upcoming, non urgent visit who are due for colorectal cancer screening.
Training: The 2-hour continuing medical education course in shared decision making, simulated patient interaction to practice skills, and monthly calls for a year to review difficult cases with clinical and shared decision making experts. | 236 |
| Notification Only Arm / Companions Enrolled patients were able to invite a companion, if applicable | 5 |
| Training and Notification Arm/ Companions Enrolled patients were able to invite a companion, if applicable | 6 |
| Total | 536 |
Baseline characteristics
| Characteristic | Notification Only Arm/Providers | Total | Training and Notification Arm/ Companions | Notification Only Arm / Companions | Training and Notification Only Arm/Patients | Training and Notification Arm/Providers | Notification Only Arm/Patients |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 9 | 79.4 years STANDARD_DEVIATION 2.8 | 77 years STANDARD_DEVIATION 12 | 70 years STANDARD_DEVIATION 11 | 79.5 years STANDARD_DEVIATION 2.8 | 53.1 years STANDARD_DEVIATION 10 | 79.2 years STANDARD_DEVIATION 2.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 6 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 509 Participants | 0 Participants | 0 Participants | 229 Participants | 28 Participants | 222 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 21 Participants | 6 Participants | 5 Participants | 3 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 15 Participants | 0 Participants | 0 Participants | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 10 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 31 Participants | 6 Participants | 5 Participants | 10 Participants | 0 Participants | 10 Participants |
| Race (NIH/OMB) White | 22 Participants | 480 Participants | 0 Participants | 0 Participants | 219 Participants | 24 Participants | 215 Participants |
| Region of Enrollment United States | 31 participants | 536 participants | 6 participants | 5 participants | 236 participants | 28 participants | 230 participants |
| Sex: Female, Male Female | 16 Participants | 286 Participants | 3 Participants | 4 Participants | 138 Participants | 14 Participants | 111 Participants |
| Sex: Female, Male Male | 15 Participants | 250 Participants | 3 Participants | 1 Participants | 98 Participants | 14 Participants | 119 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 230 | 0 / 28 | 0 / 236 | 0 / 6 | 0 / 5 |
| other Total, other adverse events | 0 / 31 | 0 / 230 | 0 / 28 | 0 / 236 | 0 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 31 | 0 / 230 | 0 / 28 | 0 / 236 | 0 / 6 | 0 / 5 |
Outcome results
Primary
Shared Decision Making Process (SDMP) Scale Score
The SDMP scale is a short, patient-reported scale that asks patients about discussion of options, pros and cons of colonoscopy and discussion of patients' preferences. Total scores range from 0-4, with higher scores indicating more shared decision making.
Time frame: About 1 week after the physician visit
Population: This analytic sample includes patients who completed the survey and completed data on all four SDM Process questions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Notification Only Arm/ Patients | Shared Decision Making Process (SDMP) Scale Score | 1.1 Score on a scale | Standard Deviation 1.2 |
| Training and Notification Arm/ Patients | Shared Decision Making Process (SDMP) Scale Score | 1.5 Score on a scale | Standard Deviation 1.2 |
Comparison: The null hypothesis SDMP is equal in the two armsp-value: 0.01195% CI: [0.08, 0.64]Regression, Linear
Secondary
Clinician Satisfaction With the Visit
The percentage of study patient visits where the clinicians' reported that they were 'extremely or very satisfied' will be compared across arms.
Time frame: 1 week post visit
Population: 59 participating physicians completed post-visit surveys for 376 participating patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Notification Only Arm/ Patients | Clinician Satisfaction With the Visit | 138 Participants |
| Training and Notification Arm/ Patients | Clinician Satisfaction With the Visit | 171 Participants |
p-value: 0.64Chi-squared
Secondary
Colorectal Cancer Screening Rates
The chart review results of cancer screening rates for patients enrolled in the study.
Time frame: 1 year
Population: 466 enrolled patients whose chart was reviewed for completion of cancer screening
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Notification Only Arm/ Patients | Colorectal Cancer Screening Rates | 29.1 percentage of participants |
| Training and Notification Arm/ Patients | Colorectal Cancer Screening Rates | 38.6 percentage of participants |
Comparison: Null hypothesis was equal screening rate in both armsp-value: 0.03295% CI: [0.9, 18]Chi-squared
Secondary
Patients' Colorectal Cancer Screening Knowledge Score
Colorectal Cancer (CRC) Screening Knowledge will be assessed with multiple choice knowledge items adapted from the CRC Decision Quality Instrument. A total score from 0-100% will be calculated based on the number of correct answers, with higher scores indicating higher knowledge.
Time frame: 1 week after physician visit
Population: The data is of patients who answered at least 4 of the 7 questions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Notification Only Arm/ Patients | Patients' Colorectal Cancer Screening Knowledge Score | 61 score on a scale | Standard Deviation 18.8 |
| Training and Notification Arm/ Patients | Patients' Colorectal Cancer Screening Knowledge Score | 63 score on a scale | Standard Deviation 17.7 |
Comparison: The null hypothesis is that the two arms have the same knowledge scorep-value: 0.3695% CI: [-2.01, 5.55]Regression, Linear
Secondary
Percentage of Patients Who Received Preferred Approach to Colorectal Cancer Testing
Colorectal Cancer Screening Preference assessed with 1 item adapted from the CRC Decision Quality Instrument will be compared with the screening approach followed (assessed via chart review and patient report) to determine the percentage of patients who received preferred approach to testing.
Time frame: 1 week after physician visit (preference); 12 months after physician visit (testing)
Population: 450 patients who indicated a clear preference on the post visit survey were analyzed. The population excludes 4 who indicated 'other' and 12 who did not answer the question.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Notification Only Arm/ Patients | Percentage of Patients Who Received Preferred Approach to Colorectal Cancer Testing | 103 Participants |
| Training and Notification Arm/ Patients | Percentage of Patients Who Received Preferred Approach to Colorectal Cancer Testing | 115 Participants |
Comparison: We will compare the percentages of patients who received their preferred screening in the 12 months after the visit across the two groups using logistic regression model with the GEE approach to adjust for clustering of patients within clinicians.p-value: 0.47Regression, Logistic
Secondary
Physician's Shared Decision Making Skills
The transcripts from the simulated patient interactions will be scored by two coders using Braddock's Informed Decision Making framework. Total scores range from 0-9 with higher scores indicating more shared decision making elements in the interaction.
Time frame: Baseline
Population: Physicians who completed a recorded simulated patient interaction with a standardized patient.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Notification Only Arm/ Patients | Physician's Shared Decision Making Skills | 5.5 Score on a scale | Standard Deviation 1.3 |
| Training and Notification Arm/ Patients | Physician's Shared Decision Making Skills | 6.1 Score on a scale | Standard Deviation 1.6 |
p-value: 0.19t-test, 2 sided
Other Pre-specified
Clinician Attitude Toward Shared Decision Making
The investigators will use five items to assess clinicians' confidence in Shared Decision Making Skills and Barriers to SDM. A total confidence score (0-20) with higher scores indicating higher confidence and a barrier score (0-8) higher scores indicating more barriers will be calculated.
Time frame: Baseline
Population: Comparator physicians' reported confidence of shared decision making and barriers to shared decision making on a baseline survey is compared to Intervention physicians' reported confidence of shared decision making and barriers to shared decision making after completion of the training webinar.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Notification Only Arm/ Patients | Clinician Attitude Toward Shared Decision Making | Total Confidence | 10.2 Score on a scale | Standard Deviation 2.4 |
| Notification Only Arm/ Patients | Clinician Attitude Toward Shared Decision Making | Barrier Confidence | 0.79 Score on a scale | Standard Deviation 1.4 |
| Training and Notification Arm/ Patients | Clinician Attitude Toward Shared Decision Making | Total Confidence | 10.7 Score on a scale | Standard Deviation 1.8 |
| Training and Notification Arm/ Patients | Clinician Attitude Toward Shared Decision Making | Barrier Confidence | 0.88 Score on a scale | Standard Deviation 1.57 |
Other Pre-specified
Companion SDM Process Scale Score
Companions will complete an adapted version of the SDM Process survey to provide a different perspective on the conversation and involvement of the patient. A total score will range from 0-4, with higher scores indicating more shared decision making.
Time frame: About a week after physician visit
Population: Very few patients indicated that they had a companion (spouse, friend, family member) with them at the visit. If a name was provided, companions were contacted and ask to complete a post-visit survey. 11 companions were identified, but only 10 completed the SDM Process questions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Notification Only Arm/ Patients | Companion SDM Process Scale Score | 2.1 Score on a scale of 0-4 | Standard Deviation 1.3 |
| Training and Notification Arm/ Patients | Companion SDM Process Scale Score | 1.9 Score on a scale of 0-4 | Standard Deviation 1.2 |