VeteranNCT07474584
OpRESTORE AI-Patient Navigator Study
A study testing AI-OpRESTORE healthcare navigator and OpRESTORE healthcare navigation in people with Veteran, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
OpRESTORE is a national NHS service that supports UK veterans with complex physical health problems linked to their military service. Veterans referred to OpRESTORE often need care from many different specialists, including surgeons, pain teams, rehabilitation, and mental health services. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Veteran
- What is being tested?
- AI-OpRESTORE healthcare navigator and OpRESTORE healthcare navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,389 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Sep 2026to 10 Sep 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets criteria for referral to OpRESTORE service
- Age 18 years or older.
- Capacity to consent.
- Have a physical health need (e.g. not purely mental health, or seeking social care advice)
Who cannot join
- Referrals processed outside standard MDT workflow.
- Patients lacking capacity to consent.
- Prisoners.
- Acute presentation best managed by emergency services and not appropriate for OpRESTORE.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
OpRESTORE, Imperial College Healthcare NHS trust
London, W2 1NY
Beth Lambert, beth.lambert4@nhs.net
About this study
Official title: The OpRESTORE AI-Patient Navigator Study: Developing and Testing an AI-enhanced Patient Navigator for UK Veterans With Service-related Physical Health Problems
OpRESTORE is a national NHS service that supports UK veterans with complex physical health problems linked to their military service. Veterans referred to OpRESTORE often need care from many different specialists, including surgeons, pain teams, rehabilitation, and mental health services. Currently, decisions about which service is most appropriate are made by a multidisciplinary team (MDT) of clinicians. While effective, this process can be slow, resource-intensive, and sometimes difficult for patients to navigate.
This study will develop and test a new digital "navigator" tool that uses artificial intelligence (AI) to support these referral decisions. The aim is to see whether the tool can safely and accurately match veterans to the right care pathway, while reducing delays and improving patient experience.
Read more
The project will be carried out in several stages:
- Reviewing past OpRESTORE records to design the AI model.
- Testing the tool alongside the MDT ("shadow testing") to check whether its recommendations match the clinical decisions.
- Running a case-control study to compare outcomes between patients referred using AI support and those referred by the MDT alone.
- Creating and testing a structured self-referral form to make it easier for veterans to access care directly.
The main outcome will be whether the AI tool makes the same referral decisions as the MDT. Other outcomes include patient satisfaction, quality of life, time taken to reach the right service, and overall costs.
The study will recruit veterans aged 18 or older who are referred to OpRESTORE with a physical health need. It will run for two years. If successful, this approach could free up clinician time, shorten waits for treatment, and improve veterans' health and wellbeing, while laying the foundations for wider use of AI-supported navigation across the NHS.
Read the detailed description
BACKGROUND
Introduction OpRESTORE was established in 2016 to provide specialist multidisciplinary care for UK military veterans with service-related physical health needs. Over the past seven years, more than 1,500 patients have been referred into the service, reflecting both the high burden of complex conditions in this group and the unmet need for coordinated care pathways. OpRESTORE has demonstrated clear benefits: patients report high satisfaction, almost 60% of cases are redirected to a more appropriate pathway, and statistically significant improvements are seen in EQ-5D-5L outcomes . However, referral rates are rising by more than 30% annually threatening to exceed clinical capacity. The challenge is not a lack of expertise but one of scalability. To continue delivering high-quality, timely, and equitable care, a digital evolution of the OpRESTORE pathway is required.
Why OpRESTORE was needed OpRESTORE arose in response to systemic inefficiencies in the NHS patient pathways. Over the last decade years in good health have declined, with 15-20% of the population affected by musculoskeletal pathology, a leading cause of disability and economic inactivity and the bulk of OpRESTORE's workload. Primary care is increasingly overstretched: for the first time in two decades, patient dissatisfaction with GP services exceeds satisfaction. Access is particularly limited in deprived communities, contributing to widening health inequalities. For veterans, these challenges are compounded by fragmented medical care following transition out of the Armed Forces, difficulties navigating civilian healthcare systems, and the psychosocial impact of leaving service life. Scepticism over civilian providers ability to understanding the nuances of military-related conditions also deters veterans from accessing NHS care.
Referral pathways are a major bottleneck. 7-9% of GP appointments result in a referral, yet 18% of patients require four or more consultations before being referred. Crucially, 21% of patients fall into the "referrals black hole", where appointments are cancelled, misdirected, or lost to follow-up. These delays prolong the already long referral journey: in 2022, 25% of people in England were waiting for an appointment, test, or intervention, and 59% of patients did not receive specialist care within the 18-week target. The net result is a system in which GPs shoulder a rising workload, specialists face inappropriate or delayed referrals, and patients experience inequitable, protracted and fragmented care. Veterans, who often present with multi-morbidity, complex physical needs and often psychosocial challenges, are especially vulnerable to these failures.
Healthcare navigation as a solution
Healthcare navigation offers a proven solution to fragmented systems. The evidence base is extensive: one meta-analysis and 13 systematic reviews were consulted for this project, in addition to relevant individual publications. Collectively, these studies demonstrate that navigation programmes consistently improve access to care and enhance patient outcomes. Key findings include:
- Increased screening uptake,
- Improved attendance to appointments, follow-up adherence and treatment compliance,
- Decreased time to diagnosis and treatment,
- Reduced unplanned care including emergency visits and hospitalisations ((8,16,17) and shorter hospitalisations when they do occur,
- Improved patient satisfaction and outcomes, particularly for chronic disease and underserved groups,
- Reduced mortality.
Navigation has also been shown to deliver measurable cost savings. Examples include reductions in cancer care spending of $1,676 per patient per month and savings of $17,780 annually for patients in the NavSTAR substance misuse programmes. Systematic reviews consistently conclude that patient navigation shortens hospital stays and decreases unplanned care, both of which are major cost drivers. Financial modelling studies similarly predict significant per-patient savings in transitional care and cancer pathways.
The OpRESTORE patient navigator has proven some of these benefits. Over half of patients are re-routed to a different pathway than originally anticipated, ensuring more appropriate use of scarce specialist services. Patient Reported Outcome Measures (PROM; EQ-5D-5L) demonstrate measurable improvement in quality of life, and patient surveys report high levels of satisfaction with the service. In short, OpRESTORE has proven the concept of navigation for veterans in the UK context.
The emerging challenge: workload and scalability Despite these successes, OpRESTORE now faces an inflection point. With referral volumes growing by more than 30% annually, the workload threatens to outstrip available staff. Continuing to expand purely through human capacity is unsustainable. What is required is a digital augmentation of the pathway, working smarter, not harder. Some elements of navigation, particularly triage of straightforward cases, are amenable to automation. However, this must be achieved without sacrificing the patient-centred and "human touch" elements that underpin OpRESTORE's success. An AI-solution could streamline workflow, decrease workload and free up human resource to add value through direct patient encounters rather than bureaucratic and administrative processes.
A further dimension is the potential for self-referral models. Across Europe, healthcare systems have increasingly turned to restrictive gatekeeping, limiting direct specialist access in the hope of controlling costs amid ageing populations and rising demand. Yet such approaches risk delaying care for those who genuinely need it. AI-enhanced patient navigation offers a more balanced alternative: enabling efficient self-referral for patients who warrant specialist care, while still ensuring intelligent gatekeeping through AI-facilitated triage.
Evidence gaps and the role of AI While patient navigation is well established in cancer care and some chronic disease contexts, there is little published research on AI-enhanced healthcare navigation, particularly in the UK and across multiple specialties. Current published literature mostly consists of study protocols or future projects and opinion pieces. Reviews highlight the potential of AI to support triage, personalise patient education, improve care coordination, and optimise resource use. However, robust, real-world evaluations are lacking.
Our team is addressing this gap through a systematic review of AI in healthcare navigation (PROSPERO 2025 CRD420251019208). This will inform the design and evaluation of a digital, AI-enhanced version of the OpRESTORE pathway.
Not only are the digitalisation and intelligent automation of OpRESTORE critical for its continued growth and success, but it is also uniquely positioned to serve as a test case for pioneering AI-patient navigation in UK veterans. It is safe, with an established multidisciplinary clinical safety net. It has almost nine years of patient-level data across >1,500 cases. The case mix offers both complexity (multi-morbidity, service-related pathology) and simplicity (nearly 50% remain on the same pathway, and there is high homogeneity with musculoskeletal referrals making up 74% of cases). This balance makes OpRESTORE both a rigorous and feasible setting to pilot AI-enabled navigation.
Policy alignment Importantly, digitising OpRESTORE aligns with UK health system priorities. The Delivery Plan for Recovering Access to Primary Care (2023-25) highlights the importance of self-referral and digital transformation to relieve GP burden and improve access to healthcare. The NHS Long-Term Plan and the Darzi Review (2024) both emphasise accelerating digitalisation, harnessing AI, and shifting towards technology-enabled efficiency in patient navigation. The Tony Blair Institute (2024) has underscored AI, specifically for triage and navigation, as a critical driver for sustainable healthcare reform.
Conclusion OpRESTORE has proven the value of patient navigation for veterans in the UK but faces an unsustainable rise in demand. Digitisation, informed by robust research and AI-enhanced tools, offers a safe, scalable pathway forward. By combining evidence-based navigation with national policy priorities, the proposed research will generate insights with relevance not only for veterans, but for wider NHS and international healthcare systems.
RATIONALE FOR CURRENT STUDY This project aims to evaluate whether an AI-enhanced patient navigation tool can replicate MDT decision-making while decreasing clinician workload. This study is designed to inform the staged implementation of a digital navigation pathway, including self-referral, clinician-verified algorithmic triage, and, ultimately, selective automation for appropriate cases.
Research Question:
Can an AI-enhanced digital patient navigator safely and accurately replicate MDT decisions in the OpRESTORE pathway, while decreasing clinician workload? Can it improve system efficiency, and patient-reported experiences and outcomes?
Hypothesis:
A digital, AI-enhanced patient navigation tool will be able to guide patients to appropriate care pathways with the same reliability as MDT decision-making, while requiring less manual input. Additionally, structured self-referral will capture richer clinical data than traditional GP-led referrals, leading to improved patient experience and engagement.
- STUDY OBJECTIVES
Primary objective:
To determine whether a digital AI-enhanced navigation algorithm is equivalent to MDT decision-making in directing patients to appropriate care pathways.
Secondary objective:
- To evaluate patient experience (PREMs) and PROMs across different referral pathways.
- To identify patient cohorts suitable for automation (defined as 80-95% initial algorithmic accuracy).
- To assess time to MDT discussion and referral issuance.
- To conduct a cost analysis comparing standard and digital workflows.
- To benchmark MDT decisions against NICE guideline-based recommendations.
- STUDY DESIGN
Type of study: Digital Health Intervention Development and Evaluation - A mixed-methods digital health and AI algorithm development study, involving retrospective analysis of clinical records, prospective observational validation, and a future interventional case-control trial of an AI-based healthcare navigation tool.
Duration: 2 years
Subjects: Veterans accessing the OpRESTORE patient navigation pathway.
3.1. STUDY OUTCOME MEASURES
Primary endpoint:
The concordance between algorithm-generated care-pathway recommendations and MDT decisions.
Secondary Endpoints:
- The accuracy of referrals, as determined by independent experts, being equal to or superior to that of the MDT.
- The increase in EQ5D-5L scores (baseline to exit) of patients under the algorithm-supported pathway being equal to or greater than those under standard pathway.
- Patient-reported experience measures (PREMs) assessed post-referral (e.g. overall satisfaction, ease of use, accessibility) of patients under the algorithm-supported pathway being equal to or greater than those under the standard pathway.
- Time from referral to MDT decision and referral issuance being faster in the algorithm-supported pathway.
- Cost per referral episode being lower in the AI-supported pathways.
- Proportion of algorithm-assisted referrals providing strong support for a treatment pathway and not requiring further input from the MDT, with a target of 40%
- The suitability of this platform for a subgroup of veteran amputees.
- Conditions
- Veteran
- Being tested
- AI-OpRESTORE healthcare navigator, OpRESTORE healthcare navigation
- Keywords
- healthcare navigation, veteran healthcare, clinical AI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-OpRESTORE healthcare navigatorOther
An algorithm is developed as part of this study that predicts a patients best treatment pathway based on basic demographic variables, targeted clinical questions and prior clinical records. This is the first version of this algorithm in development built on UK OpRESTORE veteran data and tested on this same population.
OpRESTORE healthcare navigationOther
This is the current standard of care which is a human healthcare navigation pathway where information is extracted manually, and cases are discussed at the opRESTORE MDT for UK veterans.
| Study group | Role | What they receive |
|---|---|---|
| Standard care - MDT pathway | Active comparator | The patient will run in the current OpRESTORE pathway. This means manual processing of their referral by the OpRESTORE healthcare navigation team, summarising of the medical picture, discussion at a multidisciplinary team meeting and agreement on a treatment outcome. Receives: Other: OpRESTORE healthcare navigation |
| AI-OpRESTORE - automated pathway | Experimental | In this pathway data is automatically gathered from the patients themselves through self-referral, automated screening of their medical record and only where needed human input (by members of the OpRESTORE clinical team) or additional information. This information is then run through the outcome predicting algorithm which decides on a treatment outcome. The decision is consider final but for the purpose of this study is reviewed by members of the clinical team and clinical members of the research team to ensure clinical coherence and avoid harm to participants. Receives: Other: AI-OpRESTORE healthcare navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Algorithm concordance against control
Concordance between algorithm-generated care-pathway recommendations and multidisciplinary team (MDT) decisions. MDT decisions determine the most appropriate treatment pathway and are recorded in the MDT summary document and referral tracking database. Pathways correspond to specific NHS or third-sector services grouped into categories and subcategories (e.g., orthopaedic surgery clinic by joint; ENT services subdivided into ENT clinic or audiology; pain services subdivided into NHS clinics, named consultants, or third-sector programmes). Algorithm outputs are compared with MDT decisions and classified as: full match (category and subcategory), category match only, incorrect recommendation, or referral to MDT due to low algorithm confidence.
Measured: At completion of both MDT decision and algorithm output generation (whichever occurs later), typically 8 weeks post-referral for prospective cases or after algorithm processing for retrospective data.
Secondary outcomes (6)
Patient Reported Outcomes (EQ5D-5L)
The increase inpatient reported outcomes (baseline to exit) of patients under the algorithm-supported pathway being equal to or greater than those under standard pathway. The standardised EuroQol EQ5D-5L questionnaire is used. A lower score equates to better quality of life. It is made up of 5 questions and results are presented descriptively as a 5 digit number (with each digit corresponding to each of the questions answers) or as a compound score with a minimum value of 5 and maximum value of 25 (all questions are weighted equally).
Measured: From recruitment to 6 months post recruitment.
Referral accuracy
The accuracy of referrals, as determined by independent experts, being equal to or superior to that of the MDT. Results fall into 3 categories similar to the primary outcomes: full match (category and subcategory), category match only, incorrect recommendation. Those referred to the MDT by the algorithm are not considered for this outcome.
Measured: At the point of outcome decision compared to expert input within 3 months of referral.
Patient reported experience measures
Patient-reported experience measures (PREMs) assessed post-referral compared between patients using self-referral versus GP referral, and between those running through the algorithm and those running through the manual MDT (4 resulting groups). PREMS is assessed using the Veteran Affairs Trust questionnaire. It is comprised of 4 questions with multiple choice answers on a 5 point Likert scale. Comparison is descriptive across the 4 questions (compound scoring is not validated).
Measured: From referral to 6 months post referral
Pathway time efficiency
Time from receipt of referral (self-referral or GP referral) to treatment pathway decision. In the control arm, this is the time from referral receipt to definitive treatment decision recorded at the MDT and documented in the patient tracker and MDT minutes. In the algorithm arm, this is the time from referral receipt to algorithm-generated treatment recommendation. If algorithm confidence is low, the case is referred to the MDT and the time to decision is recorded at completion of the MDT, as in the control arm.
Measured: From referral receipt to treatment pathway decision (algorithm-generated recommendation or MDT decision), up to 6 months.
Cost per referral episode
Cost per referral episode being lower in the AI-supported pathways.
Measured: From referral until discharge from the service (typical no longer than 6 months).
Degree of automation
Proportion of algorithm-assisted referrals providing strong support for a treatment pathway and not requiring further input from the MDT, with a target of 40%.
Measured: Assessed from referral to discharge from service (typical no longer than 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start10 Sep 2026 (estimated)
- Primary completion10 Mar 2028 (estimated)
- Study completion10 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for VeteranStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Prospective 50:50 randomisation within a single pathology group. * The intervention group will undergo algorithm-supported triage and referral, while the control group will follow standard MDT-led referral. * Each algorithm-generated output will be reviewed by a triage nurse (as per current practice) and a second independent clinician from the research team. If there are concerns about the appropriateness of the recommendation, the case will be referred to the MDT. * In such cases, the final MDT outcome will serve as the reference standard to determine whether the algorithm's recommendation was appropriate. * Blinding is not possible in this phase due to the nature of the intervention. * Given the speed of algorithmic processing, no delays in patient care are anticipated, though this will be actively monitored and reported.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,389 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shehan Hettiaratchy, FRCS MD, Principal investigator, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474584
- Sponsor's protocol ID
- 199335
- Other IDs
- OpRESTORE number
- Status last verified
- Aug 2026
- First submitted
- 4 Mar 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Large O, Ward D, Refsum C, Atkinson I. Preparing the NHS for the AI Era: Why Smarter Triage and Navigation Mean Better Health Care. 2025.
FIT FOR THE FUTURE 10 Year Health Plan for England Executive Summary. 2025.
NHS England. Delivery plan for recovering access to primary care: update and actions for 2024-25 [Internet]. 2024 [cited 2024 Nov 5]. Available from: https://www.england.nhs.uk/long-read/delivery-plan-for-recovering-access-to-primary-care-update-and-actions-for-2024-25/
Hill A, Morrissey D, Marsh W. "It's the future, come on!": a think aloud study exploring clinicians' use of knowledge-based AI decision support. Int J Med Inform. 2025 Dec;204:106089. doi: 10.1016/j.ijmedinf.2025.106089. Epub 2025 Aug 21.
PubMed 40850289Moser EC, Narayan G. Improving breast cancer care coordination and symptom management by using AI driven predictive toolkits. Breast. 2020 Apr;50:25-29. doi: 10.1016/j.breast.2019.12.006. Epub 2020 Jan 21.
PubMed 31978814D'Amours G, Clausen M, Luca S, Reble E, Kodida R, Assamad D, Bernier F, Chad L, Costain G, Dhalla I, Faghfoury H, Friedman JM, Hewson S, Jamieson T, Silver J, Shuman C, Osmond M, Carroll JC, Jobling R, Laberge AM, Aronson M, Liston E, Lerner-Ellis J, Marshall C, Brudno M, Pham Q, Rudzicz F, Cohn R, Mamdani M, Smith M, Shastri-Estrada S, Seto E, Thorpe K, Ungar W, Hayeems RZ, Bombard Y. Genetics Navigator: protocol for a mixed methods randomized controlled trial evaluating a digital platform to deliver genomic services in Canadian pediatric and adult populations. BMJ Open. 2024 Sep 3;14(9):e090084. doi: 10.1136/bmjopen-2024-090084.
PubMed 39231549Puthenpura V, Hunter M, Marks AM. "Techquity" in Pediatric, Adolescent, and Young Adult Oncology: Addressing Inequities Through Artificial Intelligence and Immersive Technologies. Pediatr Blood Cancer. 2025 Oct;72(10):e31909. doi: 10.1002/pbc.31909. Epub 2025 Jul 18.
PubMed 40879575Sripa P, Hayhoe B, Garg P, Majeed A, Greenfield G. Impact of GP gatekeeping on quality of care, and health outcomes, use, and expenditure: a systematic review. Br J Gen Pract. 2019 May;69(682):e294-e303. doi: 10.3399/bjgp19X702209. Epub 2019 Mar 25.
PubMed 30910875Ntais C, Kontodimopoulos N, Talias MA. Gatekeeping or Provider Choice for Sustainable Health Systems? A Literature Review on Their Impact on Efficiency, Access, and Quality of Services. J Mark Access Health Policy. 2024 Dec 6;12(4):378-387. doi: 10.3390/jmahp12040029. eCollection 2024 Dec.
PubMed 39735248Naylor MD, Brooten DA, Campbell RL, Maislin G, McCauley KM, Schwartz JS. Transitional care of older adults hospitalized with heart failure: a randomized, controlled trial. J Am Geriatr Soc. 2004 May;52(5):675-84. doi: 10.1111/j.1532-5415.2004.52202.x.
PubMed 15086645Rajabiun S, Cabral HJ, Chen CA, Lloyd-Travaglini C, Dugas JN, Amburgey D, Fitzgerald M, Lemon SC, Haas JS, Freund KM, Battaglia T; TRIP Consortium. Cost and activity analysis for a citywide patient navigation intervention to engage underserved patients in breast cancer treatment: Findings from the Translating Research Into Practice study. Cancer. 2025 Jan 1;131(1):e35671. doi: 10.1002/cncr.35671.
PubMed 39748471Orme S, Zarkin GA, Dunlap LJ, Nordeck CD, Schwartz RP, Mitchell SG, Welsh C, O'Grady KE, Gryczynski J. Cost and Cost Savings of Navigation Services to Avoid Rehospitalization for a Comorbid Substance Use Disorder Population. Med Care. 2022 Aug 1;60(8):631-635. doi: 10.1097/MLR.0000000000001743. Epub 2022 Jun 10.
PubMed 35687900Mullangi S, Worland SC, Dharmarajan K, Green RJ, Sachdeva K, Johnstone D, et al. Reduction in cancer spending due to patient navigation. JCO Oncol Pract. 2023 Nov;19(11_suppl):557-557.
Le Berre M, Maimon G, Sourial N, Gueriton M, Vedel I. Impact of Transitional Care Services for Chronically Ill Older Patients: A Systematic Evidence Review. J Am Geriatr Soc. 2017 Jul;65(7):1597-1608. doi: 10.1111/jgs.14828. Epub 2017 Apr 12.
PubMed 28403508Manderson B, McMurray J, Piraino E, Stolee P. Navigation roles support chronically ill older adults through healthcare transitions: a systematic review of the literature. Health Soc Care Community. 2012 Mar;20(2):113-27. doi: 10.1111/j.1365-2524.2011.01032.x. Epub 2011 Oct 13.
PubMed 21995806
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The OpRESTORE AI-Patient Navigator Study: Developing and Testing an AI-enhanced Patient Navigator for UK Veterans With Service-related Physical Health Problems
- ClinicalTrials.gov ID
- NCT07474584
- Acronym / sponsor ID
- 199335
- Conditions
- Veteran
- Keywords
- healthcare navigation, veteran healthcare, clinical AI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,389 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 10 Mar 2028 (estimated)
- Study completion
- 10 Sep 2028 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OpRESTORE is a national NHS service that supports UK veterans with complex physical health problems linked to their military service. Veterans referred to OpRESTORE often need care from many different specialists, including surgeons, pain teams, rehabilitation, and mental health services. Currently, decisions about which service is most appropriate are made by a multidisciplinary team (MDT) of clinicians. While effective, this process can be slow, resource-intensive, and sometimes difficult for patients to navigate.
This study will develop and test a new digital "navigator" tool that uses artificial intelligence (AI) to support these referral decisions. The aim is to see whether the tool can safely and accurately match veterans to the right care pathway, while reducing delays and improving patient experience.
The project will be carried out in several stages:
- Reviewing past OpRESTORE records to design the AI model.
- Testing the tool alongside the MDT ("shadow testing") to check whether its recommendations match the clinical decisions.
- Running a case-control study to compare outcomes between patients referred using AI support and those referred by the MDT alone.
- Creating and testing a structured self-referral form to make it easier for veterans to access care directly.
The main outcome will be whether the AI tool makes the same referral decisions as the MDT. Other outcomes include patient satisfaction, quality of life, time taken to reach the right service, and overall costs.
The study will recruit veterans aged 18 or older who are referred to OpRESTORE with a physical health need. It will run for two years. If successful, this approach could free up clinician time, shorten waits for treatment, and improve veterans' health and wellbeing, while laying the foundations for wider use of AI-supported navigation across the NHS.
Detailed description
BACKGROUND
Introduction OpRESTORE was established in 2016 to provide specialist multidisciplinary care for UK military veterans with service-related physical health needs. Over the past seven years, more than 1,500 patients have been referred into the service, reflecting both the high burden of complex conditions in this group and the unmet need for coordinated care pathways. OpRESTORE has demonstrated clear benefits: patients report high satisfaction, almost 60% of cases are redirected to a more appropriate pathway, and statistically significant improvements are seen in EQ-5D-5L outcomes . However, referral rates are rising by more than 30% annually threatening to exceed clinical capacity. The challenge is not a lack of expertise but one of scalability. To continue delivering high-quality, timely, and equitable care, a digital evolution of the OpRESTORE pathway is required.
Why OpRESTORE was needed OpRESTORE arose in response to systemic inefficiencies in the NHS patient pathways. Over the last decade years in good health have declined, with 15-20% of the population affected by musculoskeletal pathology, a leading cause of disability and economic inactivity and the bulk of OpRESTORE's workload. Primary care is increasingly overstretched: for the first time in two decades, patient dissatisfaction with GP services exceeds satisfaction. Access is particularly limited in deprived communities, contributing to widening health inequalities. For veterans, these challenges are compounded by fragmented medical care following transition out of the Armed Forces, difficulties navigating civilian healthcare systems, and the psychosocial impact of leaving service life. Scepticism over civilian providers ability to understanding the nuances of military-related conditions also deters veterans from accessing NHS care.
Referral pathways are a major bottleneck. 7-9% of GP appointments result in a referral, yet 18% of patients require four or more consultations before being referred. Crucially, 21% of patients fall into the "referrals black hole", where appointments are cancelled, misdirected, or lost to follow-up. These delays prolong the already long referral journey: in 2022, 25% of people in England were waiting for an appointment, test, or intervention, and 59% of patients did not receive specialist care within the 18-week target. The net result is a system in which GPs shoulder a rising workload, specialists face inappropriate or delayed referrals, and patients experience inequitable, protracted and fragmented care. Veterans, who often present with multi-morbidity, complex physical needs and often psychosocial challenges, are especially vulnerable to these failures.
Healthcare navigation as a solution
Healthcare navigation offers a proven solution to fragmented systems. The evidence base is extensive: one meta-analysis and 13 systematic reviews were consulted for this project, in addition to relevant individual publications. Collectively, these studies demonstrate that navigation programmes consistently improve access to care and enhance patient outcomes. Key findings include:
- Increased screening uptake,
- Improved attendance to appointments, follow-up adherence and treatment compliance,
- Decreased time to diagnosis and treatment,
- Reduced unplanned care including emergency visits and hospitalisations ((8,16,17) and shorter hospitalisations when they do occur,
- Improved patient satisfaction and outcomes, particularly for chronic disease and underserved groups,
- Reduced mortality.
Navigation has also been shown to deliver measurable cost savings. Examples include reductions in cancer care spending of $1,676 per patient per month and savings of $17,780 annually for patients in the NavSTAR substance misuse programmes. Systematic reviews consistently conclude that patient navigation shortens hospital stays and decreases unplanned care, both of which are major cost drivers. Financial modelling studies similarly predict significant per-patient savings in transitional care and cancer pathways.
The OpRESTORE patient navigator has proven some of these benefits. Over half of patients are re-routed to a different pathway than originally anticipated, ensuring more appropriate use of scarce specialist services. Patient Reported Outcome Measures (PROM; EQ-5D-5L) demonstrate measurable improvement in quality of life, and patient surveys report high levels of satisfaction with the service. In short, OpRESTORE has proven the concept of navigation for veterans in the UK context.
The emerging challenge: workload and scalability Despite these successes, OpRESTORE now faces an inflection point. With referral volumes growing by more than 30% annually, the workload threatens to outstrip available staff. Continuing to expand purely through human capacity is unsustainable. What is required is a digital augmentation of the pathway, working smarter, not harder. Some elements of navigation, particularly triage of straightforward cases, are amenable to automation. However, this must be achieved without sacrificing the patient-centred and "human touch" elements that underpin OpRESTORE's success. An AI-solution could streamline workflow, decrease workload and free up human resource to add value through direct patient encounters rather than bureaucratic and administrative processes.
A further dimension is the potential for self-referral models. Across Europe, healthcare systems have increasingly turned to restrictive gatekeeping, limiting direct specialist access in the hope of controlling costs amid ageing populations and rising demand. Yet such approaches risk delaying care for those who genuinely need it. AI-enhanced patient navigation offers a more balanced alternative: enabling efficient self-referral for patients who warrant specialist care, while still ensuring intelligent gatekeeping through AI-facilitated triage.
Evidence gaps and the role of AI While patient navigation is well established in cancer care and some chronic disease contexts, there is little published research on AI-enhanced healthcare navigation, particularly in the UK and across multiple specialties. Current published literature mostly consists of study protocols or future projects and opinion pieces. Reviews highlight the potential of AI to support triage, personalise patient education, improve care coordination, and optimise resource use. However, robust, real-world evaluations are lacking.
Our team is addressing this gap through a systematic review of AI in healthcare navigation (PROSPERO 2025 CRD420251019208). This will inform the design and evaluation of a digital, AI-enhanced version of the OpRESTORE pathway.
Not only are the digitalisation and intelligent automation of OpRESTORE critical for its continued growth and success, but it is also uniquely positioned to serve as a test case for pioneering AI-patient navigation in UK veterans. It is safe, with an established multidisciplinary clinical safety net. It has almost nine years of patient-level data across >1,500 cases. The case mix offers both complexity (multi-morbidity, service-related pathology) and simplicity (nearly 50% remain on the same pathway, and there is high homogeneity with musculoskeletal referrals making up 74% of cases). This balance makes OpRESTORE both a rigorous and feasible setting to pilot AI-enabled navigation.
Policy alignment Importantly, digitising OpRESTORE aligns with UK health system priorities. The Delivery Plan for Recovering Access to Primary Care (2023-25) highlights the importance of self-referral and digital transformation to relieve GP burden and improve access to healthcare. The NHS Long-Term Plan and the Darzi Review (2024) both emphasise accelerating digitalisation, harnessing AI, and shifting towards technology-enabled efficiency in patient navigation. The Tony Blair Institute (2024) has underscored AI, specifically for triage and navigation, as a critical driver for sustainable healthcare reform.
Conclusion OpRESTORE has proven the value of patient navigation for veterans in the UK but faces an unsustainable rise in demand. Digitisation, informed by robust research and AI-enhanced tools, offers a safe, scalable pathway forward. By combining evidence-based navigation with national policy priorities, the proposed research will generate insights with relevance not only for veterans, but for wider NHS and international healthcare systems.
RATIONALE FOR CURRENT STUDY This project aims to evaluate whether an AI-enhanced patient navigation tool can replicate MDT decision-making while decreasing clinician workload. This study is designed to inform the staged implementation of a digital navigation pathway, including self-referral, clinician-verified algorithmic triage, and, ultimately, selective automation for appropriate cases.
Research Question:
Can an AI-enhanced digital patient navigator safely and accurately replicate MDT decisions in the OpRESTORE pathway, while decreasing clinician workload? Can it improve system efficiency, and patient-reported experiences and outcomes?
Hypothesis:
A digital, AI-enhanced patient navigation tool will be able to guide patients to appropriate care pathways with the same reliability as MDT decision-making, while requiring less manual input. Additionally, structured self-referral will capture richer clinical data than traditional GP-led referrals, leading to improved patient experience and engagement.
- STUDY OBJECTIVES
Primary objective:
To determine whether a digital AI-enhanced navigation algorithm is equivalent to MDT decision-making in directing patients to appropriate care pathways.
Secondary objective:
- To evaluate patient experience (PREMs) and PROMs across different referral pathways.
- To identify patient cohorts suitable for automation (defined as 80-95% initial algorithmic accuracy).
- To assess time to MDT discussion and referral issuance.
- To conduct a cost analysis comparing standard and digital workflows.
- To benchmark MDT decisions against NICE guideline-based recommendations.
- STUDY DESIGN
Type of study: Digital Health Intervention Development and Evaluation - A mixed-methods digital health and AI algorithm development study, involving retrospective analysis of clinical records, prospective observational validation, and a future interventional case-control trial of an AI-based healthcare navigation tool.
Duration: 2 years
Subjects: Veterans accessing the OpRESTORE patient navigation pathway.
3.1. STUDY OUTCOME MEASURES
Primary endpoint:
The concordance between algorithm-generated care-pathway recommendations and MDT decisions.
Secondary Endpoints:
- The accuracy of referrals, as determined by independent experts, being equal to or superior to that of the MDT.
- The increase in EQ5D-5L scores (baseline to exit) of patients under the algorithm-supported pathway being equal to or greater than those under standard pathway.
- Patient-reported experience measures (PREMs) assessed post-referral (e.g. overall satisfaction, ease of use, accessibility) of patients under the algorithm-supported pathway being equal to or greater than those under the standard pathway.
- Time from referral to MDT decision and referral issuance being faster in the algorithm-supported pathway.
- Cost per referral episode being lower in the AI-supported pathways.
- Proportion of algorithm-assisted referrals providing strong support for a treatment pathway and not requiring further input from the MDT, with a target of 40%
- The suitability of this platform for a subgroup of veteran amputees.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- * Prospective 50:50 randomisation within a single pathology group. * The intervention group will undergo algorithm-supported triage and referral, while the control group will follow standard MDT-led referral. * Each algorithm-generated output will be reviewed by a triage nurse (as per current practice) and a second independent clinician from the research team. If there are concerns about the appropriateness of the recommendation, the case will be referred to the MDT. * In such cases, the final MDT outcome will serve as the reference standard to determine whether the algorithm's recommendation was appropriate. * Blinding is not possible in this phase due to the nature of the intervention. * Given the speed of algorithmic processing, no delays in patient care are anticipated, though this will be actively monitored and reported.
| Arm | Type | Receives |
|---|---|---|
| Standard care - MDT pathway | Active comparator | Other: OpRESTORE healthcare navigationThe patient will run in the current OpRESTORE pathway. This means manual processing of their referral by the OpRESTORE healthcare navigation team, summarising of the medical picture, discussion at a multidisciplinary team meeting and agreement on a treatment outcome. |
| AI-OpRESTORE - automated pathway | Experimental | Other: AI-OpRESTORE healthcare navigatorIn this pathway data is automatically gathered from the patients themselves through self-referral, automated screening of their medical record and only where needed human input (by members of the OpRESTORE clinical team) or additional information. This information is then run through the outcome predicting algorithm which decides on a treatment outcome. The decision is consider final but for the purpose of this study is reviewed by members of the clinical team and clinical members of the research team to ensure clinical coherence and avoid harm to participants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets criteria for referral to OpRESTORE service
- Age 18 years or older.
- Capacity to consent.
- Have a physical health need (e.g. not purely mental health, or seeking social care advice)
Key exclusion criteria (4 listed)
- Referrals processed outside standard MDT workflow.
- Patients lacking capacity to consent.
- Prisoners.
- Acute presentation best managed by emergency services and not appropriate for OpRESTORE.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-OpRESTORE healthcare navigatorAn algorithm is developed as part of this study that predicts a patients best treatment pathway based on basic demographic variables, targeted clinical questions and prior clinical records. This is the first version of this algorithm in development built on UK OpRESTORE veteran data and tested on this same population. | Other | AI-OpRESTORE - automated pathway |
| OpRESTORE healthcare navigationThis is the current standard of care which is a human healthcare navigation pathway where information is extracted manually, and cases are discussed at the opRESTORE MDT for UK veterans. | Other | Standard care - MDT pathway |
Primary outcome
Algorithm concordance against control
Time frame: At completion of both MDT decision and algorithm output generation (whichever occurs later), typically 8 weeks post-referral for prospective cases or after algorithm processing for retrospective data.
Concordance between algorithm-generated care-pathway recommendations and multidisciplinary team (MDT) decisions. MDT decisions determine the most appropriate treatment pathway and are recorded in the MDT summary document and referral tracking database. Pathways correspond to specific NHS or third-sector services grouped into categories and subcategories (e.g., orthopaedic surgery clinic by joint; ENT services subdivided into ENT clinic or audiology; pain services subdivided into NHS clinics, named consultants, or third-sector programmes). Algorithm outputs are compared with MDT decisions and classified as: full match (category and subcategory), category match only, incorrect recommendation, or referral to MDT due to low algorithm confidence.
6 secondary outcomes
Patient Reported Outcomes (EQ5D-5L)
Time frame: From recruitment to 6 months post recruitment.
Referral accuracy
Time frame: At the point of outcome decision compared to expert input within 3 months of referral.
Patient reported experience measures
Time frame: From referral to 6 months post referral
Pathway time efficiency
Time frame: From referral receipt to treatment pathway decision (algorithm-generated recommendation or MDT decision), up to 6 months.
Cost per referral episode
Time frame: From referral until discharge from the service (typical no longer than 6 months).
Degree of automation
Time frame: Assessed from referral to discharge from service (typical no longer than 6 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- BackgroundLarge O, Ward D, Refsum C, Atkinson I. Preparing the NHS for the AI Era: Why Smarter Triage and Navigation Mean Better Health Care. 2025.
- BackgroundFIT FOR THE FUTURE 10 Year Health Plan for England Executive Summary. 2025.
- BackgroundNHS England. Delivery plan for recovering access to primary care: update and actions for 2024-25 [Internet]. 2024 [cited 2024 Nov 5]. Available from: https://www.england.nhs.uk/long-read/delivery-plan-for-recovering-access-to-primary-care-update-and-actions-for-2024-25/
- Background: PubMed 40850289Hill A, Morrissey D, Marsh W. "It's the future, come on!": a think aloud study exploring clinicians' use of knowledge-based AI decision support. Int J Med Inform. 2025 Dec;204:106089. doi: 10.1016/j.ijmedinf.2025.106089. Epub 2025 Aug 21.
- Background: PubMed 31978814Moser EC, Narayan G. Improving breast cancer care coordination and symptom management by using AI driven predictive toolkits. Breast. 2020 Apr;50:25-29. doi: 10.1016/j.breast.2019.12.006. Epub 2020 Jan 21.
- Background: PubMed 39231549D'Amours G, Clausen M, Luca S, Reble E, Kodida R, Assamad D, Bernier F, Chad L, Costain G, Dhalla I, Faghfoury H, Friedman JM, Hewson S, Jamieson T, Silver J, Shuman C, Osmond M, Carroll JC, Jobling R, Laberge AM, Aronson M, Liston E, Lerner-Ellis J, Marshall C, Brudno M, Pham Q, Rudzicz F, Cohn R, Mamdani M, Smith M, Shastri-Estrada S, Seto E, Thorpe K, Ungar W, Hayeems RZ, Bombard Y. Genetics Navigator: protocol for a mixed methods randomized controlled trial evaluating a digital platform to deliver genomic services in Canadian pediatric and adult populations. BMJ Open. 2024 Sep 3;14(9):e090084. doi: 10.1136/bmjopen-2024-090084.
- Background: PubMed 40879575Puthenpura V, Hunter M, Marks AM. "Techquity" in Pediatric, Adolescent, and Young Adult Oncology: Addressing Inequities Through Artificial Intelligence and Immersive Technologies. Pediatr Blood Cancer. 2025 Oct;72(10):e31909. doi: 10.1002/pbc.31909. Epub 2025 Jul 18.
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- Background: PubMed 39748471Rajabiun S, Cabral HJ, Chen CA, Lloyd-Travaglini C, Dugas JN, Amburgey D, Fitzgerald M, Lemon SC, Haas JS, Freund KM, Battaglia T; TRIP Consortium. Cost and activity analysis for a citywide patient navigation intervention to engage underserved patients in breast cancer treatment: Findings from the Translating Research Into Practice study. Cancer. 2025 Jan 1;131(1):e35671. doi: 10.1002/cncr.35671.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shehan Hettiaratchy, FRCS MD principal investigator
Imperial College Healthcare NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-OpRESTORE healthcare navigator and OpRESTORE healthcare navigation in people with Veteran, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalia L Sanchez-Thompson, MRCS MSc (+447791700255, natalia.sanchez-thompson@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Algorithm concordance against control (time frame: At completion of both MDT decision and algorithm output generation (whichever occurs later), typically 8 weeks post-referral for prospective cases or after algorithm processing for retrospective data.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07474584, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.