Enhanced Point of Care Ultrasound for COPD

(ACCUMEN-POCUS Trial)

Overseen By Michelle Grinman, MD FRCPC MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michelle Grinman

Disqualifiers: Unstable rib fractures, Allergy to gel, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 12 months

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

How is the Enhanced Point of Care Ultrasound for COPD treatment different from other treatments?

The Enhanced Point of Care Ultrasound for COPD treatment is unique because it uses lung ultrasound technology combined with PRESUNA software to provide real-time imaging and assessment of lung conditions, which is not typically used in standard COPD treatments. This approach allows for more immediate and precise evaluation of lung health compared to traditional methods that rely on symptoms and spirometry (a test to measure lung function). ^{1 2 3 4 5}

What is the purpose of this trial?

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.

Research Team

Michelle Grinman, MD FRCPC MPH

Principal Investigator

University of Calgary

Eligibility Criteria

This trial is for adults over 18 with Chronic Obstructive Pulmonary Disease (COPD) or Congestive Heart Failure (CHF), who need home health care but are stable enough not to require more than two visits per day. They must be able to follow a management plan, have no allergies to ultrasound gel, and no new unstable rib fractures.

Inclusion Criteria

I can safely receive care at home or have someone to help me.

I have CHF or COPD and need home health care.

I can be cared for at home with stable vital signs and need no more than 2 visits a day.

Exclusion Criteria

I have new, unstable fractures in my ribs.

Not eligible for HH care

Prior history of allergy to ultrasound gel

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily home hospital care enhanced by lung POCUS acquired remotely by community paramedics or in-person by physicians, and interpreted by physicians using PRESUNA software

Up to 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of healthcare utilization, quality of life, and patient outcomes

Up to 6 months post-discharge

Treatment Details

Interventions

• Lung point of care ultrasound
• PRESUNA software

Trial Overview The study compares the use of an enhanced daily lung assessment tool called POCUS-PRESUNA against standard home-based acute care in patients with COPD/CHF. It aims to see if this technology can improve patient and provider experiences, reduce healthcare costs, and test its feasibility for long-term use by non-physicians at home.

Participant Groups

Group I: POCUS-PRESUNA Experimental Treatment 2 Interventions

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.

Group II: Standard Care Active Control 1 Intervention

Standard home hospital care

Who Is Running the Clinical Trial?

Michelle Grinman

Lead Sponsor

Trials

1

Recruited

40+

Alberta Boehringer Ingelheim Collaboration

Collaborator

Trials

2

Recruited

100+

PRESUNA

Collaborator

Trials

1

Recruited

40+

Institute of Health Economics, Canada

Collaborator

Trials

9

Recruited

3,800+

References

1. Australia pubmed.ncbi.nlm.nih.gov

Underdiagnosis and undertreatment of COPD in primary care settings. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Identifying chronic obstructive pulmonary disease in primary care of urban underserved patients: tools, applications, and challenges. [2019]

3. New Zealand pubmed.ncbi.nlm.nih.gov

A Simplified Algorithm for the Diagnosis, Treatment, and Management of COPD in Routine Primary Care Practice. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

How Well Does CAPTURE Translate?: An Exploratory Analysis of a COPD Case-Finding Method for Spanish-Speaking Patients. [2021]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Multicenter study of the COPD-6 screening device: feasible for early detection of chronic obstructive pulmonary disease in primary care? [2018]