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.
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 language | English |
|---|---|
| Article number | 103 |
| Number of pages | 11 |
| Journal | Trials |
| Volume | 21 |
| DOIs | |
| Publication status | Published - 21 Jan 2020 |
Bibliographical note
FundingThis 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.
Keywords
- older people
- pharmacist prescribing
- care homes
- polypharmacy
- randomised controlled trial
- Polypharmacy
- Older people
- Randomised controlled trial
- Pharmacist prescribing
- Care homes
- OLDER
- PEOPLE