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Procedure

Enhanced Point of Care Ultrasound for COPD (ACCUMEN-POCUS Trial)

N/A

Recruiting

Led By Michelle Grinman, MD FRCPC MPH

Research Sponsored by Michelle Grinman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

New unstable rib fractures

Participant refusal to participate in research study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of admission to discharge from the index admission, assessed up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial compares ultrasounds with standard care to improve patient experience, save costs and test feasibility of home-based acute care using non-physicians.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves non-invasive ultrasound assessments, side effects are minimal but may include discomfort from pressure during the procedure if there are existing painful conditions like broken ribs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have CHF or COPD and need home health care.

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I don't have painful or broken ribs that could be hurt by pressure during a lung ultrasound.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have new, unstable fractures in my ribs.

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I do not want to participate in a research study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of admission to discharge from the index admission, assessed up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of admission to discharge from the index admission, assessed up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of admission to discharge from the index admission, assessed up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Length of stay

Secondary study objectives

Cost analysis

Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Activities of daily living

Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Anxiety and Depression

+17 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: POCUS-PRESUNAExperimental Treatment2 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 CareActive Control1 Intervention

Standard home hospital care

0 / 5Eligibility criteria met