Protocol for a pragmatic cluster randomised controlled trial assessing the clinical effectiveness and cost-effectiveness of Electronic RIsk-assessment for CAncer for patients in general practice (ERICA).

INTRODUCTION: The UK has worse cancer outcomes than most comparable countries, with a large contribution attributed to diagnostic delay. Electronic risk assessment tools (eRATs) have been developed to identify primary care patients with a ≥2% risk of cancer using features recorded in the electronic record. METHODS AND ANALYSIS: This is a pragmatic cluster randomised controlled trial in English primary care. Individual general practices will be randomised in a 1:1 ratio to intervention (provision of eRATs for six common cancer sites) or to usual care. The primary outcome is cancer stage at diagnosis, dichotomised to stage 1 or 2 (early) or stage 3 or 4 (advanced) for these six cancers, assessed from National Cancer Registry data. Secondary outcomes include stage at diagnosis for a further six cancers without eRATs, use of urgent referral cancer pathways, total practice cancer diagnoses, routes to cancer diagnosis and 30-day and 1-year cancer survival. Economic and process evaluations will be performed along with service delivery modelling. The primary analysis explores the proportion of patients with early-stage cancer at diagnosis. The sample size calculation used an OR of 0.8 for a cancer being diagnosed at an advanced stage in the intervention arm compared with the control arm, equating to an absolute reduction of 4.8% as an incidence-weighted figure across the six cancers. This requires 530 practices overall, with the intervention active from April 2022 for 2 years. ETHICS AND DISSEMINATION: The trial has approval from London City and East Research Ethics Committee, reference number 19/LO/0615; protocol version 5.0, 9 May 2022. It is sponsored by the University of Exeter. Dissemination will be by journal publication, conferences, use of appropriate social media and direct sharing with cancer policymakers. TRIAL REGISTRATION NUMBER: ISRCTN22560297.

How do electronic risk assessment tools affect the communication and understanding of diagnostic uncertainty in the primary care consultation? A systematic review and thematic synthesis.

OBJECTIVES: To conduct a systematic review and synthesise qualitative research of electronic risk assessment tools (eRATs) in primary care, examining how they affect the communication and understanding of diagnostic risk and uncertainty. eRATs are computer-based algorithms designed to help clinicians avoid missing important diagnoses, pick up possible symptoms early and facilitate shared decision-making. DESIGN: Systematic search, using predefined criteria of the published literature and synthesis of the qualitative data, using Thematic Synthesis. Database searches on 27 November 2019 were of MEDLINE, Embase, CINAHL and Web of Science, and a secondary search of the references of included articles. Included studies were those involving electronic risk assessment or decision support, pertaining to diagnosis in primary care, where qualitative data were presented. Non-empirical studies and non-English language studies were excluded. 5971 unique studies were identified of which 441 underwent full-text review. 26 studies were included for data extraction. A further two were found from citation searches. Quality appraisal was via the CASP (Critical Appraisal Skills Program) tool. Data extraction was via line by line coding. A thematic synthesis was performed. SETTING: Primary care. RESULTS: eRATs included differential diagnosis suggestion tools, tools which produce a future risk of disease development or recurrence or calculate a risk of current undiagnosed disease. Analytical themes were developed to describe separate aspects of the clinical consultation where risk and uncertainty are both central and altered via the use of an eRAT: 'Novel risk', 'Risk refinement', 'Autonomy', 'Communication', 'Fear' and 'Mistrust'. CONCLUSION: eRATs may improve the understanding and communication of risk in the primary care consultation. The themes of 'Fear' and 'Mistrust' could represent potential challenges with eRATs. TRIAL REGISTRATION NUMBER: CRD219446.

Singing for people with aphasia (SPA): results of a pilot feasibility randomised controlled trial of a group singing intervention investigating acceptability and feasibility.

OBJECTIVES: Pilot feasibility randomised controlled trial (RCT) for the singing groups for people with aphasia (SPA) intervention to assess: (1) the acceptability and feasibility of participant recruitment, randomisation and allocation concealment; (2) retention rates; (3) variance of continuous outcome measures; (4) outcome measure completion and participant burden; (5) fidelity of intervention delivery; (6) SPA intervention costs; (7) acceptability and feasibility of trial and intervention to participants and others involved. DESIGN: A two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation. SETTING: Three community-based cohorts in the South-West of England. PARTICIPANTS: Eligible participants with post-stroke aphasia were randomised 1:1 to SPA or control. INTERVENTION: The manualised SPA intervention was delivered over 10 weekly singing group sessions, led by a music facilitator and assisted by an individual with post-stroke aphasia. The intervention was developed using the Information-Motivation-Behavioural skills model of behaviour change and targeted psychosocial outcomes. Control and intervention participants all received an aphasia information resource pack. OUTCOME MEASURES: Collected at baseline, 3 and 6 months post-randomisation, candidate primary outcomes were measured (well-being, quality of life and social participation) as well as additional clinical outcomes. Feasibility, acceptability and process outcomes included recruitment and retention rates, and measurement burden; and trial experiences were explored in qualitative interviews. RESULTS: Of 87 individuals screened, 42 participants were recruited and 41 randomised (SPA=20, control=21); 36 participants (SPA=17, control=19) completed 3-month follow-up, 34 (SPA=18, control=16) completed 6-month follow-up. Recruitment and retention (83%) were acceptable for a definitive RCT, and participants did not find the study requirements burdensome. High fidelity of the intervention delivery was shown by high attendance rates and facilitator adherence to the manual, and participants found SPA acceptable. Sample size estimates for a definitive RCT and primary/secondary outcomes were identified. CONCLUSIONS: The SPA pilot RCT fulfilled its objectives, and demonstrated that a definitive RCT of the intervention would be both feasible and acceptable. TRIAL REGISTRATION NUMBER: NCT03076736.

Singing for people with aphasia (SPA): a protocol for a pilot randomised controlled trial of a group singing intervention to improve well-being.

INTRODUCTION: The singing for people with aphasia (SPA) intervention aims to improve quality of life and well-being for people with poststroke aphasia. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost effectiveness of SPA. The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design. METHODS AND ANALYSIS: A two-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed methods process evaluation and economic evaluation. Forty-eight participants discharged from clinical speech and language therapy will be individually randomised 1:1 to SPA (10 group sessions plus a resource booklet) or control (resource booklet only). Outcome assessment at baseline, 3 and 6 months postrandomisation include: ICEpop CAPability measure for adults, Stroke and Aphasia Quality of Life, EQ-5D-5L, modified Reintegration into Normal Living Index, Communication Outcome After Stroke, Very Short Version of the Minnesota Aphasia Test, Service Receipt Inventory and Care Related Quality of Life. Feasibility, acceptability and process outcomes include recruitment and retention rates, with measurement burden and trial experiences being explored in qualitative interviews (15 participants, 2 music facilitators and 2 music champions). Analyses include: descriptive statistics, with 95% CIs where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis. ETHICS AND DISSEMINATION: NHS National Research Ethics Service and the Health Research Authority confirmed approval in April 2017; recruitment commenced in June 2017. Outputs will include: pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised intervention manual for multicentre replication of SPA; presentations at conferences, public involvement events; internationally recognised peer reviewed journal publications, open access sources and media releases. TRIAL REGISTRATION NUMBER: NCT03076736.

Community-based rehabilitation training after stroke: results of a pilot randomised controlled trial (ReTrain) investigating acceptability and feasibility.

OBJECTIVES: To assess acceptability and feasibility of trial processes and the Rehabilitation Training (ReTrain) intervention including an assessment of intervention fidelity. DESIGN: A two-group, assessor-blinded, randomised controlled trial with parallel mixed methods process and economic evaluations. SETTING: Community settings across two sites in Devon. PARTICIPANTS: Eligible participants were: 18 years old or over, with a diagnosis of stroke and with self-reported mobility issues, no contraindications to physical activity, discharged from National Health Service or any other formal rehabilitation programme at least 1 month before, willing to be randomised to either control or ReTrain and attend the training venue, possessing cognitive capacity and communication ability sufficient to participate. Participants were individually randomised (1:1) via a computer-generated randomisation sequence minimised for time since stroke and level of functional disability. Only outcome assessors independent of the research team were blinded to group allocation. INTERVENTIONS: ReTrain comprised (1) an introductory one-to-one session; (2) ten, twice-weekly group classes with up to two trainers and eight clients; (3) a closing one-to-one session, followed by three drop-in sessions over the subsequent 3 months. Participants received a bespoke home-based training programme. All participants received treatment as usual. The control group received an exercise after stroke advice booklet. OUTCOME MEASURES: Candidate primary outcomes included functional mobility and physical activity. RESULTS: Forty-five participants were randomised (ReTrain=23; Control=22); data were available from 40 participants at 6 months of follow-up (ReTrain=21; Control=19) and 41 at 9 months of follow-up (ReTrain=21; Control=20). We demonstrated ability to recruit and retain participants. Participants were not burdened by the requirements of the study. We were able to calculate sample estimates for candidate primary outcomes and test procedures for process and health economic evaluations. CONCLUSIONS: All objectives were fulfilled and indicated that a definitive trial of ReTrain is feasible and acceptable. TRIAL REGISTRATION NUMBER: NCT02429180; Results.

Community-based Rehabilitation Training after stroke: protocol of a pilot randomised controlled trial (ReTrain).

INTRODUCTION: The Rehabilitation Training (ReTrain) intervention aims to improve functional mobility, adherence to poststroke exercise guidelines and quality of life for people after stroke. A definitive randomised controlled trial (RCT) is required to assess the clinical and cost-effectiveness of ReTrain, which is based on Action for Rehabilitation from Neurological Injury (ARNI). The purpose of this pilot study is to assess the feasibility of such a definitive trial and inform its design. METHODS AND ANALYSIS: A 2-group, assessor-blinded, randomised controlled external pilot trial with parallel mixed-methods process evaluation and economic evaluation. 48 participants discharged from clinical rehabilitation despite residual physical disability will be individually randomised 1:1 to ReTrain (25 sessions) or control (exercise advice booklet). Outcome assessment at baseline, 6 and 9 months include Rivermead Mobility Index; Timed Up and Go Test; modified Patient-Specific Functional Scale; 7-day accelerometry; Stroke Self-efficacy Questionnaire, exercise diary, Fatigue Assessment Scale, exercise beliefs and self-efficacy questionnaires, SF-12, EQ-5D-5L, Stroke Quality of Life, Carer Burden Index and Service Receipt Inventory. Feasibility, acceptability and process outcomes include recruitment and retention rates; with measurement burden and trial experiences being explored in qualitative interviews (20 participants, 3 intervention providers). Analyses include descriptive statistics, with 95% CI where appropriate; qualitative themes; intervention fidelity from videos and session checklists; rehearsal of health economic analysis. ETHICS AND DISSEMINATION: National Health Service (NHS) National Research Ethics Service approval granted in April 2015; recruitment started in June. Preliminary studies suggested low risk of serious adverse events; however (minor) falls, transitory muscle soreness and high levels of postexercise fatigue are expected. Outputs include pilot data to inform whether to proceed to a definitive RCT and support a funding application; finalised Trainer and Intervention Delivery manuals for multicentre replication of ReTrain; presentations at conferences, public involvement events; internationally recognised peer-reviewed journal publications, open access sources and media releases. TRIAL REGISTRATION NUMBER: NCT02429180; Pre-results.

Telephone triage systems in UK general practice: analysis of consultation duration during the index day in a pragmatic randomised controlled trial.

BACKGROUND: Telephone triage is an increasingly common means of handling requests for same-day appointments in general practice. AIM: To determine whether telephone triage (GP-led or nurse-led) reduces clinician-patient contact time on the day of the request (the index day), compared with usual care. DESIGN AND SETTING: A total of 42 practices in England recruited to the ESTEEM trial. METHOD: Duration of initial contact (following the appointment request) was measured for all ESTEEM trial patients consenting to case notes review, and that of a sample of subsequent face-to-face consultations, to produce composite estimates of overall clinician time during the index day. RESULTS: Data were available from 16,711 initial clinician-patient contacts, plus 1290 GP, and 176 nurse face-to-face consultations. The mean (standard deviation) duration of initial contacts in each arm was: GP triage 4.0 (2.8) minutes; nurse triage 6.6 (3.8) minutes; and usual care 9.5 (5.0) minutes. Estimated overall contact duration (including subsequent contacts on the same day) was 10.3 minutes for GP triage, 14.8 minutes for nurse triage, and 9.6 minutes for usual care. In nurse triage, more than half the duration of clinician contact (7.7 minutes) was with a GP. This was less than the 9.0 minutes of GP time used in GP triage. CONCLUSION: Telephone triage is not associated with a reduction in overall clinician contact time during the index day. Nurse-led triage is associated with a reduction in GP contact time but with an overall increase in clinician contact time. Individual practices may wish to interpret the findings in the context of the available skill mix of clinicians.

The clinical effectiveness and cost-effectiveness of telephone triage for managing same-day consultation requests in general practice: a cluster randomised controlled trial comparing general practitioner-led and nurse-led management systems with usual care (the ESTEEM trial).

BACKGROUND: Telephone triage is proposed as a method of managing increasing demand for primary care. Previous studies have involved small samples in limited settings, and focused on nurse roles. Evidence is limited regarding the impact on primary care workload, costs, and patient safety and experience when triage is used to manage patients requesting same-day consultations in general practice. OBJECTIVES: In comparison with usual care (UC), to assess the impact of GP-led telephone triage (GPT) and nurse-led computer-supported telephone triage (NT) on primary care workload and cost, patient experience of care, and patient safety and health status for patients requesting same-day consultations in general practice. DESIGN: Pragmatic cluster randomised controlled trial, incorporating economic evaluation and qualitative process evaluation. SETTING: General practices (n = 42) in four regions of England, UK (Devon, Bristol/Somerset, Warwickshire/Coventry, Norfolk/Suffolk). PARTICIPANTS: Patients requesting same-day consultations. INTERVENTIONS: Practices were randomised to GPT, NT or UC. Data collection was not blinded; however, analysis was conducted by a statistician blinded to practice allocation. MAIN OUTCOME MEASURES: Primary - primary care contacts [general practice, out-of-hours primary care, accident and emergency (A&E) and walk-in centre attendances] in the 28 days following the index consultation request. Secondary - resource use and costs, patient safety (deaths and emergency hospital admissions within 7 days of index request, and A&E attendance within 28 days), health status and experience of care. RESULTS: Of 20,990 eligible randomised patients (UC n = 7283; GPT n = 6695; NT n = 7012), primary outcome data were analysed for 16,211 patients (UC n = 5572; GPT n = 5171; NT n = 5468). Compared with UC, GPT and NT increased primary outcome contacts (over 28-day follow-up) by 33% [rate ratio (RR) 1.33, 95% confidence interval (CI) 1.30 to 1.36] and 48% (RR 1.48, 95% CI 1.44 to 1.52), respectively. Compared with GPT, NT was associated with a marginal increase in primary outcome contacts by 4% (RR 1.04, 95% CI 1.01 to 1.08). Triage was associated with a redistribution of primary care contacts. Although GPT, compared with UC, increased the rate of overall GP contacts (face to face and telephone) over the 28 days by 38% (RR 1.38, 95% CI 1.28 to 1.50), GP face-to-face contacts were reduced by 39% (RR 0.61, 95% CI 0.54 to 0.69). NT reduced the rate of overall GP contacts by 16% (RR 0.84, 95% CI 0.78 to 0.91) and GP face-to-face contacts by 20% (RR 0.80, 95% CI 0.71 to 0.90), whereas nurse contacts increased. The increased rate of primary care contacts in triage arms is largely attributable to increased telephone contacts. Estimated overall patient-clinician contact time on the index day increased in triage (GPT = 10.3 minutes; NT = 14.8 minutes; UC = 9.6 minutes), although patterns of clinician use varied between arms. Taking account of both the pattern and duration of primary outcome contacts, overall costs over the 28-day follow-up were similar in all three arms (approximately £75 per patient). Triage appeared safe, and no differences in patient health status were observed. NT was somewhat less acceptable to patients than GPT or UC. The process evaluation identified the complexity associated with introducing triage but found no consistency across practices about what works and what does not work when implementing it. CONCLUSIONS: Introducing GPT or NT was associated with a redistribution of primary care workload for patients requesting same-day consultations, and at similar cost to UC. Although triage seemed to be safe, investigation of the circumstances of a larger number of deaths or admissions after triage might be warranted, and monitoring of these events is necessary as triage is implemented. TRIAL REGISTRATION: Current Controlled Trials ISRCTN20687662. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 13. See the NIHR Journals Library website for further project information.

Telephone triage for management of same-day consultation requests in general practice (the ESTEEM trial): a cluster-randomised controlled trial and cost-consequence analysis.

BACKGROUND: Telephone triage is increasingly used to manage workload in primary care; however, supporting evidence for this approach is scarce. We aimed to assess the effectiveness and cost consequences of general practitioner-(GP)-led and nurse-led telephone triage compared with usual care for patients seeking same-day consultations in primary care. METHODS: We did a pragmatic, cluster-randomised controlled trial and economic evaluation between March 1, 2011, and March 31, 2013, at 42 practices in four centres in the UK. Practices were randomly assigned (1:1:1), via a computer-generated randomisation sequence minimised for geographical location, practice deprivation, and practice list size, to either GP-led triage, nurse-led computer-supported triage, or usual care. We included patients who telephoned the practice seeking a same-day face-to-face consultation with a GP. Allocations were concealed from practices until after they had agreed to participate and a stochastic element was included within the minimisation algorithm to maintain concealment. Patients, clinicians, and researchers were not masked to allocation, but practice assignment was concealed from the trial statistician. The primary outcome was primary care workload (patient contacts, including those attending accident and emergency departments) in the 28 days after the first same-day request. Analyses were by intention to treat and per protocol. This trial was registered with the ISRCTN register, number ISRCTN20687662. FINDINGS: We randomly assigned 42 practices to GP triage (n=13), nurse triage (n=15), or usual care (n=14), and 20,990 patients (n=6695 vs 7012 vs 7283) were randomly assigned, of whom 16,211 (77%) patients provided primary outcome data (n=5171 vs 5468 vs 5572). GP triage was associated with a 33% increase in the mean number of contacts per person over 28 days compared with usual care (2·65 [SD 1·74] vs 1·91 [1·43]; rate ratio [RR] 1·33, 95% CI 1·30-1·36), and nurse triage with a 48% increase (2·81 [SD 1·68]; RR 1·48, 95% CI 1·44-1·52). Eight patients died within 7 days of the index request: five in the GP-triage group, two in the nurse-triage group, and one in the usual-care group; however, these deaths were not associated with the trial group or procedures. Although triage interventions were associated with increased contacts, estimated costs over 28 days were similar between all three groups (roughly £75 per patient). INTERPRETATION: Introduction of telephone triage delivered by a GP or nurse was associated with an increase in the number of primary care contacts in the 28 days after a patient's request for a same-day GP consultation, with similar costs to those of usual care. Telephone triage might be useful in aiding the delivery of primary care. The whole-system implications should be assessed when introduction of such a system is considered. FUNDING: Health Technology Assessment Programme UK National Institute for Health Research.