Colorectal Cancer ScreeningPRIMEDNCT03959696
Promoting Informed Decisions About Cancer Screening in Older Adults
A study testing Notification and Training in people with Colorectal Cancer Screening, run by Massachusetts General Hospital at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- Notification and Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 536 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 May 2019to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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).
Who cannot join
- 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.
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
North Shore Medical Center
Danvers, Massachusetts, 01923
Newton-Wellesley Hospital
Newton, Massachusetts, 02462
Maine Medical Center
Portland, Maine, 04102
About this study
Official title: Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED Study): Randomized Trial
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.
Read the 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.
- Conditions
- Colorectal Cancer Screening
- Being tested
- Notification, Training
- Keywords
- Shared Decision Making, Patient Reported Outcomes, Continuing Medical Education, early detection of cancer, colonoscopy, colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NotificationBehavioural
Clinicians will be notified of their patients aged 76-85 with an upcoming, non urgent visit who are due for colorectal cancer screening.
TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Notification |
| 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. Receives: Behavioral: Notification; Behavioral: Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: About 1 week after the physician visit
Secondary outcomes (5)
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.
Measured: 1 week after physician visit
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.
Measured: 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.
Measured: Baseline
Colorectal Cancer Screening Rates
The chart review results of cancer screening rates for patients enrolled in the study.
Measured: 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.
Measured: 1 week post visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2019
- Study start1 May 2019
- Primary completion30 Apr 2022
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, multi-site cluster randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 536 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MaineHealth, Brigham and Women's Hospital, Newton-Wellesley Hospital, North Shore Medical Center, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Karen Sepucha, Massachusetts General Hospital
- Investigators
- Karen R Sepucha, PhD, Principal investigator, Harvard Medical School (HMS and HSDM)Leigh Simmons, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03959696
- Sponsor's protocol ID
- 2018P002848
- Other IDs
- CDR-2017C3-9270
- Acronym
- PRIMED
- Status last verified
- Nov 2024
- First submitted
- 1 May 2019
- Last updated
- 6 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39178001Sepucha 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.
PubMed 35931908
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED Study): Randomized Trial
- ClinicalTrials.gov ID
- NCT03959696
- Acronym / sponsor ID
- PRIMED / 2018P002848
- Conditions
- Colorectal Cancer Screening
- Keywords
- Shared Decision Making, Patient Reported Outcomes, Continuing Medical Education, early detection of cancer, colonoscopy, colorectal cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 536 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- MaineHealth, Brigham and Women's Hospital, Newton-Wellesley Hospital, North Shore Medical Center, Patient-Centered Outcomes Research Institute
- Study start
- 1 May 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 22 May 2019 (actual)
- Results
- Posted 6 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, multi-site cluster randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Notification only arm | Active comparator | Behavioral: NotificationClinician 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 | Behavioral: Notification, Behavioral: TrainingClinician 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- Adults, age 76-85 at the time of the scheduled visit
Key exclusion criteria (6 listed)
- 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.
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NotificationClinicians will be notified of their patients aged 76-85 with an upcoming, non urgent visit who are due for colorectal cancer screening. | Behavioural | Notification only arm, Training and Notification arm |
| TrainingThe 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. | Behavioural | Training and Notification arm |
Primary outcome
Shared Decision Making Process (SDMP) Scale Score
Time frame: 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.
5 secondary outcomes
Patients' Colorectal Cancer Screening Knowledge Score
Time frame: 1 week after physician visit
Percentage of Patients Who Received Preferred Approach to Colorectal Cancer Testing
Time frame: 1 week after physician visit (preference); 12 months after physician visit (testing)
Physician's Shared Decision Making Skills
Time frame: Baseline
Colorectal Cancer Screening Rates
Time frame: 1 year
Clinician Satisfaction With the Visit
Time frame: 1 week post visit
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39178001Sepucha 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.
- Derived from this study: PubMed 35931908Sepucha 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen R Sepucha, PhD principal investigator
Harvard Medical School (HMS and HSDM)
Leigh Simmons, MD principal investigator
Massachusetts General Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Notification and Training in people with Colorectal Cancer Screening, run by Massachusetts General Hospital at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shared Decision Making Process (SDMP) Scale Score (time frame: About 1 week after the physician visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03959696, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.