Abstract
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.
Highlights
TANDEM 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
The evidence for optimal approaches to managing psychological comorbidities in Chronic obstructive pulmonary disease (COPD) is not conclusive, and there are few evidencebased care pathways for anxiety and depression in people with COPD [12]. Psychological therapies such as cognitive behavioural therapy (CBT) are proposed as potential treatments for patients living with long-term condition (LTC) such as COPD with co-morbid anxiety and/or depression [13,14,15]
This paper presents the protocol for a process evaluation being undertaken in parallel to a trial evaluating a tailored intervention using a cognitive behavioural approach (CBA) incorporating self-management skills which precedes, links with, and optimises the benefits of currently offered Pulmonary rehabilitation (PR), in patients with COPD and depression and/or anxiety
Summary
We 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 integrated
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