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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01MH084872-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Shared decision-making (SDM), in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The proposed study will evaluate the impact of a brief SDM nursing intervention among elderly, depressed primary care patient subjects in comparison to physician recommended Usual Care. The focus of the SDM intervention is to empower depressed patients and help them arrive at a treatment decision that can be successfully carried out.
Shared Decision Making (SDM) may be particularly relevant for depressed individuals, as it seeks to enhance their autonomy and empowerment in a manner that directly addresses the helplessness and hopelessness associated with depression. Shared decision-making interventions are being developed for depression in primary care, but have yet to be adequately tested. It is also unknown whether the same premises regarding shared decision-making's ability to enhance autonomy and empowerment pertain to elderly populations.
This randomized study will recruit elderly depressed primary care patient subjects and evaluate the impact of a three-session SDM nursing intervention on their (1) adherence to antidepressant medication or psychotherapy and on (2) their reduction in depressive symptoms. The comparison group will be physician-recommended Usual Care (UC). The focus of the SDM intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.
The study randomizes physicians to provide their depressed patients with SDM or UC. A total of 210 elderly depressed patient subjects whose physicians recommend starting depression treatment, will receive either Shared Decision-Making (SDM) or the physician recommended Usual Care (UC) comparison condition. Participants will be assessed at baseline and at weeks 4, 8, 12, and 24 to determine treatment adherence and depressive status. Nurses currently employed by the participating physicians will administer the SDM intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shared Decision Making | Experimental | 1 in person session followed by 2 telephone calls 1 and 2 weeks later. |
|
| Usual Care | Active Comparator | Physician Usual Care of depressed patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared Decision Making | Behavioral | Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Adhered to Physician Recommended Treatment | Any mental health service use over 12 weeks. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Depression Rating Scale Scores | Hamilton Depression Rating Scale change score from baseline to 12 weeks. This scale measures severity of depressive symptoms (range 0-76), with higher scores indicating more severe symptomatology. | Baseline and 12 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick J. Raue, Ph.D. | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lincoln Hospital - the New York City Health and Hospitals Corporation (HHC) | The Bronx | New York | 10451 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30967321 | Derived | Raue PJ, Schulberg HC, Bruce ML, Banerjee S, Artis A, Espejo M, Catalan I, Romero S. Effectiveness of Shared Decision-Making for Elderly Depressed Minority Primary Care Patients. Am J Geriatr Psychiatry. 2019 Aug;27(8):883-893. doi: 10.1016/j.jagp.2019.02.016. Epub 2019 Mar 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Shared Decision Making | 1 in person session followed by 2 telephone calls 1 and 2 weeks later. Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented. |
| FG001 | Usual Care | Physician Usual Care of depressed patients. Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Shared Decision Making | 1 in person session followed by 2 telephone calls 1 and 2 weeks later. Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented. |
| 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 | Number of Participants Who Adhered to Physician Recommended Treatment | Any mental health service use over 12 weeks. | Posted | Count of Participants | Participants | 12 weeks |
|
24 weeks
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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 | Shared Decision Making | 1 in person session followed by 2 telephone calls 1 and 2 weeks later. Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ER visit | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Raue, Ph.D. | Weill Cornell Medical College | 206-543-3807 | praue@uw.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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|
| Usual Care | Other | Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual. |
|
| Cornell Institute of Geriatric Psychiatry |
| White Plains |
| New York |
| 10605 |
| United States |
| BG001 | Usual Care | Physician Usual Care of depressed patients. Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
Physician Usual Care of depressed patients. Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual. |
|
|
| Secondary | Change in Hamilton Depression Rating Scale Scores | Hamilton Depression Rating Scale change score from baseline to 12 weeks. This scale measures severity of depressive symptoms (range 0-76), with higher scores indicating more severe symptomatology. | fewer number of participants in comparison to primary outcome measure reflect greater numbers of missing observations for the Hamilton outcome | Posted | Mean | Standard Deviation | units on a scale | Baseline and 12 week |
|
|
|
| 1 |
| 114 |
| 49 |
| 114 |
| 0 |
| 114 |
| EG001 | Usual Care | Physician Usual Care of depressed patients. Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual. | 0 | 88 | 47 | 88 | 0 | 88 |
| hospitalization | Surgical and medical procedures | Non-systematic Assessment |
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| hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
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| hospitalization | General disorders | Non-systematic Assessment |
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| ambulatory surgery | Surgical and medical procedures | Non-systematic Assessment |
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| ER visit | Cardiac disorders | Non-systematic Assessment |
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| ER visit | Gastrointestinal disorders | Non-systematic Assessment |
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| ER visit | Infections and infestations | Non-systematic Assessment |
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| ER visit | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| ER visit | Psychiatric disorders | Non-systematic Assessment |
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| ER visit | Renal and urinary disorders | Non-systematic Assessment |
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| ER visit | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| ER visit | Surgical and medical procedures | Non-systematic Assessment |
|
| ER visit | Vascular disorders | Non-systematic Assessment |
|
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