NCT04343534

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

Completed Results posted Last updated 5 January 2024

What this trial tests

trial in Depression in 494 participants. Completed in 30 December 2020.

Timeline

29 April 2020

Primary endpoint
1 June 2020

30 December 2020

Quick facts

Lead sponsor	Massachusetts General Hospital
Status	Completed
Study type	OBSERVATIONAL
Enrollment	494
Start date	29 April 2020
Primary completion	1 June 2020
Estimated completion	30 December 2020
Sites	1 location across United States

Conditions studied

• Depression — all drugs for Depression →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 75, any sex, with Depression. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Shared Decision Making Process Score Primary · 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.

Group	Value	95% CI
Original Shared Decision Making Process Scale	2.35	± 1.11
Revised Shared Decision Making Process Scale	2.51	± 1.05

Decisional Conflict Tool (SURE) Secondary · 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).

Group	Value	95% CI
Original Shared Decision Making Process Scale	63
Revised Shared Decision Making Process Scale	72

Decision Regret Scale Secondary · Baseline survey

5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret.

Group	Value	95% CI
Original Shared Decision Making Process Scale	23	± 18
Revised Shared Decision Making Process Scale	21	± 20

Single-Item Measure of Decision Regret Secondary · 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.

Group	Value	95% CI
Original Shared Decision Making Process Scale	119
Revised Shared Decision Making Process Scale	134
Original Shared Decision Making Process Scale	95
Revised Shared Decision Making Process Scale	102
Original Shared Decision Making Process Scale	15
Revised Shared Decision Making Process Scale	24
Original Shared Decision Making Process Scale	1
Revised Shared Decision Making Process Scale	4

Treatment Preference Secondary · 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.

Group	Value	95% CI
Original Shared Decision Making Process Scale	71
Revised Shared Decision Making Process Scale	91
Original Shared Decision Making Process Scale	28
Revised Shared Decision Making Process Scale	28
Original Shared Decision Making Process Scale	125
Revised Shared Decision Making Process Scale	138
Original Shared Decision Making Process Scale	6
Revised Shared Decision Making Process Scale	6

Adapted Controlled Preference Scale Secondary · 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.

Group	Value	95% CI
Original Shared Decision Making Process Scale	107
Revised Shared Decision Making Process Scale	125
Original Shared Decision Making Process Scale	32
Revised Shared Decision Making Process Scale	27
Original Shared Decision Making Process Scale	91
Revised Shared Decision Making Process Scale	112

Shared Decision Making Process Measure Retest Secondary · 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.

Group	Value	95% CI
Original Shared Decision Making Process Scale	2.27	± 1.05
Revised Shared Decision Making Process Scale	2.58	± 0.97

Depression Knowledge Secondary · 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

Group	Value	95% CI
Original Shared Decision Making Process Scale	55.22	± 22.96
Revised Shared Decision Making Process Scale	55.98	± 21.87

Adherence Secondary · 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.

Group	Value	95% CI
Original Shared Decision Making Process Scale	83.6	± 18.47
Revised Shared Decision Making Process Scale	84.79	± 18.25

Sponsor's own 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 reliability, to test whether the generic version has similar psychometric performance to the original, and to extend generalizability of the findings to younger adults.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.