Promoting Informed Decisions About Cancer Screening in Older Adults

Colorectal Cancer Screening Clinical Trial

— PRIMED  

Official title:

Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED Study): Randomized Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03959696
• Other study ID #: 2018P002848
• Secondary ID: CDR-2017C3-9270
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: August 30, 2022

Study information

• Verified date: May 2022
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 529
• Est. completion date: August 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Screening
• Colorectal Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	North Shore Medical Center	Danvers	Massachusetts
United States	Newton-Wellesley Hospital	Newton	Massachusetts
United States	Maine Medical Center	Portland	Maine

Sponsors (6)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital, MaineHealth, Newton-Wellesley Hospital, North Shore Medical Center, Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregiver SDM Process Scale score	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.	1 week after physician visit
Other	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
Primary	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.	1 week after physician visit
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.	1 week after physician visit
Secondary	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.	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 in the interaction.	Baseline
Secondary	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.	1 year
Secondary	Clinician satisfaction with the visit	The percentage of clinicians who report that they are extremely satisfied with the visit will be compared across arms.	1 week post visit