Project description:BackgroundManagement 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.MethodsThis 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.ResultsThree 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.ConclusionOur 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 registrationCurrent Controlled Trials, prospectively registered ISRCTN16560559 Date assigned 31/10/2014. The Prevention of Polypharmacy in Primary Care Patients Trial (4P-RCT).

Project description:ObjectivesProton pump inhibitors (PPIs) are widely prescribed medications and commonly used for the treatment of gastric acid-related disorders. Nevertheless, PPIs are often overused leading to potential adverse effects and unnecessary healthcare costs. Deprescribing strategies have emerged to safely reduce or substitute inappropriate PPIs and optimise patient care in an evidence-based manner. This protocol describes a study to evaluate the effectiveness of a PPI deprescribing intervention in comparison to usual care in the Swiss primary care setting.DesignAn open-label, cluster randomised controlled trial.SettingSwiss primary care settings.ParticipantsIncluded participants will be adults with inappropriate PPI treatment and will be recruited by general practitioners (GPs). Participants treated by the same GP constitute a cluster. Clusters are randomised 1:1 to either the intervention group or the control group.InterventionsThe intervention components consist of deprescribing tools including educational material, decision aids for both participants and GPs, and additional trainings for GPs only. Patients in the control group will receive usual care. Data will be collected at baseline, 3-, 6-, 9- and 12-month follow-up time through online surveys or a phone call for both GPs and participants.Primary and secondary outcome measuresThe first co-primary endpoint is the effectiveness of the deprescribing intervention measured by the change of prescribed PPI dose. The second co-primary endpoint is safety, which is measured with the Reflux Disease Questionnaire assessing change in gastrointestinal symptoms. There are several secondary endpoints, such as the total number of prescribed medications, occurrences of changes in prescription patterns, PPI discontinuation and cost-effectiveness.ConclusionsThe findings from this study will provide evidence on the effectiveness and safety of a PPI deprescribing intervention for patients and GPs. Successful implementation of our PPI deprescribing strategy has the potential to improve patient outcomes and lower costs.Trial registration numberNCT06129474.

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: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:BackgroundTargeted deprescribing of anticholinergic and sedative medications in older people may improve their health outcomes. This trial will determine if pharmacist-led reviews lead to general practitioners deprescribing anticholinergic and sedative medications in older people living in the community.Methods and analysisThe standard protocol items: Recommendations for Interventional Trials (SPIRIT) checklist was used to develop and report the protocol. The trial will involve older adults stratified by frailty (low, medium, and high). This will be a pragmatic two-arm randomized controlled trial to test general practitioner uptake of pharmacist recommendations to deprescribe anticholinergic and sedative medications that are causing adverse side effects in patients.Study populationCommunity-dwelling frail adults, 65 years or older, living in the Canterbury region of New Zealand, seeking publicly funded home support services or admission to aged residential care and taking at least one anticholinergic or sedative medication regularly.InterventionNew Zealand registered pharmacists using peer-reviewed deprescribing guidelines will visit participants at home in the community, review their medications, and recommend anticholinergic and sedative medications that could be deprescribed to the participant's general practitioner. The total use of anticholinergic and sedative medications will be quantified using the Drug Burden Index (DBI).OutcomesThe primary outcome will be the change in total DBI between baseline and 6-month follow-up. Secondary outcomes will include entry into aged residential care, prolonged hospitalization, and death.Data collection pointsData will be collected at the time of interRAI assessments (T0), at the time of the baseline review (T1), at 6 months following the baseline review (T2), and at the end of the study period, or end of study participation for participants admitted into aged residential care, or who died (T3).Ethics and disseminationEthical approval has been obtained from the Human, Disability and Ethics Committee: ethical number (17CEN265).Trial registrationClinicalTrials.gov ACTRN12618000729224 . Registered on May 2, 2018, with the Australian New Zealand Clinical Trials Registry.

Project description:ObjectiveTo investigate the association between older patients' willingness to have one or more medications deprescribed and: (1) change in medications, (2) change in the appropriateness of medications and (3) implementation of prescribing recommendations generated by the electronic decision support system tested in the 'Optimising PharmacoTherapy In the Multimorbid Elderly in Primary CAre' (OPTICA) trial.DesignA longitudinal sub-study of the OPTICA trial, a cluster randomised controlled trial.SettingSwiss primary care settings.ParticipantsParticipants were aged ≥65 years, with ≥3 chronic conditions and ≥5 regular medications recruited from 43 general practitioner (GP) practices.ExposuresPatients' willingness to have medications deprescribed was assessed using three questions from the 'revised Patient Attitudes Towards Deprescribing' (rPATD) questionnaire and its concerns about stopping score.Measures/analysesMedication-related outcomes were collected at 1 year follow-up. Aim 1 outcome: change in the number of long-term medications between baseline and 12 month follow-up. Aim 2 outcome: change in medication appropriateness (Medication Appropriateness Index). Aim 3 outcome: binary variable on whether any prescribing recommendation generated during the OPTICA medication review was implemented. We used multilevel linear regression analyses (aim 1 and aim 2) and multilevel logistic regression analyses (aim 3). Models were adjusted for sociodemographic variables and the clustering effect at GP level.Results298 patients completed the rPATD, 45% were women and 78 years was the median age. A statistically significant association was found between the concerns about stopping score and the change in the number of medications over time (per 1-unit increase in the score the average number of medications use was 0.65 higher; 95% CI: 0.08 to 1.22). Other than that we did not find evidence for statistically significant associations between patients' agreement with deprescribing and medication-related outcomes.ConclusionsWe did not find evidence for an association between most measures of patient agreement with deprescribing and medication-related outcomes over 1 year.Trial registration numberNCT03724539.

Project description:BackgroundPotentially inappropriate medications (PIMs) are common among nursing homes (NH) residents, as is polypharmacy. Deprescribing has emerged in the past decade as a safe and effective way to reduce the use of PIMs and improve patient outcomes. However, effective deprescribing interventions are expensive, as they require specialised staff and a great amount of time for each resident. The Quality Circle Deprescribing Module (QC-DeMo) intervention was designed to be less resource-intensive than medication reviews, the current deprescribing gold standard. It consists of a QC session in which physicians, nurses, and pharmacists define a local deprescribing consensus for specific PIMs classes, which is then implemented in the NH. The intervention was trialled in a RCT, with the NH as unit of analysis.MethodsAfter randomisation, intervention NHs enacted the QC-DeMo at the start of the follow-up year. The primary outcomes were the proportion of PIM galenic units and number of PIM defined daily dose per average resident and per day (DDD/res). PIM status was assessed by a combination of the 2015 Beers list and the Norwegian General Practice-Nursing Home criteria. Secondary outcomes were the number of DDD/res to avoid and to reevaluate; safety outcomes were mortality, hospitalisations, falls, and use of physical restraints. Outcomes were evaluated at follow-up using linear regression models, adjusting for the outcome baseline values.ResultsFifty-eight NHs took part in the trial; no individual residents were recruited. The intervention did not reduce the primary outcomes, but a strong trend towards reduction was seen for the number of PIM DDD/res, which accounts for the doses used. PIM DDD/res to reevaluate were significantly reduced, mostly through a reduction in the use of proton-pump inhibitors. Falls and use of physical restraints were not affected, but a statistical interaction between the mission of the NH (geriatric unit or specialised dementia unit) and the intervention group was seen for mortality and hospitalisations.ConclusionsThe QC-DeMo intervention can reduce the use of some PIM classes, and could usefully complement other deprescribing interventions.Trial registrationClinicalTrials.gov ( NCT03688542 ), registered on 26.09.2018, retrospectively registered.

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Impact of a deprescribing tool on the use of sedative hypnotics among older patients: study protocol for a cluster randomised controlled trial in Swiss primary care (the HYPE trial)

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