Surgical Ward Innovation: Telemonitoring Controlled by Healthdot

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-11-01

Brief Summary

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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.

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Detailed Description

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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

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Monitoring

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Evaluation of implementation regarding Philips Healthdot as monitoring device of hospitalized patients at one surgical ward

Hospitalized 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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Nurses

* Registered in the national register of medical professions (Big register)
* Appointed as a nurse at the Catharina hospital and working at the surgical department during the study period
* Willingness to participate in the core group for evaluation of the implementation

Physicians

* Registered in the national register of medical professions (Big register)
* Appointed at the Catharina hospital as a physician or resident during the study period.
* Willingness to participate in the core group for evaluation of the implementation

Exclusion Criteria

Nurses \& Physicians

* Termination of employment within the study period
* No voluntarily participation in the core group evaluation meetings

Contra-indications for applying Healthdot

* Known to have severe allergy for the tissue adhesive used in the Healthdot.
* Any skin condition, for example prior severe rash, discoloration, scars or open wounds at the area of application
* Pregnant, or breastfeeding
* Use of topicals that are known to irritate the skin at the application area (such as medical and non-medical creams or lotions)
* Patient with active implantable device such as a Implantable Cardiac Defibrillator (ICD) or pacemaker
* Unable to understand instructions
* Left lower rib (place where Healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed.
* Transfer to a different ward during hospitalization

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No