Search

Background: Despite best evidence demonstrating the effectiveness of increased intensity of exercise after stroke, current levels of therapy continue to be below those required to optimise motor recovery. We developed and tested an implementation intervention that aims to increase arm exercise in stroke rehabilitation. The aim of this study was to illustrate the use of a behaviour change framework, the Behaviour Change Wheel, to identify the mechanisms of action that explain how the intervention produced change. Methods: We implemented the intervention at three stroke rehabilitation units in the United Kingdom. A purposive sample of therapy team members were recruited to participate in semi-structured interviews to explore their perceptions of how the intervention produced change at their work place. Audio recordings were transcribed and imported into NVivo 10 for content analysis. Two coders separately analysed the transcripts and coded emergent mechanisms. Mechanisms were categorised using the Theoretical Domains Framework (TDF) (an extension of the Capability, Opportunity, Motivation and Behaviour model (COM-B) at the hub of the Behaviour Change Wheel). Results: We identified five main mechanisms of action: 'social/professional role and identity', 'intentions', 'reinforcement', 'behavioural regulation' and 'beliefs about consequences'. At the outset, participants viewed the research team as an external influence for whom they endeavoured to complete the study activities. The study design, with a focus on implementation in real world settings, influenced participants' intentions to implement the intervention components. Monthly meetings between the research and therapy teams were central to the intervention and acted as prompt or reminder to sustain implementation. The phased approach to introducing and implementing intervention components influenced participants' beliefs about the feasibility of implementation. Conclusions: The Behaviour Change Wheel, and in particular the Theoretical Domains Framework, were used to investigate mechanisms of action of an implementation intervention. This approach allowed for consideration of a range of possible mechanisms, and allowed us to categorise these mechanisms using an established behaviour change framework. Identification of the mechanisms of action, following testing of the intervention in a number of settings, has resulted in a refined and more robust intervention programme theory for future testing. [ABSTRACT FROM AUTHOR]

Background: The implementation of strategies to monitor and enhance treatment fidelity is of paramount importance in trials of complex interventions. A recent framework published by the National Institutes of Health Behavior Change Consortium recommends addressing five areas of treatment fidelity, one of which is delivery of treatment. This study aimed to explore fidelity to treatment delivery of the ICONS intervention (a systematic voiding programme [SVP]). This included exploring the feasibility of a method to assess fidelity to treatment delivery and collecting preliminary evidence of the level of fidelity to SVP delivery in order to inform strategies for improving fidelity in a future trial. Methods: Delivery of treatment was recorded by nurses through completion of daily clinical logs, which included: a voiding interval, proposed voiding times and actual voiding times. The a priori method for assessment of fidelity - comparing actual voiding times with proposed voiding times - was trialled on a small amount of data. Due to errors in documentation of the voiding intervals and proposed voiding times it was not possible to assess fidelity directly as planned. A new method was devised, which included identification of 'key quality indicators'. Results: This new approach to assessing fidelity used key quality indicators based upon presence of the data needed to make the comparison between proposed and actual voiding times. The proportion of clinical logs with correct documentation of voiding intervals and proposed voiding times was less than 40 %. For clinical logs with correct documentation, an actual voiding time within 30 min of the proposed voiding time was identified on approximately 55 % of occasions. Conclusions: Lessons learnt from this study have implications for the future ICONS definitive trial and for other trials of complex interventions. Implementation of a complex intervention may often deviate from what is intended. While careful consideration should be given to the best method of fidelity assessment, an iterative approach allowing flexibility to adapt pre-planned methods is recommended within feasibility trials. As fidelity to treatment delivery in the ICONS feasibility trial appeared to be relatively low, more attention to implementation strategies will be required in the definitive trial. Trial registration: Identifier: ISRCTN08609907; date registered: 07/07/2010. [ABSTRACT FROM AUTHOR]

Background: Two thirds of survivors will achieve independent ambulation after a stroke, but less than half will recover upper limb function. There is strong evidence to support intensive repetitive task-oriented training for recovery after stroke. The number of repetitions needed is suggested to be in the order of hundreds, but this is not currently being achieved in clinical practice. In an effort to bridge this evidence-practice gap, we have developed a behaviour change intervention that aims to increase provision of upper limb repetitive task-oriented training in stroke rehabilitation. This paper aims to describe the systematic processes that took place in collaboratively developing the behaviour change intervention. Methods: The methods used in this study were not defined a priori but were guided by the Behaviour Change Wheel. The process was collaborative and iterative with four stages of development emerging (i) establishing an intervention development group; (ii) structured discussions to understand the problem, prioritise target behaviours and analyse target behaviours; (iii) collaborative design of theoretically underpinned intervention components and (iv) piloting and refining of intervention components. Results: The intervention development group consisted of the research team and stroke therapy team at a local stroke rehabilitation unit. The group prioritised four target behaviours at the therapist level: (i) identifying suitable patients for exercises, (ii) provision of exercises, (iii) communicating exercises to family/visitors and (iv) monitoring and reviewing exercises. It also provides a method for self-monitoring performance in order to measure fidelity. The developed intervention, PRACTISE (Promoting Recovery of the Arm: Clinical Tools for Intensive Stroke Exercise), consists of team meetings and the PRACTISE Toolkit (screening tool and upper limb exercise plan, PRACTISE exercise pack and an audit tool). Conclusions: This paper provides an example of how the Behaviour Change Wheel may be applied in the collaborative development of a behaviour change intervention for health professionals. The process involved was resource-intensive, and the iterative process was difficult to capture. The use of a published behaviour change framework and taxonomy will assist replication in future research and clinical use. The feasibility and acceptability of PRACTISE is currently being explored in two other stroke rehabilitation units. [ABSTRACT FROM AUTHOR]

Background The Graded Repetitive Arm Supplementary Program (GRASP) is a hand and arm exercise programme designed to increase the intensity of exercise achieved in inpatient stroke rehabilitation. GRASP was shown to be effective in a randomised controlled trial in 2009 and has since experienced unusually rapid uptake into clinical practice. The aim of this study was to conduct a formative evaluation of the implementation of GRASP to inform the development and implementation of a similar intervention in the United Kingdom. Methods Semi-structured interviews were conducted with therapists who were involved in implementing GRASP at their work site, or who had experience of using GRASP. Normalisation Process Theory (NPT), a sociological theory used to explore the processes of embedding innovations in practice, was used to develop an interview guide. Intervention components outlined within the GRASP Guideline Manual were used to develop prompts to explore how therapists use GRASP in practice. Interview transcripts were analysed using a coding frame based on implementation theory. Results Twenty interviews were conducted across eight sites in British Columbia Canada. Therapists identified informal networks and the free online availability of GRASP as key factors in finding out about the intervention. All therapists reported positive opinions about the value of GRASP. At all sites, therapists identified individuals who advocated for the use of GRASP, and in six of the eight sites this was the practice leader or senior therapist. Rehabilitation assistants were identified as instrumental in delivering GRASP in almost all sites as they were responsible for organising the GRASP equipment and assisting patients using GRASP. Almost all intervention components were found to be adapted to some degree when used in clinical practice; coverage was wider, the content adapted, and the dose, when monitored, was less. Conclusions Although GRASP has translated into clinical practice, it is not always used in the way in which it was shown to be effective. This formative evaluation has informed the development of a novel intervention which aims to bridge this evidence-practice gap in upper limb rehabilitation after stroke. [ABSTRACT FROM AUTHOR]

Background: Stroke is a time-dependent medical emergency in which early presentation to specialist care reduces death and dependency. Up to 70% of all stroke patients obtain first medical contact from the Emergency Medical Services (EMS). Identifying 'true stroke' from an EMS call is challenging, with over 50% of strokes being misclassified. The aim of this study was to evaluate the impact of the training package on the recognition of stroke by Emergency Medical Dispatchers (EMDs).Methods: This study took place in an ambulance service and a hospital in England using an interrupted time-series design. Suspected stroke patients were identified in one week blocks, every three weeks over an 18 month period, during which time the training was implemented. Patients were included if they had a diagnosis of stroke (EMS or hospital). The effect of the intervention on the accuracy of dispatch diagnosis was investigated using binomial (grouped) logistic regression.Results: In the Pre-implementation period EMDs correctly identified 63% of stroke patients; this increased to 80% Post-implementation. This change was significant (p=0.003), reflecting an improvement in identifying stroke patients relative to the Pre-implementation period both the During-implementation (OR=4.10 [95% CI 1.58 to 10.66]) and Post-implementation (OR=2.30 [95% CI 1.07 to 4.92]) periods. For patients with a final diagnosis of stroke who had been dispatched as stroke there was a marginally non-significant 2.8 minutes (95% CI -0.2 to 5.9 minutes, p=0.068) reduction between Pre- and Post-implementation periods from call to arrival of the ambulance at scene.Conclusions: This is the first study to develop, implement and evaluate the impact of a training package for EMDs with the aim of improving the recognition of stroke. Training led to a significant increase in the proportion of stroke patients dispatched as such by EMDs; a small reduction in time from call to arrival at scene by the ambulance also appeared likely. The training package has been endorsed by the UK Stroke Forum Education and Training, and is free to access on-line. [ABSTRACT FROM AUTHOR]

Background: The occupational therapy (OT) in care homes study (OTCH) aims to investigate the effect of a targeted course of individual OT (with task training, provision of adaptive equipment, minor environmental adaptations and staff education) for stroke survivors living in care homes, compared to usual care. Methods/Design: A cluster randomised controlled trial of United Kingdom (UK) care homes (n = 90) with residents (n = 900) who have suffered a stroke or transient ischaemic attack (TIA), and who are not receiving end-of-life care. Homes will be stratified by centre and by type of care provided and randomised (50:50) using computer generated blocked randomisation within strata to receive either the OT intervention (3 months intervention from an occupational therapist) or control (usual care). Staff training on facilitating independence and mobility and the use of adaptive equipment, will be delivered to every home, with control homes receiving this after the 12 month follow-up. Allocation will be concealed from the independent assessors, but the treating therapists, and residents will not be masked to the intervention. Measurements are taken at baseline prior to randomisation and at 3, 6 and 12 months post randomisation. The primary outcome measure is independence in self-care activities of daily living (Barthel Activities of Daily Living Index). Secondary outcome measures are mobility (Rivermead Mobility Index), mood (Geriatric Depression Scale), preference based quality of life measured from EQ-5D and costs associated with each intervention group. Quality adjusted life years (QALYs) will be derived based on the EQ-5D scores. Cost effectiveness analysis will be estimated and measured by incremental cost effectiveness ratio. Adverse events will be recorded. Discussion: This study will be the largest cluster randomised controlled trial of OT in care homes to date and will clarify the currently inconclusive literature on the efficacy of OT for stroke and TIA survivors residing in care homes. Trial registration: ISRCTN00757750 [ABSTRACT FROM AUTHOR]

An abstract of the article "Practical and methodological challenges in the design and implementation of a clusterrandomised feasibility trial of the management of urinary incontinence after stroke," by Chris J. Sutton and colleagues, is presented.

Background: Stroke telemedicine can reduce healthcare inequities by increasing access to specialists. Successful telemedicine networks require specialists adapting clinical practice to provide remote consultations. Variation in experiences of specialists between different countries is unknown. To support future implementation, we compared perceptions of Australian and United Kingdom specialists providing remote acute stroke consultations., Methods: Specialist participants were identified using purposive sampling from two new services: Australia's Victorian Stroke Telemedicine Program (n = 6; 2010-13) and the United Kingdom's Cumbria and Lancashire telestroke network (n = 5; 2010-2012). Semi-structured interviews were conducted pre- and post-implementation, recorded and transcribed verbatim. Deductive thematic and content analysis (NVivo) was undertaken by two independent coders using Normalisation Process Theory to explore integration of telemedicine into practice. Agreement between coders was M = 91%, SD = 9 and weighted average κ = 0.70., Results: Cross-cultural similarities and differences were found. In both countries, specialists described old and new consulting practices, the purpose and value of telemedicine systems, and concerns regarding confidence in the assessment and diagnostic skills of unknown colleagues requesting telemedicine support. Australian specialists discussed how remote consultations impacted on usual roles and suggested future improvements, while United Kingdom specialists discussed system governance, policy and procedures., Conclusion: Australian and United Kingdom specialists reported telemedicine required changes in work practice and development of new skills. Both groups described potential for improvements in stroke telemedicine systems with Australian specialists more focused on role change and the United Kingdom on system governance issues. Future research should examine if cross-cultural variation reflects different models of care and extends to other networks.

Background: Repetitive functional task practise (RFTP) is a promising treatment to improve upper limb recovery following stroke. We report the findings of a study to determine the feasibility of a multi-centre randomised controlled trial to evaluate this intervention., Methods: A pilot randomised controlled trial recruited patients with new reduced upper limb function within 14 days of acute stroke from three stroke units. Participants were randomised to receive a four week upper limb RFTP therapy programme consisting of goal setting, independent activity practise, and twice weekly therapy reviews in addition to usual post stroke rehabilitation, or usual post stroke rehabilitation. The recruitment rate; adherence to the RFTP therapy programme; usual post stroke rehabilitation received; attrition rate; data quality; success of outcome assessor blinding; adverse events; and the views of study participants and therapists about the intervention were recorded., Results: Fifty five eligible patients were identified, 4-6 % of patients screened at each site. Twenty four patients participated in the pilot study. Two study sites met the recruitment target of 1-2 participants per month. The median number of face to face therapy sessions received was 6 [IQR 3-8]. The median number of daily repetitions of activities recorded was 80 [IQR 39-80]. Data about usual post stroke rehabilitation were available for 18/24 (75 %). Outcome data were available for 22/24 (92 %) at one month and 20/24 (83 %) at three months. Outcome assessors were unblinded to participant group allocation for 11/22 (50 %) at one month and 6/20 (30 %) at three months. Four adverse events were considered serious as they resulted in hospitalisation. None were related to study treatment. Feedback from patients and therapists about the RFTP programme was mainly positive., Conclusions: A multi-centre randomised controlled trial to evaluate an upper limb RFTP therapy programme provided early after stroke is feasible and acceptable to patients and therapists, but there are issues which need to be addressed when designing a Phase III study. A Phase III study will need to monitor and report not only recruitment and attrition but also adherence to the intervention, usual post stroke rehabilitation received, and outcome assessor blinding., Trial Registration: International Standard Randomised Controlled Trials Number (ISRCTN) 58527251.

Background: Over one million people sustain traumatic brain injury each year in the UK and more than 10 % of these are moderate or severe injuries, resulting in cognitive and psychological problems that affect the ability to work. Returning to work is a primary rehabilitation goal but fewer than half of traumatic brain injury survivors achieve this. Work is a recognised health service outcome, yet UK service provision varies widely and there is little robust evidence to inform rehabilitation practice. A single-centre cohort comparison suggested better work outcomes may be achieved through early occupational therapy targeted at job retention. This study aims to determine whether this intervention can be delivered in three new trauma centres and to conduct a feasibility, randomised controlled trial to determine whether its effects and cost effectiveness can be measured to inform a definitive trial., Methods/design: Mixed methods study, including feasibility randomised controlled trial, embedded qualitative studies and feasibility economic evaluation will recruit 102 people with traumatic brain injury and their nominated carers from three English UK National Health Service (NHS) trauma centres. Participants will be randomised to receive either usual NHS rehabilitation or usual rehabilitation plus early specialist traumatic brain injury vocational rehabilitation delivered by an occupational therapist. The primary objective is to assess the feasibility of conducting a definitive trial; secondary objectives include measurement of protocol integrity (inclusion/exclusion criteria, intervention adherence, reasons for non-adherence) recruitment rate, the proportion of eligible patients recruited, reasons for non-recruitment, spectrum of TBI severity, proportion of and reasons for loss to follow-up, completeness of data collection, gains in face-to-face V s postal data collection and the most appropriate methods of measuring primary outcomes (return to work, retention) to determine the sample size for a larger trial., Discussion: To our knowledge, this is the first feasibility randomised controlled trial of a vocational rehabilitation health intervention specific to traumatic brain injury. The results will inform the design of a definitive trial., Trial Registration: The trial is registered ISRCTN Number 38581822.

Background: Positioning a patient lying-flat in the acute phase of ischaemic stroke may improve recovery and reduce disability, but such a possibility has not been formally tested in a randomised trial. We therefore initiated the Head Position in Stroke Trial (HeadPoST) to determine the effects of lying-flat (0°) compared with sitting-up (≥ 30°) head positioning in the first 24 hours of hospital admission for patients with acute stroke., Methods/design: We plan to conduct an international, cluster randomised, crossover, open, blinded outcome-assessed clinical trial involving 140 study hospitals (clusters) with established acute stroke care programs. Each hospital will be randomly assigned to sequential policies of lying-flat (0°) or sitting-up (≥ 30°) head position as a 'business as usual' stroke care policy during the first 24 hours of admittance. Each hospital is required to recruit 60 consecutive patients with acute ischaemic stroke (AIS), and all patients with acute intracerebral haemorrhage (ICH) (an estimated average of 10), in the first randomised head position policy before crossing over to the second head position policy with a similar recruitment target. After collection of in-hospital clinical and management data and 7-day outcomes, central trained blinded assessors will conduct a telephone disability assessment with the modified Rankin Scale at 90 days. The primary outcome for analysis is a shift (defined as improvement) in death or disability on this scale. For a cluster size of 60 patients with AIS per intervention and with various assumptions including an intracluster correlation coefficient of 0.03, a sample size of 16,800 patients at 140 centres will provide 90 % power (α 0.05) to detect at least a 16 % relative improvement (shift) in an ordinal logistic regression analysis of the primary outcome. The treatment effect will also be assessed in all patients with ICH who are recruited during each treatment study period., Discussion: HeadPoST is a large international clinical trial in which we will rigorously evaluate the effects of different head positioning in patients with acute stroke., Trial Registration: ClinicalTrials.gov identifier: NCT02162017 (date of registration: 27 April 2014); ANZCTR identifier: ACTRN12614000483651 (date of registration: 9 May 2014). Protocol version and date: version 2.2, 19 June 2014.

Background: Urinary incontinence (UI) affects half of patients hospitalised after stroke and is often poorly managed. Cochrane systematic reviews have shown some positive impact of conservative interventions (such as bladder training) in reducing UI, but their effectiveness has not been demonstrated with stroke patients., Methods: We conducted a cluster randomised controlled feasibility trial of a systematic voiding programme (SVP) for the management of UI after stroke. Stroke services were randomised to receive SVP (n = 4), SVP plus supported implementation (SVP+, n = 4), or usual care (UC, n = 4).Feasibility outcomes were participant recruitment and retention. The main effectiveness outcome was presence or absence of UI at six and 12 weeks post-stroke. Additional effectiveness outcomes included were the effect of the intervention on different types of UI, continence status at discharge, UI severity, functional ability, quality of life, and death., Results: It was possible to recruit patients (413; 164 SVP, 125 SVP+, and 124 UC) and participant retention was acceptable (85% and 88% at six and 12 weeks, respectively). There was no suggestion of a beneficial effect on the main outcome at six (SVP versus UC: odds ratio (OR) 0.94, 95% CI: 0.46 to 1.94; SVP+ versus UC: OR: 0.62, 95% CI: 0.28 to 1.37) or 12 weeks (SVP versus UC: OR: 1.02, 95% CI: 0.54 to 1.93; SVP+ versus UC: OR: 1.06, 95% CI: 0.54 to 2.09).No secondary outcomes showed a strong suggestion of clinically meaningful improvement in SVP and/or SVP+ arms relative to UC at six or 12 weeks. However, at 12 weeks both intervention arms had higher estimated odds of continence than UC for patients with urge incontinence., Conclusions: The trial has met feasibility outcomes of participant recruitment and retention. It was not powered to demonstrate effectiveness, but there is some evidence of a potential reduction in the odds of specific types of incontinence. A full trial should now be considered., Trial Registration: ISRCTN Registry, ISRCTN08609907, date of registration: 7 July 2010.

Background: The use of telemedicine in acute stroke care can facilitate rapid access to treatment, but the work required to embed any new technology into routine practice is often hidden, and can be challenging. We aimed to collate recommendations and resources to support telestroke implementation., Methods: Systematic search of healthcare databases and the Internet to identify descriptions of the implementation of telestroke projects; interviews with key stakeholders during the development of one UK telestroke network. Supporting documentation from existing projects was analysed to construct a framework of implementation stages and tasks, and a toolkit of documents. Interviews and literature were analysed with other data sources using Normalisation Process Theory as described in the e-Health Implementation Toolkit., Results: 61 telestroke projects were identified and contacted. Twenty projects provided documents, 13 with published research detailing four stages of telestroke system development, implementation, use, and evaluation. Interviewees identified four main challenges: engaging and maintaining the commitment of a wide range of stakeholders across multiple organisations; addressing clinicians perceptions of evidence, workload, and payback; managing clinical and technical workability across diverse settings; and monitoring how the system is used and reconfigured by users., Conclusions: Information to guide telestroke implementation is sparse, but available. By using multiple sources of data, sufficient information was collated to construct a web-based toolkit detailing implementation tasks, resources and challenges in the development of a telestroke system for assessment and thrombolysis delivery in acute care. The toolkit is freely available online.

Background: Urinary incontinence following acute stroke is common, affecting between 40%-60% of people in hospital after a stroke. Despite the availability of clinical guidelines for urinary incontinence and urinary incontinence after stroke, national audit data suggest incontinence is often poorly managed. Conservative interventions (e.g. bladder training, pelvic floor muscle training and prompted voiding) have been shown to have some effect with participants in Cochrane systematic reviews, but have not had their effectiveness demonstrated with stroke patients., Methods/design: A cluster randomised controlled pilot trial designed to assess the feasibility of a full-scale cluster randomised trial and to provide preliminary evidence of the effectiveness and cost-effectiveness of a systematic voiding programme for the management of continence after stroke. Stroke services will be randomised to receive the systematic voiding programme, the systematic voiding programme plus supported implementation, or usual care. The trial aims to recruit at least 780 participants in 12 stroke services (4 per arm). The primary outcome is presence/absence of incontinence at six weeks post-stroke. Secondary outcomes include frequency and severity of incontinence, quality of life and cost-utility. Outcomes will be measured at six weeks, three months and (for participants recruited in the first three months) twelve months after stroke. Process data will include rates of recruitment and retention and fidelity of intervention delivery. An integrated qualitative evaluation will be conducted in order to describe implementation and assist in explaining the potential mediators and modifiers of the process., Trial Registration: ISRCTN: ISRCTN08609907