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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey in Adults With Depression

Conditions
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Depression

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Original Shared Decision Making Process scale<br>Patients receive the original version of the Shared Decision Making Process scale. | |
| Revised Shared Decision Making Process scale<br>This group completes a new version of the scale with different wording for several items. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional Conflict tool (SURE) | 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. | Baseline survey | 
| Decision Regret Scale | 5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret. | Baseline survey | 
| Single-Item Measure of Decision Regret | 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. | Baseline survey | 
| Treatment Choice | Single item asking patient What did you want to do in regard to (depending on the group) high cholesterol/high blood pressure/colon cancer screening/breast cancer screening/prostate cancer screening. | Baseline survey | 
| Adapted Controlled Preference Scale | 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. | Baseline survey | 
| Shared Decision Making Process Measure retest | 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. | 1 week after baseline survey | 
| Depression Knowledge | Multiple choice knowledge items for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge | Baseline survey | 
| Adherence | 3 item measure of adherence to medication for sample participants who indicate that they are taking medicine | Baseline survey | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shared decision making