Implementation of CareCube Negative Pressure Isolation Units

Study Overview
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Brief Summary
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Pilot study to provide a descriptive analysis of the real-world feasibility of using a CareCube for COVID-19 patients in a high-volume tertiary care hospital.

Detailed Description
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The CareCube is a modular, disposable, negative pressure, isolation patient care system that can rapidly augment hospital's capacity to care for patients with contagious droplets or airborne pathogens. It is designed as a temporary single-use negative pressure isolation care unit with PPE for common patient care protocols built into the unit. The device is intended to be used in a healthcare setting as a temporary isolation of patients with suspected or confirmed diagnosis of COVID-19 to prevent Healthcare Practitioners (HCP) and patients' visitors from being exposed to pathogenic biological airborne particulates. The system includes three components: an isolation chamber, functional gown, and gloves. The isolation chamber functions in a similar manner to a hospital negative pressure, Airborne Infection Isolation Room. The gown and gloves provide an extra layer of barrier protection beyond PPE. The CareCube is designed to provide improved protection for front-line healthcare workers, while also conserving the vital supplies of N95 masks, face shields, and gowns, which are not required since there is no direct contact with the patient. The goal of this project is to provide preliminary data to describe the experiences of 'patients', their caregivers, and providers with the CareCube.

Official Title
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Implementation of CareCube Negative Pressure Isolation Units in a High-Volume Tertiary Care Hospital: A Pilot Study

Conditions
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Infectious Disease

Intervention / Treatment
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* Device: CareCube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male or female previously hospitalized during the COVID-19 pandemic At least 21 days post- positive COVID-19 test result Able to provide written informed consent Exclusion Criteria: Under 18 years of age Unable to provide written informed consent on own behalf

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient Group<br>Patients who previously were hospitalized during the COVID-19 pandemic, receiving mock care inside the CareCube | Device: CareCube<br>* modular, disposable, negative pressure, isolation patient care system<br>|
| Patient Caregiver Group<br>Caregivers/family/friends of patients previously hospitalized during the COVID-19 pandemic, communicating with the patient inside the CareCube | |
| Heathcare Provider Group<br>Physicians, Certified Registered Nurse Anesthetists, RNs, Certified Nursing Assistants who will perform routine clinical care tasks, including passing food and medicines, drawing blood, inserting an IV. To simulate intubation, a mannequin will be used. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of Nursing Assistant Task - Nasal Swab | success of obtaining nasal swab as assessed by observer (successful/not successful) | through study completion, one day | 
| Completion of Nursing Assistant Task - Obtain Patient Weight | success of obtaining patient weight as assessed by observer (successful/not successful) | through study completion, one day | 
| Completion of Nursing Assistant Task - Obtain Vital Signs | success of obtaining vital signs as assessed by observer (successful/not successful) | through study completion, one day | 
| Completion of Nursing Assistant Task - Attach Telemetry Stickers | success of telemetry stickers attachment as assessed by observer (successful/not successful) | through study completion, one day | 
| Completion of Nursing Assistant Task - Place Nasal Cannula | success of nasal cannula O2 placement as assessed by observer (successful/not successful) | through study completion, one day | 
| Completion of Nursing Assistant Task - Pass Through Tray | success of passing a tray of food via pass-through to patient as assessed by observer (successful/not successful) | through study completion, one day | 
| Completion of Nursing Assistant Task - Receive Tray | success of collecting a tray of food/waste/ via pass-through from the patient as assessed by observer (successful/not successful) | through study completion, one day | 
| Completion of Registered Nurse Task - Medications | success of medicine reconciliation (generic medication questions, i.e., do you take an aspirin, etc.) with patient as assessed by observer (successful/not successful) | through study completion, one day | 
| Completion of Registered Nurse Task - Place Nasal Cannula | success of nasal cannula O2 placement as assessed by observer (successful/not successful) | through study completion, one day | 
| Completion of Registered Nurse Task - Place Non-Rebreather Mask | success of non-rebreather mask placement as assessed by observer (successful/not successful) | through study completion, one day | 
| Completion of Registered Nurse Task - Place Intravenous Line | success of intravenous line placement as assessed by observer (successful/not successful) | through study completion, one day | 
| Completion of CRNA Task (Mannequin) - Intubation | success of intubation as assessed by observer (successful/not successful) | through study completion, one day | 
| Completion of CRNA Task (Mannequin) - Attach Defibrillator Pads | success of external defibrillator pad placement as assessed by observer (successful/not successful) | through study completion, one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Satisfaction | level of satisfaction based on completion of caregiver survey | through study completion, one day | 
| Healthcare Provider Satisfaction | level of satisfaction based on completion of provider survey | through study completion, one day | 
| Patient Experience of Claustrophobia | subject experience based on claustrophobia assessment | through study completion, one day | 
| Patient Experience of Stress and Anxiety | subject experience based on completion of STAIAD | through study completion, one day | 
| Patient Satisfaction | level of satisfaction based on completion of patient survey | through study completion, one day |