{"protocolSection":{"identificationModule":{"nctId":"NCT01993017","orgStudyIdInfo":{"id":"AAAK9253"},"secondaryIdInfos":[{"id":"1R01HL114924","type":"NIH","link":"https://reporter.nih.gov/quickSearch/1R01HL114924"}],"organization":{"fullName":"Columbia University","class":"OTHER"},"briefTitle":"Comparison of Depression Identification After Acute Coronary Syndrome: Quality of Life and Cost Outcomes","officialTitle":"Depression Screening RCT in ACS Patients: Quality of Life and Cost Outcomes","acronym":"CODIACSQoL"},"statusModule":{"statusVerifiedDate":"2023-04","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-11","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2018-07-31","type":"ACTUAL"},"completionDateStruct":{"date":"2019-07-31","type":"ACTUAL"},"studyFirstSubmitDate":"2013-11-19","studyFirstSubmitQcDate":"2013-11-19","studyFirstPostDateStruct":{"date":"2013-11-25","type":"ESTIMATED"},"resultsFirstSubmitDate":"2019-10-24","resultsFirstSubmitQcDate":"2019-12-03","resultsFirstPostDateStruct":{"date":"2019-12-18","type":"ACTUAL"},"lastUpdateSubmitDate":"2023-04-12","lastUpdatePostDateStruct":{"date":"2023-04-14","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"PRINCIPAL_INVESTIGATOR","investigatorFullName":"Ian Kronish","investigatorTitle":"Associate Professor of Medicine","investigatorAffiliation":"Columbia University"},"leadSponsor":{"name":"Columbia University","class":"OTHER"},"collaborators":[{"name":"National Heart, Lung, and Blood Institute (NHLBI)","class":"NIH"},{"name":"Duke University","class":"OTHER"},{"name":"HealthPartners Institute","class":"OTHER"},{"name":"Kaiser Foundation Research Institute","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"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.","detailedDescription":"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.\n\nTwo 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."},"conditionsModule":{"conditions":["Acute Coronary Syndrome","Depressive Symptoms"],"keywords":["Acute Coronary Syndrome","Depressive Symptoms"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["NA"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"SCREENING","maskingInfo":{"masking":"SINGLE","whoMasked":["OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":1501,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"AHA Depression Screen & Treat","type":"EXPERIMENTAL","description":"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 brief, cognitive behavioral therapy (CBT), 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.","interventionNames":["Other: Cognitive Behavioral Therapy (CBT)","Drug: Antidepressant Medication","Other: Depressive symptom screener"]},{"label":"Depression Screen & Notify Arm Type :","type":"ACTIVE_COMPARATOR","description":"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.","interventionNames":["Other: Standard Care","Other: Depressive symptom screener"]},{"label":"No Depression Screen","type":"PLACEBO_COMPARATOR","description":"Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.","interventionNames":["Other: No intervention"]}],"interventions":[{"type":"OTHER","name":"Cognitive Behavioral Therapy (CBT)","description":"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.\n\nCBT 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 .","armGroupLabels":["AHA Depression Screen & Treat"],"otherNames":["Problem Solving Therapy (PST)"]},{"type":"DRUG","name":"Antidepressant Medication","description":"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.\n\nAntidepressants 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.","armGroupLabels":["AHA Depression Screen & Treat"],"otherNames":["Sertraline","Bupropion"]},{"type":"OTHER","name":"Standard Care","description":"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.","armGroupLabels":["Depression Screen & Notify Arm Type :"]},{"type":"OTHER","name":"Depressive symptom screener","description":"8-item Patient Health Questionnaire, PHQ-8","armGroupLabels":["AHA Depression Screen & Treat","Depression Screen & Notify Arm Type :"],"otherNames":["PHQ-8"]},{"type":"OTHER","name":"No intervention","armGroupLabels":["No Depression Screen"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Quality-Adjusted Life Years (QALYs)","description":"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.","timeFrame":"Baseline, 6, 12 and 18 months"}],"secondaryOutcomes":[{"measure":"Depression-free Days","description":"Depression-free days from baseline through 18 months post-randomization","timeFrame":"Baseline through 18 months"},{"measure":"Cost of Health Care Utilization","description":"Total cost of health care utilization from baseline through 18 months post-randomization","timeFrame":"Baseline through 18 months"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* With a documented acute coronary syndrome (ACS) within the past 2-12 months\n* Over the age of 21 years\n* Has access to a phone\n\nExclusion Criteria:\n\nMedical Exclusions:\n\n* Terminal illness (life expectancy \\<1 year as determined by physician/medical record) defined as, but not limited to:\n* NYHA class IV, ACC class D CHF requiring inotropes or mechanical assist devices or critical aortic stenosis without plan for correction\n* End-stage COPD/emphysema\n* Advanced cirrhosis with encephalopathy, varices, severe ascites\n* Severe rheumatologic diseases requiring frequent hospitalizations, and multiple cytotoxic agents and/or disease modifying drugs\n* Metastatic pancreatic, esophageal, colorectal or stomach cancer\n* Metastatic sarcoma, ovarian, melanoma or renal cell cancer\n* Metastatic breast cancer with multiple recurrences despite treatment\n* Advanced CNS malignancies\n* Recurrent hematologic malignancies with multiple recurrences despite treatment\n* Persistent AIDS, untreated or treated\n\nPsychiatric Exclusions:\n\n* History of major depression\n* Currently receiving depression treatment\n* Dementia\n* History of bipolar disorder\n* History of psychosis\n* History of suicide attempt or self-inflicted injuries\n* Current alcohol or substance abuse\n\nOther Exclusions:\n\n* Non-English and non-Spanish speaking","healthyVolunteers":false,"sex":"ALL","minimumAge":"21 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Ian M Kronish, MD, MPH","affiliation":"Columbia University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Health Partners institute for Research and Education","city":"Bloomington","state":"Minnesota","zip":"55440","country":"United States","geoPoint":{"lat":44.8408,"lon":-93.29828}},{"facility":"Columbia University Irving Medical Center","city":"New York","state":"New York","zip":"10032","country":"United States","geoPoint":{"lat":40.71427,"lon":-74.00597}},{"facility":"Duke University","city":"Henderson","state":"North Carolina","zip":"27536","country":"United States","geoPoint":{"lat":36.32959,"lon":-78.39916}},{"facility":"Kaiser Foundation Research Institute","city":"Portland","state":"Oregon","zip":"97227","country":"United States","geoPoint":{"lat":45.52345,"lon":-122.67621}}]},"referencesModule":{"references":[{"pmid":"31419605","type":"BACKGROUND","citation":"Moise N, Davidson KW, Cheung YKK, Clarke GN, Dolor RJ, Duer-Hefele J, Ladapo JA, Margolis KL, St Onge T, Parsons F, Retuerto J, Schmit KM, Thanataveerat A, Kronish IM. Rationale, design, and baseline data for a multicenter randomized clinical trial comparing depression screening strategies after acute coronary syndrome: The comparison of depression identification after acute Coronary Syndromes-Quality of Life and Cost Outcomes (CODIACS-QOL) trial. Contemp Clin Trials. 2019 Sep;84:105826. doi: 10.1016/j.cct.2019.105826. Epub 2019 Aug 13."},{"pmid":"31633746","type":"RESULT","citation":"Kronish IM, Moise N, Cheung YK, Clarke GN, Dolor RJ, Duer-Hefele J, Margolis KL, St Onge T, Parsons F, Retuerto J, Thanataveerat A, Davidson KW. Effect of Depression Screening After Acute Coronary Syndromes on Quality of Life: The CODIACS-QoL Randomized Clinical Trial. JAMA Intern Med. 2020 Jan 1;180(1):45-53. doi: 10.1001/jamainternmed.2019.4518."},{"pmid":"33933921","type":"RESULT","citation":"Ladapo JA, Davidson KW, Moise N, Chen A, Clarke GN, Dolor RJ, Margolis KL, Thanataveerat A, Kronish IM. Economic outcomes of depression screening after acute coronary syndromes: The CODIACS-QoL randomized clinical trial. Gen Hosp Psychiatry. 2021 Jul-Aug;71:47-54. doi: 10.1016/j.genhosppsych.2021.04.001. Epub 2021 Apr 3."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"A deidentified data set and study materials will be provided upon request by other researchers.","infoTypes":["STUDY_PROTOCOL","SAP","ICF","ANALYTIC_CODE"],"timeFrame":"Starting in January 2021","accessCriteria":"Contact the study PI with data requests"}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"1 participant withdrew consent soon after randomization, and this participant's data was excluded from the study.","recruitmentDetails":"Recruitment period: November 1, 2013 to March 31, 2017\n\nRecruitment 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)","groups":[{"id":"FG000","title":"AHA Depression Screen, Notify & Treat","description":"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 brief, type of 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."},{"id":"FG001","title":"Depression Screen & Notify","description":"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.\n\nStandard 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.\n\nDepressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8"},{"id":"FG002","title":"No Depression Screen","description":"Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.\n\nNo intervention"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"499"},{"groupId":"FG001","numSubjects":"501"},{"groupId":"FG002","numSubjects":"500"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"393"},{"groupId":"FG001","numSubjects":"411"},{"groupId":"FG002","numSubjects":"421"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"106"},{"groupId":"FG001","numSubjects":"90"},{"groupId":"FG002","numSubjects":"79"}]}],"dropWithdraws":[{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"26"},{"groupId":"FG002","numSubjects":"18"}]},{"type":"Could not be contacted","reasons":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"42"},{"groupId":"FG002","numSubjects":"38"}]},{"type":"Dropped out","reasons":[{"groupId":"FG000","numSubjects":"19"},{"groupId":"FG001","numSubjects":"6"},{"groupId":"FG002","numSubjects":"11"}]},{"type":"Other reasons","reasons":[{"groupId":"FG000","numSubjects":"17"},{"groupId":"FG001","numSubjects":"11"},{"groupId":"FG002","numSubjects":"7"}]},{"type":"Ineligible after randomization","reasons":[{"groupId":"FG000","numSubjects":"4"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"5"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"AHA Depression Screen, Notify & Treat","description":"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."},{"id":"BG001","title":"Depression Screen & Notify","description":"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.\n\nStandard 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.\n\nDepressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8"},{"id":"BG002","title":"No Depression Screen","description":"Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.\n\nNo intervention"},{"id":"BG003","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"499"},{"groupId":"BG001","value":"501"},{"groupId":"BG002","value":"500"},{"groupId":"BG003","value":"1500"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"499"},{"groupId":"BG001","value":"501"},{"groupId":"BG002","value":"500"},{"groupId":"BG003","value":"1500"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"66.2","spread":"11.3"},{"groupId":"BG001","value":"65.8","spread":"11.7"},{"groupId":"BG002","value":"65.8","spread":"11.7"},{"groupId":"BG003","value":"65.9","spread":"11.5"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"499"},{"groupId":"BG001","value":"501"},{"groupId":"BG002","value":"500"},{"groupId":"BG003","value":"1500"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"142"},{"groupId":"BG001","value":"137"},{"groupId":"BG002","value":"145"},{"groupId":"BG003","value":"424"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"357"},{"groupId":"BG001","value":"364"},{"groupId":"BG002","value":"355"},{"groupId":"BG003","value":"1076"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"499"},{"groupId":"BG001","value":"501"},{"groupId":"BG002","value":"500"},{"groupId":"BG003","value":"1500"}]}],"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"82"},{"groupId":"BG001","value":"88"},{"groupId":"BG002","value":"74"},{"groupId":"BG003","value":"244"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"406"},{"groupId":"BG001","value":"402"},{"groupId":"BG002","value":"410"},{"groupId":"BG003","value":"1218"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"16"},{"groupId":"BG003","value":"38"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"White","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"499"},{"groupId":"BG001","value":"501"},{"groupId":"BG002","value":"500"},{"groupId":"BG003","value":"1500"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"353"},{"groupId":"BG001","value":"368"},{"groupId":"BG002","value":"359"},{"groupId":"BG003","value":"1080"}]}]},{"title":"Black","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"499"},{"groupId":"BG001","value":"501"},{"groupId":"BG002","value":"500"},{"groupId":"BG003","value":"1500"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"47"},{"groupId":"BG001","value":"37"},{"groupId":"BG002","value":"46"},{"groupId":"BG003","value":"130"}]}]},{"title":"Other","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"499"},{"groupId":"BG001","value":"501"},{"groupId":"BG002","value":"500"},{"groupId":"BG003","value":"1500"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"92"},{"groupId":"BG001","value":"82"},{"groupId":"BG002","value":"85"},{"groupId":"BG003","value":"259"}]}]},{"title":"Refused or unknown","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"499"},{"groupId":"BG001","value":"501"},{"groupId":"BG002","value":"500"},{"groupId":"BG003","value":"1500"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"10"},{"groupId":"BG003","value":"31"}]}]}]},{"title":"Region of Enrollment","paramType":"NUMBER","unitOfMeasure":"participants","classes":[{"title":"United States","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"499"},{"groupId":"BG001","value":"501"},{"groupId":"BG002","value":"500"},{"groupId":"BG003","value":"1500"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"499"},{"groupId":"BG001","value":"501"},{"groupId":"BG002","value":"500"},{"groupId":"BG003","value":"1500"}]}]}]},{"title":"PHQ-8 Score >= 10","populationDescription":"PHQ-8 data were not collected at Baseline in the \"No Depression Screen\" Arm/Group).","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"494"},{"groupId":"BG001","value":"501"},{"groupId":"BG002","value":"0"},{"groupId":"BG003","value":"995"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"38"},{"groupId":"BG001","value":"33"},{"groupId":"BG003","value":"71"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Quality-Adjusted Life Years (QALYs)","description":"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.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"quality-adjusted life years (QALYs)","timeFrame":"Baseline, 6, 12 and 18 months","groups":[{"id":"OG000","title":"AHA Depression Screen, Notify & Treat","description":"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 brief, type of 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."},{"id":"OG001","title":"Depression Screen & Notify","description":"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.\n\nStandard 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.\n\nDepressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8"},{"id":"OG002","title":"No Depression Screen","description":"Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.\n\nNo intervention"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"499"},{"groupId":"OG001","value":"501"},{"groupId":"OG002","value":"500"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.06","spread":"0.20"},{"groupId":"OG001","value":"-0.06","spread":"0.20"},{"groupId":"OG002","value":"-0.06","spread":"0.18"}]}]}],"analyses":[{"groupIds":["OG000","OG001","OG002"],"groupDescription":"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.","nonInferiorityType":"SUPERIORITY","pValue":"0.98","pValueComment":"A 2-step gatekeeping test procedure was used. An omnibus F test using ANOVA comparing the 3 groups was first performed. Pairwise comparisons using a 2-sided t test at 5% nominal significance were planned only if the omnibus F test had a P value \\<.05.","statisticalMethod":"ANOVA"}]},{"type":"SECONDARY","title":"Depression-free Days","description":"Depression-free days from baseline through 18 months post-randomization","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"cumulative depression-free days","timeFrame":"Baseline through 18 months","groups":[{"id":"OG000","title":"AHA Depression Screen, Notify & Treat","description":"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 brief, type of 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."},{"id":"OG001","title":"Depression Screen & Notify","description":"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.\n\nStandard 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.\n\nDepressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8"},{"id":"OG002","title":"No Depression Screen","description":"Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.\n\nNo intervention"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"499"},{"groupId":"OG001","value":"501"},{"groupId":"OG002","value":"500"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"343.1","spread":"179.0"},{"groupId":"OG001","value":"351.3","spread":"175.0"},{"groupId":"OG002","value":"339.0","spread":"176.6"}]}]}]},{"type":"SECONDARY","title":"Cost of Health Care Utilization","description":"Total cost of health care utilization from baseline through 18 months post-randomization","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"US dollars","timeFrame":"Baseline through 18 months","groups":[{"id":"OG000","title":"AHA Depression Screen, Notify & Treat","description":"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."},{"id":"OG001","title":"Depression Screen & Notify","description":"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.\n\nStandard 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.\n\nDepressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8"},{"id":"OG002","title":"No Depression Screen","description":"Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.\n\nNo intervention"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"499"},{"groupId":"OG001","value":"501"},{"groupId":"OG002","value":"500"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"6745","spread":"358"},{"groupId":"OG001","value":"6204","spread":"332"},{"groupId":"OG002","value":"7440","spread":"501"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"0","timeFrame":"18 months","description":"Serious Adverse Events and mortality were assessed in all participants.\n\nOther Adverse Events were assessed using a self-report instrument at 6-mo, 12-mo, and 18-mo. As not all participants were reached to complete this questionnaire, fewer participants were assessed for Other Adverse Events than for Serious Adverse Events and mortality. Also, the number of participants who were assessed for Other Adverse Events varies according to the time period of assessment.","eventGroups":[{"id":"EG000","title":"AHA Depression Screen, Notify & Treat","description":"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 brief, type of 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.","deathsNumAffected":23,"deathsNumAtRisk":499,"seriousNumAffected":0,"seriousNumAtRisk":499,"otherNumAffected":386,"otherNumAtRisk":450},{"id":"EG001","title":"Depression Screen & Notify","description":"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.\n\nStandard 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.\n\nDepressive symptom screener: 8-item Patient Health Questionnaire, PHQ-8","deathsNumAffected":26,"deathsNumAtRisk":501,"seriousNumAffected":0,"seriousNumAtRisk":501,"otherNumAffected":398,"otherNumAtRisk":455},{"id":"EG002","title":"No Depression Screen","description":"Participants randomized to this arm will not complete a PHQ-8 assessment at randomization, and so will not be screened for depressive symptoms.\n\nNo 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appetite","stats":[{"groupId":"EG000","numAffected":72,"numAtRisk":450},{"groupId":"EG001","numAffected":74,"numAtRisk":455},{"groupId":"EG002","numAffected":76,"numAtRisk":457}]},{"term":"Drowsiness at 6 mo","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Self-report of drowsiness","stats":[{"groupId":"EG000","numAffected":218,"numAtRisk":450},{"groupId":"EG001","numAffected":212,"numAtRisk":455},{"groupId":"EG002","numAffected":217,"numAtRisk":458}]},{"term":"Gastrointestinal upset at 6 mo","organSystem":"Gastrointestinal disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","notes":"Self-report of gastrointestinal upset","stats":[{"groupId":"EG000","numAffected":128,"numAtRisk":450},{"groupId":"EG001","numAffected":116,"numAtRisk":454},{"groupId":"EG002","numAffected":112,"numAtRisk":457}]},{"term":"Any bleeding at 12 mo","organSystem":"Blood and lymphatic system disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":51,"numAtRisk":423},{"groupId":"EG001","numAffected":50,"numAtRisk":429},{"groupId":"EG002","numAffected":50,"numAtRisk":427}]},{"term":"Increased appetite at 12 mo","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":71,"numAtRisk":423},{"groupId":"EG001","numAffected":77,"numAtRisk":431},{"groupId":"EG002","numAffected":76,"numAtRisk":427}]},{"term":"Decreased appetite at 12 mo","organSystem":"Psychiatric disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":63,"numAtRisk":423},{"groupId":"EG001","numAffected":65,"numAtRisk":431},{"groupId":"EG002","numAffected":76,"numAtRisk":427}]},{"term":"Drowsiness at 12 mo","organSystem":"Psychiatric 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disorders","assessmentType":"SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":98,"numAtRisk":394},{"groupId":"EG001","numAffected":99,"numAtRisk":410},{"groupId":"EG002","numAffected":100,"numAtRisk":418}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Ian Kronish, MD, MPH, Principal Investigator","organization":"Center for Behavioral Cardiovascular Health","email":"ik2293@columbia.edu","phone":"212-342-1335"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot","hasProtocol":true,"hasSap":false,"hasIcf":false,"label":"Study Protocol","date":"2021-07-20","uploadDate":"2021-11-10T10:11","filename":"Prot_002.pdf","size":311148},{"typeAbbrev":"SAP","hasProtocol":false,"hasSap":true,"hasIcf":false,"label":"Statistical Analysis 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