Pragmatic randomised controlled trial of a personalised intervention for carers of people requiring home oxygen therapy.

We used a pragmatic randomised controlled trial to evaluate a behavioural change strategy targeting carers of chronically hypoxaemic patients using long-term home oxygen therapy. Intervention group carers participated in personalised educational sessions focusing on motivating carers to take actions to assist patients. All patients received usual care. Effectiveness was measured through a composite event of patient survival to hospitalisation, residential care admission or death to 12 months. Secondary outcomes at baseline, 3, 6 and 12 months included carer and patient emotional and physical well-being. No difference between intervention (n = 100) and control (n = 97) patients was found for the composite outcome (hazard ratio (HR) 1.22, 95% confidence interval (CI) = 0.89, 1.68; p = 0.22). Improved fatigue, mastery, vitality and general health occurred in intervention group patients (all p values < 0.05). No benefits were seen in carer outcomes. Mortality was significantly higher in intervention patients (HR = 2.01, 95% CI = 1.00, 4.14; p = 0.05; adjusted for Australia-modified Karnofsky Performance Status), with a significant diagnosis-intervention interaction (p = 0.028) showing higher mortality in patients with COPD (HR 4.26; 95% CI = 1.60, 11.35) but not those with interstitial lung disease (HR 0.83; 95% CI = 0.28, 2.46). No difference was detected in the primary outcome, but patient mortality was higher when carers had received the intervention, especially in the most disabled patients. Trials examining behavioural change interventions in severe disease should stratify for functionality, and both risks and benefits should be independently monitored. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12607000177459).

Which online format is most effective for assisting Baby Boomers to complete advance directives? A randomised controlled trial of email prompting versus online education module.

BACKGROUND: Completion of Advance Directives (ADs), being financial and healthcare proxy or instructional documents, is relatively uncommon in Australia. Efforts to increase completion rates include online education and prompting which past literature suggests may be effective. The aim of this randomized controlled trial was to assess computer-based online AD information and email prompting for facilitating completion of ADs by Australian Baby Boomers (b.1946-1965) as well as factors which may impede or assist completion of these documents by this generation when using the online environment. METHODS: Two hundred eighty-two men and women aged 49-68 years at the time of the trial were randomly assigned to one of 3 intervention groups: education module only; email prompt only; email prompt and education module; and a control group with no education module and no email prompt. The randomized controlled trial was undertaken in participants' location of choice. Randomization and allocation to trial group were carried out by a central computer system. The primary analysis was based on a final total of 189 participants who completed the trial (n = 52 education module only; n = 44 email prompt only; n = 46 email prompt and education module; and n = 47 control). The primary outcome was the number of individuals in any group completing any of the 4 legal ADs in South Australia within 12 months or less from entry into the trial. Frequency analysis was conducted on secondary outcomes such as reasons for non-completion. RESULTS: Mean follow-up post-intervention at 12 months showed that 7% of overall participants completed one or more of the 4 legal ADs but without significant difference between groups (delta = 1%, p = .48 Prompt/Non-Prompt groups, delta = 5%, p = .44 education/non-education groups). Reasons offered for non-completion were too busy (26%) and/or it wasn't the right time (21%). CONCLUSION: Our results suggest that neither email prompting nor provision of additional educational material online were sufficient to significantly impact AD completion rates for this generational cohort. Research with this cohort over longer periods of time exploring online preferences for engagement with ADs as they age may provide better insight into using this environment for ADs with this group. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12616000425493 .

Mothers after Gestational Diabetes in Australia (MAGDA): A Randomised Controlled Trial of a Postnatal Diabetes Prevention Program.

BACKGROUND: Gestational diabetes mellitus (GDM) is an increasingly prevalent risk factor for type 2 diabetes. We evaluated the effectiveness of a group-based lifestyle modification program in mothers with prior GDM within their first postnatal year. METHODS AND FINDINGS: In this study, 573 women were randomised to either the intervention (n = 284) or usual care (n = 289). At baseline, 10% had impaired glucose tolerance and 2% impaired fasting glucose. The diabetes prevention intervention comprised one individual session, five group sessions, and two telephone sessions. Primary outcomes were changes in diabetes risk factors (weight, waist circumference, and fasting blood glucose), and secondary outcomes included achievement of lifestyle modification goals and changes in depression score and cardiovascular disease risk factors. The mean changes (intention-to-treat [ITT] analysis) over 12 mo were as follows: -0.23 kg body weight in intervention group (95% CI -0.89, 0.43) compared with +0.72 kg in usual care group (95% CI 0.09, 1.35) (change difference -0.95 kg, 95% CI -1.87, -0.04; group by treatment interaction p = 0.04); -2.24 cm waist measurement in intervention group (95% CI -3.01, -1.42) compared with -1.74 cm in usual care group (95% CI -2.52, -0.96) (change difference -0.50 cm, 95% CI -1.63, 0.63; group by treatment interaction p = 0.389); and +0.18 mmol/l fasting blood glucose in intervention group (95% CI 0.11, 0.24) compared with +0.22 mmol/l in usual care group (95% CI 0.16, 0.29) (change difference -0.05 mmol/l, 95% CI -0.14, 0.05; group by treatment interaction p = 0.331). Only 10% of women attended all sessions, 53% attended one individual and at least one group session, and 34% attended no sessions. Loss to follow-up was 27% and 21% for the intervention and control groups, respectively, primarily due to subsequent pregnancies. Study limitations include low exposure to the full intervention and glucose metabolism profiles being near normal at baseline. CONCLUSIONS: Although a 1-kg weight difference has the potential to be significant for reducing diabetes risk, the level of engagement during the first postnatal year was low. Further research is needed to improve engagement, including participant involvement in study design; it is potentially more effective to implement annual diabetes screening until women develop prediabetes before offering an intervention. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12610000338066.

Use of advance directives by South Australians: results from the Health Omnibus Survey Spring 2012.

OBJECTIVE: To determine the prevalence of completion of advance directives (ADs) and wills by South Australians aged 15 years and over. DESIGN, SETTING AND PARTICIPANTS: Statewide population-based survey of a single member (aged 15 years and over) of 3055 South Australian households between 4 September and 12 December 2012. MAIN OUTCOME MEASURES: Prevalence and sociodemographic determinants of completion of the four recognised legal ADs in South Australia (enduring power of attorney [EPA] for finance, enduring power of guardianship [EPG] for health care/lifestyle, medical power of attorney [MPA] for medical treatment and anticipatory direction for end-of-life care) and wills. RESULTS: Nearly half the 3055 survey participants had not completed any AD document or will. Financial documents were more likely to be completed than health care documents. In multivariate analysis, the odds of not having completed any AD was higher among those aged 15-24 years compared with those aged over 65 years (odds ratio [OR], 55.3; 95% CI, 31.3-97.7) and 25-44 years (OR, 24.9; 95% CI, 17.3-36.1). Similarly, the odds were higher for those born in another country (OR, 2.0; 95% CI, 1.6-2.4); those never married (OR, 3.1; 95% CI, 2.3-4.2) or in de facto relationships (OR, 2.8; 95% CI, 2.1-3.8) or separated/divorced (OR, 1.8; 85% CI, 1.3-2.4) compared with those married; those who left school in Year 12 or before (OR, 1.5; 95% CI, 1.1-1.9) or with a bachelor degree (OR, 1.5; 95% CI, 1.1-2.0) compared with those who had completed a trade/apprenticeship, certificate/diploma; and those in blue collar occupations (OR 1.6; 95% CI, 1.3-2.2) or not employed (OR, 2.2; 95% CI, 1.4-3.6) versus professionals. The odds of not having completed any AD were lower for those living in rural or regional areas (OR, 0.8, 95% CI, 0.6-1.0) compared with the metropolitan area, and for those in the highest income bracket earning more than $80 000 (OR, 0.6; 95% CI, 0.5-0.8) compared with those in the middle bracket earning $40 000-$80 000. CONCLUSION: Completion rates of ADs among South Australians remain low, with financial instruments more likely to be completed than health care and lifestyle instruments. The odds of not completing ADs were associated with age and socioeconomic characteristics. General practitioners are in a good position to target advance care planning towards relevant patient groups, which would likely improve rates of decision making in future health care.

Searching MEDLINE for Aboriginal and Torres Strait Islander health literature: questionable sensitivity.

OBJECTIVE: The extent to which existing and future research can impact on reducing health disparities relates not only to the evidence available, but the ability to find that evidence. Our objective is to quantify experts' literature searching effectiveness with respect to Aboriginal and Torres Strait Islander people's health. METHODS: Nine journals were dual reviewed, and a 'gold standard' set of relevant articles was identified. Health librarians (n = 25) completed a standardised searching task using OVID MEDLINE, and results were compared with the gold standard. Sensitivity, specificity and precision rates were calculated. RESULTS: The gold standard comprised 136 of 1469 (9.3%) records from nine journals. Searches achieved a mean sensitivity of 53.2% (median = 64.7%, range 0.0-93.4%), specificity of 97.4% (median = 99.4%, range 52.6-100%) and precision of 83.3% (median = 91.0%, range 16.7-100%). Self-estimates of search sensitivity (post hoc) were significantly higher than observed (M = 78.9%, t = 4.812, P < 0.001). CONCLUSIONS: Even expert searchers struggle to find the relevant peer-reviewed literature in MEDLINE. IMPLICATIONS: A search filter may improve searching effectiveness for Aboriginal and Torres Strait Islander health literature. Assessment of health librarians' searching competencies warrants further professional debate and consideration.

The efficient price: an opportunity for funding reform.

OBJECTIVE: Proposed Australian healthcare reforms describe a move towards partial Commonwealth funding of public hospitals, whereby hospitals will be paid an 'efficient price' for each separation, incorporating both the costs and benefits of services. This paper describes a potential approach to setting the efficient price using risk adjusted cost-effectiveness (RAC-E) analysis. METHODS: RAC-E analysis uses a decision analytic framework to estimate lifetime costs and survival for individual patients, which are standardised by comparing observed and expected values. Analysis of standardised costs and effects at different hospitals identifies efficient hospitals, from which efficient prices can be defined. RESULTS: A RAC-E analysis of services for stroke patients at the four main public hospitals in South Australia demonstrates the need to account for costs and benefits in identifying efficient hospitals. The hospital with the best patient outcomes incurred additional costs relative to less effective hospitals. If an investment of AU$14760 to gain an additional life year in stroke patients is deemed to be a cost-effective use of resources, then the most effective hospital is also the most efficient hospital. CONCLUSIONS: The applied RAC-E analysis demonstrates a framework for comparing the economic efficiency of care provided at different hospitals, which provides a basis for defining the efficient price and appropriate funding incentives to achieve better patient outcomes.

Do doctors, nurses and managers have different thinking styles?

A study of the preferred thinking styles among senior health professionals is reported. A total of 49 medical consultants, 50 senior nurses and 53 health managers from two public teaching hospitals in Adelaide, Australia, were invited via a personal letter to complete a questionnaire comprising measures of thinking style (the Rational Experiential Inventory) and cognitive style (two dimensions of the Myers-Briggs Type Indicator). Managers reported a higher preference for 'rational' reasoning than nurses, whereas medical consultants reported a lower preference for 'experiential' reasoning than both managers and nurses. Cognitive style was largely homogenous. Although generalisation of the findings may be limited due to small sample sizes and the self-selection of participants, an understanding of the thinking styles of senior health professionals will likely inform the design and evaluation of future change strategies.

Measurement properties of the Inventory of Cognitive Bias in Medicine (ICBM).

BACKGROUND: Understanding how doctors think may inform both undergraduate and postgraduate medical education. Developing such an understanding requires valid and reliable measurement tools. We examined the measurement properties of the Inventory of Cognitive Bias in Medicine (ICBM), designed to tap this domain with specific reference to medicine, but with previously questionable measurement properties. METHODS: First year postgraduate entry medical students at Flinders University, and trainees (postgraduate doctors in any specialty) and consultants (N = 348) based at two teaching hospitals in Adelaide, Australia, completed the ICBM and a questionnaire measuring thinking styles (Rational Experiential Inventory). RESULTS: Questions with the lowest item-total correlation were deleted from the original 22 item ICBM, although the resultant 17 item scale only marginally improved internal consistency (Cronbach's alpha = 0.61 compared with 0.57). A factor analysis identified two scales, both achieving only alpha = 0.58. Construct validity was assessed by correlating Rational Experiential Inventory scores with the ICBM, with some positive correlations noted for students only, suggesting that those who are naïve to the knowledge base required to "successfully" respond to the ICBM may profit by a thinking style in tune with logical reasoning. CONCLUSION: The ICBM failed to demonstrate adequate content validity, internal consistency and construct validity. It is unlikely that improvements can be achieved without considered attention to both the audience for which it is designed and its item content. The latter may need to involve both removal of some items deemed to measure multiple biases and the addition of new items in the attempt to survey the range of biases that may compromise medical decision making.

Short-acting bronchodilators for the management of acute exacerbations of chronic obstructive pulmonary disease in the hospital setting: systematic review.

BACKGROUND: Currently, there is a lack of guidelines for the use of short-acting bronchodilators (SABD) in people admitted to hospital for acute exacerbation of chronic obstructive pulmonary disease (AECOPD), despite routine use in practice and risk of cardiac adverse events. AIM: To review the evidence that underpins use and optimal dose, in terms of risk versus benefit, of SABD for inpatient management of AECOPD and collate the results for future guidelines. METHODS: Medline, Embase, the Cochrane Central Register of Controlled Trials, clinicaltrials.gov and International Clinical Trials Registry Platform were searched (inception to November 2017) for published and ongoing studies. Included studies were randomised controlled trials or controlled clinical trials investigating the effect of SABD (ß2-agonist and/or ipratropium) on inpatients with a diagnosis of AECOPD. This review was undertaken in accordance with PRISMA guidelines and a pre-defined protocol. Due to heterogeneous methodologies, meta-analysis was not possible so the results were synthesised qualitatively. RESULTS: Of 1378 studies identified, 10 met inclusion criteria. Narrative synthesis of 10 studies revealed no significant differences in most outcomes of interest relative to dose, delivery via inhaler or nebuliser, and type of ß2-agonist used. However, some evidence demonstrated significantly increased cardiac side effects with increased dosage of ß2-agonist (45% versus 24%), P<0.05). CONCLUSION: This review identified a paucity of methodologically rigorous evidence evaluating use of SABD among AECOPD. The available evidence did not identify any additional benefits for participants receiving higher doses of short-acting ß2-agonists compared to lower doses, or based on type of delivery method or ß2-agonists used. However, there was a small increase in some adverse events for participants using higher doses of ß2-agonists.

Results of the first recorded evaluation of a national gestational diabetes mellitus register: Challenges in screening, registration, and follow-up for diabetes risk.

OBJECTIVE: Gestational Diabetes Mellitus (GDM) increases the risk of type 2 diabetes. A register can be used to follow-up high risk women for early intervention to prevent progression to type 2 diabetes. We evaluate the performance of the world's first national gestational diabetes register. RESEARCH DESIGN AND METHODS: Observational study that used data linkage to merge: (1) pathology data from the Australian states of Victoria (VIC) and South Australia (SA); (2) birth records from the Consultative Council on Obstetric and Paediatric Mortality and Morbidity (CCOPMM, VIC) and the South Australian Perinatal Statistics Collection (SAPSC, SA); (3) GDM and type 2 diabetes register data from the National Gestational Diabetes Register (NGDR). All pregnancies registered on CCOPMM and SAPSC for 2012 and 2013 were included-other data back to 2008 were used to support the analyses. Rates of screening for GDM, rates of registration on the NGDR, and rates of follow-up laboratory screening for type 2 diabetes are reported. RESULTS: Estimated GDM screening rates were 86% in SA and 97% in VIC. Rates of registration on the NGDR ranged from 73% in SA (2013) to 91% in VIC (2013). During the study period rates of screening at six weeks postpartum ranged from 43% in SA (2012) to 58% in VIC (2013). There was little evidence of recall letters resulting in screening 12 months follow-up. CONCLUSIONS: GDM Screening and NGDR registration was effective in Australia. Recall by mail-out to young mothers and their GP's for type 2 diabetes follow-up testing proved ineffective.

Promoting patient centred palliative care through case conferencing.

BACKGROUND: What are the characteristics of case conferences between general practitioners and specialised palliative care services (SPCS)? METHODS: Study participants were adults (N=461) with pain in the preceding 3 months who were referred to a SPCS and their GPs (N=230). Patients were randomised to case conferences or routine care by SPCS. RESULTS: One hundred and sixty-seven conferences were held; 46 patients withdrew and 142 died before the conference could be conducted. Medicare payment was requested for 72 (43%) conferences. Median time from randomisation to case conference was 52 days (SD: 55), and from case conference to death/end of study was 79 days (SD: 166). Twenty-five percent of conferences had over three health professionals participant; patients and/or their caregivers participated in 91%. Average conference duration was 39 minutes (SD: 13). Mean conference length did not increase when more health professionals were present (3 vs. >3, 39 [SD: 14] vs. 42 [SD 11] minutes, p=0.274), nor when patients/caregivers were present (present vs. absent, 39 [SD: 13] vs. 44 [SD: 14] minutes, p=0.159). DISCUSSION: Case conferencing involving SPCS, the GP, other health professionals and the patient can be an efficient part of routine care.

A pragmatic 2 x 2 x 2 factorial cluster randomized controlled trial of educational outreach visiting and case conferencing in palliative care-methodology of the Palliative Care Trial [ISRCTN 81117481].

The demand for palliative care is increasing, yet there are few data on the best models of care nor well-validated interventions that translate current evidence into clinical practice. Supporting multidisciplinary patient-centered palliative care while successfully conducting a large clinical trial is a challenge. The Palliative Care Trial (PCT) is a pragmatic 2 x 2 x 2 factorial cluster randomized controlled trial that tests the ability of educational outreach visiting and case conferencing to improve patient-based outcomes such as performance status and pain intensity. Four hundred sixty-one consenting patients and their general practitioners (GPs) were randomized to the following: (1) GP educational outreach visiting versus usual care, (2) Structured patient and caregiver educational outreach visiting versus usual care and (3) A coordinated palliative care model of case conferencing versus the standard model of palliative care in Adelaide, South Australia (3:1 randomization). Main outcome measures included patient functional status over time, pain intensity, and resource utilization. Participants were followed longitudinally until death or November 30, 2004. The interventions are aimed at translating current evidence into clinical practice and there was particular attention in the trial's design to addressing common pitfalls for clinical studies in palliative care. Given the need for evidence about optimal interventions and service delivery models that improve the care of people with life-limiting illness, the results of this rigorous, high quality clinical trial will inform practice. Initial results are expected in mid 2005.

Can volunteer companions prevent falls among inpatients? A feasibility study using a pre-post comparative design.

BACKGROUND: Falls in hospital are frequent and their consequences place an increased burden on health services. We evaluated a falls prevention strategy consisting of the introduction of volunteers to 'sit' with patients identified as being at high risk of falling. METHODS: Two four bed 'safety bays' located on medical wards in two hospitals within southern Adelaide were used. Ward fall rates (expressed as falls per 1000 occupied bed days) were compared in the baseline period (February-May 2002) with the implementation period (February - May 2003) using incident rate ratios and 95% confidence intervals. The number of hours of volunteered time was also collected. RESULTS: No patient falls occurred on either site when volunteers were present. However, there was no significant impact on overall ward fall rates. In the baseline period, there were 70 falls in 4828 OBDs (14.5 falls per 1000 OBDs). During the implementation period, there were 82 falls in 5300 OBDs (15.5 falls per 1000 OBD). The IRR for falls in the implementation versus baseline period was 1.07 (95%CI 0.77 - 1.49; P = 0.346). Volunteers carried out care activities (e.g. cutting up food), provided company, and on occasions advocated on behalf of the patients. Volunteers donated 2345 hours, at an estimated value to the hospitals of almost $57,000. CONCLUSION: Volunteers may play an important and cost-effective role in enhancing health care and can prevent falls in older hospital patients when they are present. Full implementation of this program would require the recruitment of adequate numbers of volunteers willing to sit with all patients considered at risk of falling in hospital. The challenge for future work in this area remains the sustainability of falls prevention strategies.

Connecting hospital and community care: the acceptability of a regional data linkage scheme.

Lack of information on an individual's premorbid needs and services in place can impede the transition from community to acute care. We report on a trial of an electronic data linking system between Flinders Medical Centre and Metropolitan Domiciliary Care. A sample of 82 medical, nursing and allied-health staff across the organisations completed questionnaires concerning their level of satisfaction with the trialled system. Results supported the effectiveness of an electronic data linking system across the hospital-community interface. This system was effective in reducing labour costs, increasing organisational communication and devising appropriate discharge plans. Community staff indicated they were better informed about their client's medical and disability status and were able to play an active role in their client's treatment. This study provides more support to the implementation of a patient electronic data linking system focussed on older patients, with wider benefits including the reduction of unnecessarily long admission times and decreased demand on hospital beds.

Does the addition of a pharmacist transition coordinator improve evidence-based medication management and health outcomes in older adults moving from the hospital to a long-term care facility? Results of a randomized, controlled trial.

BACKGROUND: Poorly executed transfers of older patients from hospitals to long-term care facilities carry the risk of fragmentation of care, poor clinical outcomes, inappropriate use of emergency department services, and hospital readmission. OBJECTIVE: This study was conducted to assess the impact of adding a pharmacist transition coordinator on evidence-based medication management and health outcomes in older adults undergoing first-time transfer from a hospital to a long-term care facility. METHODS: This randomized, single-blind, controlled trial enrolled hospitalized older adults awaiting transfer to a long-term residential care facility for the first time. Patients were randomized either to receive the services of the pharmacist transition coordinator (intervention group) or to undergo the usual hospital discharge process (control group). The intervention included medication-management transfer summaries from hospitals, timely coordinated medication reviews by accredited community pharmacists, and case conferences with physicians and pharmacists. The primary outcome was the quality of prescribing, measured using the Medication Appropriateness Index (MAI). Secondary outcomes were emergency department visits, hospital readmissions, adverse drug events, falls, worsening mobility, worsening behaviors, increased confusion, and worsening pain. RESULTS: One hundred ten older adults (67 women, 43 men; mean [SD] age, 82.7 [6.4] years) were recruited from 3 metropolitan hospitals and assigned to 85 metropolitan long-term care facilities. Fifty-six patients were randomized to the intervention group and 54 to the control group; 44 patients in each group were evaluable at 8-week follow-up. There were no significant differences in baseline characteristics between treatment groups, with the exception of the number of medications discontinued during hospitalization: a mean of 1.1 more drugs was discontinued in the control group compared with the intervention group (P = 0.011). The majority of patients (35 [62.5%] in the intervention group, 41 [76.0%] in the control group) changed physicians as part of the transition to a long-term care facility. At 8-week follow-up, there was no change in MAI from baseline in the intervention group, whereas it had worsened in the control group (mean [95% CI], 2.5 [1.4-3.7] vs 6.5 [3.9-9.1], respectively; P = 0.007). Patients who received the intervention and were alive at follow-up exhibited a significant protective effect of the intervention against worsening pain (relative risk ratio [95% CI], 0.55 [0.32-0.94]; P = 0.023) and hospital usage (i.e., the combination of emergency department visits and hospital readmissions) (0.38 [0.15-0.99]; P = 0.035), but did not differ from control patients in terms of adverse drug events (1.05 [0.66-1.68]), falls (1.19 [0.71-1.99]), worsening mobility (0.39 [0.13-1.15]), worsening behaviors (0.52 [0.25-1.10]), or increased confusion (0.59 [0.28-1.22]). When data for patients who had died were included, the intervention had no effect on hospital usage in all patients (0.58 [0.28-1.21]). CONCLUSIONS: Older people transferring from hospital to a long-term care facility are vulnerable to fragmentation of care and adverse events. In this study, use of a pharmacist transition coordinator improved aspects of inappropriate use of medicines across health sectors.

The Australian Centre for Evidence-based Clinical Practice generic audit tool: Auditmaker for health professionals.

Audit is an important step in the process of health care evaluation and quality improvement. Some of the barriers to audit include the lack of support in initiating an audit, difficulty with data collection and lack of time. Auditmaker is a computer package that guides the clinician through the initial process of designing an audit, choosing factors and outcomes to analyse, then provides customizable data entry forms, and finally simple reports summarizing the data. It has user-friendly features, such as help buttons, drop-down lists and built in comorbidities and outcomes of common interest. It provides a generic tool for performing an audit as well as providing an opportunity for different clinicians in different institutions or practice settings to perform similar audits using the same data collection tool, which can provide the basis of benchmarking. Auditmaker is available for downloading from the ACEPBCP website: http://www.acebcp.org.au.

Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: an update to the study protocol for a randomized controlled trial.

BACKGROUND: The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial (RCT) that aims to assess the effectiveness of a structured diabetes prevention intervention for women who had gestational diabetes. METHODS/DESIGN: The original protocol was published in Trials (http://www.trialsjournal.com/content/14/1/339). This update reports on an additional exclusion criterion and change in first eligibility screening to provide greater clarity. The new exclusion criterion "surgical or medical intervention to treat obesity" has been added to the original protocol. The risks of developing diabetes will be affected by any medical or surgical intervention as its impact on obesity will alter the outcomes being assessed by MAGDA-DPP. The screening procedures have also been updated to reflect the current recruitment operation. The first eligibility screening is now taking place either during or after pregnancy, depending on recruitment strategy. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066.

Delivery strategies to optimize resource utilization and performance status for patients with advanced life-limiting illness: results from the "palliative care trial" [ISRCTN 81117481].

CONTEXT: Evidence-based approaches are needed to improve the delivery of specialized palliative care. OBJECTIVES: The aim of this trial was to improve on current models of service provision. METHODS: This 2×2×2 factorial cluster randomized controlled trial was conducted at an Australian community-based palliative care service, allowing three simultaneous comparative effectiveness studies. Participating patients were newly referred adults, experiencing pain, and who were expected to live >48 hours. Patients enrolled with their general practitioners (GPs) and were randomized three times: 1) individualized interdisciplinary case conference including their GP vs. control, 2) educational outreach visiting for GPs about pain management vs. control, and 3) structured educational visiting for patients/caregivers about pain management vs. control. The control condition was current palliative care. Outcomes included Australia-modified Karnofsky Performance Status (AKPS) and pain from 60 days after randomization and hospitalizations. RESULTS: There were 461 participants: mean age 71 years, 50% male, 91% with cancer, median survival 179 days, and median baseline AKPS 60. Only 47% of individuals randomized to the case conferencing intervention received it; based on a priori-defined analyses, 32% of participants were included in final analyses. Case conferencing reduced hospitalizations by 26% (least squares means hospitalizations per patient: case conference 1.26 [SE 0.10] vs. control 1.70 [SE 0.13], P=0.0069) and better maintained performance status (AKPS case conferences 57.3 [SE 1.5] vs. control 51.7 [SE 2.3], P=0.0368). Among patients with declining function (AKPS <70), case conferencing and patient/caregiver education better maintained performance status (AKPS case conferences 55.0 [SE 2.1] vs. control 46.5 [SE 2.9], P=0.0143; patient/caregiver education 54.7 [SE 2.8] vs. control 46.8 [SE 2.1], P=0.0206). Pain was unchanged. GP education did not change outcomes. CONCLUSION: A single case conference added to current specialized community-based palliative care reduced hospitalizations and better maintained performance status. Comparatively, patient/caregiver education was less effective; GP education was not effective.

Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) post-natal intervention: study protocol for a randomized controlled trial.

BACKGROUND: Gestational diabetes mellitus (GDM) is defined as glucose intolerance with its onset or first recognition during pregnancy. Post-GDM women have a life-time risk exceeding 70% of developing type 2 diabetes mellitus (T2DM). Lifestyle modifications reduce the incidence of T2DM by up to 58% for high-risk individuals. METHODS/DESIGN: The Mothers After Gestational Diabetes in Australia Diabetes Prevention Program (MAGDA-DPP) is a randomized controlled trial aiming to assess the effectiveness of a structured diabetes prevention intervention for post-GDM women. This trial has an intervention group participating in a diabetes prevention program (DPP), and a control group receiving usual care from their general practitioners during the same time period. The 12-month intervention comprises an individual session followed by five group sessions at two-week intervals, and two follow-up telephone calls. A total of 574 women will be recruited, with 287 in each arm. The women will undergo blood tests, anthropometric measurements, and self-reported health status, diet, physical activity, quality of life, depression, risk perception and healthcare service usage, at baseline and 12 months. At completion, primary outcome (changes in diabetes risk) and secondary outcome (changes in psychosocial and quality of life measurements and in cardiovascular disease risk factors) will be assessed in both groups. DISCUSSION: This study aims to show whether MAGDA-DPP leads to a reduction in diabetes risk for post-GDM women. The characteristics that predict intervention completion and improvement in clinical and behavioral measures will be useful for further development of DPPs for this population. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ANZCTRN 12610000338066.

Outcomes of establishing an acute assessment unit in the general medical service of a tertiary teaching hospital.

OBJECTIVE: To evaluate the impact of an acute assessment unit (AAU) on length of hospital stay (LOS), emergency department (ED) waiting times, direct discharge rate, unplanned readmission rate and all-cause hospital mortality of general medical patients. DESIGN AND SETTING: Retrospective comparison of data for general medical patients admitted to a tertiary teaching hospital in Adelaide, South Australia, before and after the establishment of an AAU (reference years, 2003 [before] and 2006 [after]). MAIN OUTCOME MEASURES: Mean LOS, ED waiting times and all-cause hospital mortality during calendar years 2003 (pre-establishment) and 2006 (post-establishment). RESULTS: Following the establishment of an AAU, the mean LOS shortened (from 6.8 days in 2003 to 5.7 days in 2006; P < 0.001) despite a 50.5% increase in the number of admissions (from 2652 to 3992). The number of admitted patients waiting in the ED more than 8 hours for a hospital bed decreased (from 28.7% to 17.9%; P < 0.001), as did the number waiting more than 12 hours (from 20.2% to 10.4%; P < 0.001). The rates of unplanned readmission within 7 and 28 days did not change. The all-cause hospital mortality for general medical admissions was 4.6% in 2003 v 3.7% in 2006 (P = 0.056). CONCLUSION: The establishment of an AAU within the general medical service coincided with decreases in both LOS and ED waiting times, despite a 50% increase in admissions. This structural reform in the process of acute medical care may have contributed to the improvement in these key health care performance indices without compromising the quality of patient care.