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| ID | Type | Description | Link |
|---|---|---|---|
| CDR-2017C3-9270 | Other Grant/Funding Number | Patient Centered Outcomes Research Institute (PCORI) |
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| Name | Class |
|---|---|
| MaineHealth | OTHER |
| Brigham and Women's Hospital | OTHER |
| Newton-Wellesley Hospital | OTHER |
| North Shore Medical Center |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Notification only arm | Active Comparator | Clinician participants will be notified of their patients aged 76-85 with an upcoming visit who are due for colorectal cancer screening. |
|
| Training and Notification arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Notification | Behavioral | Clinicians will be notified of their patients aged 76-85 with an upcoming, non urgent visit who are due for colorectal cancer screening. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | About 1 week after the physician visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week after physician visit |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | About a week after physician visit |
For Clinicians, eligibility will not be decided by sex, gender, or age
Inclusion Criteria for clinicians:
Exclusion Criteria for clinicians:
Patients of participating clinicians will be enrolled to evaluate the impact of the interventions.
Inclusion Criteria for patients:
Exclusion Criteria for patients:
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| Name | Affiliation | Role |
|---|---|---|
| Karen R Sepucha, PhD | Harvard Medical School (HMS and HSDM) | Principal Investigator |
| Leigh Simmons, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maine Medical Center | Portland | Maine | 04102 | United States | ||
| Massachusetts General Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39178001 | Derived | Sepucha KR, Chang Y, Valentine KD, Atlas SJ, Han PKJ, Leavitt LJ, Mancini B, Richter JM, Siegel LC, Fairfield KM, Simmons LH. Shared Decision-Making in Colorectal Cancer Screening for Older Adults: A Secondary Analysis of a Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2429645. doi: 10.1001/jamanetworkopen.2024.29645. | |
| 35931908 |
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To promote research replicability, transparency and future use of the data, de-identified data sets of the patient and clinician survey data will be created and will be available, by request, to outside researchers.
After the main manuscripts have been published, de-identified data sets will also be deposited in an open access service such as, ICPSR (https://www.icpsr.umich.edu/icpsrweb/). Before a dataset is made available for access, ICPSR completes a detailed review of all datasets to assess disclosure risk. If necessary, ICPSR modifies data to reduce disclosure risk or limits access to datasets for which modifying the data would substantially limit their utility or the risk of disclosure remains high. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set.
Three months after the end of the funded grant period, the study materials and de-identified data will be available, by request, from the PI. Once data are placed on an open access service such as ICPSR they will be available indefinitely.
The PI will share a de-identified data set with outside investigators at no cost, according to approved Partners and Massachusetts General Hospital policies for data sharing. Investigators from other sites will be able to request the data and will be required to complete a data use agreement that ensures that all local Institutional Review Board requirements are met before using the data, that they will not attempt to identify any data in the dataset, and that they will not share the data set with anyone outside their project team.
On ICPSR, individuals must register and agree to ICPSR's Responsible Use statement prior to accessing datasets.
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | Training and Notification 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. |
| FG004 | Notification Only Arm/Companion | Enrolled patients were able to invite a companion, if applicable |
| FG005 | Training and Notification Arm/Companion | Enrolled patients were able to invite a companion, if applicable |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The analytic set are the eligible patients who completed a survey. Three patients were removed after determining they did not meet eligibility criteria. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This analytic sample includes patients who completed the survey and completed data on all four SDM Process questions. | Posted | Mean | Standard Deviation | Score on a scale | About 1 week after the physician visit |
|
patients were followed for 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Notification Only/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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karen Sepucha | Massachusetts General Hospital | 617-724-3350 | ksepucha@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 29, 2021 | Jul 27, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 27, 2022 | Jul 27, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| OTHER |
| Patient-Centered Outcomes Research Institute | OTHER |
Two-arm, multi-site cluster randomized controlled trial.
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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.
| Training | Behavioral | 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. |
|
| 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. | 1 week after physician visit (preference); 12 months after physician visit (testing) |
| 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. | Baseline |
| Colorectal Cancer Screening Rates | The chart review results of cancer screening rates for patients enrolled in the study. | 1 year |
| 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. | 1 week post visit |
| 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. |
| Baseline |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| North Shore Medical Center | Danvers | Massachusetts | 01923 | United States |
| Newton-Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
| Sepucha K, Han PKJ, Chang Y, Atlas SJ, Korsen N, Leavitt L, Lee V, Percac-Lima S, Mancini B, Richter J, Scharnetzki E, Siegel LC, Valentine KD, Fairfield KM, Simmons LH. Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED Study): a Physician Cluster Randomized Trial. J Gen Intern Med. 2023 Feb;38(2):406-413. doi: 10.1007/s11606-022-07738-4. Epub 2022 Aug 5. |
| 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Notification Only Arm / Companions | Enrolled patients were able to invite a companion, if applicable |
| BG005 | Training and Notification Arm/ Companions | Enrolled patients were able to invite a companion, if applicable |
| BG006 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | The patients who completed a survey | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | The analytic subset are the eligible patients who completed a survey. 3 patients were late ineligible due to: other major health issue, up to date on screening, returned survey too late. | Count of Participants | Participants |
|
| Race (NIH/OMB) | The analytic subset are the eligible patients who completed a survey. 3 patients were late ineligible due to: other major health issue, up to date on screening, returned survey too late. | Count of Participants | Participants |
|
| Region of Enrollment | The patients and companions who completed a survey. The physicians who enrolled patients. | Number | participants |
|
| OG001 | Training and Notification Arm/ Patients | 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. |
|
|
|
| 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. | The data is of patients who answered at least 4 of the 7 questions. | Posted | Mean | Standard Deviation | score on a scale | 1 week after physician visit |
|
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 1 week after physician visit (preference); 12 months after physician visit (testing) |
|
|
|
|
| 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. | Physicians who completed a recorded simulated patient interaction with a standardized patient. | Posted | Mean | Standard Deviation | Score on a scale | Baseline |
|
|
|
|
| Secondary | Colorectal Cancer Screening Rates | The chart review results of cancer screening rates for patients enrolled in the study. | 466 enrolled patients whose chart was reviewed for completion of cancer screening | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
|
|
| 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. | 59 participating physicians completed post-visit surveys for 376 participating patients. | Posted | Count of Participants | Participants | 1 week post visit |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale of 0-4 | About a week after physician visit |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | 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 | 0 | 230 | 0 | 230 | 0 | 230 |
| EG002 | 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. | 0 | 28 | 0 | 28 | 0 | 28 |
| EG003 | Training and Notification 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. | 0 | 236 | 0 | 236 | 0 | 236 |
| EG004 | Training and Notification Arm/Companions | Enrolled patients were able to invite a companion, if applicable | 0 | 6 | 0 | 6 | 0 | 6 |
| EG005 | Notification Only/Companions | Enrolled patients were able to invite a companion, if applicable | 0 | 5 | 0 | 5 | 0 | 5 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |