Randomized clinical trial of the timing it right stroke family support program: Research protocol

Background Family caregivers provide invaluable support to stroke survivors during their recovery, rehabilitation, and community re-integration. Unfortunately, it is not standard clinical practice to prepare and support caregivers in this role and, as a result, many experience stress and poor health that can compromise stroke survivor recovery and threaten the sustainability of keeping the stroke survivor at home. We developed the Timing it Right Stroke Family Support Program (TIRSFSP) to guide the timing of delivering specific types of education and support to meet caregivers' evolving needs. The objective of this multi-site randomized controlled trial is to determine if delivering the TIRSFSP across the stroke care continuum improves caregivers' sense of being supported and emotional well-being. Methods/design Our multi-site single-blinded randomized controlled trial will recruit 300 family caregivers of stroke survivors from urban and rural acute care hospitals. After completing a baseline assessment, participants will be randomly allocated to one of three groups: 1) TIRSFSP guided by a stroke support person (health care professional with stroke care experience), delivered in-person during acute care and by telephone for approximately the first six to 12 months post-stroke; 2) caregiver self-directed TIRSFSP with an initial introduction to the program by a stroke support person, or; 3) standard care receiving the educational resource "Let's Talk about Stroke" prepared by the Heart and Stroke Foundation. Participants will complete three follow-up quantitative assessments 3, 6, and 12-months post-stroke. These include assessments of depression, social support, psychological well-being, stroke knowledge, mastery (sense of control over life), caregiving assistance provided, caregiving impact on everyday life, and indicators of stroke severity and disability. Qualitative methods will also be used to obtain information about caregivers' experiences with the education and support received and the impact on caregivers' perception of being supported and emotional well-being. Discussion This research will determine if the TIRSFSP benefits family caregivers by improving their perception of being supported and emotional well-being. If proven effective, it could be recommended as a model of stroke family education and support that meets the Canadian Stroke Best Practice Guideline recommendation for providing timely education and support to families through transitions.

A crop productivity research protocol for long wall mining

Springsure Creek Coal (SCC) intends to develop a coal mine using the long wall mining process under grain farming land near Emerald in Central Queensland (CQ). While this technology will result in some subsidence of the land surface, SCC wishes to maintain productivity of the grain cropping land in the precinct after coal mining. However, the impact of the surface subsidence resulting from that mining process on productivity of cropping land in any Australian landscape is currently unclear. A research protocol to investigate the impacts of subsidence on grain productivity for when the SCC project becomes operational is proposed. The protocol has wider application for other similar mining projects throughout the country. A copy of the full report is accessible on www.aginstitute.com.au.

Efficacy of a cognitive and behavioural psychotherapy applied by primary care psychologists in patients with mixed anxiety-depressive disorder: a research protocol

Background: In contrast with the recommendations of clinical practice guidelines, the most common treatment for anxiety and depressive disorders in primary care is pharmacological. The aim of this study is to assess the efficacy of a cognitive-behavioural psychological intervention, delivered by primary care psychologists in patients with mixed anxiety-depressive disorder compared to usual care. Methods/Design: This is an open-label, multicentre, randomized, and controlled study with two parallel groups. A random sample of 246 patients will be recruited with mild-to-moderate mixed anxiety-depressive disorder, from the target population on the lists of 41 primary care doctors. Patients will be randomly assigned to the intervention group, who will receive standardised cognitive-behavioural therapy delivered by psychologists together with usual care, or to a control group, who will receive usual care alone. The cognitive-behavioural therapy intervention is composed of eight individual 60-minute face-to face sessions conducted in eight consecutive weeks. A follow-up session will be conducted over the telephone, for reinforcement or referral as appropriate, 6 months after the intervention, as required. The primary outcome variable will be the change in scores on the Short Form-36 General Health Survey. We will also measure the change in the frequency and intensity of anxiety symptoms (State-Trait Anxiety Inventory) and depression (Beck Depression Inventory) at baseline, and 3, 6 and 12 months later. Additionally, we will collect information on the use of drugs and health care services. Discussion: The aim of this study is to assess the efficacy of a primary care-based cognitive-behavioural psychological intervention in patients with mixed anxiety-depressive disorder. The international scientific evidence has demonstrated the need for psychologists in primary care. However, given the differences between health policies and health services, it is important to test the effect of these psychological interventions in our geographical setting.

A randomized controlled trial of tea tree oil (5%) body wash versus standard body wash to prevent colonization with methicillin-resistant Staphylococcus aureus (MRSA) in critically ill adults: research protocol

Background
Over the past ten years MRSA has become endemic in hospitals and is associated with increased healthcare costs. Critically ill patients are most at risk, in part because of the number of invasive therapies that they require in the intensive care unit (ICU). Washing with 5% tea tree oil (TTO) has been shown to be effective in removing MRSA on the skin. However, to date, no trials have evaluated the potential of TTO body wash to prevent MRSA colonization or infection. In addition, detecting MRSA by usual culture methods is slow. A faster method using a PCR assay has been developed in the laboratory, but requires evaluation in a large number of patients.

Methods/Design
This study protocol describes the design of a multicentre, phase II/III prospective open-label randomized controlled clinical trial to evaluate whether a concentration of 5% TTO is effective in preventing MRSA colonization in comparison with a standard body wash (Johnsons Baby Softwash) in the ICU. In addition we will evaluate the cost-effectiveness of TTO body wash and assess the effectiveness of the PCR assay in detecting MRSA in critically ill patients. On admission to intensive care, swabs from the nose and groin will be taken to screen for MRSA as per current practice. Patients will be randomly assigned to be washed with the standard body wash or TTO body wash. On discharge from the unit, swabs will be taken again to identify whether there is a difference in MRSA colonization between the two groups.

Discussion
If TTO body wash is found to be effective, widespread implementation of such a simple colonization prevention tool has the potential to impact on patient outcomes, healthcare resource use and patient confidence both nationally and internationally.

Trial Registration
[ISRCTN65190967]

Research Protocol: A Randomized Controlled Trial of Functional Family Therapy: An Early Intervention Foundation (EIF) Partnership between Croydon Council and Queen's University Belfast

The paper presents a protocol for ‘A Randomized Controlled Trial of Functional Family Therapy (FFT): An Early Intervention Foundation (EIF) Partnership between Croydon Council and Queen's University Belfast’. The protocol describes a trial that uses FFT as an alternative intervention to current use of the youth justice system and local authority care with the aim of reducing crime/recidivism in young people referred to Croydon Council. The trial will take place over a period of 36 months and will involve up to 154 families. Croydon Council will employ a team of five Functional Family Therapists who will work with families to promote effective outcomes. The Centre for Effective Education at Queen’s University Belfast will act as independent evaluators of outcomes for families and young people. The work is supported from the United Kingdom Economic & Social Research Council/Early Intervention Foundation Grant Number ES/M006921/1.

A realistic evaluation of track and trigger systems and acute care training for early recognition and treatment of deteriorating ward-based patients: research protocol.

Aim The aim of the study is to evaluate factors that enable or constrain the implementation and service delivery of early warnings systems or acute care training in practice. Background To date there is limited evidence to support the effectiveness of acute care initiatives (early warning systems, acute care training, outreach) in reducing the number of adverse events (cardiac arrest, death, unanticipated Intensive Care admission) through increased recognition and management of deteriorating ward based patients in hospital [1-3]. The reasons posited are that previous research primarily focused on measuring patient outcomes following the implementation of an intervention or programme without considering the social factors (the organisation, the people, external influences) which may have affected the process of implementation and hence measured end-points. Further research which considers the social processes is required in order to understand why a programme works, or does not work, in particular circumstances [4]. Method The design is a multiple case study approach of four general wards in two acute hospitals where Early Warning Systems (EWS) and Acute Life-threatening Events Recognition and Treatment (ALERT) course have been implemented. Various methods are being used to collect data about individual capacities, interpersonal relationships and institutional balance and infrastructures in order to understand the intended and unintended process outcomes of implementing EWS and ALERT in practice. This information will be gathered from individual and focus group interviews with key participants (ALERT facilitators, nursing and medical ALERT instructors, ward managers, doctors, ward nurses and health care assistants from each hospital); non-participant observation of ward organisation and structure; audit of patients' EWS charts and audit of the medical notes of patients who deteriorated during the study period to ascertain whether ALERT principles were followed. Discussion & progress to date This study commenced in January 2007. Ethical approval has been granted and data collection is ongoing with interviews being conducted with key stakeholders. The findings from this study will provide evidence for policy-makers to make informed decisions regarding the direction for strategic and service planning of acute care services to improve the level of care provided to acutely ill patients in hospital. References 1. Esmonde L, McDonnell A, Ball C, Waskett C, Morgan R, Rashidain A et al. Investigating the effectiveness of Critical Care Outreach Services: A systematic review. Intensive Care Medicine 2006; 32: 1713-1721 2. McGaughey J, Alderdice F, Fowler R, Kapila A, Mayhew A, Moutray M. Outreach and Early Warning Systems for the prevention of Intensive Care admission and death of critically ill patients on general hospital wards. Cochrane Database of Systematic Reviews 2007, Issue 3. www.thecochranelibrary.com 3. Winters BD, Pham JC, Hunt EA, Guallar E, Berenholtz S, Pronovost PJ (2007) Rapid Response Systems: A systematic review. Critical Care Medicine 2007; 35 (5): 1238-43 4. Pawson R and Tilley N. Realistic Evaluation. London; Sage: 1997

Tweet reach : a research protocol for using Twitter to increase information exchange in people with communication disabilities

Objective: To (a) outline the background to research evaluating Twitter use by people with severe physical and communication disabilities participating actively in online communication forums for increasing information exchange and (b) illustrate a range of potential methods that might be applied in furthering research on the use of social media by people with developmental and acquired communication disabilities. Methods: The literature on communication disabilities, augmentative and alternative communication, and social media research informed the rationale for and design of three studies investigating the use of Twitter by people with communication disabilities. Results: To date, there is little information in the literature about how people with a range of communication disabilities might use Twitter to increase their access to information and help them to feel knowledgeable and in control of their own lives. In this paper, three studies are proposed to investigate the use of Twitter by people with communication disabilities.

A standartized research protocol for platelet-rich plasma (PRP) preparation in rats

Introduction: The urgent need for studies using standardized protocols to evaluate the real biological effects of PRP has been emphasized by several authors. Objective: The purpose of this study was to standardize a methodology for autologous Platelet-Rich Plasma (PRP) preparation in rats. Material and methods: Twentyfour, 5 to 6-month-old, male rats, weighing 450 to 500 g were used. After general anesthesia, 3.15 ml of blood was collected from each animal, via cannulation of the jugular vein. A standardized technique of double centrifugation was used to prepare PRP. PRP samples and peripheral blood platelets were then manually counted using a Neubauer chamber. Student’s t-test was used to compare the differences between the number of platelets in peripheral blood and PRP samples (p < 0.05). In addition, PRP and peripheral blood smears were stained to see platelets’ morphology. Results: All surgical procedures were well tolerated by the animals and they were healthy during the entire experimental period. PRP samples showed higher significantly platelet concentrations than peripheral blood samples (2,677,583 and 683,680 respectively). Conclusion: Within the limits of this study, it can be concluded that the method used produced autologous PRP with appropriated platelet quantity and quality, in rats.

Benefits and resource implications of family meetings for hospitalized palliative care patients: research protocol.

BACKGROUND:
Palliative care focuses on supporting patients diagnosed with advanced, incurable disease; it is 'family centered', with the patient and their family (the unit of care) being core to all its endeavours. However, approximately 30-50% of carers experience psychological distress which is typically under recognised and consequently not addressed. Family meetings (FM) are recommended as a means whereby health professionals, together with family carers and patients discuss psychosocial issues and plan care; however there is minimal empirical research to determine the net effect of these meetings and the resources required to implement them systematically. The aims of this study were to evaluate: (1) if family carers of hospitalised patients with advanced disease (referred to a specialist palliative care in-patient setting or palliative care consultancy service) who receive a FM report significantly lower psychological distress (primary outcome), fewer unmet needs, increased quality of life and feel more prepared for the caregiving role; (2) if patients who receive the FM experience appropriate quality of end-of-life care, as demonstrated by fewer hospital admissions, fewer emergency department presentations, fewer intensive care unit hours, less chemotherapy treatment (in last 30 days of life), and higher likelihood of death in the place of their choice and access to supportive care services; (3) the optimal time point to deliver FM and; (4) to determine the cost-benefit and resource implications of implementing FM meetings into routine practice.
METHODS:
Cluster type trial design with two way randomization for aims 1-3 and health economic modeling and qualitative interviews with health for professionals for aim 4.
DISCUSSION:
The research will determine whether FMs have positive practical and psychological impacts on the family, impacts on health service usage, and financial benefits to the health care sector. This study will also provide clear guidance on appropriate timing in the disease/care trajectory to provide a family meeting.

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.

Research protocol for a digital intervention to reduce stigma among males with a personal experience of suicide in the Australian farming community

BACKGROUND: Australian farming communities have up to twice the suicide rate of the general population. Men, particularly, demonstrate debilitating self- and perceived-stigma associated with an experience of suicide. The Ripple Effect is aimed to reduce suicide stigma within the social, cultural, geographical and psychological contexts in which it occurs.

METHODS: A mixed-method design with multi-level evaluation will be effected following the development and delivery of a personalised website experience (combining shared stories, education, personal goal setting and links to resources) to farming men, aged 30-64 years, with an experience of suicide. Pre- and post-surveys will be used to assess changes in self- and perceived-stigma and suicide literacy. Online feedback from participants and semi-structured interviews during follow-up will be thematically analysed.

DISCUSSION: This project will provide information about increasingly accessible, innovative approaches to reducing the debilitating health and wellbeing effects of suicide stigma on a population of Australia's farmers.

TRIAL REGISTRATION: This research protocol was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR) (ACTRN: ACTRN12616000289415 ) on 7(th) March, 2016.

The use of participant-observation protocol in an industrial engineering research

Based on literature, this article aims to present the "participant-observation" research protocol, and its practical application in the industrial engineering field, more specifically within the area of design development, and in the case shown by this article, of interiors' design. The main target is to identify the concept of the method, i.e., from its characteristics to structure a general sense about the subject, so that the protocol can be used in different areas of knowledge, especially those ones which are committed with the scientific research involving the expertise from researchers, and subjective feelings and opinions of the users of an engineering product, and how this knowledge can be benefic for product design, contributing since the earliest stage of design.