NCT04317274

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 401 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colorectal Cancer
• High Cholesterol

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2020-03-13
• Primary completion: 2020-04-08
• Completion: 2020-04-08
• First posted: 2020-03-23
• Last updated: 2024-01-05
• Results posted: 2024-01-05

Locations

1 site across 1 country: United States