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Process Evaluation of the SImplification of Medications Prescribed to Long-tErm Care Residents (SIMPLER) Cluster Randomized Controlled Trial: A Mixed Methods Study.

ABSTRACT: 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.

SUBMITTER: Sluggett JK

PROVIDER: S-EPMC8199013 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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:BackgroundBronchiolitis is the most common reason for hospitalisation in infants. All international bronchiolitis guidelines recommend supportive care, yet considerable variation in practice continues with infants receiving non-evidence based therapies. We developed six targeted, theory-informed interventions; clinical leads, stakeholder meeting, train-the-trainer, education delivery, other educational materials, and audit and feedback. A cluster randomised controlled trial (cRCT) found the interventions to be effective in reducing use of five non-evidence based therapies in infants with bronchiolitis. This process evaluation paper aims to determine whether the interventions were implemented as planned (fidelity), explore end-users' perceptions of the interventions and evaluate cRCT outcome data with intervention fidelity data.MethodsA pre-specified mixed-methods process evaluation was conducted alongside the cRCT, guided by frameworks for process evaluation of cRCTs and complex interventions. Quantitative data on the fidelity, dose and reach of interventions were collected from the 13 intervention hospitals during the study and analysed using descriptive statistics. Qualitative data identifying perception and acceptability of interventions were collected from 42 intervention hospital clinical leads on study completion and analysed using thematic analysis.ResultsThe cRCT found targeted, theory-informed interventions improved bronchiolitis management by 14.1%. The process evaluation data found variability in how the intervention was delivered at the cluster and individual level. Total fidelity scores ranged from 55 to 98% across intervention hospitals (mean = 78%; SD = 13%). Fidelity scores were highest for use of clinical leads (mean = 98%; SD = 7%), and lowest for use of other educational materials (mean = 65%; SD = 19%) and audit and feedback (mean = 65%; SD = 20%). Clinical leads reflected positively about the interventions, with time constraints being the greatest barrier to their use.ConclusionOur targeted, theory-informed interventions were delivered with moderate fidelity, and were well received by clinical leads. Despite clinical leads experiencing challenges of time constraints, the level of fidelity had a positive effect on successfully de-implementing non-evidence-based care in infants with bronchiolitis. These findings will inform widespread rollout of our bronchiolitis interventions, and guide future practice change in acute care settings.Trial registrationAustralian and New Zealand Clinical Trials Registry: ACTRN12616001567415 .

Project description:ObjectivesThe aim of this study was to demonstrate the existence of systematic associations in drug prescription that lead to the establishment of patterns of polypharmacy, and the clinical interpretation of the associations found in each pattern.MethodsA cross-sectional study was conducted based on information obtained from electronic medical records and the primary care pharmacy database in 2008. An exploratory factor analysis of drug dispensing information regarding 79,089 adult patients was performed to identify the patterns of polypharmacy. The analysis was stratified by age and sex.ResultsSeven patterns of polypharmacy were identified, which may be classified depending on the type of disease they are intended to treat: cardiovascular, depression-anxiety, acute respiratory infection (ARI), chronic obstructive pulmonary disease (COPD), rhinitis-asthma, pain, and menopause. Some of these patterns revealed a clear clinical consistency and included drugs that are prescribed together for the same clinical indication (i.e., ARI and COPD patterns). Other patterns were more complex but also clinically consistent: in the cardiovascular pattern, drugs for the treatment of known risk factors-such as hypertension or dyslipidemia-were combined with other medications for the treatment of diabetes or established cardiovascular pathology (e.g., antiplatelet agents). Almost all of the patterns included drugs for preventing or treating potential side effects of other drugs in the same pattern.ConclusionsThe present study demonstrated the existence of non-random associations in drug prescription, resulting in patterns of polypharmacy that are sound from the pharmacological and clinical viewpoints and that exist in a significant proportion of the population. This finding necessitates future longitudinal studies to confirm some of the proposed causal associations. The information discovered would further the development and/or adaptation of clinical patient guidelines to patients with multimorbidity who are taking multiple drugs.

Project description:Background:To better meet long-term care (LTC) residents' (patients in LTC) needs, nurse practitioners (NPs) were proposed as part of a quality improvement initiative. No research has been conducted in LTC in Québec Canada, where NP roles are new. We collected provider interviews, field notes and resident outcomes to identify how NPs in LTC influence care quality and inform the wider implementation of these roles in Québec. This paper reports on resident outcomes and field notes. Methods:Research Design: This mixed methods quality improvement study included a prospective cohort study in six LTC facilities in Québec. Participants: Data were collected from September 2015-August 2016. The cohort consisted of all residents (n?=?538) followed by the nurse practitioners. Nurse practitioner interventions (n?=?3798) related to medications, polypharmacy, falls, restraint use, transfers to acute care and pressure ulcers were monitored. Analysis: Bivariate analyses and survival analysis of occurrence of events over time were conducted. Content analysis was used for the qualitative data. Results:Nurse practitioners (n?=?6) worked half-time in LTC with an average caseload ranging from 42 to 80 residents. Sites developed either a shared care or a consultative model. The average age of residents was 82, and two thirds were women. The most common diagnosis on admission was dementia (62%, n?=?331). The number of interventions/resident (range: 2.2-16.3) depended on the care model. The average number of medications/resident decreased by 12% overall or 10% for each 30-day period over 12?months. The incidence of polypharmacy, falls, restraint use, and transfers to acute care decreased, and very few pressure ulcers were identified. Conclusions:The implementation of NPs in LTC in Québec can improve care quality for residents. Results show that the average number of medications per day per resident, the incidence of polypharmacy, falls, restraint use, and transfers to acute care all decreased during the study, suggesting that a wider implementation of NP roles in LTC is a useful strategy to improve resident care. Although additional studies are needed, the implementation of a consultative model should be favoured as our project provides preliminary evidence of the contributions of these new roles in LTC in Québec.

Project description:With age, the acuity of the five senses (i.e., hearing, sight, taste, smell, touch) is reduced. These types of sensory changes can affect day-to-day activities, making it more difficult for individuals to communicate and to interact with the world around them. The five senses allow us to receive information from the environment in the form of sound, light, smell, taste, and touch. As an older person's senses decline, they need more stimulation to be aware of these sensations. In long-term care settings, appropriate sensory practices are needed to address the diminishing senses of older adults. The objective of this mixed-methods systematic review is to examine the relationship between the sensory practices and the quality of life of residents living in long-term care settings and to develop an aggregated synthesis of mixed-methods studies to derive recommendations for policy, practice, and research.We will conduct a mixed-methods systematic review in accordance with the Cochrane Handbook. A search strategy has been developed with an expert health sciences librarian and peer reviewed using Peer Review for Electronic Search Strategies (PRESS). Seven databases: MEDLINE (Ovid), PubMed (non-MEDLINE-Ovid), CINAHL (EBSCO), Embase (Ovid), Ageline, PsycINFO (Ovid), and Cochrane Central Register of Controlled Trials (CENTRAL) will be searched for studies that meet the inclusion criteria. Two reviewers will independently screen the results of the literature search using a two-step process. Eligible studies will undergo a quality assessment and data extraction. Disagreements will be resolved through consultation with a third reviewer. We will assess the quality of individual studies using the Mixed Methods Appraisal Tool (MMAT). The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) will be used to summarize the strength of the quantitative evidence, and the Confidence in the Evidence from Reviews of Qualitative research (CERQual) tool to assess confidence in the qualitative syntheses.This systematic review will summarize evidence-based knowledge for sensory practices, identify gaps in the literature, and inform an audit program for assessing the presence of sensory practices in the long-term care setting. The results will be relevant to policy makers, decision-makers, clinicians, and residents/families in long-term care settings.PROSPERO registration # CRD42017032330 .

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Process Evaluation of the SImplification of Medications Prescribed to Long-tErm Care Residents (SIMPLER) Cluster Randomized Controlled Trial: A Mixed Methods Study.

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