Dataset Information

Rapid Analgesia for Prehospital hip Disruption (RAPID): findings from a randomised feasibility study.

ABSTRACT: Background:In managing hip fracture, effective pain relief before admission to hospital is difficult without risking side effects. Although emergency departments routinely use fascia iliaca compartment block (FICB), there has been little evaluation of its use by paramedics before hospital admission. We aimed to assess whether a multi-centre randomised trial to evaluate FICB was feasible. Methods:Volunteer paramedics used scratchcards to allocate patients with hip fracture at random between FICB and pain relief as usual. Primary outcomes were mortality and quality of life. We also measured adverse events, costs, final diagnosis, length of stay in hospital, pain scores and quality of care and collected qualitative data about acceptability to patients in interviews, and paramedics in focus groups. We pre-specified criteria for deciding whether to progress to a fully powered trial based on the recruitment of paramedics and patients, delivery of FICB, retrieval of outcome data, safety, acceptability, and diagnostic accuracy of hip fracture. Results:We effectively met all progression criteria: we recruited 19 paramedics who randomly allocated 71 patients between trial arms between 28 June 2016 and 31 July 2017; 57 (31 experimental arm, 26 usual care arm, 80% overall) retrospectively consented to follow-up. Just over half (17/31) of experimental participants received FICB; all others had contraindications, including nine taking anticoagulants. Four of the 31 participants assigned FICB and six of the 26 assigned usual care died within 6 months of hospital admission. Serious adverse events were also similar: 3/35 experimental versus 4/36 in usual care. Paramedics' recognition of hip fracture had sensitivity of 49/64 (77%) with a positive predictive value of 46/57 (81%). We received quality of life questionnaires for 30 of 49 patients (61%) at 1 month and 12 of 17 (71%) at 6 months. Patient satisfaction was similar: experimental mean 3.4 (n = 20) versus 3.5 (n = 13) for usual care. Conclusions:RAPID met all progression criteria within reasonable limits. As equipoise remains, we plan to undertake a fully powered multi-centre trial to test clinical and cost effectiveness of paramedic-administered FICB at the scene of hip fracture. Trial registration:ISRCTN 60065373 sought 5 November 2015.

SUBMITTER: Jones JK

PROVIDER: S-EPMC6560881 | biostudies-other | 2019

REPOSITORIES: biostudies-other

ACCESS DATA

Publications

Rapid Analgesia for Prehospital hip Disruption (RAPID): findings from a randomised feasibility study.

Jones Jenna K JK Evans Bridie A BA Fegan Greg G Ford Simon S Guy Katy K Jones Sian S Keen Leigh L Khanom Ashrafunnesa A Longo Mirella M Pallister Ian I Rees Nigel N Russell Ian T IT Seagrove Anne C AC Watkins Alan A Snooks Helen A HA

Pilot and feasibility studies 20190612

<h4>Background</h4>In managing hip fracture, effective pain relief before admission to hospital is difficult without risking side effects. Although emergency departments routinely use fascia iliaca compartment block (FICB), there has been little evaluation of its use by paramedics before hospital admission. We aimed to assess whether a multi-centre randomised trial to evaluate FICB was feasible.<h4>Methods</h4>Volunteer paramedics used scratchcards to allocate patients with hip fracture at rando ...[more]

PMID: 31210961

Similar Datasets

Project description:Severe sepsis is a time critical condition which is known to have a high mortality rate. Evidence suggests that early diagnosis and early administration of antibiotics can reduce morbidity and mortality from sepsis. The prehospital phase of emergency medical care may provide the earliest opportunity for identification of sepsis and delivery of life-saving treatment for patients. We aimed to assess the feasibility of (1) paramedics recognising and screening patients for severe sepsis, collecting blood cultures and administering intravenous antibiotics; and (2) trial methods in order to decide whether a fully-powered trial should be undertaken to determine safety and effectiveness of this intervention. Paramedics were trained in using a sepsis screening tool, aseptic blood culture collection and administration of intravenous antibiotics. If sepsis was suspected, paramedics randomly allocated patients to intervention or usual care using scratchcards. Patients were followed up at 90 days using linked anonymised data to capture length of hospital admission and mortality. We collected self-reported health-related quality of life at 90 days. We pre-specified criteria for deciding whether to progress to a fully-powered trial based on: recruitment of paramedics and patients; delivery of the intervention; retrieval of outcome data; safety; acceptability; and success of anonymised follow-up. Seventy-four of the 104 (71.2%) eligible paramedics agreed to take part and 54 completed their training (51.9%). Of 159 eligible patients, 146 (92%) were recognised as eligible by study paramedics, and 118 were randomised (74% of eligible patients, or 81% of those recognised as eligible). Four patients subsequently dissented to be included in the trial (3%), leaving 114 patients recruited to follow-up. All recruited patients were matched to routine data outcomes in the Secure Anonymised Information Linkage Databank. Ninety of the 114 (79%) recruited patients had sepsis or a likely bacterial infection recorded in ED. There was no evidence of any difference between groups in patient satisfaction, and no adverse reactions reported. There were no statistically significant differences between intervention and control groups in Serious Adverse Events (ICU admissions; deaths). This feasibility study met its pre-determined progression criteria; an application will therefore be prepared and submitted for funding for a fully-powered multi-centre randomised trial.Trial registration: ISRCTN36856873 sought 16th May 2017; https://doi.org/10.1186/ISRCTN36856873.

Project description:BackgroundWe aimed to investigate clinical benefits and economic costs of inhaled methoxyflurane when used by ambulance staff for prehospital emergency patients with trauma. Comparison is to usual analgesic practice (UAP) in the UK in which patient records were selected if treatment had been with Entonox® or intravenous morphine or intravenous paracetamol.MethodsOver a 12-month evaluation period, verbal numerical pain scores (VNPS) were gathered from adults with moderate to severe trauma pain attended by ambulance staff trained in administering and supplied with methoxyflurane. Control VNPS were obtained from ambulance database records of UAP in similar patients for the same period. Statistical modelling enabled comparisons of methoxyflurane to UAP, where we employed an Ordered Probit panel regression model for pain, linked by observational rules to VNPS.ResultsOverall, 96 trained paramedics and technicians from the East Midlands Ambulance Service NHS Trust (EMAS) prepared 510 doses of methoxyflurane for administration to a total of 483 patients. Comparison data extracted from the EMAS database of UAP episodes involved: 753 patients using Entonox®, 802 patients using intravenous morphine, and 278 patients using intravenous paracetamol. Modelling results included demonstration of faster pain relief with inhaled methoxyflurane (all p-values < 0.001). Methoxyflurane's time to achieve maximum pain relief was estimated to be significantly shorter: 26.4 min (95%CI 25.0-27.8) versus Entonox® 44.4 min (95%CI 39.5-49.3); 26.5 min (95%CI 25.0-27.9) versus intravenous morphine 41.8 min (95%CI 38.9-44.7); 26.5 min (95%CI 25.1-28.0) versus intravenous paracetamol 40.8 (95%CI 34.7-46.9). Scenario analyses showed that durations spent in severe pain were significantly less for methoxyflurane. Costing scenarios showed the added benefits of methoxyflurane were achieved at higher cost, eg versus Entonox® the additional cost per treated patient was estimated to be £12.30.ConclusionWhen administered to adults with moderate or severe pain due to trauma inhaled methoxyflurane reduced pain more rapidly and to a greater extent than Entonox® and parenteral analgesics. Inclusion of inhaled methoxyflurane to the suite of prehospital analgesics provides a clinically useful addition, but one that is costlier per treated patient.

Project description:BackgroundMore people are living longer lives leading to a growth in the population of older adults, many of whom have comorbidities and low levels of physical function. Physical activity in later life can prevent or delay age-related disability. Identifying a cost-effective means of increasing physical activity in older adults therefore remains an important public health priority.Physical Activity Facilitation (PAF) is an intervention shown to increase physical activity in adults with depression. The PAF model was modified for a population of older adults at risk of disability. This study aimed to assess the feasibility of undertaking a definitive RCT of the PAF intervention in the target population.MethodsA pilot randomised controlled trial (RCT) was delivered through primary care. Patients at risk of disability and who were not meeting recommended levels of physical activity were recruited through postal invitation and direct approach in the practice waiting room. Those meeting eligibility criteria were enrolled and randomised at a 2:1 ratio to the PAF intervention and control. Behaviour change techniques were used by facilitators with participants over the telephone and face-to-face for 6 months. Outcome measures including physical function, physical activity, depression, social support, and quality of life were collected at baseline and at 6 months.ResultsA high proportion of patients responded to the initial invitation (68%), yet many were ineligible due to high levels of self-reported physical activity and baseline physical function. Fifty-one participants were recruited to the trial, with an average age of 74 years (range 65-89), and there were high rates of adherence and retention to the study (94% follow-up at 6 months). The majority of outcome data collected from participants was complete; however, the validated scale used to measure self-reported physical activity was associated with high levels of missing data.ConclusionsThe findings of this pilot RCT suggest that it is feasible to deliver a definitive RCT of the PAF intervention in this population. Further work is required to improve the efficiency of recruitment and to minimise missing data from self-reported physical activity measures.Trial registrationCurrent controlled trials ISRCTN80470273. Registered 25 October 2013.

Project description:ObjectivesTo assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of an informal caregiver training programme to support the recovery of people following hip fracture surgery.DesignTwo-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study.SettingNational Health Service (NHS) providers in five English hospitals.ParticipantsCommunity-dwelling adults, aged 60 years and over, who undergo hip fracture surgery and their informal caregivers.InterventionUsual care: usual NHS care.Experimentalusual NHS care plus a caregiver-patient dyad training programme (HIP HELPER). This programme comprised three, 1 hour, one-to-one training sessions for a patient and caregiver, delivered by a nurse, physiotherapist or occupational therapist in the hospital setting predischarge. After discharge, patients and caregivers were supported through three telephone coaching sessions.Randomisation and blindingCentral randomisation was computer generated (1:1), stratified by hospital and level of patient cognitive impairment. There was no blinding.Main outcome measuresData collected at baseline and 4 months post randomisation included: screening logs, intervention logs, fidelity checklists, acceptability data and clinical outcomes. Interviews were conducted with a subset of participants and health professionals.Results102 participants were enrolled (51 patients; 51 caregivers). Thirty-nine per cent (515/1311) of patients screened were eligible. Eleven per cent (56/515) of eligible patients consented to be randomised. Forty-eight per cent (12/25) of the intervention group reached compliance to their allocated intervention. There was no evidence of treatment contamination. Qualitative data demonstrated the trial and HIP HELPER programme was acceptable.ConclusionsThe HIP HELPER programme was acceptable to patient-caregiver dyads and health professionals. The COVID-19 pandemic impacting on site's ability to deliver the research. Modifications are necessary to the design for a viable definitive RCT.Trial registration numberISRCTN13270387.

Dataset Information

Rapid Analgesia for Prehospital hip Disruption (RAPID): findings from a randomised feasibility study.

Publications

Rapid Analgesia for Prehospital hip Disruption (RAPID): findings from a randomised feasibility study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets