Dataset Information

The Care Home Independent Prescribing Pharmacist Study (CHIPPS)-a non-randomised feasibility study of independent pharmacist prescribing in care homes.

ABSTRACT:

Background

Residents in care homes are often very frail, have complex medicine regimens and are at high risk of adverse drug events. It has been recommended that one healthcare professional should assume responsibility for their medicines management. We propose that this could be a pharmacist independent prescriber (PIP). This feasibility study aimed to test and refine the service specification and proposed study processes to inform the design and outcome measures of a definitive randomised controlled trial to examine the clinical and cost effectiveness of PIPs working in care homes compared to usual care. Specific objectives included testing processes for participant identification, recruitment and consent and assessing retention rates; determining suitability of outcome measures and data collection processes from care homes and GP practices to inform selection of a primary outcome measure; assessing service and research acceptability; and testing and refining the service specification.

Methods

Mixed methods (routine data, questionnaires and focus groups/interviews) were used in this non-randomised open feasibility study of a 3-month PIP intervention in care homes for older people. Data were collected at baseline and 3?months. One PIP, trained in service delivery, one GP practice and up to three care homes were recruited at each of four UK locations. For ten eligible residents (??65?years, on at least one regular medication) in each home, the PIP undertook management of medicines, repeat prescription authorisation, referral to other healthcare professionals and staff training. Outcomes (falls, medications, resident's quality of life and activities of daily living, mental state and adverse events) were described at baseline and follow-up and assessed for inclusion in the main study. Participants' views post-intervention were captured in audio-recorded focus groups and semi-structured interviews. Transcripts were thematically analysed.

Results

Across the four locations, 44 GP practices and 16 PIPs expressed interest in taking part; all care homes invited agreed to take part. Two thirds of residents approached consented to participate (53/86). Forty residents were recruited (mean age 84?years; 61% (24) were female), and 38 participants remained at 3?months (two died). All GP practices, PIPs and care homes were retained. The number of falls per participating resident was selected as the primary outcome, following assessment of the different outcome measures against predetermined criteria. The chosen secondary outcomes/outcome measures include total falls, drug burden index (DBI), hospitalisations, mortality, activities of daily living (Barthel (proxy)) and quality of life (ED-5Q-5?L (face-to-face and proxy)) and selected items from the STOPP/START guidance that could be assessed without need for clinical judgement. No adverse drug events were reported. The PIP service was generally well received by the majority of stakeholders (care home staff, GPS, residents, relatives and other health care professionals). PIPs reported feeling more confident implementing change following the training but reported challenges accommodating the new service within their existing workload.

Conclusion

Implementing a PIP service in care homes is feasible and acceptable to care home residents, staff and clinicians. Findings have informed refinements to the service specification, PIP training, recruitment to the future RCT and the choice of outcomes and outcome measures. The full RCT with internal pilot started in February 2016 and results are expected to be available in mid late 2020.

SUBMITTER: Inch J

PROVIDER: S-EPMC6625047 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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The Care Home Independent Prescribing Pharmacist Study (CHIPPS)-a non-randomised feasibility study of independent pharmacist prescribing in care homes.

Inch Jacqueline J Notman Frances F Bond Christine M CM Alldred David P DP Arthur Antony A Blyth Annie A Daffu-O'Reilly Amrit A Ford Joanna J Hughes Carmel M CM Maskrey Vivienne V Millar Anna A Myint Phyo K PK Poland Fiona M FM Shepstone Lee L Zermansky Arnold A Holland Richard R Wright David D

Pilot and feasibility studies 20190711

<h4>Background</h4>Residents in care homes are often very frail, have complex medicine regimens and are at high risk of adverse drug events. It has been recommended that one healthcare professional should assume responsibility for their medicines management. We propose that this could be a pharmacist independent prescriber (PIP). This feasibility study aimed to test and refine the service specification and proposed study processes to inform the design and outcome measures of a definitive randomi ...[more]

PMID: 31338204

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Project description: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.

Project description:BackgroundMedicines management in care homes requires significant improvement. CHIPPS was a cluster randomised controlled trial to determine the effectiveness of integrating pharmacist independent prescribers into care homes to assume central responsibility for medicines management. This paper reports the parallel mixed-methods process evaluation.MethodIntervention arm consisted of 25 triads: Care homes (staff and up to 24 residents), General Practitioner (GP) and Pharmacist Independent Prescriber (PIP). Data sources were pharmaceutical care plans (PCPs), pharmacist activity logs, online questionnaires and semi-structured interviews. Quantitative data were analysed descriptively. Qualitative data were analysed thematically. Results were mapped to the process evaluation objectives following the Medical Research Council framework.ResultsPCPs and activity logs were available from 22 PIPs. Questionnaires were returned by 16 PIPs, eight GPs, and two care home managers. Interviews were completed with 14 PIPs, eight GPs, nine care home managers, six care home staff, and one resident. All stakeholders reported some benefits from PIPs having responsibility for medicine management and identified no safety concerns. PIPs reported an increase in their knowledge and identified the value of having time to engage with care home staff and residents during reviews. The research paperwork was identified as least useful by many PIPs. PIPs conducted medication reviews on residents, recording 566 clinical interventions, many involving deprescribing; 93.8% of changes were sustained at 6 months. For 284 (50.2%) residents a medicine was stopped, and for a quarter of residents, changes involved a medicine linked to increased falls risk. Qualitative data indicated participants noted increased medication safety and improved resident quality of life. Contextual barriers to implementation were apparent in the few triads where PIP was not known previously to the GP and care home before the trial. In three triads, PIPs did not deliver the intervention.ConclusionsThe intervention was generally implemented as intended, and well-received by most stakeholders. Whilst there was widespread deprescribing, contextual factors effected opportunity for PIP engagement in care homes. Implementation was most effective when communication pathways between PIP and GP had been previously well-established.Trial registrationThe definitive RCT was registered with the ISRCTN registry (registration number ISRCTN 17847169 ).

Project description:ObjectiveTo estimate the effectiveness, cost effectiveness (to be reported elsewhere), and safety of pharmacy independent prescribers in care homes.DesignCluster randomised controlled trial, with clusters based on triads of a pharmacist independent prescriber, a general practice, and one to three associated care homes.SettingCare homes across England, Scotland, and Northern Ireland, their associated general practices, and pharmacy independent prescribers, formed into triads.Participants49 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.InterventionEach 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 measuresThe 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.ResultsThe 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.ConclusionsChange 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 registrationISRCTN 17847169.

Project description:BACKGROUND:Prescribing, monitoring and administration of medicines in care homes could be improved. A cluster randomised controlled trial (RCT) is ongoing to evaluate the effectiveness of an independent prescribing pharmacist assuming responsibility for medicines management in care homes compared to usual care. AIMS AND OBJECTIVES:To conduct a mixed-methods process evaluation of the RCT, in line with Medical Research Council (MRC) process evaluation guidance, to inform interpretation of main trial findings and if the service is found to be effective and efficient, to inform subsequent implementation. OBJECTIVES:1. To describe the intervention as delivered in terms of quality, quantity, adaptations and variations across triads and time. 2. To explore the effects of individual intervention components on the primary outcomes. 3. To investigate the mechanisms of impact. 4. To describe the perceived effectiveness of relevant intervention components [including pharmacist independent prescriber (PIP) training and care home staff training] from participant [general practitioner (GP), care home, PIP and resident/relative] perspectives. 5. To describe the characteristics of GP, care home, PIP and resident participants to assess reach. 6. To estimate the extent to which intervention delivery is normalised among the intervention healthcare professionals and related practice staff. METHODS:A mix of quantitative (surveys, record reviews) and qualitative (interviews) approaches will be used to collect data on the extent of the delivery of detailed tasks required to implement the new service, to collect data to confirm the mechanism of impact as hypothesised in the logic model, to collect explanatory process and final outcome data, and data on contextual factors which could have facilitated or hindered effective and efficient delivery of the service. DISCUSSION:Recruitment is ongoing and the trial should complete in early 2020. The systematic and comprehensive approach that is being adopted will ensure data is captured on all aspects of the study, and allow a full understanding of the implementation of the service and the RCT findings. With so many interrelated factors involved it is important that a process evaluation is undertaken to enable us to identify which elements of the service were deemed to be effective, explain any differences seen, and identify enablers, barriers and future adaptions. TRIAL REGISTRATION:ISRCTN17847169. Date registered: 15 December 2017.

Project description:Background Especially in elderly with polypharmacy, medication can do harm. Clinical pharmacists integrated in primary care teams might improve quality of pharmaceutical care. Objective To assess the effect of non-dispensing clinical pharmacists integrated in primary care teams on general practitioners' prescribing quality. Setting This study was conducted in 25 primary care practices in the Netherlands. Methods Non-randomised, controlled, multi-centre, complex intervention study with pre-post comparison. First, we identified potential prescribing quality indicators from the literature and assessed their feasibility, validity, acceptability, reliability and sensitivity to change. Also, an expert panel assessed the indicators' health impact. Next, using the final set of indicators, we measured the quality of prescribing in practices where non-dispensing pharmacists were integrated in the team (intervention group) compared to usual care (two control groups). Data were extracted anonymously from the healthcare records. Comparisons were made using mixed models correcting for potential confounders. Main outcome measure Quality of prescribing, measured with prescribing quality indicators. Results Of 388 eligible indicators reported in the literature we selected 8. In addition, two more indicators relevant for Dutch general practice were formulated by an expert panel. Scores on all 10 indicators improved in the intervention group after introduction of the non-dispensing pharmacist. However, when compared to control groups, prescribing quality improved solely on the indicator measuring monitoring of the renal function in patients using antihypertensive medication: relative risk of a monitored renal function in the intervention group compared to usual care: 1.03 (95% CI 1.01-1.05, p-value 0.010) and compared to usual care plus: 1.04 (1.01-1.06, p-value 0.004). Conclusion This study did not demonstrate a consistent effect of the introduction of non-dispensing clinical pharmacists in the primary care team on the quality of physician's prescribing.This study is part of the POINT-study, which was registered at The Netherlands National Trial Register with trial registration number NTR-4389.

Project description:OBJECTIVE:Limited evidence suggests integration of pharmacists into the general practice team could improve medicines management for patients, particularly those with multimorbidity and polypharmacy. This study aimed to develop and assess the feasibility of an intervention involving pharmacists, working within general practices, to optimise prescribing in Ireland. DESIGN:Non-randomised pilot study. SETTING:Primary care in Ireland. PARTICIPANTS:Four general practices, purposively sampled and recruited to reflect a range of practice sizes and demographic profiles. INTERVENTION:A pharmacist joined the practice team for 6?months (10?hours/week) and undertook medication reviews (face to face or chart based) for adult patients, provided prescribing advice, supported clinical audits and facilitated practice-based education. OUTCOME MEASURES:Anonymised practice-level medication (eg, medication changes) and cost data were collected. Patient-reported outcome measure (PROM) data were collected on a subset of older adults (aged ?65 years) with polypharmacy using patient questionnaires, before and 6?weeks after medication review by the pharmacist. RESULTS:Across four practices, 786 patients were identified as having 1521 prescribing issues by the pharmacists. Issues relating to deprescribing medications were addressed most often by the prescriber (59.8%), compared with cost-related issues (5.8%). Medication changes made during the study equated to approximately €57?000 in cost savings assuming they persisted for 12 months. Ninety-six patients aged ?65 years with polypharmacy were recruited from the four practices for PROM data collection and 64 (66.7%) were followed up. There were no changes in patients' treatment burden or attitudes to deprescribing following medication review, and there were conflicting changes in patients' self-reported quality of life. CONCLUSIONS:This non-randomised pilot study demonstrated that an intervention involving pharmacists, working within general practices is feasible to implement and has potential to improve prescribing quality. This study provides rationale to conduct a randomised controlled trial to evaluate the clinical and cost-effectiveness of this intervention.

Project description:BackgroundIn many jurisdictions, the pharmacist's role continues to evolve from drug distribution-based service delivery to expanded scopes of practice, including independent prescribing of medications.ObjectivesTo assess health authority-based pharmacists' attitudes, beliefs, and perceptions about independent prescribing, to determine how independent prescribing may affect their behaviour, and to identify perceived barriers and enablers to incorporating it into their practice.MethodsAn anonymous, cross-sectional online survey of 677 health authority-based pharmacists employed by Lower Mainland Pharmacy Services in British Columbia collected information in the following domains: demographic characteristics; attitudes, beliefs, and perceptions regarding pharmacist prescribing; anticipated effect of pharmacist prescribing on behaviour; likelihood of applying for this authority, if granted; and barriers and enablers to applying for prescribing authority and incorporating prescribing into their practice. A multivariate regression analysis was performed.ResultsA total of 266 pharmacists (39.3%) responded to the survey. Most respondents agreed that prescribing is important to the profession and relevant to their practice, and that it might enhance job satisfaction. Additionally, respondents agreed that they had the expertise to prescribe. Respondents perceived prescribing as having the potential to positively affect behaviour, including deprescribing, prescribing at time of discharge or transfer, and renewing medications. Enablers to applying for pharmacist prescribing authority included perceived positive impact on patient care and the profession, level of support from management and coworkers, and personal ability. No barriers were identified. About two-thirds of pharmacists indicated they would likely apply for prescribing authority if it were granted through legislation. Pharmacists with a clinical practice or research role were significantly more likely to apply to be a prescriber, whereas those with more than 10 years of experience were less likely to apply.ConclusionsIn this study, health authority-based pharmacists held positive attitudes and beliefs about the value and impact of independent prescribing of medications on their practice and the profession. There were no perceived barriers to applying for prescribing authority or to incorporating prescribing into practice.

Dataset Information

The Care Home Independent Prescribing Pharmacist Study (CHIPPS)-a non-randomised feasibility study of independent pharmacist prescribing in care homes.

Background

Methods

Results

Conclusion

Publications

The Care Home Independent Prescribing Pharmacist Study (CHIPPS)-a non-randomised feasibility study of independent pharmacist prescribing in care homes.

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