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

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ClinicalTrials.gov Identifier: NCT03959696
Recruitment Status : Enrolling by invitation
First Posted : May 22, 2019
Last Update Posted : May 22, 2019
Sponsor:
Collaborators:
Maine Medical Center
Brigham and Women's Hospital
Newton-Wellesley Hospital
North Shore Medical Center
Information provided by (Responsible Party):
Karen Sepucha, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Screening Behavioral: Notification Behavioral: Training Not Applicable

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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two-arm, multi-site cluster randomized controlled trial.
Masking: Single (Outcomes Assessor)
Masking Description: Physician participants will not be blinded to the study arm. Patients will not be given any information on their physician's assigned arm. Statistician will be blinded to the assignment when analyzing the results.
Primary Purpose: Health Services Research
Official Title: Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED Study): Randomized Trial
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Shared Decision Making Process (SDMP) Scale Score [ Time Frame: 1 week after physician visit ]
    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.


Secondary Outcome Measures :
  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. Proportion 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 in the interaction.

  4. Colorectal cancer screening rates [ Time Frame: 1 year ]
    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.

  5. Clinician satisfaction with the visit [ Time Frame: 1 week post visit ]
    The percentage of clinicians who report that they are extremely satisfied with the visit will be compared across arms.


Other Outcome Measures:
  1. Caregiver SDM Process Scale score [ Time Frame: 1 week after physician visit ]
    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.

  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03959696


Locations
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United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
North Shore Medical Center
Danvers, Massachusetts, United States, 01923
Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
Sponsors and Collaborators
Massachusetts General Hospital
Maine Medical Center
Brigham and Women's Hospital
Newton-Wellesley Hospital
North Shore Medical Center
Investigators
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Principal Investigator: Karen R Sepucha, PhD Harvard Medical School
Principal Investigator: Leigh Simmons, MD Massachusetts General Hospital

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Responsible Party: Karen Sepucha, Associate Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03959696     History of Changes
Other Study ID Numbers: 2018P002848
CDR-2017C3-9270 ( Other Grant/Funding Number: Patient Centered Outcomes Research Institute (PCORI) )
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
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.
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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Karen Sepucha, Massachusetts General Hospital:
Shared Decision Making
Patient Reported Outcomes
Continuing Medical Education
early detection of cancer
colonoscopy
colorectal cancer

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases