Aiding COPD and CHF Ultrasound-guided Management Through ENhanced Point Of Care UltraSound (ACCUMEN-POCUS)

Michelle Grinman

Status: Active, not recruiting

Conditions: CHF; Pneumonia; COPD

Treatments: Other: PRESUNA software; Device: Lung point of care ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT05423652

REB22-0434

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

POCUS-PRESUNA

Experimental group

Description:

Daily home hospital care will be enhanced by lung POCUS acquired remotely by community paramedics or in-person by physicians, and interpreted by physicians. They will then document their findings on PRESUNA to obtain a longitudinal record that enables monitoring of trends to support clinical decision-making.

Treatment:

Device: Lung point of care ultrasound

Other: PRESUNA software

Standard Care

No Intervention group

Description:

Standard home hospital care