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Effect of a patient-centred deprescribing procedure in older multimorbid patients in Swiss primary care - A cluster-randomised clinical trial.

ABSTRACT: BACKGROUND:Management of patients with polypharmacy is challenging, and evidence for beneficial effects of deprescribing interventions is mixed. This study aimed to investigate whether a patient-centred deprescribing intervention of PCPs results in a reduction of polypharmacy, without increasing the number of adverse disease events and reducing the quality of life, among their older multimorbid patients. METHODS:This is a cluster-randomised clinical study among 46 primary care physicians (PCPs) with a 12?months follow-up. We randomised PCPs into an intervention and a control group. They recruited 128 and 206 patients if ?60?years and taking ?five drugs for ?6 months. The intervention consisted of a 2-h training of PCPs, encouraging the use of a validated deprescribing-algorithm including shared-decision-making, in comparison to usual care. The primary outcome was the mean difference in the number of drugs per patient (dpp) between baseline and after 12?months. Additional outcomes focused on patient safety and quality of life (QoL) measures. RESULTS:Three hundred thirty-four patients, mean [SD] age of 76.2 [8.5] years participated. The mean difference in the number of dpp between baseline and after 12?months was 0.379 in the intervention group (8.02 and 7.64; p =?0.059) and 0.374 in the control group (8.05 and 7.68; p =?0.065). The between-group comparison showed no significant difference at all time points, except for immediately after the intervention (p =?0.002). There were no significant differences concerning patient safety nor QoL measures. CONCLUSION:Our straight-forward and patient-centred deprescribing procedure is effective immediately after the intervention, but not after 6 and 12?months. Further research needs to determine the optimal interval of repeated deprescribing interventions for a sustainable effect on polypharmacy at mid- and long-term. Integrating SDM in the deprescribing process is a key factor for success. TRIAL REGISTRATION:Current Controlled Trials, prospectively registered ISRCTN16560559 Date assigned 31/10/2014. The Prevention of Polypharmacy in Primary Care Patients Trial (4P-RCT).

SUBMITTER: Zechmann S

PROVIDER: S-EPMC7670707 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Effect of a patient-centred deprescribing procedure in older multimorbid patients in Swiss primary care - A cluster-randomised clinical trial.

Zechmann Stefan S Senn Oliver O Valeri Fabio F Essig Stefan S Merlo Christoph C Rosemann Thomas T Neuner-Jehle Stefan S

BMC geriatrics 20201116 1

<h4>Background</h4>Management of patients with polypharmacy is challenging, and evidence for beneficial effects of deprescribing interventions is mixed. This study aimed to investigate whether a patient-centred deprescribing intervention of PCPs results in a reduction of polypharmacy, without increasing the number of adverse disease events and reducing the quality of life, among their older multimorbid patients.<h4>Methods</h4>This is a cluster-randomised clinical study among 46 primary care phy ...[more]

PMID: 33198634

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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:ObjectiveTo examine the effect of optimising drug treatment on drug related hospital admissions in older adults with multimorbidity and polypharmacy admitted to hospital.DesignCluster randomised controlled trial.Setting110 clusters of inpatient wards within university based hospitals in four European countries (Switzerland, Netherlands, Belgium, and Republic of Ireland) defined by attending hospital doctors.Participants2008 older adults (≥70 years) with multimorbidity (≥3 chronic conditions) and polypharmacy (≥5 drugs used long term).InterventionClinical staff clusters were randomised to usual care or a structured pharmacotherapy optimisation intervention performed at the individual level jointly by a doctor and a pharmacist, with the support of a clinical decision software system deploying the screening tool of older person's prescriptions and screening tool to alert to the right treatment (STOPP/START) criteria to identify potentially inappropriate prescribing.Main outcome measurePrimary outcome was first drug related hospital admission within 12 months.Results2008 older adults (median nine drugs) were randomised and enrolled in 54 intervention clusters (963 participants) and 56 control clusters (1045 participants) receiving usual care. In the intervention arm, 86.1% of participants (n=789) had inappropriate prescribing, with a mean of 2.75 (SD 2.24) STOPP/START recommendations for each participant. 62.2% (n=491) had ≥1 recommendation successfully implemented at two months, predominantly discontinuation of potentially inappropriate drugs. In the intervention group, 211 participants (21.9%) experienced a first drug related hospital admission compared with 234 (22.4%) in the control group. In the intention-to-treat analysis censored for death as competing event (n=375, 18.7%), the hazard ratio for first drug related hospital admission was 0.95 (95% confidence interval 0.77 to 1.17). In the per protocol analysis, the hazard ratio for a drug related hospital admission was 0.91 (0.69 to 1.19). The hazard ratio for first fall was 0.96 (0.79 to 1.15; 237 v 263 first falls) and for death was 0.90 (0.71 to 1.13; 172 v 203 deaths).ConclusionsInappropriate prescribing was common in older adults with multimorbidity and polypharmacy admitted to hospital and was reduced through an intervention to optimise pharmacotherapy, but without effect on drug related hospital admissions. Additional efforts are needed to identify pharmacotherapy optimisation interventions that reduce inappropriate prescribing and improve patient outcomes.Trial registrationClinicalTrials.gov NCT02986425.

Project description:BackgroundDeprescribing polypharmacy and potentially inappropriate medications (PIMs) has been shown to be beneficial to nursing home (NH) residents' health. Medication reviews are the most widely studied deprescribing intervention; in a previous trial, we showed that another intervention, a deprescribing-focused interprofessional quality circle, can reduce the use of inappropriate medications at the NH level. However, this intervention cannot account for the variety of the residents' clinical situations. Therefore, we trialled a subsequent intervention in NH that enacted the quality circle intervention in the previous year.MethodsIn 7 NHs, the most heavily medicated residents were recruited and randomised to receive usual care or the intervention. The intervention was a pharmacist-led, deprescribing-focused medication review, followed by the creation of an individualised treatment modification plan in collaboration with nurses and physicians. Intervention's effects were assessed after four months on the number and dose of PIMs used, quality of life, and safety outcomes (mortality, hospitalisations, falls, and use of physical restraints). Data were analysed using Poisson multivariate regression models.ResultsSixty-two NH residents participated, falling short of the expected 100 participants; 4 died before initial data collection. Participants used a very high number of drugs (median 15, inter-quartile range [12-19]) and PIMs (median 5, IQR [3-7]) at baseline. The intervention did not reduce the number of PIMs prescribed to the participants; however, it significantly decreased their dose (incidence rate ratio 0.763, CI95 [0.594; 0.979]), in particular for chronic drugs (IRR 0.716, CI95 [0.546; 0.938]). No adverse effects were seen on mortality, hospitalisations, falls, and restraints use, but, in the intervention group, three participants experienced adverse events that required the reintroduction of withdrawn treatments, and a decrease in quality of life is possible.ConclusionsAs it did not reach its recruitment target, this trial should be seen as exploratory. Results indicate that, following a NH-level deprescribing intervention, a resident-level intervention can further reduce some aspects of PIMs use. Great attention must be paid to residents' well-being when further developing such deprescribing interventions, as a possible reduction in quality of life was found in the intervention group, and some participants suffered adverse events following deprescribing.Trial registrationClinicalTrials.gov (NCT03688542, https://clinicaltrials.gov/ct2/show/NCT03688542 ), registered on 31.08.2018.

Project description:BackgroundPolypharmacy is an increasing problem, leading to increased morbidity and mortality, especially in older, multimorbid patients. Consequently, there is a need for reduction of polypharmacy. The aim of this study was to explore attitudes, beliefs, and concerns towards deprescribing among older, multimorbid patients with polypharmacy who chose not to pursue at least one of their GP's offers to deprescribe.MethodsExploratory study using telephone interviews among patients of a cluster-randomized study in Northern Switzerland. The interview included a qualitative part consisting of questions in five pre-defined key areas of attitudes, beliefs, and concerns about deprescribing and an open explorative question. The quantitative part consisted of a rating of pre-defined statements in these areas.ResultsTwenty-two of 87 older, multimorbid patients with polypharmacy, to whom their GP offered a drug change, did not pursue all offers. Nineteen of these 22 were interviewed by telephone. The 19 patients were on average 76.9 (SD 10.0) years old, 74% female, and took 8.9 (SD 2.6) drugs per day. Drugs for acid-related disorders, analgesics and anti-inflammatory drugs were the three most common drug groups where patient involvement and the shared-decision-making (SDM) process led to the joint decision to not pursue the GPs offer. Eighteen of 19 patients fully trusted their GP, 17 of 19 participated in SDM even before this study and 8 of 19 perceived polypharmacy as a substantial burden. Conservatism/inertia and fragmented medical care were the main barriers towards deprescribing. No patient felt devalued as a consequence of the deprescribing offer. Our exploratory findings were supported by patients' ratings of predefined statements.ConclusionWe identified patient involvement in deprescribing and coordination of care as key issues for deprescribing among older multimorbid patients with polypharmacy. GPs concerns regarding patients' devaluation should not prevent them from actively discussing the reduction of drugs.Trial registrationISRCTN16560559 .

Project description:ObjectivesDeprescribing has been proposed as a way to reduce polypharmacy in frail older people. We aimed to reduce the number of medicines consumed by people living in residential aged care facilities (RACF). Secondary objectives were to explore the effect of deprescribing on survival, falls, fractures, hospital admissions, cognitive, physical, and bowel function, quality of life, and sleep.MethodsNinety-five people aged over 65 years living in four RACF in rural mid-west Western Australia were randomised in an open study. The intervention group (n = 47) received a deprescribing intervention, the planned cessation of non-beneficial medicines. The control group (n = 48) received usual care. Participants were monitored for twelve months from randomisation. Primary outcome was change in the mean number of unique regular medicines. All outcomes were assessed at baseline, six, and twelve months.ResultsStudy participants had a mean age of 84.3 ± 6.9 years and 52% were female. Intervention group participants consumed 9.6 ± 5.0 and control group participants consumed 9.5 ± 3.6 unique regular medicines at baseline. Of the 348 medicines targeted for deprescribing (7.4 ± 3.8 per person, 78% of regular medicines), 207 medicines (4.4 ± 3.4 per person, 59% of targeted medicines) were successfully discontinued. The mean change in number of regular medicines at 12 months was -1.9 ± 4.1 in intervention group participants and +0.1 ± 3.5 in control group participants (estimated difference 2.0 ± 0.9, 95%CI 0.08, 3.8, p = 0.04). Twelve intervention participants and 19 control participants died within 12 months of randomisation (26% versus 40% mortality, p = 0.16, HR 0.60, 95%CI 0.30 to 1.22) There were no significant differences between groups in other secondary outcomes. The main limitations of this study were the open design and small participant numbers.ConclusionsDeprescribing reduced the number of regular medicines consumed by frail older people living in residential care with no significant adverse effects on survival or other clinical outcomes.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12611000370909.

Project description:IntroductionMultimorbidity and polypharmacy are important risk factors for drug-related hospital admissions (DRAs). DRAs are often linked to prescribing problems (overprescribing and underprescribing), as well as non-adherence with drug regimens for different reasons. In this trial, we aim to assess whether a structured medication review compared with standard care can reduce DRAs in multimorbid older patients with polypharmacy.Methods and analysisOPtimising thERapy to prevent Avoidable hospital admissions in Multimorbid older people is a European multicentre, cluster randomised, controlled trial. Hospitalised patients ≥70 years with ≥3 chronic medical conditions and concurrent use of ≥5 chronic medications are included in the four participating study centres of Bern (Switzerland), Utrecht (The Netherlands), Brussels (Belgium) and Cork (Ireland). Patients treated by the same prescribing physician constitute a cluster, and clusters are randomised 1:1 to either standard care or Systematic Tool to Reduce Inappropriate Prescribing (STRIP) intervention with the help of a clinical decision support system, the STRIP Assistant. STRIP is a structured method performing customised medication reviews, based on Screening Tool of Older People's Prescriptions/Screening Tool to Alert to Right Treatment criteria to detect potentially inappropriate prescribing. The primary endpoint is any DRA where the main reason or a contributory reason for the patient's admission is caused by overtreatment or undertreatment, and/or inappropriate treatment. Secondary endpoints include number of any hospitalisations, all-cause mortality, number of falls, quality of life, degree of polypharmacy, activities of daily living, patient's drug compliance, the number of significant drug-drug interactions, drug overuse and underuse and potentially inappropriate medication.Ethics and disseminationThe local Ethics Committees in Switzerland, Ireland, The Netherlands and Belgium approved this trial protocol. We will publish the results of this trial in a peer-reviewed journal.Main fundingEuropean Union's Horizon 2020 programme.Trial registration numberNCT02986425 , SNCTP000002183 , NTR6012, U1111-1181-9400.

Project description:BackgroundThe management of people with multiple chronic conditions challenges health-care systems designed around single conditions. There is international consensus that care for multimorbidity should be patient-centred, focus on quality of life, and promote self-management towards agreed goals. However, there is little evidence about the effectiveness of this approach. Our hypothesis was that the patient-centred, so-called 3D approach (based on dimensions of health, depression, and drugs) for patients with multimorbidity would improve their health-related quality of life, which is the ultimate aim of the 3D intervention.MethodsWe did this pragmatic cluster-randomised trial in general practices in England and Scotland. Practices were randomly allocated to continue usual care (17 practices) or to provide 6-monthly comprehensive 3D reviews, incorporating patient-centred strategies that reflected international consensus on best care (16 practices). Randomisation was computer-generated, stratified by area, and minimised by practice deprivation and list size. Adults with three or more chronic conditions were recruited. The primary outcome was quality of life (assessed with EQ-5D-5L) after 15 months' follow-up. Participants were not masked to group assignment, but analysis of outcomes was blinded. We analysed the primary outcome in the intention-to-treat population, with missing data being multiply imputed. This trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN06180958.FindingsBetween May 20, 2015, and Dec 31, 2015, we recruited 1546 patients from 33 practices and randomly assigned them to receive the intervention (n=797) or usual care (n=749). In our intention-to-treat analysis, there was no difference between trial groups in the primary outcome of quality of life (adjusted difference in mean EQ-5D-5L 0·00, 95% CI -0·02 to 0·02; p=0·93). 78 patients died, and the deaths were not considered as related to the intervention.InterpretationTo our knowledge, this trial is the largest investigation of the international consensus about optimal management of multimorbidity. The 3D intervention did not improve patients' quality of life.FundingNational Institute for Health Research.

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Effect of a patient-centred deprescribing procedure in older multimorbid patients in Swiss primary care - A cluster-randomised clinical trial.

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Effect of a patient-centred deprescribing procedure in older multimorbid patients in Swiss primary care - A cluster-randomised clinical trial.

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