Paramedic Acute Stroke Treatment Assessment (PASTA): study protocol for a randomised controlled trial
This study is evaluating whether an enhanced care pathway delivered by paramedics (the Paramedic Acute Stroke Treatment Assessment (PASTA)) could increase the number of patients who receive IV thrombolysis treatment.MethodsStudy design: Cluster randomised trial with economic analysis and parallel process evaluation.Setting: National Health Service ambulance services, emergency departments and hyper-acute stroke units within three geographical regions of England and Wales.Randomisation: Ambulance stations within each region are the units of randomisation. According to station allocation, paramedics based at a station delive...
Source: Trials - February 12, 2019 Category: Research Source Type: clinical trials

A protocol for the process evaluation of a multi-centre randomised trial to compare the effectiveness of geriatrician-led admission avoidance hospital at home versus inpatient admission
DiscussionThis process evaluation will enable evaluation of implementation processes prior to knowing trial outcomes. We encompass domains of reach, delivery, change, context and response to the intervention by patients, their carers, health professionals and the health system.Trial registrationISRCTN60477865. Registered on 10 March 2014. Trial sponsor: University of Oxford.Version 3.1, registered on 14 June 2016. (Source: Trials)
Source: Trials - October 19, 2018 Category: Research Source Type: clinical trials

A community-based intervention (Young SMILES) to improve the health-related quality of life of children and young people of parents with serious mental illness: randomised feasibility protocol
DiscussionThis paper details the rationale, design, training and recruitment methods for a feasibility study to inform the design and effective implementation of a larger scale randomised controlled trial of Young SMILES.Trial RegistrationISRCTN36865046, registered 18 December 2015. (Source: Trials)
Source: Trials - October 11, 2018 Category: Research Source Type: clinical trials

Nerve root block versus surgery (NERVES) for the treatment of radicular pain secondary to a prolapsed intervertebral disc herniation: study protocol for a multi-centre randomised controlled trial
DiscussionNERVES is the first trial to evaluate the comparative clinical and cost-effectiveness of microdiscectomy to local anaesthetic and steroid administered via TFESI. The results of this research may facilitate the development of an evidence-based treatment strategy for patients with sciatica.Trial registrationISRCTN, ID:ISRCTN04820368. Registered on 5 June 2014.EudraCT EudraCT2014 –002751-25. Registered on 8 October 2014. (Source: Trials)
Source: Trials - September 5, 2018 Category: Research Source Type: clinical trials

Metacognitive therapy home-based self-help for cardiac rehabilitation patients experiencing anxiety and depressive symptoms: study protocol for a feasibility randomised controlled trial (PATHWAY Home-MCT)
DiscussionThe Home-MCT feasibility randomised controlled trial will provide evidence on the acceptability of delivering metacognitive therapy in a home-based self-help format for cardiac rehabilitation patients experiencing symptoms of anxiety and/or depression and on the feasibility and design of a full-scale trial. In addition, it will provide provisional point estimates, with appropriately wide measures of uncertainty, relating to the effectiveness and cost-effectiveness of the intervention.Trial registrationClinicalTrials.gov,NCT03129282, Submitted to Registry: 11 April 2017. (Source: Trials)
Source: Trials - August 16, 2018 Category: Research Source Type: clinical trials

Improving the effectiveness of psychological interventions for depression and anxiety in the cardiac rehabilitation pathway using group-based metacognitive therapy (PATHWAY Group MCT): study protocol for a randomised controlled trial
DiscussionThis trial will evaluate the effectiveness and cost-effectiveness of group-based metacognitive therapy in alleviating anxiety and depression in cardiac rehabilitation patients. The therapy, if effective, offers the potential to improve psychological wellbeing and quality of life in this large group of patients.Trial registrationUK Clinical Trials Gateway,ISRCTN74643496, Registered on 8 April 2015. (Source: Trials)
Source: Trials - April 3, 2018 Category: Research Source Type: clinical trials

Evaluation of mindfulness-based cognitive therapy for life and a cognitive behavioural therapy stress-management workshop to improve healthcare staff stress: study protocol for two randomised controlled trials
DiscussionThis trial will examine whether a one-day CBT stress-management workshop and an 8-session MBCT-L course are effective at reducing healthcare staff stress and other mental health outcomes compared to wait-list, and, whether these interventions are effective at reducing sickness absence and presenteeism and at enhancing wellbeing, self-compassion, mindfulness and compassion for others. Findings will help inform approaches offered to reduce healthcare staff stress and other key variables. A note of caution is that individual-level approaches should only be part of the solution to reducing healthcare staff stress wit...
Source: Trials - April 2, 2018 Category: Research Source Type: clinical trials