Unpacking the Cinderella black box of complex intervention development through the Partners at Care Transitions (PACT) programme of research

INTRODUCTION Complex intervention development has been described as the 'Cinderella' black box in health services research. Greater transparency in the intervention development process is urgently needed to help reduce research waste. METHODS We applied a new consensus-based framework for complex intervention development to our programme of research, in which we developed an intervention to improve the safety and experience of care transitions for older people. Through this process, we aimed to reflect on the framework's utility for intervention development and identify any important gaps within it to support its continued development. FINDINGS The framework was a useful tool for transparent reporting of the process of complex intervention development. We identified potential 'action' gaps in the framework including 'consolidation of evidence' and 'development of principles' that could bracket and steer decision-making in the process. CONCLUSIONS We consider that the level of transparency demonstrated in this report, aided through use of the framework, is essential in the quest for reducing research waste. PATIENT OR PUBLIC CONTRIBUTION We have involved our dedicated patient and public involvement group in all work packages of this programme of research. Specifically, they attended and contributed to co-design workshops and contributed to finalizing the intervention for the pilot evaluation. Staff also participated by attending co-design workshops, helping us to prioritize content ideas for the intervention and supporting the development of intervention components outside of the workshops.

[1]  J. Murray,et al.  A qualitative formative evaluation of a patient facing intervention to improve care transitions for older people moving from hospital to home , 2022, Health expectations : an international journal of public participation in health care and health policy.

[2]  A. Cracknell,et al.  Doing involvement: A qualitative study exploring the ‘work’ of involvement enacted by older people and their carers during transition from hospital to home , 2021, Health expectations : an international journal of public participation in health care and health policy.

[3]  M. Petticrew,et al.  A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance , 2021, BMJ.

[4]  C. Hewitt,et al.  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 , 2020, Pilot and Feasibility Studies.

[5]  R. Lawton,et al.  Delivering exceptionally safe transitions of care to older people: a qualitative study of multidisciplinary staff perspectives , 2020, BMC Health Services Research.

[6]  C. Vincent,et al.  Validation of the Partners at Care Transitions Measure (PACT-M): assessing the quality and safety of care transitions for older people in the UK , 2020, BMC Health Services Research.

[7]  J. O'Hara,et al.  'Handing over to the patient': A FRAM analysis of transitional care combining multiple stakeholder perspectives. , 2020, Applied ergonomics.

[8]  A. O’Cathain,et al.  Guidance for reporting intervention development studies in health research (GUIDED): an evidence-based consensus study , 2020, BMJ Open.

[9]  Lucy Yardley,et al.  Guidance on how to develop complex interventions to improve health and healthcare , 2019, BMJ Open.

[10]  C. Vincent,et al.  Developing a measure to assess the quality of care transitions for older people , 2019, BMC Health Services Research.

[11]  J. Murray,et al.  How older people enact care involvement during transition from hospital to home: A systematic review and model , 2019, Health expectations : an international journal of public participation in health care and health policy.

[12]  A. O’Cathain,et al.  Understanding successful development of complex health and healthcare interventions and its drivers from the perspective of developers and wider stakeholders: an international qualitative interview study , 2019, BMJ Open.

[13]  S. Dombrowski,et al.  Examining the theory‐effectiveness hypothesis: A systematic review of systematic reviews , 2019, British journal of health psychology.

[14]  A. Blenkinsopp,et al.  Gaps, traps, bridges and props: a mixed-methods study of resilience in the medicines management system for patients with heart failure at hospital discharge , 2019, BMJ Open.

[15]  Luci K. Leykum,et al.  Interventions to reduce readmissions: can complex adaptive system theory explain the heterogeneity in effectiveness? A systematic review , 2018, BMC Health Services Research.

[16]  Kathleen M Mazor,et al.  We want to know: patient comfort speaking up about breakdowns in care and patient experience , 2018, BMJ Quality & Safety.

[17]  R. Foy,et al.  Partners at Care Transitions: exploring healthcare professionals’ perspectives of excellence at care transitions for older people , 2018, BMJ Open.

[18]  J. Waring,et al.  Scaffolding our systems? Patients and families ‘reaching in’ as a source of healthcare resilience. , 2018, BMJ Quality & Safety.

[19]  Nienke Bleijenberg,et al.  Increasing value and reducing waste by optimizing the development of complex interventions: Enriching the development phase of the Medical Research Council (MRC) Framework. , 2018, International journal of nursing studies.

[20]  R. Lilford Implementation science at the crossroads , 2017, BMJ Quality & Safety.

[21]  A. Blenkinsopp,et al.  A qualitative study of patient involvement in medicines management after hospital discharge: an under-recognised source of systems resilience , 2017, BMJ Quality & Safety.

[22]  E. Duthie,et al.  Patients' Perspectives of Engagement as a Safety Strategy. , 2017, Oncology nursing forum.

[23]  A. Cracknell,et al.  Partners at Care Transitions (PACT)—exploring older peoples’ experiences of transitioning from hospital to home in the UK: protocol for an observation and interview study of older people and their families to understand patient experience and involvement in care at transitions , 2017, BMJ Open.

[24]  I. Vedel,et al.  Impact of Transitional Care Services for Chronically Ill Older Patients: A Systematic Evidence Review , 2017, Journal of the American Geriatrics Society.

[25]  G. Robert,et al.  What outcomes are associated with developing and implementing co-produced interventions in acute healthcare settings? A rapid evidence synthesis , 2017, BMJ Open.

[26]  Tracy Finch,et al.  Implementation, context and complexity , 2016, Implementation Science.

[27]  R. Lawton,et al.  At a crossroads? Key challenges and future opportunities for patient involvement in patient safety , 2016, BMJ Quality & Safety.

[28]  P. Hoddinott A new era for intervention development studies , 2015, Pilot and Feasibility Studies.

[29]  Nicola Mackintosh,et al.  The role of patients and their relatives in ‘speaking up’ about their own safety – a qualitative study of acute illness , 2015, Health expectations : an international journal of public participation in health care and health policy.

[30]  Penelope Hawe,et al.  Lessons from complex interventions to improve health. , 2015, Annual review of public health.

[31]  Y. Gustafson,et al.  Length of hospital stay after hip fracture and short term risk of death after discharge: a total cohort study in Sweden , 2015, BMJ : British Medical Journal.

[32]  Ruth Jepson,et al.  Six steps in quality intervention development (6SQuID) , 2014, Journal of Epidemiology & Community Health.

[33]  Donald L. McGuinness,et al.  Enhancing Community-Based Rehabilitation for Stroke Survivors: Creating a Discharge Link , 2014, Topics in stroke rehabilitation.

[34]  R. Burke,et al.  Identifying keys to success in reducing readmissions using the ideal transitions in care framework , 2014, BMC Health Services Research.

[35]  Vikram Patel,et al.  Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions , 2014, Trials.

[36]  Michael R Gionfriddo,et al.  Preventing 30-day hospital readmissions: a systematic review and meta-analysis of randomized trials. , 2014, JAMA internal medicine.

[37]  V. Bekkers,et al.  A Systematic Review of Co-Creation and Co-Production: Embarking on the social innovation journey , 2014 .

[38]  Iain Chalmers,et al.  How to increase value and reduce waste when research priorities are set , 2014, The Lancet.

[39]  Sarah M. Greene,et al.  Toward patient-centered cancer care: patient perceptions of problematic events, impact, and response. , 2012, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[40]  N Sevdalis,et al.  Patient involvement in patient safety: How willing are patients to participate? , 2011, Quality and Safety in Health Care.

[41]  V. Entwistle,et al.  Speaking up about safety concerns: multi-setting qualitative study of patients' views and experiences , 2010, Quality and Safety in Health Care.

[42]  David L. B. Schwappach,et al.  Review: Engaging Patients as Vigilant Partners in Safety , 2010, Medical care research and review : MCRR.

[43]  Vikki Entwistle,et al.  Scoping Review and Approach to Appraisal of Interventions Intended to Involve Patients in Patient Safety , 2010, Journal of health services research & policy.

[44]  P. Glasziou,et al.  Avoidable waste in the production and reporting of research evidence , 2009, The Lancet.

[45]  M. Petticrew,et al.  Developing and evaluating complex interventions: the new Medical Research Council guidance , 2008, BMJ : British Medical Journal.

[46]  M. Grypdonck,et al.  The development of evidence-based nursing interventions: methodological considerations. , 2004, Journal of advanced nursing.