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Older people often have complex medication regimens. In residential aged care, complex medication regimens are often a burden for residents and time-consuming for nurses and aged care workers to administer. This thesis investigated factors associated with complex medication regimens, developed the first tool to guide clinicians to simplify complex medication regimens, and investigated the time taken to administer complex regimens. The thesis also investigated whether having a complex medication regimen is a risk factor for bleeding in people who take anticoagulant medications. The findings will inform better care for older people with complex medication regimens.

SPIRIT checklist for the SIMPLER trial protocol. (PDF 173 kb)

WHO trial registration data set for the SIMPLER study. (PDF 327 kb)

Model consent form for the SIMPLER study. (PDF 293 kb)

SPIRIT checklist for the SIMPLER trial protocol. (PDF 173 kb)

Model consent form for the SIMPLER study. (PDF 293 kb)

Background Oral anticoagulants (OACs) are high-risk medications often used in older people with complex medication regimens. This study was the first to assess the association between overall regimen complexity and bleeding in people with atrial fibrillation (AF) initiating OACs. Methods Patients diagnosed with AF who initiated an OAC (warfarin, dabigatran, rivaroxaban, apixaban) between 2010 and 2016 were identified from the Hong Kong Clinical Database and Reporting System. Each patient’s Medication Regimen Complexity Index (MRCI) score was computed. Baseline characteristics were balanced using inverse probability of treatment weighting. People were followed until a first hospitalization for bleeding (intracranial hemorrhage, gastrointestinal bleeding, or other bleeding) and censored at discontinuation of the index OAC, death, or end of the follow-up period, whichever occurred first. Cox regression was used to estimate hazard ratios (HR) between MRCI quartiles and bleeding during initiation and all follow-up. Results There were 19 292 OAC initiators (n = 9 092 warfarin, n = 10 200 direct oral anticoagulants) with a mean (standard deviation) age at initiation of 73.9 (11.0) years. More complex medication regimens were associated with an increased risk of bleeding (MRCI > 14.0–22.00: aHR 1.17, 95% confidence interval [CI] 0.93–1.49; MRCI > 22.0–32.5: aHR 1.32, 95%CI 1.06–1.66; MRCI > 32.5: aHR 1.45, 95%CI 1.13–1.87, compared to MRCI ≤ 14). No significant association between MRCI and bleeding risk was observed during the initial 30, 60, or 90 days of treatment. Conclusion In this cohort study of people with AF initiating an OAC, a more complex medication regimen was associated with higher bleeding risk over periods longer than 90 days. Further prospective studies are needed to assess whether MRCI should be considered in OAC prescribing.

Esa YH Chen,1,2 J Simon Bell,1–3 Jenni Ilomaki,2,3 Claire Keen,1 Megan Corlis,2,4 Michelle Hogan,4 Jan Van Emden,2,4 Sarah N Hilmer,2,5 Janet K Sluggett1,2 1Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Parkville, VIC, Australia; 2NHMRC Cognitive Decline Partnership Centre, Hornsby Ku-ring-gai Hospital, Hornsby, NSW, Australia; 3Department of Epidemiology and Preventive Medicine, School of Public Health and Preventative Medicine, Monash University, Melbourne, VIC, Australia; 4Helping Hand Aged Care, North Adelaide, SA, Australia; 5Kolling Institute, Faculty of Medicine and Health, The University of Sydney and Royal North Shore Hospital, St Leonards, NSW, AustraliaCorrespondence: Esa YH ChenCentre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, 381 Royal Parade, Parkville, VIC 3052, AustraliaTel +61 3 9903 9533Email Esa.Chen@monash.eduObjective: To explore variation in medication regimen complexity in residential aged care facilities (RACFs) according to resident age, length of stay, comorbidity, dementia severity, frailty, and dependence in activities of daily living (ADLs), and compare number of daily administration times and Medication Regimen Complexity Index (MRCI) as measures of regimen complexity.Methods: This study was a cross-sectional analysis of baseline data from the SImplification of Medications Prescribed to Long-tErm care Residents (SIMPLER) cluster-randomized controlled trial. The SIMPLER study recruited 242 residents with at least one medication charted for regular administration from 8 RACFs in South Australia. Comorbidity was assessed using the Charlson Comorbidity Index (CCI). Dementia severity was assessed using the Dementia Severity Rating Scale. Frailty was assessed using the FRAIL-NH scale. Dependence in ADLs was assessed using the Katz ADL scale.Results: The median age of participants was 87 years (interquartile range 81–92). Over one-third of participants (n=86, 36%) had 5 or more daily medication administration times. The number of daily administration times and MRCI scores were positively correlated with resident length of stay (rs=0.19; 0.27), FRAIL-NH score (rs=0.23; 0.34) and dependence in ADLs (rs=−0.21; −0.33) (all p

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.

Background Older people use increasingly complex medication regimens. Complex regimens are challenging to administer, particularly for those with cognitive impairment, frailty, poor eyesight or limited dexterity. Complex regimens have been linked to non-adherence, medication errors and hospital admissions. Objective The aim of this article is to describe strategies to reduce the complexity of medication regimens in community and residential aged care settings. Discussion Medication regimen simplification is the process of reducing medication burden through strategies such as consolidating dosing times, standardising routes of administration, using long-acting rather than shorter-acting formulations, and switching to combination products in place of single-ingredient products. Obtaining a best possible medication history, ensuring appropriateness of current therapy, and deprescribing are important steps prior to implementing regimen simplification. Implementing such strategies should be based on a discussion and consideration of patient preferences, and include clinical judgement to limit the risk of unintended consequences for patients or carers Refereed/Peer-reviewed

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

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.

Rationale/aim: Medication administration is a complex and time-consuming task in residential aged care facilities (RACFs). Understanding the time associated with each administration step may help identify opportunities to optimize medication management in RACFs. This study aimed to investigate the time taken to administer medications to residents, including those with complex care needs such as cognitive impairment and swallowing difficulties. Method: A time-and-motion study was conducted in three South Australian RACFs. A representative sample of 57 scheduled medication administration rounds in 14 units were observed by a single investigator. The rounds were sampled to include different times of day, memory support units for residents living with dementia and standard units, and medication administration by registered and enrolled nurses. Medications were administered from pre-prepared medication strip packaging. The validated Work Observation Method By Activity Timing (WOMBAT) software was used to record observations. Results: Thirty nurses were observed. The average time spent on scheduled medication administration rounds was 5.2 h/unit of average 22 residents/day. The breakfast medication round had the longest duration (1.92 h/unit). Resident preparation, medication preparation and provision, documentation, transit, communication, and cleaning took an average of 5 minutes per resident per round. Medication preparation and provision comprised 60% of overall medication round time and took significantly longer in memory support than in standard units (66 vs 49 seconds per resident per round for preparation, 79 vs 58 for provision; P

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 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. Refereed/Peer-reviewed

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 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., Video abstract

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.

usc Refereed/Peer-reviewed

Objectives: The objective of our study was to describe spontaneously reported haemorrhagic adverse events associated with rivaroxaban and dabigatran in Australia. Methods: Data were sourced from the Australian Therapeutic Goods Administration (TGA) Database of Adverse Event Notifications between June 2009 and May 2014. Records of haemorrhagic adverse events in which rivaroxaban or dabigatran was considered as a potential cause were analysed. Results: There were 240 haemorrhagic adverse events associated with rivaroxaban and 504 associated with dabigatran. Age was specified for 164 (68%) haemorrhages associated with rivaroxaban, of which 101 occurred in people aged ⩾75 years. Age was specified for 437 (87%) haemorrhages associated with dabigatran, of which 300 occurred in people aged ⩾75 years. Time from treatment initiation to haemorrhage was specified for 122 (51%) haemorrhages associated with rivaroxaban, with 69 (57%) haemorrhages occurring within 30 days of rivaroxaban initiation. Time from treatment initiation to haemorrhage was specified for 253 (50%) haemorrhages associated with dabigatran, with 123 (49%) haemorrhages occurring within 30 days of dabigatran initiation. Gastrointestinal (GI) haemorrhages were the most frequent type of haemorrhages associated with both rivaroxaban ( n = 105, 44%) and dabigatran ( n = 302, 60%). Data were available on the severity of haemorrhage for 101 (42%) haemorrhages associated with rivaroxaban, with haemorrhage leading to death in 17 people. The severity of haemorrhage was specified for 384 (76%) haemorrhages associated with dabigatran, with haemorrhage leading to death in 61 people. Conclusions: Our study highlights the need for research on the haemorrhagic complications of anticoagulation in clinical care. A considerable proportion of reported haemorrhagic events occurred within 30 days of rivaroxaban and dabigatran initiation. This highlights the importance of considering bleeding risk at the time of treatment initiation.