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Keywords: nurses, multidisciplinary, older people, nutrition, mobilisation, cognitive engagement, fundamental care, hospital associated decline, functional decline, implementation science, behaviour change theory
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Naughton C, Cummins H, de Foubert M et al. Implementation of the Frailty Care Bundle (FCB) to promote mobilisation, nutrition and cognitive engagement in older people in acute care settings: protocol for an implementation science study [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2022, 5:3 (https://doi.org/10.12688/hrbopenres.13473.1)
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Study Protocol
Implementation of the Frailty Care Bundle (FCB) to promote mobilisation, nutrition and cognitive engagement in older people in acute care settings: protocol for an implementation science study
[version 1; peer review: 1 approved, 1 approved with reservations]
PUBLISHED 11 Jan 2022
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This article is included in the Ageing Populations collection.
Abstract
Corresponding author:
Corina Naughton
Competing interests:
No competing interests were disclosed.
Grant information:
This research was funded by the Health Research Board (HRB) and South South West Hospital (APA-2019-009) under the Applied Partnership Award. The grant was assigned to Professor Corina Naughton.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Copyright:
© 2022 Naughton C et al.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Naughton C, Cummins H, de Foubert M et al. Implementation of the Frailty Care Bundle (FCB) to promote mobilisation, nutrition and cognitive engagement in older people in acute care settings: protocol for an implementation science study [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2022, 5:3 (https://doi.org/10.12688/hrbopenres.13473.1)
First published: 11 Jan 2022, 5:3 (https://doi.org/10.12688/hrbopenres.13473.1)
Latest published: 11 Jan 2022, 5:3 (https://doi.org/10.12688/hrbopenres.13473.1)
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Introduction
Older adults are among the highest users of acute care hospital and rehabilitation services (Boltz et al., 2012 and Smyth et al., 2017). The socio-demographic and health profile of older people admitted to acute care has changed over the past decades (Rechel et al., 2013). Patients are older with higher levels of co-morbidity, physical and cognitive frailty, and polypharmacy (Buurman et al., 2011; Walsh et al., 2019). Due to these underlying vulnerabilities, this group are more susceptible to hospital harm and prolonged hospitalisation. Hospital associated decline (HAD) is the term used to describe a new functional or cognitive deficit that develops during hospitalisation that was not present at admission (Zisberg et al., 2015). The main manifestations of HAD are reduction in mobility and function independence (washing, dressing, loss of continence) (Koch et al., 2020; Tasheva et al., 2020). In recent years there is a greater awareness of HAD, but many hospital systems struggle to implement effective and sustainable strategies as part of ward routinised care to mitigate HAD risk (de Foubert et al., 2021).
In an older hospitalised population, the prevalence of HAD ranges from 33% to 40% and can persist for up to six months post discharge (Tasheva et al., 2020; Zisberg et al., 2011). The factors that contribute to HAD are a combination of disease focused models of care, a restrictive patient safety culture and routinised care that fails to consistently prioritise fundamental care above competing demands (Asmus-Szepesi et al., 2015; WHO, 2015; Zisberg et al., 2015). In particular, inadequate attention to early mobilisation, nutrition and cognitive engagement are associated with adverse patient outcomes including functional decline, sarcopenia, falls, delirium, pressure ulcers, delayed hospital discharge, readmissions and early transition to institutionalised care (Brown et al., 2009; Covinsky et al., 2011; Falvey et al., 2015; Hoogerduijn et al., 2012; Mudge et al., 2016 and Zisberg et al., 2015).
High quality older adult care is dependent on an effective multidisciplinary team approach, but the nursing team (nurses and health care assistants (HCAs)) are centrally responsible for delivering fundamental care. Nursing teams do not deliberately neglect fundamental care activities but competing priorities, inadequate staffing levels and skill-mix to meet the dependency and acuity of older patients, lack of workforce gerontological competencies, and hospital environments that are maladapted to the vulnerabilities of older people make hospitals a hazardous environment for this patient group (Aiken et al., 2017; Recio‐Saucedo et al., 2018 and Szlejf et al., 2012).
A systematic review of the literature identified 18 quasi-experimental studies of ward-based interventions, designed to promote behavioural change in prioritising fundamental care to improve patient outcomes (de Foubert et al., 2021). The majority of studies focused on single care activities mainly mobilisation (n=10), followed by nutrition (n=6), with only four studies targeting two or more care activities that included cognition (de Foubert et al., 2021). The Australian ‘Eat, Walk, Engage’ project suggested that it was possible to target all three areas simultaneously with synergistic benefits from addressing the major risk factors for HAD (Mudge et al., 2015).
The Irish Health Service Executive (HSE) is acutely aware of hospital risk and have initiated recent campaigns such as ‘Pressure Ulcer to Zero’ and falls prevention as well as updated guidance on Nutrition in Acute Care Hospitals (HSE, 2018) and delirium. The initiatives are siloed and tend to focus on downstream risk for a single harm (e.g. documentation, single risk screening tools) rather than target the core, modifiable risk factors that manifests as pressure ulcers, falls, malnutrition or delirium. The protective behaviours to reduce HAD are early and consistent mobilisation, optimising nutrition intake (especially protein) and preserving cognitive function through cognitive orientation and stimulation (de Foubert et al., 2021; Mudge et al., 2015; Zisberg et al., 2015).
The Frailty Care Bundle (FCB) is a new intervention in that it brings together the evidence-based principles on early mobilisation, enhanced nutrition and increased cognitive engagement into a single bundle of care to prevent hospital associated decline in older patients. It is a hybrid implementation science project with an equal focus on the intervention design, the process of implementation and evaluation of the effect on patient and service outcomes.
Aim
The Frailty Care Bundle (FCB) intervention aims to implement and evaluate evidence-based principles on early mobilisation, enhanced nutrition and increased cognitive engagement to prevent functional and hospital associated decline in older patients.
Objectives
Objective1: Situational analysis
Conduct a situational analysis on each study site to collect baseline information including ward routines, staff and patients’ experiences, organisation nursing metrics (falls, pressure ulcers), and staffing levels.
Objective 2: Intervention co-design and implementation
Co-produce and implement the FCB principles in the target wards using a practice facilitation model and plan-do-study- act (PDSA) cycles to refine the intervention and implementation strategy.
Methods
Study design
The hybrid study will use a pragmatic prospective cohort design with a pre-post mixed methods evaluation. The Standards for Reporting Implementation Studies (StaRI) guides the description of the dual implementation process and testing of the intervention effect (Pinnock et al., 2017). The evaluation will focus on the process of implementation (to what extent was the intervention taken-up and used by staff) and the outcomes (what was the effect on patients and service outcomes). An economic analysis will entail a budget impact analysis to estimate the potential economic and financial impacts of adopting the intervention into clinical practice (Sullivan et al., 2014).
The outcome and process measures are outlined below.
Study outcomes
Primary patient outcomes
Patients’ functional status (admission to discharge) will be measured using the modified Barthel Index (mBI) and patients’ mobility measured as ‘step count’ using accelerometers
Secondary outcomes
Patients’ 4- meter walk test and hand grip strength
Patients’ self-reported physical function and activity 1-month following discharge compared to pre-admission baseline (2 weeks prior to admission)
Patients’ quality of life (QoL) measured using the EQ-5DL
Service outcomes
Ward data on hospital stay, falls and pressure ulcers from nursing metrics
Financial consequences of adoption FCB within a specific healthcare region.
Process outcomes
Several process outcomes will be monitored to better understand how the implementation plan was interpreted and operationalised by nursing staff and the MDT. We will examine contextual features of different wards and sites to identify how factors influenced uptake of the intervention.
Nursing staff uptake of the FCB principles in daily practice will be identified through observation and staff self-report.
Staff and patient attitude to mobilisation and nutrition during hospitalisation
Environmental layout and workforce (nurse staffing levels and skill mix, allied health professional and catering staff work routines).
Setting
This study will take place in three Irish hospitals from the South / South West Hospital Group (SSWHG). Hospitals were purposefully selected to represent different hospital models and urban and rural location.
Cork University Hospital (CUH) is a model 4, tertiary referral centre and academic teaching hospital with acute medical, surgical and orthopaedic trauma wards and emergency department (800 beds).
South Infirmary Victoria University Hospital (SIVUH) is a model 2 hospital providing post-acute orthopaedic rehabilitation care and elective inpatient services (192 beds).
Mallow General Hospital (MGH) is a model 2 district hospital serving a rural population providing mainly medical and day-case services (54 beds).
Organisations were selected to examine how organisational context and operational model impact on implementation. The Director of Nursing in each hospital agreed to participate in the study and hospitals signed data sharing agreements.
Six wards (two from each site) will be recruited. Wards will be purposefully sampled to represent a medical and surgical context and which have a high proportion of older patients (i.e. >50% bed occupancy by patients aged 65 years or older in the past 12 months).
Hospital 1: Orthopedic Rehabilitation - ward A (15 beds); ward B (18 beds)
Hospital 2: Acute Trauma wards – ward C (31 beds); ward D (31 beds)
Hospital 3: General Medical wards- ward E (22 beds); ward F (22 beds)
Ethics statement
Ethical approval to undertake the research was obtained from the Clinical Research Ethics Committee (CREC) of the Cork Teaching hospitals (ECM 4 10/09/2019). This research has minimal additional risk above standard clinical care. The intervention components are already well-established fundamentals of nursing care; the purpose of this study is to improve consistent implementation. It is not feasible or advisable to exclude patients from activities such as protected mealtime, mobilisation assessment or early mobilisation where it is deemed safe to do so. Thus a Wavier of Consent to participate was granted by CREC to deliver the intervention. i.e. patients and staff do not need to sign a consent form to be eligible for inclusion in the intervention component.
Patients will provide informed written consent to be included as part of the evaluation component and to allow collection of their personal medical data for follow-up. Staff will be deemed to consent to participate by completing and returning the staff surveys, while staff who participate in interviews will be asked to give written informed consent.
Intervention design & implementation
The intervention design and implementation strategy are informed by the behaviour change theory COM-B (capability, motivation, opportunity) and the Promoting Action on Research Implementation in Health Services (i-PARIHS) framework. We used the Implementation Guide and Toolkit for National Clinical Guidelines (NCEC 2018, p11) as a pragmatic resource to operationalise implementation principles. Sustainability will be assessed using NHS Institute for Innovation and improvement sustainability model and guide (2010).
Intervention components
The FCB operationalises evidence-based principles (EBP) of fundamental care to prevent hospital associated decline through enabling ward staff to consistently prioritise and deliver the principles outlined in Table 1.
Table 1. Principles of Frailty Care Bundle (FCB).
Proposed mechanism of the intervention
The underpinning concept is to enable nursing teams to prioritise patient early mobility (walking), nutrition intake (especially protein) and cognitive activity above competing demands on nursing time. The intervention aims to provide staff with strategies to keep fundamental care as a central component of daily nursing team communication and active decision making with a range of feasible and appropriate actions deliverable in real time (each shift) to address individual patient needs.
All patients will continue to receive care as normal, the FCB is complimentary to usual care and MDT management. The intervention is delivered at ward level (cluster) i.e. targeting nurses and HCAs, thus all patients on the ward will be included in the intervention during 2020–2021.
The causal assumptions of the intervention and theoretical framework guiding this evaluation are outlined in the logic model presented in Figure 1, The figure outlines the inputs, activities, outcomes as short-term, intermediate and long term. The policy impetus for the intervention were the updated HSE guideline (2018) Food, Nutrition, Hydration policy for Adult Patients in Acute Hospitals, The National Dementia Strategy (2014) and the Report of the Second Irish National Audit of Dementia care in acute Hospitals (Bracken-Scally et al., 2020) as well as the social media campaign ‘End PJ Paralysis’.
Figure 1. Logic model for Frailty Care Bundle.
The project is delivered over three phases:
Phase 1: A detailed situational analysis will be undertaken on each hospital site (see evaluation) over a four-six week period. At baseline, ward data on mealtime routines and patient mobility will be collected using structured audit (appendix I). In addition, nursing staff will be asked to identify their ideas and priorities for change as part of the staff survey. Patient data will be collected on functional capability, average daily step count and attitudes to nutrition and mobilisation. Ward and system level barriers and enablers (resources, environmental lay-out, ward routines around communication and exchange of information) will be identified to inform the intervention.
Phase 2: Intervention design and implementation will take a two-tier approach focusing on system change through the establishment of a local implementation group (LIG); and ward level change whereby a clinical facilitator will work with the ward manager and staff over a four to six week period on each ward. Introducing change will use a plan-do-study-act (PDSA) cycles (Donnelly & Kirk, 2015) to work collaboratively with staff to:
a) establish a local implementation group
b) identify ward priorities for change
c) establish a time frame and sequence to implement the intervention components on each ward
c) identify specific actions and modes of implementation
d) adapt new and modify existing practice
e) sustain new ways of working
Phase 3: Sustainability (Post intervention evaluation)
Three months following the end of the intervention period the ward level situational analysis and individual patient data collection will be undertaken to examine the uptake and sustainability of the intervention.
Intervention design and implementation
A clinical facilitation model will be used with a full-time clinical facilitator (MdF) employed to support implementation. The facilitator will work at both a ward and system level to effect change. Intervention components will be selected to address local barriers guided by the COM-B behaviour change theory. The theory proposes that behaviour change and adopting new practices is dependent on having the Capability (psychological knowledge and physical skills); Opportunity (physical and social) and Motivation (reflective and automatic) to change (Michie et al., 2011). Table 2 provides an overview of potential intervention components aligned to the COM-B model.
Table 2. Outlining role of facilitator and use of COM-B to select intervention components.
The facilitator will gradually withdraw support as ward staff become more self-reliant and self-monitor to address ongoing barriers to implementation. The clinical facilitator will maintain a diary of implementation strategies and modifications and adaptations required for different wards and sites to achieve the project objectives.
A local implementation group (LIG) will be established on each site with representation from nursing and the wider multidisciplinary team (physiotherapy, nutrition, medical, nursing management, catering). The LIG will be chaired by an Assistant Director of Nursing (ADON) to enable the escalation of system level changes to hospital management to leverage resources and influence organisation culture. The research team will help support the LIG and assist it to develop and modify local policies and procedures to incorporate FCB principles, e.g. ward policy on protected mealtimes.
Patient and public involvement (PPI)
The FCB involves older people within the community through the Cork Age Alliance. We held a workshop with six members (prior to COVID-19) of the Cork Age Alliance to frame the project principles and identify change ideas from the older person's perspective. We will recruit 3-4 patients during the baseline data collection to act as a patient advisory panel. The role of the panel is to advise on the development of patient resources (information leaflet, mobility goal setting).
Evaluation
A mixed methods pre-post evaluation will be used. Baseline data (Time 1) will be collected prior to the intervention and at three-months post implementation on each of the participating wards. Data collection will include: individual patient, staff, mapping of ward activity, routine ward data on adverse events and economic costs.
While all patients will be included in the intervention and ward audits (mealtimes and mobility), a volunteer sub-group of patients will be recruited to participate in the pre-post evaluation (patient level).
Age 65 years or older
Medically stable and able to sit out of bed within 72 hours of admission
Patients are eligible to be mobilised by nursing staff based on physiotherapy or nursing assessment
Mobile prior to admission (able to walk across a medium size room (e.g. siting room, 3-4 meters, +/-walking aid) in the two weeks prior to admission
Can provide written informed consent (no significant cognitive impairment or delirium as measured by 4-AT or recorded in medical notes)
Sample size
Based on ward bed occupancy (currently>95%) and weekly patient flow (discharge rates), it is anticipated it will be feasible to collect data on an average of 15 patients per ward pre-post the intervention. This will provide an overall population sample of 180 patients. At this sample size (90 pre and 90 post), a between-patient effect size should be detected reflecting a 40% improvement in average daily step count (using log-linear models) with 80% power (the variance estimate underpinning this calculation is from our previous research on in-hospital walking in this population (McCullagh et al., 2020). Further, adjustment for baseline predictors of walking (e.g. age, physical performance) will reduce the variance of the estimator, allowing for the detection of even smaller effect sizes (and greater power to detect the 40% improvement noted above).
Data collection
Eligible patients will be identified in consultation with ward nurses and the patients’ medical/surgical teams. A log will be maintained of all eligible patients screened, patients recruited or declined, discharged, withdrew and lost to follow-up.
Data will be collected by the research team (MdF, HC, FB) on patients’ recruited to the study (T1) and patient discharge (T2) using structured questionnaires in face-to-face interviews and medical chart reviews (appendix 1). Patient participants will be contacted at one-month follow-up (T3) using telephone interviews.
All questionnaires, interview schedules and data collection instruments for audit are available in an open access repository (Naughton et al., 2021).
Descriptive data
Patient demographic and health profile data will be collected including age and gender and validated instruments will be used to collect medical profile (Table 3).
Table 3. Patient level data.
Charlson co-morbidity index (CCI) (Charlson et al., 1994) will be calculated based on the presence (yes, no) of 19 chronic disease categories. There are several modifications of the CCI but summation of chronic disease burden remains strongly predictive of hospital outcomes and mortality (Austin et al., 2015).
The clinical frailty scale (CFS) developed by Rockwood et al. (2005) is a judgement-based frailty tool that evaluates specific domains including comorbidity, function, and cognition to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill). It is a widely used clinical tool and is an accurate predictor of hospital outcomes and mortality (Church et al., 2020).
Sarcopenia will be measured using SACR -F (Cruz-Jentoft et al., 2010), it is a five-item instrument used as a screening tool with good construct validity and good internal consistency reliability and factorial, criterion, and construct validity (Malmstrom & Morley, 2013).
Additional single items to indicate functional capability (energy, pain, sleeping, falls) will be used based on Tilda longitudinal study of ageing.
Table 3 provides an overview of the patient level data to be collected.
Primary outcome measures
The main patient outcome measures will be functional outcome measured using the modified Barthel Index (basic activities of daily living) (Shah et al., 1989). In a hospitalised population baseline mBI looks at functional ability two weeks prior to admission. In this study we will also look at current mBI which is likely to be disrupted due to a temporary health crisis e.g. hip fracture. The mBI is widely used clinically and in research as a valid measure of functional capability in older people and across a wide range of conditions. It demonstrated good inter-rater reliability and predictive outcomes (Hopman-Rock et al., 2019).
Patient process outcomes will include a measure of inpatient mobility recorded as average step count over a four-day period. Due to slow gait speed, the Step Watch Activity Monitor (SAM) attached via a Velcro strap to the patient’s ankle was selected as the most reliable measure (McCullagh et al., 2017; Resnick et al., 2001). The SAM can be worn continuously and is waterproof to allow patients to shower. The SAM is programmed to each individual specified to the patient’s height, gait pattern and gait cycle.
Secondary outcomes
Functional capability
A range of secondary outcomes will be measured including the Lawton scale for instrumental activities of living (managing transport, finances, medication) (Graf, 2008), the four-metre walk test (Peters et al., 2013) and hand grip strength measured using analogue, hydraulic hand dynamometer. The instruments are widely used in frailty research and show good internal reliability and predictive outcomes (Bobos et al., 2020; Carmona-Torres et al., 2019; Kon et al., 2014).
Patient attitude to mobility will be measured using 3-items from the measure of older adult patients' attitudes towards mobility during hospitalization (ATM-H) (Levin et al., 2017).
At one-month follow-up, the Yale physical assessment scale will be used to compare pre-admission activity with one-month post discharge activity level (Dipietro et al., 1993) and has established reliability (De Abajo et al., 2001).
Nutrition
Measures of nutrition will include patient body mass index (BMI), malnutrition universal screening tool (MUST) score (BAPEN 2020) and simplified nutritional appetite questionnaire (SNAQ) (Kruizenga et al., 2005). The SNAQ was included as it uses self-report and is suitable for use in the one-month telephone follow-up. Both tools are widely used and validated (Dent et al., 2019). Bespoke questions (4-items) will be used to assess attitudes to nutrition.
Quality of life
Quality of life will be measured at T1 and T3 using the EQ-5D-5L. The EQ-5D-5L consists of the 5D descriptive system and the EQ visual analogue scale (EQ VAS) (EuroQol Group 2009). The five dimensions are: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1=no problems, slight problems, moderate problems, severe problems and 5=extreme problems. The digits for the five dimensions can be combined into a 5-digit number that describes the patient’s health state. The EQ VAS records the patient’s self-rated health on a vertical visual analogue scale, where the endpoints are labelled ‘The best health you can imagine’ and ‘The worst health you can imagine’. The VAS can be used as a quantitative measure of health outcome that reflect the patient’s own judgement. In a systematic review, Feng et al. (2021, p 647) concluded the ‘EQ-5D-5L exhibits excellent psychometric properties across a broad range of populations, conditions and settings’.
Ward staff
All ward staff members (nurses and HCA) will be asked to complete a survey at baseline and three months’ post intervention in relation to attitudes to mobilisation and nutrition, care left undone and quality of ward environment. Surveys will be distributed by ward managers and returned by staff to a sealed survey collection box on the ward. Return of the survey will indicate respondents’ consent to participate in the study.
We will aim to achieve a consensus sample whereby all eligible staff will have the opportunity to complete the survey. It is estimated up to 100 staff will be eligible to participate. Table 4 provides an overview of the staff data to be collected, data instruments and schedule.
Table 4. Ward Staff Survey.
| Category | Tool | Pre Intervention | Three months post intervention |
|---|---|---|---|
| Staff demographic: Age Gender Staff grade Duration as registered staff Duration on current ward | |||
| Attitude to Mobilisation | Barriers to Early Mobilisation (Hoyer et al., 2015). | X | X |
| Attitude to nutrition | Bespoke questions modeled on the items from Hoyer et al. (2015) | X | X |
| Care environment (nurses only) | Practice Environment Scale of the Nursing Work Index (Aiken & Patrician, 2000; Lake, 2007). | X | X |
| Readiness to change | Organisation readiness to implement change (Shea et al., 2014) | X |
Interviews. In addition, key ward staff members (ward managers) and AHPs, (physiotherapy dieticians) will be identified for interview to provide insight into ward barriers and facilitators and the implementation processes. Participants will be asked to sign consent forms.
Ward activity mapping
A situational analysis of each ward will involve non-participant observation of ward activity (observer not involved in patient care) using structured audit tools for mealtimes and patient mobilisation and qualitative observation on ward environment and nursing team communication. Each ward will have 1-2 days of detailed observation (08:00 – 17:00) pre and post the intervention.
Mealtime observation. Mealtime observation aims to estimate how much of each meal (breakfast, lunch, and supper) a patient eats (Young et al., 2016). This is based on visual inspection of the food tray and is coded as: none, 25%, 50%, 75% or 100%. Associated factors such as meal type (general or texture modified), assistance required, and delay in receiving assistance and mealtime interruptions will be recorded (Supplemental file). Observers will also note ward context (busyness of environment, how staff were occupied during meal times, nutrition communication) (Naughton et al., 2021).
Mobilisation observation. Observation of patient activity will be recorded every 30 minutes from 08:00 to 17:00. Only patients eligible for mobilisation (can sit out of bed) will be included. Patients on bed-rest or palliative pathway are excluded. Each room or patient bay will be observed for two minutes at a time, noting patient location (hall, bedroom, bathroom), patient position (walking, sitting in a chair, sitting in bed, or lying-in bed) and activity (exercise, resting, sleeping, eating, TV, radio, reading, talking). The mean proportion of time in each location, position and activity is calculated across all patients observed (Mudge et al., 2016).
Observation will also include the quality of the environment (clutter on corridors, signage, lighting), busyness and noise on ward, interaction between patients and staff.
No patient or staff identifying information will be collected during this activity. Results from the observations will be returned to staff as part of audit and feedback.
Workforce. Ward staffing levels and skill mix will be monitored over one week as part of the environmental mapping. As there is no electronic record of staffing, we will record the number of nurses (excluding CNMII), HCAs and student nurses at 10 am and the number of patients (Table 5) to calculate nurse to patient ratios and total staff to patient ratios (Griffiths et al., 2020).
Table 5. Daily ward staffing statistics.
Ward organisation. Monthly ward data on pressure ulcer and falls will be monitored over the course of the project (see Table 5). Data is routinely collected as part of nursing metrics.
Patient safety monitoring
Falls are the most likely unintended consequence of the intervention due to increased mobilisation and will be actively monitored (see above). Each falls incident is subject to critical incident review, the potential role of the FCB will be considered, any incident that implicates the FCB will be reported to CREC and the hospital patient safety officer. Any patient complaint will be managed through the hospital patient safety and advise service.
As part of patient follow-up, we will ask patients about their overall hospital experience. It is possible that both positive and negative experiences will be recorded. Where patients make a complaint, they will be advised of the hospital patient complaints procedure.
Process evaluation
A concurrent process evaluation will run in tandem with the intervention implementation and evaluation.Using the MRC process evaluation framework, the study will focus on the measures and research questions outlined in Table 6. The process evaluation will examine how the intervention was received by ward staff and to what extent staff could make sense of the changes and incorporate them into their clinical practice.
Table 6. Process evaluation framework.
Economic analysis
A budget impact analysis using a micro-costing analysis will be employed to estimate the resource implications of implementing the intervention. This will examine how much it will cost (affordability) and describe the incremental (change) in costs and resources of implementation. Primary data will be collected on wards to identify and measure resources for the intervention and current practice which will then be valued (nursing time spent in training and delivering the intervention, mobilisation coach, education material). Potential cost off-sets will be identified (reduction in length of stay, incidents of adverse patient outcomes).
Data management
A detailed data management plan (DMP) will be developed by HC and BP. Data will be managed in line with General Data Protection Regulations (GDPR 2018). Patient data will be entered and stored in Castor EDC., a cloud-based, encrypted and password protected data management platform for clinical trials. Data entry will be undertaken by HC and MdF directly into castor, data checking rules will be built into the database and 20% of data entry will be independently checked by CN.
Staff survey, ward audit and ward falls and pressure ulcer data will be entered into SPSS v25 data analysis software and stored in UCC password protected google drive, the same mechanism for data entry and checking will apply.
Staff interview data will be recorded and transcribed verbatim and entered into NIVO software package for analysis.
Statistical methods
All quantitative analyses will be conducted by the Principal Statistician [DD]. Prior to any analyses, research data will be made FAIR, and undergo quality checking, and any potential errors will be verified against source documents.
The specifics of the statistical modelling will vary, but will feature mixed-effects generalized linear models with adjustment for key patient and (time-varying), ward/hospital-level predictors of outcomes. The project will recruit two distinct patient populations the first is a surgical orthopaedic (acute and rehabilitation) and the second medical population.
The model estimated effect of the intervention on outcomes will be reported alongside 95% confidence intervals.
A detailed Statistical Analysis Plan (SAP) will be finalised and registered on the Open Science Framework, alongside the analysis script, written in R, using R Studio.
The SAP will outline the research hypotheses tested, methods for dealing with missing data, data transformation for non-linear data, statistical tests and associated R codes.
Qualitative data will be analysed using Braun & Clarke (2006) thematic analysis framework, guided by the research questions outlined in Table 5.
Modifications of study due to COVID-19
Over the past 24 months the pandemic has significantly disrupted the delivery of the intervention and data collection.
Timeline. The FCB project commenced in March 2020, however, three weeks later due to the COVID-19 pandemic the project was suspended. Over the following 24 months the project was suspended on two further occasions due to national infection control measures. There was also periodic disruption at local ward level as they managed COVID-19 or other infectious disease outbreaks. All the clinical sites involved in the project experienced outbreaks of COVID-19.
The main change to the protocol has been the length of time required to deliver the intervention and to modify the delivery in the context of a nursing workforce that is experiencing unprecedented strain. The original intension was for the clinical facilitator to work intensively with each ward for four to six weeks, then gradually withdraw support over four weeks. This time-frame was unrealistic and the clinical facilitator works with participating wards over a longer period.
- More time is required to provide education to staff as social distancing measures requires that attendance is limited to 1-2 people per session or sessions are rescheduled due to staff shortages.
- The clinical facilitator works more flexibly and at a pace that recognises the high levels of physical and psychological fatigue among front-line staff as they face on-going challenges in delivering patient care as the pandemic continues.
- The average time the clinical facilitator spends with each ward is four to five months
- As senior leadership is pre-occupied with managing COVID-19, it has been very difficult to establish a LIG to action system changes on some sites.
Patient recruitment
- The number of patients aged 65 years and older and who met all the eligibility criteria especially cognition and in hospital for more than 3-4 days was below expected. In order to reach our target sample we made a pragmatic decision to reduce the recruitment age to 60 years to increase the pool of potentially eligible patients. This was a modification to the protocol.
Intervention components
- Intervention components were altered due to the COVID-19 pandemic. It was envisioned that patients' families and friends relative’s would be a key component in assisting patients with mobilisation, nutrition, and cognitive engagement. Due to visitor restrictions this was no longer possible.
- Mobilisation on corridors was restricted during COVID-19 outbreaks
- Alterations to the patient information leaflet was required to reflect this.
- Patient cognitive engagement resources and activities are required to be single patient use packs. The use of patient group activities sessions can no longer be facilitated.
- Health care assistants, a key part of the workforce involved in direct patient care, have to spend a significant part of their time undertaking ward and medical equipment cleaning duties thus time to focus on mobilisation, nutrition and cognitive activity is compromised
Research Staff
- Extension of staff contracts and further funding for same was required due to increased time required to deliver the FCB project
- A risk register was required by the governing university body to continue to allow research staff be present in the clinical site during Covid-19 pandemic.
- An activity log detailing time spent in the clinical site of all researchers was required daily by the governing university body
- Research staff must limit the amount of time spent on the clinical site and only be present if deemed necessary for the purpose of the FCB project. This continues to impact the overall presence and visibility of the FCB project and continues to adversely affect timelines to deliver the intervention.
Dissemination plan
We have undertaken concurrent dissemination during the course of the project. One of the main mechanism for dissemination is our twitter account @FrailtyCareBund
We have shared resources developed as part of the project directly through email e.g. a patient leaflet highlighting the benefits of nutrition, mobilisation and cognitive engagement for older people during hospital.
We were part of an ‘Health Ageing’ series featured in the Irish Examiner.
de Foubert, M., Cummins, H., McCullagh, R., Brueton, V. and Naughton, C., 2021. Systematic review of interventions targeting fundamental care to reduce hospital-associated decline in older patients. Journal of Advanced Nursing
Corina Naughton, Helen Cummins, Marguerite de Foubert. A systematic review and meta-analysis of interventions targeting ward culture (nursing teams) to reduce hospital associated decline in hospitalised older patients. PROSPERO 2020 CRD42020177969
Conferences presentations
• Irish Society for Clinical Nutrition and Metabolism 2021, oral presentation
• Irish Hip Fracture Meeting 2021, oral presentation
• European Geriatric Medicine Society 2021 Congress, poster presentation
• “What Matters” Innovation towards Age Friendly Systems UCC SONM, oral presentation
• “Stepping Forward with Confidence” Irish Frailty Network Conference 2021, oral presentation
• Irish Gerontology Society, 2021, oral presentation
Study status
The status of the project on 12/11/2021 are outlined in Table 7.
Table 7. Study phase.
Discussion
The FCB intervention protocol uses a theory driven approach to address some of the concerns in care for older people in acute care hospitals, namely, how to consistently prioritise fundamental care related to mobility, nutrition and cognition above competing demands on nursing time (Palmer, 2018; Zisberg et al., 2015). The project proposes a multilevel approach focusing on system enablers as well as behaviour change of the nursing and wider multidisciplinary team. A detailed baseline situational analysis with stakeholders will inform the intervention components and implementation plan. The evaluation uses a pre-post design and the primary outcomes are patient functional capability and in-hospital mobilisation measured as step-count using accelerometers.
This is one of only a few studies studies that aims to improve the three major components of HAD simultaneously (de Foubert et al., 2021). Older people are among the most vulnerable patient groups in acute care and experience longer hospital stays and more adverse events than other age groups (Connolly et al., 2021; Long et al., 2013). In older patients there are multiple reasons for longer hospital stays including that recovery from acute health crisis takes longer and discharge can be more complicated due to social factors, the need for community support or transfer to rehabilitation or long-term care. The time spent in acute care is more than the management of an acute condition, it represents a valuable opportunity to accelerate recovery through implementation of rehabilitation principles (Stucki et al., 2005). Expert input from AHPs is essential for higher risk and more complex patients, but individual patient time with an AHP is limited to short episodic periods and management plans (Boltz et al., 2012; Zisberg et al., 2015). It is nursing team interventions that determines patients’ activation over the course of the day and seven days a week.
A detailed understanding of how the nursing team can remember, prioritise and motivate patients to walk more, eat more, and engage more in cognitive activities is essential to reduce HAD and related adverse events. At the core of how activities become a priority is the quality of inter and intra-team communication, that is how nurses communicate with the wider interdisciplinary team around patient safety and recovery goals and how nurses communicate with each other to set priorities during their day (Ryan et al., 2019; Wong et al., 2020).
Delivering the project has become significantly more difficulty during the COVID-19 pandemic, but it is even more essential due to older adult decondition following prolonged restricted physical activity and the debilitating effects of COVID-19 infection itself (de Biase et al., 2020; Spruit et al., 2020). The protocol has be to adopt to the new reality of COVID-19 infection control precautions, high levels of fatigue among front-line staff, staff shortages and episodic interruptions. None the less, staff have demonstrated enormous resilience and have retained enthusiasm and energy to engage with and test change ideas to achieve the project objective of improving care for older people.
Conclusion
The importance of the FCB has taken on new significance in the face of the COVID-19 pandemic. Understanding how to support the capacity of nursing and the wider multi-disciplinary team to deliver mobilisation, optimise nutrition and cognitive activity is vital in the current climate. Equally important is measuring the effect on patient functional outcomes in order to build the business case for resources and sustainability.
Data availability
Extended data
Figshare: Frailty Care Bundle Data Collection, https://doi.org/10.6084/m9.figshare.16692553. (Naughton et al., 2021)
This project contains the following extended data:
- All Data collection materials.docx (All questionnaires, interview schedules and data collection instruments for audit)
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
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Naughton C, Cummins H, de Foubert M et al. Implementation of the Frailty Care Bundle (FCB) to promote mobilisation, nutrition and cognitive engagement in older people in acute care settings: protocol for an implementation science study [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2022, 5:3 (https://doi.org/10.12688/hrbopenres.13473.1)
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PUBLISHED 11 Jan 2022
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How to cite this report:
Pérez Zepeda MU. Reviewer Report For: Implementation of the Frailty Care Bundle (FCB) to promote mobilisation, nutrition and cognitive engagement in older people in acute care settings: protocol for an implementation science study [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2022, 5:3 (https://doi.org/10.21956/hrbopenres.14685.r34803)
The direct URL for this report is:
https://hrbopenresearch.org/articles/5-3/v1#referee-response-34803
https://hrbopenresearch.org/articles/5-3/v1#referee-response-34803
NOTE: it is important to ensure the information in square brackets after the title is included in this citation.
Reviewer Report 19 Jul 2023
Approved with Reservations
VIEWS 4
This is a very interesting work, reporting the highlights of a protocol aimed at improving functional health of older adults while looking at the underpinnings of implementation of this intervention. I have some comments on the document:
CITE
HOW TO CITE THIS REPORT
Pérez Zepeda MU. Reviewer Report For: Implementation of the Frailty Care Bundle (FCB) to promote mobilisation, nutrition and cognitive engagement in older people in acute care settings: protocol for an implementation science study [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2022, 5:3 (https://doi.org/10.21956/hrbopenres.14685.r34803)
The direct URL for this report is:
https://hrbopenresearch.org/articles/5-3/v1#referee-response-34803
https://hrbopenresearch.org/articles/5-3/v1#referee-response-34803
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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3
How to cite this report:
Romero-Ortuno R. Reviewer Report For: Implementation of the Frailty Care Bundle (FCB) to promote mobilisation, nutrition and cognitive engagement in older people in acute care settings: protocol for an implementation science study [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2022, 5:3 (https://doi.org/10.21956/hrbopenres.14685.r31201)
The direct URL for this report is:
https://hrbopenresearch.org/articles/5-3/v1#referee-response-31201
https://hrbopenresearch.org/articles/5-3/v1#referee-response-31201
NOTE: it is important to ensure the information in square brackets after the title is included in this citation.
Reviewer Report 12 Jan 2022
Approved
VIEWS 3
This is a well-written protocol of a complex intervention underpinned by behaviour change theories that will implement and evaluate evidence-based principles on early mobilisation, enhanced nutrition and increased cognitive engagement to prevent functional decline and hospital-associated decline in older patients
... Continue reading
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HOW TO CITE THIS REPORT
Romero-Ortuno R. Reviewer Report For: Implementation of the Frailty Care Bundle (FCB) to promote mobilisation, nutrition and cognitive engagement in older people in acute care settings: protocol for an implementation science study [version 1; peer review: 1 approved, 1 approved with reservations]. HRB Open Res 2022, 5:3 (https://doi.org/10.21956/hrbopenres.14685.r31201)
The direct URL for this report is:
https://hrbopenresearch.org/articles/5-3/v1#referee-response-31201
https://hrbopenresearch.org/articles/5-3/v1#referee-response-31201
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
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A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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