Depression
Conditions
Keywords
shared decision making
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.
Interventions
None listed
Sponsors
University of Massachusetts, Boston
Massachusetts General Hospital
Study design
Observational model
OTHER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Decision Regret Scale | Baseline survey | 5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret. |
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Original Shared Decision Making Process Scale Patients receive the original version of the Shared Decision Making Process scale. | 230 |
| Revised Shared Decision Making Process Scale This group completes a new version of the scale with different wording for several items. | 264 |
| Total | 494 |
Baseline characteristics
| Characteristic | Original Shared Decision Making Process Scale | Total | Revised Shared Decision Making Process Scale |
|---|---|---|---|
| Age, Continuous | 42 years STANDARD_DEVIATION 14 | 43 years STANDARD_DEVIATION 14 | 44 years STANDARD_DEVIATION 14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 35 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 218 Participants | 459 Participants | 241 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 8 Participants | 14 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 12 Participants | 26 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 13 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 21 Participants | 11 Participants |
| Race (NIH/OMB) White | 193 Participants | 417 Participants | 224 Participants |
| Region of Enrollment United States | 230 Participants | 494 Participants | 264 Participants |
| Sex/Gender, Customized Female | 158 Participants | 355 Participants | 197 Participants |
| Sex/Gender, Customized Male | 72 Participants | 138 Participants | 66 Participants |
| Sex/Gender, Customized Non-Binary | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 230 | 0 / 264 |
| other Total, other adverse events | 0 / 230 | 0 / 264 |
| serious Total, serious adverse events | 0 / 230 | 0 / 264 |
Outcome results
Primary
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.
Time frame: Baseline survey
Population: participants who answered the shared decision making process items and provided sufficient information to calculate a SDM Process score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Original Shared Decision Making Process Scale | Shared Decision Making Process Score | 2.35 score on a scale | Standard Deviation 1.11 |
| Revised Shared Decision Making Process Scale | Shared Decision Making Process Score | 2.51 score on a scale | Standard Deviation 1.05 |
Comparison: SDM Process score distributions were compared to determine of the scores spanned the range of possible values, were normally distributed, had low rates of missing data, and whether there was indications of floor or ceiling effects.~we conducted independent t-tests to determine if there were differences in SDM Process scores between the two versions.p-value: 0.09295% CI: [-0.02, 0.33]t-test, 2 sided
Secondary
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.
Time frame: Baseline survey
Population: participants who answered the controlled preference scale question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Original Shared Decision Making Process Scale | Adapted Controlled Preference Scale | Mainly my decision | 107 Participants |
| Original Shared Decision Making Process Scale | Adapted Controlled Preference Scale | Mainly the healthcare provider's decision | 32 Participants |
| Original Shared Decision Making Process Scale | Adapted Controlled Preference Scale | We made the decision together | 91 Participants |
| Revised Shared Decision Making Process Scale | Adapted Controlled Preference Scale | Mainly my decision | 125 Participants |
| Revised Shared Decision Making Process Scale | Adapted Controlled Preference Scale | We made the decision together | 112 Participants |
| Revised Shared Decision Making Process Scale | Adapted Controlled Preference Scale | Mainly the healthcare provider's decision | 27 Participants |
Secondary
Adherence
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.
Time frame: Baseline survey
Population: participants who completed all 3 measures of adherence to calculate an adherence score. 373/494 provided sufficient information to calculate an adherence score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Original Shared Decision Making Process Scale | Adherence | 83.6 score on a scale | Standard Deviation 18.47 |
| Revised Shared Decision Making Process Scale | Adherence | 84.79 score on a scale | Standard Deviation 18.25 |
Secondary
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. The measure is top-scored and we report the percentage of participants who scored a 4 (no decisional conflict).
Time frame: Baseline survey
Population: participants who completed all 4 items of the short decisional conflict scale. Only 485/494 participants provided enough information to calculate a SURE score.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Original Shared Decision Making Process Scale | Decisional Conflict Tool (SURE) | 63 percentage of patients |
| Revised Shared Decision Making Process Scale | Decisional Conflict Tool (SURE) | 72 percentage of patients |
Secondary
Decision Regret Scale
5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret.
Time frame: Baseline survey
Population: Participants who answered all 5 decision regret questions. All 494 participants provided enough information to calculate decision regret score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Original Shared Decision Making Process Scale | Decision Regret Scale | 23 score on a scale | Standard Deviation 18 |
| Revised Shared Decision Making Process Scale | Decision Regret Scale | 21 score on a scale | Standard Deviation 20 |
Secondary
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
Time frame: Baseline survey
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Original Shared Decision Making Process Scale | Depression Knowledge | 55.22 percentage of correct answers | Standard Deviation 22.96 |
| Revised Shared Decision Making Process Scale | Depression Knowledge | 55.98 percentage of correct answers | Standard Deviation 21.87 |
Secondary
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.
Time frame: 1 week after baseline survey
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Original Shared Decision Making Process Scale | Shared Decision Making Process Measure Retest | 2.27 score on a scale | Standard Deviation 1.05 |
| Revised Shared Decision Making Process Scale | Shared Decision Making Process Measure Retest | 2.58 score on a scale | Standard Deviation 0.97 |
Secondary
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.
Time frame: Baseline survey
Population: participants who answered the single-item regret question.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Original Shared Decision Making Process Scale | Single-Item Measure of Decision Regret | Probably yes | 95 Participants |
| Original Shared Decision Making Process Scale | Single-Item Measure of Decision Regret | Definitely no | 1 Participants |
| Original Shared Decision Making Process Scale | Single-Item Measure of Decision Regret | Probably no | 15 Participants |
| Original Shared Decision Making Process Scale | Single-Item Measure of Decision Regret | Definitely yes | 119 Participants |
| Revised Shared Decision Making Process Scale | Single-Item Measure of Decision Regret | Probably no | 24 Participants |
| Revised Shared Decision Making Process Scale | Single-Item Measure of Decision Regret | Definitely yes | 134 Participants |
| Revised Shared Decision Making Process Scale | Single-Item Measure of Decision Regret | Probably yes | 102 Participants |
| Revised Shared Decision Making Process Scale | Single-Item Measure of Decision Regret | Definitely no | 4 Participants |
Secondary
Treatment Preference
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.
Time frame: Baseline survey
Population: participants who answered the treatment preference question. 493/494 provided information for this question
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Original Shared Decision Making Process Scale | Treatment Preference | Anti-depressant medicine alone | 71 Participants |
| Original Shared Decision Making Process Scale | Treatment Preference | Counseling or therapy alone | 28 Participants |
| Original Shared Decision Making Process Scale | Treatment Preference | Both medicine and counseling | 125 Participants |
| Original Shared Decision Making Process Scale | Treatment Preference | Do something else | 6 Participants |
| Revised Shared Decision Making Process Scale | Treatment Preference | Do something else | 6 Participants |
| Revised Shared Decision Making Process Scale | Treatment Preference | Anti-depressant medicine alone | 91 Participants |
| Revised Shared Decision Making Process Scale | Treatment Preference | Both medicine and counseling | 138 Participants |
| Revised Shared Decision Making Process Scale | Treatment Preference | Counseling or therapy alone | 28 Participants |