Aiding COPD and CHF Ultrasound-guided Management Through ENhanced Point Of Care UltraSound
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Length of stay
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
POCUS-PRESUNA
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.
干预措施: Lung point of care ultrasound (Device)
POCUS-PRESUNA
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.
干预措施: PRESUNA software (Other)
Standard Care
Standard home hospital care
结局指标
主要结局
Length of stay
时间窗: From the date of admission to discharge from the index admission, assessed up to 1 year
Length of stay for index Home Hospital admission
次要结局
- Patient outcome - Time to resolution of infection(Assessed up to 24 months after infection identified)
- Patient outcome - Escalation of care(From date of randomization until the patient is discharged from the index admission (assessed up to 12 months).)
- Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Mobility(At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge)
- Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Anxiety and Depression(At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge)
- Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) Visual Analogue Scale (EQ-VAS)(At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge)
- Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Pain and discomfort(At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge)
- Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Index Score(At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge)
- Patient experience(Upon discharge from the Home Hospital (up to 7 business days post-discharge))
- Provider experience(Within 1 week of being on the Hospital at Home service)
- Healthcare utilization - Incidence rate ratio of acute care days pre/during/post(90 days before randomization until 90 days after index admission (assessed up to 15 months))
- Healthcare utilization - Incidence rate ratio of ED/Urgent Care visits pre/during/post(90 days before, during and 90 days after index admission)
- Cost analysis(From date of discharge from index admission, assessed up to 90 days.)
- Patient outcome - time to decongestion(Assessed up to one year after congestion identified)
- Patient outcome - Mortality(From date of randomization until the date of death, assessed up to 12 months)
- Patient outcome - rate of change in NT-BNP(Change from admission to when decongestion occurred, assessed up to 12 months)
- Patient outcome - Adverse events(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).)
- Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Activities of daily living(At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge)
- Health Related Quality of Life - EuroQuol- 5-Dimension-5-Level (EQ-5D-5L) -Self care(At time of randomization, within one week of discharge from the index admission, at 3 months post-discharge, and at 6 months post-discharge)
- Healthcare utilization cost - Diagnostic testing(Between the date and time of hospital admission to up to 3 months post-discharge)
- Patient outcome - Admission to facility living(From date and time of discharge from index admission, assessed up to 12 months)
- Cost analysis(From date of admission until the date of discharge from the index admission, assessed up to 12 months").)
研究者
Michelle Grinman
Principal Investigator
University of Calgary