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Clinical Trial Summary

Single-center, two-arm, parallel, randomized controlled trial comparing enhanced daily assessments for patients with COPD and/or CHF using point of care ultrasound with PRESUNA software (POCUS-PRESUNA) versus standard care provided by home-based acute care through a tertiary acute care medical teaching hospital. The objectives are to evaluate POCUS-PRESUNA on improving patient experience, provider experience, improve healthcare utilization/costs, and to test the feasibility of incorporating longitudinal POCUS assessments in home-based acute care via remotely acquired images by non-physicians.


Clinical Trial Description

PRESUNA, a new medical software platform that supports clinicians in optimizing their use of POCUS for CHF and COPD patients in the community, is designed to enhance clinical decision-making and long-term monitoring of patients with CHF and COPD. The aim is to more precisely identify changes in the lungs in order to proactively treat exacerbations and confirm treatment responses. It will also enable practitioners to share information from each scan visually and in a standard format in order to track changes longitudinally. This is expected to reduce potentially avoidable hospitalizations and increase patient quality of life in the community. This study will implement the use of POCUS enhanced by PRESUNA software in the clinical practice of clinicians on a home hospital (HH) program at a tertiary teaching hospital in Calgary, Alberta. On this home hospital, patients are seen and examined either by home visiting community paramedics who consult with the physician, or in-person by physicians in the home hospital clinic space when expedited diagnostic imaging or investigations are required. Objective: To perform a randomized control trial comparing patients with COPD and/or CHF admitted to the HH who will undergo usual care versus usual care enhanced with POCUS and PRESUNA. Methods: 1. Practitioner Recruitment Home hospital clinicians will be provided information about this study in order to obtain informed consent for participation in the study. Physicians who are already POCUS experts will provide informed consent to undergo training on how to use PRESUNA software and to incorporate POCUS into their home hospital care for intervention study patients. Non-POCUS expert clinicians (community paramedics, some of the physicians and nurses) will provide informed consent to undergo group POCUS training and subsequent individual training sessions in order to enable them to become proficient at using POCUS. They will also consent to being trained on how to use PRESUNA software, as well as incorporating POCUS and PRESUNA into their home hospital care for intervention arm patients. 2. Patient Recruitment Patients admitted to HH with CHF and/or COPD will be approached to participate in the research study by the Nurse Navigator or Research Assistant. Those that provide informed consent will be randomized (1:1) to the intervention (POCUS-PRESUNA enhanced HH care) versus control group (usual HH care). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05423652
Study type Interventional
Source University of Calgary
Contact Michelle Grinman, MD FRCPC MPH
Phone 403.943.3889
Email michelle.grinman@ucalgary.ca
Status Recruiting
Phase N/A
Start date October 16, 2023
Completion date December 31, 2024

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