Surgical Ward Innovation: Telemonitoring Controlled by Healthdot (SWITCH)

Catharina Hospital

Status: Enrolling

Conditions: Monitoring

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05956210

nWMO-2022.061

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Nurses and physicians form the primary research population.

• Nurses and physicians, participating in het focus group will sign informed consent.

Patients won't be included for participation since the Healthdot will be the new standard of care regarding monitoring. Patients will however sign informed consent at admission for use of anonymized data.

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

Trial design