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AnteayerBMJ Open

INDIGO randomised controlled digital clinical trial: INvestigating DIgital outcomes and quality of life in cancer survivors - a study protocol

Por: Le Calvez · K. · Gregory · J. J. · Gath · J. · Wheatstone · P. · Ashley · L. · Chinembiri · O. · Cunliffe · A. · Davenport · G. · Jamieson Gilmore · K. · Langel · K. · Miglio · C. · Pakzad-Shahabi · L. · Padmasri · D. · Ruta · D. · Williams · H. · Williams · M.
Introduction

There are estimated to be 3.4 million patients in the UK living after a diagnosis of cancer. We know very little about their quality of life or healthcare usage. Patient-reported outcome measures (PROMs) are tools which help to translate a patient’s quality of life into measurable categories, but how to do this at scale remains underexplored. The study employs a randomised design to assess different engagement strategies for optimising participation, data linkage and questionnaire completion in Northwest London and then nationally, with appropriate research approvals.

Methods and analysis

We have designed and implemented an online, patient-completed, randomised observational trial. We will pilot it in Northwest London before national roll-out, using initially the General Practice (GP) record of a cancer diagnosis and then exploring the use of social media. The primary objective is to explore the feasibility of recruiting participants via self-identification or contact from the primary care research network and obtaining consent to link participants’ PROMs responses to their cancer registry records. Data collection occurs through a secure platform, with participants directly responsible for data entry. There is no formal target sample size because this is a feasibility study, and we want to explore how many patients we can recruit. Analyses will be conducted using descriptive statistics, repeated measures multilevel modelling and machine learning techniques. If a substantial difference in responses between randomisation arms is detected, ineffective strategies will be removed. If no clear difference is observed, recruitment will continue with periodic reviews based on response rates and data completeness.

Ethics and dissemination

The Study Coordination Centre has obtained approval from the London—Surrey Research Ethics Committee and Health Research Authority. We will publish and disseminate the results in local, national and international meetings, in peer-reviewed journals, on social media and on websites.

It has been registered under ‘Investigating Digital Outcomes for Cancer Survivors in the Community’ (NCT06095024).

Trial registration number

NCT06095024: Investigating Digital Outcomes for Cancer Survivors in the Community.

Exploring the feasibility and acceptability of DIALOG+ (a structured digital communication tool) in strengthening psychiatric care in India and Pakistan: a qualitative pilot study

Por: Qureshi · O. · Divya · K. · Dawood · M. · Davis · S. · Venkatraman · L. · Baig · M. · Priya · K. · Peppl · R. · Pari · M. · Ramachandran · P. · Pasha · A. · Sajun · S. Z. · Sarwar · H. · Shahab · A. · Bird · V. J.
Objectives

To assess the implementation feasibility and acceptability of a structured digital psychosocial communication tool (DIALOG+) to strengthen the quality of person-centric care in psychiatric settings within Pakistan and India.

Design

A hybrid inductive and thematic qualitative analysis using individual interviews (IDIs) and focus group discussions (FGDs).

Setting

Two psychiatric hospitals (Karwan-e-Hayat and Jinnah Postgraduate Medical Centre) in Karachi, Pakistan and one psychiatric care organisation (Schizophrenia Research Foundation) in Chennai, India

Participants

Interviews were conducted with 8 mental health clinicians and 40 patients who completed the DIALOG+ pilot as well as wider stakeholders, that is, 12 mental health clinical providers, 15 caregivers of people with psychosis and 13 mental health experts.

Intervention

A technology-assisted communication tool (DIALOG+) to structure routine meetings and inform care planning, consisting of monthly sessions over a period of 3 months. The intervention comprises a self-reported assessment of patient satisfaction and quality of life on eight holistic life domains and three treatment domains, followed by a four-step solution-focused approach to address the concerns raised in chosen domains for help.

Outcome measures

Key insights for the implementation feasibility and acceptability of DIALOG+ were assessed qualitatively using inductive thematic analysis of 22 IDIs and 8 FGDs with 54 individuals.

Results

Clinicians and patients ascribed value to the efficiency and structure that DIALOG+ introduced to consultations but agreed it was challenging to adopt in busy outpatient settings. Appointment systems and selective criteria for who is offered DIALOG+ were recommended to better manage workload. Caregiver involvement in DIALOG+ delivery was strongly emphasised by family members, along with pictorial representation and relevant life domains by patients to enhance the acceptability of the DIALOG+ approach.

Conclusion

Findings highlight that the feasibility of implementing DIALOG+ in psychiatric care is closely tied to strategies that address clinician workload. Promoting institutional ownership in strengthening resource allocation is essential to reduce the burden on mental health professionals in order to enable them to provide more patient-centric and holistic care for people with psychosis. Further research is required to explore the appropriateness of including caregivers in DIALOG+ delivery to adapt to communal cultural attitudes in South Asia.

Promoting smoking cessation and preventing relapse to tobacco use following a smoke-free mental health inpatient stay (SCEPTRE feasibility study): a multicentre randomised controlled feasibility study protocol

Por: Petersen Williams · P. · Huddlestone · L. · Shoesmith · E. · Brady · S. · Mitchell · A. · Exley · V. · Wiggins · F. · Sinclair · L. · Pervin · J. · Horspool · M. · Leahy · M. · Paul · C. · Colley · L. · Shahab · L. · Watson · J. · Hewitt · C. · Hough · S. · Britton · J. · Coleman · T. · Gilb
Introduction

Thousands of patients with mental illness are admitted to acute adult mental health wards every year in England, where local guidance recommends that all mental health settings be entirely smokefree. Mental health Trusts presently invest substantial effort and resources to implement smoke-free policies and to deliver tobacco dependence treatment to patients. Providing adequate support can help those who smoke remain abstinent or quit smoking during their smoke-free inpatient stay and beyond. At present, little is known about how best to support patients to prevent their return to pre-admission smoking behaviours after discharge from a smoke-free mental health inpatient stay. We have developed an intervention which includes targeted resources to support smoking-related behaviour change in patients following discharge from a smoke-free mental health setting. The aim of this trial is to determine the feasibility of a large-scale clinical trial to test the effectiveness and cost-effectiveness of the SCEPTRE intervention, compared with usual care.

Methods and analysis

This feasibility study will be an individually randomised, controlled trial in eight National Health Service mental health Trusts recruiting adults (≥18 years) admitted to an acute adult mental health inpatient setting who smoke tobacco on admission, or at any point during their inpatient stay. Consenting participants will be randomised to receive a 12-week intervention consisting of components aimed at promoting or maintaining positive smoking-related behaviour change following discharge from a smoke-free mental health inpatient setting or usual care. Data will be collected at baseline, 3 months and a second timepoint between 4 and 6 months post-randomisation. With 64 participants (32 in each group), the trial will allow a participation rate of 15% and completion rate of 80% to be estimated within a 95% CI of ±3% and ±10%, respectively. The analysis will be descriptive and follow a prespecified plan.

Ethics and dissemination

Ethics approval was obtained from the North West—Greater Manchester West Research Ethics Committee. We will share results widely through local, national and international academic, clinical and patient and public involvement networks. The results will be disseminated through conference presentations, peer-reviewed journals and will be published on the trial website: https://sceptreresearch.com/.

Trial registration number

ISRCTN77855199.

Protocol for a prospective cohort study to determine the multimodal biomarkers of delirium and new dementia after acute illness in older adults: ORCHARD-PS

Por: Gan · J. M. · Elderton · L. · Vijayakumar Sheela · M. · Knight · J. · Louca · J. · Evans · S. · Shahab · K. · Lovett · N. G. · Sneade · M. · Muchenje · N. · Fenchyn · M. · Simonato · D. · McColl · A. · Pendlebury · S. T.
Introduction

Delirium is common in the older hospital population and is often precipitated by acute illness. Delirium is associated with poor outcomes including subsequent cognitive decline and dementia and may therefore be a modifiable risk factor for dementia. However, the mechanisms underpinning the delirium–dementia relationship and the role of coexisting acute illness factors remain uncertain. Current biomarker studies of delirium have limitations including lack of detailed delirium characterisation with few studies on neurodegenerative or neuroimaging biomarkers especially in the acute setting. The Oxford and Reading Cognitive Health After Recovery from acute illness and Delirium—Prospective Study (ORCHARD-PS) aims to elucidate the pathophysiology of delirium and subsequent cognitive decline after acute illness in older adults, through acquisition of multimodal biomarkers for deep phenotyping of delirium and acute illness, and follow-up for incident dementia.

Methods and analysis

ORCHARD-PS is a bi-centre, prospective cohort study. Consecutive eligible patients requiring acute hospital admission or assessment are identified by the relevant acute clinical care team. All patients age >65 years without advanced dementia, nursing home residence, end-stage frailty or terminal illness are eligible. Details of potential participants are communicated to the research team and written informed consent or consultee agreement is obtained. Participants are interviewed as soon as possible after admission/assessment using a structured proforma.

Data are collected on demographics, diagnosis and comorbidities, social and functional background. Delirium is assessed using the 4A’s test, Confusion Assessment Method (long-form), Observational Scale of Level of Arousal, Richmond Agitation-Sedation Scale and Memorial Delirium Assessment Scale and diagnosed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria. Delirium is categorised by time of onset (prevalent vs incident), dementia status, motoric subtype, severity and duration. Cognitive tests include the 10-point Abbreviated Mental Test and Montreal Cognitive Assessment. Participants are reassessed every 48–72 hours if remaining in hospital. Informant questionnaire data and interview are supplemented by hand searching of medical records and linkage to electronic patient records for nursing risk assessments, vital observations, laboratory results and International Classification of Diseases, Tenth Revision diagnostic and procedure codes.

In-person follow-up with more detailed cognitive testing and informant interview is undertaken at 3 months, and 1 and 3 years supplemented with indirect follow-up using medical records. Blood banking is performed at baseline and all follow-ups for future biomarker analyses. CT-brain and MRI-brain imaging acquired as part of standard care is obtained for quantification of brain atrophy and white matter disease/stroke supplemented by research CT-brain imaging. Outcomes include length of hospitalisation, change in care needs, institutionalisation, mortality, readmission, longitudinal changes in cognitive and functional status and incident dementia. Biomarker associations with delirium, and with incident dementia on follow-up, will be determined using logistic or Cox regression as appropriate, unadjusted and adjusted for covariates including demographics, baseline cognition, frailty, comorbidity and apolipoprotein E genotype.

Ethics and dissemination

ORCHARD-PS is approved by the South Central—Berkshire Research Ethics Committee (REC Reference: 23/SC/0199). Results will be disseminated through peer-reviewed publications and conference presentations.

Trial registration number

ISRCTN24171810.

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