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| Name | Class |
|---|---|
| University of Massachusetts, Boston | OTHER |
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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.
Study staff are working with a national sampling firm to recruit subjects and obtain 400 responses. Subjects were randomly assigned to one of four arms. (1) Colorectal cancer screening good shared decision making video then poor video second (2) Colorectal cancer screening poor shared decision making video then good video (3) Treatment of high cholesterol good video then poor video and (4) Treatment of high cholesterol poor shared decision making video first then good video. Participants completed measures of Shared Decision Making after each video.
The sample size was determined to ensure sufficient power to detect differences between the good and the poor shared decision making videos in this repeated measure design and analyses were planned to be separate for each arm (i.e. one analysis for the colorectal cancer screening videos and a separate parallel analysis of the statins for high cholesterol video). To detect an eta2 effect size of .04 with an alpha of 0.05 with 80% power would require 190 observations per clinical condition. Study staff rounded this to 200 observations per clinical condition, for a total required sample size of 400 patients.
The interventions were short Shared Decision Making Videos that were developed as part of two training courses on shared decision making by investigators at Massachusetts General Hospital.
For the analyses, study staff will examine the descriptives of the Shared Decision Making Process items for the two clinical conditions and orders. Study staff will examine rates of missing data to determine acceptability, and will examine descriptive results to see whether the scores span the range of total possible scores, are normally distributed, and whether there is evidence of floor or ceiling effects. Then, study staff examine discriminant validity of the measure by examining whether scores for the good videos are higher then for the poor videos. Further, study staff will examine concurrent validity with the alternative shared decision making measure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Cholesterol Good Video First | Experimental | Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see good video first and poor video second. |
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| Colorectal Cancer Good Video First | Experimental | Participants see videos of a conversation around screening for colorectal cancer. Patients see good video first and poor video second. |
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| High Cholesterol Poor Video First | Experimental | Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see poor video first and good video second. |
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| Colorectal Cancer Poor Video First | Experimental | Participants see videos of a conversation around screening for colorectal cancer. Patients see poor video first and good video second. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Good high cholesterol video | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Shared Decision Making Questionnaire (SDM-Q-9) | The SDM-Q9 is a 9-item patient reported measure of the amount of shared decision making that occurs in an interaction. Items are scored on a six-point Likert scale from 0 (completely disagree) to 5 (completely agree); items are summed up to a total raw score between 0-45. The score is then transformed to range from 0-100 where higher values indicate a better shared decision making process occurred. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Sepucha, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | High Cholesterol Good Video First | Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see good video first and poor video second. Good high cholesterol video: 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. Poor high cholesterol video: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 6, 2023 |
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Subjects were randomly assigned to one of the two clinical conditions (colorectal cancer screening or high cholesterol) then randomly assigned to view the two videos in one of two orders. Participants either viewed the good shared decision making video first (and the poor shared decision making video second) or the poor shared decision making video first (and the good shared decision making video second). Thus we used a 2 (clinical condition; colorectal cancer screening v. high cholesterol) x 2 (video; good v. poor) x 2 (order; good first v. poor first) factorial design.
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| Poor high cholesterol video | Behavioral | 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. |
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| Good colon cancer screening video | Behavioral | 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. |
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| Poor colon cancer screening video | Behavioral | 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. |
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| Immediately after viewing each video (typically within 15 minutes of watching the video) |
| Healthcare Provider Treatment Recommendation | Single item asking what the healthcare provider recommended the patient do in the video | Immediately after viewing each video (typically within 15 minutes of watching the video) |
| Patient Treatment Preference | Single item asking what the patient in the video wanted to do | Immediately after viewing each video (typically within 15 minutes of watching the video) |
| Adapted Controlled Preference Item | Single item asking the participant who made the ultimate decision in the video. The categorical response options are 1) the patient made the decision, 2)the provider made the decision, or 3) both patient and provider made the decision together. | Immediately after viewing each video (typically within 15 minutes of watching the video) |
| FG001 | Colorectal Cancer Good Video First | Participants see videos of a conversation around screening for colorectal cancer. Patients see good video first and poor video second. Good colon cancer screening video: 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. Poor colon cancer screening video: 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. |
| FG002 | High Cholesterol Poor Video First | Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see poor video first and good video second. Good high cholesterol video: 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. Poor high cholesterol video: 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. |
| FG003 | Colorectal Cancer Poor Video First | Participants see videos of a conversation around screening for colorectal cancer. Patients see poor video first and good video second. Good colon cancer screening video: 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. Poor colon cancer screening video: 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. |
| COMPLETED |
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| NOT COMPLETED |
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Participants who provided sufficient information to calculate the shared decision making process score (primary outcome of interest)
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| ID | Title | Description |
|---|---|---|
| BG000 | High Cholesterol Good Video First | Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see good video first and poor video second. Good high cholesterol video: 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. Poor high cholesterol video: 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. |
| BG001 | Colorectal Cancer Good Video First | Participants see videos of a conversation around screening for colorectal cancer. Patients see good video first and poor video second. Good colon cancer screening video: 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. Poor colon cancer screening video: 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. |
| BG002 | High Cholesterol Poor Video First | Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see poor video first and good video second. Good high cholesterol video: 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. Poor high cholesterol video: 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. |
| BG003 | Colorectal Cancer Poor Video First | Participants see videos of a conversation around screening for colorectal cancer. Patients see poor video first and good video second. Good colon cancer screening video: 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. Poor colon cancer screening video: 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | participants who answered the shared decision making process items and provided sufficient information to calculate a SDM Process score. | Posted | Mean | Standard Deviation | score on a scale | Immediately after viewing each video (typically within 15 minutes of watching the video) |
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| Secondary | Shared Decision Making Questionnaire (SDM-Q-9) | The SDM-Q9 is a 9-item patient reported measure of the amount of shared decision making that occurs in an interaction. Items are scored on a six-point Likert scale from 0 (completely disagree) to 5 (completely agree); items are summed up to a total raw score between 0-45. The score is then transformed to range from 0-100 where higher values indicate a better shared decision making process occurred. | Participants who completed the 9-item SDM-Q9 measure. 388/388 participants provided sufficient information to calculate an SDMQ9 score. | Posted | Mean | Standard Deviation | score on a scale | Immediately after viewing each video (typically within 15 minutes of watching the video) |
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| Secondary | Healthcare Provider Treatment Recommendation | Single item asking what the healthcare provider recommended the patient do in the video | Participants who answered the healthcare provider recommendation question. 388/388 provided sufficient information for this outcome. | Posted | Count of Participants | Participants | Immediately after viewing each video (typically within 15 minutes of watching the video) |
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| Secondary | Patient Treatment Preference | Single item asking what the patient in the video wanted to do | Participants who answered the patient treatment preference question. Only 385/388 provided sufficient information for this outcome. | Posted | Count of Participants | Participants | Immediately after viewing each video (typically within 15 minutes of watching the video) |
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| Secondary | Adapted Controlled Preference Item | Single item asking the participant who made the ultimate decision in the video. The categorical response options are 1) the patient made the decision, 2)the provider made the decision, or 3) both patient and provider made the decision together. | Participants who completed the adapted controlled preference question. 388/388 participants provided sufficient information for this outcome. | Posted | Count of Participants | Participants | Immediately after viewing each video (typically within 15 minutes of watching the video) |
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Survey responses were assessed within 2 weeks of survey completion for evidence of adverse events.
Participants had the contact information for 3 members of the study team to contact with any problems or to report any adverse events. Of note, this was not a cross-over study, participants were selected for 1 of 2 topics (colorectal cancer screening or high cholesterol) and then randomized to viewing order to create 4 arms. Each participant in the listed arms saw both videos in the same order and were combined for assessment of adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Cholesterol Good Video First | Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see good video first and poor video second. Good high cholesterol video: 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. Poor high cholesterol video: 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. | 0 | 97 | 0 | 97 | 0 | 97 |
| EG001 | Colorectal Cancer Good Video First | Participants see videos of a conversation around screening for colorectal cancer. Patients see good video first and poor video second. Good colon cancer screening video: 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. Poor colon cancer screening video: 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. | 0 | 94 | 0 | 94 | 0 | 94 |
| EG002 | High Cholesterol Poor Video First | Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see poor video first and good video second. Good high cholesterol video: 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. Poor high cholesterol video: 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. | 0 | 103 | 0 | 103 | 0 | 103 |
| EG003 | Colorectal Cancer Poor Video First | Participants see videos of a conversation around screening for colorectal cancer. Patients see poor video first and good video second. Good colon cancer screening video: 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. Poor colon cancer screening video: 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. | 0 | 107 | 0 | 107 | 0 | 107 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen R. Sepucha | Massachusetts General Hospital | 617-724-3350 | KSEPUCHA@mgh.havard.edu |
| Mar 30, 2023 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Male |
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| Genderfluid |
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| Nonbinary |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Good video score |
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We tested for interaction effect of order and video version within the colorectal cancer group.
| Mixed Models Analysis |
Original plan was to conduct ANOVAs, but failed tests of assumptions |
| <0.001 |
| Slope |
| -1.23 |
| 2-Sided |
| Other |
| OG002 | High Cholesterol Poor Video First | Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see poor video first and good video second. Good high cholesterol video: 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. Poor high cholesterol video: 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. |
| OG003 | Colorectal Cancer Poor Video First | Participants see videos of a conversation around screening for colorectal cancer. Patients see poor video first and good video second. Good colon cancer screening video: 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. Poor colon cancer screening video: 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. |
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| OG002 | High Cholesterol Poor Video First | Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see poor video first and good video second. Good high cholesterol video: 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. Poor high cholesterol video: 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. |
| OG003 | Colorectal Cancer Poor Video First | Participants see videos of a conversation around screening for colorectal cancer. Patients see poor video first and good video second. Good colon cancer screening video: 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. Poor colon cancer screening video: 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. |
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| OG002 | High Cholesterol Poor Video First | Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see poor video first and good video second. Good high cholesterol video: 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. Poor high cholesterol video: 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. |
| OG003 | Colorectal Cancer Poor Video First | Participants see videos of a conversation around screening for colorectal cancer. Patients see poor video first and good video second. Good colon cancer screening video: 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. Poor colon cancer screening video: 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. |
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| OG002 | High Cholesterol Poor Video First | Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see poor video first and good video second. Good high cholesterol video: 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. Poor high cholesterol video: 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. |
| OG003 | Colorectal Cancer Poor Video First | Participants see videos of a conversation around screening for colorectal cancer. Patients see poor video first and good video second. Good colon cancer screening video: 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. Poor colon cancer screening video: 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. |
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| Have a colonoscopy |
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| Do a stool-based test |
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| Not take medicine/Not be screened |
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| Do something else |
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| Did not express an opinion |
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| Have a colonoscopy |
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| Do a stool-based test |
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| Not take medicine/Not be screened |
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| Do something else |
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| Missing |
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| Mainly the patient |
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| The doctor and the patient made the decision together |
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| Missing |
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