[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656595":3},{"organization":4,"outcomesModule":7,"designInfo":54,"detailedDescription":60,"studyPopulation":53,"armGroups":61,"interventions":71,"overallOfficials":77,"centralContacts":81,"locations":87,"responsibleParty":100,"collaborators":103,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":108,"sex":114,"minAge":115,"maxAge":53,"enrollmentInfo":116,"targetDuration":53,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":129,"whyStopped":53,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Corewell Health West","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":28,"otherOutcomes":53},[9,13,16,19,22,25],{"measure":10,"description":11,"timeFrame":12},"Patient Participation Rates","Number of patients who agree to study in comparison to number of patients that decline","1 year",{"measure":14,"description":15,"timeFrame":12},"Medical assistant (MA) training and ability of MAs to conduct accurate POCUS-based estimates of EF","Of the medical assistant's trained for the study how many are successful at the implementation of POCUS for accurate LVEF prediction in comparison to those trained that are unsuccessful at utilizing POCUS for LVEF prediction",{"measure":17,"description":18,"timeFrame":12},"Clinic adherence to the protocol","The number of protocol deviations that occur during study timeframe.",{"measure":20,"description":21,"timeFrame":12},"Ability to conduct randomization and provide same-day POCUS results","On the day of randomization how many treatment patients receive same day POCUS results in comparison to the treatment patients that don't receive same day results",{"measure":23,"description":24,"timeFrame":12},"How many days between HFrEF diagnosis and initiation of GDMT protocols","For both the treatment and non-treatment groups how days between HFeEF diagnosis and the start of GDMT protocols",{"measure":26,"description":27,"timeFrame":12},"Implementation and completion rates of patient and provider quantitative and qualitative questionnaires on the burden and benefits of using POCUS in a clinical setting","Number of questionnaires filled out in comparison to the number of blank or missed questionnaires.",[29,33,37,40,43,47,50],{"measure":30,"description":31,"timeFrame":32},"Magnitude of effect between pocus treatment and standard of care on the time to HFrEF diagnosis and GDMT initiation.","Quantifying the magnitude\u002Fsample size\u002Fpower needed to estimate enrollment for potential full trial","2 years",{"measure":34,"description":35,"timeFrame":36},"Difference in patient-level POCUS burden 1-week","Patient level burden will be determined using the Likert-scale (zero burden to burdensome)","1-week",{"measure":38,"description":35,"timeFrame":39},"Difference in patient-level POCUS burden 3-month","3 Months",{"measure":41,"description":42,"timeFrame":12},"Healthcare utilization after randomization follow up outpatient visits","Differences in number of follow up outpatient visits",{"measure":44,"description":45,"timeFrame":46},"Healthcare utilization after randomization Emergency room visits","Number of patient ER visits","1-year",{"measure":48,"description":49,"timeFrame":46},"Healthcare utilization after randomization follow up inpatient visits","Number of inpatient visits",{"measure":51,"description":52,"timeFrame":46},"Healthcare utilization after randomization GDMT prescriptions","Number of patients prescribed GDMT therapy",null,{"allocation":55,"interventionModel":56,"interventionModelDescription":53,"primaryPurpose":57,"observationalModel":53,"timePerspective":53,"maskingInfo":58},"RANDOMIZED","PARALLEL","DIAGNOSTIC",{"masking":59,"maskingDescription":53,"whoMasked":53},"NONE","The Investogators will harness the power of a novel turn-by-turn guidance software embedded within a point-of-care ultrasound (POCUS) device that can generate an accurate estimate of left ventricular ejection fraction in \\\u003C5 minutes by medical assistants (MA) with minimal training at a single Corewell Health outpatient practice. Using a randomized clinical trial design in patients with new cardiac symptoms, POCUS-HF will quantify the benefits of using POCUS for heart failure reduced ejection fraction (HFrEF) diagnosis and establishment of Guideline-Directed Medical Therapy (GDMT).\n\nPoint of care ultrasound (POCUS) is an adaptation of formal ultrasound technology used to evaluate cardiac structure and function known as transthoracic echocardiography (TTE). TTE is conducted by a trained sonographer and is the initial imaging modality in heart failure diagnoses. POCUS is unique in that it is portable, provides real-time imaging feedback while being relatively inexpensive and accessible to users of variating level of training. POCUS is particularly well positioned to serve the growing HF community throughout Michigan and if performed in the office, may potentially shorten the time to GDMT initiation in new cases of HF. While the investigators posit that a POCUS screening tool will have the greatest impact in rural communities who are already overburdened, the POCUS-HF findings will be applicable in other urbanization levels or geographic regions across the United States, and potentially to other under resourced areas.\n\nOne area ideal for intervention is in obtaining accurate measures of left ventricular EF via TTE. In a patient with cardiac symptomatology, the typical workflow includes: 1) initial visit with one's primary care physician including referral to a cardiology specialist and ordering a TTE, 2) TTE 3) cardiology appointment to diagnose HFrEF, and 4) discussion\u002Freview of the results with the patient, 5) followed finally by the initiation of GDMT. This process is long and burdensome and is likely particularly more challenging in underserved communities that lack specialists. Thus, TTE acquisition is an ideal place for intervention to shorten this timeline.\n\nThere are many innovative components of the POCUS-HF trial including the overarching theoretical framework and the use of guided software within the POCUS device. While POCUS is not a uniquely new concept, the combination of a rigorous POCUS device with real-time software guided turn-by-turn instructions allows for novice capture of LVEF. Another innovation is that the POCUS-HF trial is designed to not only quantitatively, but also qualitatively identify barriers and optimal use cases for POCUS. The Investigators believe this will facilitate the implementation of such screening practices by other institutions and care settings. Future work will aim to define other scenarios where POCUS may be effective, such as routine monitoring of progression in HF patients, or in vascular disease diagnosis settings.",[62,68],{"label":63,"type":64,"description":65,"interventionNames":66},"POCUS","ACTIVE_COMPARATOR","Left ventricular Ejection fraction is estimated using a novel turn-by-turn guidance software embedded within a point-of-care ultrasound (POCUS) device.",[67],"Device: Point of Care Ultrasound",{"label":69,"type":70,"description":69,"interventionNames":53},"Standard of Care","NO_INTERVENTION",[72],{"type":73,"name":74,"description":75,"armGroupLabels":76,"otherNames":53},"DEVICE","Point of Care Ultrasound","Point of care ultrasound will be used in patients as an early diagnostic tool for HFrEF",[63],[78],{"name":79,"affiliation":5,"role":80},"David McNamara, MD, MPh","PRINCIPAL_INVESTIGATOR",[82],{"name":83,"role":84,"phone":85,"phoneExt":53,"email":86},"Jacob M Gonzales, BA,MA","CONTACT","6162670612","Jacob.Gonzales@corewellhealth.org",[88],{"facility":5,"status":53,"city":89,"state":90,"zip":91,"country":92,"countryCode":93,"cosmosGeoPoint":94,"geoPoint":99,"contacts":53},"Grand Rapids","Michigan","49503","United States","US",{"type":95,"coordinates":96},"Point",[97,98],-85.66809,42.96336,{"lat":98,"lon":97},{"type":80,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"David Mcnamara","Advanced Imaging Cardiologist",[104],{"name":105,"class":6},"Michigan State University","100656595","utilization-of-guided-point-of-care-ultrasound-in-heart-failure-diagnosis-pilot-trial-100656595",false,"NCT07828834","Utilization of Guided Point of Care Ultrasound in Heart Failure Diagnosis Pilot Trial","A Pilot Single-center Randomized Controlled Trial of Software Guided Point-of-care","POCUS-HF","Patient Inclusion\u002FExclusion Criteria\n\nInclusion Criteria:\n\n* 18 years of age or older at time of consent\n* Presenting to an enrolled CH study site with visit type:\n* A. PCP - New onset cardiac complaints (e.g., dyspnea on exertion, orthopnea, etc)\n* B. Cardiology - New Patient\n* Weight ≥ 40kg\n\nExclusion Criteria:\n\n* Documented echocardiogram in the past 3 years\n* History of cardiac surgery or congenital heart disease\n* O2-dependent pulmonary disease\n* BMI ≥40kg\u002Fm2\n* Pregnancy\n* Non-native English speakers who have limited spoken or written understanding of the English language to be able to consent or complete surveys in English\n* Cognitively impaired individuals with a legally authorized representative or guardian\n\nStaff Participant Inclusion\u002FExclusion Criteria\n\nInclusion:\n\n* 18 years of age or older at time of verbal consent\n* Employed to work at a CH clinic where patient enrollment is planned\n\nExclusion:\n\n* Deemed inappropriate or ineligible for any reason at PI discretion","ALL","18 Years",{"count":117,"type":118},100,"ESTIMATED","INTERVENTIONAL",[121],"NA","The purpose of the study is to implement point of care ultrasound (POCUS) to generate preliminary, or pilot, data to support a full future POCUS study across multiple Corewell Health outpatient rural facilities. The study aims to demonstrate feasibility of the procedure utilizing input from the patient, provider, and the clinic staff. Preliminary data will also be used to estimate the magnitude of effect in estimating sample size and power in participants who receive the POCUS procedure versus those who continue with standard of care. Up to 100 participants will be enrolled.",[124],"Heart Failure With Reduced Ejection Fraction",[126,63,127,128,74],"HFrEF","GDMT","LVEF","NOT_YET_RECRUITING","2026-09-14",{"date":132,"type":133},"2026-09-18","ACTUAL",{"date":135,"type":118},"2026-09-30",{"date":137,"type":118},"2028-09-30",{"name":5,"class":6},1]