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Complex medication regimens are highly prevalent, burdensome for residents and staff, and associated with poor health outcomes in residential aged care facilities (RACFs). The SIMPLER study was a non-blinded, matched-pair, cluster randomized controlled trial in eight Australian RACFs that investigated the one-off application of a structured 5-step implicit process to simplify medication regimens. The aim of this study was to explore the processes underpinning study implementation and uptake of the medication simplification intervention. A mixed methods process evaluation with an explanatory design was undertaken in parallel with the main outcome evaluation of the SIMPLER study and was guided by an established 8-domain framework. The qualitative component included a document analysis and semi-structured interviews with 25 stakeholders (residents, family, research nurses, pharmacists, RACF staff, and a general medical practitioner). Interviews were transcribed verbatim and reflexively thematically content analyzed. Descriptive statistics were used to summarize quantitative data extracted from key research documents. The SIMPLER recruitment rates at the eight RACFs ranged from 18.9% to 48.6% of eligible residents (38.4% overall). Participation decisions were influenced by altruism, opinions of trusted persons, willingness to change a medication regimen, and third-party hesitation regarding potential resident distress. Intervention delivery was generally consistent with the study protocol. Stakeholders perceived regimen simplification was beneficial and low risk if the simplification recommendations were individualized. Implementation of the simplification recommendations varied between the four intervention RACFs, with simplification implemented at 4-month follow-up for between 25% and 86% of residents for whom simplification was possible. Good working relationships between stakeholders and new remunerated models of medication management were perceived facilitators to wider implementation. In conclusion, the one-off implicit medication simplification intervention was feasible and generally delivered according to the protocol to a representative sample of residents. Despite variable implementation, recommendations to simplify complex regimens were valued by stakeholders, who also supported wider implementation of medication simplification in RACFs. Refereed/Peer-reviewed

Janet K Sluggett,1– 3 Choon Ean Ooi,1 Stephanie Gibson,1 Manya T Angley,4 Megan Corlis,3,5 Michelle E Hogan,3,5 Tessa Caporale,5 Georgina A Hughes,1,4 Jan Van Emden,3,5 J Simon Bell1,3,6 1Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, Victoria, Australia; 2University of South Australia, UniSA Allied Health and Human Performance, Adelaide, South Australia, Australia; 3National Health and Medical Research Council (NHMRC) Cognitive Decline Partnership Centre, Hornsby Ku-ring-gai Hospital, Hornsby, New South Wales, Australia; 4University of South Australia, UniSA Clinical and Health Sciences, Adelaide, South Australia, Australia; 5Helping Hand Aged Care, North Adelaide, South Australia, Australia; 6Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, Victoria, AustraliaCorrespondence: Janet K Sluggett Email janet.sluggett@unisa.edu.auPurpose: Being able to manage a complex medication regimen is key to older people continuing to live at home. This study determined the feasibility of a multi-component intervention to simplify medication regimens for people receiving community-based home care services.Patients and Methods: Research nurses recruited people receiving community-based home care services to participate in this non-randomized pilot and feasibility study (Australian New Zealand Clinical Trials Registry ACTRN12618001130257). Participants received a one-off clinical pharmacist intervention comprising medication reconciliation, assessment of capacity to self-manage medications, and application of a structured 5-step tool to identify medication simplification opportunities. A mixed-methods feasibility assessment with an explanatory design was undertaken to assess recruitment, protocol adherence and stakeholder acceptability. Data from interviews with 12 stakeholders were thematically analyzed. Secondary outcome measures, including medication discrepancies, and changes in number of medication administration times per day, quality of life, medication adherence and health service utilization, were determined over a 4-month follow-up.Results: Twenty-five out of the target 50 participants were recruited. Initial recruitment was impacted by apparent uncertain role responsibilities in medication management, with some clients who declined to participate perceiving they would be unlikely to benefit or being reluctant to change regimens. However, with few exceptions, participants who received intervention did so with a high degree of protocol adherence and acceptability. Stakeholders valued the intervention and supported wider implementation. Discrepancies between the baseline medication history from the general medical practitioner and the pharmacist-compiled “best possible medication history” were identified for all participants’ regimens (median of 6 per participant), with one-third resolved at follow-up. Simplification was possible for 14 participants (56%) and implemented for 7 (50%) at follow-up. No significant changes in other secondary outcomes were observed.Conclusion: The intervention was delivered as planned, and valued by stakeholders. Recruitment barriers should be addressed before wider implementation.Keywords: aged care, medication management, community services, medication simplification, Australia

In the SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER) cluster-randomized controlled trial, we evaluated the impact of structured medication regimen simplification on medication administration times, falls, hospitalization, and mortality at 8 residential aged care facilities (RACFs) at 12 month follow up. In total, 242 residents taking &ge, 1 medication regularly were included. Opportunities for simplification among participants at 4 RACFs were identified using the validated Medication Regimen Simplification Guide for Residential Aged CarE (MRS GRACE). Simplification was possible for 62 of 99 residents in the intervention arm. Significant reductions in the mean number of daily medication administration times were observed at 8 months (&minus, 0.38, 95% confidence intervals (CI) &minus, 0.69 to &minus, 0.07) and 12 months (&minus, 0.47, 95%CI &minus, 0.84 to &minus, 0.09) in the intervention compared to the comparison arm. A higher incidence of falls was observed in the intervention arm (incidence rate ratio (IRR) 2.20, 95%CI 1.33 to 3.63) over 12-months, which was primarily driven by a high falls rate in one intervention RACF and a simultaneous decrease in comparison RACFs. No significant differences in hospitalizations (IRR 1.78, 95%CI 0.57&ndash, 5.53) or mortality (relative risk 0.81, 95%CI 0.48&ndash, 1.38) over 12 months were observed. Medication simplification achieves sustained reductions in medication administration times and should be implemented using a structured resident-centered approach that incorporates clinical judgement.

IntroductionManaging 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 analysisThis 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 disseminationEthical 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 numberACTRN12618001130257; Pre-results.

Objective: To assess the application of a structured process to consolidate the number of medication administration times for residents of aged care facilities.Design A nonblinded, matched-pair, cluster randomized controlled trial. Setting and Participants: Permanent residents who were English-speaking and taking at least 1 regular medication, recruited from 8 South Australian residential aged care facilities (RACFs). Methods: The intervention involved a clinical pharmacist applying a validated 5-step tool to identify opportunities to reduce medication complexity (eg, by administering medications at the same time or through use of longer-acting or combination formulations). Residents in the comparison group received routine care. The primary outcome at 4-month follow-up was the number of administration times per day for medications charted regularly. Resident satisfaction and quality of life were secondary outcomes. Harms included falls, medication incidents, hospitalizations, and mortality. The association between the intervention and primary outcome was estimated using linear mixed models. Results: Overall, 99 residents participated in the intervention arm and 143 in the comparison arm. At baseline, the mean resident age was 86 years, 74% were female, and medications were taken an average of 4 times daily. Medication simplification was possible for 62 (65%) residents in the intervention arm, with 57 (62%) of 92 simplification recommendations implemented at follow-up. The mean number of administration times at follow-up was reduced in the intervention arm in comparison to usual care (−0.36, 95% confidence interval −0.63 to −0.09, P = .01). No significant changes in secondary outcomes or harms were observed. Conclusions and Implications: One-off application of a structured tool to reduce regimen complexity is a low-risk intervention to reduce the burden of medication administration in RACFs and may enable staff to shift time to other resident care activities. Refereed/Peer-reviewed

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. Electronic supplementary material The online version of this article (10.1186/s13063-017-2417-2) contains supplementary material, which is available to authorized users.