Dataset Information

Process evaluation for the Care Homes Independent Pharmacist Prescriber Study (CHIPPS).

ABSTRACT:

Background

Medicines 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.

Method

Intervention 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.

Results

PCPs 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.

Conclusions

The 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 registration

The definitive RCT was registered with the ISRCTN registry (registration number ISRCTN 17847169 ).

SUBMITTER: Birt L

PROVIDER: S-EPMC8487235 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundResidents 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.MethodsMixed 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.ResultsAcross 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.ConclusionImplementing 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.

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: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:Advance Care Planning (ACP) is the repeated communication and decision-making process between the patient, family, and healthcare professionals. This study describes an ACP intervention in nursing homes and evaluates the outcomes of the implementation process.The ACP intervention was part of a 4-month complex, cluster randomized controlled trial (COSMOS). 37 Norwegian nursing homes with 72 units (1 cluster?=?1 unit) and 765 patients were invited to participate and eligible units were randomised to the intervention group or control. Nursing home staff in the intervention group was offered a standardized education programme to learn early and repeated communication with patients and families and to implement ACP in their units. We used a train-the-trainer approach to educate staff in the units, supported by regular telephone calls and a midway seminar after two months. Individual patient logs consisting of different communication deliverables were used to evaluate the implementation process. Supported by Qualitative Content Analyses, we identified facilitators and barriers of the ACP implementation based on feedback during midway seminars and individual patient logs.The ACP intervention was conducted in 36 NH units (n?=?297); 105 healthcare providers participated at the education seminar prior to the study, and 3-4 employees from each unit participated in the midway seminar. NH staff reported the educational material relevant for the implementation strategy. The patient logs showed that ACP was successfully implemented in 62% (n?=?183) of the patients using our predefined implementation criteria. The staff emphasized the clear communication of the relevance of ACP addressed to leaders and staff as important facilitators, along with the clearly defined routines, roles and responsibilities. Identified barriers included lack of competence, perceived lack of time, and conflicting culture and staff opinions.Monthly communication with the family was the most frequently conducted communication, and the predefined criteria of successfully implemented ACP were largely achieved. Nursing home routines and engagement of leaders and staff were crucial facilitators, whereas lack of time and competence reduced the implementation success.The COSMOS-trial was registered in the ClinicalTrials.gov ( NCT02238652 ) July 7th, 2014.

Project description:In the UK care homes are one of the main providers of long term care for older people with dementia. Despite the recent increase in care home research, residents with dementia are often excluded from studies. Care home research networks have been recommended by the Ministerial Advisory Group on Dementia Research (MAGDR) as a way of increasing research opportunities for residents with dementia. This paper reports on an evaluation of the feasibility and early impact of an initiative to increase care home participation in research.A two phase, mixed methods approach was used; phase 1 established a baseline of current and recent studies including the National Institute for Health Research portfolio. To explore the experiences of recruiting care homes and research participation, interviews were conducted with researchers working for the Dementia and Neurodegenerative Diseases Research Network (DeNDRoN) and care home managers. In phase 2, four DeNDRoN area offices recruited care homes to a care home network for their region. The care home networks were separate from the DeNDRoN research network. Diaries were used to document and cost recruitment; DeNDRoN staff were interviewed to understand the barriers, facilitators and impact of the care home networks.Thirty three current or recent studies were identified as involving care homes as care home specific studies or those which included residents. Further details of care home recruitment were obtained on 20 studies by contacting study teams. Care home managers were keen to be involved in research that provided staff support, benefits for residents and with minimal disruption. In phase 2, 141 care homes were recruited to the care home research networks, through corporate engagement and individual invitation. Pre-existing relationships with care homes facilitated recruitment. Sites with minimal experience of working with care homes identified the need for care home training for researchers.Phase 1 review revealed a small but increasing number of studies involving care homes. Phase 2 demonstrated the feasibility of care home research networks, their potential to increase recruitment to research and develop partnerships between health services and care homes, but highlighted the need for care home training for researchers.

Project description:BACKGROUND:Research has highlighted the need for improving the implementation of advance care planning (ACP) in nursing homes. We developed a theory-based multicomponent ACP intervention (the ACP+ programme) aimed at supporting nursing home staff with the implementation of ACP into routine nursing home care. We describe here the protocol of a cluster randomised controlled trial (RCT) that aims to evaluate the effects of ACP+ on nursing home staff and volunteer level outcomes and its underlying processes of change. METHODS:We will conduct a cluster RCT in Flanders, Belgium. Fourteen eligible nursing homes will be pair-matched and one from each pair will be randomised to either continue care and education as usual or to receive the ACP+ programme (a multicomponent programme which is delivered stepwise over an eight-month period with the help of an external trainer). Primary outcomes are: nursing home care staff's knowledge of, and self-efficacy regarding ACP. Secondary outcomes are: 1) nursing home care staff's attitudes towards ACP and ACP practices; 2) support staff's and volunteer's ACP practices and 3) support staff's and volunteers' self-efficacy. Measurements will be performed at baseline and eight months post-measurement, using structured self-reported questionnaires. A process evaluation will accompany the outcome evaluation in the intervention group, with measurements throughout and post-intervention to assess implementation, mechanisms of impact and context and will be carried out using a mixed-methods design. DISCUSSION:There is little high-quality evidence regarding the effectiveness and underlying processes of change of ACP in nursing homes. This combined outcome and process evaluation of the ACP+ programme aims to contribute to building the necessary evidence to improve ACP and its uptake for nursing home residents and their family. TRIAL REGISTRATION:The study is registered at ClinicalTrials.gov (no. NCT03521206). Registration date: May 10, 2018. Inclusion of nursing homes started March, 2018. Hence, the trial was retrospectively registered but before end of data collection and analyses.

Project description:BackgroundRapid and mass transmission of the SARS-CoV-2 virus amongst vulnerable people led to devastating effects from COVID-19 in care homes. The CONTACT intervention introduced Bluetooth Low Energy 'smart' wearable devices (BLE wearables) as a basis for automated contact tracing in, and feedback on infection risks and patterns to, care homes to try and improve infection prevention and control (IPC). We planned a cluster randomised controlled trial (RCT) of CONTACT. To be feasible, homes had to adopt CONTACT's technology and new ways of working. This paper reports on the process evaluation conducted alongside CONTACT's feasibility study and explains why it lacked the feasibility and acceptability for a definitive RCT.MethodsThis mixed method process evaluation used Normalisation Process Theory (NPT) qualitative (interviews, field notes, study case report forms and documents, and observation) and quantitative (survey instruments, counts of activity) data to plan, implement, and analyse the mechanisms, effects, and contextual factors that shaped the feasibility and acceptability of the CONTACT intervention.ResultsThirteen themes within four core NPT constructs explained CONTACT's lack of feasibility. Coherence: the home's varied in the scale and extent of commitment and understanding of the technology and study procedures. Leadership credibility was important but compromised by competing priorities. Management and direct care staff saw CONTACT differently. Work to promote (cognitive participation) and enact (collective action) CONTACT was burdensome and failed to be prioritised over competing COVID-19-related demands on time and scarce human and cognitive resources. Ultimately, staff appraisal of the value of CONTACT-generated information and study procedures (reflexivity) was that any utility for IPC was insufficient to outweigh the perceived burden and complexity involved.ConclusionsDespite implementation failure, dismissing BLE wearables' potential for contact tracing is premature. In non-pandemic conditions, with more time, better co-design and integration of theory-driven implementation strategies tailored to care homes' unique contexts, researchers could enhance normalisation in readiness for future pandemic challenges.Trial registrationISRCTN registration: 11,204,126 registered 17/02/2021.