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Study protocol for a process evaluation of a cluster randomised controlled trial to reduce potentially inappropriate prescribing and polypharmacy in patients with multimorbidity in Irish primary care (SPPiRE).

ABSTRACT: Background: Multimorbidity (the presence of two or more chronic conditions) is associated with poorer health outcomes, particularly for patients with significant polypharmacy (?15 medications), due to the higher risk of adverse events and drug interactions. The SPPiRE study will assess the effectiveness of a complex intervention to support general practitioners (GPs) to reduce potentially inappropriate prescribing and consider deprescribing in older people with multimorbidity and significant polypharmacy. The aim of the SPPiRE process evaluation is to understand how and why the intervention is effective or ineffective and to explore the potential for system wide implementation of the intervention using the Medical Research Council general themes of context, implementation and mechanism of impact. Methods: The SPPiRE study is a clustered randomised controlled trial (RCT), aiming to recruit 55 general practices and 400 patients (?65 years) on ?15 medications throughout the Republic of Ireland. This mixed-methods process evaluation of the SPPiRE study will integrate both quantitative and qualitative data. Quantitative data will be collected on use of the intervention elements and from GP questionnaires. Qualitative data will be collected from semi-structured telephone interviews with all intervention GPs and a purposeful sample of patients from intervention practices. The topic guide will explore barriers and facilitators to participation and implementation of the intervention. Quantitative data will be analysed using descriptive statistics. Interviews will be transcribed and analysed using thematic analysis. Quantitative and qualitative data will be then be integrated. Discussion: The SPPiRE cluster RCT will provide evidence regarding the effectiveness and practicability of delivering a structured medication review in reducing polypharmacy and potentially inappropriate prescribing for patients with multimorbidity. This process evaluation will provide information on how the intervention was implemented, how it was or was not effective and the potential for a system wide implementation. Trial registration: ISRCTN 12752680, registration: 20/10/2016.

SUBMITTER: Kyne K

PROVIDER: S-EPMC7016882 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Study protocol for a process evaluation of a cluster randomised controlled trial to reduce potentially inappropriate prescribing and polypharmacy in patients with multimorbidity in Irish primary care (SPPiRE).

Kyne Karen K McCarthy Caroline C Kiely Bridget B Smith Susan M SM Clyne Barbara B

HRB open research 20190823

<b>Background:</b> Multimorbidity (the presence of two or more chronic conditions) is associated with poorer health outcomes, particularly for patients with significant polypharmacy (≥15 medications), due to the higher risk of adverse events and drug interactions. The SPPiRE study will assess the effectiveness of a complex intervention to support general practitioners (GPs) to reduce potentially inappropriate prescribing and consider deprescribing in older people with multimorbidity and signific ...[more]

PMID: 32104779

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Project description:BackgoundPotentially inappropriate prescribing (PIP) has been evaluated in several countries, and several strategies have been devised for deprescribing drugs in older adults. The aim of this study was to evaluate the efficacy of a mobile application in reducing PIP for older adults in primary care facilities in Brazil.MethodsThis randomised, triple-blind, parallel-group trial was conducted in 22 public primary care facilities in Brazil. During the intervention phase, the general practitioners (GPs) were randomly allocated to the intervention (MPI Brasil app provides information about PIP, therapeutic alternatives and deprescribing) or control (MedSUS app provides general information about medications) group. All GPs were trained on the Clinical Decision-Making Process and how to access an Evidence-Based Health website. The GPs received an Android tablet with an installed mobile application depending on their allocated group, which they used when caring for older patients over at least 3 months. At the end of this period, a sample of older patients aged ≥ 60 years who had been awaiting medical consultation by the participating GPs were interviewed and their prescriptions analysed. The primary outcome was the frequency of PIP in and between the groups.ResultsAmong 53 GPs who were administered the baseline survey, 14 were included in the clinical trial. At baseline, 146 prescriptions were analysed: the PIP overall was 37.7% (55/146), in the intervention group was 40.6% (28/69), and in the control group was 35.1% (27/77). After the intervention, 284 prescriptions were analysed: the PIP overall was 31.7% (90/284), in the intervention group was 32.2% (46/143), and in the control group was 31.2% (44/141) (RR: 1.16; 95% CI, 0.76-1.76). In the within-group analysis, the PIP reduced from before to after the intervention in both groups-more significantly in the intervention than in the control group (p < 0.001). In the stratified analysis of PIP frequency by GPs, there was a relative risk reduction in 86% (6/7) of GPs in the intervention group compared to 71% (5/7) in the control group.ConclusionWe found that the MPI Brasil app effectively reduced PIP, suggesting that it may be useful to incorporate this tool into clinical practice.Trial registrationThe study was registered at ClinicalTrials.gov (NCT02918643). First registration on 22/09/2016.

Project description:BACKGROUND:Multimorbidity is a global health challenge that is associated with polypharmacy, increasing the risk of potentially inappropriate prescribing (PIP). There are tools to improve prescription, such as implicit and explicit criteria. OBJECTIVE:To estimate the prevalence of PIP in a population aged 65 to 74 years with multimorbidity and polypharmacy, according to American Geriatrics Society Beers Criteria® (2015, 2019), the Screening Tool of Older Person's Prescription -STOPP- criteria (2008, 2014), and the Medication Appropriateness Index -MAI- criteria in primary care. METHODS:This was an observational, descriptive, cross-sectional study. The sample included 593 community-dwelling elderly aged 65 to 74 years, with multimorbidity and polypharmacy, who participated in the MULTIPAP trial. Socio-demographic, clinical, professional, and pharmacological-treatment variables were recorded. Potentially inappropriate prescribing was detected by computerized prescription assistance system, and family doctors evaluated the MAI. The MAI-associated factors were analysed using a logistic regression model. RESULTS:A total of 4,386 prescriptions were evaluated. The mean number of drugs was 7.4 (2.4 SD). A total of 94.1% of the patients in the study had at least one criterion for drug inappropriateness according to the MAI. Potentially inappropriate prescribing was detected in 57.7%, 43.6%, 68.8% and 71% of 50 patients according to the explicit criteria STOPP 2014, STOPP 2008, Beers 2019 and Beers 2015 respectively. For every new drug taken by a patient, the MAI score increased by 2.41 (95% CI 1.46; 3.35) points. Diabetes, ischaemic heart disease and asthma were independently associated with lower summated MAI scores. CONCLUSIONS:The prevalence of potentially inappropriate prescribing detected in the sample was high and in agreement with previous literature for populations with multimorbidity and polypharmacy. The MAI criteria detected greater inappropriateness than did the explicit criteria, but their application was more complex and difficult to automate.

Project description:BackgroundThere is a rising prevalence of multimorbidity, particularly in older patients, and a need for evidence-based medicines management interventions for this population. The Supporting Prescribing in Older Adults with Multimorbidity in Irish Primary Care (SPPiRE) trial aimed to investigate the effect of a general practitioner (GP)-delivered, individualised medication review in reducing polypharmacy and potentially inappropriate prescriptions (PIPs) in community-dwelling older patients with multimorbidity in primary care.Methods and findingsWe conducted a cluster randomised controlled trial (RCT) set in 51 GP practices throughout the Republic of Ireland. A total of 404 patients, aged ≥65 years with complex multimorbidity, defined as being prescribed ≥15 regular medicines, were recruited from April 2017 and followed up until October 2020. Furthermore, 26 intervention GP practices received access to the SPPiRE website where they completed an educational module and used a template for an individualised patient medication review that identified PIP, opportunities for deprescribing, and patient priorities for care. A total of 25 control GP practices delivered usual care. An independent blinded pharmacist assessed primary outcome measures that were the number of medicines and the proportion of patients with any PIP (from a predefined list of 34 indicators based predominantly on the STOPP/START version 2 criteria). We performed an intention-to-treat analysis using multilevel modelling. Recruited participants had substantial disease and treatment burden at baseline with a mean of 17.37 (standard deviation [SD] 3.50) medicines. At 6-month follow-up, both intervention and control groups had reductions in the numbers of medicines with a small but significantly greater reduction in the intervention group (incidence rate ratio [IRR] 0.95, 95% confidence interval [CI]: 0.899 to 0.999, p = 0.045). There was no significant effect on the odds of having at least 1 PIP in the intervention versus control group (odds ratio [OR] 0.39, 95% CI: 0.140 to 1.064, p = 0.066). Adverse events recorded included mortality, emergency department (ED) presentations, and adverse drug withdrawal events (ADWEs), and there was no evidence of harm. Less than 2% of drug withdrawals in the intervention group led to a reported ADWE. Due to the inability to electronically extract data, primary outcomes were measured at just 2 time points, and this is the main limitation of this work.ConclusionsThe SPPiRE intervention resulted in a small but significant reduction in the number of medicines but no evidence of a clear effect on PIP. This reduction in significant polypharmacy may have more of an impact at a population rather than individual patient level.Trial registrationISRCTN Registry ISRCTN12752680.

Project description:ObjectivePolypharmacy occurs in approximately 30% of older adults aged 65 years or more, particularly among those with multimorbidity. With polypharmacy, there is an associated risk of potentially inappropriate prescribing (PIP). The aims of this scoping review were to (1) identify the intervention elements that have been adopted to reduce PIP in the outpatient setting and (2) determine the behaviour change wheel (BCW) intervention functions performed by each of the identified intervention elements.DesignScoping review DATA SOURCES: PubMed, Cumulative Index to Nursing and Allied Health Literature, EMBASE, Web of Science and Cochrane Library databases, grey literature sources, six key geriatrics journals and the reference lists of review papers.Study selectionAll studies reporting an intervention or strategy that addressed PIP in the older adult population (age ≥65) with multimorbidity in the outpatient setting and in which the primary prescriber is the physician.Data extractionData extracted from the included studies can be broadly categorised into (1) publication details, (2) intervention details and (3) results. This was followed by data synthesis and analysis based on the BCW framework.ResultsOf 8195 studies yielded, 80 studies were included in the final analysis and 14 intervention elements were identified. An average of two to three elements were adopted in each intervention. The three most frequently adopted intervention elements were medication review (70%), training (26.3%) and tool/instrument(s) (22.5%). Among medication reviews, 70% involved pharmacists. The 14 intervention elements were mapped onto five intervention functions: 'education', 'persuasion', 'training', 'environmental restructuring' and 'enablement'.ConclusionPIP is a multifaceted problem that involves multiple stakeholders. As such, interventions that address PIP require multiple elements to target the behaviour of the various stakeholders. The intervention elements and their corresponding functions identified in this scoping review will serve to inform the design of complex interventions that aim to reduce PIP.

Project description:BackgroundMultimorbidity and polypharmacy are common problems among the older population globally. They not only reduce the quality of life of older adults but also increase the prevalence of potentially inappropriate medication (PIM) use. This study aimed to examine the prevalence and the predictors of PIMs in hospitalized geriatric patients with multimorbidity and polypharmacy in Chengdu based on the 2015 American Geriatric Society Beers Criteria (2015 AGS Beers Criteria) and 2019 American Geriatric Society Beers Criteria (2019 AGS Beers Criteria).MethodsFrom 2016 to 2018, a cross-sectional study was conducted using electronic medical data from nine tertiary hospitals in Chengdu. The 2019 and 2015 AGS Beers Criteria were used to evaluate the PIM status of older inpatients (age ≥65 years), and logistic regression was used to identify the risk factors for PIM use.ResultsA total of 17,352 inpatients were included in the study between 2016 and 2018. The prevalence of PIM use based on the 2019 AGS Beers Criteria (72.54%) was slightly higher than that based on the 2015 AGS Beers Criteria (70.10%). Further, the prevalence of PIM use based on the 2019 AGS Beers Criteria showed an increasing trend, from 71.17% in 2016 to 73.39% in 2018. Logistic regression demonstrated that female, advanced age, and polypharmacy were positively associated with PIM use in older adults. The most frequently used PIMs in the inpatients were diuretics, benzodiazepines, non-steroidal anti-inflammatory drugs, antipsychotics, and selective serotonin reuptake inhibitors.ConclusionsThere is a high prevalence of PIM use in older inpatients with multimorbidity and polypharmacy in Chengdu. The 2019 AGS Beers Criteria is more sensitive for evaluating older adults in Chengdu than the 2015 AGS Beers Criteria. Further, based on the 2019 AGS Beers Criteria, the prevalence of PIM use is increasing year by year. Research on interventions rationing PIM use in the geriatric population in Chengdu are necessary in the future.

Project description:BackgroundMultimorbidity, polypharmacy, and potentially inappropriate medication (PIM) pose challenges for the care of people with cognitive impairment. The aim of the present study is to explore whether multimorbidity, polypharmacy, and PIM predict falls and hospital admissions in a sample of people with cognitive impairment in day-care centers in Germany.MethodsWe used data from the German day-care study (multicenter longitudinal study, n = 433). Multimorbidity was defined as ≥ 2 chronic diseases. Polypharmacy was defined as prescriptions to ≥ 5 drugs. Potentially inappropriate medication was defined as scoring on the PRISCUS list. Binary logistic regression analyses were computed to determine whether multimorbidity, polypharmacy, and potentially inappropriate medication at t0 predicted falls and hospital admissions as outcomes at t1 (six months later).ResultsThe rate of multimorbidity and polypharmacy was 87.8% and 60.3%, respectively. 15.9% of the people with cognitive impairment received PIM / PRISCUS-listed drugs, 43.6% ACB-listed drugs, and 52.7% CNS depressant drugs. Falls and hospital admissions during follow-up were prevalent in 19.4% and 24.7% of the people with cognitive impairment. Both were significantly predicted by the total number of drugs (falls: OR = 1.152, p = 0.001, overall model: p < 0.001; hospital admissions: OR = 1.103, p = 0.020, overall model: p = 0.001), even if regression analyses were controlled for the number of comorbidities.ConclusionsPolypharmacy and potentially inappropriate medication are highly prevalent in people with cognitive impairment in German day-care centers. The number of drugs and appropriateness of medication seem to be crucial for the risk of falls and hospital admissions. Polypharmacy and PIM should be critically reviewed by healthcare providers and avoided as much as and whenever possible.Trial registrationISRCTN16412551, 30 July 2014, registered partly retrospectively.

Dataset Information

Study protocol for a process evaluation of a cluster randomised controlled trial to reduce potentially inappropriate prescribing and polypharmacy in patients with multimorbidity in Irish primary care (SPPiRE).

Publications

Study protocol for a process evaluation of a cluster randomised controlled trial to reduce potentially inappropriate prescribing and polypharmacy in patients with multimorbidity in Irish primary care (SPPiRE).

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