The TANDEM trial: protocol for the process evaluation of a randomised trial of a complex intervention for anxiety and/or depression in people living with chronic obstructive pulmonary disease (COPD)

Trials

Hilary Pinnock¹  Kristie-Marie Mammoliti²  Vari Wileman³  Moira Kelly³  Liz Steed³  Sian Newton³  Stephanie Taylor³  Ratna Sohanpal³  Vickie Rowland⁴  Amy Barradell⁵  Anna Moore⁶  Clarisse Dibao-Dina⁷ 

[1] Allergy and Respiratory Research Group, Usher Institute of Population Health Sciences and Informatics, Doorway 3, Medical School, Teviot Place, EH8 9AG, Edinburgh, UK;Birmingham Clinical Trials Unit and WHO Collaborating Centre for Global Women’s Health Research, University of Birmingham, B15 2TT, Birmingham, UK;Centre for Primary Care and Mental Health, Institute of Population Health Sciences, Barts and The London School of Medicine and Dentistry, Yvonne Carter Building, 58, Turner Street, E1 2AB, London, UK;Department of Health & Social Sciences, University of the West of England, Frenchay Campus, Coldharbour Lane, BS16 1QY, Bristol, UK;Department of Respiratory Sciences, College of Life Sciences, NIHR Leicester Biomedical Research Centre- Respiratory Glenfield Hospital, University of Leicester, Groby Road, LE3 9QP, Leicester, UK;The Education Academy, Barts Health NHS Trust, Royal London Hospital, Whitechapel Road, E1 1FR, London, UK;Université de Tours, Université de Nantes, INSERM, SPHERE U1246, 10 Boulevard Tonnellé, B.P. 3223, 37044, Tours, cedex 1, France;

关键词: Process evaluation;    Implementation;    Complex intervention;    Chronic obstructive pulmonary disease (COPD);    Depression;    Anxiety;    Cognitive behavioural therapy (CBT);   

DOI  :  10.1186/s13063-021-05460-w

来源: Springer

【 摘 要 】

BackgroundTANDEM is a randomised controlled trial of a complex healthcare intervention to improve the psychological and physical health of people living with chronic obstructive pulmonary disease (COPD) and anxiety and/or depression. Based on health psychology theory set out in a logic model, respiratory health professionals were recruited and trained to deliver a cognitive behavioural approach intervention (The TANDEM intervention) under the supervision of senior cognitive behavioural practitioners. Here, we describe the protocol for the process evaluation commissioned alongside the trial. A realist approach that includes attention to describing contexts and mechanisms has been adopted.MethodsWe set up a multi-disciplinary team to develop and deliver the process evaluation. The mixed-methods design incorporates quantitative process data; monitoring of intervention fidelity; qualitative interviews with patients, carers, health professionals (facilitators) and clinical supervisors about their perspectives on acceptability of the intervention; and exploration with all stakeholders (including management/policy-makers) on future implementation. Normalisation process theory (NPT) will inform data collection and interpretation with a focus on implementation. Quantitative process data will be analysed descriptively. Qualitative interview data will be analysed before the trial outcomes are known using analytic induction and constant comparison to develop themes. Findings from the different elements will be reported separately and then integrated.ConclusionDetailed description and analysis of study processes in a research trial such as TANDEM enables research teams to describe study contexts and mechanisms and to examine the relationship with outcomes. In this way, learning from the trial goes beyond the randomised control trial (RCT) model where effectiveness is prioritised and makes it possible to explore issues arising for post-trial study implementation.Trial registrationISRCTN ISRCTN59537391. Registered on 20 March 2017. Trial protocol version 6.0, 22 April 2018.Process evaluation protocol version 4.0, 1 November 2020.

【 授权许可】

CC BY