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.

The integration of mixed methods data to develop the quality of life - aged care consumers (QOL-ACC) instrument.

BACKGROUND: This paper describes the collection and integration of mixed methods data to facilitate the final selection of items for the Quality of Life - Aged Care Consumers (QOL-ACC) instrument. The aim of the wider project is to develop a preference-based quality of life instrument that can be used for quality assessment and economic evaluation. Older people have been involved at every stage of the development of the QOL-ACC to ensure that the final instrument captures their perspectives and preferences. METHODS: Mixed methods data was collected on draft items for the QOL-ACC instrument across six key quality of life dimensions (mobility, pain management, emotional well-being, independence, social connections, and activities). Qualitative face validity data was collected from older people (aged 66 to 100 years) living in the community and in residential aged care via semi-structured interviews (n = 59). Quantitative data was collected from older people (aged 65 to 91 years) receiving aged care services in the community via an online survey (n = 313). A traffic light pictorial approach was adopted as a practical and systematic way to categorise and present data in a meaningful way that was easy for non-academic workshop members to understand and to be able to discuss the relative merits of each draft item. RESULTS: The traffic light approach supported the involvement of consumer and aged care provider representatives in the selection of the final items. Six items were selected for the QOL-ACC instrument with one item representing each of the six dimensions. CONCLUSIONS: This methodological approach has ensured that the final instrument is psychometrically robust as well as meaningful, relevant and acceptable to aged care consumers and providers.

Some gain for a small investment: An economic evaluation of an exercise program for people living in residential aged care.

OBJECTIVE: To evaluate the cost-effectiveness of a 12-week Exercise Physiology (EP) program for people living in a residential aged care facility. METHODS: A within-study pre- and postintervention design to calculate incremental cost-effectiveness ratios per quality-adjusted life years gained. A health service provider perspective was used. RESULTS: Fifty-nine participants enrolled in a 12-week program. The program cost was A$514.30 per resident. At a willingness-to-pay threshold of A$64 000, the likelihood of being cost-effective of the program is approximately 60%, due to a small increase in participants' quality of life, as reported by care staff. The model showed great variance, depending on who rated the participants' quality of life outcomes. CONCLUSION: It is uncertain that a 12-week EP program is cost-effective based on the evidence of the current trial. However, it appears that a low-cost program can produce small improvements for residents in care facilities.

A cross-sectional assessment of the relationship between sedative medication and anticholinergic medication use and the movement behaviour of older adults living in residential aged care.

OBJECTIVES: Medications with anticholinergic or sedative effects are frequently used by older people but can increase risk of falls and adverse events; however, less is known about their effect on movement behaviour. Here we examine the cross-sectional association between medication use and movement behaviour in older adults living in residential aged care. MATERIALS AND METHODS: Twenty-eight older adults living in residential aged care in metropolitan Australia participated. Medication data were collected from participants' medical charts and sedative load and anticholinergic burden were determined. Seven-day movement behaviour was objectively assessed by a wrist-worn triaxial accelerometer. Raw accelerations were converted to sleep, sedentary time, and time in light, moderate, and moderate-to-vigorous physical activity. To explore the relationship between medication and movement behaviour, Spearman's Rho correlations were conducted, as the data were not normally distributed. RESULTS: Analyses indicated that while anticholinergic burden was not associated with movement behaviour, sedative load was negatively correlated with a number of variables, accounting for 14% variance in moderate-to-vigorous physical activity (MVPA), and 17% in the bout length of MVPA (p < .02). CONCLUSION: The findings of this study showed a negative association between sedative load, due to medicines, and an individual's movement behaviour. The impact of this could be a reduction in the ability of this population to maintain or improve their functional mobility, which may overshadow any benefits of the medicine in some circumstances.

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.

Challenges associated with physical assessments for people living with dementia: Modifying standard assessment protocols.

OBJECTIVES: Regular physical activity for older adults as they age is important for maintaining not only physical function but also independence and self-worth. To be able to monitor changes in physical function, appropriate validated measures are required. Reliability of measures such as the timed-up-and-go, five-repetition sit-to-stand, handgrip strength, two-minute walk, 30-second sit-to-stand, and four-metre walk has been demonstrated; however, the appropriateness of such measures in a population of adults living with dementia, who may be unable to follow instructions or have diminished physical capacity, is not as well quantified. This study sought to test modified standard protocols for these measures. METHODS: Modification to the standard protocols of the timed-up-and-go, five-repetition sit-to-stand, handgrip strength, two-minute walk, 30-second sit-to-stand, and four-metre walk was trialled. This occurred through modification of procedural components of the assessment, such as encouraging participants to use their hands to raise themselves from a seated position, or the incorporation of staged verbal cueing, demonstration, or physical guidance where required. The test-retest reliability of the modified protocols was assessed using Pearson's correlation, and performance variances were assessed using the %coefficient of variation. Intraclass correlations were included for comparisons to previous research and to examine measurement consistency within three trials. RESULTS: At least 64% of the population were able to complete all measures. Good test-retest reliability was indicated for the modified measures (timed-up-and-go = 0.87; five-repetition sit-to-stand = 0.75; handgrip strength = 0.94; two-minute walk = 0.87; the 30-second sit-to-stand = 0.93; and the four-metre walk = 0.83), and the %coefficient of variation (7.2%-14.8%) and intraclass correlation (0.77-0.98) were acceptable to good. CONCLUSION: This article describes the methodology of the modified assessments, presents the test-retest statistics, and reports how modification of the current protocols for common measures of physical function enabled more older adults living with dementia in a residential aged care facility to participate in assessments, with high reliability demonstrated for the measures.

Partnering with people with dementia and their care partners, aged care service experts, policymakers and academics: A co-design process.

OBJECTIVE: To describe the co-design process in a project that "evaluated how the key worker role can best support people living with dementia in the community setting." METHODS: People with dementia, care-partners, aged-care service experts, policymakers and academics utilised a co-design process to undertake a systematic literature review and a qualitative evaluation study. RESULTS: The development of a successful co-design process that includes people living with dementia and their care-partners ("consumers") at all stages of the research process and addresses their individual needs. CONCLUSIONS: The co-design approach utilised in this project provided support, for consumers living in the community to be fully involved in the research design, conduct and plans for dissemination and implementation of the findings. Consequently, the research outcomes are based on solid evidence and consumer need. Additionally, a successful model for supporting consumers to facilitate their involvement in all aspects of the research process, was developed.

Process, impact and outcomes of medication review in Australian residential aged care facilities: A systematic review.

OBJECTIVE: To systematically review literature reporting processes, impact and outcomes of medication review and reconciliation in Australian residential aged care facilities (RACFs). METHODS: PubMed/MEDLINE, EMBASE, CINAHL, Informit Health and grey literature were searched from 1995 to July 2018. Studies reporting outcomes of a stand-alone medication review or reconciliation interventions in Australian RACFs were included. RESULTS: Thirteen studies investigated medication review, eight of which studied Residential Medication Management Reviews (RMMRs). Five studies reported that medication reviews identified an average of 2.7-3.9 medication-related problems (MRPs) per resident. One study reported medication reviews had no impact on quality of life, hospitalisation or mortality, but was not powered to assess these. Three studies reported general practitioners' acceptance of pharmacists' recommendations to resolve MRPs, ranging between 45 and 84%. CONCLUSIONS: Medication review may be a useful strategy to identify and prompt resolution of MRPs. However, the impact on clinical and resident-centred outcomes remains unclear.

How do people with dementia and family carers value dementia-specific quality of life states? An explorative "Think Aloud" study.

OBJECTIVE: To investigate the decision-making processes applied by people with dementia and family carers participating in using health economic approaches to value dementia-specific quality of life states. METHODS: People with dementia (n = 13) and family carers (n = 14) participated in valuing quality of life states using two health economic approaches: Discrete Choice Experiment (DCE) and Best Worst Scaling (BWS). Participants were encouraged to explain their reasoning using a "Think Aloud" approach. RESULTS: People with dementia and family carers adopted a range of decision-making strategies including "anchoring" the presented states against current quality of life, or simplifying the decision-making by focusing on the sub-set of attributes deemed most important. Overall, there was strong evidence of task engagement for BWS and DCE. CONCLUSIONS: Health economic valuation approaches can be successfully applied with people with dementia and family carers. These data can inform the assessment of benefits from their perspectives for incorporation within economic evaluation.

Protocol for a non-randomised pilot and feasibility study evaluating a multicomponent intervention to simplify medication regimens for people receiving community-based home care services.

INTRODUCTION: Managing medication regimens is one of the most complex and burdensome tasks performed by older people, and can be prone to errors. People living with dementia may require medication administration assistance from formal and informal caregivers. Simplified medication regimens maintain the same therapeutic intent, but have less complex instructions and administration schedules. This protocol paper outlines a study to determine the feasibility of a multicomponent intervention to simplify medication regimens for people receiving community-based home care services. METHODS AND ANALYSIS: This is a non-randomised pilot and feasibility study. Research nurses will recruit 50 people receiving community-based home care services. All participants will receive the intervention from a clinical pharmacist, who will undertake medication reconciliation, assess each participant's capacity to self-manage their medication regimen and apply a structured tool to identify opportunities for medication simplification. The pharmacist will communicate recommendations regarding medication simplification to registered nurses at the community-based home care provider organisation. The primary outcome will be a description of study feasibility (recruitment and retention rates, protocol adherence and stakeholder acceptability). Secondary outcomes include the change in number of medication administration times per day, medication adherence, quality of life, participant satisfaction, medication incidents, falls and healthcare utilisation at 4 months. ETHICS AND DISSEMINATION: Ethical approval was obtained from the Monash University Human Research Ethics Committee and the community-based home care provider organisation's ethical review panel. Research findings will be disseminated to consumers and caregivers, health professionals, researchers and healthcare providers through the National Health and Medical Research Council Cognitive Decline Partnership Centre and through conference presentations, lay summaries and peer-reviewed publications. This study will enable an improved understanding of medication management and administration among people receiving community-based home care services. This study will inform the decision to proceed with a randomised controlled trial to assess the effect of this intervention. TRIAL REGISTRATION NUMBER: ACTRN12618001130257; Pre-results.

Registry of Older South Australians (ROSA): framework and plan.

INTRODUCTION: Australia's ageing population puts significant demands on the aged care and healthcare sectors. To monitor the provision of aged care and healthcare services to older people, each government body has an individual data collection system. Together these systems can be the basis for creating the evidence necessary to support future allocation of resources for our ageing community. The Registry of Older South Australians (ROSA) is a cross-sector multidisciplinary (ie, aged care and healthcare) platform built to address the challenges of monitoring people in aged care settings. This protocol describes the ROSA's framework and plans. METHODS AND ANALYSIS: A registry to capture 16 000 South Australians/year undergoing an aged care eligibility assessment was designed. ROSA will contain information captured by the Commonwealth and South Australian state Health Authority, linked by two data integrating authorities, and housed on a secured data platform. ROSA will contain information on the sociodemographic, health, function, psychological, social, home and safety assessment and concerns characteristics, aged care services, general health services, and mortality of people receiving aged care services. Registered participants will be prospectively monitored until their death and yearly updates of their aged care and healthcare services information will be added to the registry. ETHICS AND DISSEMINATION: ROSA will longitudinally monitor the services provided to a population that puts costly demands on the state healthcare and aged care systems, identify unwanted variation, and underpin future research. ROSA's expected outputs include an annual report, a research agenda that focuses on high burden conditions and potentially economically impactful questions, educational materials, and risk profiling tools. ROSA was approved by the South Australian Department for Health and Ageing HREC (HREC/17/SAH/125) and the Australian Institute of Health and Welfare HREC (EO2018/2/429).

Development and validation of the Medication Regimen Simplification Guide for Residential Aged CarE (MRS GRACE).

BACKGROUND: Residents of aged care facilities use increasingly complex medication regimens. Reducing unnecessary medication regimen complexity (eg, by consolidating the number of administration times or using alternative formulations) may benefit residents and staff. OBJECTIVE: To develop and validate an implicit tool to facilitate medication regimen simplification in aged care facilities. METHOD: A purposively selected multidisciplinary expert panel used modified nominal group technique to identify and prioritize factors important in determining whether a medication regimen can be simplified. The five prioritized factors were formulated as questions, pilot-tested using non-identifiable medication charts and refined by panel members. The final tool was validated by two clinical pharmacists who independently applied the tool to a random sample of 50 residents of aged care facilities to identify opportunities for medication regimen simplification. Inter-rater agreement was calculated using Cohen's kappa. RESULTS: The Medication Regimen Simplification Guide for Residential Aged CarE (MRS GRACE) was developed as an implicit tool comprising of five questions about 1) the resident; 2) regulatory and safety requirements; 3) drug interactions; 4) formulation; and 5) facility and follow-up considerations. Using MRS GRACE, two pharmacists independently simplified medication regimens for 29/50 and 30/50 residents (Cohen's kappa=0.38, 95% CI 0.12-0.64), respectively. Simplification was possible for all residents with five or more administration times. Changing an administration time comprised 75% of the two pharmacists' recommendations. CONCLUSIONS: Using MRS GRACE, two clinical pharmacists independently simplified over half of residents' medication regimens with fair agreement. MRS GRACE is a promising new tool to guide medication regimen simplification in aged care.

SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER): study protocol for a cluster randomised controlled trial.

BACKGROUND: Complex medication regimens are highly prevalent in residential aged care facilities (RACFs). Strategies to reduce unnecessary complexity may be valuable because complex medication regimens can be burdensome for residents and are costly in terms of nursing time. The aim of this study is to investigate application of a structured process to simplify medication administration in RACFs. METHODS: SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER) is a non-blinded, matched-pair, cluster randomised controlled trial of a single multidisciplinary intervention to simplify medication regimens. Trained study nurses will recruit English-speaking, permanent residents from eight South Australian RACFs. Medications taken by residents in the intervention arm will be assessed once using a structured tool (the Medication Regimen Simplification Guide for Residential Aged CarE) to identify opportunities to reduce medication regimen complexity (e.g. by administering medications at the same time, or through the use of longer-acting or combination formulations). Residents in the comparison group will receive routine care. Participants will be followed for up to 36 months after study entry. The primary outcome measure will be the total number of charted medication administration times at 4 months after study entry. Secondary outcome measures will include time spent administering medications, medication incidents, resident satisfaction, quality of life, falls, hospitalisation and mortality. Individual-level analyses that account for clustering will be undertaken to determine the impact of the intervention on the study outcomes. DISCUSSION: Ethical approval has been obtained from the Monash University Human Research Ethics Committee and the aged care provider organisation. Research findings will be disseminated through conference presentations and peer-reviewed publications. SIMPLER will enable an improved understanding of the burden of medication use in RACFs and quantify the impact of regimen simplification on a range of outcomes important to residents and care providers. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12617001060336 . Retrospectively registered on 20 July 2017.

Developing a dementia-specific preference--based quality of life measure (AD-5D) in Australia: a valuation study protocol.

INTRODUCTION: Generic instruments for assessing health-related quality of life may lack the sensitivity to detect changes in health specific to certain conditions, such as dementia. The Quality of Life in Alzheimer's Disease (QOL-AD) is a widely used and well-validated condition-specific instrument for assessing health-related quality of life for people living with dementia, but it does not enable the calculation of quality-adjusted life years, the basis of cost utility analysis. This study will generate a preference-based scoring algorithm for a health state classification system -the Alzheimer's Disease Five Dimensions (AD-5D) derived from the QOL-AD. METHODS AND ANALYSIS: Discrete choice experiments with duration (DCETTO) and best-worst scaling health state valuation tasks will be administered to a representative sample of 2000 members of the Australian general population via an online survey and to 250 dementia dyads (250 people with dementia and their carers) via face-to-face interview. A multinomial (conditional) logistic framework will be used to analyse responses and produce the utility algorithm for the AD-5D. ETHICS AND DISSEMINATION: The algorithms developed will enable prospective and retrospective economic evaluation of any treatment or intervention targeting people with dementia where the QOL-AD has been administered and will be available online. Results will be disseminated through journals that publish health economics articles and through professional conferences. This study has ethical approval.

Medication management policy, practice and research in Australian residential aged care: Current and future directions.

Eight percent of Australians aged 65 years and over receive residential aged care each year. Residents are increasingly older, frailer and have complex care needs on entry to residential aged care. Up to 63% of Australian residents of aged care facilities take nine or more medications regularly. Together, these factors place residents at high risk of adverse drug events. This paper reviews medication-related policies, practices and research in Australian residential aged care. Complex processes underpin prescribing, supply and administration of medications in aged care facilities. A broad range of policies and resources are available to assist health professionals, aged care facilities and residents to optimise medication management. These include national guiding principles, a standardised national medication chart, clinical medication reviews and facility accreditation standards. Recent Australian interventions have improved medication use in residential aged care facilities. Generating evidence for prescribing and deprescribing that is specific to residential aged care, health workforce reform, medication-related quality indicators and inter-professional education in aged care are important steps toward optimising medication use in this setting.