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Completed

NCT Number: NCT03959696

Promoting Informed Decisions About Cancer Screening in Older Adults

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maine Medical Center, Portland, Maine, United States

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About this study

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.

Who can participate

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:

  • 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

Treatment and study plan

Notification

Behavioral

Clinicians will be notified of their patients aged 76-85 with an upcoming, non urgent visit who are due for colorectal cancer screening.

Training

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. Patients' Colorectal Cancer Screening Knowledge Score

    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.

  2. 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)

    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.

  3. Physician's Shared Decision Making Skills

    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.

  4. Colorectal Cancer Screening Rates

    Time frame: 1 year

    The chart review results of cancer screening rates for patients enrolled in the study.

  5. Clinician Satisfaction With the Visit

    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.

Other outcomes

  1. Companion SDM Process Scale Score

    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.

  2. Clinician Attitude Toward 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Brigham and Women's Hospital
  • MaineHealth
  • Newton-Wellesley Hospital
  • North Shore Medical Center
  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

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

Acronym: PRIMED

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 22, 2019
Registry last updated
Jan 6, 2025

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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