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

Completed

Conditions: Depression

Registration Number: NCT04343534

Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description: 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 psychometric performance of the scale, compare performance of different wording for items, and to extend generalizability of the findings to younger adults.

Subjects are randomly assigned to one of the two versions of the Shared Decision Making Process scale and complete a set of measures regarding their experiences with decision making for depression, demographics, and health status. A subset of respondents will complete the Shared Decision Making Process scale and selected other items again 1 week later to examine short term test-retest reliability.

Staff will work with a national sampling firm to recruit subjects and obtain 500 responses to the baseline survey (n=250 for each version) and a subset will complete a retest survey (n=200; 50 from each age and survey type group). Eligible subjects are adults aged 18-75 who talked with a health care provider about treatment for depression in the preceding 12 months. The sample is not a national probability sample; however, the recruitment efforts will ensure about 50% of respondents aged 18-39 and 50% aged 40-75, and to ensure at least 25% of the sample is racial/ethnic minorities (Black or African American, Asian, Hispanic or Latino).

The investigators will examine validity and reliability of the different versions. The sample size was determined to ensure sufficient power to detect differences in key subgroups, including age (younger adults vs. older adults) and version (A vs. B). To detect a difference of about 0.33 standard deviations at 0.05 significance with 80% power would require 125 per group.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 494

Inclusion Criteria

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.

Exclusion Criteria

None

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Shared Decision Making Process Score	Baseline survey	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.

Secondary Outcome Measures

Name	Time	Method
Decisional Conflict Tool (SURE)	Baseline survey	Measures decisional conflict, consists of 4 yes/no items. Scores range 0-4 where 0 indicates high decisional conflict, 4 indicates no decisional conflict, and scores less than or equal to 3 indicate decisional conflict. The measure is top-scored and we report the percentage of participants who scored a 4 ("no decisional conflict).
Treatment Preference	Baseline survey	Single item asking "What did you want to do to manage your depression" with response options (1) Anti-depressant medicine alone, (2) Counseling or therapy alone, (3) Both medicine and counseling, and (4) Do something else.
Single-Item Measure of Decision Regret	Baseline survey	Single item asking "If you knew then what you know now, do you think you would make the same decision about depression?" Responses are definitely yes, probably yes, probably no and definitely no.
Shared Decision Making Process Measure Retest	1 week after baseline survey	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 range from 0-4 where higher values indicate a better shared decision making process occurred.
Decision Regret Scale	Baseline survey	5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret.
Adapted Controlled Preference Scale	Baseline survey	Single item asking the participant who made the ultimate decision. 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.
Depression Knowledge	Baseline survey	Multiple choice knowledge items for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge
Adherence	Baseline survey	3 item measure of adherence to medication for sample participants who indicate that they are taking medicine. A total score is calculated with scores ranging form 0-100; higher values indicated greater medication adherence.