Notification
BehavioralClinicians will be notified of their patients aged 76-85 with an upcoming, non urgent visit who are due for colorectal cancer screening.
NCT Number: NCT03959696
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.
Looking for future studies?
Notify Me21 year and older
All sexes
Interventional
Not applicable
Maine Medical Center, Portland, Maine, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
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.
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.
Time frame: 1 week after physician visit
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 (preference); 12 months after physician visit (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.
Time frame: Baseline
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.
Time frame: 1 year
The chart review results of cancer screening rates for patients enrolled in the study.
Time frame: 1 week post visit
The percentage of study patient visits where the clinicians' reported that they were 'extremely or very satisfied' will be compared across arms.
Time frame: About a week after physician visit
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.
Time frame: Baseline
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.
Massachusetts General Hospital
Other
Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED Study): Randomized Trial
Acronym: PRIMED
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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