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

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.

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

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.

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

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.

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

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.

Multimorbidity: will it stand the test of time?

The concept of multimorbidity has risen in popularity over the past few years. Its use has led to, or coincided with, an increased recognition that patients often have more than one health problem which should not be treated in isolation. The motivation for more holistic, person-centred care that lies behind multimorbidity is to be welcomed. The 2016 National Institute for Health and Care Excellence multimorbidity management guideline helpfully makes recommendations in key areas that are important in the care of patients with complicated medical problems.However, we question the sustainability of the term for the following four reasons: (i) it is doctor and researcher centred rather than patient centred, focusing upon the number of diagnoses rather than the patient's lived experience, (ii) it is not a positive term for patients and is at odds with the move towards promoting active and healthy ageing, (iii) its non-specific nature means it holds little value in daily clinical practice and (iv) most definitions apply to a large segment of the population making it of limited use for health care planners. We argue that the complementary concepts of complexity and frailty would fit better with the delivery of patient centred care for people with multiple co-existing health problems and would be more useful to clinicians, commissioners and researchers.

How should we investigate CUO (C-Reactive Protein elevation of unknown origin)? A case-based discussion of infective endocarditis in an octogenarian.

Infective endocarditis and other chronic infections may cause diagnostic difficulties, regardless of age. The likelihood of an atypical presentation of chronic infection probably increases with age. Serum CRP may be a useful guide to the presence of underlying infection and its resolution in older people. The term CUO (CRP elevation of unknown origin) may have a place in triggering further investigation for the presence of infection or other pathology.

Inappropriate prescribing of proton pump inhibitors in older patients: effects of an educational strategy.

BACKGROUND: An increasing number of older patients are prescribed proton pump inhibitors (PPIs). However, the extent of inappropriate PPI prescribing in this group is largely unknown. OBJECTIVE: We sought to identify clinical and demographic factors associated with inappropriate PPI prescribing in older patients and to assess the effects of a targeted educational strategy in a controlled hospital environment. METHODS: Clinical and demographic characteristics and full medication exposure on admission were recorded in 440 consecutive older patients (mean ± SD age 84 ± 7 years) admitted to a teaching hospital between 1 February 2011 and 30 June 2011. A 4-week educational strategy to reduce inappropriate PPI prescribing during hospital stay, either by stopping or reducing PPI doses, was conducted within the study period. The main outcome measures of the study were the incidence of inappropriate PPI prescribing and the effects of interventions to reduce it. RESULTS: On admission, PPIs were established therapy in 164 patients (37%). This was considered inappropriate in 100 patients (61%). Lower Charlson Comorbidity Index score (odds ratio [OR] 0.76; 95% CI 0.57, 0.94; p = 0.006) and history of dementia (OR 1.65; 95% CI 1.28, 1.83; p = 0.005) were independently associated with inappropriate PPI prescribing. Interventions to reduce inappropriate PPI prescribing occurred more frequently during and after the education phase (frequency of interventions in patients with inappropriate PPI prescribing: pre-education phase 9%, during education phase 43%, and post-education phase 46%, p = 0.006). Prescribing interventions were not associated with acid rebound symptoms. CONCLUSIONS: Inappropriate PPI prescribing in older patients is frequent and independently associated with co-morbidities and dementia. A targeted in-hospital educational strategy can significantly and safely reduce inappropriate PPI prescribing in the short term.

An evaluation of sharp safety blood evacuation devices.

This article describes an evaluation of three sharp safety blood evacuation devices in seven Welsh NHS boards and the Welsh Blood Service. Products consisted of two phlebotomy needles possessing safety shields and one phlebotomy device with wings, tubing and a retractable needle. The device companies provided the devices and appropriate training. Participating healthcare workers used the safety device instead of the conventional device to sample blood during the evaluation period and each type of device was evaluated in random order. Participants filled in a questionnaire for each type of device and then a further questionnaire comparing the two shielded evacuation needles with each other Results showed that responses to all three products were fairly positive, although each device was not liked by everyone who used it. When the two shielded evacuation devices were compared with each other, most users preferred the device with the shield positioned directly above the needle to the device with the shield at the side. However, in laboratory tests, the preferred device produced more fluid splatter than the other shielded device on activation.

An evaluation of sharp safety hypodermic needle devices.

Sharps injury and exposure to blood-borne viruses is an occupational hazard for healthcare professionals. This article describes an evaluation of three sharp safety hypodermic needle devices in six hospitals in Wales. User acceptability and performance was assessed.

An evaluation of sharp safety intravenous cannula devices.

This article describes an evaluation of seven sharp safety intravenous (IV) cannula devices in six Welsh NHS hospitals and the Welsh Ambulance Service. Products analysed included six passive devices designed to engage the safety feature automatically on withdrawal of the needle from the cannula and one active device that requires a button to be pressed to activate it. The companies concerned provided the devices and appropriate training. Participating healthcare workers used the safety device instead of the conventional device to perform IV cannulations during the evaluation and each type of device was evaluated in random order Participants filled in a questionnaire for each device and then a further questionnaire comparing each one at the end of the process. Results showed that two of the passive devices were the most preferred. Most users stated that they would use either of these devices instead of the conventional device. It was not possible to identify a favourite between these two devices. Some devices were considered to be unfavourable. The main disadvantages that users experienced included slow flashback (where venepuncture is confirmed by blood visibly entering the device), blood leakage from the back of the device and resistance when withdrawing the needle from the cannula.

How to evaluate sharp safety-engineered devices.

With increasing concerns of occupational exposure to bloodborne viruses in healthcare settings, NHS trusts are under pressure to consider opting for safer sharps devices that are designed to protect users from needlestick injuries. However, with an ever-increasing range of 'sharp safety' devices on the market, deciding what to purchase is a complex issue. In addition, evidence shows that purchasing safety devices alone will not eliminate the problem of needlestick injuries. This article discusses the criteria that should be taken into account when trusts consider introducing sharp safety devices into their workplace.

Are aloe-coated gloves effective in healthcare?

The moisturising properties of aloe vera have long been known. Examination gloves with aloe coatings are now available on the UK market for use in healthcare settings. This article examines the evidence surrounding the use of these gloves in the workplace to prevent dry, sore hands.

Endochondral ossification in fracture callus during long bone repair: the localisation of 'cavity-lining cells' within the cartilage.

Successful fracture healing typically involves the production of a cartilaginous callus, which is eventually remodelled into new bone. The blood vessels in the advancing front of endochondral ossification are likely to play an important role in the replacement of cartilage with bone within the callus. This was investigated by histology and immunohistochemistry techniques carried out on rabbit tibial osteotomy tissue. Cavities within the cartilage were identified by histology and in many cases, there appeared to be vascular structures within them, identified by the immunolocalisation of the transmembrane proteins CD31 and CD34. Osteocalcin localisation and Alizarin red histology was carried out to identify 'osteoblastic' cells and mineral localisation within the cartilaginous callus respectively. However, it was the identification of a population of cells lining the cavities within the cartilage that became the main focus of this study. These cells were 'osteoblastic' in nature, (positive localisation of osteocalcin), and were also positive for the adhesion proteins CD31 and CD34. It is thought that these cells play a role in the conversion of cartilage to bone during the fracture healing process.

The fate of soft callus chondrocytes during long bone fracture repair.

Following fracture, the cartilaginous tissue of the soft callus is eventually replaced by bone. Removal of the cartilage is a critical part of the bone healing process but information concerning the changes in chondrocytes during this process is sparse. The aim of the study was to investigate the fate of chondrocytes in the soft callus during the bone repair process using a rabbit tibial fracture model. Fracture tissue was processed for collagen I-III and keratan sulphate immunohistochemistry to study changes in matrix composition and the TUNEL technique (terminal deoxynucleotidyl transferase medicated dUTP nick-end labelling) to identify death of soft callus chondrocytes. Transmission electron microscopy (TEM) was also carried out to investigate the ultrastructure of chondrocytes within the soft callus. Results showed that the size of the cartilage area decreased over time and that cartilage matrix was replaced with new matrix rich in collagen I and III. Chondrocytes became engulfed in the new matrix and appeared to stop producing cartilage matrix. Chondrocyte cell death was seen at the border of the soft callus, just within the newly produced matrix. TEM revealed that these dying/dead cells were not typically apoptotic in appearance. In conclusion, results indicate that chondrocytes of the soft callus die as a result of the progressive production of bone matrix which eventually engulfs them and leads to the remodelling of the area and eventual bone repair.