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

Christine Bond*, Richard Holland, David P Alldred, Antony Arthur, Garry Barton, Annie Blyth, James Desborough, Joanna Ford, Christine Handford, Helen Hill, Carmel Hughes, Vivienne Maskrey, Kate Massey, Phyo K. Myint, Nigel Norris, Fiona M. Poland, Lee Shepstone, David Turner, Arnold Zermansky, David Wrightthe CHIPPS Team

*Corresponding author for this work

Research output: Contribution to journalArticle

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.
Original languageEnglish
Article number103
Number of pages11
JournalTrials
Volume21
DOIs
Publication statusPublished - 21 Jan 2020

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Home Care Services
Pharmacists
Cost-Benefit Analysis
Randomized Controlled Trials
General Practitioners
General Practice
Pharmaceutical Services
Pharmacies
Random Allocation
Sample Size
Hospitalization
Economics
Quality of Life
Safety
Mortality
Health
Research

Keywords

  • older people
  • pharmacist prescribing
  • care homes
  • polypharmacy
  • randomised controlled trial

Cite this

Protocol for a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care homes : the CHIPPS study. / Bond, Christine; Holland, Richard; Alldred, David P ; Arthur, Antony; Barton, Garry; Blyth, Annie; Desborough, James; Ford, Joanna; Handford, Christine; Hill, Helen; Hughes, Carmel; Maskrey, Vivienne; Massey, Kate; Myint, Phyo K.; Norris, Nigel; Poland, Fiona M.; Shepstone, Lee; Turner, David; Zermansky, Arnold; Wright, David ; the CHIPPS Team.

In: Trials, Vol. 21, 103, 21.01.2020.

Research output: Contribution to journalArticle

Bond, C, Holland, R, Alldred, DP, Arthur, A, Barton, G, Blyth, A, Desborough, J, Ford, J, Handford, C, Hill, H, Hughes, C, Maskrey, V, Massey, K, Myint, PK, Norris, N, Poland, FM, Shepstone, L, Turner, D, Zermansky, A, Wright, D & the CHIPPS Team 2020, 'Protocol for a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care homes: the CHIPPS study', Trials, vol. 21, 103. https://doi.org/10.1186/s13063-019-3827-0
Bond, Christine ; Holland, Richard ; Alldred, David P ; Arthur, Antony ; Barton, Garry ; Blyth, Annie ; Desborough, James ; Ford, Joanna ; Handford, Christine ; Hill, Helen ; Hughes, Carmel ; Maskrey, Vivienne ; Massey, Kate ; Myint, Phyo K. ; Norris, Nigel ; Poland, Fiona M. ; Shepstone, Lee ; Turner, David ; Zermansky, Arnold ; Wright, David ; the CHIPPS Team. / Protocol for a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care homes : the CHIPPS study. In: Trials. 2020 ; Vol. 21.
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title = "Protocol for a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care homes: the CHIPPS study",
abstract = "BackgroundPrescribing, 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 objectivesTo 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.ObjectivesTo 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.MethodsThis 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.DiscussionRecruitment 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 registrationISRCTN, ID: 17847169. Registered on 15 December 2017.",
keywords = "older people, pharmacist prescribing, care homes, polypharmacy, randomised controlled trial",
author = "Christine Bond and Richard Holland and Alldred, {David P} and Antony Arthur and Garry Barton and Annie Blyth and James Desborough and Joanna Ford and Christine Handford and Helen Hill and Carmel Hughes and Vivienne Maskrey and Kate Massey and Myint, {Phyo K.} and Nigel Norris and Poland, {Fiona M.} and Lee Shepstone and David Turner and Arnold Zermansky and David Wright and {the CHIPPS Team}",
note = "Funding This study is funded by the National Institute for Health Research (NIHR) (Programme Grants for Applied Research (Grant Reference Number RP-PG-0613-20007)). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Other than receiving routine monitoring reports, the funders have had no further involvement in the design and conduct of the trial nor any input to this paper. A copy of the paper has been sent to them for information. Acknowledgements We also thank the members of the research team who have contributed, or are contributing, daily to deliver the RCT (University of East Anglia: Laura Watts, Joanna Williams, Bronwen Harry, Jeanette Blacklock, Caroline Hill, Frances Johnston; University of Aberdeen: Jacqueline Inch, Frances Notman, Lindsey Dalgarno; University of Leeds: Amrit Daffu O’Reilly; Queens University Belfast: Anna Millar, Maureen Spargo, Mairead McGrattan); PPIRes (Public and Patient Involvement in Research) for being formal collaborators on the grant and for advice on ongoing conduct of the study as represented by Kate Massey (sadly deceased) and Christine Handford. We thank Ian Small, lead primary care medicines management pharmacist in Norwich (now retired) and a co-applicant on the NIHR programme grant. On behalf of the CHIPPS Team, we would also like to acknowledge the NHS South Norfolk Clinical Commissioning Group (CCG) as the study sponsor and host of PPIRes and, especially, Clare Symms, Norfolk and Suffolk Primary and Community Care Research Office for her contribution towards management of the study budget. The research is also supported by the NIHR Yorkshire and Humber Patient Safety Translational Research Centre.",
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TY - JOUR

T1 - Protocol for a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care homes

T2 - the CHIPPS study

AU - Bond, Christine

AU - Holland, Richard

AU - Alldred, David P

AU - Arthur, Antony

AU - Barton, Garry

AU - Blyth, Annie

AU - Desborough, James

AU - Ford, Joanna

AU - Handford, Christine

AU - Hill, Helen

AU - Hughes, Carmel

AU - Maskrey, Vivienne

AU - Massey, Kate

AU - Myint, Phyo K.

AU - Norris, Nigel

AU - Poland, Fiona M.

AU - Shepstone, Lee

AU - Turner, David

AU - Zermansky, Arnold

AU - Wright, David

AU - the CHIPPS Team

N1 - Funding This study is funded by the National Institute for Health Research (NIHR) (Programme Grants for Applied Research (Grant Reference Number RP-PG-0613-20007)). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Other than receiving routine monitoring reports, the funders have had no further involvement in the design and conduct of the trial nor any input to this paper. A copy of the paper has been sent to them for information. Acknowledgements We also thank the members of the research team who have contributed, or are contributing, daily to deliver the RCT (University of East Anglia: Laura Watts, Joanna Williams, Bronwen Harry, Jeanette Blacklock, Caroline Hill, Frances Johnston; University of Aberdeen: Jacqueline Inch, Frances Notman, Lindsey Dalgarno; University of Leeds: Amrit Daffu O’Reilly; Queens University Belfast: Anna Millar, Maureen Spargo, Mairead McGrattan); PPIRes (Public and Patient Involvement in Research) for being formal collaborators on the grant and for advice on ongoing conduct of the study as represented by Kate Massey (sadly deceased) and Christine Handford. We thank Ian Small, lead primary care medicines management pharmacist in Norwich (now retired) and a co-applicant on the NIHR programme grant. On behalf of the CHIPPS Team, we would also like to acknowledge the NHS South Norfolk Clinical Commissioning Group (CCG) as the study sponsor and host of PPIRes and, especially, Clare Symms, Norfolk and Suffolk Primary and Community Care Research Office for her contribution towards management of the study budget. The research is also supported by the NIHR Yorkshire and Humber Patient Safety Translational Research Centre.

PY - 2020/1/21

Y1 - 2020/1/21

N2 - BackgroundPrescribing, 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 objectivesTo 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.ObjectivesTo 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.MethodsThis 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.DiscussionRecruitment 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 registrationISRCTN, ID: 17847169. Registered on 15 December 2017.

AB - BackgroundPrescribing, 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 objectivesTo 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.ObjectivesTo 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.MethodsThis 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.DiscussionRecruitment 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 registrationISRCTN, ID: 17847169. Registered on 15 December 2017.

KW - older people

KW - pharmacist prescribing

KW - care homes

KW - polypharmacy

KW - randomised controlled trial

U2 - 10.1186/s13063-019-3827-0

DO - 10.1186/s13063-019-3827-0

M3 - Article

VL - 21

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 103

ER -