Step One – Building an Expert Team
Dr Karen Heslop Marshall, a clinical respiratory academic who had experience of delivering CBT in COPD agreed to be part of the expert team, as did Professor Sally Singh a pulmonary rehabilitation expert. Education for Health, a health education charity, were approached and agreed as did psychologists Dr Liz Steed and Dr Sarah Saqi-Waseem. Chris Warburton was an expert patient who joined the team and offered PPI consultation throughout. Methodologists included Moira Kelly and Ratna Sohanpal, who both had experience of working in the field of COPD.
This expert team proposed combining CBA and a supportive self-management intervention with exercise, provided by explicitly linking in to routine PR, in order to build upon an evidence-based service already embedded within the NHS. The team proposed building on two pre-developed interventions The Lung Manual (44) and the SPACE Manual (45) including use of their materials e.g. SPACE materials as well as the full range of information leaflets for people with COPD and their carers from the British Lung Foundation to meet educational and self-management needs. This meant materials which had already had extensive PPI input were available. We also drew on CORE competencies for delivering CBT (46)
Step Two – Use of theory to develop a logic model and preliminary outline of the intervention
Both The Lung Manual and the SPACE manual are evidence-based and draw on theory. The Lung Manual applies Beck’s theory of CBT (47) for managing anxiety and breathlessness in COPD whilst the SPACE manual applies a self-management approach based on Bandura’s social learning/cognitive theory (48, 49). These theories were therefore considered important underpinnings for TANDEM. LS suggested that Leventhal’s Self-Regulation theory (50) may also be relevant to self-managing COPD. This was supported by the literature and therefore incorporated in the programme theory for patient-facing aspects of the intervention.
Consultation with Education for Health suggested that the pedagogical theory that would be most relevant for training facilitators was the VARK (Visual, Auditory, Read, Kinesthetic (i.e. experience or practice, simulated or real)) model of learning (51). This has been used frequently in training interventions and ensures that the training suits individuals with different learning styles and we adopted it in the current study.
For intervention development the person-based approach (52) with its focus on using qualitative work to inform guiding principles was considered particularly relevant and therefore guided the intervention development process.
Figure two shows the logic model for TANDEM. The basic premise is that how an individual thinks about their COPD (cognitions - including illness and treatment beliefs) influences how they behave (including self-management actions taken) and how they feel (both physical symptoms and emotions). These factors have interactional effects such that depression and /or anxiety can be both reduced or exacerbated depending on the individual’s cognitions and behaviours. Consequently, by targeting change at a cognitive, behavioural or symptom level this will influence emotional outcomes. This improvement in emotional outcomes and self-management outcomes is then hypothesised to make attendance at pulmonary rehabilitation more likely, which itself is known to have positive outcomes including on both physical and psychological outcomes(30, 31).
Based on the logic model and content from the Lung and SPACE manuals a preliminary outline intervention for discussion in step three was developed (see supplementary file one). This included information on COPD including illness and treatment beliefs, and skills such as breathing techniques; cognitive behavioural techniques such as monitoring, diaries, distraction; basic self-management techniques such as goal setting and problem solving; delivery options were open as were the best ways to train facilitators and who those facilitators should be and other factors which would support implementation
Step Three – Qualitative findings, themes and development of guiding principles
One focus group comprising six rHCPs (one respiratory consultant, one occupational therapist, three physiotherapists and one exercise practitioner) and seven individual interviews (four psychologists, two physiotherapists and one general practitioner) were conducted. All participants had experience in working with patients with COPD, either in the community or secondary care. Roles varied, including some with management responsibilities who were able to discuss implementation.
One focus group was held with patients of whom four had COPD, two had other respiratory conditions and two were carers. Very tight timelines precluded formal analysis of transcripts from the patient focus group data, so data were limited to quotes selected from the audio recording. Major local governance delays prevented conduct of the second focus group with patients and their carers who had experience of CBT in time to inform intervention development.
Both patients and professionals presented an overall positive attitude to the idea of the TANDEM intervention:-
And I do think in the long run something like this could be more cost effective and stuff, things like that…I think it would be really useful (rHCP FG002 Occupational therapist)
Themes were developed which related to i) life with COPD, ii) intervention considerations and iii) issues for implementation.
Life with COPD
All participants, including patients and rHCPs, recognised depression and anxiety as common in COPD although patients did not always use this terminology. Other issues such as frustration and embarrassment, along with role adjustment and loss, including of social contacts, were common and seen as contributors to mood problems.
“The approach is good…because of all the other things happening in people’s lives which can stop them attending PR and make them anxious and depressed.” (focus group patient)
Intervention considerations
rHCPs emphasised the challenge of breathlessness to patients with COPD and suggested that discussion and teaching of breathing control early in the intervention would be a helpful way to raise issues around mood as well as providing practical help which may increase engagement. There was also recognition that this group may be quite socially isolated and health literacy may vary so the intervention must be accessible to all.
Implementation considerations
The majority of issues for implementation related to the workforce and who would realistically be able to deliver a CBA service. Both rHCPs and psychologists recommended rHCPs to be best placed, however all recognised that there would need to be some selection process and supervision. One clinician was concerned about the cost of the intervention, although others considered that in the long run CBA could be cost-effective.
These themes were subsequently interpreted to provide guiding principles as recommended by the patient-based approach to intervention development (52). Table 1 shows these principles and example data extracts.
Step Four: Detailed design of intervention materials and mode of delivery
Having agreed the guiding principles for the intervention the expert team met to discuss the detailed design of the TANDEM intervention. It was understood that the intervention would be working at two levels i) patient-facing (i.e. CBA delivery) and ii) facilitator-facing (i.e. training programme).
For the patient-facing CBA a range of core patient self-completion materials were designed that could be provided as part of the intervention. These covered the topics of ‘Controlling your breathing’, ‘Mood and COPD’, ‘Anxiety and COPD’, ‘Depression and COPD’, ‘Problem Solving’, ‘Saving Energy’. These were developed for TANDEM but where possible drew on, or used, the SPACE manual (46) handouts and were of similar format to published CBT leaflets accessible on the internet (53) as these have been developed with extensive PPI. The aim of these leaflets was as homework, (called “home practice” in the TANDEM intervention based on PPI advice that connotations of school may be off putting for people who had poor experiences of school), which is a central part of CBT and to reinforce knowledge that had been covered in the one-to-one sessions. The approach is also in line with (Integrated Access to Psychological Therapies (IAPT)) services low-intensity provision (54). LS developed all materials with iterative refinement from the expert team including PPI. At the start of session one each patient was given a TANDEM folder, in which they could store handouts relevant to them so that individuals had a tailored version of TANDEM materials whilst maintaining consistency in the content provided. In total 6-8 face to face sessions were designed, covering nine topics; with core content and additional modules tailored to individual problems and complexity. Table two provides an overview of TANDEM topics
One topic (dealing with ‘other problems’) was specifically added as a strategy for keeping the focus of initial sessions on COPD whilst having space later to address issues the person may have outside COPD, for example debt, substance abuse etc. This topic looked at how the CBA, learnt in the context of COPD, could be generalised to different problems, with sign-posting to additional sources of help. At the final session discussion was around pulmonary rehabilitation. If there was to be a delay in individuals commencing PR then the facilitator arranged up to nine weekly telephone calls.
The three-day facilitator training was provided with a supporting manual which covered the skills needed to deliver TANDEM.
Table 3 shows the content of the training programme. There was a high level of practical and experiential learning in the group and supportive links within the group were encouraged. Throughout delivery of the CBA intervention facilitators received regular telephone supervision, one-to-one with senior cognitive behavioural therapists at approximately fortnightly intervals. This on-going supervision was considered to be an integral part of the intervention.
Phase Five – Whole intervention pre-pilot study
All three TANDEM facilitators completed the three training days and two went on to deliver the intervention to three patients (one delivered it to two patients and one to a single patient). The third facilitator (a respiratory practice nurse without prior CBT training) did not manage to see any patients due to unanticipated research governance delays and a consequent change in work commitments.
TANDEM Facilitators
After the initial training session, facilitators suggested some changes (see supplementary file two), specifically an overview of the intervention at the beginning of the training in order to orientate individuals. All the facilitators felt that the role-play activity with a simulated patient (actor), which was conducted as part of the original group training on day one, was too threatening and at too early a stage of skill development. Instead they requested more demonstrations and more practice in developing a formulation.
Interviews at the end of delivering TANDEM to patients, revealed that both facilitators felt the intervention had been well received by participants and feasible to implement, although one had to deliver it over a longer period than scheduled due to patient illness.
‘Yeah, I mean the two patients who I had were very, very enthusiastic about all elements of the intervention. (PPHCP01)’
Generally, the facilitators appeared able to follow the manual and found it a helpful guide, but there was questioning of whether someone without previous CBA training would be able to manage:
‘I mean section nine, it's got identifying maintenance factors, and it talks about safety behaviours, avoidance and escape, catastrophic interpretation, scanning or hypervigilance, self-fulfilling prophecies, fear of fear, reductions, affectionism, short term rewards. If you're trying to talk to a patient and remember what it says in the manual you might get yourself a little bit flustered.’ (PPHCP02)
One facilitator recommended presenting basic intervention techniques as a toolbox and also the provision of a crib sheet for easy prompting within sessions.
‘I feel that people who come away from the training need to have something like a virtual toolbox of techniques that they can refer to …they expected quite a lot of you… I made myself a crib sheet type of thing’ (PPHCP01)
One element that was not adhered to as planned was supervision with a senior psychologist, as the facilitators relied on supervision by an experienced member of their team who was already known to them and who was also part of the study team (KHM). However, both facilitators reported this supervision was useful.
Patient perspective
Patients who had received the TANDEM intervention reported it to be acceptable and beneficial, observing that the facilitators had very good interpersonal skills. There were no substantive suggestions for improvement.
‘And then [facilitator] and I just seemed to get on very well, he's a likeable chap, very laid back. And so it went from there. And then we started doing the things that you asked in TANDEM. Planning… They're just small things, but marvelous’ (PPP01, male participant)
The findings, such as patients reporting activities like planning (see quote above), and facilitators commenting on applicability of acceptance exercises suggested that the facilitators delivered the intervention with fidelity, however this needs to be explored in more detail through use of for example audio-recordings of sessions. This is planned for the process evaluation in the pilot and main trial (39)
Refinements to TANDEM after the pre-pilot
Changes and additions were primarily made to the TANDEM facilitator training, as there were few recommendations for changes to patient materials. These are shown in Table 3 with additions highlighted in bold. All suggestions were followed: e.g. providing a greater overview of TANDEM at the beginning of session one, keeping to a core set of CBA techniques and outlining a “toolbox” of techniques which could be used, (literally presented like a tool box in the revised manual). We made video recordings to demonstrate therapeutic skills and CBA techniques. These were made available online, with a facilitator chat facility for ongoing support.
The use of a simulated patient was omitted from the first two days of training and replaced by partnered role-play. The simulated patient role-play was, however, added to the end of day three. Each TANDEM facilitator was individually video-recorded conducting a cognitive behavioural assessment and feedback with the actor. Each video was subsequently assessed by LS and at least one independent assessor with a psychology background to ensure that a minimum standard of competency (see study protocol(37)) had been acquired. This also enhanced fidelity of delivery. To enhance learning, and boost confidence, facilitators received one-to-one feedback on their video. A training session on the importance of supervision was added with reflection that supervision is a standard part of psychological training and practice (in contrast to more managerial supervision with which HCPs may be more familiar).
Refinements to improve implementation
To improve delivery of the intervention within the trial and future implementation within routine healthcare contexts, five features were added:
- Facilitators were provided with crib cards for use as prompts within sessions.
- An optional session was added for use when a break in sessions had become necessary (e.g. due to patient illness) in order to refresh topics that had been covered before the break and re-establish current priorities.
- Some flexibility in the order of delivery of sessions was allowed reflecting the reality that some patients commenced PR before the end of the TANDEM sessions. It was stipulated that Topics 1-5(or 6) must have been conducted but that if necessary the final topic on expectations of PR could be brought forward as there was no sense in delivering this once PR had started.
- A structure for screening potential facilitators including a formal application with a curriculum vitae and telephone interview with one of the principal investigators was developed. The aim was to ensure only fully committed individuals who were interested in the psychological aspects of the experience of living with COPD and who could meet the study-specific requirements (e.g. flexibility to travel, willingness to complete research modules and good clinical practice training) received training. Also facilitators needed to be made aware that training involved some role play and that all intervention sessions would be recorded for fidelity assessments.
- A booster training session was designed to be delivered to facilitators if there were delays of 3 months or more between initial training and delivery of TANDEM.
For a description of the intervention following TIDieR guidance please see additional file 1.