Acute Coronary Syndrome, Depressive Symptoms
Conditions
Keywords
Acute Coronary Syndrome, Depressive Symptoms
Brief summary
The purpose of this study is to examine, in a randomized controlled trial, the benefits and costs of the American Heart Association's (AHA) advisory for depression screen and treatment of post-acute coronary syndrome patients.
Detailed description
Patients with an acute coronary syndrome (ACS) and comorbid depression have a 2-fold higher risk for recurrent ACS and mortality, worse quality of life, and higher costs of care than nondepressed ACS patients. The strength of these observational findings prompted the American Heart Association (AHA) to advise that routine depression screening for ACS patients and referral for depression diagnosis and treatment as indicated occur. Unfortunately, there are no randomized controlled trials (RCT) to inform this potentially expensive screening recommendation. Additionally, screening guidelines/advisories in the absence of RCT evidence have recently been extensively criticized (and withdrawn). This poses a serious dilemma for clinicians, health care systems, and for health care policy leaders. A RCT is urgently needed to provide evidence for these different constituents about the costs and benefits of the AHA depression screen and treat algorithm. Two critical gaps in knowledge must be filled to determine if public health would be improved by the AHA strategy for depression screening in post-ACS patients: 1) Does this strategy improve quality-adjusted life years for patients with a recent ACS 2) Is the cost of providing depression screening and any type of depression treatment within the acceptable and typical amounts reimbursed for health care services? Our specific aim is to determine the quality-adjusted life year benefits and health care costs of following the AHA's advisory for depression screening and then referral for further diagnosis and treatment in post-ACS patients, if depression is found. To accomplish this aim, we will randomize patients from four different, geographically diverse health care systems to three different groups: 1) to the AHA depression screen and treat if depression is found algorithm (screen and treat intervention group) or: 2) to be screened and a primary care provider notified (screen and notify intervention group) or: 3) to receive no depression screening (control group). Health-related quality of life, depressive symptoms, and costs will be obtained from all patients, so that the benefits and the costs of these three different depression screening strategies can be compared.
Interventions
OTHERCognitive Behavioral Therapy (CBT)
The main intervention is the impact of screening on quality of life and health care costs. CBT is provided only if depressive symptoms are detected and participant prefers this type of treatment. CBT will be centrally telephone-administered by a trained CBT treatment specialist. The treatment specialist will work with local team members throughout a participant's involvement in the study, and will closely follow each participant until he or she has reached a requisite level of improvement .
The main intervention is the impact of screening on quality of life and health care costs. Antidepressant Medication is provided only if depressive symptoms are detected and patient prefers this type of treatment. Antidepressants should be started at the lowest dose, but should be adjusted upward to be within the therapeutic range within 1 week, with further adjustment higher in the therapeutic range possible at 3-4 weeks. Dosage of the first medication selected will be in the therapeutic range by 3 weeks of the initial step, as tolerated.
OTHERStandard Care
Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.
OTHERDepressive symptom screener
8-item Patient Health Questionnaire, PHQ-8
OTHERNo intervention
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Duke University
HealthPartners Institute
Kaiser Foundation Research Institute
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* With a documented acute coronary syndrome (ACS) within the past 2-12 months * Over the age of 21 years * Has access to a phone
Exclusion criteria
Medical Exclusions: * Terminal illness (life expectancy \<1 year as determined by physician/medical record) defined as, but not limited to: * NYHA class IV, ACC class D CHF requiring inotropes or mechanical assist devices or critical aortic stenosis without plan for correction * End-stage COPD/emphysema * Advanced cirrhosis with encephalopathy, varices, severe ascites * Severe rheumatologic diseases requiring frequent hospitalizations, and multiple cytotoxic agents and/or disease modifying drugs * Metastatic pancreatic, esophageal, colorectal or stomach cancer * Metastatic sarcoma, ovarian, melanoma or renal cell cancer * Metastatic breast cancer with multiple recurrences despite treatment * Advanced CNS malignancies * Recurrent hematologic malignancies with multiple recurrences despite treatment * Persistent AIDS, untreated or treated Psychiatric Exclusions: * History of major depression * Currently receiving depression treatment * Dementia * History of bipolar disorder * History of psychosis * History of suicide attempt or self-inflicted injuries * Current alcohol or substance abuse Other Exclusions: * Non-English and non-Spanish speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality-Adjusted Life Years (QALYs) | Baseline, 6, 12 and 18 months | Change in QALYs from baseline through 18 months. QALYs are a generic measure of disease burden, including both the quality and the quantity of life lived. One QALY equates to one year in perfect health. To measure change in QALYs, utility scores \[an overall assessment of well-being on a scale from 0 (death) to 1 (perfect health)\], were estimated using the Short Form-6 dimension, with scores derived from responses to the 12-Item Short-Form Health Survey, version 2, at baseline and 6, 12, and 18 months. QALYs for the period from baseline to 18 months were then calculated as the area under the curve by linearly interpolating the utility scores at the 4 assessments. Change in QALYs was then obtained by subtracting the baseline QALY from the observed QALY for an 18-month period, where baseline QALY was calculated under the assumption that the baseline utility score remained constant during the 18-month period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression-free Days | Baseline through 18 months | Depression-free days from baseline through 18 months post-randomization |
| Cost of Health Care Utilization | Baseline through 18 months | Total cost of health care utilization from baseline through 18 months post-randomization |
Countries
United States
Participant flow
Recruitment details
Recruitment period: November 1, 2013 to March 31, 2017 Recruitment sites: HealthPartners (Minneapolis, Minnesota), Duke University Health System (Durham, North Carolina), Kaiser Permanente Northwest (Portland, Oregon), and New York-Presbyterian/Columbia University Irving Medical Center (New York, New York)
Pre-assignment details
1 participant withdrew consent soon after randomization, and this participant's data was excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| AHA Depression Screen, Notify & Treat Participants randomized to this arm will complete the Depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will be offered treatment. Treatment will be delivered according to participant preference, and will be managed according to stepped care. Stepped care includes, a) participant preference for either a type of brief, cognitive behavioral therapy (CBT) called problem solving therapy (PST), delivered centrally by telephone, or antidepressant medication managed at the local site, or both, or neither, and b) review of progress at approximately 2-month intervals, with stepping up of care if sufficient progress is not being realized. | 499 |
| Depression Screen & Notify Participants randomized to this arm will complete the depressive symptom screener (8-item Patient Health Questionnaire, PHQ-8) after randomization. Those with clinically significant score (\>=10) will have a letter sent to their primary care provider about their positive screen for depressive symptoms, with subsequent actions at the provider's discretion.
Standard Care: Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.
Depressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8 | 501 |
| No Depression Screen Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.
No intervention | 500 |
| Total | 1,500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Could not be contacted | 43 | 42 | 38 |
| Overall Study | Death | 23 | 26 | 18 |
| Overall Study | Dropped out | 19 | 6 | 11 |
| Overall Study | Ineligible after randomization | 4 | 5 | 5 |
| Overall Study | Other reasons | 17 | 11 | 7 |
Baseline characteristics
| Characteristic | Depression Screen & Notify | No Depression Screen | Total | AHA Depression Screen, Notify & Treat |
|---|---|---|---|---|
| Age, Continuous | 65.8 years STANDARD_DEVIATION 11.7 | 65.8 years STANDARD_DEVIATION 11.7 | 65.9 years STANDARD_DEVIATION 11.5 | 66.2 years STANDARD_DEVIATION 11.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 88 Participants | 74 Participants | 244 Participants | 82 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 402 Participants | 410 Participants | 1218 Participants | 406 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 11 Participants | 16 Participants | 38 Participants | 11 Participants |
| PHQ-8 Score >= 10 | 33 Participants | — | 71 Participants | 38 Participants |
| Race/Ethnicity, Customized Black | 37 Participants | 46 Participants | 130 Participants | 47 Participants |
| Race/Ethnicity, Customized Other | 82 Participants | 85 Participants | 259 Participants | 92 Participants |
| Race/Ethnicity, Customized Refused or unknown | 14 Participants | 10 Participants | 31 Participants | 7 Participants |
| Race/Ethnicity, Customized White | 368 Participants | 359 Participants | 1080 Participants | 353 Participants |
| Region of Enrollment United States | 501 participants | 500 participants | 1500 participants | 499 participants |
| Sex: Female, Male Female | 137 Participants | 145 Participants | 424 Participants | 142 Participants |
| Sex: Female, Male Male | 364 Participants | 355 Participants | 1076 Participants | 357 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 23 / 499 | 26 / 501 | 18 / 500 |
| other Total, other adverse events | 386 / 450 | 398 / 455 | 399 / 458 |
| serious Total, serious adverse events | 0 / 499 | 0 / 501 | 0 / 500 |
Outcome results
Primary
Quality-Adjusted Life Years (QALYs)
Change in QALYs from baseline through 18 months. QALYs are a generic measure of disease burden, including both the quality and the quantity of life lived. One QALY equates to one year in perfect health. To measure change in QALYs, utility scores \[an overall assessment of well-being on a scale from 0 (death) to 1 (perfect health)\], were estimated using the Short Form-6 dimension, with scores derived from responses to the 12-Item Short-Form Health Survey, version 2, at baseline and 6, 12, and 18 months. QALYs for the period from baseline to 18 months were then calculated as the area under the curve by linearly interpolating the utility scores at the 4 assessments. Change in QALYs was then obtained by subtracting the baseline QALY from the observed QALY for an 18-month period, where baseline QALY was calculated under the assumption that the baseline utility score remained constant during the 18-month period.
Time frame: Baseline, 6, 12 and 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AHA Depression Screen, Notify & Treat | Quality-Adjusted Life Years (QALYs) | -0.06 quality-adjusted life years (QALYs) | Standard Deviation 0.2 |
| Depression Screen & Notify | Quality-Adjusted Life Years (QALYs) | -0.06 quality-adjusted life years (QALYs) | Standard Deviation 0.2 |
| No Depression Screen | Quality-Adjusted Life Years (QALYs) | -0.06 quality-adjusted life years (QALYs) | Standard Deviation 0.18 |
Comparison: We determined that a sample size per group of 500, assuming 5% loss to follow-up, would yield 80% power for a 2-sided t test at the 5% level. These calculations were based on an assumed SD for QALYs of 0.17, expected prevalence of screening-detected depression of 20%, and assumed net improvement in QALYs of 0.155 over 18 months for individuals with depression who received treatment for depression in the Screen, Notify, and Treat group.p-value: 0.98ANOVA
Secondary
Cost of Health Care Utilization
Total cost of health care utilization from baseline through 18 months post-randomization
Time frame: Baseline through 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AHA Depression Screen, Notify & Treat | Cost of Health Care Utilization | 6745 US dollars | Standard Error 358 |
| Depression Screen & Notify | Cost of Health Care Utilization | 6204 US dollars | Standard Error 332 |
| No Depression Screen | Cost of Health Care Utilization | 7440 US dollars | Standard Error 501 |
Secondary
Depression-free Days
Depression-free days from baseline through 18 months post-randomization
Time frame: Baseline through 18 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AHA Depression Screen, Notify & Treat | Depression-free Days | 343.1 cumulative depression-free days | Standard Deviation 179 |
| Depression Screen & Notify | Depression-free Days | 351.3 cumulative depression-free days | Standard Deviation 175 |
| No Depression Screen | Depression-free Days | 339.0 cumulative depression-free days | Standard Deviation 176.6 |