Improving patient experience and safety at transitions of care through the Your Care Needs You (YCNY) intervention: a study protocol for a cluster randomised controlled feasibility trial

Baxter, Ruth; Murray, Jenni; O’Hara, Jane; Hewitt, Catherine; Richardson, Gerry; Cockayne, Sarah; Sheard, Laura; Mills, Thomas; Lawton, Rebecca

doi:10.1186/s40814-020-00655-5

Cited by 12 publications

(12 citation statements)

References 34 publications

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“…Although our logic model may be of interest to future trials of foot orthoses, the development process we used could be of interest beyond foot and ankle research. Our logic model and menu of options for each intervention explicitly enable adaptability and provide a solution to an issue identified by Mills et al [ 22 , 29 ] whereby sometimes models and interventions are too prescriptive to enable implementation. The process we used to develop them did not force consensus that produces precise guidance that is inappropriate across different settings and becomes redundant beyond the trial.…”

Section: Discussionmentioning

confidence: 99%

Using a modified nominal group technique to develop complex interventions for a randomised controlled trial in children with symptomatic pes planus

Backhouse

Parker

Morison

et al. 2022

Trials

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Background Children with symptomatic flat feet (pes planus) frequently present for care but there remains uncertainty about how best to manage their condition. There is considerable variation in practice between and within professions. We intend to conduct a three-arm trial to evaluate three frequently used interventions for pes planus (exercise and advice, exercise and advice plus prefabricated orthoses, and exercise and advice plus custom made orthoses). Each of these interventions are complex and required developing prior to starting the trial. This paper focusses on the development process undertaken to develop the interventions. Methods We used a modified Nominal Group Technique combining an electronic survey with two face-to-face meetings to achieve consensus on the final logic model and menu of options for each intervention. Using the Nominal Group Technique across consecutive meetings in combination with a questionnaire is novel, and enabled us to develop complex interventions that reflect contemporary clinical practice. Results In total 16 healthcare professionals took part in the consensus. These consisted of 11 podiatrists, two orthotists, two physiotherapists, and one orthopaedic surgeon. Both meetings endorsed the logic model with amendments to reflect the wider psychosocial impact of pes planus and its treatment, as well as the increasing use of shared decision making in practice. Short lists of options were agreed for prefabricated and custom made orthoses, structures to target in stretching and strengthening exercises, and elements of health education and advice. Conclusions Our novel modification of the nominal group technique produced a coherent logic model and shortlist of options for each of the interventions that explicitly enable adaptability. We formed a consensus on the range of what is permissible within each intervention so that their integrity is kept intact and they can be adapted and pragmatically applied. The process of combining survey data with face-to-face meetings has ensured the interventions mirror contemporary practice and may provide a template for other trials.

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Section: Discussionmentioning

confidence: 99%

Using a modified nominal group technique to develop complex interventions for a randomised controlled trial in children with symptomatic pes planus

Backhouse

Parker

Morison

et al. 2022

Trials

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“…It was anticipated that intervention wards would deliver the Your Care Needs You intervention to all patients aged 75 or above who were expected to go home after their hospital stay, or their carers or families. The feasibility study protocol has been published (Baxter et al, 2020) and a full findings paper, reporting on the feasibility of trial methodology and the Your Care Needs You intervention, will be published shortly. This article reports on the development of a RWLM as part of the qualitative research, with the aim being to enrich understanding of how the Your Care Needs You intervention is to work in the trial.…”

Section: Methodsmentioning

confidence: 99%

“…The 'Your Care Needs You' intervention 'Your Care Needs You' is a complex intervention developed as part of the Partners-at-Care-Transitions programme of research, a multi-stage, National Institute for Health Research (NIHR)-funded study of transitions from hospital to home for older patients (Baxter et al, 2020;Baxter et al, 2018;O'Hara et al, 2019O'Hara et al, , 2020. A theory-based approach to intervention development was adopted which sought to accommodate context-sensitivity within a trial setting.…”

Section: Introductionmentioning

confidence: 99%

Development of a ‘real-world’ logic model through testing the feasibility of a complex healthcare intervention: the challenge of reconciling scalability and context-sensitivity

et al. 2022

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Logic models feature prominently in intervention research yet there is increasing debate about their ability to express how interventions work in the real-world. ‘Real-world’ logic models are a new proposition which express complex interventions in context. They are designed to help researchers strike a balance between context-sensitivity and scalability. This article explores the utility of real-world logic models in a trial involving a complex intervention called ‘Your Care Needs You’, designed to improve hospital-home transitions for UK older patients. The approach is found to usefully capture, refine and express important learning about intervention-implementation-context dynamics. The findings imply the need for intervention researchers to think creatively about how to implement interventions in diverse and sometimes challenging environments and to develop understanding of how complex interventions adapt on implementation to produce outcomes. The possibility of assessing the wider social and policy context within intervention research is also posed.

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“…The protocol was published [ 23 ] and the trial registered on the International Standard Randomised Controlled Trials registry (ISRCTN: 51154948). The CONSORT (Consolidated Standards of Reporting Trials statement) guidelines for pilot and feasibility studies and TIDieR (Template for Intervention Description and Replication) checklist are provided in supplementary file 1 [ 24 ].…”

Section: Methodsmentioning

confidence: 99%

Improving the safety and experience of transitions from hospital to home: a cluster randomised controlled feasibility trial of the 'Your Care Needs You' intervention versus usual care

Baxter

Murray²,

Cockayne

et al. 2022

Pilot Feasibility Stud

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Background The ‘Your Care Needs You’ (YCNY) intervention aims to increase the safety and experience of transitions for older people through greater patient involvement during the hospital stay. Methods A cluster randomised controlled feasibility trial was conducted on NHS inpatient wards (clusters) where ≥ 40% of patients were routinely ≥ 75 years. Wards were randomised to YCNY or usual care using an unequal allocation ratio (3:2). We aimed to recruit up to 20 patients per ward. Follow-up included routine data collection and questionnaires at 5-, 30-, and 90-days post-discharge. Eligible patients were ≥ 75 years, discharged home, stayed overnight on participating wards, and could read and understand English. The trial assessed the feasibility of delivering YCNY and the trial methodology through recruitment rates, outcome completion rates, and a qualitative evaluation. The accuracy of using routinely coded data for the primary outcome in the definitive trial was assessed by extracting discharge information for up to ten nonindividual consenting patients per ward. Results Ten wards were randomised (6 intervention, 4 control). One ward withdrew, and two wards were unable to deliver the intervention. Seven-hundred twenty-one patients were successfully screened, and 161 were recruited (95 intervention, 66 control). The patient post-discharge attrition rate was 17.4% (n = 28). Primary outcome data were gathered for 91.9% of participants with 75.2% and 59.0% providing secondary outcome data at 5 and 30 days post-discharge respectively. Item completion within questionnaires was generally high. Post-discharge follow-up was terminated early due to the COVID-19 pandemic affecting 90-day response rates (16.8%). Data from 88 nonindividual consenting patients identified an error rate of 15% when using routinely coded data for the primary outcome. No unexpected serious adverse events were identified. Most patients viewed YCNY favourably. Staff agreed with it in principle, but ward pressures and organisational contexts hampered implementation. There was a need to sustain engagement, provide clarity on roles and responsibilities, and account for fluctuations in patients’ health, capacity, and preferences. Conclusions If implementation challenges can be overcome, YCNY represents a step towards involving older people as partners in their care to improve the safety and experience of their transitions from hospital to home. Trial registration ISRCTN: 51154948.

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Improving patient experience and safety at transitions of care through the Your Care Needs You (YCNY) intervention: a study protocol for a cluster randomised controlled feasibility trial

Cited by 12 publications

References 34 publications

Using a modified nominal group technique to develop complex interventions for a randomised controlled trial in children with symptomatic pes planus

Using a modified nominal group technique to develop complex interventions for a randomised controlled trial in children with symptomatic pes planus

Development of a ‘real-world’ logic model through testing the feasibility of a complex healthcare intervention: the challenge of reconciling scalability and context-sensitivity

Improving the safety and experience of transitions from hospital to home: a cluster randomised controlled feasibility trial of the 'Your Care Needs You' intervention versus usual care

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