Online Trial Examining Validity of the Shared Decision Making Process Survey With Video Vignettes
1 other identifier
interventional
401
1 country
1
Brief Summary
This study will recruit subjects online and randomly assigned them to one of four arms. The arms vary by clinical decision (colorectal cancer screening or treatment of high cholesterol) by video order (poor shared decision making followed by good or good shared decision making followed by poor). Participants will view two videos and complete the Shared Decision Making process survey along with a few other measures after each video. Our main hypothesis is that respondents watching the good shared decision making videos will score higher on the Shared Decision Making Process survey compared to those watching the poor videos.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable colorectal-cancer
Started Mar 2020
Shorter than P25 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 13, 2020
CompletedFirst Submitted
Initial submission to the registry
March 17, 2020
CompletedFirst Posted
Study publicly available on registry
March 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 8, 2020
CompletedResults Posted
Study results publicly available
January 5, 2024
CompletedJanuary 5, 2024
March 1, 2023
26 days
March 17, 2020
May 19, 2022
March 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Shared Decision Making Process Score
The Shared Decision Making Process is a short, 4-item patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred.
Immediately after viewing each video (typically within 15 minutes of watching the video)
Secondary Outcomes (4)
Shared Decision Making Questionnaire (SDM-Q-9)
Immediately after viewing each video (typically within 15 minutes of watching the video)
Healthcare Provider Treatment Recommendation
Immediately after viewing each video (typically within 15 minutes of watching the video)
Patient Treatment Preference
Immediately after viewing each video (typically within 15 minutes of watching the video)
Adapted Controlled Preference Item
Immediately after viewing each video (typically within 15 minutes of watching the video)
Study Arms (4)
High Cholesterol Good Video First
EXPERIMENTALParticipants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see good video first and poor video second.
Colorectal Cancer Good Video First
EXPERIMENTALParticipants see videos of a conversation around screening for colorectal cancer. Patients see good video first and poor video second.
High Cholesterol Poor Video First
EXPERIMENTALParticipants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see poor video first and good video second.
Colorectal Cancer Poor Video First
EXPERIMENTALParticipants see videos of a conversation around screening for colorectal cancer. Patients see poor video first and good video second.
Interventions
The short video illustrated key components of a high quality shared decision making conversation between a doctor and patient actor around treatment of high cholesterol.
The short video illustrated a typical conversation between a doctor and patient actor that did not cover key aspects of share decision making around treatment of high cholesterol.
The short video illustrated key components of a high quality shared decision making conversation between a doctor and patient actor around screening for colorectal cancer.
The short video illustrated a typical conversation between a doctor and patient actor that did not cover key aspects of share decision making around screening for colorectal cancer.
Eligibility Criteria
You may qualify if:
- Speak English
- No prior diagnosis of colorectal cancer
- No history of heart attack
- No history of stroke
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Karen R. Sepucha
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Sepucha, PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Health Decision Sciences Center
Study Record Dates
First Submitted
March 17, 2020
First Posted
March 23, 2020
Study Start
March 13, 2020
Primary Completion
April 8, 2020
Study Completion
April 8, 2020
Last Updated
January 5, 2024
Results First Posted
January 5, 2024
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
The study team will create a complete, cleaned, de-identified copy of the final data set for each online field test. After the main analyses have been published, information for accessing the data will be made available on the Health Decision Sciences Center website and in publications of the data. Dr. Sepucha will share a de-identified data set with outside investigators at no cost, according to approved Massachusetts General Hospital/Partners 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.