983 resultados para service trial
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Abstract Background: Depression is highly prevalent within individuals diagnosed with schizophrenia, and is associated with an increased risk of suicide. There are no current evidence based treatments for low mood within this group. The specific targeting of co-morbid conditions within complex mental health problems lends itself to the development of short-term structured interventions which are relatively easy to disseminate within health services. A brief cognitive intervention based on a competitive memory theory of depression, is being evaluated in terms of its effectiveness in reducing depression within this group. Methods/Design: This is a single blind, intention-to-treat, multi-site, randomized controlled trial comparing Positive Memory Training plus Treatment as Usual with Treatment as Usual alone. Participants will be recruited from two NHS Trusts in Southern England. In order to be eligible, participants must have a DSM-V diagnosis of schizophrenia or schizo-affective disorder and exhibit at least a mild level of depression. Following baseline assessment eligible participants will be randomly allocated to either the Positive Memory Training plus Treatment as Usual group or the Treatment as Usual group. Outcome will be assessed at the end of treatment (3-months) and at 6-month and 9-month post randomization by assessors blind to group allocation. The primary outcome will be levels of depression and secondary outcomes will be severity of psychotic symptoms and cost-effectiveness. Semi-structured interviews will be conducted with all participants who are allocated to the treatment group so as to explore the acceptability of the intervention. Discussion: Cognitive behaviour therapy is recommended for individuals diagnosed with schizophrenia. However, the number of sessions and length of training required to deliver this intervention has caused a limit in availability. The current trial will evaluate a short-term structured protocol which targets a co-morbid condition often considered of primary importance by service users. If successful the intervention will be an important addition to current initiatives aimed at increasing access to psychological therapies for people diagnosed with severe mental health problems. Trial registration: Current Controlled Trials. ISRCTN99485756. Registered 13 March 2014.
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The World Health Organisation suggests that simplification of the medical abortion regime will contribute to an increased acceptability of medical abortion, among women as well as providers. It is expected that a home-based follow-up after a medical abortion will increase the willingness to opt for medical abortion as well as decrease the workload and service costs in the clinic. Trial design The study is a randomised, controlled, non-superiority trial . Methods Women screened to participate in the study are those with unwanted pregnancies and gestational ages equal to or less than nine weeks. Eligible women randomised to the home-based assessment group will use a low-sensitivity pregnancy test and a pictorial instruction sheet at home, while the women in the clinic follow-up group will return to the clinic for routine follow-up carried out by a doctor. The primary objective of the study is to evaluate the effectiveness of home-based assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet 10-14 days after an early medical abortion. Providers or research assistants will not be blinded during outcome assessment. To ensure feasibility of the self-assessment intervention an adaption phase took place at the selected study sites before study initiation. This was to optimise and tailor-make the intervention and the study procedures and resulted in the development of the pictorial instruction sheet for how to use the low-sensitivity pregnancy test and the danger signs after a medical abortion. Discussion In this paper, we will describe the study protocol for a randomised control trial investigating the efficacy of simplified follow-up in terms of home-based assessment, 10-14 days after a medical abortion. Moreover, a description of the adaptation phase is included for a better understanding of the implementation of the intervention in a setting where literacy is low and the road-connections are poor. Trial registration: Clinicaltrials.gov NCT01827995. Registered 04 May 2013
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Objective: To evaluate the use of a standard pen-and-paper test versus the use of a checklist for the early identification of women at risk of postpartum depression and to investigate the experiences of nurses in using the checklist.
Design: A prospective cohort design using repeated measures.
Setting: The booking-in prenatal clinic at a regional hospital in Victoria, Australia, and the community-based postpartum maternal and child health service.
Participants: 107 pregnant women over 20 years of age.
Main Measures: Postpartum Depression Prediction Inventory (PDPI), Postpartum Depression Screening Scale (PDSS), Edinburgh Postnatal Depression Scale (EPDS), demographic questionnaire, and data on the outcome from the midwives and nurses.
Results: The PDPI identified 45% of the women at risk of depression during pregnancy and 30% postpartum. The PDSS and EPDS both identified the same 8 women (10%), who scored highly for depression at the 8-week postpartum health visit. Nurses provided 80% of the women with anticipatory guidance on postpartum depression in the prenatal period and 46% of women at the 8-week postpartum health visit. Nurse counseling or anticipatory guidance was provided for 60% of the women in the prenatal period.
Conclusion: The PDPI was found to be a valuable checklist by many nurses involved in this research, particularly as a way of initiating open discussion with women about postpartum depression. It correlated strongly with both the PDSS and the EPDS, suggesting that it is useful as an inventory to identify women at risk of postpartum depression.
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Aims. The aim of this paper is to report a trial to investigate the feasibility of the nurse practitioner role in local health service delivery and to provide information about the educational and legislative requirements for nurse practitioner practice.
Background. Nurse practitioners have been shown to offer a beneficial service and fill a gap in health care provision. However, the lack of publications describing, critiquing, or defending the way that existing nurse practitioner roles have been developed may lead to a lack of clarity in comparing the nurse practitioner scope of practice internationally. In Australia, credible exploratory research is needed to realize the potential of nurse practitioners to bridge the divide of inequitable distribution of health services. A trial of nurse practitioner services in the Australian Capital Territory provided an excellent opportunity to investigate these scope and continuity issues.
Methods. This was an observational analytic study using multiple data sources. Four models of nurse practitioner service were chosen from a competitive field of applications that were evaluated according to efficacy, feasibility, and sustainability across specified selection criteria. Each model in the trial included a clinical support team, with the nurse practitioner candidate 'working-into-the-role' and collecting demographic, clinical practice, patient outcome, and health service and consumer survey data over a 10 month period.
Findings. The trial identified the broad potential of the nurse practitioner role, its breadth and limitations, and its impact on selected health services in the Australian Capital Territory. Data from individual models were compared highlighting generic elements, and formed the basis for the development of the scope of practice for the Australian Capital Territory nurse practitioner models.
Conclusions. This study has validated a research-based, iterative process for initial development of nurse practitioner scope of practice for any Australian specialization. Importantly, the study concluded with the scope of practice as a finding, rather than commencing with it a priori. Although general areas of health care need and under-servicing were identified at the outset, the process tested both the expansion and parameters of the roles.
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Aims. The development of acceptable, widely available and effective smoking cessation methods is central to public health strategy for tobacco control. We examined the effectiveness of a telephone callback counselling intervention, compared to the provision of self-help resources alone.
Methods. Participants were 998 smokers calling a state-wide "Quitline" service randomly allocated to either callback counselling or ordinary care. The callback condition consisted of a series of brief counselling calls at strategic times in addition to ordinary care. The number of calls varied according to caller needs, and most occurred generally just before the person's quit day and in the week or two after it. The service was delivered by trained telephone counsellors.
Results. At the 3-month follow-up, significantly more participants in the callback group (24%) reported that they were quit, compared to those in the usual care comparison group (13%). The difference in point prevalence of smoking declined to 6% by the 12-month follow-up. Using sustained abstinence there was a significant benefit of callback counselling at 12-month follow-up. Treating dropouts as smokers reduced the overall magnitude of the effects somewhat. The benefit of callbacks was to marginally increase quit attempts and to significantly reduce relapse.
Conclusion. Our findings are consistent with those of other studies demonstrating benefits of callback telephone counselling to facilitate cessation. Such counselling provides a flexible, relatively inexpensive and widely available form of cessation service. It appears to encourage a greater proportion of quit attempts and to reduce the rate of relapse among those quitting. Further research is required to determine ways to enhance effectiveness, particularly studies of how to reduce relapse.
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Aim To assess the effectiveness of a program of computer-generated tailored advice for callers to a telephone helpline, and to assess whether it enhanced a series of callback telephone counselling sessions in aiding smoking cessation.
Design Randomized controlled trial comparing: (1) untailored self-help materials; (2) computer-generated tailored advice only, and (3) computer-generated tailored advice plus callback telephone counselling. Assessment surveys were conducted at baseline, 3, 6 and 12 months.
Setting Victoria, Australia.
Participants A total of 1578 smokers who called the Quitline service and agreed to participate.
Measurements Smoking status at follow-up; duration of cessation, if quit; use of nicotine replacement therapy; and extent of participation in the callback service.
Findings At the 3-month follow-up, significantly more (χ2(2) = 16.9; P < 0.001) participants in the computer-generated tailored advice plus telephone counselling condition were not smoking (21%) than in either the computer-generated advice only (12%) or the control condition (12%). Proportions reporting not smoking at the 12-month follow-up were 26%, 23% and 22%, respectively (NS) for point prevalence, and for 9 months sustained abstinence; 8.2, 6.0, and 5.0 (NS). In the telephone counselling group, those receiving callbacks were more likely than those who did not to have sustained abstinence at 12 months (10.2 compared with 4.0, P < 0.05). Logistic regression on 3-month data showed significant independent effects on cessation of telephone counselling and use of NRT, but not of computer-generated tailored advice.
Conclusion Computer-generated tailored advice did not enhance telephone counselling, nor have any independent effect on cessation. This may be due to poor timing of the computer-generated tailored advice and poor integration of the two modes of advice.
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Objective: The aim of the present study was to assess the impact of attending targeted clinical education on borderline personality disorder on the attitudes of health clinicians towards working with deliberate self-harm behaviours commonly exhibited by patients diagnosed with this complex disorder. Comparisons of clinicians across service settings, occupational fields, and other demographic areas were also made.
Method: A purpose-designed demographic questionnaire and the Attitudes Towards Deliberate Self-Harm Questionnaire were used to collect the demographic information and assess the attitudes of 99 mental health and emergency medicine practitioners across two Australian health services and a New Zealand health service, both before and after education attendance.
Results: Statistically significant improvements in attitude ratings were found for both emergency medicine clinicians and mental health clinicians in working with deliberate self-harm behaviours in borderline personality disorder, following attendance at the education program with a medium affect size (t(32)=−3.45, p=0.002, d=0.43 and t(65)=−5.12, p=0.000, d=0.42, respectively). Clinicians across occupational areas of nursing, allied health, and medical fields demonstrated equivocal levels of improvement in their attitude ratings.
Conclusions: Results are discussed in terms of the necessity of providing regular access to targeted clinical education for health professionals working with patients diagnosed with borderline personality disorder.
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This paper describes the development and validation of bicultural clinical indicators that measure achievement of mental health nursing practice standards in New Zealand (ANZMCHN, 1995, Standards of practice for mental health nursing in New Zealand. ANZCMHN, Greenacres). A four-stage research design was utilised including focus groups, Delphi surveys, a pilot, and a national field study, with mental health nurses and consumers as participants. During the national field study, consumer files (n=327) from 11 District Health Boards, and registered nurses (n=422) completed an attitude questionnaire regarding the regularity of specific nursing and service activities. Results revealed a variation in the mean occurrence of the clinical indicators in consumer case notes of 18.5–89.9%. Five factors with good internal consistency, encompassing domains of mental health nursing required for best practice, were derived from analysis of the questionnaire. This study presents a research framework for developing culturally and clinically valid, reliable measures of clinical practice.
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Background
Recognition of the importance of the early years in determining health and educational attainment and promotion of the World Health Organization Health for All (HFA) principles has led to an international trend towards community-based initiatives to improve developmental outcomes among socio-economically disadvantaged children. In this study we examine whether, Best Start, an Australian area-based initiative to improve child health was effective in improving access to Maternal and Child Health (MCH) services.
Methods
The study compares access to information, parental confidence and annual 3.5 year Ages and Stages visiting rates before (2001/02) and after (2004/05) the introduction of Best Start. Access to information and parental confidence were measured in surveys of parents with 3 year old children. There were 1666 surveys in the first wave and 1838 surveys in the second wave. The analysis of visiting rates for the 3.5 year Ages and Stages visit included all eligible Victorian children. Best Start sites included 1,739 eligible children in 2001/02 and 1437 eligible children in 2004/05. The comparable figures in the rest of the state were and 45, 497 and 45, 953 respectively.
Results
There was a significant increase in attendance at the 3.5 year Ages and Stages visit in 2004/05 compared to 2001/02 in all areas. However the increase in attendance was significantly greater at Best Start sites than the rest of the state. Access to information and parental confidence improved over the course of the intervention in Best Start sites with MCH projects compared to other Best Start sites.
Conclusion
These results suggest that community-based initiatives in disadvantaged areas may improve parents' access to child health information, improve their confidence and increase MCH service use. These outcomes suggest such programmes could potentially contribute to strategies to reduce child health inequalities.
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Background Self-management is seen as a primary mechanism to support the optimization of care for people with chronic diseases such as symptomatic vascular disease. There are no established and evidence-based stroke-specific chronic disease self-management programs. Our aim is to evaluate whether a stroke-specific program is safe and feasible as part of a Phase II randomized-controlled clinical trial.
Methods Stroke survivors are recruited from a variety of sources including: hospital stroke services, local paper advertisements, Stroke South Australia newsletter (volunteer peer support organization), Divisions of General Practice, and community service providers across Adelaide, South Australia. Subjects are invited to participate in a multi-center, single-blind, randomized, controlled trial. Eligible participants are randomized to either;
• standard care,
• standard care plus a six week generic chronic condition self-management group education program, or,
• standard care plus an eight week stroke specific self-management education group program.
Interventions are conducted after discharge from hospital. Participants are assessed at baseline, immediate post intervention and six months.
Study Outcomes The primary outcome measures determine study feasibility and safety, measuring, recruitment, participation, compliance and adverse events.
Secondary outcomes include:
• positive and active engagement in life measured by the Health Education Impact Questionnaire,
• improvements in quality of life measured by the Assessment of Quality of Life instrument,
• improvements in mood measured by the Irritability, Depression and Anxiety Scale,
• health resource utilization measured by a participant held diary and safety.
Conclusion The results of this study will determine whether a definitive Phase III efficacy trial is justified.
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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
Resumo:
Background: The World Health Organization predicts that by 2030 internalising problems (e.g. depression and anxiety) will be second only to HIV/AIDS in international burden of disease. Internalising problems affect 1 in 7 school aged children, impacting on peer relations, school engagement, and later mental health, relationships and employment. The development of early childhood prevention for internalising problems is in its infancy. The current study follows two successful ‘efficacy’ trials of a parenting group intervention to reduce internalising disorders in temperamentally inhibited preschool children. Cool Little Kids is a population-level randomised trial to determine the impacts of systematically screening preschoolers for inhibition then offering a parenting group intervention, on child internalising problems and economic costs at school entry.
Methods/Design: This randomised trial will be conducted within the preschool service system, attended by more than 95% of Australian children in the year before starting school. In early 2011, preschool services in four local government areas in Melbourne, Australia, will distribute the screening tool. The ≈16% (n≈500) with temperamental inhibition will enter the trial. Intervention parents will be offered Cool Little Kids, a 6-session group program in the local community, focusing on ways to develop their child’s bravery skills by reducing overprotective parenting interactions. Outcomes one and two years post-baseline will comprise child internalising diagnoses and symptoms, parenting interactions, and parent wellbeing. An economic evaluation (costconsequences framework) will compare incremental differences in costs of the intervention versus control children to incremental differences in outcomes, from a societal perspective. Analyses will use the intention-to-treat principle, using logistic and linear regression models (binary and continuous outcomes respectively) to compare outcomes between the trial arms.
Discussion: This trial addresses gaps for internalising problems identified in the 2004 World Health Organization Prevention of Mental Disorders report. If effective and cost-effective, the intervention could readily be applied at a population level. Governments consider mental health to be a priority, enhancing the likelihood that an effective early prevention program would be adopted in Australia and internationally.
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Background: Low academic achievement is common and is associated with adverse outcomes such as grade repetition, behavioural disorders and unemployment. The ability to accurately identify these children and intervene before they experience academic failure would be a major advance over the current ‘wait to fail’ model. Recent research suggests that a possible modifiable factor for low academic achievement is working memory, the ability to temporarily store and manipulate information in a ‘mental workspace’. Children with working memory difficulties are at high risk of academic failure. It has recently been demonstrated that working memory can be improved with adaptive training tasks that encourage improvements in working memory capacity. Our trial will determine whether the intervention is efficacious as a selective prevention strategy for young children at risk of academic difficulties and is cost-effective.
Methods/Design: This randomised controlled trial aims to recruit 440 children with low working memory after a school-based screening of 2880 children in Grade one. We will approach caregivers of all children from 48 participating primary schools in metropolitan Melbourne for consent. Children with low working memory will be randomised to usual care or the intervention. The intervention will consist of 25 computerised working memory training sessions, which take approximately 35 minutes each to complete. Follow-up of children will be conducted at 6, 12 and 24 months post-randomisation through child face-to-face assessment, parent and teacher surveys and data from government authorities. The primary outcome is academic achievement at 12 and 24 months, and other outcomes include child behaviour, attention, health-related quality of life, working memory, and health and educational service
utilisation.
Discussion: A successful start to formal learning in school sets the stage for future academic, psychological and economic well-being. If this preventive intervention can be shown to be efficacious, then we will have the potential to prevent academic underachievement in large numbers of at-risk children, to offer a ready-to-use intervention to the Australian school system and to build international research partnerships along the health education interface, in order to carry our further studies of effectiveness and generalisability.
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This paper reports on a small trial with 6 pre-service teachers who videoed their own teaching practices. The pre-service teachers used the tool to reflect on practice and to enhance their own understandings of themselves as teachers. The initial footage was used to by the pre-service teachers to gauge quite specific elements of their teaching: for example, were they asking effective questions, or were they responding appropriately to questions children asked and as always, what management strategies seemed to be working? Critical feedback from other students was initially „less than critical‟, but again over time, this also appeared to sharpen as they had more opportunity to use the technology. Initial embarrassment of being on screen was replaced with a professional approach to seeing the video as a tool for providing the opportunity to systematically deconstruct practices and for providing concrete feedback for improvement. Used in conjunction with teaching preparation courses, the videoed segments of teaching practice could be used to highlight exemplars, to show what actually happens in classrooms and to explain certain practices. Cunningham and Benedetto (2002) state “Recent developments in digital video technologies permit teacher candidates to collect, review, and manipulate video to demonstrate their growth as a professional and as a reflective practitioner.” However, in the development of the trial, the issue was raised by the pre-service teachers that they would be interested in keeping the videos as evidence of their teaching competence to be used in applications for teaching positions. In the small trial, ethics permission had not been gained for that to happen, but it is certainly a valid and viable possibility for the future. Currently prospective employers have to rely on paper applications which respond to selection criteria, evidence from pre-service teachers‟ teaching rounds and the subjective impressions of an interview. If students were able to present a 5 minute segment of them teaching, it might count for much more than any other evidence. Video capture of teaching practice would provide potential employers with an indication of a pre-service teacher‟s management strategies, relationships with children and a snapshot of a pre-service teacher‟s instructional practice. The idea of video-capture as a tool for pre-service teachers to illustrate teaching capabilities will be more fully investigated in this paper.
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Background
Reducing patient length of stay is a high priority for health service providers. Preliminary information suggests additional Saturday rehabilitation services could reduce the time a patient stays in hospital by three days. This large trial will examine if providing additional physiotherapy and occupational therapy services on a Saturday reduces health care costs, and improves the health of hospital inpatients receiving rehabilitation compared to the usual Monday to Friday service. We will also investigate the cost effectiveness and patient outcomes of such a service.
Methods/Design A randomised controlled trial will evaluate the effect of providing additional physiotherapy and occupational therapy for rehabilitation. Seven hundred and twelve patients receiving inpatient rehabilitation at two metropolitan sites will be randomly allocated to the intervention group or control group. The control group will receive usual care physiotherapy and occupational therapy from Monday to Friday while the intervention group will receive the same amount of rehabilitation as the control group Monday to Friday plus a full physiotherapy and occupational therapy service on Saturday. The primary outcomes will be patient length of stay, quality of life (EuroQol questionnaire), the Functional Independence Measure (FIM), and health utilization and cost data. Secondary outcomes will assess clinical outcomes relevant to the goals of therapy: the 10 metre walk test, the timed up and go test, the Personal Care Participation Assessment and Resource Tool (PC PART), and the modified motor assessment scale. Blinded assessors will assess outcomes at admission and discharge, and follow up data on quality of life, function and health care costs will be collected at 6 and 12 months after discharge. Between group differences will be analysed with analysis of covariance using baseline measures as the covariate. A health economic analysis will be carried out alongside the randomised controlled trial.
Discussion This paper outlines the study protocol for the first fully powered randomised controlled trial incorporating a health economic analysis to establish if additional Saturday allied health services for rehabilitation inpatients reduces length of stay without compromising discharge outcomes. If successful, this trial will have substantial health benefits for the patients and for organizations delivering rehabilitation services.
