Trial Outcomes & Findings for Examining Validity and Reliability of the Shared Decision Making Process Survey in Adults With Depression (NCT NCT04343534)
NCT ID: NCT04343534
Last Updated: 2024-01-05
Results Overview
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.
COMPLETED
494 participants
Baseline survey
2024-01-05
Participant Flow
April 2020 - May 2020 using a national, non-probability panel obtained from Marketing Systems Group (MSG). MSG recruited participants by sending out invitation emails to potential responders.
Eligible respondents were adults in the US who had talked with a healthcare provider about starting or stopping medication for depression in the past 12 months. The sample was selected to have approximately equal age distribution above and below 40 years old (e.g. 18-39 and 40-75). Respondents were re-contacted approximately one-week post survey for a re-test survey.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
230
|
264
|
|
Overall Study
COMPLETED
|
230
|
264
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Examining Validity and Reliability of the Shared Decision Making Process Survey in Adults With Depression
Baseline characteristics by cohort
| Measure |
Original Shared Decision Making Process Scale
n=230 Participants
Patients receive the original version of the Shared Decision Making Process scale.
|
Revised Shared Decision Making Process Scale
n=264 Participants
This group completes a new version of the scale with different wording for several items.
|
Total
n=494 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 14 • n=5 Participants
|
44 years
STANDARD_DEVIATION 14 • n=7 Participants
|
43 years
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Sex/Gender, Customized
Female
|
158 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
355 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
72 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Non-Binary
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
218 Participants
n=5 Participants
|
241 Participants
n=7 Participants
|
459 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
193 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
417 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
230 Participants
n=5 Participants
|
264 Participants
n=7 Participants
|
494 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline surveyPopulation: participants who answered the shared decision making process items and provided sufficient information to calculate a SDM 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.
Outcome measures
| Measure |
Original Shared Decision Making Process Scale
n=230 Participants
Patients receive the original version of the Shared Decision Making Process scale.
|
Revised Shared Decision Making Process Scale
n=264 Participants
This group completes a new version of the scale with different wording for several items.
|
|---|---|---|
|
Shared Decision Making Process Score
|
2.35 score on a scale
Standard Deviation 1.11
|
2.51 score on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Baseline surveyPopulation: participants who completed all 4 items of the short decisional conflict scale. Only 485/494 participants provided enough information to calculate a SURE score.
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).
Outcome measures
| Measure |
Original Shared Decision Making Process Scale
n=227 Participants
Patients receive the original version of the Shared Decision Making Process scale.
|
Revised Shared Decision Making Process Scale
n=258 Participants
This group completes a new version of the scale with different wording for several items.
|
|---|---|---|
|
Decisional Conflict Tool (SURE)
|
63 percentage of patients
|
72 percentage of patients
|
SECONDARY outcome
Timeframe: Baseline surveyPopulation: Participants who answered all 5 decision regret questions. All 494 participants provided enough information to calculate decision regret score.
5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret.
Outcome measures
| Measure |
Original Shared Decision Making Process Scale
n=230 Participants
Patients receive the original version of the Shared Decision Making Process scale.
|
Revised Shared Decision Making Process Scale
n=264 Participants
This group completes a new version of the scale with different wording for several items.
|
|---|---|---|
|
Decision Regret Scale
|
23 score on a scale
Standard Deviation 18
|
21 score on a scale
Standard Deviation 20
|
SECONDARY outcome
Timeframe: Baseline surveyPopulation: participants who answered the single-item regret question.
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.
Outcome measures
| Measure |
Original Shared Decision Making Process Scale
n=230 Participants
Patients receive the original version of the Shared Decision Making Process scale.
|
Revised Shared Decision Making Process Scale
n=264 Participants
This group completes a new version of the scale with different wording for several items.
|
|---|---|---|
|
Single-Item Measure of Decision Regret
Probably yes
|
95 Participants
|
102 Participants
|
|
Single-Item Measure of Decision Regret
Definitely yes
|
119 Participants
|
134 Participants
|
|
Single-Item Measure of Decision Regret
Probably no
|
15 Participants
|
24 Participants
|
|
Single-Item Measure of Decision Regret
Definitely no
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline surveyPopulation: participants who answered the treatment preference question. 493/494 provided information for this question
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.
Outcome measures
| Measure |
Original Shared Decision Making Process Scale
n=230 Participants
Patients receive the original version of the Shared Decision Making Process scale.
|
Revised Shared Decision Making Process Scale
n=263 Participants
This group completes a new version of the scale with different wording for several items.
|
|---|---|---|
|
Treatment Preference
Anti-depressant medicine alone
|
71 Participants
|
91 Participants
|
|
Treatment Preference
Counseling or therapy alone
|
28 Participants
|
28 Participants
|
|
Treatment Preference
Both medicine and counseling
|
125 Participants
|
138 Participants
|
|
Treatment Preference
Do something else
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline surveyPopulation: participants who answered the controlled preference scale question.
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.
Outcome measures
| Measure |
Original Shared Decision Making Process Scale
n=230 Participants
Patients receive the original version of the Shared Decision Making Process scale.
|
Revised Shared Decision Making Process Scale
n=264 Participants
This group completes a new version of the scale with different wording for several items.
|
|---|---|---|
|
Adapted Controlled Preference Scale
Mainly my decision
|
107 Participants
|
125 Participants
|
|
Adapted Controlled Preference Scale
Mainly the healthcare provider's decision
|
32 Participants
|
27 Participants
|
|
Adapted Controlled Preference Scale
We made the decision together
|
91 Participants
|
112 Participants
|
SECONDARY outcome
Timeframe: 1 week after baseline surveyPopulation: A subset of participants who completed the baseline survey (n=200) were re-contacted approximately 1 week post-survey for a retest. Participants who completed the retest survey and provided enough information to calculate the shared decision making process score were part of this analysis. 163/200 participants provided sufficient information to calculate a retest SDM 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 range from 0-4 where higher values indicate a better shared decision making process occurred.
Outcome measures
| Measure |
Original Shared Decision Making Process Scale
n=79 Participants
Patients receive the original version of the Shared Decision Making Process scale.
|
Revised Shared Decision Making Process Scale
n=84 Participants
This group completes a new version of the scale with different wording for several items.
|
|---|---|---|
|
Shared Decision Making Process Measure Retest
|
2.27 score on a scale
Standard Deviation 1.05
|
2.58 score on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Baseline surveyPopulation: participants who completed at least 60% of the knowledge questions for their respective cancer screening group. All 494 participants provided sufficient information to calculate a knowledge score.
Multiple choice knowledge items for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge
Outcome measures
| Measure |
Original Shared Decision Making Process Scale
n=230 Participants
Patients receive the original version of the Shared Decision Making Process scale.
|
Revised Shared Decision Making Process Scale
n=264 Participants
This group completes a new version of the scale with different wording for several items.
|
|---|---|---|
|
Depression Knowledge
|
55.22 percentage of correct answers
Standard Deviation 22.96
|
55.98 percentage of correct answers
Standard Deviation 21.87
|
SECONDARY outcome
Timeframe: Baseline surveyPopulation: participants who completed all 3 measures of adherence to calculate an adherence score. 373/494 provided sufficient information to calculate an adherence score.
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.
Outcome measures
| Measure |
Original Shared Decision Making Process Scale
n=169 Participants
Patients receive the original version of the Shared Decision Making Process scale.
|
Revised Shared Decision Making Process Scale
n=204 Participants
This group completes a new version of the scale with different wording for several items.
|
|---|---|---|
|
Adherence
|
83.6 score on a scale
Standard Deviation 18.47
|
84.79 score on a scale
Standard Deviation 18.25
|
Adverse Events
Original Shared Decision Making Process Scale
Revised Shared Decision Making Process Scale
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place