Clinical trial NCT04317274: Online Trial Examining Validity of the Shared Decision Making Process Survey With Video Vignettes
Official title: Online Trial Examining Validity of the Shared Decision Making Process Survey With Video Vignettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
High Cholesterol
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Boston
First posted: 2020-03-23
Enrollment: 401
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Shared Decision Making Process Score
timeFrame: Immediately after viewing each video (typically within 15 minutes of watching the video)
Secondary outcomes:
measure: Shared Decision Making Questionnaire (SDM-Q-9)
timeFrame: Immediately after viewing each video (typically within 15 minutes of watching the video)
measure: Healthcare Provider Treatment Recommendation
timeFrame: Immediately after viewing each video (typically within 15 minutes of watching the video)
measure: Patient Treatment Preference
timeFrame: Immediately after viewing each video (typically within 15 minutes of watching the video)
measure: Adapted Controlled Preference Item
timeFrame: Immediately after viewing each video (typically within 15 minutes of watching the video)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen Sepucha, PhD
role: PRINCIPAL_INVESTIGATOR
References: