A whole-school child maltreatment prevention programme in primary schools in Northern Ireland: 1 year results of Keeping Safe,a cluster-randomised controlled trial

Background

Child maltreatment has a pervasive, detrimental impact on children's wellbeing. There exist gaps in evidence on school-based prevention programmes—namely, failure to use experimental designs and standardised validated measures in evaluation, and design limitations in terms of their duration, intensity, and breadth. We aimed to address these gaps in evaluating the effectiveness of Keeping Safe, a whole school child maltreatment prevention programme.

Effect of health literacy and exercise interventions on glycated haemoglobin levels in Chinese patients with type 2 diabetes: a cluster-randomised controlled trial

Background

Patients with diabetes in China have low health literacy, which likely leads to poor glycaemic control and clinical outcomes. This study was designed to evaluate the effectiveness of health literacy-focused and exercise-focused interventions on glycated haemoglobin A_1c (HbA_1c) in the population.

Implementation of a fire-prevention injury prevention briefing in children's centres: a multicentre cluster-randomised controlled trial

BackgroundEngland has high morbidity and mortality from house fires, with steep social gradients for child deaths: 106 people were admitted to hospital in 2012–13, and 44 deaths between 2008 and 2012 were in children under 5 years old. We developed an evidence-based fire-prevention intervention for use in children's centres comprising an injury prevention briefing (IPB), training, and facilitation for IPB implementation.MethodsWe conducted a multicentre cluster-randomised controlled trial, with a nested qualitative study, in four English study sites. Parents who were at least 16 years old with a child younger than 3 years were recruited from children's centres in disadvantaged areas. Once 30 parent participants were recruited at each centre, centres were stratified by trial site, randomly allocated within strata to one of three arms by an independent statistician using randomisation algorithm in Stata with permuted block randomisation and block size of three: IPB plus facilitation (IPB+), IPB only, and usual care (control). Training (month 0) and facilitation were provided for centres allocated IPB+ at months 1, 3, and 8. Both intervention arms completed follow-up interviews at 12 months. The primary outcome was the proportion of families reporting a fire-escape plan. 11 centres per arm were required to detect an absolute difference of 20% or more in families with fire-escape plans in either intervention arm compared with control (80% power, 5% significance level, intraclass correlation (ICC)=0·05), assuming responses from 20 families per centre. Treatment arms were compared by use of multilevel models to account for clustering by centre. Ethics approval was given by Derbyshire ethics committee (11/EM/0011). Written informed consent was obtained from individual parents and children's centres. This trial is registered with ClinicalTrials.gov, NCT01452191.Findings1112 parents at 36 centres were recruited (373 IPB+, 369 IPB only, 370 control). At 12 months 751 (68%) parents (241 IPB+, 252 IPB only, 258 control) were followed up. Possession of a fire-escape plan was reported by 120 (51%) IPB+ participants, 108 (44%) IPB only, and 119 (47%) controls. There was no significant effect on family possession of fire-escape plans (IPB+ vs control odds ratio 1·41, 95% CI 0·91–2·20; IPB only vs control 0·93, 0·58–1·49 [ICC=0·003]). No adverse events were reported.InterpretationThe IPB, training, and facilitation did not increase parents' possession of fire-escape plans. Both the difficulties faced by children's centres in delivering the intervention to participating families and the secondary outcomes help to explain this outcome. Further research is required to explore both enhancement of penetration of interventions, such as the IPB, to disadvantaged communities and what single item questions about fire escape plans actually measure.FundingNational Institute for Health Research under its Programme Grants for Applied Research programme (RP-PG-0407-10231).     

An intervention to improve mental health support and training available to secondary school teachers (the WISE study): a cluster-randomised controlled trial

BackgroundSchool teachers are at heightened risk of mental health difficulties. A small number of trials have introduced teacher training to improve support for students, but none have increased support available for teachers themselves. We aimed to evaluate the effect of a mental health support and training intervention on secondary school teachers’ and students’ wellbeing and mental health.MethodsDrawing on social support theory and an ecological view of school connectedness, we developed an intervention that comprised training in Mental Health First Aid, a 1-h mental health awareness raising session, and a confidential staff peer support service. This cluster-randomised controlled trial tested intervention effectiveness compared with usual practice. Mainstream, non-fee paying, secondary schools in England and Wales, stratified by geographical area and free school meal entitlement (a proxy for student deprivation), were randomly allocated to intervention or control groups after collection of baseline measures. Participants and study team were aware of group assignment. We analysed data using mixed-effects repeated measures models in the intention-to-treat population, adjusted for stratification variables, sex, and years of experience (teacher outcomes only). A mixed-methods process evaluation was done. The primary outcome was teacher wellbeing (Warwick-Edinburgh Mental Wellbeing Scale). Secondary outcomes were teacher depression, absence, and presenteeism, and student wellbeing, mental health difficulties, attendance, and attainment. Follow-up was done at months 12 and 24. This trial is registered with ISRCTN, number 95909211.FindingsBetween March 24 and June 30, 2016, 25 schools (12 intervention, 13 control) were recruited; cluster sizes were 40–119 teachers. 1722 teachers were included in the primary analysis. Teacher wellbeing did not differ between groups (adjusted mean difference ?0·90, 95% CI ?2·07 to 0·27; intracluster correlation coefficient 0·01), nor did any of the secondary outcomes (adjusted p=0·203–0·964). Participant checklists showed good fidelity to training content (mean score 4·7/5 [SD 0·6]), and peer support reports indicated good adherence to service delivery guidelines. Teacher focus group data showed good initial acceptability, but usage of the peer support service waned over 2 years. Participants reported that the intervention had little impact on school culture and lacked genuine buy-in from senior leaders.InterpretationThe intervention did not achieve population-level improvement to teacher or student mental health, possibly due to a failure to instigate sustained, school-level cultural change. Future research should focus on how to create systemic change in schools to improve the effectiveness of interventions.FundingNational Institute for Health Research Public Health Research programme, Public Health Wales, Public Health England, and Bristol City Council.     

Relationship between outcome and baseline blood pressure and other haemodynamic measures in acute ischaemic stroke: data from the TAIST trial

BACKGROUND: A poor outcome after stroke is associated independently with high blood pressure during the acute phase; however, relationships with other haemodynamic measures [heart rate (HR), pulse pressure (PP), rate-pressure product (RPP)] remain less clear. METHODS: The Tinzaparin in Acute Ischaemic Stroke Trial is a randomised, controlled trial assessing the safety and efficacy of tinzaparin versus aspirin in 1484 patients with acute ischaemic stroke. Systolic blood pressure (SBP), diastolic blood pressure (DBP) and HR measurements taken immediately prior to randomization were averaged, and the mid-blood pressure (MBP), PP, mean arterial pressure (MAP), pulse pressure index, and RPP were calculated. The relationship between these haemodynamic measures and functional outcome (death or dependency, modified Rankin Scale > 2) and early recurrent stroke, were studied with adjustment for baseline prognostic factors and treatment group. Odds ratios (OR) and 95% confidence intervals (CI) refer to a change in haemodynamic measure by 10 points. RESULTS: A poor functional outcome was associated with SBP (adjusted OR; 1.11; 95% CI, 1.03-1.21), HR (adjusted OR; 1.15; 95% CI, 1.00-1.31), MBP (adjusted OR; 1.15, 95% CI, 1.03-1.29), PP (adjusted OR; 1.14; 95% CI, 1.02-1.26), MAP (adjusted OR; 1.15; 95% CI, 1.02-1.31) and RPP (adjusted OR; 1.01; 95% CI, 1.00-1.02). Early recurrent stroke was associated with SBP, DBP, MBP and MAP. CONCLUSIONS: A poor outcome is independently associated with elevations in blood pressure, HR and their derived haemodynamic variables, including PP and the RPP. Agents that modify these measures may improve functional outcome after stroke.     

Improved retention rates with low-cost interventions in hypertension and diabetes management in a rural African environment of nurse-led care: a cluster-randomised trial

Objective To compare the effects of low‐level facility‐based interventions on patient retention rates for cardiovascular (CV) disease in an environment of task shifting and nurse‐led care in rural health districts in Central Cameroon. Methods This study is an open‐label, three‐arm, cluster‐randomised trial in nurse‐led facilities. All three groups implemented a treatment contract. The control group (group 1) had no additional intervention, group 2 received the incentive of 1 month of free treatment every forth month of regularly respected visits, and group 3 received reminder letters in case of a missed follow‐up visit. The primary outcome was patient retention at 1 year. Secondary outcomes were adherence to follow‐up visit schemes and changes in blood pressure (BP) and blood glucose levels. Patients’ monthly spending for drugs and transport was calculated retrospectively. Results A total of 33 centres and 221 patients were included. After 1 year, 109 patients (49.3%) remained in the programme. Retention rates in groups 2 and 3 were 60% and 65%, respectively, against 29% in the control group. The differences between the intervention groups and the control group were significant (P < 0.001), but differences between the two intervention groups were not (P = 0.719). There were no significant differences in BP or fasting plasma glucose trends between retained patients in the study groups. Average monthly cost to patients for antihypertensive medication was € 1.1 ± 0.9 and for diabetics €1.2 ± 1.1. Transport costs to the centres were on average €1.1 ± 1.0 for hypertensive patients and €1.1 ± 1.6 for patients with diabetes. Conclusions Low‐cost interventions suited to an environment of task shifting and nurse‐led care and needing minimal additional resources can significantly improve retention rates in CV disease management in rural Africa. The combination of a treatment contract and reminder letters in case of missed appointments was an effective measure to retain patients in care.     

Evaluation of the patient acceptable symptom state as an outcome measure in patients with ankylosing spondylitis: data from a randomized controlled trial

OBJECTIVE: To evaluate the feasibility/acceptability, reliability, external validity, and discriminant capacity of the Patient Acceptable Symptom State (PASS) concept in patients with active ankylosing spondylitis (AS). METHODS: PASS was assessed by asking patients to respond yes or no to a single question: "Considering all the different ways your disease is affecting you, if you would stay in this state for the next months, do you consider that your current state is satisfactory?" during the 24-week, randomized (2:1 ratio), double-blind, placebo-controlled portion of an adalimumab study of 315 patients. RESULTS: PASS reliability was high (kappa = 0.86) in patients with stable disease. Significantly more patients who answered yes to PASS than patients who answered no to PASS were responders based on the ASsessment in Ankylosing Spondylitis (ASAS) International Working Group criteria for 20% improvement (75% who answered yes versus 29% who answered no), the ASAS criteria for 40% improvement (61% versus 16%), the ASAS partial remission criteria (37% versus 3%), and > or =50% improvement on the Bath Ankylosing Spondylitis Disease Activity Index (65% versus 19%; P < 0.001 for all comparisons), demonstrating external validity of the PASS concept. More adalimumab-treated than placebo-treated patients achieved PASS at week 12 (42.3% versus 22.4%; P < 0.001), and more adalimumab-treated than placebo-treated patients achieved sustained PASS through week 20 (34.6% versus 12.3%; P < 0.001), indicating excellent discriminant capacity. CONCLUSION: PASS is a feasible, acceptable, reliable, and valid assessment of satisfactory health state in patients with AS.     

A cluster randomized controlled trial of an adapted U.S. model of pharmaceutical care for nursing home residents in Northern Ireland (Fleetwood Northern Ireland study): a cost-effectiveness analysis

OBJECTIVES: To evaluate the cost‐effectiveness of an adapted U.S. model of pharmaceutical care to improve psychoactive prescribing for nursing home residents in Northern Ireland (Fleetwood NI Study). DESIGN: Economic evaluation alongside a cluster randomized controlled trial. SETTING: Nursing homes in NI randomized to intervention (receipt of the adapted model of care; n=11) or control (usual care continued; n=11). PARTICIPANTS: Residents aged 65 and older who provided informed consent (N=253; 128 intervention, 125 control) and who had full resource use data at 12 months. INTERVENTION: Trained pharmacists reviewed intervention home residents' clinical and prescribing information for 12 months, applied an algorithm that guided them in assessing the appropriateness of psychoactive medication, and worked with prescribers (general practitioners) to make changes. The control homes received usual care in which there was no pharmacist intervention. MEASUREMENTS: The proportion of residents prescribed one or more inappropriate psychoactive medications (according to standardized protocols), costs, and a cost‐effectiveness acceptability curve. The latter two outcomes are the focus for this article. RESULTS: The proportions of residents receiving inappropriate psychoactive medication at 12 months in the intervention and control group were 19.5% and 50.4%, respectively. The mean cost of healthcare resources used per resident per year was $4,923 (95% confidence interval (CI)=$4,206–5,640) for the intervention group and $5,053 (95% CI=$4,328–5,779) for the control group. The probability of the intervention being cost‐effective was high, even at low levels of willingness to pay to avoid a resident receiving inappropriately prescribed psychoactive medication. CONCLUSION: The Fleetwood NI model of care was more cost‐effective than usual care.     

The family partners for health study: a cluster randomized controlled trial for child and parent weight management

Objective:

The purpose of this study was to test a two-phased nutrition and exercise education, coping skills training, and exercise intervention program for overweight or obese low-income ethnic minority 2nd to 4th grade children and their parents in rural North Carolina, USA.

Methods:

A cluster randomized controlled trial was carried out with 358 children (7–10 years) and a parent for each child (n=358). General linear mixed models were used to determine the effects of the intervention on weight, adiposity, health behaviors, and eating and exercise self-efficacy by examining changes in children and parents from baseline to completion of the study (18 months).

Results:

At 18 months, children in the experimental group did not have a significantly decreased body mass index (BMI) percentile (P=0.470); however, they showed a reduction in the growth rate of their triceps (P=0.001) and subscapular skinfolds (P<0.001) and an improvement in dietary knowledge (P=0.018) and drank less than one glass of soda per day (P=0.052) compared with the control group. Parents in the experimental group had decreased BMI (P=0.001), triceps (P<0.001) and subscapular skinfolds (P<0.001) and increased nutrition (P=0.003) and exercise (P<0.001) knowledge and more often drank water or unsweetened drinks (P=0.029). At 18 months, children in the experimental group did not show significant improvement in eating (P=0.956) or exercise self-efficacy (P=0.976). Experimental parents demonstrated improved socially acceptable eating self-efficacy (P=0.013); however, they did not show significant improvement in self-efficacy pertaining to emotional eating (P=0.155) and exercise (P=0.680).

Conclusion:

The results suggest that inclusion of children and parents in the same intervention program is an effective way to decrease adiposity and improve nutrition behaviors in both children and parents and improve weight and eating self-efficacy in parents.