Back to resultsPromoting Informed Decisions About Cancer Screening in Older Adults (PRIMED)
Primary Purpose
Colorectal Cancer Screening
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Notification
Training
Sponsored by
About this trial
This is an interventional health services research trial for Colorectal Cancer Screening focused on measuring Shared Decision Making, Patient Reported Outcomes, Continuing Medical Education, early detection of cancer, colonoscopy, colorectal cancer
Eligibility 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).
Exclusion Criteria for patients:
- Prior diagnosis of colon or rectal cancer, inflammatory bowel disease or genetic disorder that raises CRC risk (e.g. hereditary non-polyposis CRC and familial adenomatous polyposis)
- Unable to consent for themselves (e.g. moderate to severe dementia or other major cognitive limitations)
- Unable to read or write in English or Spanish
Sites / Locations
- Maine Medical Center
- Massachusetts General Hospital
- Brigham and Women's Hospital
- North Shore Medical Center
- Newton-Wellesley Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Notification only arm
Training and Notification arm
Arm Description
Clinician participants will be notified of their patients aged 76-85 with an upcoming visit who are due for colorectal cancer screening.
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.
Outcomes
Primary Outcome Measures
Shared Decision Making Process (SDMP) Scale Score
The SDM score is generated from the patient responses to the SDM Process survey instrument. Total scores range from 0-4, with higher scores indicating more shared decision making.
Secondary Outcome Measures
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.
Proportion 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.
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 in the interaction.
Colorectal cancer screening rates
The investigators will use established, validated algorithms for calculating cancer screening rates for patients aged 76-85 from a combination of administrative, billing and clinical data. Data will be aggregated at the physician, practice, and network level to identify the annual rate or percentage of eligible patients up to date for screening during the historical control period and concurrent control observation period both for clinicians enrolled in the study and clinicians not enrolled in the study.
Clinician satisfaction with the visit
The percentage of clinicians who report that they are extremely satisfied with the visit will be compared across arms.
Full Information
NCT ID
NCT03959696
First Posted
May 1, 2019
Last Updated
May 19, 2022
Sponsor
Massachusetts General Hospital
Collaborators
MaineHealth, Brigham and Women's Hospital, Newton-Wellesley Hospital, North Shore Medical Center, Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT03959696
Brief Title
Promoting Informed Decisions About Cancer Screening in Older Adults
Acronym
PRIMED
Official Title
Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED Study): Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
MaineHealth, Brigham and Women's Hospital, Newton-Wellesley Hospital, North Shore Medical Center, Patient-Centered Outcomes Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening
Keywords
Shared Decision Making, Patient Reported Outcomes, Continuing Medical Education, early detection of cancer, colonoscopy, colorectal cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two-arm, multi-site cluster randomized controlled trial.
Masking
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.
Allocation
Randomized
Enrollment
529 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Notification only arm
Arm Type
Active Comparator
Arm Description
Clinician participants will be notified of their patients aged 76-85 with an upcoming visit who are due for colorectal cancer screening.
Arm Title
Training and Notification arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Notification
Intervention Description
Clinicians will be notified of their patients aged 76-85 with an upcoming, non urgent visit who are due for colorectal cancer screening.
Intervention Type
Behavioral
Intervention Name(s)
Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Shared Decision Making Process (SDMP) Scale Score
Description
The SDM score is generated from the patient responses to the SDM Process survey instrument. Total scores range from 0-4, with higher scores indicating more shared decision making.
Time Frame
1 week after physician visit
Secondary Outcome Measure Information:
Title
Patients' Colorectal Cancer Screening Knowledge Score
Description
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
Title
Proportion of Patients who received preferred approach to Colorectal Cancer Testing
Description
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)
Title
Physician's shared decision making skills
Description
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 in the interaction.
Time Frame
Baseline
Title
Colorectal cancer screening rates
Description
The investigators will use established, validated algorithms for calculating cancer screening rates for patients aged 76-85 from a combination of administrative, billing and clinical data. Data will be aggregated at the physician, practice, and network level to identify the annual rate or percentage of eligible patients up to date for screening during the historical control period and concurrent control observation period both for clinicians enrolled in the study and clinicians not enrolled in the study.
Time Frame
1 year
Title
Clinician satisfaction with the visit
Description
The percentage of clinicians who report that they are extremely satisfied with the visit will be compared across arms.
Time Frame
1 week post visit
Other Pre-specified Outcome Measures:
Title
Caregiver SDM Process Scale score
Description
Caregivers will complete an adapted version of the SDM Process survey to provide 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
1 week after physician visit
Title
Clinician attitude toward shared decision making
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Exclusion Criteria for patients:
Prior diagnosis of colon or rectal cancer, inflammatory bowel disease or genetic disorder that raises CRC risk (e.g. hereditary non-polyposis CRC and familial adenomatous polyposis)
Unable to consent for themselves (e.g. moderate to severe dementia or other major cognitive limitations)
Unable to read or write in English or Spanish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen R Sepucha, PhD
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Leigh Simmons, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
North Shore Medical Center
City
Danvers
State/Province
Massachusetts
ZIP/Postal Code
01923
Country
United States
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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.
Citations:
PubMed Identifier
35931908
Citation
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.
Results Reference
derived
Learn more about this trial
Promoting Informed Decisions About Cancer Screening in Older Adults
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