Aiding COPD and CHF Ultrasound-guided Management Through ENhanced Point Of Care UltraSound

N/AActive Not RecruitingNCT05423652

Michelle Grinman20 enrolled

Overview

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.

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).

Interventions

Lung point of care ultrasoundDEVICE

Point of care ultrasound of the lungs will be performed to enhance physical assessments as needed to make clinical decisions for patients with CHF, COPD and/or pneumonia. The majority of images will be acquired and uploaded to a web-based portal by community paramedics in patients' homes and interpreted remotely by hospital-based physicians on call for the home hospital.

PRESUNA softwareOTHER

PRESUNA is a new medical software that enables clinicians to summarize POCUS findings and document them on a platform that provides a visual summary of findings over time. PRESUNA also provides POCUS educators and learners to see the learners' progress over time in terms of the accuracy of their assessments when compared to POCUS experts providing longitudinal mentorship.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Patient Inclusion Criteria: * 18 years of age or older * Has a provincial health care number * Functionally safe to receive HH care or have sufficient caregiving to support them at home * Stable enough to be cared for at home - stable vital signs and requiring no more than 2 visits per day * Able and willing to follow a management plan * Provides consent to receive care on HH * Diagnosis of CHF and/or COPD that requires HH care * No painful/broken ribs that could be affected by pressure applied when performing lung POCUS Patient Exclusion Criteria: * Not eligible for HH care * New unstable rib fractures * Prior history of allergy to ultrasound gel * Participant refusal to participate in research study Provider inclusion criteria * Attending clinician on the home hospital program within the next 3-6 months * Provides informed consent to participate in the study, including necessary training for the use of POCUS and/or PRESUNA Provider exclusion criteria * Not a home hospital clinician * Refuses to consent for the study / training.

Outcomes

Primary Outcomes

Length of stay

Length of stay for index Home Hospital admission

Time frame: From the date of admission to discharge from the index admission, assessed up to 1 year

Secondary Outcomes

Patient outcome - Time to resolution of infection

return to baseline oxygen saturation and normalization of white blood cell count

Time frame: Assessed up to 24 months after infection identified

Patient outcome - time to decongestion

absence of crackles and baseline oxygen saturation on lung examination

Time frame: Assessed up to one year after congestion identified

Patient outcome - rate of change in NT-BNP

Difference between NT-BNP on admission and at time of decongestion over total number of days

Time frame: Change from admission to when decongestion occurred, assessed up to 12 months

Patient outcome - Admission to facility living

Proportion of patients in each study arm that required admission to facility living (eg: long-term care, supportive living) after their index admission

Time frame: From date and time of discharge from index admission, assessed up to 12 months

Patient outcome - Escalation of care

Incidence rate ratio for frequency with which patients are transferred back to the bricks and mortar hospital from the home hospital.

Time frame: From date of randomization until the patient is discharged from the index admission (assessed up to 12 months).

Patient outcome - Adverse events

Frequency and severity of adverse events (venous thromboembolism, new infections, falls, delirium)

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first until the patient is discharged from the hospital (assessed up to 12 months).

Patient outcome - Mortality

Date and cause of mortality of occurrence of mortality

Time frame: From date of randomization until the date of death, assessed up to 12 months

Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Mobility

The ability to mobilize is rated by patients on a scale from 1-5 (1= no problems, 2= slight problems, 3= moderate problems, 4= Severe problems, 5= Unable to perform activity)