Title: Single-centre, feasibility, cluster-randomised, controlled trial of remote, near-continuous monitoring versus National Early Warning Score monitoring in patients admitted to adult general surgical wards
Funder: Department of Health and Social Care

Abstract: IntroductionRegular monitoring of surgical patients helps detect complications earlier and reduce their impact. The National Early Warning Score (NEWS) is the current NHS standard, but suffers from several drawbacks. It is resource intensive in terms of staff time to manually record observations, vulnerable to user error in recording observations correctly, and can fail to pick up patient deterioration that occurs between monitoring intervals. SensiumVitals is a wearable, wireless patch that monitors heart rate, respiratory rate, and temperature every two minutes. It is hypothesised that remote monitoring using the SensiumVitals system will allow earlier detection of patient deterioration as compared to standard NEWS monitoring, allowing timely intervention and improving patient outcomes.Study designSingle-centre, feasibility, cluster-randomised, controlled trial of SensiumVitals monitoring versus National Early Warning Score monitoring in patients admitted to adult general surgical wards. Realist evaluation of patient and nurse satisfaction with the SensiumVitals monitoring system.Qualitative analysis of the challenges to implementing a new monitoring system in another centre. Micro-costing study to begin to evaluate the costs of the new monitoring system. Methods Upon admission to one of four general surgical wards at St. James's University Hospital, Leeds, patients will be allocated randomly to a bay containing 4-6 beds. Bed allocation will be done by the surgical bed manager, who is independent of the study. Prior to patient recruitment, each bay will be randomised to receive either the patch or the control. Patients allocated to a patch bay will receive SensiumVitals monitoring with NEWS monitoring if the patch detects deterioration. The control arm will consist of patients allocated to non-patch bays, who will receive standard NEWS monitoring. All other interventions and monitoring will be the same in both arms. Patients will receive the same type of monitoring throughout their hospital stay, unless they are moved to another ward where SensiumVitals monitoring is not available. The qualitative aspect of the study will involve a mixed methods approach: semi-structured interviews will form a realist evaluation of staff experiences with the SensiumVitals system. Patient satisfaction will be assessed with a questionnaire, semi-structured interviews and focus groups. A separate study to identify challenges to implementation will be undertaken in a different hospital in the Yorkshire region and will take the form of semi-structured interviews with nursing staff, information managers, and clinical service managers. Outcome measuresPatient and staff satisfaction (qualitative study)Recruitment rate, including proportion of ineligible patients and reasons for non-consent Information on the ideal RCT protocol, including methods of randomisation and management of cross-over patientsAdherence to protocol, and reasons for non-adherence (patients and staff)Amount of missing data and loss to follow-upOptimal outcome measures to test effectiveness, e.g. time to administration of antibiotics in cases of sepsis, critical care admission rate, length of hospital stay.Estimation of sample size for definitive RCTChallenges to implementing SensiumVitals monitoring in a new hospitalAnalysis Analysis will be on an intention-to-treat basis. Each of the outcome measures will be summarised by intervention or control group using appropriate descriptive statistics. As this is a feasibility study no formal comparison between the study arms will be undertaken. The summary statistics will provide important information on the parameters required in any sample size calculation for a definitive RCT. Dissemination Outputs from this project will be disseminated to public and patient forums, relevant healthcare professional organisations, and NHS managerial groups so that the benefits, or otherwise, can be of use to the wider NHS. The results of this feasibility study will inform the design of a multicentre study to rigorous evaluate the SensiumVitals system, including a cost-effectiveness analysis.

Lay abstract: Background Patients having surgery are at high risk of complications, some of which can be life-threatening. Identifying complications early makes them easier to treat and improves the outcome for the patient. One of the ways patients are monitored for complications is by charting their vital signs: blood pressure, heart rate, breathing rate and temperature. The nurse looking after the patient will usually check these signs every four hours in the first few days after surgery.The vital signs are used to form a score, the National Early Warning Score (NEWS), which can alert if the patient becomes unwell. One of the problems with NEWS is that patients can deteriorate in the interval between monitoring, which can delay vital treatment. The SensiumVitals monitoring system measures heart rate, breathing rate and temperature continuously, and sends the information to a mobile phone carried by the nurse every two minutes. It is a wearable, wireless patch that is applied to the patient's chest after surgery, and alerts the nurse if the patient's vital signs become abnormal. This could help detect unwell patients earlier than traditional NEWS monitoring. Aims In order to test this theory, a study will be done comparing the SensiumVitals system with NEWS monitoring. The research methods used have to be tested in a small study first, called a feasibility study, before the device is tested on a larger scale. The main aim is to provide important information about whether the research works and how best to undertake a larger study to fully test the new monitoring system. Participants Patients will be asked to join the study if they are admitted to one of four General Surgery wards at St. James's University Hospital, Leeds. They will be given information about the study and will be allowed time to decide whether they would like to take part. Methods Patients will be randomly chosen to receive the SensiumVitals patch or standard NEWS monitoring based on the bed they go in to on each ward.This decision is made by hospital bed managers, who are not involved in the study: it is a random' process and roughly half of the patients will be offered the new system. Patients will be followed during the course of their hospital stay, including any operation they have. Information about their hospital stay will be collected. This information will include how quickly antibiotics are given in cases of infection, the number of patients who are moved to high-dependency wards, and how long they stay in hospital. Information will also be collected regarding the number of patients who agree to take part in the study, those who do not and the reason for not taking part. An important part of the study will be to assess how patients and nurses feel about SensiumVitals system. The patient's perspective of the study will be assessed in a number of ways: interviews, questionnaires and focus groups. Nurses' feedback will also be assessed in the form of interviews.Patient and public involvementIt is important to involve the public in the running of the study, as it may have a direct bearing of how patients are cared for in the NHS.A Patient Advisory Group will be set up, including 6-8 patients who have experience of wearing the patch. This group will meet 6 times at key points throughout the study and provide feedback on issues such as ethics, the wording of study documents and patient interview processes (including the findings of the interviews). A member of the public will join the study's Steering Group. This group will meet regularly to discuss the progress of the study. The member of the public will have an equal voice and be important in shaping the study, and support will be offered to them to ensure they are able to participate fully in the meetings. The patient and public representatives will also be involved in communicating the results of the study, especially to patient forums and charities, to inform the wider public. Distribution of resultsThe results of this study will provide important information about the performance of the SensiumVitals system, how patients and clinical staff feel about the system, and whether it is possible to undertake a larger study to fully test the new monitoring system. The results will be communicated to healthcare professionals, patients and the public through journal articles, press releases and presentations to charities, NHS Trusts and the media.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: GENERIC HEALTH RELEVANCE