Online Trial Examining Validity of the Shared Decision Making Process Survey With Video Vignettes

Not Applicable

Completed

Conditions: Colorectal Cancer
High Cholesterol

Interventions: Behavioral: Good high cholesterol video
Behavioral: Good colon cancer screening video
Behavioral: Poor high cholesterol video
Behavioral: Poor colon cancer screening video

Registration Number: NCT04317274

Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 401

Inclusion Criteria

Speak English
No prior diagnosis of colorectal cancer
No history of heart attack
No history of stroke

Exclusion Criteria

None

Study & Design

Study Type: INTERVENTIONAL

Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
High Cholesterol Good Video First	Poor high cholesterol video	Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see good video first and poor video second.
High Cholesterol Good Video First	Good high cholesterol video	Participants 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	Poor colon cancer screening video	Participants see videos of a conversation around screening for colorectal cancer. Patients see good video first and poor video second.
Colorectal Cancer Poor Video First	Good colon cancer screening video	Participants see videos of a conversation around screening for colorectal cancer. Patients see poor video first and good video second.
Colorectal Cancer Poor Video First	Poor colon cancer screening video	Participants see videos of a conversation around screening for colorectal cancer. Patients see poor video first and good video second.
High Cholesterol Poor Video First	Good high cholesterol video	Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see poor video first and good video second.
High Cholesterol Poor Video First	Poor high cholesterol video	Participants see videos of a conversation around taking medications (statins) for high cholesterol. Patients see poor video first and good video second.
Colorectal Cancer Good Video First	Good colon cancer screening video	Participants see videos of a conversation around screening for colorectal cancer. Patients see good video first and poor video second.

Primary Outcome Measures

Name	Time	Method
Shared Decision Making Process Score	Immediately after viewing each video (typically within 15 minutes of watching the video)	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.

Secondary Outcome Measures

Name	Time	Method
Adapted Controlled Preference Item	Immediately after viewing each video (typically within 15 minutes of watching the video)	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.
Patient Treatment Preference	Immediately after viewing each video (typically within 15 minutes of watching the video)	Single item asking what the patient in the video wanted to do
Healthcare Provider Treatment Recommendation	Immediately after viewing each video (typically within 15 minutes of watching the video)	Single item asking what the healthcare provider recommended the patient do in the video
Shared Decision Making Questionnaire (SDM-Q-9)	Immediately after viewing each video (typically within 15 minutes of watching the video)	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.