Effectiveness of targeted falls prevention programme in subacute hospital setting : randomised controlled trial

Objective : To assess the effectiveness of a targeted, multiple intervention falls prevention programme in reducing falls and injuries related to falls in a subacute hospital.

Design : Randomised controlled trial of a targeted multiple intervention programme implemented in addition to usual carecompared with usual care alone.

Setting :Three subacute wards in a metropolitan hospital specialising in rehabilitation and care of elderly patients.

Participants : 626 men and women aged 38 to 99 years (average 80 years) were recruited from consecutive admissions to subacute hospital wards.

Intervention : Falls risk alert card with information brochure, exercise programme, education programme, and hip protectors.

Main outcome measures : Incidence rate of falls, injuries related to falls, and proportion of participants who experienced one or more falls during their stay in hospital.

Results : Participants in the intervention group (n = 310) experienced 30% fewer falls than participants in the control group (n = 316). This difference was significant (Peto log rank test P = 0.045) and was most obvious after 45 days of observation. In the intervention group there was a trend for a reduction in the proportion of participants who experienced falls (relative risk 0.78, 95% confidence interval 0.56 to 1.06) and 28% fewer falls resulted in injury (log rank test P = 0.20).

Conclusions : A targeted multiple intervention falls prevention programme reduces the incidence of falls in the subacute hospital setting.

Contextual influences on femoral injecting behaviour in the UK Randomised Injectable Opiate Treatment Trial

Femoral injecting amongst participants of the Randomised Injectable Opiate Treatment Trial (RIOTT) has created a number of procedural, ethical and medical dilemmas for staff, clients and researchers. This study investigated the effect on femoral injecting behaviour of a drug consumption room (DCR) in the context of the RIOTT currently being conducted at the Maudsley Hospital, South London. It uses in-depth qualitative interviews with 10 RIOTT clients to investigate the effects of this environmental intervention on the injecting behaviour of individuals who injected femorally upon treatment entry. Interviewees were selected on the basis of membership in one of four groups: 1) never injected femorally, 2) injected femorally prior to trial and have ceased completely, 3) injected femorally prior to trial and have ceased within the DCR, and 4) have continued to inject femorally the inside and outside clinical settings. The paper uses case studies and clinical protocols to interpret changes in behaviour in injecting behaviour in regards to the goals of treatment. Preliminary results indicate that there are major advantages and disadvantages associated with femoral injecting. The most commonly reported reason for commencing femoral injecting was a lack of other viable veins and interviewee narratives illustrate how this issue use addressed within the context of the DCR. Within this setting, the paper explores the boundaries of harm reduction in the context of a traditional 'risk boundary' within the 'ideal' risk environment. Other issues explored include: gender differences in femoral injecting episodes, femoral injecting as a risk boundary and the importance of time pressures as a major predictor of choosing to inject femorally.

Evaluation of a community pharmacy-based intervention for improving patient adherence to antihypertensives: a randomised controlled trial

Background
The majority of patients using antihypertensive medications fail to achieve their recommended target blood pressure. Poor daily adherence with medication regimens and a lack of persistence with medication use are two of the major reasons for failure to reach target blood pressure. There is no single intervention to improve adherence with antihypertensives that is consistently effective. Community pharmacists are in an ideal position to promote adherence to chronic medications. This study aims to test a specific intervention package that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient adherence and/or persistence with antihypertensive medications - Hypertension Adherence Program in Pharmacy (HAPPY).

Methods/Design
The HAPPY trial is a multi-centre prospective randomised controlled trial. Fifty-six pharmacies have been recruited from three Australian states. To identify potential patients, a software application (MedeMine CVD) extracted data from a community pharmacy dispensing software system (FRED Dispense®). The pharmacies have been randomised to either 'Pharmacist Care Group' (PCG) or 'Usual Care Group' (UCG). To check for 'Hawthorne effect' in the UCG, a third group of patients 'Hidden Control Group' (HCG) will be identified in the UCG pharmacies, which will be made known to the pharmacists at the end of six months. Each study group requires 182 patients. Data will be collected at baseline, three and six months in the PCG and at baseline and six months in the UCG. Changes in patient adherence and persistence at the end of six months will be measured using the self-reported Morisky score, the Tool for Adherence Behaviour Screening and medication refill data.

Discussion
To our knowledge, this is the first research testing a comprehensive package of evidence-based interventions that could be integrated into the community pharmacy workflow to enable pharmacists to improve patient adherence and/or persistence with antihypertensive medications. The unique features of the HAPPY trial include the use of MedeMine CVD to identify patients who could potentially benefit from the service, control for the 'Hawthorne effect' in the UCG and the offer of the intervention package at the end of six months to patients in the UCG, a strategy that is expected to improve retention.

Trial Registration
Australian New Zealand Clinical Trial Registry ACTRN12609000705280

Healthy eating and obesity prevention for preschoolers : a randomised controlled trial

Background
Developing effective prevention and intervention programs for the formative preschool years is seen as an essential step in combating the obesity epidemic across the lifespan. The overall goal of the current project is to measure the effectiveness of a healthy eating and childhood obesity prevention intervention, the MEND (Mind Exercise Nutrition Do It!) program that is delivered to parents of children aged 2-4 years.

Methods/Design
This randomised controlled trial will be conducted with 200 parents and their 2-4 year old children who attend the MEND 2-4 program in metropolitan and regional Victoria. Parent-child dyads will attend ten 90-minute group workshops. These workshops focus on general nutrition, as well as physical activity and behaviours. They are typically held at community or maternal and child health centres and run by a MEND 2-4 trained program leader. Child eating habits, physical activity levels and parental behaviours and cognitions pertaining to nutrition and physical activity will be assessed at baseline, the end of the intervention, and at 6 and 12 months post the intervention. Informed consent will be obtained from all parents, who will then be randomly allocated to the intervention or wait-list control group.

Discussion
Our study is the first RCT of a healthy eating and childhood obesity prevention intervention targeted specifically to Australian parents and their preschool children aged 2-4 years. It responds to the call by experts in the area of childhood obesity and child health that prevention of overweight in the formative preschool years should focus on parents, given that parental beliefs, attitudes, perceptions and behaviours appear to impact significantly on the development of early overweight. This is 'solution-oriented' rather than 'problem-oriented' research, with its focus being on prevention rather than intervention. If this is a positive trial, the MEND2-4 program can be implemented as a national program.

Trial Registration
Australian New Zealand Clinical Trials Registry ACTRN12610000200088

A low intensity, community based lifestyle programme to prevent weight gain in women with young children : cluster randomised controlled trial

Objective To develop and evaluate the effectiveness of a community behavioural intervention to prevent weight gain and improve health related behaviours in women with young children.
Design Cluster randomised controlled trial.
Setting A community setting in urban Australia. 
Participants 250 adult women with a mean age of 40. 39 years (SD 4.77, range 25-51) and a mean body mass index of 27.82 kg/m2 (SD 5.42, range 18-47) were recruited as clusters through 12 primary (elementary) schools. Intervention Schools were randomly assigned to the intervention or the control. Mothers whose schools fell in the intervention group (n=127) attended four interactive group sessions that involved simple health messages, behaviour change strategies, and group discussion, and received monthly support using mobile telephone text messages for 12 months. The control group (n=123)
attended one non-interactive information session based on population dietary and physical activity guidelines. 
Main outcome measures The main outcome measures were weight change and difference in weight change between the intervention group and the control group at 12 months. Secondary outcomes were changes in serum concentrations of fasting lipids and glucose, and changes in dietary behaviours, physical activity, and self management behaviours.
Results All analyses were adjusted for baseline values and the possible clustering effect. Women in the control group gained weight over the 12 month study period (0.83 kg, 95% confidence interval (CI) 0.12 to 1.54), whereas those in the intervention group lost weight (−0.20 kg, −0.90 to 0.49). The difference in weight change between the intervention group and the control group at 12 months was −1.13 kg (−2.03 to −0.24 kg; P<0.05) on the basis of observed values and −1.11 kg (−2.17 to −0.04) after multiple imputation to account for possible bias created by missing values. Secondary analyses after multiple imputation showed a difference in the intervention group compared with the control group for total cholesterol concentration (−0.35 mmol/l, −0.70 to −0.001), self management behaviours (diet score 0.18, 0.13 to 0.33; physical activity score 0.24, 0.05 to 0.43), and confidence to control weight (0.40, 0.11 to 0.69). Regular self weighing was associated with weight loss in the intervention group only (−1.98 kg, −3.75 to −0.23).
Conclusions Weight gain in women with young children could be prevented using a low intensity self management intervention delivered in a community setting. Self management of health behaviours improved with the intervention. The response rate of 12%, although comparable with that in other community studies, might limit the ability to generalise to other populations.    
Trial registration Australian New Zealand Clinical Trials Registry number ACTRN12608000110381.

An exploratory cluster randomised controlled trial of knowledge translation strategies to support evidence-informed decision-making in local governments (The KT4LG study)

Background: Childhood overweight and obesity is the most prevalent and, arguably, politically complex child health problem internationally. Governments, communities and industry have important roles to play, and are increasingly expected to deliver an evidence-informed system-wide prevention program. However, efforts are impeded by a lack of organisational access to and use of research evidence. This study aims to identify feasible, acceptable and ideally, effective knowledge translation (KT) strategies to increase evidence-informed decision making in local governments, within the context of childhood obesity prevention as a national policy priority.
Methods/Design: This paper describes the methods for KT4LG, a cluster randomised controlled trial which is exploratory in nature, given the limited evidence base and methodological advances. KT4LG aims to examine a program of KT strategies to increase the use of research evidence in informing public health decisions in local governments. KT4LG will also assess the feasibility and acceptability of the intervention. The intervention program comprises a facilitated program of evidence awareness, access to tailored research evidence, critical appraisal skills development, networking and evidence summaries and will be compared to provision of evidence summaries alone in the control program. 28 local governments were randomised to intervention or control, using computer generated numbers, stratified by budget tertile (high, medium or low). Questionnaires will be used to measure impact, costs, and outcomes, and key informant interviews will be used to examine processes, feasibility, and experiences. Policy tracer studies will be included to examine impact of intervention on policies within relevant government policy documents.
Discussion: Knowledge translation intervention studies with a focus on public health and prevention are very few in number. Thus, this study will provide essential data on the experience of program implementation and evaluation of a system-integrated intervention program employed within the local government public health context. Standardised programs of system, organisational and individual KT strategies have not been described or rigorously evaluated. As such, the findings will make a significant contribution to understanding whether a facilitated program of KT strategies hold promise for facilitating evidence-informed public health decision making within complex multisectoral government organisations.

Annual high-dose vitamin D3 and mental well-being: randomised controlled trial

Background Epidemiological evidence supports a relationship between vitamin D and mental well-being, although evidence from large-scale placebo-controlled intervention trials is lacking.

Aims To examine if vitamin D supplementation has a beneficial effect on mood in community-dwelling older women; if a single annual large dose of vitamin D has a role in the prevention of depressive symptoms; and if there is an association between serum 25-hydroxyvitamin D levels and mental health.

Method A double-blind, randomised, placebo-controlled trial of women aged 70 or older (the Vital D Study: ISRCTN83409867 and ACTR12605000658617). Participants were randomly assigned to receive 500 000 IU vitamin D3 (cholecalciferol) orally or placebo every autumn/winter for 3–5 consecutive years. The tools utilised at various time points were the General Health Questionnaire, the 12-item Short Form Health Survey, the Patient Global Impression–Improvement scale and the WHO Well-Being Index. Serum 25-hydroxyvitamin D levels were measured in a subset of 102 participants.

Results In this non-clinical population, no significant differences between the vitamin D and placebo groups were detected in any of the measured outcomes of mental health. Serum 25-hydroxyvitamin D levels in the vitamin D group were 41% higher than the placebo group 12 months following their annual dose. Despite this difference, scores from the questionnaires did not differ. Furthermore, there was no interaction between those on antidepressant/anxiety medication at baseline and the treatment groups.

Conclusions The lack of improvement in indices of mental well-being in the vitamin D group does not support the hypothesis that an annual high dose of vitamin D3 is a practical intervention to prevent depressive symptoms in older community-dwelling women.

Continuity of midwifery care and gestational weight gain in obese women : a randomised controlled trial

Background: The increased prevalence of obesity in pregnant women in Australia and other developed countries is a significant public health concern. Obese women are at increased risk of serious perinatal complications and guidelines recommend weight gain restriction and additional care. There is limited evidence to support the effectiveness of dietary and physical activity lifestyle interventions in preventing adverse perinatal outcomes and new strategies need to be evaluated. The primary aim of this project is to evaluate the effect of continuity of midwifery care on restricting gestational weight gain in obese women to the recommended range. The secondary aims of the study are to assess the impact of continuity of midwifery care on: women’s experience of pregnancy care; women’s satisfaction with care and a range of psychological factors.
Methods/Design: A two arm randomised controlled trial (RCT) will be conducted with primigravid women recruited from maternity services in Victoria, Australia. Participants will be primigravid women, with a BMI≥30 who are less than 17 weeks gestation. Women allocated to the intervention arm will be cared for in a midwifery continuity of care model and receive an informational leaflet on managing weight gain in pregnancy. Women allocated to the control group will receive routine care in addition to the same informational leaflet. Weight gain during pregnancy, standards of care, medical and obstetric information will be extracted from medical records. Data collected at recruitment (self administered survey) and at 36 weeks by postal survey will include sociodemographic information and the use of validated scales to measure secondary outcomes.
Discussion: Continuity of midwifery care models are well aligned with current Victorian, Australian and many international government policies on maternity care. Increasingly, midwifery continuity models of care are being introduced in low risk maternity care, and information on their application in high risk populations is required. There is an identified need to trial alternative antenatal interventions to reduce perinatal risk factors for women who are obese and the findings from this project may have application in other maternity services. In addition this study will inform a larger trial that will focus on birth and postnatal outcomes.

The 6-PACK programme to decrease fall-related injuries in acute hospitals: protocol for a cluster randomised controlled trial

Background and aims In-hospital fall-related injuries are a source of personal harm, preventable hospitalisation costs, and access block through increased length of stay. Despite increased fall prevention awareness and activity over the last decade, rates of reported fall-related fractures in hospitals appear not to have decreased. This cluster randomised controlled trial (RCT) aims to determine the efficacy of the 6-PACK programme for preventing fall-related injuries, and its generalisability to other acute hospitals.

Methods 24 acute medical and surgical wards from six to eight hospitals throughout Australia will be recruited for the study. Wards will be matched by type and fall-related injury rates, then randomly allocated to the 6-PACK intervention (12 wards) or usual care control group (12 wards). The 6-PACK programme includes a nine-item fall risk assessment and six nursing interventions: ‘falls alert’ sign; supervision of patients in the bathroom; ensuring patient’s walking aids are within reach; establishment of a toileting regime; use of a low-low bed; and use of bed/chair alarm. Intervention wards will be supported by a structured implementation strategy. The primary outcomes are fall and fall-related injury rates 12 months following 6-PACK implementation.

Discussion This study will involve approximately 16 000 patients, and as such is planned to be the largest hospital fall prevention RCT to be undertaken and the first to be powered for the important outcome of fall-related injuries. If effective, there is potential to implement the programme widely as part of daily patient care in acute hospital wards where fall-related injuries are a problem.