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Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy: study protocol of a cluster randomized clinical trial (Multi-PAP project).

ABSTRACT: Multimorbidity is associated with negative effects both on people's health and on healthcare systems. A key problem linked to multimorbidity is polypharmacy, which in turn is associated with increased risk of partly preventable adverse effects, including mortality. The Ariadne principles describe a model of care based on a thorough assessment of diseases, treatments (and potential interactions), clinical status, context and preferences of patients with multimorbidity, with the aim of prioritizing and sharing realistic treatment goals that guide an individualized management. The aim of this study is to evaluate the effectiveness of a complex intervention that implements the Ariadne principles in a population of young-old patients with multimorbidity and polypharmacy. The intervention seeks to improve the appropriateness of prescribing in primary care (PC), as measured by the medication appropriateness index (MAI) score at 6 and 12 months, as compared with usual care.Design: pragmatic cluster randomized clinical trial. Unit of randomization: family physician (FP). Unit of analysis: patient.PC health centres in three autonomous communities: Aragon, Madrid, and Andalusia (Spain).patients aged 65-74 years with multimorbidity (?3 chronic diseases) and polypharmacy (?5 drugs prescribed in ?3 months).n?=?400 (200 per study arm).complex intervention based on the implementation of the Ariadne principles with two components: (1) FP training and (2) FP-patient interview.MAI score, health services use, quality of life (Euroqol 5D-5L), pharmacotherapy and adherence to treatment (Morisky-Green, Haynes-Sackett), and clinical and socio-demographic variables.primary outcome is the difference in MAI score between T0 and T1 and corresponding 95% confidence interval. Adjustment for confounding factors will be performed by multilevel analysis. All analyses will be carried out in accordance with the intention-to-treat principle.It is essential to provide evidence concerning interventions on PC patients with polypharmacy and multimorbidity, conducted in the context of routine clinical practice, and involving young-old patients with significant potential for preventing negative health outcomes.Clinicaltrials.gov, NCT02866799.

SUBMITTER: Prados-Torres A

PROVIDER: S-EPMC5406997 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy: study protocol of a cluster randomized clinical trial (Multi-PAP project).

Prados-Torres Alexandra A Del Cura-González Isabel I Prados-Torres Daniel D López-Rodríguez Juan A JA Leiva-Fernández Francisca F Calderón-Larrañaga Amaia A López-Verde Fernando F Gimeno-Feliu Luis A LA Escortell-Mayor Esperanza E Pico-Soler Victoria V Sanz-Cuesta Teresa T Bujalance-Zafra Mª Josefa MJ Morey-Montalvo Mariel M Boxó-Cifuentes José Ramón JR Poblador-Plou Beatriz B Fernández-Arquero José Manuel JM González-Rubio Francisca F Ramiro-González María D MD Coscollar-Santaliestra Carlos C Martín-Fernández Jesús J Barnestein-Fonseca Mª Pilar MP Valderas-Martínez José María JM Marengoni Alessandra A Muth Christiane C

Implementation science : IS 20170427 1

<h4>Background</h4>Multimorbidity is associated with negative effects both on people's health and on healthcare systems. A key problem linked to multimorbidity is polypharmacy, which in turn is associated with increased risk of partly preventable adverse effects, including mortality. The Ariadne principles describe a model of care based on a thorough assessment of diseases, treatments (and potential interactions), clinical status, context and preferences of patients with multimorbidity, with the ...[more]

PMID: 28449721

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Project description:ObjectivesTo assess the effectiveness of a pharmacist-led systematic review of medications on: potentially inappropriate medications (PIM), health outcomes and costs.DesignProspective, open, controlled and cluster-randomized clinical trial.SettingSix primary care clinics from Balearic Islands.ParticipantsForty-two clusters (21 per group), and 549 patients aged ≥65 years and ≥5 chronic medications were included; of which 277 were allocated to Intervention Group (IG) and 272 to Control Group (CG). Patients were excluded if they were: institutionalized, temporarily displaced, routinely monitored under private healthcare, or home care.InterventionPIM detection by the pharmacist using a combination of explicit and implicit methods; and communication of the most appropriate therapeutic strategies to the physician.MeasurementsProportion of patients with PIM and mean number of PIM/patient (main outcomes); and morbidity, mortality, and costs (secondary outcomes) were assessed.Statistical planFollowing an intention-to-treat approach, quantitative and qualitative outcomes variables were compared by T-Student and Chi-square tests, respectively. Results were providing as difference in proportions for qualitative outcomes and difference in means for quantitative outcomes with respective 95% confidence intervals (95% CI).ResultsAfter intervention, proportion of patients with PIM decreased by 13.7% (95% CI: 9.3; 18.2) more in IG than CG. Mean number of PIM/patient and mean cost of PIM/patient decreased by 0.43 (95% CI: 0.32; 0.54) and 72.11€ (95% CI: 26.15; 118.06) more in IG than CG, respectively. However, no statistically significant differences were observed in morbidity, mortality or costs of healthcare resources.ConclusionsPIM detection and recommendations provided by pharmacist could contribute to reduce significantly PIM and drug expenditure; but without reaching statistically significant differences in morbidity, mortality, and healthcare resources costs.

Project description:Investigate the effectiveness of a complex intervention aimed at improving the appropriateness of medication in older patients with multimorbidity in general practice.Pragmatic, cluster randomised controlled trial with general practice as unit of randomisation.72 general practices in Hesse, Germany.505 randomly sampled, cognitively intact patients (?60 years, ?3?chronic conditions under pharmacological treatment, ?5?long-term drug prescriptions with systemic effects); 465 patients and 71 practices completed the study.Intervention group (IG): The healthcare assistant conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision support system, the general practitioner optimised medication, discussed it with patients and adjusted it accordingly. The control group (CG) continued with usual care.The primary outcome was a modified Medication Appropriateness Index (MAI, excluding item 10 on cost-effectiveness), assessed in blinded medication reviews and calculated as the difference between baseline and after 6 months; secondary outcomes after 6 and 9?months' follow-up: quality of life, functioning, medication adherence, and so on.At baseline, a high proportion of patients had appropriate to mildly inappropriate prescriptions (MAI 0-5 points: n=350 patients). Randomisation revealed balanced groups (IG: 36 practices/252 patients; CG: 36/253). Intervention had no significant effect on primary outcome: mean MAI sum scores decreased by 0.3 points in IG and 0.8 points in CG, resulting in a non-significant adjusted mean difference of 0.7 (95% CI -0.2 to 1.6) points in favour of CG. Secondary outcomes showed non-significant changes (quality of life slightly improved in IG but continued to decline in CG) or remained stable (functioning, medication adherence).The intervention had no significant effects. Many patients already received appropriate prescriptions and enjoyed good quality of life and functional status. We can therefore conclude that in our study, there was not enough scope for improvement.ISRCTN99526053. NCT01171339; Results.

Project description:ObjectivesTo evaluate the effectiveness of an intervention, with and without a height adjustable desk, on daily sitting time, and to investigate the relative effectiveness of the two interventions, and the effectiveness of both interventions on physical behaviours and physical, biochemical, psychological, and work related health and performance outcomes.DesignCluster three arm randomised controlled trial with follow-up at three and 12 months.SettingLocal government councils in Leicester, Liverpool, and Greater Manchester, UK.Participants78 clusters including 756 desk based employees in defined offices, departments, or teams from two councils in Leicester, three in Greater Manchester, and one in Liverpool.InterventionsClusters were randomised to one of three conditions: the SMART Work and Life (SWAL) intervention, the SWAL intervention with a height adjustable desk (SWAL plus desk), or control (usual practice).Main outcomes measuresThe primary outcome measure was daily sitting time, assessed by accelerometry, at 12 month follow-up. Secondary outcomes were accelerometer assessed sitting, prolonged sitting, standing and stepping time, and physical activity calculated over any valid day, work hours, workdays, and non-workdays, self-reported lifestyle behaviours, musculoskeletal problems, cardiometabolic health markers, work related health and performance, fatigue, and psychological measures.ResultsMean age of participants was 44.7 years, 72.4% (n=547) were women, and 74.9% (n=566) were white. Daily sitting time at 12 months was significantly lower in the intervention groups (SWAL -22.2 min/day, 95% confidence interval -38.8 to -5.7 min/day, P=0.003; SWAL plus desk -63.7 min/day, -80.1 to -47.4 min/day, P<0.001) compared with the control group. The SWAL plus desk intervention was found to be more effective than SWAL at changing sitting time (-41.7 min/day, -56.3 to -27.0 min/day, P<0.001). Favourable differences in sitting and prolonged sitting time at three and 12 month follow-ups for both intervention groups and for standing time for the SWAL plus desk group were observed during work hours and on workdays. Both intervention groups were associated with small improvements in stress, wellbeing, and vigour, and the SWAL plus desk group was associated with improvements in pain in the lower extremity, social norms for sitting and standing at work, and support.ConclusionsBoth SWAL and SWAL plus desk were associated with a reduction in sitting time, although the addition of a height adjustable desk was found to be threefold more effective.Trial registrationISRCTN Registry ISRCTN11618007.

Project description:BACKGROUND:Men's perpetration of intimate partner violence (IPV) limits gains in health and wellbeing for populations globally. Largely informal, rapidly expanding peri-urban settlements, with limited basic services such as electricity, have high prevalence rates of IPV. Evidence on how to reduce men's perpetration, change social norms and patriarchal attitudes within these settings is limited. Our cluster randomised controlled trial aimed to determine the effectiveness of the Sonke CHANGE intervention in reducing use of sexual and/or physical IPV and severity of perpetration by men aged 18-40?years over 2 years. METHODOLOGY:The theory-based intervention delivered activities to bolster community action, including door-to-door discussions, workshops, drawing on the CHANGE curriculum, and deploying community action teams over 18?months. In 2016 and 2018, we collected data from a cohort of men, recruited from 18 clusters; nine were randomised to receive the intervention, while the nine control clusters received no intervention. A self-administered questionnaire, using audio-computer assisted software, asked about sociodemographics, gender attitudes, mental health, and the use and severity of IPV. We conducted an intention-to-treat analysis at the cluster level comparing the expected risk to observed risk of using IPV while controlling for baseline characteristics. A secondary analysis used latent classes (LCA) of men to see whether there were differential effects of the intervention for subgroups of men. RESULTS:Of 2406 men recruited, 1458 (63%) were followed to 2 years. Overall, we saw a reduction in men's reports of physical, sexual and severe IPV from baseline to endpoint (40.2% to 25.4%, 31.8% to 15.8%, and 33.4% to 18.2%, respectively). Intention-to-treat analysis showed no measurable differences between intervention and control clusters for primary IPV outcomes. Difference in the cluster-level proportion of physical IPV perpetration was 0.002 (95% confidence interval [CI] -?0.07 to 0.08). Similarly, differences between arms for sexual IPV was 0.01 (95% CI -?0.04 to 0.06), while severe IPV followed a similar pattern (Diff?=?0.01; 95% CI -?0.05 to 0.07). A secondary analysis using LCA suggests that among the men living in intervention communities, there was a greater reduction in IPV among less violent and more law abiding men than among more highly violent men, although the differences did not reach statistical significance. CONCLUSION:The intervention, when implemented in a peri-urban settlement, had limited effect in reducing IPV perpetrated by male residents. Further analysis showed it was unable to transform entrenched gender attitudes and use of IPV by those men who use the most violence, but the intervention showed promise for men who use violence less. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02823288. Registered on 30 June 2016.

Project description:BackgroundIt is now well recognised that the risk of severe COVID-19 increases with some long-term conditions (LTCs). However, prior research primarily focuses on individual LTCs and there is a lack of data on the influence of multimorbidity (≥2 LTCs) on the risk of COVID-19. Given the high prevalence of multimorbidity, more detailed understanding of the associations with multimorbidity and COVID-19 would improve risk stratification and help protect those most vulnerable to severe COVID-19. Here we examine the relationships between multimorbidity, polypharmacy (a proxy of multimorbidity), and COVID-19; and how these differ by sociodemographic, lifestyle, and physiological prognostic factors.Methods and findingsWe studied data from UK Biobank (428,199 participants; aged 37-73; recruited 2006-2010) on self-reported LTCs, medications, sociodemographic, lifestyle, and physiological measures which were linked to COVID-19 test data. Poisson regression models examined risk of COVID-19 by multimorbidity/polypharmacy and effect modification by COVID-19 prognostic factors (age/sex/ethnicity/socioeconomic status/smoking/physical activity/BMI/systolic blood pressure/renal function). 4,498 (1.05%) participants were tested; 1,324 (0.31%) tested positive for COVID-19. Compared with no LTCs, relative risk (RR) of COVID-19 in those with 1 LTC was no higher (RR 1.12 (CI 0.96-1.30)), whereas those with ≥2 LTCs had 48% higher risk; RR 1.48 (1.28-1.71). Compared with no cardiometabolic LTCs, having 1 and ≥2 cardiometabolic LTCs had a higher risk of COVID-19; RR 1.28 (1.12-1.46) and 1.77 (1.46-2.15), respectively. Polypharmacy was associated with a dose response higher risk of COVID-19. All prognostic factors were associated with a higher risk of COVID-19 infection in multimorbidity; being non-white, most socioeconomically deprived, BMI ≥40 kg/m2, and reduced renal function were associated with the highest risk of COVID-19 infection: RR 2.81 (2.09-3.78); 2.79 (2.00-3.90); 2.66 (1.88-3.76); 2.13 (1.46-3.12), respectively. No multiplicative interaction between multimorbidity and prognostic factors was identified. Important limitations include the low proportion of UK Biobank participants with COVID-19 test data (1.05%) and UK Biobank participants being more affluent, healthier and less ethnically diverse than the general population.ConclusionsIncreasing multimorbidity, especially cardiometabolic multimorbidity, and polypharmacy are associated with a higher risk of developing COVID-19. Those with multimorbidity and additional factors, such as non-white ethnicity, are at heightened risk of COVID-19.

Project description:An increasing number of people are living with multimorbidity. The evidence base for how best to manage these patients is weak. Current clinical guidelines generally focus on single conditions, which may not reflect the needs of patients with multimorbidity. The aim of the 3D study is to develop, implement and evaluate an intervention to improve the management of patients with multimorbidity in general practice.This is a pragmatic two-arm cluster randomised controlled trial. 32 general practices around Bristol, Greater Manchester and Glasgow will be randomised to receive either the '3D intervention' or usual care. 3D is a complex intervention including components affecting practice organisation, the conduct of patient reviews, integration with secondary care and measures to promote change in practice organisation. Changes include improving continuity of care and replacing reviews of each disease with patient-centred reviews with a focus on patients' quality of life, mental health and polypharmacy. We aim to recruit 1383 patients who have 3 or more chronic conditions. This provides 90% power at 5% significance level to detect an effect size of 0.27 SDs in the primary outcome, which is health-related quality of life at 15 months using the EQ-5D-5L. Secondary outcome measures assess patient centredness, illness burden and treatment burden. The primary analysis will be a multilevel regression model adjusted for baseline, stratification/minimisation, clustering and important co-variables. Nested process evaluation will assess implementation, mechanisms of effectiveness and interaction of the intervention with local context. Economic analysis of cost-consequences and cost-effectiveness will be based on quality-adjusted life years.This study has approval from South-West (Frenchay) National Health Service (NHS) Research Ethics Committee (14/SW/0011). Findings will be disseminated via final report, peer-reviewed publications and guidance to healthcare professionals, commissioners and policymakers.ISRCTN06180958; Pre-results.

Project description:BACKGROUND:The population of cancer survivors is rapidly growing in the United States. Long-term and late effects of cancer, combined with the ongoing management of other chronic conditions, make survivors particularly vulnerable to polypharmacy and its adverse effects. In the current study, the authors examined patterns of prescription medication use and polypharmacy in a population-based sample of cancer survivors. METHODS:Using data from the Medical Expenditure Panel Survey (MEPS), the authors matched cancer survivors (5216 survivors) with noncancer controls (19,588 controls) by age, sex, and survey year. Polypharmacy was defined as ?5 unique medications. The authors estimated the percentage of respondents prescribed medications within therapeutic classes and total prescription expenditures. RESULTS:A higher percentage of cancer survivors were prescribed ?5 unique medications (64.0%; 95% confidence interval [95% CI], 62.3%-65.8%) compared with noncancer controls (51.5%; 95% CI, 50.4%-52.6%), including drugs with abuse potential. Across all therapeutic classes, a higher percentage of newly (?1 year since diagnosis) and previously (>1 years since diagnosis) diagnosed survivors were prescribed medications compared with controls, with large differences observed with regard to central nervous system agents (65.8% [95% CI, 62.3%-69.3%] vs 57.4% [95% CI, 55.3%-59.5%] vs 46.0% [95% CI, 45.0%-46.9%]). Specifically, nearly 10% of survivors were prescribed benzodiazepines and/or opioids compared with approximately 5% of controls. Survivors had more than double the prescription expenditures (median of $1633 vs $784 among controls). Findings persisted across age and comorbidity categories. CONCLUSIONS:Cancer survivors were prescribed a higher number of unique medications, including drugs with abuse potential, thereby increasing their risk of adverse drug events, financial toxicity, poor adherence, and drug-drug interactions. Cancer 2018;124:2850-2857. © 2018 American Cancer Society.

Dataset Information

Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy: study protocol of a cluster randomized clinical trial (Multi-PAP project).

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Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy: study protocol of a cluster randomized clinical trial (Multi-PAP project).

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