TY - JOUR
T1 - Study protocol
T2 - randomised controlled hybrid type 2 trial evaluating the scale-up of two arts interventions for postnatal depression and Parkinson's disease
AU - Soukup, Tayana
AU - Davis, Rachel E
AU - Baldellou Lopez, Maria
AU - Healey, Andy
AU - Estevao, Carolina
AU - Fancourt, Daisy
AU - Dazzan, Paola
AU - Pariante, Carmine
AU - Dye, Hannah
AU - Osborn, Tim
AU - Bind, Rebecca
AU - Sawyer, Kristi
AU - Rebecchini, Lavinia
AU - Hazelgrove, Katie
AU - Burton, Alexandra
AU - Manoharan, Manonmani
AU - Perkins, Rosie
AU - Podlewska, Aleksandra
AU - Chaudhuri, Ray
AU - Derbyshire-Fox, Fleur
AU - Hartley, Alison
AU - Woods, Anthony
AU - Crane, Nikki
AU - Bakolis, Ioannis
AU - Sevdalis, Nick
N1 - Funding Information:
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.
Funding Information:
Funding This research was funded in whole, or in part, by the Wellcome Trust [219425/Z/19/Z]. For the purpose of open access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission. These trials included in SHAPER-Implement are part of the SHAPER programme, a Scaling-up Health-Arts Programme to scale up arts interventions. IB, AH and NS are funded by and RD is supported by the National Institute for Health Research (NIHR) via the ‘Applied Research Collaboration South London’ (NIHR ARC South London) at King’s College Hospital National Health Service (NHS) Foundation Trust, London, UK. AH and NS are members of King’s Improvement Science, which offers co-funding to the NIHR ARC South London and is funded by King’s Health Partners (Guy’s and St Thomas’ NHS Foundation Trust, King’s College Hospital NHS Foundation Trust, King’s College London and South London and Maudsley NHS Foundation Trust), and Guy’s and St Thomas’ Foundation. IB (is further funded) and CP are supported by the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and CP is a NIHR Senior Investigator. MLB is further funded by Diabetes UK. RP is supported by HEartS, a project funded by the UK’s Arts and Humanities Research Council to investigate the health, economic and social impact of the arts (Grant ref. AH/P005888/1). The funding agreements ensured the authors’ independence in designing the study, interpreting the data, writing, and publishing the report. The views expressed are those of the authors and not necessarily reflect those of the NHS, the Wellcome Trust, the NIHR, the charities or the Department of Health and Social Care.
Publisher Copyright:
© 2022 BMJ Publishing Group. All rights reserved.
PY - 2022/2/1
Y1 - 2022/2/1
N2 - 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://clinicaltrials.gov/ct2/show/NCT04834622?term=shaper-pnd&draw=2&rank=1) (date of registration: 8 Apr 2021).
AB - 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://clinicaltrials.gov/ct2/show/NCT04834622?term=shaper-pnd&draw=2&rank=1) (date of registration: 8 Apr 2021).
UR - http://www.scopus.com/inward/record.url?scp=85124061276&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-055691
DO - 10.1136/bmjopen-2021-055691
M3 - Article
C2 - 35105591
SN - 2044-6055
VL - 12
JO - BMJ Open
JF - BMJ Open
IS - 2
M1 - e055691
ER -
