A pragmatic, multi-centered, stepped wedge, cluster randomized controlled trial pilot of the clinical and cost effectiveness of a complex Stroke Oral healthCare intervention pLan Evaluation II (SOCLE II) compared with usual oral healthcare in stroke wards.

BACKGROUND: Patients with stroke-associated pneumonia experience poorer outcomes (increased hospital stays, costs, discharge dependency, and risk of death). High-quality, organized oral healthcare may reduce the incidence of stroke-associated pneumonia and improve oral health and quality of life. AIMS: We piloted a pragmatic, stepped-wedge, cluster randomized controlled trial of clinical and cost effectiveness of enhanced versus usual oral healthcare for people in stroke rehabilitation settings. METHODS: Scottish stroke rehabilitation wards were randomly allocated to stepped time-points for conversion from usual to enhanced oral healthcare. All admissions and nursing staff were eligible for inclusion. We piloted the viability of randomization, intervention, data collection, record linkage procedures, our sample size, screening, and recruitment estimates. The stepped-wedge trial design prevented full blinding of outcome assessors and staff. Predetermined criteria for progression included the validity of enhanced oral healthcare intervention (training, oral healthcare protocol, assessment, equipment), data collection, and stroke-associated pneumonia event rate and relationship between stroke-associated pneumonia and plaque. RESULTS: We screened 1548/2613 (59%) admissions to four wards, recruiting n = 325 patients and n = 112 nurses. We observed marked between-site diversity in admissions, recruitment populations, stroke-associated pneumonia events (0% to 21%), training, and resource use. No adverse events were reported. Oral healthcare documentation was poor. We found no evidence of a difference in stroke-associated pneumonia between enhanced versus usual oral healthcare (P = 0.62, odds ratio = 0.61, confidence interval: 0.08 to 4.42). CONCLUSIONS: Our stepped-wedge cluster randomized control trial accommodated between-site diversity. The stroke-associated pneumonia event rate did not meet our predetermined progression criteria. We did not meet our predefined progression criteria including the SAP event rate and consequently were unable to establish whether there is a relationship between SAP and plaque. A wide confidence interval did not exclude the possibility that enhanced oral healthcare may result in a benefit or detrimental effect. TRIAL REGISTRATION: NCT01954212.

Evidence of perceived psychosocial stress as a risk factor for stroke in adults: a meta-analysis.

BACKGROUND: Several studies suggest that perceived psychosocial stress is associated with increased risk of stroke; however results are inconsistent with regard to definitions and measurement of perceived stress, features of individual study design, study conduct and conclusions drawn and no meta-analysis has yet been published. We performed a systematic review and meta-analysis of studies assessing association between perceived psychosocial stress and risk of stroke in adults.The results of the meta-analysis are presented. METHODS: Systematic searches of MEDLINE, EMBASE, CINAHL, PsycInfo, and Cochrane Database of Systematic Reviews were undertaken between 1980 and June 2014. Data extraction and quality appraisal was performed by two independent reviewers. Hazard ratios (HR) and odds ratios (OR) were pooled where appropriate. RESULTS: 14 studies were included in the meta-analysis, 10 prospective cohort, 4 case-control design. Overall pooled adjusted effect estimate for risk of total stroke in subjects exposed to general or work stress or to stressful life events was 1.33 (95 % confidence interval [CI], 1.17, 1.50; P < 0.00001). Sub-group analyses showed perceived psychosocial stress to be associated with increased risk of fatal stroke (HR 1.45 95 % CI, 1.19,1.78; P = 0.0002), total ischaemic stroke (HR 1.40 95 % CI, 1.00,1.97; P = 0.05) and total haemorrhagic stroke (HR 1.73 95 % CI, 1.33,2.25; P > 0.0001).A sex difference was noted with higher stroke risk identified for women (HR 1.90 95 % CI, 1.4, 2.56: P < 0.0001) compared to men (HR 1.24 95 % CI, 1.12, 1.36; P < 0.0001). CONCLUSIONS: Current evidence indicates that perceived psychosocial stress is independently associated with increased risk of stroke.

Clinical and cost effectiveness of enhanced oral healthcare in stroke care settings (SOCLE II): a pilot, stepped wedge, cluster randomized, controlled trial protocol.

RATIONALE: Stroke-associated pneumonia, a leading cause of hospital-acquired infection after stroke, affects a fifth of stroke survivors annually. Associated with increased risk of death and poorer rehabilitation outcomes, research suggests a possible relationship between stroke-associated pneumonia and patients' oral health. AIM: The aim of this study is to evaluate the feasibility of a randomized controlled trial of the clinical and cost effectiveness of enhanced oral healthcare vs. usual oral healthcare for people in stroke care settings. DESIGN: Our pilot, multicentered, pragmatic, stepped wedge, cluster randomized controlled trial oral healthcare [Stroke Oral healthCare pLan Evaluation (SOCLE II)] will compare enhanced oral healthcare intervention and usual oral healthcare. Over 13 months, across 4 wards, we seek to recruit 400 patients (estimating an average of 23 beds per site and a 50% recruitment rate) and 60 nursing staff (estimating an average of 20 members of staff per site and a 75% recruitment rate). Initially, control data (usual oral healthcare) will be collected from all sites. In a randomized, stepped manner, wards will convert to deliver the enhanced oral healthcare intervention. STUDY OUTCOME(S): Outcomes will be captured across dimensions of care (as recommended for evaluations of complex interventions) at baseline and weekly thereafter. Primary outcomes are pneumonia (patients), knowledge and attitudes (staff), and specialist dental referrals (service). Secondary outcomes include oral health quality of life, plaque, antibiotics, length of stay, death (patients), use of oral healthcare equipment and products, completed assessments, and documented oral healthcare plans (staff). DISCUSSION: As one of the first stepped wedge, cluster randomized, controlled trials in stroke care mapping of the complex intervention, our choice of primary and secondary outcomes and choice of trial design are described.

Promoting stroke-specific education.

Stroke is the most common cause of adult neurological disability in the UK. This article describes the reasons for the establishment of the UK Forum for Stroke Training and the Stroke-Specific Education Framework. It illustrates how these initiatives can be used to access a range of endorsed, stroke-specific courses to develop excellence in stroke care and multidisciplinary teamwork, as demanded by the Department of Health's National Stroke Strategy.

Developing and evaluating the implementation of a complex intervention: using mixed methods to inform the design of a randomised controlled trial of an oral healthcare intervention after stroke.

BACKGROUND: Many interventions delivered within the stroke rehabilitation setting could be considered complex, though some are more complex than others. The degree of complexity might be based on the number of and interactions between levels, components and actions targeted within the intervention. The number of (and variation within) participant groups and the contexts in which it is delivered might also reflect the extent of complexity. Similarly, designing the evaluation of a complex intervention can be challenging. Considerations include the necessity for intervention standardisation, the multiplicity of outcome measures employed to capture the impact of a multifaceted intervention and the delivery of the intervention across different clinical settings operating within varying healthcare contexts. Our aim was to develop and evaluate the implementation of a complex, multidimensional oral health care (OHC) intervention for people in stroke rehabilitation settings which would inform the development of a randomised controlled trial. METHODS: After reviewing the evidence for the provision of OHC following stroke, multi-disciplinary experts informed the development of our intervention. Using both quantitative and qualitative methods we evaluated the implementation of the complex OHC intervention across patients, staff and service levels of care. We also adopted a pragmatic approach to patient recruitment, the completion of assessment tools and delivery of OHC, alongside an attention to the context in which it was delivered. RESULTS: We demonstrated the feasibility of implementing a complex OHC intervention across three levels of care. The complementary nature of the mixed methods approach to data gathering provided a complete picture of the implementation of the intervention and a detailed understanding of the variations within and interactions between the components of the intervention. Information on the feasibility of the outcome measures used to capture impact across a range of components was also collected, though some process orientated uncertainties including eligibility and recruitment rates remain to be further explored within a Phase II exploratory trial. CONCLUSIONS: Complex interventions can be captured and described in a manner which facilitates evaluation in the form of exploratory and subsequently definitive clinical trials. If effective, the evidence captured relating to the intervention context will facilitate translation into clinical practice.

The use of innovative methods designed to relieve social isolation in patients with chronic heart failure; volunteer befriending, forums and a newsletter.

INTRODUCTION: Social isolation in patients with chronic heart failure (CHF) is an adverse prognostic factor. This paper reports the creation of a supportive patient/carer network (Heart Failure Support Service), led by a voluntary sector/National Health Service (NHS) partnership which involved volunteer befriending, regular patient and carer forum and a newsletter. THE PROJECT: Over 3 years, 37 volunteers were 'befrienders' to over 50 individuals with CHF. A thorough training and matching process ensured that the first befriending visit was a positive experience. 100% of patients found the visits from the volunteer worthwhile and said they would recommend the service to other patients. Prior to the first patient-carer forum, 200 questionnaires were sent out with a 56% response rate, 44% of respondents believed that a forum and a newsletter would be valued. Over a period of 3 years, 12 quarterly meetings were held with an average attendance of 30-40 per meeting. The newsletter (current circulation >800 per quarter) contributed to self-management and encouraged communication between professionals and patients-carers. CONCLUSIONS: The Heart Failure Support Service (volunteers, forum and newsletter) created a supportive patient-carer network and represents a successful voluntary sector/NHS partnership.