Online Trial Examining Validity of the Shared Decision Making Process Survey With Video Vignettes
Condition: Colorectal Cancer; High Cholesterol
MeSH terms: Hypercholesterolemia
Study type: Interventional

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.
    

Intervention name(s): Good high cholesterol video; Poor high cholesterol video; Good colon cancer screening video; Poor colon cancer screening video
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 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.
Masking: None (Open Label)
Primary purpose: Other