Introducing structured caregiver training in stroke care: findings from the TRACS process evaluation study.

OBJECTIVE: To evaluate the process of implementation of the modified London Stroke Carers Training Course (LSCTC) in the Training Caregivers After Stroke (TRACS) cluster randomised trial and contribute to the interpretation of the TRACS trial results. The LSCTC was a structured competency-based training programme designed to help develop the knowledge and skills (eg, patient handling or transfer skills) essential for the day-to-day management of disabled survivors of stroke. The LSCTC comprised 14 components, 6 were mandatory (and delivered to all) and 8 non-mandatory, to be delivered based on individual assessment of caregiver need. DESIGN: Process evaluation using non-participant observation, documentary analysis and semistructured interviews. PARTICIPANTS: Patients with stroke (n=38), caregivers (n=38), stroke unit staff (n=53). SETTINGS: 10 of the 36 stroke units participating in the TRACS trial in four English regions (Yorkshire, North West, South East and South West, Peninsula). RESULTS: Preparatory cascade training on delivery of the LSCTC did not reach all staff and did not lead to multidisciplinary team (MDT) wide understanding of, engagement with or commitment to the LSCTC. Although senior therapists in most intervention units observed developed ownership of the LSCTC, MDT working led to separation rather than integration of delivery of LSCTC elements. Organisational features of stroke units and professionals' patient-focused practices limited the involvement of caregivers. Caregivers were often invited to observe therapy or care being provided by professionals but had few opportunities to make sense of, or to develop knowledge and stroke-specific skills provided by the LSCTC. Where provided, caregiver training came very late in the inpatient stay. Assessment and development of caregiver competence was not commonly observed. CONCLUSIONS: Contextual factors including service improvement pressures and staff perceptions of the necessity for and work required in caregiver training impacted negatively on implementation of the caregiver training intervention. Structured caregiver training programmes such as the LSCTC are unlikely to be practical in settings with short inpatient stays. Stroke units where early supported discharge is in place potentially offer a more effective vehicle for introducing competency based caregiver training. LINKED TRACS CLUSTER RANDOMISED CONTROLLED TRIAL NUMBER: ISRCTN49208824.

A cluster randomised controlled trial and economic evaluation of a structured training programme for caregivers of inpatients after stroke: the TRACS trial.

BACKGROUND: The majority of stroke patients are discharged home dependent on informal caregivers, usually family members, to provide assistance with activities of daily living (ADL), including bathing, dressing and toileting. Many caregivers feel unprepared for this role and this may have a detrimental effect on both the patient and caregiver. OBJECTIVE: To evaluate whether or not a structured, competency-based training programme for caregivers [the London Stroke Carer Training Course (LSCTC)] improved physical and psychological outcomes for patients and their caregivers after disabling stroke, and to determine if such a training programme is cost-effective. DESIGN: A pragmatic, multicentre, cluster randomised controlled trial. SETTING: Stratified randomisation of 36 stroke rehabilitation units (SRUs) to the intervention or control group by geographical region and quality of care. PARTICIPANTS: A total of 930 stroke patient and caregiver dyads were recruited. Patients were eligible if they had a confirmed diagnosis of stroke, were medically stable, were likely to return home with residual disability at the time of discharge and had a caregiver available, willing and able to provide support after discharge. The caregiver was defined as the main person--other than health, social or voluntary care provider--helping with ADL and/or advocating on behalf of the patient. INTERVENTION: The intervention (the LSCTC) comprised a number of caregiver training sessions and competency assessment delivered by SRU staff while the patient was in the SRU and one recommended follow-up session after discharge. The control group continued to provide usual care according to national guidelines. Recruitment was completed by independent researchers and participants were unaware of the SRUs' allocation. MAIN OUTCOME MEASURES: The primary outcomes were self-reported extended ADL for the patient and caregiver burden measured at 6 months after recruitment. Secondary outcomes included quality of life, mood and cost-effectiveness, with final follow-up at 12 months. RESULTS: No differences in primary outcomes were found between the groups at 6 months. Adjusted mean differences were -0.2 points [95% confidence interval (CI) -3.0 to 2.5 points; p = 0.866; intracluster correlation coefficient (ICC) = 0.027] for the patient Nottingham Extended Activities of Daily Living score and 0.5 points (95% CI -1.7 to 2.7 points; p = 0.660; ICC = 0.013) for the Caregiver Burden Scale. Furthermore, no differences were detected in any of the secondary outcomes. Intervention compliance varied across the units. Half of the participating centres had a compliance rating of > 60%. Analysis showed no evidence of higher levels of patient independence or lower levels of caregiver burden in the SRUs with better levels of intervention compliance. The economic evaluation suggests that from a patient and caregiver perspective, health and social care costs, societal costs and outcomes are similar for the intervention and control groups at 6 months, 12 months and over 1 year. CONCLUSIONS: We have conducted a robust multicentre, cluster randomised trial, demonstrating for the first time that this methodology is feasible in stroke rehabilitation research. There was no difference between the LSCTC and usual care with respect to improving stroke patients' recovery, reducing caregivers' burden, or improving other physical and psychological outcomes, nor was it cost-effective compared with usual care. Compliance with the intervention varied, but analysis indicated that a dose effect was unlikely. It is possible that the immediate post-stroke period may not be the ideal time for the delivery of structured training. The intervention approach might be more relevant if delivered after discharge by community-based teams. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49208824. FUNDING: This project was funded by the MRC and is managed by the NIHR (project number 09/800/10) on behalf of the MRC-NIHR partnership, and will be published in full in Health Technology Assessment; Vol. 17, No. 46. See the NIHR Journals Library website for further project information.

Long-term outcome after stroke: does dysphagia matter?

BACKGROUND: swallowing problems (dysphagia) are common following acute stroke and are independent predictors of short-term outcome. It is uncertain as to whether these swallowing problems are associated with outcome in the longer-term. AIM: insert to determine whether dysphagia present in the first week of acute stroke associated with long-term outcome. METHODS: a population-based long-term follow-up of people with first in a life-time stroke. Dysphagia was assessed within 1 week of stroke and patients were followed up at 3 months and yearly for 5 years by face-to-face interview. Outcome was defined by survival and place of residence, using multinomial logistic regression. Barthel Scores were divided into the two groups 15-20 and 0-14, and modelled using multiple logistic regression. RESULTS: there were 567 patients with dysphagia (mean age 74.3 years) and 621 with a safe swallow (mean age 69.6 years). Following multinomial logistic regression, residence in a nursing home was more likely to occur in those who failed the swallow test during the first week of their stroke; however, this only reached statistical significance at 3 months (relative risk ratio (RRR)=1.73; 95% confidence interval (CI) 1.02 to 2.95), and years 4 (RRR 3.35, 1.37-8.19) and 5 (RRR 3.06, 1.06-8.83). There was also a significant association with increased mortality only during the first three months (RRR 2.03, 1.12 to 3.67). CONCLUSION: this study confirms that the presence of dysphagia during the acute phase of stroke is associated with poor outcome during the subsequent year, particularly at 3 months, and is associated with increased institutionalisation rate in the long term.

Assessment and management of dysphagia.

Swallowing problems are common in hospital inpatients and may affect morbidity and mortality. Accurate assessment of dysphagia is important, allowing optimal management and minimizing potential complications. This article considers the methods of swallow assessment available and ways in which problems can be addressed.

Interventions for dysphagia in acute stroke.

BACKGROUND: It is unclear how dysphagic patients should be fed and treated after acute stroke. OBJECTIVES: The objective of this review was to assess the effect of different management strategies for dysphagic stroke patients, in particular how and when to feed, whether to supplement nutritional intake, and how and whether to treat dysphagia. SEARCH STRATEGY: We searched the Cochrane Stroke Group trials register, Medline, Embase, ISI, and existing review articles. We contacted researchers in the field and equipment manufacturers. Date of the most recent searches: March 1999. SELECTION CRITERIA: Unconfounded truly or quasi randomised controlled trials in dysphagic patients with acute/subacute (within 3 months) stroke. DATA COLLECTION AND ANALYSIS: Three reviewers independently applied the trial inclusion criteria. Two reviewers assessed trial quality and extracted the data. MAIN RESULTS: Percutaneous endoscopic gastrostomy (PEG) versus nasogastric tube (NGT) feeding: two trials (49 patients) suggest that PEG reduces end-of-trial case fatality (Peto Odds Ratio, OR 0.28, 95% CI 0.09 to 0.89) and treatment failures (OR 0.10, 95% CI 0.02 to 0.52), and improves nutritional status, assessed as weight (Weighted Men Difference, WMD +4.1 kg, 95% CI -4.3 to +12.5), mid-arm circumference (WMD +2.2 cm, 95% CI -0.5 to +4.9) or serum albumin (WMD + 7.0 g/l, 95% CI +4.9 to +9.1) as compared with NGT feeding; two larger studies are ongoing. Timing of feeding: no completed trials; one large study is ongoing. Swallowing therapy for dysphagia: two trials (85 patients) suggest that formal swallowing therapy does not significantly reduce end-of-trial dysphagia rates (OR 0.55, 95% CI 0.18 to 1.66). Drug therapy for dysphagia: one trial (17 patients); nifedipine did not alter end-of-trial case fatality or the frequency of dysphagia. Nutritional supplementation: one trial (42 patients) found a non-significant trend to a lower case fatality, and significantly increased energy and protein intake; one large trial is ongoing and data is awaited from two other studies. Fluid supplementation: one trial (20 patients) found that supplementation did not alter the time to resolution of dysphagia. REVIEWER'S CONCLUSIONS: Too few studies have been performed, and these have involved too few patients. PEG feeding may improve outcome and nutrition as compared with NGT feeding. Further research is required to assess how and when patients are fed, and the effect of swallowing or drug therapy on dysphagia.

Does prior use of aspirin affect outcome in ischemic stroke?

BACKGROUND: Large intervention studies suggest that aspirin may reduce mortality when given to patients who present with strokes or transient ischemic attacks. We sought to determine whether patients who were already using aspirin at the time of an ischemic stroke had a lower mortality than those who were not. METHODS: A prospective cohort study was undertaken in patients (mean age 76 +/- 15 years) with acute ischemic stroke. Detailed information on demography, stroke characteristics, and aspirin use prior to the stroke was collected from patients, medical records, and other sources. Patients were classified by cause and subtype of stroke using standard criteria. Mortality was measured 4 weeks after the initial episode. RESULTS: Of the 1,457 patients, 650 (45%) were using aspirin (median dose 75 mg; range 75 to 300 mg) prior to the stroke. Prior use of aspirin was associated with lower 4-week mortality (14% versus 20%, P <0.01 ). Beneficial effects of prior aspirin use on mortality were seen in patients with atherosclerotic strokes (15% versus 21%, P <0.05) and with cardioembolic strokes (21% versus 34%, P <0.05), but not among patients with strokes due to small vessel occlusion (10% versus 11%, P = 0.8). Prior aspirin use was also associated with lower mortality in patients in whom the cause of ischemic stroke could not be determined (15% versus 22%, P <0.01). The effect of prior aspirin use on mortality was independent of age, gender, other risk factors, and use of other medication. CONCLUSIONS: Prior use of low-dose aspirin may be associated with a small but significant reduction in stroke mortality.

Secular trends in the management of hypertension and atrial fibrillation in patients presenting with stroke.

We studied changes in stroke prevention in 2000 ischaemic stroke patients using prospectively collected data from an incident stroke register over 3 years. Patients were divided into those with risk factors but no previous history of a vascular event (asymptomatic vascular disease) and those with risk factors and a previous history of stroke or TIAs, ischaemic heart disease, angina, myocardial infarction or peripheral vascular disease (symptomatic vascular disease). Time trends were analysed for the use of aspirin, management of hypertension and atrial fibrillation prior to the presenting episode. Median age of those with known risk factors included in the study was 75 years (range 44-99 years); 60% were women. Year-by-year analysis showed no differences in demography, stroke characteristics or vascular risk profile. The use of aspirin for symptomatic vascular disease increased with time (28% to 72%) (p<0.001), but did not increase for asymptomatic vascular disease, despite risk factors being present. The proportion of patients receiving antihypertensive treatment for symptomatic vascular disease was unchanged with time (66% to 64%) but there was a significant increase in the number of patients receiving antihypertensive treatment for asymptomatic vascular disease (28% to 44%) (p<0.05). The proportion of patients with atrial fibrillation receiving antithrombotic treatment did not increase for asymptomatic vascular disease (23% to 21%) (p=0.54) but did increase for symptomatic vascular disease (19.5% to 37%) (p<0.01) over 3 years. The use of warfarin in atrial fibrillation increased both in the case of asymptomatic (4.5% to 42%) (p<0.01) and symptomatic vascular disease (12.5% to 33.0%) (p<0.01).

Pharmacological treatment of dysphagia in stroke.

The pharynx is important for a normal swallow and it has been suggested that pharmacological agents may play a role in the management of pharyngeal dysphagia, but none have been formally evaluated. A pilot double-blind, placebo-controlled study was undertaken in 17 hospitalized patients with persistent dysphagia 2 weeks after stroke. Patients were randomized to treatment with slow-release nifedipine 30 mg orally (n = 8) or placebo (n = 9) following specialist swallowing assessment and videofluoroscopy to exclude severe dysphagia. Videofluoroscopy was repeated after 4 weeks of treatment. Fourteen patients (active 6, placebo 8) completed the study. Two patients died (active 1, placebo 1) and 1 patient in the active group had to be withdrawn because of progressive heart failure. Initial assessment showed impairment in the pharyngeal phase with delayed triggering of swallow, poor laryngeal elevation, and prolonged pharyngeal transit times in all patients. Silent aspiration was seen in 4 patients (active 2, placebo 2). Improvement in swallowing was seen in 8 patients (active 5, placebo 3) at the end of 4 weeks. There were significant changes in the pharyngeal transit time (mean -1.34 second; 95% C.I. -2.56, -0.11) and swallow delay (mean -1.91 seconds; 95% C.I. -3.58, -0.24) in the active group suggesting improvement in the initiation of pharyngeal contractions and reduction in the time taken for the bolus to transverse the pharynx. A similar change was not seen in the placebo group. It is suggested that pharmacological agents such as nifedipine may have a role in the management of stroke-related dysphagia and merit further investigation.

Can bedside assessment reliably exclude aspiration following acute stroke?

OBJECTIVE: To investigate the ability of a bedside swallowing assessment to reliably exclude aspiration following acute stroke. SUBJECTS: Consecutive patients admitted within 24 h of stroke onset to two hospitals. METHODS: A prospective study. Where possible, all patients had their ability to swallow assessed on the day of admission by both a doctor and a speech and language therapist using a standardized proforma. A videofluoroscopy examination was conducted within 3 days of admission. RESULTS: 94 patients underwent videofluoroscopy; 20 (21%) were seen to be aspirating, although this was not detected at the bedside in 10. In 18 (22%) of the patients the speech and language therapist considered the swallow to be unsafe. In the medical assessment, 39 patients (41%) had an unsafe swallow. Bedside assessment by a speech and language therapist gave a sensitivity of 47%, a specificity of 86%, positive predictive value (PPV) of 50% and a negative predictive value (NPV) of 85% for the presence of aspiration. Multiple logistic regression was used to identify the optimum elements of the bedside assessments for predicting the presence of aspiration. A weak voluntary cough and any alteration in conscious level gave a sensitivity of 75%, specificity of 72%, PPV of 41% and NPV of 91% for aspiration. CONCLUSION: Bedside assessment of swallowing lacks the necessary sensitivity to be used as a screening instrument in acute stroke, but there are concerns about the use of videofluoroscopy as a gold standard. The relative importance of aspiration and bedside assessment in predicting complications and outcome needs to be studied.

The natural history of dysphagia following a stroke.

To assess the frequency and natural history of swallowing problems following an acute stroke, 121 consecutive patients admitted within 24 hours of the onset of their stroke were studied prospectively. The ability to swallow was assessed repeatedly by a physician, a speech and language therapist, and by videofluoroscopy. Clinically 51% (61/121) of patients were assessed as being at risk of aspiration on admission. Many swallowing problems resolved over the first 7 days, through 28/110 (27%) were still considered at risk by the physician. Over a 6-month period, most problems had resolved, but some patients had persistent difficulties (6, 8%), and a few (2, 3% at 6 months) had developed swallowing problems. Ninety-five patients underwent videofluoroscopic examination within a median time of 2 days; 21 (22%) were aspirating. At 1 month a repeat examination showed that 12 (15%) were aspirating. Only 4 of these were persistent; the remaining 8 had not been previously identified. This study has confirmed that swallowing problems following acute stroke are common, and it has been documented that the dysphagia may persist, recur in some patients, or develop in others later in the history of their stroke.

Aspiration following stroke: is it related to the side of the stroke?

OBJECTIVE: To investigate the relationship between the side of stroke and the presence of aspiration on videofluoroscopy. DESIGN: Observational prospective study. SUBJECTS: Eighty-seven patients (50% female) admitted with an acute stroke to the University Hospital of South Manchester. METHODS: Patients admitted to the study underwent brain CT scanning and repeated videofluoroscopy. RESULTS: CT scanning was performed within a median three days (interquartile range 2-4 days) following stroke and videofluoroscopic (VF) examination (median 2, interquartile range 1-4 days following stroke) of their swallow. Seventeen (19.5%) patients were noted to be aspirating. There were no significant relationships at this time between side or site of lesion and the presence of aspiration. A second assessment was carried out at a median time of 29 days (interquartile range 26-45) following acute stroke. Nine of 69 (13.5%) patients were noted to be aspirating, seven of whom, had right hemisphere lesions (p < 0.01). CONCLUSIONS: Continuing aspiration may be related to the side of the cerebral lesion.

Complications and outcome after acute stroke. Does dysphagia matter?

BACKGROUND AND PURPOSE: The published data on the relationship between dysphagia and both outcome and complications after acute stroke have been inconclusive. We examined the relationship between these, using bedside assessment and videofluoroscopic examination. METHODS: We prospectively studied 121 consecutive patients admitted with acute stroke. A standardized bedside assessment was performed by a physician. We performed videofluoroscopy blinded to this assessment within 3 days of stroke onset and within a median time of 24 hours of the bedside evaluations. The presence of aspiration was recorded. Mortality, functional outcome, lengthy of stay, place of discharge, occurrence of chest infection, nutritional status, and hydration were the main outcome measures. RESULTS: Patients with an abnormal swallow (dysphagia) on bedside assessment had a higher risk of chest infection (P=.05) and a poor nutritional state (P=.001). The presence of dysphagia was associated with an increased risk of death (P=.001), disability (P=.02), length of hospital stay (P<.001), and institutional care (P<.05). When other factors were taken into account, dysphagia remained as an independent predictor of outcome only with regard to mortality. The use of videofluoroscopy in detecting aspiration did not add to the value of bedside assessment. CONCLUSIONS: Bedside assessment of swallowing is of use in identifying patients at risk of developing complications. The value of routine screening with videofluoroscopy to detect aspiration is questioned.