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UnknownNCT05956210

Surgical Ward Innovation: Telemonitoring Controlled by Healthdot

SWITCH- Surgical Ward Innovation: Telemonitoring Controlled by Healthdot Evaluation of Implementation

Status
Unknown
Phase
Study type
Observational
Enrollment
500 (estimated)
Sponsor
Catharina Ziekenhuis Eindhoven · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers

Summary

This observational clinical, single center trial is designed to evaluate the implementation of an already validated smart monitoring device, the Philips Healthdot, on one surgical ward at the Catharina hospital in Eindhoven, The Netherlands. This study is performed during 6 months in which all patients admitted to one surgical ward will be enrolled. Implementation is established by a step-by-step approach in which the current manually performed spot check monitoring (blood pressure, oxygen saturation, respiratory rate, heart rate, temperature and pain score), with the early warning score (EWS), is continued besides smart monitoring with the Healthdot (respiratory rate, heart rate and physical activity) during the first three months (phase 1). This phase aims at optimizing the infrastructure, education of hospital staff and practice with application/ activation and interpretation of the device. Upward of 4 months, Healthdot monitoring will be the primary monitoring method and spot check monitoring is only performed additionally in case of doubt about clinical condition or requirement of additional vital parameters. Evaluation of the implementation will be performed with a focus group and various questionnaire regarding fidelity, acceptability, adoption, feasibility, appropriateness and costs. Thereby additional analysis regarding monitoring algorithms will be performed.

Detailed description

This project is a 6 months monocenter prospective cohort study at the Catharina hospital in the Netherlands. Every patient admitted to the one surgery department will receive a Healthdot. Implementation of the Healthdot will be performed stepwise. During phase 1 (month 1-3, the pre-implementation phase), the current standard method of care with manual spot checks and EWS will be continued. During this phase Healthdots will be applied only for training purposes in preparation to the implementation phase, phase 2 (month 3-6). This phase consists of primarily Healthdot monitoring and manual spot checks only if indicated. After these 6 months, the implementation will be evaluated and optimized and potentially extended. Participants: The main research population for answering the research objectives are the nurses working at the specific surgical ward at the Catharina hospital. In total amount of 500 patients, 250 during each phase, admitted to one surgical ward at the Catharina hospital will participate and receive a Healthdot as the new standard of care. These patients will sign informed consent for use of anonymized data. This population differs in age, gender, admission cause, admission duration and comorbidities but reflects the demographics of the general population on this ward which is essential to investigate implementation and prevent selection bias.

Conditions

Interventions

TypeNameDescription
DEVICEEvaluation of implementation regarding Philips Healthdot as monitoring device of hospitalized patients at one surgical wardHospitalized patients at one surgical ward will receive a Healthdot as monitoring device which will be used as primary monitoring after 3 months of preparation with education of hospital staff, improving infrastructure and training with application, activation and interpretation

Timeline

Start date
2022-11-01
Primary completion
2023-10-01
Completion
2023-11-01
First posted
2023-07-21
Last updated
2023-07-21

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT05956210. Inclusion in this directory is not an endorsement.