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

NCT ID: NCT04317274

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 401 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-13
• Study Completion Date: 2020-04-08

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.

Conditions

Colorectal Cancer; High Cholesterol

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Good high cholesterol video

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Good colon cancer screening video

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Good high cholesterol video

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

Good colon cancer screening video

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Massachusetts, Boston

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Karen Sepucha

Director of the Health Decision Sciences Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen Sepucha, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019P001434

Identifier Type: -

Identifier Source: org_study_id