Evaluation of effectiveness and safety of pharmacist independent prescribers in care homes: cluster randomised controlled trial

Richard Holland; Christine Bond; David P Alldred; Antony Arthur; Garry Barton; Linda Birt; Jeanette Blacklock; Annie Blyth; Stamatina Cheilari; Amrit Daffu-O'Reilly; Lindsay Dalgarno; James Desborough; Joanna Ford; Kelly Grant; Bronwen Harry; Helen Hill; Carmel Hughes; Jacqueline Inch; Vivienne Maskrey; Phyo Myint; Nigel Norris; Fiona Poland; Lee Shepstone; Maureen Spargo; David Turner; Laura Watts; Arnold Zermansky; David Wright

doi:10.1136/bmj-2022-071883

Evaluation of effectiveness and safety of pharmacist independent prescribers in care homes: cluster randomised controlled trial

Richard Holland, Christine Bond, David P Alldred, Antony Arthur, Garry Barton, Linda Birt, Jeanette Blacklock, Annie Blyth, Stamatina Cheilari, Amrit Daffu-O'Reilly, Lindsay Dalgarno, James Desborough, Joanna Ford, Kelly Grant, Bronwen Harry, Helen Hill, Carmel Hughes, Jacqueline Inch, Vivienne Maskrey, Phyo MyintNigel Norris, Fiona Poland, Lee Shepstone, Maureen Spargo, David Turner, Laura Watts, Arnold Zermansky, David Wright^* (Corresponding Author)

^*Corresponding author for this work

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Abstract

OBJECTIVE: To estimate the effectiveness, cost effectiveness (to be reported elsewhere), and safety of pharmacy independent prescribers in care homes.

DESIGN: Cluster randomised controlled trial, with clusters based on triads of a pharmacist independent prescriber, a general practice, and one to three associated care homes.

SETTING: Care homes across England, Scotland, and Northern Ireland, their associated general practices, and pharmacy independent prescribers, formed into triads.

PARTICIPANTS: 49 triads and 882 residents were randomised. Participants were care home residents, aged ≥65 years, taking at least one prescribed drug, recruited to 20 residents/triad.

INTERVENTION: Each pharmacy independent prescriber provided pharmaceutical care to approximately 20 residents across one to three care homes, with weekly visits over six months. Pharmacy independent prescribers developed a pharmaceutical care plan for each resident, did medicines reviews/reconciliation, trained staff, and supported with medicines related procedures, deprescribing, and authorisation of prescriptions. Participants in the control group received usual care.

MAIN OUTCOMES MEASURES: The primary outcome was fall rate/person at six months analysed by intention to treat, adjusted for prognostic variables. Secondary outcomes included quality of life (EQ-5D by proxy), Barthel score, Drug Burden Index, hospital admissions, and mortality. Assuming a 21% reduction in falls, 880 residents were needed, allowing for 20% attrition.

RESULTS: The average age of participants at study entry was 85 years; 70% were female. 697 falls (1.55 per resident) were recorded in the intervention group and 538 falls (1.26 per resident) in the control group at six months. The fall rate risk ratio for the intervention group compared with the control group was not significant (0.91, 95% confidence interval 0.66 to 1.26) after adjustment for all model covariates. Secondary outcomes were not significantly different between groups, with exception of the Drug Burden Index, which significantly favoured the intervention. A third (185/566; 32.7%) of pharmacy independent prescriber interventions involved medicines associated with falls. No adverse events or safety concerns were identified.

CONCLUSIONS: Change in the primary outcome of falls was not significant. Limiting follow-up to six months combined with a small proportion of interventions predicted to affect falls may explain this. A significant reduction in the Drug Burden Index was realised and would be predicted to yield future clinical benefits for patients. This large trial of an intensive weekly pharmacist intervention with care home residents was also found to be safe and well received.

TRIAL REGISTRATION: ISRCTN 17847169.

Original language	English
Article number	e071883
Number of pages	9
Journal	BMJ (Clinical research ed.)
Volume	380
Early online date	14 Feb 2023
DOIs	https://doi.org/10.1136/bmj-2022-071883
Publication status	Published - 14 Feb 2023

Bibliographical note

Acknowledgments
We thank all participating care home residents, care homes, and general practices; the pharmacist independent prescribers; our patient and public involvement group; our pharmacist trainers and assessors; Norwich Clinical Trials Unit; Comprehensive Research Network Eastern; our sponsor (Norfolk and Waveney CCG); members of our Programme Steering Committee and Data Monitoring and Ethics Committee; our funders; and all the many other people who supported the delivery of the programme of research that culminated in this trial.
Funding: This work was funded by National Institutes of Health Research (NIHR) through their Programme Grant for Applied Research (PGfAR) stream (RP-PG-0613-20007). The funder had no role in design, data collection, data analysis, data interpretation, or writing of this paper.

Data Availability Statement

Data availability statement
De-identified participant data, including primary, secondary, and patient reported outcome data, interview transcripts, prescription data, protocol, and statistical analysis plan, are available on request from DW (d.j.wright@leicester.ac.uk), LS (l.shepstone@uea.ac.uk), and Norfolk and Waveney Integrated Care Board (NWICB) research office (nwicb.RandDoffice@nhs.net). Reuse of the CHIPPS dataset will be made available on reasonable request for the purpose of improving patient care in health and social care and will be subject to completion of a data sharing agreement between NWICB, the University of East Anglia, and the third-party organisation.

Keywords

Humans
Female
Aged, 80 and over
Male
Pharmacists
Quality of Life
Northern Ireland
Scotland
Pharmaceutical Services

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Holland, R., Bond, C., Alldred, D. P., Arthur, A., Barton, G., Birt, L., Blacklock, J., Blyth, A., Cheilari, S., Daffu-O'Reilly, A., Dalgarno, L., Desborough, J., Ford, J., Grant, K., Harry, B., Hill, H., Hughes, C., Inch, J., Maskrey, V., ... Wright, D. (2023). Evaluation of effectiveness and safety of pharmacist independent prescribers in care homes: cluster randomised controlled trial. BMJ (Clinical research ed.), 380, Article e071883. https://doi.org/10.1136/bmj-2022-071883

Holland, R, Bond, C, Alldred, DP, Arthur, A, Barton, G, Birt, L, Blacklock, J, Blyth, A, Cheilari, S, Daffu-O'Reilly, A, Dalgarno, L, Desborough, J, Ford, J, Grant, K, Harry, B, Hill, H, Hughes, C, Inch, J, Maskrey, V, Myint, P, Norris, N, Poland, F, Shepstone, L, Spargo, M, Turner, D, Watts, L, Zermansky, A & Wright, D 2023, 'Evaluation of effectiveness and safety of pharmacist independent prescribers in care homes: cluster randomised controlled trial', BMJ (Clinical research ed.), vol. 380, e071883. https://doi.org/10.1136/bmj-2022-071883

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abstract = "OBJECTIVE: To estimate the effectiveness, cost effectiveness (to be reported elsewhere), and safety of pharmacy independent prescribers in care homes.DESIGN: Cluster randomised controlled trial, with clusters based on triads of a pharmacist independent prescriber, a general practice, and one to three associated care homes.SETTING: Care homes across England, Scotland, and Northern Ireland, their associated general practices, and pharmacy independent prescribers, formed into triads.PARTICIPANTS: 49 triads and 882 residents were randomised. Participants were care home residents, aged ≥65 years, taking at least one prescribed drug, recruited to 20 residents/triad.INTERVENTION: Each pharmacy independent prescriber provided pharmaceutical care to approximately 20 residents across one to three care homes, with weekly visits over six months. Pharmacy independent prescribers developed a pharmaceutical care plan for each resident, did medicines reviews/reconciliation, trained staff, and supported with medicines related procedures, deprescribing, and authorisation of prescriptions. Participants in the control group received usual care.MAIN OUTCOMES MEASURES: The primary outcome was fall rate/person at six months analysed by intention to treat, adjusted for prognostic variables. Secondary outcomes included quality of life (EQ-5D by proxy), Barthel score, Drug Burden Index, hospital admissions, and mortality. Assuming a 21% reduction in falls, 880 residents were needed, allowing for 20% attrition.RESULTS: The average age of participants at study entry was 85 years; 70% were female. 697 falls (1.55 per resident) were recorded in the intervention group and 538 falls (1.26 per resident) in the control group at six months. The fall rate risk ratio for the intervention group compared with the control group was not significant (0.91, 95% confidence interval 0.66 to 1.26) after adjustment for all model covariates. Secondary outcomes were not significantly different between groups, with exception of the Drug Burden Index, which significantly favoured the intervention. A third (185/566; 32.7%) of pharmacy independent prescriber interventions involved medicines associated with falls. No adverse events or safety concerns were identified.CONCLUSIONS: Change in the primary outcome of falls was not significant. Limiting follow-up to six months combined with a small proportion of interventions predicted to affect falls may explain this. A significant reduction in the Drug Burden Index was realised and would be predicted to yield future clinical benefits for patients. This large trial of an intensive weekly pharmacist intervention with care home residents was also found to be safe and well received.TRIAL REGISTRATION: ISRCTN 17847169.",

keywords = "Humans, Female, Aged, 80 and over, Male, Pharmacists, Quality of Life, Northern Ireland, Scotland, Pharmaceutical Services",

author = "Richard Holland and Christine Bond and Alldred, {David P} and Antony Arthur and Garry Barton and Linda Birt and Jeanette Blacklock and Annie Blyth and Stamatina Cheilari and Amrit Daffu-O'Reilly and Lindsay Dalgarno and James Desborough and Joanna Ford and Kelly Grant and Bronwen Harry and Helen Hill and Carmel Hughes and Jacqueline Inch and Vivienne Maskrey and Phyo Myint and Nigel Norris and Fiona Poland and Lee Shepstone and Maureen Spargo and David Turner and Laura Watts and Arnold Zermansky and David Wright",

note = "Acknowledgments We thank all participating care home residents, care homes, and general practices; the pharmacist independent prescribers; our patient and public involvement group; our pharmacist trainers and assessors; Norwich Clinical Trials Unit; Comprehensive Research Network Eastern; our sponsor (Norfolk and Waveney CCG); members of our Programme Steering Committee and Data Monitoring and Ethics Committee; our funders; and all the many other people who supported the delivery of the programme of research that culminated in this trial. Funding: This work was funded by National Institutes of Health Research (NIHR) through their Programme Grant for Applied Research (PGfAR) stream (RP-PG-0613-20007). The funder had no role in design, data collection, data analysis, data interpretation, or writing of this paper.",

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doi = "10.1136/bmj-2022-071883",

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T1 - Evaluation of effectiveness and safety of pharmacist independent prescribers in care homes

T2 - cluster randomised controlled trial

AU - Holland, Richard

AU - Bond, Christine

AU - Alldred, David P

AU - Arthur, Antony

AU - Barton, Garry

AU - Birt, Linda

AU - Blacklock, Jeanette

AU - Blyth, Annie

AU - Cheilari, Stamatina

AU - Daffu-O'Reilly, Amrit

AU - Dalgarno, Lindsay

AU - Desborough, James

AU - Ford, Joanna

AU - Grant, Kelly

AU - Harry, Bronwen

AU - Hill, Helen

AU - Hughes, Carmel

AU - Inch, Jacqueline

AU - Maskrey, Vivienne

AU - Myint, Phyo

AU - Norris, Nigel

AU - Poland, Fiona

AU - Shepstone, Lee

AU - Spargo, Maureen

AU - Turner, David

AU - Watts, Laura

AU - Zermansky, Arnold

AU - Wright, David

N1 - Acknowledgments We thank all participating care home residents, care homes, and general practices; the pharmacist independent prescribers; our patient and public involvement group; our pharmacist trainers and assessors; Norwich Clinical Trials Unit; Comprehensive Research Network Eastern; our sponsor (Norfolk and Waveney CCG); members of our Programme Steering Committee and Data Monitoring and Ethics Committee; our funders; and all the many other people who supported the delivery of the programme of research that culminated in this trial. Funding: This work was funded by National Institutes of Health Research (NIHR) through their Programme Grant for Applied Research (PGfAR) stream (RP-PG-0613-20007). The funder had no role in design, data collection, data analysis, data interpretation, or writing of this paper.

PY - 2023/2/14

Y1 - 2023/2/14

N2 - OBJECTIVE: To estimate the effectiveness, cost effectiveness (to be reported elsewhere), and safety of pharmacy independent prescribers in care homes.DESIGN: Cluster randomised controlled trial, with clusters based on triads of a pharmacist independent prescriber, a general practice, and one to three associated care homes.SETTING: Care homes across England, Scotland, and Northern Ireland, their associated general practices, and pharmacy independent prescribers, formed into triads.PARTICIPANTS: 49 triads and 882 residents were randomised. Participants were care home residents, aged ≥65 years, taking at least one prescribed drug, recruited to 20 residents/triad.INTERVENTION: Each pharmacy independent prescriber provided pharmaceutical care to approximately 20 residents across one to three care homes, with weekly visits over six months. Pharmacy independent prescribers developed a pharmaceutical care plan for each resident, did medicines reviews/reconciliation, trained staff, and supported with medicines related procedures, deprescribing, and authorisation of prescriptions. Participants in the control group received usual care.MAIN OUTCOMES MEASURES: The primary outcome was fall rate/person at six months analysed by intention to treat, adjusted for prognostic variables. Secondary outcomes included quality of life (EQ-5D by proxy), Barthel score, Drug Burden Index, hospital admissions, and mortality. Assuming a 21% reduction in falls, 880 residents were needed, allowing for 20% attrition.RESULTS: The average age of participants at study entry was 85 years; 70% were female. 697 falls (1.55 per resident) were recorded in the intervention group and 538 falls (1.26 per resident) in the control group at six months. The fall rate risk ratio for the intervention group compared with the control group was not significant (0.91, 95% confidence interval 0.66 to 1.26) after adjustment for all model covariates. Secondary outcomes were not significantly different between groups, with exception of the Drug Burden Index, which significantly favoured the intervention. A third (185/566; 32.7%) of pharmacy independent prescriber interventions involved medicines associated with falls. No adverse events or safety concerns were identified.CONCLUSIONS: Change in the primary outcome of falls was not significant. Limiting follow-up to six months combined with a small proportion of interventions predicted to affect falls may explain this. A significant reduction in the Drug Burden Index was realised and would be predicted to yield future clinical benefits for patients. This large trial of an intensive weekly pharmacist intervention with care home residents was also found to be safe and well received.TRIAL REGISTRATION: ISRCTN 17847169.

AB - OBJECTIVE: To estimate the effectiveness, cost effectiveness (to be reported elsewhere), and safety of pharmacy independent prescribers in care homes.DESIGN: Cluster randomised controlled trial, with clusters based on triads of a pharmacist independent prescriber, a general practice, and one to three associated care homes.SETTING: Care homes across England, Scotland, and Northern Ireland, their associated general practices, and pharmacy independent prescribers, formed into triads.PARTICIPANTS: 49 triads and 882 residents were randomised. Participants were care home residents, aged ≥65 years, taking at least one prescribed drug, recruited to 20 residents/triad.INTERVENTION: Each pharmacy independent prescriber provided pharmaceutical care to approximately 20 residents across one to three care homes, with weekly visits over six months. Pharmacy independent prescribers developed a pharmaceutical care plan for each resident, did medicines reviews/reconciliation, trained staff, and supported with medicines related procedures, deprescribing, and authorisation of prescriptions. Participants in the control group received usual care.MAIN OUTCOMES MEASURES: The primary outcome was fall rate/person at six months analysed by intention to treat, adjusted for prognostic variables. Secondary outcomes included quality of life (EQ-5D by proxy), Barthel score, Drug Burden Index, hospital admissions, and mortality. Assuming a 21% reduction in falls, 880 residents were needed, allowing for 20% attrition.RESULTS: The average age of participants at study entry was 85 years; 70% were female. 697 falls (1.55 per resident) were recorded in the intervention group and 538 falls (1.26 per resident) in the control group at six months. The fall rate risk ratio for the intervention group compared with the control group was not significant (0.91, 95% confidence interval 0.66 to 1.26) after adjustment for all model covariates. Secondary outcomes were not significantly different between groups, with exception of the Drug Burden Index, which significantly favoured the intervention. A third (185/566; 32.7%) of pharmacy independent prescriber interventions involved medicines associated with falls. No adverse events or safety concerns were identified.CONCLUSIONS: Change in the primary outcome of falls was not significant. Limiting follow-up to six months combined with a small proportion of interventions predicted to affect falls may explain this. A significant reduction in the Drug Burden Index was realised and would be predicted to yield future clinical benefits for patients. This large trial of an intensive weekly pharmacist intervention with care home residents was also found to be safe and well received.TRIAL REGISTRATION: ISRCTN 17847169.

KW - Humans

KW - Female

KW - Aged, 80 and over

KW - Male

KW - Pharmacists

KW - Quality of Life

KW - Northern Ireland

KW - Scotland

KW - Pharmaceutical Services

U2 - 10.1136/bmj-2022-071883

DO - 10.1136/bmj-2022-071883

M3 - Article

C2 - 36787910

SN - 0959-8146

VL - 380

JO - BMJ (Clinical research ed.)

JF - BMJ (Clinical research ed.)

M1 - e071883

ER -

Evaluation of effectiveness and safety of pharmacist independent prescribers in care homes: cluster randomised controlled trial

Abstract

Bibliographical note

Data Availability Statement

Keywords

Access to Document

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