Clinical trial NCT06270953: Non-invasive Monitoring: Impact on Patient Management and Outcomes
Official title: Impact of Non-invasive Continuous Patient Monitoring System on Patient Management and Health Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: No Specific Medical Conditions or Disease States
Lead sponsor: Turtle Shell Technologies Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-21
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be conducted on subjects in the age group above 18 years regardless of gender. The study is done on patients admitted in the SNF who fulfill the inclusion and exclusion criteria

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Care Escalation and/or Transfers (Subgroup- ER visits, Surgical Interventions & Hospitalizations, ICU Admissions),
timeFrame: 3 months
Secondary outcomes:
measure: HCP experience response data
timeFrame: 3 Months
measure: Care pathway mapping
timeFrame: 3 Months
Other outcomes:
Locations:
city: Lake Jackson
country: United States
facility: Oak Village Healthcare
state: Texas
Study officials:
affiliation: Oak Village Healthcare
name: Lindsay Darthard, LNFA
role: PRINCIPAL_INVESTIGATOR
References: