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      Improving care for elderly patients living with polypharmacy: protocol for a pragmatic cluster randomized trial in community-based primary care practices in Canada

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          Abstract

          Background

          Elders living with polypharmacy may be taking medications that do not benefit them. Polypharmacy can be associated with elevated risks of poor health, reduced quality of life, high care costs, and persistently complex care needs. While many medications could be problematic, this project targets medications that should be deprescribed for most elders and for which guidelines and evidence-based deprescribing tools are available. These are termed potentially inappropriate prescriptions (PIPs) and are as follows: proton pump inhibitors, benzodiazepines, antipsychotics, and sulfonylureas. Implementation strategies for deprescribing PIPs in complex older patient populations are needed.

          Methods

          This will be a pragmatic cluster randomized controlled trial in community-based primary care practices across Canada. Eligible practices provide comprehensive primary care and have at least one physician that consents to participate. Community-dwelling patients aged 65 years and older with ten or more unique medication prescriptions in the past year will be included. The objective is to assess whether the intervention reduces targeted PIPs for these patients compared with usual care. The intervention, Structured Process Informed by Data, Evidence and Research (SPIDER), is a collaboration between quality improvement (QI) and research programs. Primary care teams will form interprofessional Learning Collaboratives and work with QI coaches to review electronic medical record data provided by their regional Practice Based Research Networks (PBRNs), identify areas of improvement, and develop and implement changes. The study will be tested for feasibility in three PBRNs (Toronto, Montreal, and Edmonton) using prospective single-arm mixed methods. Findings will then guide a pragmatic cluster randomized controlled trial in five PBRNs (Calgary, Winnipeg, Ottawa, Montreal, and Halifax). Seven practices per PBRN will be recruited for each arm. The analysis will be by intention to treat. Ten percent of patients who have at least one PIP at baseline will be randomly selected to participate in the assessment of patient experience and self-reported outcomes. Qualitative methods will be used to explore patient and physician experience and evaluate SPIDER’s processes.

          Conclusion

          We are testing SPIDER in a primary care population with complex care needs. This could provide a widely applicable model for care improvement.

          Trial registration

          Clinicaltrials.gov NCT03689049; registered September 28, 2018

          Electronic supplementary material

          The online version of this article (10.1186/s13012-019-0904-4) contains supplementary material, which is available to authorized users.

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          Most cited references68

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          STOPP/START criteria for potentially inappropriate prescribing in older people: version 2

          Purpose: screening tool of older people's prescriptions (STOPP) and screening tool to alert to right treatment (START) criteria were first published in 2008. Due to an expanding therapeutics evidence base, updating of the criteria was required. Methods: we reviewed the 2008 STOPP/START criteria to add new evidence-based criteria and remove any obsolete criteria. A thorough literature review was performed to reassess the evidence base of the 2008 criteria and the proposed new criteria. Nineteen experts from 13 European countries reviewed a new draft of STOPP & START criteria including proposed new criteria. These experts were also asked to propose additional criteria they considered important to include in the revised STOPP & START criteria and to highlight any criteria from the 2008 list they considered less important or lacking an evidence base. The revised list of criteria was then validated using the Delphi consensus methodology. Results: the expert panel agreed a final list of 114 criteria after two Delphi validation rounds, i.e. 80 STOPP criteria and 34 START criteria. This represents an overall 31% increase in STOPP/START criteria compared with version 1. Several new STOPP categories were created in version 2, namely antiplatelet/anticoagulant drugs, drugs affecting, or affected by, renal function and drugs that increase anticholinergic burden; new START categories include urogenital system drugs, analgesics and vaccines. Conclusion: STOPP/START version 2 criteria have been expanded and updated for the purpose of minimizing inappropriate prescribing in older people. These criteria are based on an up-to-date literature review and consensus validation among a European panel of experts.
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            A systematic review of the emerging definition of 'deprescribing' with network analysis: implications for future research and clinical practice.

            The aim of this study was to identify what definitions have been published for the term 'deprescribing', and determine whether a unifying definition could be reached. A secondary aim was to uncover patterns between the published definitions which could explain any variation.
              • Record: found
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              Systematic review and meta-analysis of practice facilitation within primary care settings.

              This study was a systematic review with a quantitative synthesis of the literature examining the overall effect size of practice facilitation and possible moderating factors. The primary outcome was the change in evidence-based practice behavior calculated as a standardized mean difference. In this systematic review, we searched 4 electronic databases and the reference lists of published literature reviews to find practice facilitation studies that identified evidence-based guideline implementation within primary care practices as the outcome. We included randomized and nonrandomized controlled trials and prospective cohort studies published from 1966 to December 2010 in English language only peer-reviewed journals. Reviews of each study were conducted and assessed for quality; data were abstracted, and standardized mean difference estimates and 95% confidence intervals (CIs) were calculated using a random-effects model. Publication bias, influence, subgroup, and meta-regression analyses were also conducted. Twenty-three studies contributed to the analysis for a total of 1,398 participating practices: 697 practice facilitation intervention and 701 control group practices. The degree of variability between studies was consistent with what would be expected to occur by chance alone (I2 = 20%). An overall effect size of 0.56 (95% CI, 0.43-0.68) favored practice facilitation (z = 8.76; P <.001), and publication bias was evident. Primary care practices are 2.76 (95% CI, 2.18-3.43) times more likely to adopt evidence-based guidelines through practice facilitation. Meta-regression analysis indicated that tailoring (P = .05), the intensity of the intervention (P = .03), and the number of intervention practices per facilitator (P = .004) modified evidence-based guideline adoption. Practice facilitation has a moderately robust effect on evidence-based guideline adoption within primary care. Implementation fidelity factors, such as tailoring, the number of practices per facilitator, and the intensity of the intervention, have important resource implications.

                Author and article information

                Contributors
                416-756-6483 , michelle.greiver@nygh.on.ca
                sdahrouge@bruyere.org
                patricia.obrien@utoronto.ca
                dpmanca@ualberta.ca
                marie.therese.lussier@umontreal.ca
                jianmin.wang@nygh.on.ca
                fred.burge@dal.ca
                mathew.grandy@dal.ca
                (204)789-3314 , alexander.singer@umanitoba.ca
                margo.twohig@nygh.on.ca
                rahim.moineddin@utoronto.ca
                sumeet.kalia@utoronto.ca
                babaka@cpcssn.org
                noahivers@gmail.com
                sgaries@ucalgary.ca
                justin.turner@criugm.qc.ca
                bfarrell@bruyere.org
                Journal
                Implement Sci
                Implement Sci
                Implementation Science : IS
                BioMed Central (London )
                1748-5908
                6 June 2019
                6 June 2019
                2019
                : 14
                : 55
                Affiliations
                [1 ]ISNI 0000 0004 0485 2091, GRID grid.416529.d, North York General Hospital, ; 4001 Leslie Street, LE-140, Toronto, Ontario M2K 1E1 Canada
                [2 ]ISNI 0000 0001 2157 2938, GRID grid.17063.33, Department of Family and Community Medicine, Faculty of Medicine, , University of Toronto, ; 4001 Leslie Street, LE-140, Toronto, Ontario M2K 1E1 Canada
                [3 ]ISNI 0000 0001 2182 2255, GRID grid.28046.38, Department of Family Medicine, , University of Ottawa, ; 85 Primrose Avenue, Ottawa, Ontario K1R 6M1 Canada
                [4 ]ISNI 0000 0000 9064 3333, GRID grid.418792.1, Bruyère Research Institute, ; 43 Bruyère Street, Ottawa, Ontario K1N 5C8 Canada
                [5 ]GRID grid.17089.37, Department of Family Medicine, , University of Alberta, ; 8303 - 112 Street NW, 610 University Terrace, Edmonton, Alberta T6G 2T4 Canada
                [6 ]ISNI 0000 0001 2292 3357, GRID grid.14848.31, Department of Family Medicine and Emergency Medicine, , University of Montreal, ; 1755 René Laennec, Bureau DS-079, Laval, Québec H7M3L9 Canada
                [7 ]ISNI 0000 0004 1936 8200, GRID grid.55602.34, Department of Family Medicine, , Dalhousie University, ; 8F, 8525 Abbie J Lane Building, 5909 Veterans’ Memorial Lane, Halifax, Nova Scotia B3H 2E2 Canada
                [8 ]ISNI 0000 0004 1936 9609, GRID grid.21613.37, Department of Family Medicine, , University of Manitoba, ; D009 – 780 Bannatyne Ave, Winnipeg, Manitoba R3T 2N2 Canada
                [9 ]ISNI 0000 0004 0474 0188, GRID grid.417199.3, Family Practice Health Centre and Women’s College Research Institute, , Women’s College Hospital, ; 76 Grenville Street, Toronto, Ontario M5S 1B2 Canada
                [10 ]ISNI 0000 0004 1936 7697, GRID grid.22072.35, Department of family Medicine, Cumming School of Medicine, , University of Calgary, ; G012 Health Sciences Centre, 3330 Hospital Drive NW, Calgary, Alberta T2N 4N1 Canada
                [11 ]ISNI 0000 0001 2292 3357, GRID grid.14848.31, Faculty of Pharmacy, , University of Montreal, ; 2900 Edouard Montpetit Boulevard, Montreal, Quebec H3T 1J4 Canada
                [12 ]GRID grid.294071.9, Centre de Recherche, , Institut Universitaire de Geriatrie de Montreal, ; Montreal, Canada
                [13 ]ISNI 0000 0000 8644 1405, GRID grid.46078.3d, School of Pharmacy, , University of Waterloo, ; Waterloo, Canada
                [14 ]ISNI 0000 0000 8849 1617, GRID grid.418647.8, ICES, ; Toronto, Canada
                [15 ]ISNI 0000 0001 2157 2938, GRID grid.17063.33, Institute of Health Policy, Management and Evaluation, , University of Toronto, ; 500 University Avenue, Toronto, Ontario M5G 1V7 Canada
                Author information
                http://orcid.org/0000-0001-8957-0285
                Article
                904
                10.1186/s13012-019-0904-4
                6551894
                31171011
                5d56fc1b-eab7-4caa-874d-f3aeab53151e
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 26 April 2019
                : 13 May 2019
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000024, Canadian Institutes of Health Research;
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2019

                Medicine
                polypharmacy,inappropriate prescribing,aged,primary health care,quality improvement,electronic health records,social facilitation,clinical trials, randomized

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