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Impact of Medication Regimen Simplification on Medication Incidents in Residential Aged Care: SIMPLER Randomized Controlled Trial.

ABSTRACT: 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.

SUBMITTER: Dugre N

PROVIDER: S-EPMC7961370 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Impact of Medication Regimen Simplification on Medication Incidents in Residential Aged Care: SIMPLER Randomized Controlled Trial.

Dugré Nicolas N Bell J Simon JS Hopkins Ria E RE Ilomäki Jenni J Chen Esa Y H EYH Corlis Megan M Van Emden Jan J Hogan Michelle M Sluggett Janet K JK

Journal of clinical medicine 20210306 5

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 interventi ...[more]

PMID: 33800845

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Project description:BackgroundComplex 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.MethodsSImplification 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.DiscussionEthical 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 registrationAustralian New Zealand Clinical Trials Registry, ACTRN12617001060336 . Retrospectively registered on 20 July 2017.

Project description:IntroductionClinical practice guidelines recommend against the routine use of psychotropic medications in residential aged care facilities (RACFs). Knowledge brokers are individuals or groups who facilitate the transfer of knowledge into practice. The objective of this trial is to evaluate the effectiveness and cost-effectiveness of using knowledge brokers to translate Australia's new Clinical Practice Guidelines for the Appropriate Use of Psychotropic Medications in People Living with Dementia and in Residential Aged Care.Methods and analysisThe Evidence-based Medication knowledge Brokers in Residential Aged CarE (EMBRACE) trial is a helix-counterbalanced randomised controlled trial. The 12-month trial will be conducted in up to 19 RACFs operated by four Australian aged care provider organisations in Victoria, New South Wales, Western Australia and Queensland. RACFs will be randomised to receive three levels of implementation strategies (knowledge broker service, pharmacist-led quality use of medications education activities and distribution of the Guidelines and supporting materials) across three medication contexts (antipsychotics, benzodiazepines and antidepressants). Implementation strategies will be delivered by an embedded on-site aged care pharmacist working at a system level across each participating RACF. All RACFs will receive all implementation strategies simultaneously but for different medication contexts. The primary outcome will be a composite dichotomous measure of 6-month RACF-level concordance with Guideline recommendations and good practice statements among people using antipsychotics, benzodiazepines and antidepressants for changed behaviours. Secondary outcomes will include proportion of residents with Guideline concordant use of antipsychotics, benzodiazepines and antidepressants measured at the RACF-level and proportion of residents with psychotropic medication use, hospitalisation, falls, falls with injury, polypharmacy, quality of life, activities of daily living, medication incidents and behavioural incidents measured at the RACF-level.DiscussionThe EMBRACE trial investigates a novel guideline implementation strategy to improve the safe and effective use of psychotropic medications in RACFs. We anticipate that the findings will provide new information on the potential role of knowledge brokers for successful and cost-effective guideline implementation.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12623001141639. Registered 6 November 2023 - retrospectively registered, https://www.anzctr.org.au/TrialSearch.aspx .

Project description:BackgroundOlder populations in residential aged care facilities (RACFs) in many immigrant-receiving countries are now being increasingly culturally and linguistically diverse (CALD). CALD populations require tailored social and health services to support their needs and improve health outcomes. Falls among the elderly are common and can have significant health and psychosocial consequences. There is some evidence to suggest that country of birth may influence risk of falls among older people, but such evidence has been scarce. This study aimed to determine the association between place of birth and the incidence of falls in RACFs.MethodsRoutinely collected incident data relating to 5,628 residents aged ≥ 65 years in 25 RACFs in Sydney, New South Wales, Australia were used. RACF residents were classified into two groups, Australia-born (N = 4,086) and overseas-born (N = 1,542). Overseas-born RACF residents were further categorised into two subgroups: overseas-English-speaking-country (N = 743) and overseas-non-English-speaking-country (N = 799). Outcomes measures were rate of all falls, injurious falls and falls requiring hospitalisation. Multilevel binary negative regression was used to examine the relationship between fall risk and place of birth.ResultsIncidence rates of all falls, injurious falls and falls requiring hospitalisation were 8.62, 3.72 and 1.07 incidents per 1,000 resident days, respectively, among the Australia-born RACF residents, but were higher at 11.02, 4.13 and 1.65, respectively, among the overseas-born RACF residents. Within those born overseas, fall rates were higher among the overseas-non-English-speaking-country-born residents (11.32, 4.29 and 2.22, respectively) than those overseas-English-speaking-country-born (10.70, 3.96 and 1.05, respectively). After controlling for confounders, the overseas-born RACF residents overall experienced a higher risk of all three types of falls (incidence rate ratios: [IRR] = 1.278, 95% confidence interval [CI] = 1.131, 1.443; injurious falls: IRR = 1.164 [95% CI = 1.013, 1.338]; falls requiring hospitalisation: IRR = 1.460 [95% CI = 1.199, 1.777]) than the Australia-born RACF residents. Among the overseas-born RACF residents, males, respite residents and those overseas-non-English-speaking-country-born experienced higher rates of falls.ConclusionsFall incidence in RACFs varies significantly by place of birth. With increasingly diverse RACF populations, fall intervention and prevention programs should consider cultural and linguistical backgrounds of RACF residents. Greater attention to understand the mechanisms for the differences by place of birth in risk profiles is warranted.

Project description: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.

Project description:BackgroundSuboptimal patient adherence to pharmacological therapy of type 2 diabetes may be due in part to pill burden. One way to reduce pill burden in patients who need multiple medications is to use fixed-dose combinations. Our study aimed to compare the effects of fixed-dose combination versus loose-dose combination therapy on medication adherence and persistence, health care utilization, therapeutic safety, morbidities, and treatment modification in patients with type 2 diabetes over three years.MethodsUsing administrative data, we conducted a retrospective controlled cohort study comparing type 2 diabetes patients who switched from monotherapy to either a fixed-dose combination or a loose-dose combination. Adherence was assessed as the primary endpoint and calculated as the proportion of days covered with medication. After using entropy balancing to eliminate differences in observable baseline characteristics between the two groups, we applied difference-in-difference estimators for each outcome to account for time-invariant unobservable heterogeneity.ResultsOf the 990 type 2 diabetes patients included in our analysis, 756 were taking a fixed-dose combination and 234 were taking a loose-dose combination. We observed a statistically significantly higher change in adherence (year one: 0.22, p<0.001, year two: 0.25, p<0.001, and year three: 0.29, p<0.001) as well as higher persistence and a smaller change in the number of drug prescriptions in each of the three years in the fixed-dose combination group compared to the loose-dose combination group. The differences were most pronounced in patients who were poorly adherent, had a high pill burden, or did not have a severe concomitant disease.ConclusionOur results indicate that taking a fixed-dose combination can lead to a significant improvement in adherence to pharmacological therapy of type 2 diabetes compared to a loose-dose combination. In particular, these findings suggest that reducing pill burden may improve disease management among patients with more complex medication demand and patients who have demonstrated poor medication adherence.

Dataset Information

Impact of Medication Regimen Simplification on Medication Incidents in Residential Aged Care: SIMPLER Randomized Controlled Trial.

Publications

Impact of Medication Regimen Simplification on Medication Incidents in Residential Aged Care: SIMPLER Randomized Controlled Trial.

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