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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04317274
• Other study ID #: 2019P001434
• Status: Completed
• Phase: N/A
• Start date: March 13, 2020
• Est. completion date: April 8, 2020

Study information

• Verified date: March 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 401
• Est. completion date: April 8, 2020
• Est. primary completion date: April 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Speak English

• No prior diagnosis of colorectal cancer

• No history of heart attack

• No history of stroke

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Colorectal Cancer
• High Cholesterol
• Hypercholesterolemia

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Center for Survey Research, University of Massachusetts, Boston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Immediately after viewing each video (typically within 15 minutes of watching the video)
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.	Immediately after viewing each video (typically within 15 minutes of watching the video)
Secondary	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)
Secondary	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)
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.	Immediately after viewing each video (typically within 15 minutes of watching the video)