Overall design:
This pragmatically designed, pilot, proof-of-concept, observational study was reviewed and approved by London – Queen Square Research Ethics Committee (IRAS: 281757). The objective is to determine the feasibility of remote healthcare delivery in a hotel with rapid implementation in the COVID-19 era.
The SensiumVitals™ (Sensium Healthcare Ltd., United Kingdom) system can be engineered in the building (hotel) for use with the wearable sensor. All participants would be fitted with the sensor on arrival and would always be worn. A designated area within the facility would act as a central hub allowing for remote monitoring to occur by healthcare staff. Alerts would be generated, in accordance with NEWS parameters (Table 1), to identify deteriorating participants with escalation to hospital in appropriate acute cases but can be individually tailored. The temperature alert threshold was lowered to the lowest score in the NEWS chart, allowing for earlier detection and improved sensitivity11; this decision was made from previous work which demonstrated varying limits of agreement for temperature when compared to nursing observations.12 Escalation protocols will be developed and trialled, allowing staff to address issues as they arise (Figure 1).
Table 1: Criteria for generating vitals alert
Parameter
|
Alert threshold
|
Respiratory rate (breaths per minute)
|
>25
|
Temperature (Celsius)
|
>38.1
|
Heart rate (beats per minute)
|
>131
|
Wearable sensor system
SensiumVitals™ by the Surgical Company, have produced a lightweight, waterproof, single-use, wearable wireless ‘patch’ with a battery life of 5 days measuring vital signs every two minutes. The sensor attaches to an individual’s chest with two ECG electrodes, recording HR, RR, and a wire attaches around the individual’s back, measuring axillary temperature. The sensor is FDA approved and CE marked. Data are transmitted through radiofrequency and dedicated intranet hotspots. Physiological parameters can be viewed by clinical staff on a mobile device/desktop computer, allowing trends towards deterioration to be noted, with tailored alerts generated for deteriorating individuals in accordance with NEWS (Figure 2).
Following the completion of quarantine, participants will be invited to share their experiences through using semi-structured interviews and questionnaires. Individual interviews allow for anonymity and truthful perceptions/attitudes. This method enables narratives to be elicited through guided but open questioning.
Hypotheses:
1) Continuous remote monitoring with wearable sensors of vital signs will identify deteriorating patients.
2) Healthcare provision in a hotel will be feasible and acceptable amongst healthcare staff and participants.
Sequence of events:
Patching patients and using data for academic research
- Eligible participants from the airport will be transferred to the hotel by paramedics.
- Upon arrival to the engineered hotel, an initial assessment of all participants will be undertaken. A study information sheet will be provided, and informed consent taken for wearable sensors to be applied, allowing remote monitoring of vital signs. To ensure appropriate quarantine.
- In a designated area within the building, a central monitoring hub will be set up to monitor the recorded parameters by National Health Service (NHS) healthcare staff from a local Trust.
- If a participant deteriorates, an alert should be generated on a smartphone device/desktop computer; following this, an escalation protocol will be trialled to action the alert in an appropriate manner; hospitalisation may be necessary.
- Participants will be invited for an interview and be asked to complete a survey on their experiences following quarantine completion.
- Participant care records will be stored on an online Care Information Exchange system that is currently in place across the trust. Electronic health records and patient notes will be reviewed to determine clinically relevant events if transfer to hospital occurs (e.g. hospital length of stay, mortality, escalation to ITU).
- Sensor data will be extracted from the central servers containing sensor data for appropriate statistical analyses for associated clinical efficacy of health outcomes in COVID-19.
Semi-structured interviews/Questionnaires (mixed methods)
- All participants alongside healthcare staff will be invited to take part in semi-structured interviews and be given questionnaires. These will take place by the primary lead researcher using prepared topic guides.
- Written consent will be obtained from those who agree to participate.
- An audio recording will be made of the interviews. Notes reflecting verbal responses may be taken. The interviews will be conducted at the engineered hotel.
- The recordings will be transcribed, and the data will undergo thematic analyses.
- Validated and unvalidated questionnaires will also be given enquiring about experiences (e.g. PHQ-913, GAD-714, satisfaction, anxiety related to the devices).
Participant eligibility:
The study will recruit flight arrivals returning to the UK in London. High risk travellers are screened at the airport and tested for COVID-19, with transfer to hospital if appropriate; this cohort would be ineligible for the study.
Additionally, healthcare professionals who display symptoms of COVID-19 and are unable to isolate safely at home (e.g. lodging with vulnerable persons) would be eligible to take part in the study and invited to stay at the hotel.
Inclusion Criteria
- Aged 18 years or over.
- Able to provide written consent.
- Travellers returning with milder symptoms suggestive of COVID-19 or returning from high risk areas requiring quarantine, as recommended by Public Health England.
- Healthcare professionals with milder symptoms suggestive of COVID-19 unable to isolate at home.
Exclusion Criteria
- Any participants that withdraw their consent.
- A skin condition/reaction preventing wearing the wearable sensor.
- The presence of a permanent pacemaker or cardiac defibrillator.
- Any form of psychiatric disorder or a condition that, in the opinion of the investigator, may hinder communication with the research team.
- Inability to cooperate or communicate with the research team.
Statistical considerations:
Quantitative analysis:
Descriptive statistics will be obtained about the baseline characteristics of participants. Continuous variables will be presented as mean ± standard deviation and categorical variables will be reported as numbers and percentages. The total number of alerts, proportion of actioned alerts, and resultant actions will be measured. Outcome measures (e.g. phone consultation, virtual GP review, transfer to hospital) will be reviewed from case notes should escalation occur. Data will be analysed using SPSS and Stata.
Qualitative analyses:
Semi structured interviews will take place by the primary lead researcher using the prepared topic guides. An audio recording will be made of all interviews. The interviewer may also take field notes reflecting the verbal responses and reflections to be used to adapt the topic/study direction. The audio recordings will be transcribed. The data will be analysed appropriately using thematic analysis.
To ensure confidentiality and anonymity, each interview will be allocated a pseudonym, to be applied to the corresponding consent form, topic guide form/field notes and audio file. Their name will not be included in the audio recording; the pseudonym will be used.
Summaries of interview field notes will be typed into a word processor. All paper and soft copies of field notes, audio files and consent forms will be kept securely in a locker within a locked office and if in digital format, on a password protected computer and backed up regularly. Information will only be shared within the study team.
Audio recordings will be professionally transcribed verbatim, and a random selection of transcripts will be checked against recordings for accuracy. A phenomenological approach to analysis will be taken, with thematic analysis the most appropriate approach, guided by a paper outlining the methods for thematic analysis, and aided by qualitative management software. To counter analysis bias, a selection will be reviewed and coded by a second researcher, with any disagreement resolved through discussion.
Power considerations:
As a pilot study in an unknown viral pandemic, the progression of which is not well established, this study will appraise the feasibility for hotel remote sensing under these circumstances. Sufficient other data do not exist to allow for power calculations.
Patient and public involvement:
Due to the nature of the pandemic and the current climate (national lockdown advised from the government) with COVID-19, patient and public involvement was not undertaken for this observational trial. All eligible participants will be approached to enter the study and all recruited participants can provide email addresses should they wish for dissemination of results.