Surgical Ward Innovation: Telemonitoring Controlled by Healthdot

Monitoring Clinical Trial

— SWITCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05956210
• Other study ID #: nWMO-2022.061
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: November 1, 2023

Study information

• Verified date: July 2023
• Source: Catharina Ziekenhuis Eindhoven
• Contact: Friso Schonck
• Phone: +31629357105
• Email: friso.schonck[@]catharinaziekenhuis.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 1, 2023
• Est. primary completion date: October 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Monitoring

Intervention

Device:
• 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

Locations

Country	Name	City	State
Netherlands	Catharina hospital	Eindhoven	Noord-Brabant

Sponsors (2)

Lead Sponsor	Collaborator
Catharina Ziekenhuis Eindhoven	Philips Electronics Nederland B.V. acting through Philips CTO organization

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the implementation of a continuous monitoring method on the surgical ward	Workload: the experienced workload for nursing staff during the implementation of the Healthdot measured with the IWS and during focus group analysis	Conducted on a daily base during the entire study, month 1-6
Secondary	Adoption	The intention and attitude towards the use of the Healthdot monitoring method. Measured with evidence-based practise attitude scale (EBPAS)	3 focus groups sessions at month 3, 5 and 6
Secondary	Feasibility of the Healthdot	The extent to which the Healthdot monitoring method can be successfully carried out by the healthcare employees. Measured with a thematic analysis and input from the core group (Braun and Clark)	3 focus groups sessions at month 3, 5 and 6
Secondary	Acceptability	The additional effort regarding the amount of spot checks per hospital admission day per patient. Calculated with data from the electronic patient file records	Evaluated at month 4 and 6
Secondary	Appropriateness	Relation between device false alarms (noise) and correct alarms based on the alarming protocol. Measured as signal to noise ratio (SNR)	Evaluated after at month 4 and 6
Secondary	Usability	Number of unexpected events that occur during or result from the use of the Healthdot medical device. Measured as adverse device events (ADE)	Evaluated after at month 4 and 6
Secondary	Feasibility and effectiveness	The amount of time needed to perform and process a complete manual spot check or digital monitoring check. Measured by manual time measurement	Manual time measurement during month 1-6, 2 times a week at different days
Secondary	Costs	Cost-effectiveness analysis based on the duration of admission, the associated admission costs and the monitoring method. Calculation based on provided care and associated costs	After completing of the study at 6 months
Secondary	Algorithm improvement	Advanced algorithm analyses for improved monitoring protocols with use of artificial intelligence (AI)	After completing of the study at 6 months