MedPath

Non-invasive Monitoring: Impact on Patient Management and Outcomes

Recruiting
Conditions
No Specific Medical Conditions or Disease States
Interventions
Device: Dozee Pro NX
Registration Number
NCT06270953
Lead Sponsor
Turtle Shell Technologies Pvt. Ltd.
Brief Summary

Enhancing patient monitoring in SNFs and ALFs is crucial due to challenges in recognizing deteriorating health. Gaps in vital sign checks lead to missed indicators and adverse outcomes. Turtle Shell Technologies' Dozee Pro NX offers continuous non-invasive monitoring, alerting healthcare providers of vital sign changes. This clinical study aims to evaluate Dozee Pro Nx's impact on patient outcomes, practitioner efficiency, and healthcare costs in SNFs and ALFs, addressing gaps in care delivery.

Detailed Description

In skilled nursing facilities (SNFs) and assisted living facilities (ALFs), managing patient health presents considerable hurdles in accurately identifying and responding to deteriorating conditions. The intricacies of care within these settings are compounded by a high patient-to-healthcare provider ratio, often leading to infrequent vital sign checks with significant time gaps between assessments. This monitoring gap may result in overlooking early signs of health decline, potentially causing adverse patient outcomes. A February 2014 report by the Office of Inspector General (OIG) underscored this issue, revealing that around 22% of Medicare beneficiaries experienced adverse events during their stays in SNFs, with an additional 11% facing temporary harm events. Notably, 59% of these incidents were considered preventable, largely due to insufficient patient monitoring, care delays, and substandard treatment. In response to these challenges, Turtle Shell Technologies (TST) Private Limited has developed Dozee Pro NX, an innovative system tailored to improve patient monitoring in these healthcare settings. This system employs non-invasive sensors to continuously monitor crucial parameters such as heart rate, respiration rate, blood pressure, temperature, and SpO2. Distinguished from traditional patient monitoring devices, Dozee Pro Nx offers advanced functionalities, including customizable notifications to alert healthcare providers of vital sign deterioration, thereby enabling prompt intervention. The primary objective of this clinical study is to evaluate the potential impact of the Dozee Pro Nx system on patient outcomes, healthcare practitioner efficiency, and overall healthcare costs. This investigation aims to ascertain whether the implementation of this advanced monitoring technology can effectively address the identified gaps in patient care within SNFs and ALFs, ultimately leading to improved health outcomes and enhanced care delivery.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
150
Inclusion Criteria
  • Age 18 years or older.
  • Weight between 40kg-120kgs
Exclusion Criteria
  • Terminal illness with a life expectancy of less than 1 month.
  • Have any condition that could interfere with the subject's ability to lie flat or stable on the bed
  • Needs the use of equipment whose operation can interfere with Investigation System operations
  • Patients planned to be transferred from the facility within 72 hours
  • Prisoners
  • Pregnant

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Obervational groupDozee Pro NXPatients admitted in the SNF facility during the study period
Primary Outcome Measures
NameTimeMethod
Number of Care Escalation and/or Transfers (Subgroup- ER visits, Surgical Interventions & Hospitalizations, ICU Admissions),3 months
Secondary Outcome Measures
NameTimeMethod
Care pathway mapping3 Months
HCP experience response data3 Months

Trial Locations

Locations (1)

Oak Village Healthcare

🇺🇸

Lake Jackson, Texas, United States

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