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      Protocol for a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care homes: the CHIPPS study

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          Abstract

          Background

          Prescribing, monitoring and administration of medicines in care homes could be improved. Research has identified the need for one person to assume overall responsibility for the management of medicines within each care home. and shown that a pharmacist independent prescriber service is feasible in this context.

          Aims and objectives

          To conduct a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of a pharmacist-independent prescribing service in care homes compared to usual general practitioner (GP)-led care.

          Objectives

          To perform a definitive randomised controlled trial (RCT) with an internal pilot to determine the intervention’s effectiveness and cost-effectiveness and enable modelling beyond the end of the trial.

          Methods

          This protocol is for a cluster RCT with a 3-month internal pilot to confirm that recruitment is achievable, and there are no safety concerns. The unit of randomisation is a triad comprising a pharmacist-independent prescriber (PIP) based in a GP practice with sufficient registered patients resident in one or more care homes to allow recruitment of an average of 20 participants. In the intervention group, the PIP will, in collaboration with the GP: assume responsibility for prescribing and managing residents’ medicines including medication review and pharmaceutical care planning; support systematic ordering and administration in the care home, GP practice and supplying pharmacy; train care home and GP practice staff; communicate with GP practice, care home, supplying community pharmacy and study team.

          The intervention will last 6 months. The primary outcome will be resident falls at 6 months. Secondary outcomes include resident health-related quality of life, falls at 3 months, medication burden, medication appropriateness, mortality and hospitalisations. A full health economic analysis will be undertaken. The target sample size is 880 residents (440) in each arm) from 44 triads. This number is sufficient to detect a decrease in fall rate from 1.5 per individual to 1.178 (relative reduction of 21%) with 80% power and an ICC of 0.05 or less.

          Discussion

          Recruitment is on-going and the trial should complete in early 2020. The trial results will have implications for the future management of residents in care homes and the ongoing implementation of independent pharmacist prescribing.

          Trial registration

          ISRCTN, ID: 17847169. Registered on 15 December 2017.

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          Most cited references12

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          A drug burden index to define the functional burden of medications in older people.

          Older people carry a high burden of illness for which medications are indicated, along with increased risk of adverse drug reactions. We developed an index to determine drug burden based on pharmacologic principles. We evaluated the relationship of this index to physical and cognitive performance apart from disease indication. Data from the Health, Aging, and Body Composition Study on 3075 well-functioning community-dwelling persons aged 70 to 79 years were analyzed by multiple linear regression to assess the cross-sectional association of drug burden index with a validated composite continuous measure for physical function, and with the Digit Symbol Substitution Test for cognitive performance. Use of anticholinergic and sedative medications was associated with poorer physical performance score (anticholinergic exposure, 2.08 vs 2.21, P<.001; sedative exposure, 2.09 vs 2.19, P<.001) and cognitive performance on the Digit Symbol Substitution Test (anticholinergic exposure, 34.5 vs 35.5, P = .045; sedative exposure, 34.0 vs 35.5, P = .01). Associations were strengthened when exposure was calculated by principles of dose response. An increase of 1 U in drug burden index was associated with a deficit of 0.15 point (P<.001) on the physical function scale and 1.5 points (P = .01) on the Digit Symbol Substitution Test. These values were more than 3 times those associated with a single comorbid illness. The drug burden index demonstrates that anticholinergic and sedative drug exposure is associated with poorer function in community-dwelling older people. This pharmacologic approach provides a useful evidence-based tool for assessing the functional effect of exposure to medications in this population.
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            Clinical medication review by a pharmacist of elderly people living in care homes--randomised controlled trial.

            to measure the impact of pharmacist-conducted clinical medication review with elderly care home residents. randomised controlled trial of clinical medication review by a pharmacist against usual care. sixty-five care homes for the elderly in Leeds, UK. a total of 661 residents aged 65+ years on one or more medicines. clinical medication review by a pharmacist with patient and clinical records. Recommendations to general practitioner for approval and implementation. Control patients received usual general practitioner care. primary: number of changes in medication per participant. Secondary: number and cost of repeat medicines per participant; medication review rate; mortality, falls, hospital admissions, general practitioner consultations, Barthel index, Standardised Mini-Mental State Examination (SMMSE). the pharmacist reviewed 315/331 (95.2%) patients in 6 months. A total of 62/330 (18.8%) control patients were reviewed by their general practitioner. The mean number of drug changes per patient were 3.1 for intervention and 2.4 for control group (P < 0.0001). There were respectively 0.8 and 1.3 falls per patient (P < 0.0001). There was no significant difference for GP consultations per patient (means 2.9 and 2.8 in 6 months, P = 0.5), hospitalisations (means 0.2 and 0.3, P = 0.11), deaths (51/331 and 48/330, P = 0.81), Barthel score (9.8 and 9.3, P = 0.06), SMMSE score (13.9 and 13.8, P = 0.62), number and cost of drugs per patient (6.7 and 6.9, P = 0.5) (pounds sterling 42.24 and pounds sterling 42.94 per 28 days). A total of 75.6% (565/747) of pharmacist recommendations were accepted by the general practitioner; and 76.6% (433/565) of accepted recommendations were implemented. general practitioners do not review most care home patients' medication. A clinical pharmacist can review them and make recommendations that are usually accepted. This leads to substantial change in patients' medication regimens without change in drug costs. There is a reduction in the number of falls. There is no significant change in consultations, hospitalisation, mortality, SMMSE or Barthel scores.
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              Care homes’ use of medicines study: prevalence, causes and potential harm of medication errors in care homes for older people

              Introduction: Care home residents are at particular risk from medication errors, and our objective was to determine the prevalence and potential harm of prescribing, monitoring, dispensing and administration errors in UK care homes, and to identify their causes. Methods: A prospective study of a random sample of residents within a purposive sample of homes in three areas. Errors were identified by patient interview, note review, observation of practice and examination of dispensed items. Causes were understood by observation and from theoretically framed interviews with home staff, doctors and pharmacists. Potential harm from errors was assessed by expert judgement. Results: The 256 residents recruited in 55 homes were taking a mean of 8.0 medicines. One hundred and seventy-eight (69.5%) of residents had one or more errors. The mean number per resident was 1.9 errors. The mean potential harm from prescribing, monitoring, administration and dispensing errors was 2.6, 3.7, 2.1 and 2.0 (0 = no harm, 10 = death), respectively. Contributing factors from the 89 interviews included doctors who were not accessible, did not know the residents and lacked information in homes when prescribing; home staff’s high workload, lack of medicines training and drug round interruptions; lack of team work among home, practice and pharmacy; inefficient ordering systems; inaccurate medicine records and prevalence of verbal communication; and difficult to fill (and check) medication administration systems. Conclusions: That two thirds of residents were exposed to one or more medication errors is of concern. The will to improve exists, but there is a lack of overall responsibility. Action is required from all concerned.
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                Author and article information

                Contributors
                c.m.bond@abdn.ac.uk
                rch23@leicester.ac.uk
                d.p.alldred@leeds.ac.uk
                antony.arthur@uea.ac.uk
                G.Barton@uea.ac.uk
                A.Blyth@uea.ac.uk
                j.desborough@uea.ac.uk
                Joanna.Ford@addenbrookes.nhs.uk
                Christine.handford@yahoo.com
                caremanagement2015@gmail.com
                c.hughes@qub.ac.uk
                vivienne.maskrey@gmail.com
                phyo.myint@abdn.ac.uk
                N.Norris@uea.ac.uk
                f.poland@uea.ac.uk
                L.Shepstone@uea.ac.uk
                David.A.Turner@uea.ac.uk
                A.G.Zermansky@leeds.ac.uk
                d.j.wright@uea.ac.uk
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                21 January 2020
                21 January 2020
                2020
                : 21
                : 103
                Affiliations
                [1 ]ISNI 0000 0004 1936 7291, GRID grid.7107.1, Institute of Applied Health Sciences, School of Medicine, , University of Aberdeen, ; Foresterhill, Aberdeen, Scotland AB25 2ZD
                [2 ]ISNI 0000 0004 1936 8411, GRID grid.9918.9, Leicester Medical School, , University of Leicester, ; Leicester, UK
                [3 ]ISNI 0000 0004 1936 8403, GRID grid.9909.9, School of Healthcare, Baines Wing, , University of Leeds, ; Leeds, UK
                [4 ]ISNI 0000 0001 1092 7967, GRID grid.8273.e, School of Health Sciences, Faculty of Medicine and Health Sciences, , University of East Anglia, ; Norwich, UK
                [5 ]ISNI 0000 0001 1092 7967, GRID grid.8273.e, Norwich Medical School, , University of East Anglia, ; Norwich, UK
                [6 ]ISNI 0000 0001 1092 7967, GRID grid.8273.e, School of Pharmacy, , University of East Anglia, ; Norwich, UK
                [7 ]ISNI 0000 0004 0622 5016, GRID grid.120073.7, Consultant Geriatrician, , Addenbrookes Hospital Cambridge, ; Cambridge, UK
                [8 ]Norfolk and Suffolk Primary and Community Care Research Office, South Norfolk CCG, Norwich, UK
                [9 ]Athena Care Homes, Unit 2 Rima House, A13 Approach, Ripple Road, Barking, Essex, IG11 0RH UK
                [10 ]ISNI 0000 0004 0374 7521, GRID grid.4777.3, School of Pharmacy, , Queen’s University Belfast, ; Belfast, UK
                [11 ]ISNI 0000 0001 1092 7967, GRID grid.8273.e, School of Education and Lifelong Learning, , University of East Anglia, ; Norwich, UK
                [12 ]ISNI 0000 0001 1092 7967, GRID grid.8273.e, School of Health Sciences, , University of East Anglia, ; Norwich, UK
                [13 ]ISNI 0000 0004 1936 8403, GRID grid.9909.9, School of Healthcare, , University of Leeds, ; Leeds, UK
                [14 ]ISNI 0000 0001 1092 7967, GRID grid.8273.e, University of East Anglia, ; Norwich, UK
                Author information
                http://orcid.org/0000-0003-0429-5208
                Article
                3827
                10.1186/s13063-019-3827-0
                6975047
                31964398
                ac5dd94c-3aed-4ecb-8a44-b63dd524803d
                © The Author(s). 2020

                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
                : 15 July 2019
                : 22 October 2019
                Funding
                Funded by: NHS National Institute for Health Research
                Award ID: RP-PG-0613-20007
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2020

                Medicine
                older people,pharmacist prescribing,care homes,polypharmacy,randomised controlled trial
                Medicine
                older people, pharmacist prescribing, care homes, polypharmacy, randomised controlled trial

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