Building the capacity of family day care educators to promote children’s social and emotional wellbeing: Results of an exploratory cluster randomised-controlled trial

© 2015 Early Childhood Australia Inc. All rights reserved. THIS PAPER PRESENTS THE results of an exploratory cluster randomised-controlled trial that was used to pilot Thrive, a capacity-building program for family day care (FDC) educators. Participants were educators and coordinators from one FDC service in Melbourne, Australia. Data collection consisted of a survey including information on costs, an in-home quality of care observation and process evaluation. Data was collected over 12 months (2011–2012), at baseline and one, six and 12 months post-intervention. Positive caregiver interaction scores increased over time for the intervention group: F (3, 51.69) = 3.08, p < 0.05, and detached interaction scores decreased over time: F (3, 51.19) = 2.78, p < 0.05. Educators’ knowledge and confidence in children’s social and emotional wellbeing showed no significant change. Thrive gives important information about the challenges FDC educators face and is relevant to implementing changes in their education and support. For a program like Thrive to be successful in engaging educators, a stronger framework for supporting additional learning activities at both the FDC organisational and scheme level is warranted.

Is there scope for community health nurses to address lifestyle risk factors? The community nursing SNAP trial

Background
This paper examines the opportunity and need for lifestyle interventions for patients attending generalist community nursing services in Australia. This will help determine the scope for risk factor management within community health care by generalist community nurses (GCNs).

Methods
This was a quasi-experimental study conducted in four generalist community nursing services in NSW, Australia. Prior to service contacts, clients were offered a computer-assisted telephone interview to collect baseline data on socio-demographics, health conditions, smoking status, physical activity levels, alcohol consumption, height and weight, fruit and vegetable intake and 'readiness-to-change' for lifestyle risk factors.

Results
804 clients participated (a response rate of 34.1%). Participants had higher rates of obesity (40.5% vs 32.1%) and higher prevalence of multiple risk factors (40.4% vs 29.5%) than in the general population. Few with a SNAPW (S moking-N utrition-A lcohol-P hysical-Activity-Weight) risk factor had received advice or referral in the previous 3 months. The proportion of clients identified as at risk and who were open to change (i.e. contemplative, in preparation or in action phase) were 65.0% for obese/overweight; 73.8% for smokers; 48.2% for individuals with high alcohol intake; 83.5% for the physically inactive and 59.0% for those with poor nutrition.

Conclusions
There was high prevalence of lifestyle risk factors. Although most were ready to change, few clients recalled having received any recent lifestyle advice. This suggests that there is considerable scope for intervention by GCNs. The results of this trial will shed light on how best to implement the lifestyle risk factor management in routine practice.

Cognitive versus exposure therapy for problem gambling: randomised controlled trial

BACKGROUND: Problem gambling-specific cognitive therapy (CT) and behavioural (exposure-based) therapy (ET) are two core cognitive-behavioural techniques to treating the disorder, but no studies have directly compared them using a randomised trial. AIMS: To evaluate differential efficacy of CT and ET for adult problem gamblers at a South Australian gambling therapy service. METHODS: Two-group randomised, parallel design. Primary outcome was rated by participants using the Victorian Gambling Screen (VGS) at baseline, treatment-end, 1, 3, and 6 month follow-up. FINDINGS: Of eighty-seven participants who were randomised and started intervention (CT = 44; ET = 43), 51 (59%) completed intervention (CT = 30; ET = 21). Both groups experienced comparable reductions (improvement) in VGS scores at 12 weeks (mean difference -0.18, 95% CI: -4.48-4.11) and 6 month follow-up (mean difference 1.47, 95% CI: -4.46-7.39). CONCLUSIONS: Cognitive and exposure therapies are both viable and effective treatments for problem gambling. Large-scale trials are needed to compare them individually and combined to enhance retention rates and reduce drop-out.

Text message and internet support for coronary heart disease self-management: results from the text4heart randomized controlled trial

BACKGROUND: Mobile technology has the potential to deliver behavior change interventions (mHealth) to reduce coronary heart disease (CHD) at modest cost. Previous studies have focused on single behaviors; however, cardiac rehabilitation (CR), a component of CHD self-management, needs to address multiple risk factors. OBJECTIVE: The aim was to investigate the effectiveness of a mHealth-delivered comprehensive CR program (Text4Heart) to improve adherence to recommended lifestyle behaviors (smoking cessation, physical activity, healthy diet, and nonharmful alcohol use) in addition to usual care (traditional CR). METHODS: A 2-arm, parallel, randomized controlled trial was conducted in New Zealand adults diagnosed with CHD. Participants were recruited in-hospital and were encouraged to attend center-based CR (usual care control). In addition, the intervention group received a personalized 24-week mHealth program, framed in social cognitive theory, sent by fully automated daily short message service (SMS) text messages and a supporting website. The primary outcome was adherence to healthy lifestyle behaviors measured using a self-reported composite health behavior score (≥3) at 3 and 6 months. Secondary outcomes included clinical outcomes, medication adherence score, self-efficacy, illness perceptions, and anxiety and/or depression at 6 months. Baseline and 6-month follow-up assessments (unblinded) were conducted in person. RESULTS: Eligible patients (N=123) recruited from 2 large metropolitan hospitals were randomized to the intervention (n=61) or the control (n=62) group. Participants were predominantly male (100/123, 81.3%), New Zealand European (73/123, 59.3%), with a mean age of 59.5 (SD 11.1) years. A significant treatment effect in favor of the intervention was observed for the primary outcome at 3 months (AOR 2.55, 95% CI 1.12-5.84; P=.03), but not at 6 months (AOR 1.93, 95% CI 0.83-4.53; P=.13). The intervention group reported significantly greater medication adherence score (mean difference: 0.58, 95% CI 0.19-0.97; P=.004). The majority of intervention participants reported reading all their text messages (52/61, 85%). The number of visits to the website per person ranged from zero to 100 (median 3) over the 6-month intervention period. CONCLUSIONS: A mHealth CR intervention plus usual care showed a positive effect on adherence to multiple lifestyle behavior changes at 3 months in New Zealand adults with CHD compared to usual care alone. The effect was not sustained to the end of the 6-month intervention. A larger study is needed to determine the size of the effect in the longer term and whether the change in behavior reduces adverse cardiovascular events. TRIAL REGISTRATION: ACTRN 12613000901707; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=364758&isReview=true (Archived by WebCite at http://www.webcitation.org/6c4qhcHKt).

A randomised trial of the Flinders Program to improve patient self-management competencies in a range of chronic conditions : study rationale and protocol

Background: Supporting self management is seen as an important health service strategy in dealing with the large and increasing health burden of chronic conditions. Several types of self-management programs are available. Evidence to date suggests that disease specific and lay-led self management programs provide only part of the support needed for improved outcomes. The Flinders Program is promising as a generic self management intervention, which can be combined with targeted disease specific and lay-led interventions, but it has yet to be evaluated for a range of chronic conditions using a rigorous controlled trial design. This paper gives the rationale for a randomised controlled trial and process evaluation of the Flinders Program of chronic condition self-management in community practice, and details and justifies the design of such a study.Method: The design for a randomised trial and associated process evaluation, suited to evaluation of a complex and behavioural intervention as it is applied in actual practice, is presented and justified.Conclusion: A randomised trial of the Flinders Program is required and a functional design is presented. Results from this trial, currently underway, will test the effectiveness of the Flinders Program in improving patient competencies in self-management of chronic conditions in practice conditions. A process evaluation alongside the trial will explore system, provider and patient factors associated with greater and lesser Program effectiveness.

Two-group randomised, parallel trial of cognitive and exposure therapies for problem gambling: a research protocol

BACKGROUND: Problem gambling is a serious public health concern at an international level where population prevalence rates average 2% or more and occurs more frequently in younger populations. The most empirically established treatments until now are combinations of cognitive and behavioural techniques labelled cognitive behaviour therapy (CBT). However, there is a paucity of high quality evidence for the comparative efficacy of core CBT interventions in treating problem gamblers. This study aims to isolate and compare cognitive and behavioural (exposure-based) techniques to determine their relative efficacy.

METHODS: A sample of 130 treatment-seeking problem gamblers will be allocated to either cognitive or exposure therapy in a two-group randomised, parallel design. Repeated measures will be conducted at baseline, mid and end of treatment (12 sessions intervention period), and at 3, 6 and 12 months (maintenance effects). The primary outcome measure is improvement in problem gambling severity symptoms using the Victorian Gambling Screen (VGS) harm to self-subscale. VGS measures gambling severity on an extensive continuum, thereby enhancing sensitivity to change within and between individuals over time.

DISCUSSION: This article describes the research methods, treatments and outcome measures used to evaluate gambling behaviours, problems caused by gambling and mechanisms of change. This study will be the first randomised, parallel trial to compare cognitive and exposure therapies in this population.

ETHICS AND DISSEMINATION: The study was approved by the Southern Adelaide Health Service/Flinders University Human Research Ethics Committee. Study findings will be disseminated through peer-reviewed publications and conference presentations.

Beyond community-based diabetes management and the COAG coordinated care trial

OBJECTIVE: This article describes the patient management processes developed during the Council of Australian Governments (COAG) coordinated care trial and use of health outcome measures to monitor changes in utilisation patterns and patient well-being over time for a subgroup of 398 patients with type 2 diabetes. DESIGN: The Eyre component of the South Australian (SA) HealthPlus coordinated care trial was a matched geographically controlled study in which the outcomes for the intervention group of 1350 patients were compared with those of a similar control group of 500 patients in another rural health region in SA. SETTING: The trial was carried out on Eyre Peninsula in SA across populations in rural communities and in the main centres of Whyalla, Port Lincoln and Ceduna. Care planning was organised through general practitioner practices and services negotiated with allied health services and hospitals to meet patient needs. SUBJECTS: The SA HealthPlus trial included 1350 patients with chronic and complex illness. A subset of this group comprising 398 patients with type 2 diabetes is described in this report. Patients recruited into the three-year trial were care planned using a patient centred care planning model through which patient goals were generated along with medical management goals developed by clinicians and primary health care professionals. Relevant health services were scheduled in line with best practice and care plans were reviewed each year. Patient service utilisation, progress towards achieving health related goals and patient health outcomes were recorded and assessed to determine improvements in health and well-being along with the cost and profile of the services provided. RESULTS: Significant numbers of patients experienced improved health outcomes as a consequence of their involvement in the trial, and utilisation data showed reductions in hospital and medical expenditure for some patients. These results suggest that methods applied in the SA HealthPlus coordinated care trial have led to improvements in health outcomes for patients with diabetes and other chronic illnesses. In addition, the processes associated with the COAG trial motivated significant organisational change in the Regional Health Service as well as providing an opportunity to study the health and well-being outcomes resulting from a major community health intervention. CONCLUSIONS: The importance of the SA HealthPlus trial has been the demonstrated link between a formal research trial and significant developments in the larger health system with the trial not only leading to improvements in clinical outcomes for patients, but also acting as a catalyst for organisational reform. We now need to look beyond the illness focus of health outcome research to develop population based health approaches to improving overall community well-being.

SA HealthPlus : a controlled trial of a statewide application of a generic model of chronic illness care

SA HealthPlus, one of nine national Australian coordinated care trials, addressed chronic illness care by testing whether coordinated care would improve health outcomes at the cost of usual care. SA HealthPlus compared a generic model of coordinated care for 3,115 intervention patients with the usual care for 1,488 controls. Service coordinators and the behavioral and care-planning approach were new. The health status (SF-36) in six of eight projects improved, and those patients who had been hospitalized in the year immediately preceding the trial were the most likely to save on costs. A mid-trial review found that health benefits from coordinated care depended more on patients' self-management than the severity of their illness, a factor leading to the Flinders Model of Self-Management Support.

Patient participation in postoperative care activities in patients undergoing total knee replacement surgery: multimedia intervention for managing patient experience (MIME). Study protocol for a cluster randomised crossover trial

BACKGROUND: Patient participation is an important indicator of quality care. Currently, there is little evidence to support the belief that participation in care is possible for patients during the acute postoperative period. Previous work indicates that there is very little opportunity for patients to participate in care in the acute context. Patients require both capability, in terms of having the required knowledge and understanding of how they can be involved in their care, and the opportunity, facilitated by clinicians, to engage in their acute postoperative care. This cluster randomised crossover trial aims to test whether a multimedia intervention improves patient participation in the acute postoperative context, as determined by pain intensity and recovery outcomes.

METHODS/DESIGN: A total of 240 patients admitted for primary total knee replacement surgery will be invited to participate in a cluster randomised, crossover trial and concurrent process evaluation in at least two wards at a major non-profit private hospital in Melbourne, Australia. Patients admitted to the intervention ward will receive the multimedia intervention daily from Day 1 to Day 5 (or day of discharge, if prior). The intervention will be delivered by nurses via an iPad™, comprising information on the goals of care for each day following surgery. Patients admitted to the control ward will receive usual care as determined by care pathways currently in use across the organization. The primary endpoint is the "worst pain experienced in the past 24 h" on Day 3 following TKR surgery. Pain intensity will be measured using the numerical rating scale. Secondary outcomes are interference of pain on activities of daily living, length of stay in hospital, function and pain following TKR surgery, overall satisfaction with hospitalisation, postoperative complications and hospital readmission.

DISCUSSION: The results of this study will contribute to our understanding of the effectiveness of interventions that provide knowledge and opportunity for patient participation during postoperative in-hospital care in actually increasing participation, and the impact of participation on patient outcomes. The results of this study will also provide data about the barriers and enablers to participation in the acute care context.

Improving access for community health and sub-acute outpatient services: protocol for a stepped wedge cluster randomised controlled trial

BACKGROUND: Waiting lists for treatment are common in outpatient and community services, Existing methods for managing access and triage to these services can lead to inequities in service delivery, inefficiencies and divert resources from frontline care. Evidence from two controlled studies indicates that an alternative to the traditional "waitlist and triage" model known as STAT (Specific Timely Appointments for Triage) may be successful in reducing waiting times without adversely affecting other aspects of patient care. This trial aims to test whether the model is cost effective in reducing waiting time across multiple services, and to measure the impact on service provision, health-related quality of life and patient satisfaction.

METHODS/DESIGN: A stepped wedge cluster randomised controlled trial has been designed to evaluate the impact of the STAT model in 8 community health and outpatient services. The primary outcome will be waiting time from referral to first appointment. Secondary outcomes will be nature and quantity of service received (collected from all patients attending the service during the study period and health-related quality of life (AQOL-8D), patient satisfaction, health care utilisation and cost data (collected from a subgroup of patients at initial assessment and after 12 weeks). Data will be analysed with a multiple multi-level random-effects regression model that allows for cluster effects. An economic evaluation will be undertaken alongside the clinical trial.

DISCUSSION: This paper outlines the study protocol for a fully powered prospective stepped wedge cluster randomised controlled trial (SWCRCT) to establish whether the STAT model of access and triage can reduce waiting times applied across multiple settings, without increasing health service costs or adversely impacting on other aspects of patient care. If successful, it will provide evidence for the effectiveness of a practical model of access that can substantially reduce waiting time for outpatient and community services with subsequent benefits for both efficiency of health systems and patient care.

Trial for reducing weight retention in new mums: a randomised controlled trial evaluating a low intensity, postpartum weight management programme

BACKGROUND: Failure to return to pregnancy weight by 6 months postpartum is associated with long-term obesity, as well as adverse health outcomes. This research evaluated a postpartum weight management programme for women with a body mass index (BMI) > 25 kg m(-2) that combined behaviour change principles and a low-intensity delivery format with postpartum nutrition information. METHODS: Women were randomised at 24-28 weeks to control (supported care; SC) or intervention (enhanced care; EC) groups, stratified by BMI cohort. At 36 weeks of gestation, SC women received a 'nutrition for breastfeeding' resource and EC women received a nutrition assessment and goal-setting session about post-natal nutrition, plus a 6-month correspondence intervention requiring return of self-monitoring sheets. Weight change, anthropometry, diet, physical activity, breastfeeding, fasting glucose and insulin measures were assessed at 6 weeks and 6 months postpartum. RESULTS: Seventy-seven percent (40 EC and 41 SC) of the 105 women approached were recruited; 36 EC and 35 SC women received a programme and 66.7% and 48.6% completed the study, respectively. No significant differences were observed between any outcomes. Median [interquartile range (IQR)] weight change was EC: -1.1 (9.5) kg versus SC: -1.1 (7.5) kg (6 weeks to 6 months) and EC: +1.0 (8.7) kg versus SC: +2.3 (9) kg (prepregnancy to 6 months). Intervention women breastfed for half a month longer than control women (180 versus 164 days; P = 0.10). An average of 2.3 out of six activity sheets per participant was returned. CONCLUSIONS: Despite low intervention engagement, the high retention rate suggests this remains an area of interest to women. Future strategies must facilitate women's engagement, be individually tailored, and include features that support behaviour change to decrease women's risk of chronic health issues.

Randomised controlled trial of a digitally assisted low intensity intervention to promote personal recovery in persisting psychosis: SMART-Therapy study protocol

BACKGROUND: Psychosocial interventions have an important role in promoting recovery in people with persisting psychotic disorders such as schizophrenia. Readily available, digital technology provides a means of developing therapeutic resources for use together by practitioners and mental health service users. As part of the Self-Management and Recovery Technology (SMART) research program, we have developed an online resource providing materials on illness self-management and personal recovery based on the Connectedness-Hope-Identity-Meaning-Empowerment (CHIME) framework. Content is communicated using videos featuring persons with lived experience of psychosis discussing how they have navigated issues in their own recovery. This was developed to be suitable for use on a tablet computer during sessions with a mental health worker to promote discussion about recovery.

METHODS/DESIGN: This is a rater-blinded randomised controlled trial comparing a low intensity recovery intervention of eight one-to-one face-to-face sessions with a mental health worker using the SMART website alongside routine care, versus an eight-session comparison condition, befriending. The recruitment target is 148 participants with a schizophrenia-related disorder or mood disorder with a history of psychosis, recruited from mental health services in Victoria, Australia. Following baseline assessment, participants are randomised to intervention, and complete follow up assessments at 3, 6 and 9 months post-baseline. The primary outcome is personal recovery measured using the Process of Recovery Questionnaire (QPR). Secondary outcomes include positive and negative symptoms assessed with the Positive and Negative Syndrome Scale, subjective experiences of psychosis, emotional symptoms, quality of life and resource use. Mechanisms of change via effects on self-stigma and self-efficacy will be examined.

DISCUSSION: This protocol describes a novel intervention which tests new therapeutic methods including in-session tablet computer use and video-based peer modelling. It also informs a possible low intensity intervention model potentially viable for delivery across the mental health workforce.