Promoting Informed Decisions About Cancer Screening in Older Adults
PRIMED
2 other identifiers
interventional
536
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedFirst Posted
Study publicly available on registry
May 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2022
CompletedResults Posted
Study results publicly available
January 6, 2025
CompletedJanuary 6, 2025
November 1, 2024
3 years
May 1, 2019
September 27, 2022
November 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Patients' Colorectal Cancer Screening Knowledge Score
1 week after physician visit
Percentage of Patients Who Received Preferred Approach to Colorectal Cancer Testing
1 week after physician visit (preference); 12 months after physician visit (testing)
Physician's Shared Decision Making Skills
Baseline
Colorectal Cancer Screening Rates
1 year
Clinician Satisfaction With the Visit
1 week post visit
Other Outcomes (2)
Companion SDM Process Scale Score
About a week after physician visit
Clinician Attitude Toward Shared Decision Making
Baseline
Study Arms (2)
Notification only arm
ACTIVE COMPARATORClinician 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
EXPERIMENTALClinician 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.
Interventions
Clinicians will be notified of their patients aged 76-85 with an upcoming, non urgent visit who are due for colorectal cancer screening.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- 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).
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- MaineHealthcollaborator
- Brigham and Women's Hospitalcollaborator
- Newton-Wellesley Hospitalcollaborator
- North Shore Medical Centercollaborator
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (5)
Maine Medical Center
Portland, Maine, 04102, United States
Massachusetts General Hospital
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
Related Publications (2)
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.
PMID: 39178001DERIVEDSepucha 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.
PMID: 35931908DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Karen Sepucha
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Karen R Sepucha, PhD
Harvard Medical School (HMS and HSDM)
- PRINCIPAL INVESTIGATOR
Leigh Simmons, MD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 1, 2019
First Posted
May 22, 2019
Study Start
May 1, 2019
Primary Completion
April 30, 2022
Study Completion
August 30, 2022
Last Updated
January 6, 2025
Results First Posted
January 6, 2025
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- 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.
- 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.
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.