Promoting Informed Decisions About Cancer Screening in Older Adults (PRIMED)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer Screening
• Intervention / Treatment: Behavioral: Notification; Behavioral: Training

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 Type: Interventional
• Enrollment (Actual): 529
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maine
    • Portland, Maine, United States, 04102
      • Maine Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Danvers, Massachusetts, United States, 01923
      • North Shore Medical Center
    • Newton, Massachusetts, United States, 02462
      • Newton-Wellesley Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Notification only arm; Clinician participants will be notified of their patients aged 76-85 with an upcoming visit who are due for colorectal cancer screening.	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.
EXPERIMENTAL: Training and Notification arm; 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.	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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Patient-Centered Outcomes Research Institute; Brigham and Women's Hospital; MaineHealth; Newton-Wellesley Hospital; North Shore Medical Center
• Investigators: Principal Investigator: Karen R Sepucha, PhD, Harvard Medical School (HMS and HSDM); Principal Investigator: Leigh Simmons, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• Sepucha 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. 2022 Aug 5:1-8. doi: 10.1007/s11606-022-07738-4. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): April 30, 2022
• Study Completion (ANTICIPATED): August 30, 2022

Study Registration Dates

• First Submitted: May 1, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (ACTUAL): May 22, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: colorectal cancer; colonoscopy; Shared Decision Making; Patient Reported Outcomes; Continuing Medical Education; early detection of cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 2018P002848; CDR-2017C3-9270 (OTHER_GRANT: Patient Centered Outcomes Research Institute (PCORI))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No