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| Name | Class |
|---|---|
| Foundation for Informed Medical Decision Making | OTHER |
| Massachusetts General Hospital | OTHER |
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The purpose of this randomized controlled trial is to examine the impact of a patient decision aid on the quality of decisions about managing symptoms of depression. In particular, we will examine whether the decision aid increases knowledge about depression/managing depression symptoms and concordance between goals and treatment choices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decision Aid | Experimental | Group receiving the decision aid (DVD/booklet) |
|
| Control | No Intervention | Group not receiving the decision aid (DVD/booklet) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DVD/Booklet: Coping with Symptoms of Depression | Behavioral | DVD and booklet that provides information about treatment choices for depression symptoms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Depression Knowledge | Total knowledge score from factual questions about depression and methods for managing depression symptoms. Score is the percent of knowledge items answered correctly (0 - 100%). | 2 weeks, on average |
| Measure | Description | Time Frame |
|---|---|---|
| Value Concordance | Measure of how concordant respondents' actual decisions about treatment for their depression are with their stated beliefs | 2 weeks, on average |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia M Gallagher, PhD | University of Massachusetts, Boston | Study Director |
| Karen R Sepucha, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Survey Research - University of Massachusetts Boston | Boston | Massachusetts | 02125 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34445969 | Derived | Brodney S, Valentine KD, Sepucha K. Psychometric evaluation of a decision quality instrument for medication decisions for treatment of depression symptoms. BMC Med Inform Decis Mak. 2021 Aug 27;21(1):252. doi: 10.1186/s12911-021-01611-w. |
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Eligible patients received a mailed survey and were randomly selected to receive a DVD or no DVD and booklet about depression.
Patients were recruited through online and newspaper ads by the Center for Survey Research in 17 cities: Atlanta, Baltimore, Boston, Chicago, Dallas-Ft. Worth, Denver, Detroit, Ft. Myers, Houston, Los Angeles, Minneapolis, New York, Phoenix, Portland, Raleigh-Durham, San Francisco, Washington, D.C. August 5, 2010-Jan 10, 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Decision Aid | Group receiving the decision aid (DVD/booklet) |
| FG001 | Control | Group not receiving the decision aid (DVD/booklet) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Decision Aid | Group receiving the decision aid (DVD/booklet) |
| BG001 | Control | Group not receiving the decision aid (DVD/booklet) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Depression Knowledge | Total knowledge score from factual questions about depression and methods for managing depression symptoms. Score is the percent of knowledge items answered correctly (0 - 100%). | Participants were randomized to receive the DVD and booklet. | Posted | Mean | Standard Deviation | percent of correct responses | 2 weeks, on average |
|
August 5, 2010 through January 10, 2011.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Decision Aid | Group receiving the decision aid (DVD/booklet) |
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Those who answered fewer than half of the knowledge questions do not have a total knowledge score (primary outcome).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Sepucha | Massachusetts General Hospital | 617-724-3350 | ksepucha@partners.org |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D003661 | Decision Support Techniques |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
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| Secondary | Value Concordance | Measure of how concordant respondents' actual decisions about treatment for their depression are with their stated beliefs | Not Posted | 2 weeks, on average |
| 0 |
| 191 |
| 0 |
| 191 |
| EG001 | Control | Group not receiving the decision aid (DVD/booklet) | 0 | 214 | 0 | 214 |
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