Examining Validity and Reliability of the Shared Decision Making Process Survey in Adults With Depression

NCT04343534 | Completed Results

• 1 other identifier: 2019P001434-2
• Study Type: observational
• Target: 494
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test two differently worded versions of the Shared Decision Making Process scale in a sample of adults who have recently made a decision about treatment of depression. The main goals are to gather evidence of reliability, to test whether the generic version has similar psychometric performance to the original, and to extend generalizability of the findings to younger adults.

Conditions

Depression

Keywords

shared decision making

Outcome Measures

Primary Outcomes (1)

• Shared Decision Making Process Score

  The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores for both versions of the scale range from 0-4 where higher values indicate a better shared decision making process occurred.

  Baseline survey

Secondary Outcomes (8)

• Decisional Conflict Tool (SURE)

  Baseline survey

• Decision Regret Scale

  Baseline survey

• Single-Item Measure of Decision Regret

  Baseline survey

• Treatment Preference

  Baseline survey

• Adapted Controlled Preference Scale

  Baseline survey

Study Arms (2)

Original Shared Decision Making Process scale

Patients receive the original version of the Shared Decision Making Process scale.

Revised Shared Decision Making Process scale

This group completes a new version of the scale with different wording for several items.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sample of adults in the United States who have made decision about treatment of depression in the past 12 months will be recruited from an online panel.

You may qualify if:

• Must have spoken to a healthcare provider about treatment for depression in the past 12 months
• Must have started or stopped medication for depression between January 2018 and their surveyed date.

You may not qualify if:

• None

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of Massachusetts, Boston: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Karen R. Sepucha
• Organization: Massachusetts General Hospital

KSEPUCHA@mgh.havard.edu

617-724-3350

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Health Decision Sciences Center

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 13, 2020
• Study Start: April 29, 2020
• Primary Completion: June 1, 2020
• Study Completion: December 30, 2020
• Last Updated: January 5, 2024
• Results First Posted: January 5, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: The data will be available to outside investigators starting 6 months after publication.
• Access Criteria: Information about the data sets will be 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 (MGH)/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 (IRB) 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.

Locations

US (1)