Clinical trial NCT05956210: Surgical Ward Innovation: Telemonitoring Controlled by Healthdot
Official title: SWITCH- Surgical Ward Innovation: Telemonitoring Controlled by Healthdot Evaluation of Implementation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Monitoring
Lead sponsor: Catharina Ziekenhuis Eindhoven
Sponsor class: OTHER
Collaborators: name: Philips Electronics Nederland B.V. acting through Philips CTO organization
First posted: 2023-07-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The main research population for answering the research objectives are the nurses and physicians working at the specific surgical ward at the Catharina hospital. In total around 500 adult patients, 250 during each phase, admitted to one surgical ward at the Catharina hospital will participate and receive a Healthdot. These patients will sign informed consent for use of anonymized data. This population differs in age, gender, admission cause, admission duration and comorbidities.

Brief 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.

Eligibility 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

Primary outcomes:
measure: Evaluation of the implementation of a continuous monitoring method on the surgical ward
timeFrame: Conducted on a daily base during the entire study, month 1-6
Secondary outcomes:
measure: Adoption
timeFrame: 3 focus groups sessions at month 3, 5 and 6
measure: Feasibility of the Healthdot
timeFrame: 3 focus groups sessions at month 3, 5 and 6
measure: Acceptability
timeFrame: Evaluated at month 4 and 6
measure: Appropriateness
timeFrame: Evaluated after at month 4 and 6
measure: Usability
timeFrame: Evaluated after at month 4 and 6
measure: Feasibility and effectiveness
timeFrame: Manual time measurement during month 1-6, 2 times a week at different days
measure: Costs
timeFrame: After completing of the study at 6 months
measure: Algorithm improvement
timeFrame: After completing of the study at 6 months
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina hospital
state: Noord-Brabant
Study officials:
affiliation: Catharina Ziekenhuis Eindhoven
name: Friso Schonck
role: PRINCIPAL_INVESTIGATOR
References: