A Pre-post Intervention Study Evaluating Home-based Management of Patients With COPD or CAP

Study Overview
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Brief Summary
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Risk of rehospitalization within 30 days of discharge is higher than 20% in patients with chronic obstructive pulmonary disease (COPD) and up to 20% for patients with community acquired pneumonia (CAP). This pre-post intervention study aims to quantify the impact of continuous remote patient monitoring (RPM) on rates of hospital readmission for patients presenting with CAP or exacerbation of COPD and compare the intervention group to historical controls that did not have access to the intervention. We hypothesize that an intervention combining remote patient monitoring with the remote clinical services and escalation pathways available at SSH (including the Mobile Integrated Health (MIH) program) will reduce hospital readmission within the 30 days following hospital discharge compared to standard of care in this population.

Official Title
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A Pre-post Intervention Study Evaluating Home-based Management of Patients With Chronic Obstructive Pulmonary Disease or Community Acquired Pneumonia

Conditions
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Chronic Obstructive Pulmonary Disease, Community-acquired Pneumonia

Intervention / Treatment
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* Device: Current Health platform


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21 years or older confirmed diagnosis of moderate-severe COPD or community acquired pneumonia attendance at South Shore Hospital with an exacerbation of COPD / CAP fit for discharge to home Exclusion Criteria: suspicion of COVID-19 or confirmed COVID-19 positive life-threatening exacerbation requiring invasive ventilation or prolonged stay in critical care (> 24 hours) unable/unwilling to use Current Health bilateral axillary lymph node dissection persistent atrial fibrillation heavy tattooing on upper arms discharged to skilled nursing facility no access to home or mobile telephone

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Participants will be remotely monitored with the Current Health platform, respond to daily respiratory surveys, receive daily medication reminders and an action plan. Daily dashboard rounds and vital sign alarms from the continuously collected vital signs will be used to identify changes in health and escalated accordingly. | Device: Current Health platform<br>* A remote patient monitoring system which includes a small footprint device and tablet, combined with an AI-powered, cloud-based system driving advanced real-time and predictive analytics related to a patient's clinical condition. The wearable records heart rate, respiratory rate, oxygen saturation, skin temperature and step count.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with a hospital readmission |  | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to service use |  | up to 30 days | 
| Rate of clinical visits | telehealth and/or ambulatory visits | up to 30 days | 
| Length of Stay | original and subsequent readmissions or emergency department attendance | up to 30 days | 
| Rate of Mortality |  | up to 30 days | 
| Rate of medication adherence |  | up to 30 days | 
| Progression of Disease | medication requirements, oxygen dependence, spirometric changes | up to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wearable, Current Health platform, 30 day readmission