Effect of an ongoing pharmacist service to reduce medicine-induced deterioration and adverse reactions in aged-care facilities (nursing homes): a multicentre, randomised controlled trial (the ReMInDAR trial).

OBJECTIVE: To assess the effectiveness of a pharmacist-led intervention using validated tools to reduce medicine-induced deterioration and adverse reactions. DESIGN AND SETTING: Multicenter, open-label parallel randomised controlled trial involving 39 Australian aged-care facilities. PARTICIPANTS: Residents on ≥4 medicines or ≥1 anticholinergic or sedative medicine. INTERVENTION: Pharmacist-led intervention using validated tools to detect signs and symptoms of medicine-induced deterioration which occurred every 8 weeks over 12 months. COMPARATOR: Usual care (Residential Medication Management Review) provided by accredited pharmacists. OUTCOMES: Primary outcome was change in Frailty Index at 12 months. Secondary outcomes included changes in cognition, 24-hour movement behaviour by accelerometry, grip strength, weight, adverse events and quality of life. RESULTS: 248 persons (median age 87 years) completed the study; 120 in the interventionand, 128 in control arms. In total 575 pharmacist, sessions were undertaken in the intervention arm. There was no statistically significant difference for change in frailty between groups (mean difference: 0.009, 95% CI: -0.028, 0.009, P = 0.320). A significant difference for cognition was observed, with a mean difference of 1.36 point change at 12 months (95% CI: 0.01, 2.72, P = 0.048). Changes in 24-hour movement behaviour, grip strength, adverse events and quality of life were not significantly different between groups. Point estimates favoured the intervention arm at 12 months for frailty, 24-hour movement behaviour and grip strength. CONCLUSIONS: The use of validated tools by pharmacists to detect signs of medicine-induced deterioration is a model of practice that requires further research, with promising results from this trial, particularly with regards to improved cognition.

Reducing medicine-induced deterioration and adverse reactions (ReMInDAR) trial: study protocol for a randomised controlled trial in residential aged-care facilities assessing frailty as the primary outcome.

INTRODUCTION: Many medicines have adverse effects which are difficult to detect and frequently go unrecognised. Pharmacist monitoring of changes in signs and symptoms of these adverse effects, which we describe as medicine-induced deterioration, may reduce the risk of developing frailty. The aim of this trial is to determine the effectiveness of a 12-month pharmacist service compared with usual care in reducing medicine-induced deterioration, frailty and adverse reactions in older people living in aged-care facilities in Australia. METHODS AND ANALYSIS: The reducing medicine-induced deterioration and adverse reactions trial is a multicentre, open-label randomised controlled trial. Participants will be recruited from 39 facilities in South Australia and Tasmania. Residents will be included if they are using four or more medicines at the time of recruitment, or taking more than one medicine with anticholinergic or sedative properties. The intervention group will receive a pharmacist assessment which occurs every 8 weeks. The pharmacists will liaise with the participants' general practitioners when medicine-induced deterioration is evident or adverse events are considered serious. The primary outcome is a reduction in medicine-induced deterioration from baseline to 6 and 12 months, as measured by change in frailty index. The secondary outcomes are changes in cognition scores, 24-hour movement behaviour, grip strength, weight, percentage robust, pre-frail and frail classification, rate of adverse medicine events, health-related quality of life and health resource use. The statistical analysis will use mixed-models adjusted for baseline to account for repeated outcome measures. A health economic evaluation will be conducted following trial completion using data collected during the trial. ETHICS AND DISSEMINATION: Ethics approvals have been obtained from the Human Research Ethics Committee of University of South Australia (ID:0000036440) and University of Tasmania (ID:H0017022). A copy of the final report will be provided to the Australian Government Department of Health. TRIAL REGISTRATION NUMBER: Australian and New Zealand Trials Registry ACTRN12618000766213.

Home-Based Education and Learning Program for Atrial Fibrillation: Rationale and Design of the HELP-AF Study.

BACKGROUND: Atrial fibrillation (AF) is a growing global epidemic, with its prevalence expected to significantly rise over coming decades. AF poses a substantial burden on health care systems, largely due to hospitalizations. Home-based clinical characterization has demonstrated improved outcomes in cardiac populations, but its impact on AF remains poorly defined. To test this hypothesis in AF, we developed the Home-Based Education and Learning Program for Patients With Atrial Fibrillation (HELP-AF) study. METHODS: The HELP-AF study is a prospective multicentre randomized controlled trial that will recruit 620 patients presenting to hospital emergency departments (EDs) with symptomatic AF (ANZCTR Registration: ACTRN12611000607976). Patients will be randomized to either the HELP-AF intervention or usual care. The intervention consists of 2 home visits by a nurse or pharmacist trained in the structured educational visiting (SEV) method. Patients in the control group will receive usual discharge follow-up care. RESULTS: The primary endpoints are total unplanned hospital admissions and quality of life. Secondary endpoints include AF symptom severity and burden score; time to first hospital admission; total unplanned days in hospital; total AF-related hospital admissions (including atrial flutter); total cardiac and noncardiac hospital admissions; total AF- or atrial flutter-related; cardiac- and noncardiac-related ED presentations; and all-cause mortality. An economic evaluation will also be performed. Clinical endpoints will be adjudicated by independent blinded assessors. Follow-up will be at 24 months. CONCLUSIONS: This study will assess the efficacy of a home-based structured patient-centred educational intervention in patients with AF.

Opioid errors in inpatient palliative care services: a retrospective review.

Opioids are a high-risk medicine frequently used to manage palliative patients' cancer-related pain and other symptoms. Despite the high volume of opioid use in inpatient palliative care services, and the potential for patient harm, few studies have focused on opioid errors in this population. OBJECTIVES: To (i) identify the number of opioid errors reported by inpatient palliative care services, (ii) identify reported opioid error characteristics and (iii) determine the impact of opioid errors on palliative patient outcomes. METHODS: A 24-month retrospective review of opioid errors reported in three inpatient palliative care services in one Australian state. RESULTS: Of the 55 opioid errors identified, 84% reached the patient. Most errors involved morphine (35%) or hydromorphone (29%). Opioid administration errors accounted for 76% of reported opioid errors, largely due to omitted dose (33%) or wrong dose (24%) errors. Patients were more likely to receive a lower dose of opioid than ordered as a direct result of an opioid error (57%), with errors adversely impacting pain and/or symptom management in 42% of patients. Half (53%) of the affected patients required additional treatment and/or care as a direct consequence of the opioid error. CONCLUSION: This retrospective review has provided valuable insights into the patterns and impact of opioid errors in inpatient palliative care services. Iatrogenic harm related to opioid underdosing errors contributed to palliative patients' unrelieved pain. Better understanding the factors that contribute to opioid errors and the role of safety culture in the palliative care service context warrants further investigation.

Potential economic impact on hospitalisations of the Palliative Care Clinical Studies Collaborative (PaCCSC) ketamine randomised controlled trial.

OBJECTIVE: The aim of the present study was to estimate the potential healthcare cost savings associated with reduced prescribing of subcutaneous ketamine for the treatment of chronic cancer pain after publication of the Palliative Care Clinical Studies Collaborative (PaCCSC) ketamine randomised controlled trial (RCT), to provide further reasons to modify ketamine prescribing practice in this setting. METHODS: Potential cost savings in this setting were estimated from a health system perspective using a 1-year impact model. The model was populated with estimates derived using an epidemiological approach informed by morbidity and prevalence data, the PaCCSC feasibility study, ketamine RCT and national ketamine utilisation survey results, as well as clinical opinion. RESULTS: The total estimated annual hospitalisation costs associated with subcutaneous ketamine prescribing were A$3 899 600 (2605 bed-days). A 17% reduction in ketamine prescribing lowered hospitalisation costs to A$3 236 668 (2162 bed-days), a reduction of A$662 932 (443 bed-days) because of reduced in-patient stays associated with ketamine toxicity and prescribing process. CONCLUSIONS: The findings from the modelled impact analysis suggest that dissemination of the PaCCSC ketamine RCT results may have saved the Australian healthcare system approximately A$663 000 in annual hospitalisation costs and freed up 443 in-patient bed-days, although there was high uncertainty within the study. Wider dissemination over time and targeted, local de-adoption strategies could result in further savings.

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.

Community pharmacists: a forgotten resource for palliative care.

Timely access to medicines within the community is important for palliative patients where their preferred place of care is the home environment. The objective of this observational study is to establish baseline data to quantify the issue of poor access to medicines for symptom control in the last few days of life. The list of 13 medicines was generated from medicine use within a metropolitan palliative care unit. A survey was designed to determine which of these 13 medicines community pharmacies stock, the expiry date of this stock, awareness of palliative care patients by community pharmacists and basic demographic characteristics of the community pharmacies. Surveys were distributed, by post, to all community pharmacies in South Australia. The response rate was 23.7%, and was representative of all socioeconomic areas. Each pharmacy stocked a median of 3 medicines (range 0-12) with 1 in 8 pharmacies having none of the 13 medicines listed in the survey. When the data was combined to identify the range of medicines from all pharmacies within a geographical postcode region, the median number of medicines increased to 5 medicines per postcode. Just over 1 in 5 pharmacies reported learning about the palliative status of a patient through another health practitioner. Community pharmacies remain an underused resource to support timely access to medicines for community-based palliative patients. Palliative care services and government agencies can develop new strategies for better access to medicines that will benefit community patients and their carers.

Using national health policies to improve access to palliative care medications in the community.

Access to affordable priority palliative care medicines needs to be informed by good clinical data from well-conducted clinical trials designed to address efficacy, cost-effectiveness, and safety. Availability of priority palliative care symptom control medicines improves the provision of palliation in the place of patient's choice including the community. Within Australia, a National Medicines Policy and a Palliative Care Strategy endorsed by Federal and State and Territory health ministers have facilitated a process to improve the evidence for palliative clinical practice and, through this, improve community availability of key medications for people at the end of life. The initiative, coordinated by a working party under government auspices, has brought together medicine regulators, the pharmaceutical industry, government, policy makers, and clinicians. The brief was to improve availability of key palliative care medications within the current national drug regulatory and funding frameworks. The results to date include: a palliative care section within the Pharmaceutical Benefits Scheme generating the first ever patient-defined section; medicines not previously listed now available; commitment of AU$9.46 M for a national multisite collaborative clinical study network to improve the evidence for clinical interventions in the palliative care setting through systematic investigation with rigorous Phase III and IV studies to inform registration and subsidy applications; and establishing a national Communication Network of the Palliative Care Medications Working Group for the health workforce and community to improve the quality use where improved access has been achieved.

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.

Prostate cancer, the PSA test and academic detailing in Australian general practice: an economic evaluation.

OBJECTIVES: To evaluate whether introduction of a national education program for GPs to improve decision making relating to the use of prostate specific antigen (PSA) testing for screening represents 'value-for-money' from the perspective of the Australian Government. METHODS: The annual equivalent costs and consequences of a proposed national program in steady state operation are estimated for Australia using 1996 as the reference year. Because of the controversy about the efficacy of screening using PSA testing, two scenarios are modelled. Uncertainty in the model is examined using Monte Carlo simulation methods. RESULTS: In scenario one, our model predicts that the national program would cost dollars 12.5 million (gross) or dollars 6.6 million (net), would reduce the burden of disease by 4.7% of total DALYs due to prostate cancer in those aged 70 and over, with no loss of life and an incremental cost effectiveness ratio (ICER) of dollars 16,000/DALY (gross) and dollars 8,500/DALY (net). In scenario two, the proposed program would cost dollars 12.5 million (gross) or dollars 7.1 million (net), would reduce the burden of disease by 3.1% of total, increase by 44 the prostate cancer deaths at an ICER of dollars 24,000/DALY (gross) and dollars 14,000/DALY (net). CONCLUSIONS: These findings, with an overall health benefit at moderate cost and acceptable ICER, support the case for consideration of a national education program on the assumption that prostate cancer screening over age 70 does not reduce mortality. A larger Australian study currently being conducted should provide stronger evidence on the value of implementing a full national program.

An outreach geriatric medication advisory service in residential aged care: a randomised controlled trial of case conferencing.

BACKGROUND: efficient strategies are needed to provide specialist advice in nursing homes to ensure quality medical care. We describe a case conference intervention involving a multidisciplinary team of health professionals. OBJECTIVES: to evaluate the impact of multidisciplinary case conferences on the appropriateness of medications and on patient behaviours in high-level residential aged care facilities. DESIGN: cluster-randomised controlled trial. SETTING: ten high-level aged care facilities. PARTICIPANTS: 154 residents with medication problems and/or challenging behaviours were selected for case conference by residential care staff. INTERVENTION: two multidisciplinary case conferences involving the resident's general practitioner, a geriatrician, a pharmacist and residential care staff were held at the nursing home for each resident. MEASUREMENTS: outcomes were assessed at baseline and 3 months. The primary outcome was the Medication Appropriateness Index (MAI). The behaviour of each resident was assessed via the Nursing Home Behaviour Problem Scale. RESULTS: 45 residents died before follow-up. Medication appropriateness improved in the intervention group [MAI mean change 4.1, 95% confidence interval (CI) 2.1-6.1] compared with the control group (MAI mean change 0.4, 95% CI -0.4-1.2; P < 0.001). There was a significant reduction in the MAI for benzodiazepines (mean change control -0.38, 95% CI -1.02-0.27 versus intervention 0.73, 95% CI 0.16-1.30; P = 0.017). Resident behaviours were unchanged after the intervention and the improved medication appropriateness did not extend to other residents in the facility. CONCLUSION: multidisciplinary case conferences in nursing homes can improve care. Outreach specialist services can be delivered without direct patient contact and achieve improvements in prescribing.

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.