Clinical trial NCT05423652: Aiding COPD and CHF Ultrasound-guided Management Through ENhanced Point Of Care UltraSound
Official title: Aiding COPD and CHF Ultrasound-guided Management Through ENhanced Point Of Care UltraSound
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: COPD
CHF
Pneumonia
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: PRESUNA
name: Institute of Health Economics, Canada
name: Alberta Boehringer Ingelheim Collaboration
First posted: 2022-06-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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).

Eligibility 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.

Primary outcomes:
measure: Length of stay
timeFrame: From the date of admission to discharge from the index admission, assessed up to 1 year
Secondary outcomes:
measure: Patient outcome - Time to resolution of infection
timeFrame: Assessed up to 24 months after infection identified
measure: Patient outcome - time to decongestion
timeFrame: Assessed up to one year after congestion identified
measure: Patient outcome - rate of change in NT-BNP
timeFrame: Change from admission to when decongestion occurred, assessed up to 12 months
measure: Patient outcome - Admission to facility living
timeFrame: From date and time of discharge from index admission, assessed up to 12 months
measure: Patient outcome - Escalation of care
timeFrame: From date of randomization until the patient is discharged from the index admission (assessed up to 12 months).
measure: Patient outcome - Adverse events
timeFrame: 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).
measure: Patient outcome - Mortality
timeFrame: From date of randomization until the date of death, assessed up to 12 months
measure: Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Mobility
timeFrame: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
measure: Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Activities of daily living
timeFrame: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
measure: Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Pain and discomfort
timeFrame: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
measure: Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Self care
timeFrame: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
measure: Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Anxiety and Depression
timeFrame: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
measure: Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Index Score
timeFrame: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
measure: Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) Visual Analogue Scale (EQ-VAS)
timeFrame: At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge
measure: Patient experience
timeFrame: Upon discharge from the Home Hospital (up to 7 business days post-discharge)
measure: Provider experience
timeFrame: Within 1 week of being on the Hospital at Home service
measure: Healthcare utilization cost - Diagnostic testing
timeFrame: Between the date and time of hospital admission to up to 3 months post-discharge
measure: Healthcare utilization - Incidence rate ratio of acute care days pre/during/post
timeFrame: 90 days before randomization until 90 days after index admission (assessed up to 15 months)
measure: Healthcare utilization - Incidence rate ratio of ED/Urgent Care visits pre/during/post
timeFrame: 90 days before, during and 90 days after index admission
measure: Cost analysis
timeFrame: From date of admission until the date of discharge from the index admission, assessed up to 12 months").
measure: Cost analysis
timeFrame: From date of discharge from index admission, assessed up to 90 days.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Rockyview General Hospital
Study officials:
affiliation: University of Calgary
name: Michelle Grinman, MD FRCPC MPH
role: PRINCIPAL_INVESTIGATOR
References: