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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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This study compares the effects of depression screening and case management to usual care in cardiology outpatients with documented evidence of coronary heart disease. Despite strong evidence that depression is a risk factor for cardiac events, there is insufficient evidence to support the use of depression screening in cardiac patients.
Depression and cardiovascular disease are highly comorbid, and depression is a risk factor for psychosocial morbidity, poor adherence to medical treatment regimens, physical inactivity, poor physical functioning, and medical morbidity and mortality in cardiac patients, especially following an acute coronary syndrome (ACS). The American Heart Association recently recommended that all cardiac patients be screened for depression in order to improve identification and treatment of this risk factor.
Patients are screened for depression during an outpatient cardiology visit and those that screen positive will be contacted for enrollment into this study. Patients are then randomized to receive collaborative care involving the patient, the patient's primary care physician (PCP), the cardiologist and the nurse case manager, or usual care (the patient is informed he/she screened positive for depression and is advised to contact their PCP and/or cardiologist). The PCP and/or cardiologist are free to evaluate, treat and refer that patient to mental health services as they deem necessary.
Patients in both groups will be monitored for depression severity and duration at 3, 6 and 12 months after enrollment. The course of their depression since enrollment or last follow-up includes remissions, new onsets, relapses, recurrences, and treatment will be determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care (UC) | No Intervention | Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study. | |
| Collaborative Care (CC) | Experimental | Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collaborative Care | Behavioral | No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory 2 | Self report depression symptom inventory. Scale ranges from 0-63. The higher the score the more depression symptoms. A score of 12 or greater is considered to indicate a clinically significant depression. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Satisfaction Scale. | This one item scale asks patients to rate their satisfaction with their depression treatment on a one (very dissatisfied) to 5 (very satisfied) scale. | 12 months |
| PROMIS Physical Functioning Scale 10a Short Form |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert M. Carney, PhD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Behavioral Medicine Center at Washington University | St Louis | Missouri | 63108 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care (UC) | Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study. |
| FG001 | Collaborative Care (CC) | Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care. Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care (UC) | Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study. |
| BG001 | Collaborative Care (CC) |
| 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 | Beck Depression Inventory 2 | Self report depression symptom inventory. Scale ranges from 0-63. The higher the score the more depression symptoms. A score of 12 or greater is considered to indicate a clinically significant depression. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
One year
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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 | Usual Care (UC) | Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Carney | Washington University School of Medicine | 314-286-1313 | carneyr@wustl.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
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This is a 10 item questionnaire that assesses the respondent's ability to perform common physical activities as rated on a 1-5 scale. The total score is converted to a T score which expresses where the individual ranks relative to the reference group.
| 12 months |
Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.
Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
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| Secondary | Treatment Satisfaction Scale. | This one item scale asks patients to rate their satisfaction with their depression treatment on a one (very dissatisfied) to 5 (very satisfied) scale. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | PROMIS Physical Functioning Scale 10a Short Form | This is a 10 item questionnaire that assesses the respondent's ability to perform common physical activities as rated on a 1-5 scale. The total score is converted to a T score which expresses where the individual ranks relative to the reference group. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
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| 8 |
| 101 |
| 0 |
| 101 |
| 0 |
| 101 |
| EG001 | Collaborative Care (CC) | Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care. Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period. | 1 | 100 | 0 | 100 | 0 | 100 |
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| D002318 |
| Cardiovascular Diseases |
| D014652 | Vascular Diseases |