The 6-PACK programme to decrease falls and fall-related injuries in acute hospitals : protocol for an economic evaluation alongside a cluster randomised controlled trial

Background Falls are a common hospital occurrence complicating the care of patients. From an economic perspective, the impact of in-hospital falls and related injuries is substantial. However, few studies have examined the economic implications of falls prevention interventions in an acute care setting. The 6-PACK programme is a targeted nurse delivered falls prevention programme designed specifically for acute hospital wards. It includes a risk assessment tool and six simple strategies that nurses apply to patients classified as high-risk by the tool.
Objective To examine the incremental cost-effectiveness of the 6-PACK programme for the prevention of falls and fall-related injuries, compared with usual care practice, from an acute hospital perspective.
Methods and design The 6-PACK project is a multicentre cluster randomised controlled trial (RCT) that includes 24 acute medical and surgical wards from six hospitals in Australia to investigate the efficacy of the 6-PACK programme. This economic evaluation will be conducted alongside the 6-PACK cluster RCT. Outcome and hospitalisation cost data will be prospectively collected on approximately 16 000 patients admitted to the participating wards during the 12-month trial period. The results of the economic evaluation will be expressed as ‘cost or saving per fall prevented’ and ‘cost or saving per fall-related injury prevented’ calculated from differences in mean costs and effects in the intervention and control groups, to generate an incremental cost-effectiveness ratio (ICER).
Discussion This economic evaluation will provide an opportunity to explore the cost-effectiveness of a targeted nurse delivered falls prevention programme for reducing in-hospital falls and fall-related injuries. This protocol provides a detailed statement of a planned economic evaluation conducted alongside a cluster RCT to investigate the efficacy of the 6-PACK programme to prevent falls and fall-related injuries.

A cluster-randomised, controlled trial to assess the impact of a workplace osteoporosis prevention intervention on the dietary and physical activity behaviours of working women: study protocol

Background Osteoporosis is a debilitating disease and its risk can be reduced through adequate calcium consumption and physical activity. This protocol paper describes a workplace-based intervention targeting behaviour change in premenopausal women working in sedentary occupations. Method/Design A cluster-randomised design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the clusters and units of randomisation and intervention. Sample size calculations incorporated the cluster design. Final number of clusters was determined to be 16, based on a cluster size of 20 and calcium intake parameters (effect size 250 mg, ICC 0.5 and standard deviation 290 mg) as it required the highest number of clusters. Sixteen workplaces were recruited from a pool of 97 workplaces and randomly assigned to intervention and control arms (eight in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organisation wide educational activities. Workplaces in the control/standard care arm received print resources. Intervention workshops were guided by self-efficacy theory and included participatory activities such as goal setting, problem solving, local food sampling, exercise trials, group discussion and behaviour feedback. Outcomes measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, four weeks and six months post intervention. Discussion This study addresses the current lack of evidence for behaviour change interventions focussing on osteoporosis prevention. It addresses missed opportunities of using workplaces as a platform to target high-risk individuals with sedentary occupations. The intervention was designed to modify behaviour levels to bring about risk reduction. It is the first to address dietary and physical activity components each with unique intervention strategies in the context of osteoporosis prevention. The intervention used locally relevant behavioural strategies previously shown to support good outcomes in other countries. The combination of these elements have not been incorporated in similar studies in the past, supporting the study hypothesis that the intervention will be more efficacious than standard practice in osteoporosis prevention through improvements in calcium intake and physical activity.

The efficacy of a clinician referral and 12 week physical activity program among men living with prostate cancer: a multicentre cluster randomised controlled trial

BACKGROUND : The purpose of this study was to determine the efficacy of a clinician referral and exercise program in improving exercise levels and quality of life for men with prostate cancer.

METHODS : This was a multicenter cluster randomized controlled trial in Melbourne, Australia comprising 15 clinicians: 8 clinicians were randomized to refer eligible participants (n = 54) to a 12-week exercise program comprising 2 supervised gym sessions and 1 home-based session per week, and 7 clinicians were randomized to follow usual care (n = 93). The primary outcome was self-reported physical activity; the secondary outcomes were quality of life, anxiety, and symptoms of depression.

RESULTS : A significant intervention effect was observed for vigorous-intensity exercise (effect size: Cohen's d, 0.46; 95% confidence interval [CI], 0.09-0.82; P = .010) but not for combined moderate and vigorous exercise levels (effect size: d, 0.08; 95% CI, −0.28 to 0.45; P = .48). Significant intervention effects were also observed for meeting exercise guidelines (≥150 min/wk; odds ratio, 3.9; 95% CI, 1.9-7.8; P = .002); positive intervention effects were observed in the intervention group for cognitive functioning (effect size: d, 0.34; 95% CI, −0.02 to 0.70; P = .06) and depression symptoms (effect size: d, −0.35; 95% CI, −0.71 to 0.02; P = .06). Eighty percent of participants reported that the clinician's referral influenced their decision to participate in the exercise program.

CONCLUSIONS : The clinician referral and 12-week exercise program significantly improved vigorous exercise levels and had a positive impact on mental health outcomes for men living with prostate cancer. Further research is needed to determine the sustainability of the exercise program and its generalizability to other cancer populations.

A cluster randomized controlled trial to reduce office workers' sitting time: impact on activity outcomes

PURPOSE: To evaluate, compared to usual practice, the initial and long-term effectiveness of a workplace intervention targeting reducing sitting on activity outcomes.

METHODS: Office worksites (≥1km apart) from a single organization in Victoria, Australia were cluster randomized to intervention (n=7) or control (n=7). Participants were 231 desk-based office workers (5 to 39 participants per worksite) working at least 0.6 full time equivalent. The workplace-delivered intervention addressed organizational, physical environment, and individual behavioural change to reduce sitting time. Assessments occurred at baseline, three-, and 12-months, with the primary outcome participants' objectively measured (activPAL3 device) workplace sitting time (mins/8-h workday). Secondary activity outcomes were: workplace time spent standing, stepping (light, moderate-vigorous and total) and in prolonged (≥30min) sitting bouts (h/8-h workday); usual duration of workplace sitting bouts; and, overall sitting, standing and stepping time (mins/16-h day). Analysis was by linear mixed models, accounting for repeated measures and clustering and adjusting for baseline values and potential confounders.

RESULTS: At baseline, on average, participants (68% women; mean±SD age = 45.6±9.4 years) sat, stood and stepped for 78.8±9.5%, 14.3±8.2%, and 6.9±2.9% of work hours respectively. Workplace sitting time was significantly reduced in the intervention group compared to the controls at three months (-99.1 [95% CI -116.3 to -81.8] min/8-h workday) and 12 months (-45.4 [-64.6 to -26.2] min/8-h workday). Significant intervention effects (all favoring intervention) were observed for standing, prolonged sitting, and usual sitting bout duration at work, as well as overall sitting and standing time, with no significant nor meaningful effects observed for stepping.

CONCLUSIONS: This workplace-delivered multicomponent intervention was successful at reducing workplace and overall daily sitting time in both the short- and long- term.

Assessing the sustained impact of a school-based obesity prevention program for adolescent boys: the ATLAS cluster randomized controlled trial

BACKGROUND: Obesity prevention interventions targeting 'at-risk' adolescents are urgently needed. The aim of this study is to evaluate the sustained impact of the 'Active Teen Leaders Avoiding Screen-time' (ATLAS) obesity prevention program.

METHODS: Cluster RCT in 14 secondary schools in low-income communities of New South Wales, Australia. Participants were 361 adolescent boys (aged 12-14 years) 'at risk' of obesity. The intervention was based on Self-Determination Theory and Social Cognitive Theory and involved: professional development, fitness equipment for schools, teacher-delivered physical activity sessions, lunch-time activity sessions, researcher-led seminars, a smartphone application, and parental strategies. Assessments for the primary (body mass index [BMI], waist circumference) and secondary outcomes were conducted at baseline, 8- (post-intervention) and 18-months (follow-up). Analyses followed the intention-to-treat principle using linear mixed models.

RESULTS: After 18-months, there were no intervention effects for BMI or waist circumference. Sustained effects were found for screen-time, resistance training skill competency, and motivational regulations for school sport.

CONCLUSIONS: There were no clinically meaningful intervention effects for the adiposity outcomes. However, the intervention resulted in sustained effects for secondary outcomes. Interventions that more intensively target the home environment, as well as other socio-ecological determinants of obesity may be needed to prevent unhealthy weight gain in adolescents from low-income communities.

The hairiness of worsted wool and cashmere yarns and the impact of fiber curvature on hairiness

In this study, a range of carefully selected wool and cashmere yarns as well as their blends were used to examine the effects of fiber curvature and blend ratio on yarn hairiness. The results indicate that yarns spun from wool fibers with a higher curvature have lower yarn hairiness than yarns spun from similar wool of a lower curvature. For blend yarns made from wool and cashmere of similar diameter, yarn hairiness increases with the increase in the cashmere content in the yarn. This is probably due to the presence of increased proportion of the shorter cashmere fibers in the surface regions of the yarn, leading to increased yarn hairiness. A modified hairiness composition model is used to explain these results and the likely origin of leading and trailing hairs. This model highlights the importance of yarn surface composition on yarn hairiness.

In the shadow of the volcanoes: the impact of intervention on the nutrition and health status of Rwandan refugee children in Zaire two years from the exodus

Objective: To evaluate the public health and nutritional situation of refugee children in Katale camp, Eastern Zaire, after two years of nutritional and health intervention from 1994 to 1996.
Design: Cross-sectional survey using a two-stage cluster sampling method. Anthropometric data were collected from 28 May 1996 to 4 June 1996. Retrospective review of food basket monitoring data over the preceding six months and the United Nations High Commission for Refugees' weekly mortality data was conducted. Measles immunisation coverage data were surveyed simultaneously, using child health records.
Main outcome measures: Nutritional status measured by weight-for-height index (W/H), measles immunisation status, average daily energy content of the general food ration and crude mortality rate.
Setting: Katale refugee camp, Zaire, June 1996.
Analysis: Weight-for-height index and proportion of immunised children were computed using EPINUT, part of EPINFO computer package.
Results: Malnutrition was found to be most prevalent in children aged six to 29 months old (W/H < -2 Z-score and/or oedema: 6.2%; 95% CI: 3.4%, 10.6%), among whom the malnutrition rate was almost double the overall malnutrition prevalence (W/H < -2 Z-score and/or oedema: 3.5% (95% CI: 1.5%, 7.2%). The general food ration, although conforming to the World Food Program minimum standards of adequacy in terms of variety (being composed of cereals, oil, beans, blended cereal and legume mixes and salt), provided only 6240 kJ on average (95% CI: 5040, 7140 kJ) per person per day, thus meeting only 57% to 84% of the minimum energy requirements for an adult, and falling well below the needs for sub groups with higher nutritional requirements such as children, pregnant and breastfeeding women and the sick. Measles immunisation coverage in children nine to 59 months was 88.6%. The crude mortality rate was found to be 0.3 per 10 000 per day. Refugees received 15 litres of clean water per person per day.
Conclusion: Public health interventions in Katale camp 1994 to 1996 had reduced mortality and morbidity rates dramatically. This was not reflected in the malnutrition rates for children under five years, that remained stable after an initial fall despite two years of nutritional intervention. The factors contributed to this were related to an inadequate general food ration (due to food shortages), lack of ability to supplement the diet, (due to economic restrictions that were imposed in the camp) and inequities in the food distribution process (due to food being siphoned off by camp leaders for military purposes).

Impact of an empowerment-based parent education program on the reduction of youth suicide risk factors

Purpose: To evaluate the impact of parent education groups on youth suicide risk factors. The potential for informal transmission of intervention impacts within school communities was assessed.

Methods: Parent education groups were offered to volunteers from 14 high schools that were closely matched to 14 comparison schools. The professionally led groups aimed to empower parents to assist one another to improve communication skills and relationships with adolescents. Australian 8th-grade students (aged 14 years) responded to classroom surveys repeated at baseline and after 3 months. Logistic regression was used to test for intervention impacts on adolescent substance use, deliquency, self-harm behavior, and depression. There were no differences between the intervention (n = 305) and comparison (n = 272) samples at baseline on the measures of depression, health behavior, or family relationships.

Results: Students in the intervention schools demonstrated increased maternal care (adjusted odds ratio [AOR] 1.9), reductions in conflict with parents (AOR .5), reduced substance use (AOR .5 to .6), and less delinquency (AOR .2). Parent education group participants were more likely to be sole parents and their children reported higher rates of substance use at baseline. Intervention impacts revealed a dose-response with the largest impacts associated with directly participating parents, but significant impacts were also evident for others in the intervention schools. Where best friend dyads were identified, the best friend’s positive family relationships reduced subsequent substance use among respondents. This and other social contagion processes were posited to explain the transfer of positive impacts beyond the minority of directly participating families.

Conclusions: A whole-school parent education intervention demonstrated promising impacts on a range of risk behaviors and protective factors relevant to youth self-harm and suicide.

An analysis of update ordering in a cluster of replicated servers

This paper analyses update ordering and its impact on the performance of a cluster of replicated servers. We propose a model for update orderings and constraints and develop a number of algorithms for implementing different ordering constraints. A performance study is then carried out to analyse the update ordering model.

Methods for exploring implementation variation and local context within a cluster tandomised community intervention trial

Insignificant or modest findings in intervention trials may be attributable to poorly designed or theorised interventions, poorly implemented interventions, or inadequate evaluation methods. The pre-existing context may also account for the effects observed. A combination of qualitative and quantitative methods is outlined that will permit the determination of how context level factors might modify intervention effectiveness, within a cluster randomised community intervention trial to promote the health of mothers with new babies. The methods include written and oral narratives, key informant interviews, impact logs, and inter-organisational network analyses. Context level factors, which may affect intervention uptake, success, and sustainability are the density of inter-organisational ties within communities at the start of the intervention, the centrality of the primary care agencies expected to take a lead with the intervention, the extent of context-level adaptation of the intervention, and the amount of local resources contributed by the participating agencies. Investigation of how intervention effects are modified by context is a new methodological frontier in community intervention trial research.

Mortality rates, prevalence of malnutrition, and prevalence of lost pregnancies among the drought-ravaged population of Tete province Mozambique

Background: Tete Province, Mozambique has experienced chronic food insecurity and a dramatic fall in livestock numbers due to the cyclic problems characterized by the floods in 2000 and severe droughts in 2002 and 2003. The Province has been a beneficiary of emergency relief programs, which have assisted >22% of the population. However, these programs were not based on sound epidemiological data, and they have not established baseline data against which to assess the impact of the programs. Objective: The objective of this study was to document mortality rates, causes of death, the prevalence of malnutrition, and the prevalence of lost pregnancies after 2.5 years of humanitarian response to the crisis. Methods: A two-stage, 30-cluster household survey was conducted in the Cahora Bassa and Changara districts from 22 October to 08 November 2004. A total of 838 households were surveyed, with a population size of 4,688 people. Results: Anthropometric data were collected among children 6-59 months of age. In addition, crude mortality rates (CMRs), under five mortality rates (U5MRs), causes of deaths, and prevalence of lost pregnancies were determined among the sample population. The prevalence of malnutrition was 8.0% (95% confidence interval (CI)=6.2-9.8%) for acute malnutrition, 26.9% (95% CI=24.0-29.9%) for being underweight, and 37.0% (95% CI=33.8-40.2%) for chronic malnutrition. Boys were more likely to be underweight than were girls (odds ratio (OR)=1.34; 95% CI=1.00, 1.82; p<0.05) after controlling for age, household size, and food aid beneficiary status. Similarly, children 30-59 months of age were significantly less likely to suffer from acute malnutrition (OR=0.45; 95% CI=0.26, 0.79; p<0.01) and less likely to be underweight (OR=0.37; 95% CI=0.27, 0.51; p<0.01) than children 6-29 months of age, after adjusting for the other, aforementioned factors. The proportion of lost pregnancies was estimated at 7.7% (95% CI=4.5-11.0%). A total of 215 deaths were reported during the year preceding the survey. Thirty-nine (18.1%) children <5 years of age died. The CMR was 1.23/10 000/day (95% CI=1.08-1.38), and an U5MR was 1.03/10 000/day (95% CI=0.71-1.35). Diarrheal diseases, malaria, tuberculosis, and human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) accounted for more than two-thirds of all deaths. Conclusions: The observed CMR in Tete Province, Mozambique is three times higher than the baseline rate for sub-Saharan Africa and 1.4 times higher than the CMR cut-off point used to define excess mortality in emergencies. The current humanitarian response in Tete Province would benefit from an improved alignment of food aid programming in conjunction with diarrheal disease control, HIV/AIDS, and malaria prevention and treatment programs. The impact of the food programs would be improved if mutually acceptable food aid programme objectives, verifiable indicators relevant to each objective, and beneficiary targets and selection criteria are developed. Periodic re-assessments and evaluations of the impact of the program and evidenced-based decision-making urgently are needed to avert a chronic dependency on food aid.

Family, school, peer and individual influences on early adolescent alcohol use: first-year impact of the Resilient Families programme

Introduction and Aims:  This study aimed to examine: (a) the influence of family factors relative to school, peer and individual influences on the development of adolescent alcohol use during the first year of secondary school; and (b) the feasibility of preventing adolescent alcohol use by modifying family factors. Design and Methods:  Twenty-four schools in Melbourne, Australia were randomly assigned to either the 'Resilient Families' intervention or a control condition. A baseline cohort of 2315 grade 7 students (mean age 12.3 years) were followed-up one year later (n = 2128 for longitudinal analyses). A sub-set of parents (n = 1166) also returned baseline surveys. Results: The prevalence of lifetime alcohol use in year 7 was 33% and rose to 47% by year 8. Student-reported predictors of year 8 alcohol use included baseline alcohol [Odds Ratio (OR) 3.64] and tobacco use (2.68), and school friend's alcohol (1.41) and tobacco use (1.64). After adjusting for other influences, student-reported family factors were not maintained as significant predictors of year 8 alcohol use. Parent-report predictors of student-reported alcohol use included allowing alcohol use in the home (2.55), parental alcohol use (1.88) and child hyperactivity (1.85). Protective factors included attendance at brief parent education (0.60) and parent involvement in school education (0.65). Discussion and Conclusions: The intervention appeared to benefit education-related outcomes, but no overall effect in reducing student alcohol use was found in year 8. Intervention effects on alcohol misuse may become significant in later secondary school once the entire program has been implemented. Considerable alcohol use was detected in early secondary school,   suggesting that interventions to reduce alcohol use may be usefully implemented prior to this period.

Does interpersonal psychotherapy improve clinical care for adolescents with depression attending a rural child and adolescent mental health service? Study protocol for a cluster randomised feasibility trial

Background: Depression amongst adolescents is a costly societal problem. Little research documents the effectiveness of public mental health services in mapping this problem. Further, it is not clear whether usual care in such services can be improved via clinician training in a relevant evidence based intervention. One such intervention, found to be effective and easily learned amongst novice clinicians, is Interpersonal Psychotherapy (IPT). The study described in the current paper has two main objectives. First, it aims to investigate the impact on clinical care of implementing Interpersonal Psychotherapy for Adolescents for the treatment of adolescent depression within a rural mental health service compared with Treatment as Usual (TAU). The second objective is to record the process and challenges (i.e. feasibility, acceptability, sustainability) associated with implementing and evaluating an evidence-based intervention within a community service. This paper outlines the study rationale and design for this community based research trial.

Methods/design: The study involves a cluster randomisation trial to be conducted within a Child and Adolescent Mental Health Service in rural Australia. All clinicians in the service will be invited to participate.  Participating clinicians will be randomised via block design at each of four sites to (a) training and delivery of IPT, or (b) TAU. The primary measure of impact on care will be a clinically significant change in depressive  symptomatology, with secondary outcomes involving treatment satisfaction and changes in other symptomatology. Participating adolescents with significant depressive symptomatology, aged 12 to 18 years, will complete assessment measures at Weeks 0, 12 and 24 of treatment. They will also complete a depression inventory once a month during that period. This study aims to recruit 60 adolescent participants and their parent/guardian/s. A power analysis is not indicated as an intra-class correlation coefficient will be calculated and used to inform sample size calculations for subsequent large-scale trials. Qualitative data regarding process implementation will be collected quarterly from focus groups with participating clinicians over 18 months, plus phone interviews with participating adolescents and parent/guardians at 12 weeks and 24 weeks of treatment. The focus group qualitative data will be analysed using a Fourth Generation Evaluation methodology that includes a constant comparative cyclic analysis method.

Discussion: This study protocol will be informative for researchers and clinicians interested in considering, designing and/or conducting cluster randomised trials within community practice such as mental health services.

Cost-effectiveness of physical activity counselling in general practice

AIM: To assess the cost-effectiveness of the 'Green Prescription' physical activity counselling programme in general practice.
METHOD: Prospective cost-effectiveness study undertaken as part of a cluster randomised controlled trial with 12-month follow-up of 878 'less-active' patients aged 40-79 years in 42 general practices in the Waikato. The intervention was verbal advice and a written exercise prescription given by general practitioners, with telephone exercise specialist follow-up compared with usual care. Main outcome measures included cost per total and leisure-time physical activity gain from health-funders' and societal perspectives.
RESULTS: Significant increases in physical activity were found in the randomised controlled trial. Programme-cost per patient was NZ170 dollars from a funder's perspective. The monthly cost-effectiveness ratio for total energy expenditure achieved was 11 dollars per kcal/kg/day. The incremental cost of converting one additional 'sedentary' adult to an 'active' state over a twelve-month period was NZ1,756 dollars in programme costs.
CONCLUSION: Verbal and written physical activity advice given in general practice with telephone follow-up is an inexpensive way of increasing activity for sedentary people, and has the potential to have significant economic impact through reduction in cardiovascular and other morbidity and mortality.

Parent-reported health status of overweight and obese Australian primary school children: a cross-sectional population survey

Introduction: Childhood overweight/obesity is associated with poor physical and psychosocial health in clinical samples. However, there is little information on the health status of overweight and obese children in the community, who now represent a large proportion of the child population. We examined parent-reported child health and well-being and parent concern about child weight by body mass index (BMI) category in a population sample of primary school children.

Design: A stratified two-stage random cluster sample of 24 primary schools representative of the state of Victoria, Australia.

Measures: BMI (weight/height2) transformed to normalised Z-scores using the 1990 UK Growth Reference; the Child Health Questionnaire (CHQ), a 13-scale 50-item parent-completed measure of health and well-being; parent self-reported height and weight; parent concern about child's weight.

Results: Data were available for 2863 children aged 5-13 y (50.5% male), of whom 17% were overweight and 5.7% obese. Using logistic regression analyses with 'normal weight' as the referent category, obese boys were at greater risk of poor health (ie <15th centile) on seven of the 12 CHQ scales: Physical Functioning (odds ratio (OR) 2.8), Bodily Pain (OR 1.8), General Health (OR 3.5), Mental Health (OR 2.8), Self Esteem (OR 1.8), Parent Impact¾Emotional (OR 1.7) and Parent Impact¾Time (OR 1.9). Obese girls were at greater risk of poor health on only two scales: General Health (OR 2.1) and Self Esteem (OR 1.8). Forty-two percent of parents with obese children and 81% with overweight children did not report concern about their child's weight. Parents were more likely to report concern if the child was obese (OR 21.3), overweight (OR 3.5) or underweight (OR 5.4) than normal weight (P<0.05). Concern was not related to child gender, parental BMI or parental education after controlling for child BMI. Perceived health and well-being of overweight/obese children varied little by weight category of the reporting parent (overweight vs non-overweight).

Conclusions: Parents were more likely to report poorer health and well-being for overweight and obese children (particularly obese boys). Parental concern about their child's weight was strongly associated with their child's actual BMI. Despite this, most parents of overweight and obese children did not report poor health or well-being, and a high proportion did not report concern. This has implications for the early identification of such children and the success of prevention and intervention efforts.