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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; High Cholesterol
• Intervention / Treatment: Behavioral: Good high cholesterol video; Behavioral: Poor high cholesterol video; Behavioral: Good colon cancer screening video; Behavioral: Poor colon cancer screening video

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.

• Study Type: Interventional
• Enrollment (Actual): 401
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Center for Survey Research, University of Massachusetts, Boston
• Investigators: Principal Investigator: Karen Sepucha, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Actual): April 8, 2020
• Study Completion (Actual): April 8, 2020

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 23, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: 2019P001434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study team will create a complete, cleaned, de-identified copy of the final data set for each online field test. After the main analyses have been published, information for accessing the data will be made available on the Health Decision Sciences Center website and in publications of the data. Dr. Sepucha will share a de-identified data set with outside investigators at no cost, according to approved Massachusetts General Hospital/Partners policies for data sharing. Investigators from other sites will be able to request the data and will be required to complete a data use agreement that ensures that all local Institutional Review Board requirements are met before using the data, that they will not attempt to identify any data in the dataset, and that they will not share the data set with anyone outside their project team.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No