Improving oral health in institutionalised elderly people by educating caregivers: a randomised controlled trial. A cluster-randomized trial to improve stroke care in hospitals. Routine oral nutritional supplementation for stroke patients in hospital (FOOD): a multicentre randomised controlled trial.
This cluster-randomised controlled trial assessed whether oral health care education (OHCE) for nursing home caregivers would achieve improvements in clients' oral health.
                Twenty-two nursing homes were randomly allocated to intervention or control group. Clients were examined at baseline and at follow-up visits 1- and 6-months after caregivers received OHCE. Main outcome measures were denture plaque, denture-induced stomatitis, dental plaque and gingivitis. Differences in group means/medians were compared with adjustment for cluster randomisation.
                Clients' baseline oral health was poor. After OHCE, the intervention group's oral health scores improved significantly. Reductions in denture plaque scores (0-4 scale) exceeded those of the control group by 1.15 (95%CI=0.83, 1.47) at 1 month and by 1.47 (95%CI=1.13, 1.80) at 6 months. Denture-induced stomatitis prevalence reduced significantly over 6 months compared to the control group (P<0.0001). Group differences in favour of the intervention group were 0.41 (95%CI=0.18, 0.65) at 1 month and 0.34 (95%CI=0.14, 0.53) at 6 months for dental plaque (0-3 scale), and 0.17 (95%CI= -0.01, 0.35) at 1 month and 0.28 (95%CI 0.15, 0.42) at 6 months for gingivitis (0-2 scale). Key differences remained significant after adjustment for clustering effects. The provider's costs would currently be approximately pounds 6700 per year to deliver the intervention to a Health Authority with 100 homes.
                Although final levels of residents' oral health were still short of ideal, this study clearly shows that, for a modest cost, OHCE can improve caregivers' knowledge, attitudes and oral health care performance for elderly, functionally dependent clients. We evaluated the effect of performance feedback on acute ischemic stroke care quality in Minnesota hospitals.
                A cluster-randomized controlled trial design with hospital as the unit of randomization was used. Care quality was defined as adherence to 10 performance measures grouped into acute, in-hospital, and discharge care. Following preintervention data collection, all hospitals received a report on baseline care quality. Additionally, in experimental hospitals, clinical opinion leaders delivered customized feedback to care providers and study personnel worked with hospital administrators to implement changes targeting identified barriers to stroke care. Multilevel models examined experimental vs control, preintervention and postintervention performance changes and secular trends in performance.
                Nineteen hospitals were randomized with a total of 1,211 acute ischemic stroke cases preintervention and 1,094 cases postintervention. Secular trends were significant with improvement in both experimental and control hospitals for acute (odds ratio = 2.7, p = 0.007) and in-hospital (odds ratio = 1.5, p < 0.0001) care but not discharge care. There was no significant intervention effect for acute, in-hospital, or discharge care.
                There was no definite intervention effect: both experimental and control hospitals showed significant secular trends with performance improvement. Our results illustrate the potential fallacy of using historical controls for evaluating quality improvement interventions.
                This study provides Class II evidence that informing hospital leaders of compliance with ischemic stroke quality indicators followed by a structured quality improvement intervention did not significantly improve compliance more than informing hospital leaders of compliance with stroke quality indicators without a quality improvement intervention. Undernutrition is common in hospital patients with stroke, can develop or worsen in hospital, and is associated with poor outcomes. We aimed to establish whether routine oral nutritional supplements improve outcome after stroke.
                The FOOD trials are a family of three pragmatic, multicentre, randomised controlled trials. We measured the outcomes of stroke patients who could swallow and who were randomly allocated normal hospital diet or normal hospital diet plus oral nutritional supplements until hospital discharge. The primary outcome was death or poor outcome (modified Rankin scale [MRS] grade 3-5), 6 months after enrollment, measured unaware of treatment allocation. Analysis was by intention to treat.
                Between Nov 1, 1996, and July 31, 2003, 4023 patients were enrolled by 125 hospitals in 15 countries. Only 314 (8%) patients were judged to be undernourished at baseline. Vital status and MRS at the end of the trial were known for 4012 and 4004 patients, respectively. Supplemented diet was associated with an absolute reduction in risk of death of 0.7% (95% CI -1.4 to 2.7) and an increased risk of death or poor outcome of 0.7% (-2.3 to 3.8).
                We could not confirm the anticipated 4% absolute benefit for death or poor outcome from routine oral nutritional supplements for mainly well nourished stroke patients in hospital. Our results would be compatible with a 1% or 2% absolute benefit or harm from oral supplements. These results do not support a policy of routine oral supplementation after stroke.
Based on two trials involving a small number of stroke survivors, OHC interventions can improve staff knowledge and attitudes, the cleanliness of patients' dentures and reduce the incidence of pneumonia. Improvements in the cleanliness of patients teeth were not observed. Further evidence relating to staff-led oral care interventions is severely lacking.