Abstract
Background:
Medicine prescribing, monitoring and administration in care homes can be significantly enhanced. Effective interventions to improve pharmaceutical care and resident outcomes are required. The enablement of pharmacists to prescribe provides an opportunity for pharmacist independent prescribers to assume responsibility for improving pharmaceutical care, medication-related outcomes and resident safety whilst reducing general practitioner workload.
Objective(s):
To determine the effectiveness and cost-effectiveness of pharmacist independent prescribing in care homes.
Design:
Development work was undertaken through five work packages before the delivery of the definitive trial. Triads of pharmacist independent prescribers, care home and general practice with responsibility over 20 care home residents were recruited and cluster randomised to intervention or usual care for 6 months. Researchers were blinded at recruitment stage only. Recruitment of 880 residents was required to provide 80% statistical power, to show a 21% reduction in falls over 6 months, assuming 20% attrition. Randomisation was undertaken electronically at triad level, stratified by geographical area. Intention-to-treat analysis undertaken using a negative binomial model. Parameters were estimated using a generalised estimating equation approach. Costs were captured from an NHS perspective. Quality of life (EuroQol; five domain; five level) was collected by proxy to enable cost/quality-adjusted life-year estimation. A concurrent process evaluation was performed. Safety was monitored through a review of pharmacist independent prescriber activities, independent concerns reporting and review of adverse events.
Participants:
Forty-nine triads of general practitioners, pharmacist independent prescribers and care homes were recruited with 454 residents allocated to the intervention arm and 428 to the control arm.
Intervention:
Medication review and care planning, medication reconciliation, staff training, support with care home medication-related procedures, deprescribing and authorisation of monthly prescriptions.
Main outcome measure:
Fall rate per person over 6 months.
Results:
Data for 449 intervention and 427 control residents available for final analysis.
The 6-month fall rate ratio in favour of intervention was 0.91 (95% confidence interval 0.66 to 1.26; p=0.58). No significant difference in secondary outcomes was identified except Drug Burden Index (rate ratio 0.83, 95% confidence interval 0.75 to 0.92; p<0.001).
No harms were identified. One quarter of medication-related interventions were associated with a reduced risk of falls. The intervention was positively received.
Limitations
Participant self-selection bias may have affected the generalisability of findings.
Open-label cluster randomised controlled trial limited by 6-month follow-up.
Potential ceiling effect due to concurrent pharmacist-led interventions.
Falls potentially insufficiently proximal to the intervention.
Conclusions:
To enhance effectiveness and acceptance of the proposed model, effective integration into care home and general practitioner teams was identified as a central requirement. A core outcome set and a training package were developed.
The final model of care, whilst being safe and well received and resulting in a reduction in drug burden, demonstrated no improvement in the primary outcome of falls. With no improvement in quality-adjusted life-years identified, the pharmacist independent prescriber intervention was not estimated to be cost-effective.
Future work:
To develop and evaluate better models of care for enhancing medication outcomes and safety in care homes or re-test with a longer intervention and follow-up period and a stronger primary outcome.
Trial registration:
This trial is registered as ISRCTN10663852, definitive trial: ISRCTN17847169.
Study registration:
This study is registered as PROSPERO CRD20150907.
Funding:
This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-0613-20007) and is published in full in Programme Grants for Applied Research; Vol. 11, No. 10. See the NIHR Funding and Awards website for further award information.
Plain language summary
The purpose of this study was to explore whether a pharmacist who can prescribe drugs could work with care homes and general practitioners to improve how medicines are prescribed, how they are monitored to see whether they are working or causing problems and how the medicines are then given to the residents. The question was whether this approach was likely to be safe, to improve care for residents and to be a good way for utilising NHS money.
The project included six parts:
Listening to everyone to help us design a service to create something that was likely to be acceptable and effective
Thinking about what the best way would be to capture whether the service worked or not [i.e. what outcome(s) to measure]
Thinking about the costs and benefits of the service and how best to capture these to find out whether the service was likely to provide value for money to the NHS
Designing a training package for the pharmacists to increase the chances of them being effective in their role
Testing the study design to make sure that we had thought about everything
Running the main study that involved 882 residents and 72 care homes where half of them received the pharmacist service and half did not, to find out whether the pharmacist service reduced falls (a common side effect of medication).
The service presented no safety concerns. The pharmacists switched and stopped the medication, of which one quarter should have reduced the chances of falls. The service was generally liked. However, there is no evidence to suggest that the service reduced the number of falls or that it represented good value for NHS money.
Our public and patient involvement members have helped us at every stage of the process. They were a central part of our final reporting event.
Medicine prescribing, monitoring and administration in care homes can be significantly enhanced. Effective interventions to improve pharmaceutical care and resident outcomes are required. The enablement of pharmacists to prescribe provides an opportunity for pharmacist independent prescribers to assume responsibility for improving pharmaceutical care, medication-related outcomes and resident safety whilst reducing general practitioner workload.
Objective(s):
To determine the effectiveness and cost-effectiveness of pharmacist independent prescribing in care homes.
Design:
Development work was undertaken through five work packages before the delivery of the definitive trial. Triads of pharmacist independent prescribers, care home and general practice with responsibility over 20 care home residents were recruited and cluster randomised to intervention or usual care for 6 months. Researchers were blinded at recruitment stage only. Recruitment of 880 residents was required to provide 80% statistical power, to show a 21% reduction in falls over 6 months, assuming 20% attrition. Randomisation was undertaken electronically at triad level, stratified by geographical area. Intention-to-treat analysis undertaken using a negative binomial model. Parameters were estimated using a generalised estimating equation approach. Costs were captured from an NHS perspective. Quality of life (EuroQol; five domain; five level) was collected by proxy to enable cost/quality-adjusted life-year estimation. A concurrent process evaluation was performed. Safety was monitored through a review of pharmacist independent prescriber activities, independent concerns reporting and review of adverse events.
Participants:
Forty-nine triads of general practitioners, pharmacist independent prescribers and care homes were recruited with 454 residents allocated to the intervention arm and 428 to the control arm.
Intervention:
Medication review and care planning, medication reconciliation, staff training, support with care home medication-related procedures, deprescribing and authorisation of monthly prescriptions.
Main outcome measure:
Fall rate per person over 6 months.
Results:
Data for 449 intervention and 427 control residents available for final analysis.
The 6-month fall rate ratio in favour of intervention was 0.91 (95% confidence interval 0.66 to 1.26; p=0.58). No significant difference in secondary outcomes was identified except Drug Burden Index (rate ratio 0.83, 95% confidence interval 0.75 to 0.92; p<0.001).
No harms were identified. One quarter of medication-related interventions were associated with a reduced risk of falls. The intervention was positively received.
Limitations
Participant self-selection bias may have affected the generalisability of findings.
Open-label cluster randomised controlled trial limited by 6-month follow-up.
Potential ceiling effect due to concurrent pharmacist-led interventions.
Falls potentially insufficiently proximal to the intervention.
Conclusions:
To enhance effectiveness and acceptance of the proposed model, effective integration into care home and general practitioner teams was identified as a central requirement. A core outcome set and a training package were developed.
The final model of care, whilst being safe and well received and resulting in a reduction in drug burden, demonstrated no improvement in the primary outcome of falls. With no improvement in quality-adjusted life-years identified, the pharmacist independent prescriber intervention was not estimated to be cost-effective.
Future work:
To develop and evaluate better models of care for enhancing medication outcomes and safety in care homes or re-test with a longer intervention and follow-up period and a stronger primary outcome.
Trial registration:
This trial is registered as ISRCTN10663852, definitive trial: ISRCTN17847169.
Study registration:
This study is registered as PROSPERO CRD20150907.
Funding:
This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-0613-20007) and is published in full in Programme Grants for Applied Research; Vol. 11, No. 10. See the NIHR Funding and Awards website for further award information.
Plain language summary
The purpose of this study was to explore whether a pharmacist who can prescribe drugs could work with care homes and general practitioners to improve how medicines are prescribed, how they are monitored to see whether they are working or causing problems and how the medicines are then given to the residents. The question was whether this approach was likely to be safe, to improve care for residents and to be a good way for utilising NHS money.
The project included six parts:
Listening to everyone to help us design a service to create something that was likely to be acceptable and effective
Thinking about what the best way would be to capture whether the service worked or not [i.e. what outcome(s) to measure]
Thinking about the costs and benefits of the service and how best to capture these to find out whether the service was likely to provide value for money to the NHS
Designing a training package for the pharmacists to increase the chances of them being effective in their role
Testing the study design to make sure that we had thought about everything
Running the main study that involved 882 residents and 72 care homes where half of them received the pharmacist service and half did not, to find out whether the pharmacist service reduced falls (a common side effect of medication).
The service presented no safety concerns. The pharmacists switched and stopped the medication, of which one quarter should have reduced the chances of falls. The service was generally liked. However, there is no evidence to suggest that the service reduced the number of falls or that it represented good value for NHS money.
Our public and patient involvement members have helped us at every stage of the process. They were a central part of our final reporting event.
| Original language | English |
|---|---|
| Number of pages | 150 |
| Journal | Programme Grants for Applied Research |
| Volume | 11 |
| Issue number | 10 |
| DOIs | |
| Publication status | Published - Dec 2023 |
Bibliographical note
This research was supported by the National Institute for Health and Care Research (NIHR) Yorkshire and Humber Patient Safety Translational Research Centre (NIHR YH PSTRC). The views expressed in this article are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.This report is dedicated to Kate Massey, an active and enthusiastic member of the CHIPPS patient and public involvement team who sadly passed away during the delivery of this study.
Keywords
- care homes
- pharmacist
- polypharmacy
- pharmaceutical care
- medication review
- deprescribing
- independent prescriber
- core outcome set
- training package
- feasibility study
- randomised controlled trial
Access to Document
- Wright_etal_PGfAR_Care_Home_Independent_VOR
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