FP-00011

Section 1 - Basic information about you and your application:

Title of research project
BoneFIt - A Student-Led Multimodal Prehabilitation Service for Orthopaedic Surgical Patients in Deprived Communities in Kingston-upon-Hull

Grant Type
The ORUK Inspiration Fund

Research area
Treatment

Duration
12

Start date
March 1, 2024

Have you previously received funding from ORUK?
No.

Profession
Academic scientist

Your current job title/position
Professor

Are you an early-career researcher (ECR)? (definition of ECR)
no

Section 2 - Lay summary

Lay summary:

Kingston-upon-Hull is a port city in the north east of England. The city has some of the poorest health outcomes in the country. We would like to help improve some of these outcomes by being able to help prepare our local people for  hip and knee surgery more effectively so they recover more quickly and leave hospital earlier.

In the UK, we perform over 8 million surgical operations every year, and this is likely to rise due to the increasing ageing population. Surgery can lead to reduction in physical function, a loss of independence due to continued bed rest, increased pain and discomfort, and can lead to physical and mental complications including increased stress, anxiety and depression. These symptoms can lead to higher hospital readmission rates and longer hospital stays.

Due to the global pandemic. surgical procedures in our local Trust (Hull University Teaching Hospitals; HUTH) were cancelled regularly leading to increased waiting list delays. Current waiting times for orthopaedic (bone) surgery in our centre are approximately 18 months. This means that more and more patients are continuing to decondition as they wait for their surgery. 

In the UK, ‘prehabilitation’ is a treatment package designed to help prepare individuals for the physical and mental insult of surgery. Being able to ‘optimise’ an individual prior to surgery is likely to lead to improved patient outcomes and should save the NHS money by reducing the length of hospital stay, complications and readmission rates. Prehabilitation interventions have evolved over the years becoming multimodal in nature. Interventions typically include exercise, nutrition, and psychological support delivered by a multidisciplinary team.

Currently, there are no prehabilitation pathways for any surgical intervention offered by HUTH and we know that local patients who undertake surgery have poorer recoveries than other patients who receive the same surgery in more affluent parts of the country. We wish to develop a partnership between HUTH and the University of Hull who already run a sports injuries clinic. Our vision is to turn surgical waiting list times (currently 18 months) into surgical preparation lists where we can ‘optimise’ our patients.

We will monitor physical, quality of life, and psychological wellbeing, as well as clinical outcomes both before and following surgery in a group of surgical patients who receive our BoneFit programme. We will compare these outcomes to a group of people who do not receive any intervention.

Patients awaiting surgery will be at the heart of our research. We have developed a patient support group who have advised us and helped us develop our BoneFit intervention, and we will invite members of this group onto our project management group to help steer the project forward if we are successful with our funding application. 

 

Section 3 - Purpose of research

Purpose of research:

The aim of BoneFit is to provide local people living in the Hull region with a needs-based prehabilitation care package (PCP) to improve their physical and mental health, quality of life & reduce their length of hospital stay, complications and readmission rates to hospital following orthopaedic surgery (initially TKR and THR procedures). 

The primary outcome measures are feasibility and acceptability of the BoneFit intervention. Feasibility will be assessed by determining the number of participants recruited, trained and retained at the end of the intervention, the proportion of intervention sessions delivered and fidelity of delivery. Moreover, participant recruitment, retention and adherence to the intervention will be measured, as well as any adverse events. To determine the acceptability of the intervention and to explore barriers and enablers to the implementation of the intervention, interviews will be conducted amongst participants (n=6), and staff involved in referral and intervention delivery (n=6).

Secondary objectives will be to identify a signal of efficacy for positive changes in physical health, mental wellbeing, and quality of life compared to usual care. We will identify differences in length of hospital stay, complications and readmission rates to hospital following orthopaedic surgery (initially TKR and THR procedures) compared to usual care; 

Our 12-month funding request is to appoint a clinical co-ordinator who will work between HUTH and the UoH. The coordinator would have a number of roles including working collaboratively with orthopaedic teams to develop a shared understanding of opportunities and training requirements to implement a local prehabilitation pathway, scope current in-house capability to refer to the BoneFit intervention; formalise a referral pathway between the institutions; foster a culture of impact and innovation allowing service impact to be generated. They will also provide clinical supervision to students who would lead on the  screening, assessment and intervention phases for referred patients.

Section 4 - Background to investigation

Background to investigation:

In the UK, there are >8 million surgical operations performed every year, and this is likely to continue to rise due to the increasing ageing population [1,2]. Surgery can lead to reduction in physical function, a loss of independence due to continued bed rest and deconditioning, increased pain and discomfort, and can lead to physical and mental complications including increased stress, anxiety and depression. These symptoms can lead to higher readmission rates and longer hospital stays [3]. 

Due to the recent global pandemic. surgical procedures were cancelled en masse leading to increasing waiting lists and, at an individual level, continued deconditioning and an increasing risk of functional limitations particularly in the elderly. In the UK, prehabilitation is a single component of Early Recovery After Surgery (ERAS), a multi-step treatment package designed to help prepare individuals for the physical and mental insult of surgery. Being able to optimise an individual prior to surgery is likely to lead to improved patient outcomes and should save the NHS money by reducing the length of hospital stay, complications and readmission rates [4]. Prehabilitation interventions have evolved over the years becoming multimodal in nature. Interventions typically include exercise, nutrition, and psychological support delivered by a multidisciplinary team [5]. 

In people receiving orthopaedic surgery, the evidence-base showing the positive  impact of prehabilitation continues to grow. In 2023, a large-scale systematic review and meta-analysis based on 48 unique trials involving 3,570 participants (61.5% female, mean age 64 years) reported level I moderate-certainty evidence supporting prehabilitation versus usual-care for improving pre-operative function and strength in people undergoing total knee replacement (TKR) surgery, and moderate-certainty evidence for increased health-related quality of life (HRQoL) and muscle strength for individuals undergoing total hip replacement (THR) surgery [6].

Prof Ingle is the Chief Investigator and has published around 150 papers in the field of rehabilitation and prehabilitation across a range of different clinical conditions. He is passionate about developing prehabilitation pathways at his local hospital Trust – Hull University Teaching Hospitals as he knows how effective they can be for improving patient outcomes. Prof Ingle has worked at the University of Hull for over a decade and understands the challenges of healthcare in the region. Currently there are no prehabilitation pathways offered for any surgical pathways within HUTH, and the current wait list time for patients requiring orthopaedic surgery is around 18 months. In this time, patients are continuing to decline physically and emotionally, and we wish to use the BoneFit intervention, a partnership between the University of Hull and HUTH, to help prepare patients for surgery so they can “wait well”. Dr Tom Symes is the clinical lead for orthopaedic surgery at HUTH and is a strong advocate for ERAS and early optimisation of patients prior to surgery. Joanna Snook is the Hip-Hub sports injury clinic manager and will co-ordinate and oversee the student-led clinics.

References:

1 Abbott TEF, Fowler AJ, Dobbs TD, et al. Frequency of surgical treatment and related Hospital procedures in the UK: a national ecological study using Hospital episode statistics. Br J Anaesth 2017;119:249–57. 

2 Etzioni DA, Liu JH, Maggard MA, et al. The aging population and its impact on the surgery workforce. Ann Surg 2003;238:170–7. 

3. Hoogeboom TJ, Dronkers JJ, Hulzebos EHJ, et al. Merits of exercise therapy before and after major surgery. Curr Opin Anaesthesiol 2014;27:161–6. 

4. Ditmyer MM, Topp R, Pifer M. Prehabilitation in preparation for orthopaedic surgery. Orthopaedic Nursing 2002;21:43–54. 

5. Bolshinsky V, Li MH-G, Ismail H, et al. Multimodal prehabilitation programs as a bundle of care in gastrointestinal cancer surgery: a systematic review. Dis Colon Rectum 2018;61:124–38. 

6. Punnoose A, Claydon-Mueller LS, Weiss O, et al. Prehabilitation for Patients Undergoing Orthopedic Surgery: A Systematic Review and Meta-analysis, JAMA Network Open 2023; ;6(4):e238050. 

Section 5 - Plan of investigation

Plan of investigation:

The University of Hull (UoH) will partner with HUTH to provide a student-led multimodal prehabilitation service for referred patients awaiting orthopaedic surgery (initially TKR or THR). This is a proof-of-concept pilot feasibility study.

• Inclusion criteria:

Age 18-75 years;

Waiting for unilateral TKR or THR surgery for a minimum of 6 months;

Able to provide informed consent;

• Exclusion criteria:

Previous TKR/THR surgery;

Any medical conditions for which moderate to vigorous exercise is contraindicated;

Patellar or hip joint instability; 

Any other disease/condition which severely effects functional performance e.g. stroke or Parkinson’s disease;

Age <18 years or >75 years;

No access to smartphone or home internet;

Chronic depression or significant psychiatric disorder;

Enrolled in a clinical trial (or recently completed one);

Cognitive impairment which would affect compliance to BoneFIt service;

Patients unable or unwilling to commit to required study follow-ups and unwilling ness to work with students;

Pregnancy;

• UoH Student-Led PCPs:

Only low-to-moderate risk patients will be referred to receive a PCP. All students will work under the guidance of a qualified professional based at the UoH. Multimodal prehabilitation involves the core disciplines of exercise, nutrition and clinical psychology. Therefore, students involved in the following programmes will help supply PCPs as part of their student placements, projects/dissertations or as part of an internship:

• BSc Physiotherapy
• BSc Sports Rehabilitation
• MSc Dietetics 
• BSc Sport Nutrition
• MSc Clinical Exercise Physiology
• MSc Cardiovascular Rehabilitation
• Clinical Psychology Doctorate

• Service Design:

Following guidance from the 2019 NHS Long Term Plan (https://www.longtermplan.nhs.uk/) we will use a personalised approach when developing the PCPs. Validated screening and assessment tools will enable assignment of participants. Those with no increased risk factors and with no increased surgical risk will receive universal support. Further assessment will be undertaken for those requiring more than universal support and they will be allocated to targeted (intermediate risk/needs) or specialist (high risk/complex needs). Patients may receive different levels of support for the different intervention components: exercise, nutrition and psychological support. 

Controls (usual care): We will identify a group of age- and sex-matched individuals referred for hip or knee replacement surgery from GP practices in the region who do not provide/receive multimodal rehabilitation. We will track this group of patient and will remotely request that they complete DASI (at the same timepoints as BoneFit), and also evaluate their hospital length of stay, complications and readmission rates, and compare them with participants who have received BoneFit. 

The Hip-Hub (https://hiphub.hull.ac.uk/)- the UoH sports injuries clinic will manage the patient referral process and BoneFit will benefit from existing referral, data management, facilities, equipment, and communication systems already embedded within the clinic. Referred patients will initially be contacted by Hip-Hub staff and invited to attend for an initial screening session (see Screening, Assessment and Outcomes sections below). Validated screening tools and outcome measures will be used to determine the type of PCP required, and patient data will be recorded. The type of intervention received will depend on whether a patient requires universal, targeted or specialist PCPs. 

All students will be working under the support and guidance of trained clinical professionals in physiotherapy, sports therapy, nutrition/dietetics, and clinical psychology or clinical exercise physiology. Student-patient interactions will be delivered either in a face-to-face individual or group setting, virtual (one-to-one or group-based using Teams or equivalent) or via telephone. 

Outcome measures for each of the three core components (exercise, nutrition and clinical psychology) will be evaluated at 3 timepoints (baseline [2 months from surgery], immediately prior to surgery [2 to 10 days], and 4 weeks after surgery). Within the 1-year project brief we aim to recruit 20 patients to the BoneFit intervention and 20 controls (recruitment rate: 2 patients and 2 controls per month) which we believe is realistic given the backlog of patients awaiting surgery in the region.  See Table 1 attached showing outcome measure and timepoints. 

At initial surgical referral, all participants referred for BoneFit will receive existing ERAS guidance on developing healthier lifestyle choices in preparation for surgery (material delivered by post, or via app and website). It is important to intervene immediately after surgical referral as the longer people sit on a waiting list, the more deconditioned they become, and the harder it is to start making positive lifestyle choices (low activators). 

Functional Screening: We will use the Duke Activity Status Index (DASI) to screen for reduced functional capacity. Patients with a DASI score > 34 are at low risk and will be assigned to universal support, those with a DASI score <34 will be referred for an assessment. 

Assessment: An incremental shuttle walk test (ISWT) will be performed to assess patients’ functional capacity. Patients with ISWT distance of <475m will be assigned to targeted intervention. Patients with a ISWT distance of <400m or patients with a medical comorbidity that necessitates supervised exercise will be assigned to specialist intervention.

Nutrition: we will use the Malnutrition Universal Screening Tool (MUST score) to identify patients at nutritional risk. If the patient scores <1 on the MUST score, they will be assigned to universal support. 

Assessment: Patients scoring >1 on MUST will be referred to a student dietitian for a nutrition assessment. This may result in the prescription of oral nutritional supplements. This will include using the patient-generated and professional component of the Patient-Generated Subjective Global Assessment (PG-SGA) and will be allocated to targeted or specialist groups accordingly. 

Psychological screening: Patients will be screened using the General Anxiety Disorder Assessment (GAD-7), the Patient Health Questionnaire 9 (PHQ-9) and the ‘need for help’ emotions thermometer. Patients scoring <9 on the GAD-7 or PHQ-9 and/or <5 on the ‘need for help’ item of the emotions thermometer will be assigned to universal support. 

Assessment: Patients scoring >9 on the GAD-7 or PHQ-9, and/or >5 on the ‘need for help’ item of the emotions thermometer will be invited to speak to a student clinical psychologist to determine targeted or specialist groups. 

Please see Tables 1 and 2 (attached) for specific details of screening, assessment and intervention planning.

Section 6 - Research environment and resources

Research environment and resources:

The student-led Hip-Hub has been running for almost 2 years and is available to staff, students and the local community in Kingston-upon-Hull. It is based at the University of Hull. Please see link: https://hiphub.hull.ac.uk/

The student-led clinic model is well established and works well under experienced clinical supervision. In the last 2 years, the Hip-Hub clinic has scheduled >1500 appointments with clients with orthopaedic limitations (85% attendance rates over this period). Over this period, >150 students have gained experience working directly with clients.

The Hip-Hub already uses a purpose-built, state-of-the-art exercise pre/rehabilitation suite.   Students (under supervision) will provide one-to-one support for patients and  ensure safe and effective participation which may be group-based. one-to-one or digitally delivered interventions – based on the needs/physical limitations of the patients.

We require funding to support the appointment of a clinical coordinator for 12 months while we pilot our BoneFit intervention. The coordinator would have a number of roles including working collaboratively with orthopaedic teams to develop a shared understanding of opportunities and training requirements to implement a local prehabilitation pathway, scope current in-house capability to refer to the BoneFit intervention; formalise a referral pathway between the institutions; facilitate a culture of impact and innovation allowing service impact to be generated. They will also provide clinical supervision to students who will lead on the  screening, assessment and intervention phases of referred patients.

Apart from the additional human resource required (highlighted above) we do not envisage further physical (equipment or consumables) or human resources (technical or clinical). What we require is already in place.  Our plan is to pilot the BoneFit intervention and then evaluate its feasibility and effectiveness. If deemed to be successful, we will then look for alternative funding streams to secure longer-term funding.

Our final funding request would be for dissemination purposes. We wish to provide a stakeholder dissemination one-day event at the University of Hull in the summer of 2025. The event would provide a platform to showcase our findings (both qualitative and quantitative)  and to provide a plan for the next steps of BoneFit in the region. We would invite clinicians, managers, university academics, as well as students and patient representatives to the event. Finally, funding for a UK-based academic conference would be requested so we can disseminate our findings to academic and clinical colleagues on a national level.

 

 

Section 7: Research impact

Who will benefit from this research?

BoneFit will benefit the NHS and patients in 4 ways: 1) informing clinical guidelines and developing the evidence-base around multimodal prehabilitation for patients requiring orthopaedic surgery; 2) improving local patient care and service delivery through enhancing equity of access to services and building on the principles required to deliver effective, safe services. Supporting patients who would benefit from optimisation of co-morbidities and needs-based multimodal PCPs, thereby helping them “wait well” for surgery; 3) identifying and delivering education, training and advocacy for student healthcare professionals; 4) local workforce transformation through informing the development of new service pathways. Further funding from national (NIHR, MRC, orthopaedic charities) and local/regional sources will be sought if we can identify that the pathway is successful in terms of improving patient outcomes. 

How can your research be translated in real-life?

The BoneFit intervention is highly translatable into real-world healthcare particularly in Kingston-upon-Hull where current prehabilitation pathways do not exist within HUTH. If we can show that the BoneFit pilot intervention is feasible and effective, improving patient outcomes and reducing hospital length of stay, then our student-led intervention and partnership with the University of Hull would be deemed a success. Our costs to continue to co-ordinate this service in the future appear to be fairly minor  – we would need a full-time permanent Band 6 coordinator clinician to continue to provide a conduit between HUTH and UoH and provide clinical supervision to the students whilst they are delivering BoneFit. Based on our experiences of BoneFit we would be able to identify how many students one clinician can supervise safely at any one time, and be able to gauge how many patients could be screened and assessed per year, per clinician.

How will your research be beneficial for ORUK and its purpose?

This project has many avenues which benefit ORUK and its overall aims/objectives. Initially the project will:

• Expand our knowledge – highlighting whether a student-led prehabilitation programme can improve patient outcomes following surgery;
• Improve patient outcomes – BoneFit will assess physical, psychological, quality of life and clinical outcomes before and following surgery;
• Pioneer new forms of diagnosis and treatment – student-led prehabilitation packages are potentially a new form of treatment and we are assessing their efficacy, safety and feasibility.
• Ease the burden on the NHS – we are assessing clinical outcomes to determine if student-led prehabilitation reduces hospital length of stay, complications and readmission rates.
• Develop our understanding of MSK conditions – does prehabilitation reduce deconditioning whilst waiting for surgery?
• Support a healthy ageing society – improve outcomes in an area of high health inequalities

These points highlighted above are the objectives of ORUK, and the BoneFit project targets them all.

Section 8: Outreach and engagement

We have planned a range of options for communicating the results of BoneFit. We will of course be bound by a core ethical framework enshrined around anonymity and confidentiality of study outcomes.
For participants involved in the trial, we will ask within the consent form, how they wish to receive the study findings. Options may include include face-to-face, digital options (e.g. email) or via the post.

We will also be heavily reliant on our PPI group who will provide a steer on how best to communicate the findings. This group will meet on four occasions over the course of the BoneFit intervention. Their role around outreach and engagement will be to:
– Ensure we regularly hear the patient’s voice.
– Develop dissemination plans, for example, utilising their links with support groups.
– Include their testimonies at conferences and stakeholder events. We have done this with previous trials and know testimonies are hugely powerful and very well received by audiences consisting of clinicians, academics, allied health professionals, commissioners, third sector organisations, and the general public.
– Involve them in the writing of project reports and trial newsletters. Participants will be sent newsletters at six and 12 months following the initiation of the trial. A report describing study results specifically for participants will be prepared by our PPI team in lay language. The PPI group will also advise on local solutions around requirements for language translation services, and solutions to combat digital literacy and poverty in relation to the communication of study findings.

Initially, we have costed for and scheduled a face-to-face stakeholders event following the completion of BoneFit where a non-academic audience will be invited. Following the successful completion of the BoneFit trial we will liaise closely with ORUK, the Royal College of Anaesthetists and Surgeons, the Centre for Perioperative Care, the International Prehabilitation Society, The Perioperative and Exercise Training Society and the James Lind Alliance Priority Setting Partnership for Anaesthesia and Perioperative Care, and the UK Perioperative Medicine Clinical Trials Network in order to promulgate findings. Via these networks, non-academic public will receive BoneFit trial outcomes via websites and patient-focused newsletters.

BoneFit will provide information on the feasibility of delivering a needs-based prehabilitation intervention in a pragmatic fashion to patients in the NHS setting. The results of the trial will inform national and international guidelines on optimising the perioperative care pathway for people requiring TKR/THR surgery, which, in time, will contribute to NICE guidelines for multimodal prehabilitation and the implementation of service as business as usual.

Section 9: Research budget

Requested funding from ORUK

University fees (if any)
£0

Salary
£44391

Consumables
£0

Publications
£0

Conference attendance
£600

Other items
£1000

Total 'requested fund'
£45991



Other items
Stakeholder dissemination event at the University of Hull



Other secured funds

Internal funding
£0

Partner (University)
£0

Partner (Commercial)
£0

Partner (Charity)
£0

Other sources
£7771

Total 'other funds)
£7771

Section 10: Intellectual property and testing on animal

Is there an IP linked to this research?
No

Who owns and maintains this patent?


Does your research include procedures to be carried out on animals in the UK under the Animals (Scientific Procedures) Act?
No

If yes, have the following necessary approvals been given by:

The Home office(in relation to personal, project and establishment licences)?


Animal Welfare and Ethical Review Body?


Does your research involve the use of animals or animal tissue outside the UK?
No

Does the proposed research involve a protected species? (If yes, state which)



Does the proposed research involve genetically modified animals?


Include details of sample size calculations and statistical advice sought. Please use the ARRIVE guidelines when designing and describing your experiments.


There should be sufficient information to allow for a robust review of any applications involving animals. Further guidance is available from the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), including an online experimental design assistant to guide researchers through the design of animal experiments.

Please provide details of any moderate or severe procedures


Why is animal use necessary, are there any other possible approaches?


Why is the species/model to be used the most appropriate?