Protocol for a randomised crossover trial to evaluate patient and nurse satisfaction with electronic and elastomeric portable infusion pumps for the continuous administration of antibiotic therapy in the home: the Comparing Home Infusion Devices (CHID) study

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/Introduction Previous studies comparing satisfaction with electronic and elastomeric infusion pumps are limited, and improvements in size and usability of electronic pumps have since occurred. The Comparing Home Infusion Devices (CHID) study plans to assess patient and nurse satisfaction with an elastomeric and electronic pump for delivering intravenous antibiotic treatment in the home. Secondary objectives are to determine pump-related complications and actual antibiotic dose administered, evaluate temperature variation and compare pump operating costs. Methods and analysis The CHID study will be a randomised, crossover trial. A trained research nurse will recruit patients with infectious disease aged ≥18 years and prescribed ≥8 days of continuous intravenous antibiotic therapy from the Royal Adelaide Hospital (RAH) (Adelaide, Australia). Patients will be randomised to receive treatment at home via an elastomeric (Baxter Infusor) or an electronic (ambIT Continuous) infusion pump for 4–7 days, followed by the other for a further 4–7 days. Patient satisfaction will be assessed by a 10-item survey to be completed at the end of each arm. Nurse satisfaction will be assessed by a single 24-item survey. Patient logbooks and case notes from clinic visits will be screened to identify complications. Pumps/infusion bags will be weighed to estimate the volume of solution delivered. Temperature sensors will record skin and ambient temperatures during storage and use of the pumps throughout the infusion period. Costs relating to pumps, consumables, antibiotics and servicing will be determined. Descriptive statistics will summarise study data

Impact of medication regimen simplification on medication incidents in residential aged care: Simpler randomized controlled trial

In the SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER) cluster-randomized controlled trial, we investigated the impact of a structured medication regimen simplification intervention on medication incidents in residential aged care facilities (RACFs) over a 12-month follow-up. A clinical pharmacist applied the validated 5-step Medication Regimen Simplification Guide for Residential Aged CarE (MRS GRACE) for 96 of the 99 participating residents in the four intervention RACFs. The 143 participating residents in the comparison RACFs received usual care. Over 12 months, medication incident rates were 95 and 66 per 100 resident-years in the intervention and comparison groups, respectively (adjusted incident rate ratio (IRR) 1.13; 95% confidence interval (CI) 0.53–2.38). The 12-month pre/post incident rate almost halved among participants in the intervention group (adjusted IRR 0.56; 95%CI 0.38–0.80). A significant reduction in 12-month pre/post incident rate was also observed in the comparison group (adjusted IRR 0.67, 95%CI 0.50–0.90). Medication incidents over 12 months were often minor in severity. Declines in 12-month pre/post incident rates were observed in both study arms; however, rates were not significantly different among residents who received and did not receive a one-off structured medication regimen simplification intervention

National trends and policy impacts on provision of Home Medicines Reviews and Residential Medication Management Reviews in older Australians, 2009–2019

Comprehensive medicines reviews such as Home Medicines Review (HMR) and Residential Medication Management Review (RMMR) can resolve medicines-related problems. Changes to Australia’s longstanding HMR and RMMR programs were implemented between 2011 and 2014. This study examined trends in HMR and RMMR provision among older Australians during 2009–2019 and determined the impact of program changes on service provision. Monthly rates of general medical practitioner (GP) HMR claims per 1000 people aged ≥65 years and RMMR claims per 1000 older residents of aged care facilities were determined using publicly available data. Interrupted time series analysis was conducted to examine changes coinciding with dates of program changes. In January 2009, monthly HMR and RMMR rates were 0.80/1000 older people and 20.17/1000 older residents, respectively. Small monthly increases occurred thereafter, with 1.89 HMRs/1000 and 34.73 RMMRs/1000 provided in February 2014. In March 2014, immediate decreases of –0.32 (95%CI –0.52 to –0.11) HMRs/1000 and –12.80 (95%CI –15.22 to –10.37) RMMRs/1000 were observed. There were 1.07 HMRs/1000 and 35.36 RMMRs/1000 provided in December 2019. In conclusion, HMR and RMMR program changes in March 2014 restricted access to subsidized medicines reviews and were associated with marked decreases in service provision. The low levels of HMR and RMMR provision observed do not represent a proactive approach to medicines safety and effectiveness among older Australians.Janet K. Sluggett, Luke R. Collier, Jonathan D. Bartholomaeus, Maria C. Inacio, Steve L. Wesselingh and Gillian E. Caughe

The risk of fall-related hospitalisations at entry into permanent residential aged care

Background: Entering permanent residential aged care (PRAC) is a vulnerable time for individuals. While falls risk assessment tools exist, these have not leveraged routinely collected and integrated information from the Australian aged and health care sectors. Our study examined individual, system, medication, and health care related factors at PRAC entry that are predictors of fall-related hospitalisations and developed a risk assessment tool using integrated aged and health care data. Methods: A retrospective cohort study was conducted on N=32,316 individuals ≥65 years old who entered a PRAC facility (01/01/2009-31/12/2016). Fall-related hospitalisations within 90 or 365days were the outcomes of interest. Individual, system, medication, and health care-related factors were examined as predictors. Risk prediction models were developed using elastic nets penalised regression and Fine and Gray models. Area under the receiver operating characteristics curve (AUC) assessed model discrimination. Results: 64.2% (N =20,757) of the cohort were women and the median age was 85 years old (interquartile range 80-89). After PRAC entry, 3.7% (N =1209) had a fall-related hospitalisation within 90days and 9.8% (N =3156) within 365days. Twenty variables contributed to fall-related hospitalisation prediction within 90days and the strongest predictors included fracture history (sub-distribution hazard ratio (sHR)=1.87, 95% confdence interval (CI) 1.63-2.15), falls history (sHR=1.41, 95%CI 1.21-2.15), and dementia (sHR=1.39, 95%CI 1.22-1.57). Twenty-seven predictors of fallrelated hospitalisation within 365days were identifed, the strongest predictors included dementia (sHR=1.36, 95%CI 1.24-1.50), history of falls (sHR=1.30, 95%CI 1.20-1.42) and fractures (sHR=1.28, 95%CI 1.15-1.41). The risk prediction models had an AUC of 0.71 (95%CI 0.68-0.74) for fall-related hospitalisations within 90days and 0.64 (95%CI 0.62-0.67) for within 365days. Conclusion: Routinely collected aged and health care data, when integrated at a clear point of action such as entry into PRAC, can identify residents at risk of fall-related hospitalisations, providing an opportunity for better targeting risk mitigation strategies.Maria C. Inacio, Max Moldovan, Craig Whitehead, Janet K. Sluggett, Maria Crotty, Megan Corlis, Renuka Visvanathan, Steve Wesselingh, and Gillian E. Caughe

Initiation of antipsychotics after moving to residential aged care facilities and mortality: a national cohort study.

BACKGROUND:There is a high burden of antipsychotic use in residential aged care facilities (RACFs) and there is concern regarding potential inappropriate prescribing of antipsychotics in response to mild behavioural symptoms. Antipsychotic use has been associated with a higher risk of mortality in community-dwelling older adults with dementia, but few studies have examined associations upon RACF entry. AIMS:To examine associations between incident antipsychotic use and risk of mortality for people with and without diagnosed dementia in RACFs. METHODS:A retrospective cohort study, employing a new-user design (individuals did not receive an antipsychotic 6 months before enrolment) of 265,820 people who accessed RACFs in Australia between 1/4/2008 and 30/6/2015 was conducted. Cox regression models were used to examine adjusted associations between antipsychotic use in the first 100 days of RACF entry and mortality. RESULTS:In the 100 days after entering care, 29,455 residents (11.1%) were dispensed an antipsychotic. 180,956 (68.1%) residents died [38,249 (14.4%) were related to cerebrovascular causes] over a median 2.1 years (interquartile range 1.0-3.6) follow-up. Of the residents included, 119,665 (45.0%) had a diagnosis of dementia. Incident antipsychotic use was associated with higher risk of mortality in residents with dementia (adjusted hazard ratio 1.20, 95% confidence interval 1.18-1.22) and without dementia (1.28, 1.24-1.31). CONCLUSION:Initiation of antipsychotics after moving to RACFs is associated with a higher risk of mortality. Careful consideration of the potential benefits and harms should be given when starting a new prescription for antipsychotics for people moving to RACFs

Provision of a comprehensive medicines review is associated with lower mortality risk for residents of aged care facilities: a retrospective cohort study

Background: no studies have examined the impact of residential medication management review (RMMR, a 24-year government subsidised comprehensive medicines review program) in Australian residential aged care facilities (RACFs) on hospitalisation or mortality. Objective: to examine associations between RMMR provision in the 6–12 months after RACF entry and the 12-month risk of hospitalisation and mortality among older Australians in RACFs. Design retrospective cohort study. Subjects: individuals aged 65–105 years taking at least one medicine, who entered an RACF in three Australian states between 1 January 2012 and 31 December 2015 and spent at least 6 months in the RACF (n = 57,719). Methods: Cox regression models estimated adjusted hazard ratios (aHRs) with 95% confidence intervals (CIs) for associations between RMMR provision and mortality. Adjusted subdistribution hazard ratios were estimated for associations between RMMR provision and next (i) emergency department (ED) presentation or unplanned hospitalisation or (ii) fall-related ED presentation or hospitalisation. Results: there were 12,603 (21.8%) individuals who received an RMMR within 6–12 months of RACF entry, of whom 22.2% (95%CI 21.4–22.9) died during follow-up, compared with 23.3% (95%CI 22.9–23.7) of unexposed individuals. RMMR provision was associated with a lower risk of death due to any cause over 12-months (aHR 0.96, 95%CI 0.91–0.99), but was not associated with ED presentations or hospitalisations for unplanned events or falls. Conclusions: provision of an RMMR in the 6–12 months after RACF entry is associated with a 4.4% lower mortality risk over 12-months but was not associated with changes in hospitalisations for unplanned events or falls.Janet K Sluggett, Gillian E Caughey, Tracy Air, Max Moldovan, Catherine Lang, Grant Martin, Stephen R Carter, Shane Jackson, Andrew C Stafford, Steve L Wesselingh, Maria C Inaci

Patterns of High-Dose and Long-Term Proton Pump Inhibitor Use: A Cross-Sectional Study in Six South Australian Residential Aged Care Services

Aim: While proton pump inhibitors (PPIs) are generally considered safe and well tolerated, frail older people who take PPIs long term may be susceptible to adverse events. This study characterized PPI use and determined factors associated with high-dose use among older adults in residential aged care services (RACSs).Methods: A cross-sectional study of 383 residents of six South Australian RACSs within the same organization was conducted. Clinical, diagnostic, and medication data were collected by study nurses. The proportions of residents who took a PPI for > 8 weeks and without documented indications were calculated. Factors associated with high-dose PPI use compared to standard/low doses were identified using age- and sex-adjusted logistic regression models.Results: 196 (51%) residents received a PPI, with 45 (23%) prescribed a high dose. Overall, 173 (88%) PPI users had documented clinical indications or received medications that can increase bleeding risk. Three-quarters of PPI users with gastroesophageal reflux disease or dyspepsia had received a PPI for > 8 weeks. High-dose PPI use was associated with increasing medication regimen complexity [odds ratio (OR) 1.02; 95% confidence interval (CI) 1.01–1.04 per one-point increase in Medication Regimen Complexity Index score] and a greater number of medications prescribed for regular use (OR 1.11; 95% CI 1.01–1.21 per additional medication).Conclusions: Half of all residents received a PPI, of whom the majority had documented clinical indications or received medications that may increase bleeding risk. There remains an opportunity to review the continuing need for treatment and consider “step-down” approaches for high-dose PPI users.</p

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.Esa YH Chen, Janet K Sluggett, Jenni Ilomäki, Sarah N Hilmer, Megan Corlis, Leonie J Picton, Laura Dean, Christopher P Alderman, Nicholas Farinola, Joy Gailer, Jane Grigson, Andrew R Kellie, Peter JC Putsey, Solomon Yu, J Simon Bel

Primary, allied health, geriatric, pain and palliative healthcare service utilisation by aged care residents, 2012-2017.

OnlinePublObjectives To examine the incidence and trends in primary care, allied health, geriatric, pain and palliative care service use by permanent residential aged care (PRAC) residents and the older Australian population. Methods Repeated cross-sectional analyses on PRAC residents (N = 318,484) and the older (≥65 years) Australian population (N ~ 3.5 million). Outcomes were Medicare Benefits Schedule (MBS) subsidised primary care, allied health, geriatric, pain and palliative services between 2012-13 and 2016-17. GEE Poisson models estimated incidence rates and incidence rate ratios (IRR). Results In 2016-17, PRAC residents had a median of 13 (interquartile range [IQR] 5-19) regular general medical practitioner (GP) attendances, 3 (IQR 1-6) after-hours attendances and 5% saw a geriatrician. Highlights of utilisation changes from 2012-13 to 2016-17 include the following: GP attendances increased by 5%/year (IRR = 1.05, 95% confidence interval [CI] 1.05-1.05) for residents compared to 1%/year (IRR = 1.01, 95%CI 1.01-1.01) for the general population. GP after-hours attendances increased by 15%/year (IRR = 1.15, 95%CI 1.14-1.15) for residents and 9%/year (IRR = 1.08, 95%CI 1.07-1.20) for the general population. GP management plans increased by 12%/year (IRR = 1.12, 95%CI 1.11-1.12) for residents and 10%/year (IRR = 1.10, 95%CI 1.09-1.11) for the general population. Geriatrician consultations increased by 28%/year (IRR = 1.28, 95%CI 1.27-1.29) for residents compared to 14%/year (IRR = 1.14, 95%CI 1.14-1.15) in the general population. Conclusions The utilisation of most examined services increased in both cohorts over time. Preventive and management care, by primary care and allied health care providers, was low and likely influences the utilisation of other attendances. PRAC residents' access to pain, palliative and geriatric medicine services is low and may not address the residents' needs.Maria C. Inacio, Luke Collier, Tracy Air, Kailash Thapaliya, Maria Crotty, Helena Williams, Steve L. Wesselingh, Andrew Kellie, David Roder, Adrienne Lewis, Gillian Harvey, Janet K. Sluggett, Monica Cations, Tiffany K. Gill, Jyoti Khadka, Gillian E. Caughe

Consumer and Healthcare Professional Led Priority Setting for Quality Use of Medicines in People with Dementia: Gathering Unanswered Research Questions

Background: Historically, research questions have been posed by the pharmaceutical industry or researchers, with little involvement of consumers and healthcare professionals. Objective: To determine what questions about medicine use are important to people living with dementia and their care team and whether they have been previously answered by research. Methods: The James Lind Alliance Priority Setting Partnership process was followed. A national Australian qualitative survey on medicine use in people living with dementia was conducted with consumers (people living with dementia and their carers including family, and friends) and healthcare professionals. Survey findings were supplemented with key informant interviews and relevant published documents (identified by the research team). Conventional content analysis was used to generate summary questions. Finally, evidence checking was conducted to determine if the summary questions were 'unanswered'. Results: A total of 545 questions were submitted by 228 survey participants (151 consumers and 77 healthcare professionals). Eight interviews were conducted with key informants and four relevant published documents were identified and reviewed. Overall, analysis resulted in 68 research questions, grouped into 13 themes. Themes with the greatest number of questions were related to co-morbidities, adverse drug reactions, treatment of dementia, and polypharmacy. Evidence checking resulted in 67 unanswered questions. Conclusion: A wide variety of unanswered research questions were identified. Addressing unanswered research questions identified by consumers and healthcare professionals through this process will ensure that areas of priority are targeted in future research to achieve optimal health outcomes through quality use of medicines