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出境医 / 临床实验 / Promoting Informed Decisions About Cancer Screening in Older Adults (PRIMED)

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

Study Description
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.
Study Design
Layout table for study information
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
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : August 30, 2022
Arms and Interventions
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.
Outcome Measures
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.


Eligibility Criteria
Layout table for eligibility information
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
Contacts and Locations

Locations
Layout table for location information
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
MaineHealth
Brigham and Women's Hospital
Newton-Wellesley Hospital
North Shore Medical Center
Patient-Centered Outcomes Research Institute
Investigators
Layout table for investigator information
Principal Investigator: Karen R Sepucha, PhD Harvard Medical School
Principal Investigator: Leigh Simmons, MD Massachusetts General Hospital
Tracking Information
First Submitted Date  ICMJE May 1, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date July 13, 2020
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: May 21, 2019)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Promoting Informed Decisions About Cancer Screening in Older Adults
Official Title  ICMJE Promoting Informed Decisions About Colorectal Cancer Screening in Older Adults (PRIMED Study): Randomized Trial
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Colorectal Cancer Screening
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Notification
  • 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.
    Interventions:
    • Behavioral: Notification
    • Behavioral: Training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 30, 2022
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03959696
Other Study ID Numbers  ICMJE 2018P002848
CDR-2017C3-9270 ( Other Grant/Funding Number: Patient Centered Outcomes Research Institute (PCORI) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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.
Responsible Party Karen Sepucha, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE
  • MaineHealth
  • Brigham and Women's Hospital
  • Newton-Wellesley Hospital
  • North Shore Medical Center
  • Patient-Centered Outcomes Research Institute
Investigators  ICMJE
Principal Investigator: Karen R Sepucha, PhD Harvard Medical School
Principal Investigator: Leigh Simmons, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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