OP5  A two armed, randomised, controlled exploratory study of adding the ambugard cleaning system to normal deep cleaning procedures in a regional ambulance service

2020 ◽  
Vol 37 (10) ◽  
pp. e4.1-e4
Author(s):  
Graham McClelland ◽  
Karl Charlton ◽  
Jacqueline Mains ◽  
Karen Millican ◽  
Caroline Cullerton
Keyword(s):  
Controlled Trial ◽  
Research Question ◽  
Single Point ◽  
Temporal Trends ◽  
Ambulance Service ◽  
Transmission Risk ◽  
Steering Wheel ◽  
Coagulase Negative Staphylococci ◽  
North East ◽  
Randomised Controlled

BackgroundAmbulance services transport patients with infections and diseases and could pose a cross transmission risk to patients and staff through environmental contamination. The literature suggests that environmental pathogens are present on ambulances, cleaning is inconsistent and patient/staff impact is difficult to quantify. Eco-Mist developed a dry misting decontamination system for ambulance use called AmbuGard which works in <30 minutes and is 99.9999% effective against common pathogens. The research question is ‘What pathogens are present on North East Ambulance Service ambulances and what impact does adding the AmbuGard to the deep cleaning process make?’MethodsA two armed, randomised controlled trial enrolled fourteen ambulances during their regular 24 week deep clean which were 1:1 randomised to deep cleaning (control arm) or deep cleaning plus AmbuGard (intervention arm). Polywipe swabs were taken before and after cleaning from five locations selected for high rates of contact (steering wheel, shelf, side door grab rail, patient seat armrest, rear door handle/grab rail). Microbiology culture methods identified the presence and amount of bacterial organisms present including the selected pathogens: Enterococcus spp.; Enterobacter spp.; Klebsiella spp.; Staphylococcus aureus; Acinetobacter spp.; Pseudomonas spp.; Clostridium difficile; coagulase-negative staphylococci (CoNS)). The researcher taking the swabs and the laboratory were blinded to the trial arm.ResultsPathogens of interest were found on 10 (71%) vehicles. CoNS were found on all vehicles. Pathogens were found on all locations swabbed. Normal deep cleaning was effective at eliminating pathogens and the addition of AmbuGard showed no obvious improvement in effectiveness.ConclusionPathogens associated with healthcare acquired infections were found throughout all ambulances. Normal deep cleaning was effective and adding AmbuGard showed no obvious improvement. This was a small study at a single point in time. Further research is needed into temporal trends, how to reduce pathogens during normal clinical duties and patient/staff impact.

scholarly journals A two-armed, randomised, controlled exploratory study of adding the AmbuGard cleaning system to normal deep-cleaning procedures in a regional ambulance service

2020 ◽  
Vol 5 (2) ◽  
pp. 10-17
Author(s):  
Graham McClelland ◽  
Karl Charlton ◽  
Jacqueline Mains ◽  
Karen Millican ◽  
Caroline Cullerton
Keyword(s):  
Controlled Trial ◽  
Research Question ◽  
Single Point ◽  
Temporal Trends ◽  
Ambulance Service ◽  
Transmission Risk ◽  
Steering Wheel ◽  
Coagulase Negative Staphylococci ◽  
North East ◽  
Randomised Controlled

Background: Ambulance services transport patients with infections and diseases, and could pose a cross-transmission risk to patients and staff through environmental contamination. The literature suggests that environmental pathogens are present in ambulances, cleaning is inconsistent and patient/staff impact is difficult to quantify. Eco-Mist developed a dry misting decontamination system for ambulance use called AmbuGard, which works in < 30 minutes and is 99.9999% effective against common pathogens. The research question is: ‘What pathogens are present in North East Ambulance Service ambulances and what impact does adding AmbuGard to the deep-cleaning process make?’.Methods: A two-armed, randomised controlled trial enrolled 14 ambulances during their regular 24-week deep clean, which were 1:1 randomised to deep cleaning (control arm) or deep cleaning plus AmbuGard (intervention arm). Polywipe swabs were taken before and after cleaning from five locations selected for high rates of contact (steering wheel, shelf, side-door grab rail, patient seat armrest, rear door handle/grab rail). Microbiology culture methods identified the presence and amount of bacterial organisms present, including the selected pathogens: Enterococcus spp.; Enterobacter spp.; Klebsiella spp.; Staphylococcus aureus; Acinetobacter spp.; Pseudomonas spp.; Clostridium difficile; coagulase-negative staphylococci (CoNS). The researcher taking the swabs and the laboratory were blinded to the trial arm.Results: Pathogens of interest were found in 10 (71%) vehicles. CoNS were found in all vehicles. Pathogens were found on all locations swabbed. Normal deep cleaning was effective at eliminating pathogens and the addition of AmbuGard showed no obvious improvement in effectiveness.Conclusion: Pathogens associated with healthcare-acquired infections were found throughout all ambulances. Normal deep cleaning was effective, and adding AmbuGard showed no obvious improvement. This was a small study at a single point in time. Further research is needed into temporal trends, how to reduce pathogens during normal clinical duties and patient/staff impact.

PP23  Soiled airway tracheal intubation and the effectiveness of decontamination by north east paramedics: a randomised controlled manikin study. The satiated2 study

2020 ◽  
Vol 37 (10) ◽  
pp. e11.1-e11
Author(s):  
Graham McClelland ◽  
Richard Pilbery ◽  
Sarah Hepburn
Keyword(s):  
Controlled Trial ◽  
Research Question ◽  
Ambulance Service ◽  
Success Rates ◽  
North East ◽  
Significant Difference ◽  
Intubation Success ◽  
First Pass ◽  
Intubation Success Rate ◽  
Randomised Controlled

BackgroundVomiting and regurgitation are commonly encountered in out-of-hospital cardiac arrest, but traditional paramedic suctioning techniques may be insufficient to manage severely soiled airways.A technique called Suction Assisted Laryngoscopy and Airway Decontamination (SALAD) has been developed to help clinicians manage these difficult airways. The only UK SALAD study (SATIATED) reported improved paramedic first-pass intubation success rate. This study has now been replicated in a different ambulance service.The primary research question was: Does paramedic first-pass intubation rate in North East Ambulance Service improve following training in SALAD? The secondary research question was: Does training in SALAD affect the time taken to intubate by paramedics?MethodsA randomised controlled trial of SALAD was conducted using a modified airway manikin capable of vomiting to simulate a soiled airway. The intervention comprised SALAD training and the introduction of the DuCanto catheter for post-training attempts. Participants were randomised into two groups: A01A02B01 who made two pre-training intubation attempts and one post-training attempt, and A11B11B12, who made one pre-training and two post-training attempts. Data were collected on length of service, success rates, timings and techniques used.ResultsParamedics (n=102 participants, n=99 completed the study) were recruited between August and December 2019. First-pass intubation success rates on the second attempts (A02versus B11) were 86% and 96% respectively; a non-significant improvement of 10% (95% CI 1–21%, p=0.09). Both groups intubated faster on third attempts compared to first attempts. A01 to B01 mean improvement 5 (SD 14) seconds, A11 to B12 mean improvement 9 (SD 15) seconds. There was no significant difference in improvement between groups (mean difference -4 seconds, 95% CI -11–3 seconds, p=0.22).ConclusionsNorth East Ambulance Service paramedics demonstrated improved first-pass intubation success rates in a simulated soiled airway following SALAD training and improved time to intubation. This study supports the findings of the SATIATED study.

scholarly journals Phenomenological study exploring ethics in prehospital research from the paramedic’s perspective: experiences from the Paramedic-2 trial in a UK ambulance service

2019 ◽  
Vol 36 (9) ◽  
pp. 535-540 ◽  
Author(s):  
Karl Charlton ◽  
John Franklin ◽  
Rebekah McNaughton
Keyword(s):  
Phenomenological Study ◽  
Controlled Trial ◽  
Phenomenological Approach ◽  
Ambulance Service ◽  
Trial Participation ◽  
North East ◽  
Personal Perceptions ◽  
The Many ◽  
Randomised Controlled

ObjectivesWe set out to investigate paramedics’ views of ethics and research, drawing on experiences from Paramedic-2, a randomised controlled trial comparing epinephrine and placebo in out-of-hospital cardiac arrest (OHCA).MethodsAn interpretative phenomenological approach was adopted. A purposive sample of paramedics (n=6) from North East Ambulance Service NHS Foundation Trust were invited to a semi-structured, in-depth interview.ResultsThree superordinate themes emerged: (1) morality, (2) emotion and (3) equipoise. Some viewed Paramedic-2 as an opportunity to improve OHCA outcomes for the many, viewing participation as a moral obligation; others viewed the study as unethical, equating participation with immoral behaviour. Morality was a motivator to drive individual action. Positive and negative emotions were exhibited by the paramedics involved reflecting the wider view each paramedic held about trial participation. Those morally driven to participate in Paramedic-2 discussed their pride in being associated with the trial, while those who found participation unethical, discussed feelings of guilt and regret. Individual experience and perceptions of epinephrine guided each paramedic’s willingness to accept or reject equipoise. Some questioned the role of epinephrine in OHCA; others believed withholding epinephrine was synonymous to denying patient care.ConclusionA paucity of evidence exists to support any beneficial role of epinephrine in OHCA. Despite this, some paramedics were reluctant to participate in Paramedic-2 and relied on their personal perceptions and experiences of epinephrine to guide their decision regarding participation. Failure to acknowledge the importance of individual perspectives may jeopardise the success of future out-of-hospital trials.

PP25 The take home naloxone intervention multicentre emergency setting feasibility (TIME) trial: an early perspective from one UK ambulance service

2021 ◽  
Vol 38 (9) ◽  
pp. A11.1-A11
Author(s):  
Sasha Johnston ◽  
Helen Snooks ◽  
Jenna Jones ◽  
Fiona Bell ◽  
Jonathan Benger ◽  
...  
Keyword(s):  
Life Support ◽  
Controlled Trial ◽  
Advanced Life Support ◽  
Time Trial ◽  
Ambulance Service ◽  
Feasibility Trial ◽  
Royal Infirmary ◽  
Emergency Setting ◽  
Training Time ◽  
Randomised Controlled

BackgroundDrug poisoning deaths in England and Wales have increased by 52% since 2011 with over half involving opioids. Deaths are preventable if naloxone is administered in time. Take Home Naloxone (THN) kits have been distributed through drug services; however, uptake is low and effectiveness unproven. The TIME trial tests the feasibility of conducting a full randomised controlled trial of providing THN administration and basic life support training to high-risk opioid-users in emergency care settings.MethodsA multi-site feasibility trial commenced in June 2019 with two hospitals and their surrounding ambulance services (Bristol Royal Infirmary (BRI) with South Western Ambulance NHS Foundation Trust (SWASFT) and Hull Royal Infirmary with Yorkshire Ambulance Service) randomly allocated to intervention arms; and sites in Wrexham and Sheffield allocated as ‘usual care’ controls. SWASFT began recruiting in October 2019 with the aim of recruiting and training 50% (n=111) of paramedics working within the BRI’s catchment area, to supply THN to at least 100 eligible patients during a 12-month period.ResultsThe trial was suspended between 17.03.2020-06.08.2020 and extended to 01.03.2021 (COVID-19). Despite this, 121 SWASFT paramedics undertook TIME training. TIME trained paramedics attended 30% (n=57) of the n=190 opioid-related emergency calls requiring naloxone administration during the study period. A total of n=29 potentially eligible patients were identified before and n=28 after the COVID-19 suspension. Two patients were supplied with THN during each period. During the COVID-19 suspension, twenty-two potentially eligible patients were missed. The majority of eligible patients presented with a reduced consciousness level, preventing recruitment (73%; n=42/48). These patients were transported to hospital for further treatment (n=39) or died on scene following advanced life support (n=3).ConclusionsThe lowered consciousness levels of prehospital emergency ambulance patients who present with opioid poisoning, often prevent the delivery of training required to enable the supply of THN.

126 A Student Pilot for A Feasibility Study of the Theoretical 3S Trial (SPFT3S): GP and Ethics Committee Members Questionnaire

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i12-i42
Author(s):  
L Brown ◽  
R Foster ◽  
M Dodd ◽  
T McCormack
Keyword(s):  
Feasibility Study ◽  
Controlled Trial ◽  
Negative Attitude ◽  
Population Group ◽  
Ethics Committee ◽  
Willingness To Participate ◽  
Double Blind ◽  
North East ◽  
The North ◽  
Randomised Controlled

Abstract Introduction Emerging research suggests that statin use for primary prevention in people without diabetes aged 75 and older has no benefit. This study aims to determine the feasibility of the theoretical Stop Statin Study (3S), a double-blind randomised controlled trial carried out in general practice, which would test this hypothesis. 50% of trial patients would stop taking statins for 5 years in an event driven study. The questionnaires aim to identify the attitudes of general practitioners (GPs) and ethics committee members (ECMs) regarding stopping statins for 5 years in patients aged 75 and older without diabetes or history of cardiovascular disease and their willingness to allow patients to participate in the 3S study. Method Questionnaires comprised of 6 questions were designed. 4 students distributed the questionnaire and it was completed by 19 GPs based at 8 practices in the North-East of England. 31 ECMs (12 expert and 19 lay) responded by email. Results 95% of GPs who completed the survey would agree to their patients participating in the theoretical study with 47% of GPs indicating that their willingness to participate in the study is patient dependent. 95% of GPs would also consider stopping statins in this population group if sufficient research had been carried out or if the guidelines were changed. 42% of GPs have a negative attitude to prescribing statins in this population group. All the ECMs would approve the study, citing over-prescribing and polypharmacy as their reason. Conclusions The majority of GPs will participate in the theoretical 3S study, if their patients are willing to participate. There is already a negative perception amongst GPs towards the use of statins in elderly people without disease. The 3S study appears to be feasible from the GP and ethics perspective but would require a larger feasibility study.

scholarly journals Acceptability and feasibility pilot randomised controlled trial of medical skin camouflage for recovery of women prisoners with self-harm scarring (COVER): the study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e021891
Author(s):  
Heather Mitchell ◽  
Kathryn M Abel ◽  
Brendan James Dunlop ◽  
Tammi Walker ◽  
Sandeep Ranote ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Well Being ◽  
Self Esteem ◽  
Health Concern ◽  
Women Prisoners ◽  
Pilot Randomised Controlled Trial ◽  
North East ◽  
Self Harm ◽  
Randomised Controlled

IntroductionSelf-harm in prison is a major public health concern. Less than 5% of UK prisoners are women, but they carry out more than a fifth of prison self-harm. Scars resulting from self-harm can be traumatising and stigmatising, yet there has been little focus on recovery of women prisoners with self-harm scarring. Medical skin camouflage (MSC) clinics treat individuals with disfiguring skin conditions, with evidence of improved well-being, self-esteem and social interactions. Only one community study has piloted the use of MSC for self-harm scarring.Methods and analysisWe describe an acceptability and feasibility pilot randomised controlled trial; the first to examine MSC for women prisoners who self-harm. We aim to randomise 20–25 women prisoners to a 6-week MSC intervention and 20–25 to a waitlist control (to receive the MSC after the study period). We aim to train at least 6–10 long-term prisoners with personal experience of self-harm to deliver the intervention. Before and after intervention, we will pilot collection of women-centred outcomes, including quality of life, well-being and self-esteem. We will pilot collection of self-harm incidents during the intervention, resources used to manage/treat self-harm and follow-up of women at 12 weeks from baseline. Data on recruitment, retention and dropout will be recorded. We aim for the acceptability of the intervention to prison staff and women prisoners to be explored in qualitative interviews and focus groups.Ethics and disseminationEthical approval for COVER has been granted by the North East–York Research Ethics Committee (REC) for phases 1 and 2 (reference: 16/NE/0030) and West of Scotland REC 3 for phases 3 and 4 (reference: 16/WS/0155). Informed consent will be the primary consideration; it will be made clear that participation will have no effect on life in prison or eligibility for parole. Due to the nature of the study, disclosures of serious self-harm may need to be reported to prison officials. We aim for findings to be disseminated via events at the study prison, presentations at national/international conferences, journal publications, prison governor meetings and university/National Health Service trust communications.Trial registration numberNCT02638974; Pre-results.

scholarly journals EXercise to Prevent frailty and Loss Of independence in insulin treated older people with DiabetEs (EXPLODE): protocol for a feasibility randomised controlled trial (RCT)

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e048932
Author(s):  
Rachel Stocker ◽  
James Shaw ◽  
Guy S Taylor ◽  
Miles D Witham ◽  
Daniel J West
Keyword(s):  
Randomised Controlled Trial ◽  
Resistance Training ◽  
Resistance Exercise ◽  
Physical Function ◽  
Controlled Trial ◽  
Well Being ◽  
Training Programme ◽  
North East ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled

IntroductionThere are 3.9 million people in the UK with diabetes. Sarcopenia, increased frailty and loss of independence are often unappreciated complications of diabetes. Resistance exercise shows promise in reducing these complications in older adult diabetes patients. The aim of this feasibility randomised controlled trial is to (1) characterise the physical function, cardiovascular health and the health and well-being of older adults with mild frailty with/without diabetes treated with insulin, (2) to understand the feasibility and acceptability of a 4-week resistance exercise training programme in improving these parameters for those with diabetes and (3) to test the feasibility of recruiting and randomising the diabetic participant group to a trial of resistance training.Methods and analysisThirty adults aged ≥60 years with insulin-treated diabetes mellitus (type 1 or 2), and 30 without, all with mild frailty (3–4 on the Rockwood Frailty Scale) will be recruited. All will complete blood, cardiovascular and physical function testing. Only the diabetic group will then proceed into the trial itself. They will be randomised 1:1 to a 4-week semisupervised resistance training programme, designed to increase muscle mass and strength, or to usual care, defined as their regular physical activity, for 4 weeks. This group will then repeat testing. Primary outcomes include recruitment rate, attrition rate, intervention fidelity and acceptability, and adherence to the training programme. A subset of participants will be interviewed before and after the training programme to understand experiences of resistance training, impact on health and living with diabetes (where relevant) as they have aged. Analyses will include descriptive statistics and qualitative thematic analysis.Ethics and disseminationThe North East-Newcastle and North Tyneside 2 Research Ethics Committee (20/NE/0178) approved the study. Outputs will include feasibility data to support funding applications for a future definitive trial, conference and patient and public involvement presentations, and peer-reviewed publications.Trial registration numberISRCTN13193281.

scholarly journals Depression screening using patient-targeted feedback in general practices: study protocol of the German multicentre GET.FEEDBACK.GP randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e035973 ◽  
Author(s):  
Sebastian Kohlmann ◽  
Marco Lehmann ◽  
Marion Eisele ◽  
Lea-Elena Braunschneider ◽  
Gabriella Marx ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Patient Engagement ◽  
Controlled Trial ◽  
Mental Healthcare ◽  
Depression Screening ◽  
Depression Severity ◽  
Feedback Intervention ◽  
North East ◽  
Randomised Controlled

IntroductionApproximately one out of six patients in primary care suffers from depression, which often remains undetected. Evidence regarding the efficacy of depression screening in primary care, however, is inconsistent. A previous single-centre randomised controlled trial (RCT) in cardiac patients, the DEPSCREEN-INFO trial, provided the first evidence that written feedback to patients following a positive depression screening reduces depression severity and leads to more comprehensive patient engagement in mental healthcare. To amplify these effects, the feedback should be tailored according to patients’ needs and preferences. The GET.FEEDBACK.GP RCT will test the efficacy of this patient-targeted feedback intervention in primary care.Methods and analysisThe multicentre three-arm GET.FEEDBACK.GP RCT aims to recruit a total of 1074 primary care patients from North, East and South Germany. Patients will be screened for depression using the Patient Health Questionnaire-9 (PHQ-9). In the case of a positive depression screening result (PHQ-9 score ≥10), the participant will be randomised into one of three groups to either receive (a) patient-targeted and general practitioner (GP)-targeted feedback regarding the depression screening results, (b) only GP-targeted feedback or (c) no feedback. Patients will be followed over a period of 12 months. The primary outcome is depression severity (PHQ-9) 6 months after screening. Secondary outcomes include patient engagement in mental healthcare, professional depression care and cost-effectiveness. According to a statistical analysis plan, the primary endpoint of all randomised patients will be analysed regarding the intention-to-treat principle.Ethics and disseminationThe Ethics Committee of the Hamburg Medical Association approved the study. A clinical trial company will ensure data safety, monitoring and supervision. The multicentre GET.FEEDBACK.GP RCT is the first trial in primary care that tests the efficacy of a patient-targeted feedback intervention as an adjunct to depression screening. Its results have the potential to influence future depression guidelines and will be disseminated in scientific as well as patient-friendly language.Trial registration numberNCT03988985.

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