Study protocol: randomised controlled hybrid type 2 trial evaluating the scale-up of two arts interventions for postnatal depression and Parkinson's disease

Tayana Soukup, Rachel E Davis, Maria Baldellou Lopez, Andy Healey, Carolina Estevao, Daisy Fancourt, Paola Dazzan, Carmine Pariante, Hannah Dye, Tim Osborn, Rebecca Bind, Kristi Sawyer, Lavinia Rebecchini, Katie Hazelgrove, Alexandra Burton, Manonmani Manoharan, Rosie Perkins, Aleksandra Podlewska, Ray Chaudhuri, Fleur Derbyshire-Fox, Alison Hartley, Anthony Woods, Nikki Crane, Ioannis Bakolis, Nick Sevdalis, Tayana Soukup, Rachel E Davis, Maria Baldellou Lopez, Andy Healey, Carolina Estevao, Daisy Fancourt, Paola Dazzan, Carmine Pariante, Hannah Dye, Tim Osborn, Rebecca Bind, Kristi Sawyer, Lavinia Rebecchini, Katie Hazelgrove, Alexandra Burton, Manonmani Manoharan, Rosie Perkins, Aleksandra Podlewska, Ray Chaudhuri, Fleur Derbyshire-Fox, Alison Hartley, Anthony Woods, Nikki Crane, Ioannis Bakolis, Nick Sevdalis

Abstract

Introduction: Research on the benefits of 'arts' interventions to improve individuals' physical, social and psychological well-being is growing, but evidence on implementation and scale-up into health and social care systems is lacking. This protocol reports the SHAPER-Implement programme (Scale-up of Health-Arts Programmes Effectiveness-Implementation Research), aimed at studying the impact, implementation and scale-up of: Melodies for Mums (M4M), a singing intervention for postnatal depression; and Dance for Parkinson's (PD-Ballet) a dance intervention for Parkinson's disease. We examine how they could be embedded in clinical pathways to ensure their longer-term sustainability.

Methods and analysis: A randomised two-arm effectiveness-implementation hybrid type 2 trial design will be used across M4M/PD-Ballet. We will assess the implementation in both study arms (intervention vs control), and the cost-effectiveness of implementation. The design and measures, informed by literature and previous research by the study team, were refined through stakeholder engagement. Participants (400 in M4M; 160 in PD-Ballet) will be recruited to the intervention or control group (2:1 ratio). Further implementation data will be collected from stakeholders involved in referring to, delivering or supporting M4M/PD-Ballet (N=25-30 for each intervention).A mixed-methods approach (surveys and semi-structured interviews) will be employed. 'Acceptability' (measured by the 'Acceptability Intervention Measure') is the primary implementation endpoint for M4M/PD-Ballet. Relationships between clinical and implementation outcomes, implementation strategies (eg, training) and outcomes will be explored using generalised linear mixed models. Qualitative data will assess factors affecting the acceptability, feasibility and appropriateness of M4M/PD-Ballet, implementation strategies and longer-term sustainability. Costs associated with implementation and future scale-up will be estimated.

Ethics and dissemination: SHAPER-PND (the M4M trial) and SHAPER-PD (the PD trial) are approved by the West London and GTAC (20/PR/0813) and the HRA and Health and Care Research Wales (REC Reference: 20/WA/0261) Research Ethics Committees. Study findings will be disseminated through scientific peer-reviewed journals and scientific conferences.

Trial registration numbers: Both trials are registered with NIH US National Library of Medicine, ClinicalTrials.gov. The trial registration numbers, URLs of registry records, and dates of registration are: (1) PD-Ballet: URL: NCT04719468 (https://eur03.safelinks.protection.

Outlook: com/?url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fct2%2Fshow%2FNCT04719468%3Fterm%3DNCT04719468%26draw%3D2%26rank%3D1&data=04%7C01%7Crachel.davis%40kcl.ac.uk%7C11a7c5142782437919f808d903111449%7C8370cf1416f34c16b83c724071654356%7C0%7C0%7C6375441942616) (date of registration: 22 Jan 2021). (2) Melodies for Mums: NCT04834622 (https://ichgcp.net/clinical-trials-registry/NCT04834622?term=shaper-pnd&draw=2&rank=1) (date of registration: 8 Apr 2021).

Keywords: Parkinson-s disease; health economics; health services administration & management; maternal medicine.

Conflict of interest statement

Competing interests: NS is the Director of London Safety & Training Solution Ltd, which offers training in patient safety, implementation solutions and human factors to healthcare organisations and the pharmaceutical industry. TS received funding from Cancer Alliances and Health Education England for training multidisciplinary teams in assessment and quality improvement methods in the UK. TS received consultancy fees from Roche Diagnostics in relation to implementation of innovations for multidisciplinary teams and their meetings in the USA. DF is a non-executive board director for Breathe Arts Health Research. But she receives no financial compensation for her involvement. CP has received research funding from Johnson & Johnson for research on depression and inflammation, and by a Wellcome Trust strategy award to the Neuroimmunology of Mood Disorders and Alzheimer’s Disease (NIMA) Consortium (104025), which is also funded by Janssen, GlaxoSmithKline, Lundbeck and Pfizer. The work presented in this paper is unrelated to this funding.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ.

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