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Richards DA, Bower P, Chew-Graham C, et al. Clinical effectiveness and cost-effectiveness of collaborative care for depression in UK primary care (CADET): a cluster randomised controlled trial. Southampton (UK): NIHR Journals Library; 2016 Feb. (Health Technology Assessment, No. 20.14.)

Cover of Clinical effectiveness and cost-effectiveness of collaborative care for depression in UK primary care (CADET): a cluster randomised controlled trial

Clinical effectiveness and cost-effectiveness of collaborative care for depression in UK primary care (CADET): a cluster randomised controlled trial.

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Chapter 4Results of the process evaluation

Alongside the main clinical and economic evaluation we undertook a process evaluation to investigate the implementation of the intervention, moderators of outcome and possible mechanisms of effect. This chapter utilises material from one61 of the four Open Access articles previously published by the research team in accordance with the terms of the Creative Commons Attribution (CC BY 2.0)61 licence. Qualitative data from this work are reproduced verbatim to preserve the integrity of the data analysis.

Objectives

The objectives of the process evaluation were to investigate:

  • the potential moderators of differential participant response62,63 and the possible mechanisms of symptom change in collaborative care
  • the process of implementation of collaborative care.

Methods

To investigate moderators and mechanisms of effect we recorded a number of baseline covariates together with intermediate process variables that were targets of the intervention, regressing these against depression severity (PHQ-9) at 4 and 12 months using multilevel multiple linear regression.

Measures

Moderators

We recorded six possible moderators at baseline: patients’ attitudes towards antidepressant medication, patients’ attitudes towards behavioural activation, depression severity (PHQ-9), history of depression (number of previous episodes), physical health (comorbidity) and socioeconomic status. To measure attitudes towards treatment we asked ‘How acceptable is it to you to use antidepressant medication?’ and ‘How acceptable is it to you to review and change your routines and increase your daily activities as a way of helping with depression?’ Response options were from 1 (definitely acceptable) to 4 (definitely not acceptable). To investigate the moderating effect of patients’ socioeconomic status we used their postcode to obtain an IMD34 score at the lower super output area level.

Mechanisms of change

We measured participants’ adherence to antidepressant medication and level of behavioural activation at 4 and 12 months through self-report of medication adherence and the Behavioural Activation for Depression Scale – Short Form.64

Process of implementation

We conducted face-to-face interviews with six care managers and five supervisors involved in delivering and supervising collaborative care and undertook telephone interviews with a sample of GPs from intervention practices. Telephone interviews were offered to GPs in such a way as to cause minimum disruption to their working day. We sampled GPs purposively based on location, GP surgery, years of experience and practice demographics. We ceased recruitment when category saturation of data was achieved (n = 15). We used a flexible topic guide for all interviews with open-ended questions to encourage discussion. All interviews were audio-recorded with consent, anonymised and transcribed verbatim.

Further, we used routinely collected data from session audio tapes collected by care managers for supervision to analyse the process of implementation. We purposively sampled 30 files for transcription and analysis from 656 collected, to cover as wide a range as possible of care managers, patient sex and different treatment sessions, from assessment to the final session.

Analysis

Consistent with the mechanisms of change framework described by Kraemer and colleagues for randomised controlled trials, all of our analyses were exploratory, hypotheses generating activities.62 Analyses were undertaken in Stata 12.1 following a predefined analysis plan.

To explore the role of moderators we analysed the direct effects of our six baseline covariates on depression severity (PHQ-9) at 4 and 12 months using multilevel multiple linear regression, with a preliminary step to assess ‘overall moderation’ (regression including all moderator variables), thereby controlling for type I error inflation as a result of performing a large number of statistical tests.65 We used the xtmixed command in Stata, modelling surgery as a random effect, to account for nested structure of the data (patients nested within surgeries). Trial site location was modelled as a fixed effect rather than the top random-effects level to reduce model complexity and avoid non-convergence issues. Each of the six baseline covariates and their interactions with the intervention (through which we investigated moderation) were included in the overall model; all variables were appropriately centred.66 We planned to proceed with individual moderator analyses only in the presence of ‘overall moderation’.

Potential mediating effects of collaborative care were investigated using structural equation modelling (SEM) in Stata. We analysed available data on the effect of medication adherence and behavioural activation at 4 months on PHQ-9 scores at 4 and 12 months and we explored the effect of medication adherence and behavioural activation at 12 months on the 12-month PHQ-9 scores. To explore and control for possible confounding,63,67 for mediators that were found to have a statistically significant effect on outcome, we analysed the effect of pre-randomisation variables on mediation by including all of the baseline covariates (hypothesised moderators) in the respective structural equation model. To investigate the effect of possible post-randomisation confounding variables on mediation, we analysed the direct effects of the collaborative care participants’ care manager and number of treatment sessions on the intervention group’s 4- and 12-month PHQ-9 scores using multilevel multiple linear regressions, with GP surgery modelled as a random effect and trial site as a fixed effect. We planned to proceed with mediation analyses (SEM) allowing for post-randomisation confounding variables only if there was evidence of a direct effect of care manager or number of treatment sessions on depression severity.

In all mediation and confounding analyses we analysed the effect of missing process data in sensitivity analysis, in which we used 1000 sample bootstraps. For the post-randomisation confounding investigation we performed an additional sensitivity analysis in which we controlled for all of the baseline covariates in the regression model and bootstrapped 1000 times.

Qualitative interview analysis

The transcripts from each interview formed the data. We used an iterative approach using constant comparison techniques68 and topic guides that we reviewed and adapted after each interview following discussions between authors as the study progressed, allowing for emerging themes to be incorporated into the topic guides. CCG, NC, EA and PS conducted an initial thematic analysis and coding,69 independently at first, and themes were agreed through discussion between researchers of different professional backgrounds (general practice, nursing, psychology). Following the thematic analysis we conducted a further theory-driven analysis of the data guided by the four main constructs of normalisation process theory24 (coherence, cognitive participation, collective action and reflexive monitoring), detailed in Box 1, building on a previous process evaluation in which we had used the normalisation process model71 to identify the work required to implement collaborative care for depression.72 Our analyses aimed to identify barriers to and facilitators of the successful implementation of collaborative care into UK primary care.

Box Icon

BOX 1

The four key elements of normalisation process theory Coherence: a set of ideas about the meaning, uses and utility of a practice (defined as an ensemble of beliefs, behaviours and acts that manipulate or organise objects and others), which hold the practice (more...)

This analysis was conducted individually by CCG, NC, EA and LG and the final analysis was agreed through discussion, with data being tabulated to illustrate the four constructs of normalisation process theory. Disconfirmatory evidence was sought in the data throughout the analysis.

Audio-tape analysis

We analysed the implementation of the intervention by initial transcription of 30 audio files and then analysis of the files by reading the transcriptions, referring in detail to the trial manual. We undertook a thematic analysis69 similar to that for the interview data, with initial open coding of themes carried out first by SB and then by LG, utilising MAXQDA version 10 qualitative software [VERBI Software GmBH, Berlin, Germany; www.maxqda.com/ (accessed 10 December 2015)] to manage the data and develop codes and categories within the data set. Memos were used in the development of emerging themes, specifically comparing the interviews with the CADET manual and model of intervention. LG and SB met regularly to discuss, clarify and characterise the themes.

Results

Moderation

The level of participants’ depressive symptoms, number of previous depressive episodes, attitudes to antidepressant medication, attitudes to behavioural activation, number of limiting physical health problems and socioeconomic status at baseline are summarised in Table 15. There was little evidence of overall moderation of depression severity at 4 months (χ2 = 10.01; p = 0.35) or 12 months (χ2 = 5.63; p = 0.78). Multiple imputation data produced similar results (overall moderator effect at 4 months F9,37799.1 = 0.76; p = 0.66; at 12 months F9,30924.1 = 0.42; p = 0.93).

TABLE 15

TABLE 15

Mean baseline scores and regression coefficients for potential moderators of collaborative care

Mediation

Participants’ levels of behavioural activation, medication adherence and PHQ-9 scores at 4 and 12 months are provided in Table 16.

TABLE 16

TABLE 16

Level of behavioural activation, medication adherence and depression severity at 4 and 12 months

Effect of 4-month mediators on depression at 4 months

We found strong evidence of an effect of behavioural activation (coefficient 4.00, 95% CI 1.46 to 6.55) but not medication adherence (coefficient –0.03, 95% CI –0.14 to 0.08) on the intervention. The effect of behavioural activation led to strong evidence of an indirect effect of collaborative care on depression severity (coefficient –1.53, 95% CI –2.49 to –0.57). This is larger than the effect of collaborative care if the model did not include behavioural activation and medication adherence (coefficient –1.22, 95% CI –2.86 to 0.41). The effect of collaborative care at 4 months was therefore mediated in full by behavioural activation at 4 months.

When we undertook a structural equation model including behavioural activation at 4 months but not medication adherence we also found strong evidence for the effect of behavioural activation on the intervention (coefficient 3.56, 95% CI 1.78 to 5.34) and an indirect effect of collaborative care on depression severity (coefficient –1.33, 95% CI 1.99 to –0.67). There was little evidence of a direct effect of collaborative care (coefficient –0.08, 95% CI –1.10 to 0.94), suggesting that its effect on depression severity at 4 months was mediated in full by behavioural activation at 4 months. However, including the pre-randomisation variables in the model produced little evidence of an indirect effect of collaborative care, although the size of the effect was similar (coefficient –1.33, 95% CI –3.53 to 0.86). The direct effect of the intervention remained small and non-significant (coefficient –0.15, 95% –1.03 to 0.73). These results of the structural equation models were verified after a 1000-replication bootstrap.

Effect of 4-month mediators on depression at 12 months

When we analysed the effect of medication adherence and behavioural activation at 4 months on PHQ-9 scores at 12 months we found strong evidence of an effect of behavioural activation (coefficient 3.86, 95% CI 1.30 to 6.42) but not medication adherence (coefficient –0.01, 95% CI –0.12 to 0.17) on the intervention. There was strong evidence of an indirect effect of collaborative care on depression (coefficient –1.20, 95% CI –2.00 to –0.39), larger than the equivalent effect if the model did not include behavioural activation and medication adherence (coefficient –0.97, 95% CI –2.89 to 0.96). The effect of collaborative care at 12 months was therefore mediated in full by behavioural activation at 4 months.

Moreover, when we undertook SEM including behavioural activation at 4 months but not medication adherence we found strong evidence for the effect of behavioural activation on the intervention (coefficient 3.57, 95% CI 1.78 to 5.37) and an indirect effect of collaborative care on depression severity at 12 months (coefficient –1.03, 95% CI –1.54 to –0.52). Although there was little evidence of a direct effect of collaborative care and the magnitude was relatively small (coefficient –0.42, 95% CI –1.63 to 0.80), we observed partial (not full) mediation; the effect of the intervention on depression severity at 12 months did not completely pass through levels of behavioural activation at 4 months. Including the pre-randomisation variables in the model produced little evidence of an indirect effect of collaborative care (coefficient –0.86, 95% CI –2.53 to 0.80). The direct effect of the intervention was larger but non-significant (coefficient –0.77, 95% CI –1.91 to 0.36). The results of the structural equation models were verified after a 1000-replication bootstrap.

Effect of 12-month mediators on depression at 12 months

When we undertook a structural equation model including medication adherence and behavioural activation at 12 months we found weak evidence of a moderately sized effect of behavioural activation (coefficient 2.52, 95% CI –0.80 to 5.85) but not medication adherence (coefficient 0.02, 95% CI –0.12 to 0.15) on the intervention. There was weak evidence of an indirect effect of collaborative care on depression severity (coefficient –0.96, 95% CI –2.19 to 0.28), which was similar to the size and strength of the direct effect (coefficient –0.95, 95% CI –2.29 to 0.40). We therefore conclude that the effect of the intervention on depression severity at 12 months partly passed through levels of behavioural activation at 12 months.

Using similar procedures to those at 4 months, including behavioural activation at 12 months but not medication adherence we found that the effect of the intervention on depression severity at 1 year was partly mediated by level of behavioural activation at 12 months. There was strong evidence for the effect of behavioural activation on the intervention (coefficient 3.53, 95% CI 1.09 to 5.97) and an indirect effect of collaborative care on depression severity (coefficient –1.40, 95% CI –2.34 to –0.45). However, although the direct effect of the intervention is relatively small and non-significant (coefficient –0.31, 95% CI –1.38 to 0.76), the effect of the intervention on depression severity is not fully mediated by behavioural activation at 12 months. Including the pre-randomisation variables produced strong evidence of a larger indirect effect of collaborative care (coefficient –2.87, 95% CI –4.94 to –0.80) and little evidence of a direct effect (coefficient –0.62, 95% CI –1.74 to 0.50). Results were verified after a 1000-replication bootstrap.

Effect of post-randomisation confounding variables on mediation

When we undertook multilevel multiple linear regression to explore the effect of participants’ care manager and number of treatment sessions on the intervention group’s 4-month PHQ-9 scores we found little evidence of an effect of care manager (χ2 = 2.21; p = 0.99) or number of sessions (coefficient –0.11, 95% CI –0.38 to 0.15). We also found little evidence of an effect of care manager (χ2 = 7.57; p = 0.58) or number of treatment sessions (coefficient –0.07, 95% CI –0.32 to 0.17) on depression severity at 12 months. We observed no difference between the result of the multilevel multiple linear regression including observed data and the sensitivity analyses. The mediating effects of behavioural activation on treatment outcome were not confounded by care manager or number of treatment sessions.

Results of the qualitative interview analyses

We present our results using the a priori normalisation process theory concepts of coherence, cognitive participation, collective action and reflexive monitoring with respect to the implementation of collaborative care as described in the methods section. We present data to support the analysis, which is labelled by identifier (CM = care manager, S = supervisor, GP = general practitioner) and number.

The demographics of care managers and supervisors have not been included to ensure the anonymity of participants. GP demographics can be seen in Table 17. The initial thematic analysis is summarised in Table 18, with some illustrative data provided.

TABLE 17

TABLE 17

Demographics of GPs interviewed

TABLE 18

TABLE 18

Qualitative data thematic analysis illustrations

Understanding the collaborative care framework (coherence)

Behavioural activation, which formed the psychological intervention component of collaborative care in this study, was described by care managers as a user-friendly intervention and easy to understand, not just for themselves as practitioners but also for the patients, as they didn’t find it ‘too overcomplicated’ (CM105). The care managers did find that the intervention encouraged them to develop joint plans with patients to a greater extent than in their usual practice:

By collaborative care what do I mean? Erm, I mean more that sense of working with the patient . . . and I think it’s more about reaching a shared understanding and working towards shared goals with enough input from other professionals that are involved in that person’s care.

CM101

Supervisors and care mangers understandably demonstrated a good understanding of the collaborative care framework in addition to the intervention itself. For supervisors, this level of understanding was because of their role as co-investigators in the trial. Care mangers reported that the CADET training had provided them with sufficient information and opportunities to clarify and improve their understanding of collaborative care, the intervention they were to deliver to patients and the expectation of working with GPs. Care mangers described how their understanding of collaborative care and their role had been changed by the training prior to working on the trial:

I’d assumed [collaborative care] would be self-help-based stuff because we were primary care, and collaborating with other professionals. Since doing the training it’s mainly GPs that I’ve learned, but I kind of had the idea that it would be collaborating with other mental health workers, but not specifically GPs.

CM103

Only a minority of GPs demonstrated a good understanding of collaborative care, either because of their self-declared interest in mental health or because of previous experience of working within a collaborative care framework:

So we’ve got more likelihood of being aware of what’s happening in terms of the management and then that can affect any input that we might have, say in terms of medication if we’re treating patients with antidepressants, we can get a feel for whether things were moving in the right direction and get the therapists’ input as well as our own assessment. So it can potentially improve our understanding of how the patient is progressing and responding and aid our management.

GP010

However, the majority of GP respondents did not fully understand the collaborative care framework and could not differentiate between the management of patients with depression in collaborative care and routine care. As a result, some GPs used the qualitative interview as an opportunity for further clarification, perhaps suggesting a lack of such opportunities during their initial discussions about involvement in the trial:

GP014:

Are you able to define collaborative care for me so I know what you’re talking about, or not?

Researcher:

Erm, I mean what we’re trying to do it get an understanding of your understanding of it, so if you’re not aware.

GP014:

I mean they’re all buzz words, so collaborative care, what it actually means?

Some GPs described the main benefit of participating in the trial as the potential for increased support in their management of patients with depression in the context of limited access to psychological therapy services to which to refer patients:

The CADET trial offered to me a resource which I thought would be beneficial. Another opportunity for somebody else to look at these patients, talk to them and share the workload in a way, with me.

GP011

This GP is not reflecting specifically on the collaborative care framework; rather, she seems to be reflecting on the benefits of participation in any trial in which patients can access an additional ‘service’.

Most GPs identified the potential benefits of adopting a more collaborative approach to patient care, particularly for patients with more complex problems:

[I]t’s likely to be those sorts of people, the more complex your problem the more likely you are to benefit from it, erm, yeah, I would say comorbidity, absolutely . . . the more complicated the things are, the more likely it is that the collaborative approach is going to help.

GP015

It was not clear, even with probing in the interviews, what GPs actually meant by a ‘collaborative approach’ and GPs were not clear whether or not a collaborative care intervention would fit with their existing ways of working.

Establishing relationships (cognitive participation)

A number of new relationships needed to be established within the collaborative care intervention. Supervisors and care managers reported well-structured, weekly, scheduled supervisory sessions that were arranged as part of the trial. Supervisors and care managers reported the value of an initial face-to face meeting to establish the relationship, followed by weekly telephone supervision. Supervision was also supported by the PC-MIS, a web-based patient management system, demonstrating evidence of the work carried out for both establishing and sustaining collaboration between these two parties:

The supervision has been excellent I must say. It’s really nice to have it weekly, and it’s great to have PC-MIS because it means we’re both looking at the same screen, so it’s been really good.

CM103

Supervision as part of the CADET trial was also considered by care managers as ongoing learning, affirming to their practice and confidence boosting:

[T]hey might point stuff out to me or they might anticipate problems before they arrived which in my lesser experience maybe wouldn’t have foreseen so therefore they gave me some advice about how I might manage certain situations or what I might say to prepare a patient for something, erm, so yeah, it was fantastic, really, really good.

CM105

Supervisors also considered that supervision in the trial was superior to that received in usual care and highlighted the importance of such supervision to the success of collaborative care, with one describing it as an ‘integral part of . . . the whole collaborative care process’ (S102).

However, supervisors identified potential problems around identifying the right people to provide supervision outside of the research study, including finding people who are both willing and able to provide the same level of supervision as was delivered in the CADET study.

I think the biggest issue is the amount of supervisor time, and I think that, I think that we’re fairly generous in CADET in that the same supervisor is involved in following people up, and that means that you do get, that means that people do get really good supervision, but it’s quite, there’s quite a lot of time involved in that . . . It’s not that there’d be less time, there’d be less people that, erm, that are used to doing that kind of supervision.

S102

In contrast, there was limited evidence of new relationships being established between the care managers and GPs in participating practices. Any liaison between care managers and GPs consisted of written information from the care manager to the practice, with direct contact unusual and reported to have occurred only when risk was deemed high, with few reports of care managers having direct access to the practice information technology system:

[E]very 4 weeks we send a review letter, obviously you send the initial assessment letter to say ‘we’ve assessed this person, their main problem is, their scores are’ and then follow-up letters every 4 weeks.

CM105

Researcher:

Have you been able to access to the patient records, has there been a sharing of information?

CM103:

Erm, there’s a couple where I’ve needed to, and I can’t remember what practice it was but I went there and she said I had to send them a letter, so I had to come back here to fax them and then they faxed me a letter back, it was a bit, kind of ridiculous.

One care manager did report having access to the patient records at some GP practices, but encountered different information technology systems in different practices, which was initially problematic, and she reported that developing good relationships with the practice administrative staff was essential to enable utilisation of these:

[T]he other barrier I had was using the different computer systems in different surgeries, so that was dead complicated, but I got past that, and I found the staff were great because they’d just come and sign you on and things like that, because I couldn’t remember the password.

CM102

As care managers were already working within existing services and were seconded to the trial, a minority of care managers described pre-existing relationships with GPs that they found beneficial to engaging GPs in the collaborative care framework. Care managers also described a number of strategies that they had attempted to use to enhance opportunities for collaboration with GPs, including identifying the GPs’ preferred method of communication at the beginning of the trial in anticipation of the need to communicate with them when working within a collaborative care framework:

Initially with the study, what I did was, I went out and visited the GPs . . . and just said ‘what’s the best way for communicating?’ . . . so it’s looking at what’s best for that GP, you know if you do get a relationship with them.

CM102

Data suggest that the work carried out around setting up supervision and establishing care manager–supervisor relationships was important and appreciated by both parties. However, direct contact between care managers and GPs seemed to be the exception rather than the rule, and occurred at a time of crisis for an individual patient. Additional work was needed by care managers, as well as building on prior knowledge of practices, to establish working relationships with GPs that would enable engagement as a routine.

Working within a collaborative care framework (collective action)

Care managers identified few difficulties in delivering the psychosocial intervention to patients; rather, they focused on the difficulties encountered in liaising or collaborating with GPs. Despite care managers reporting sending regular summary letters to GPs, the majority of GPs reported limited or no communication with care managers. It is unclear, therefore, whether GPs did not receive these letters or whether they did not have time to read them:

I’ve had very little, if any, involvement with the study except notification from you that a particular patient has been included on the study.

GP004

I don’t think I had any contact personally with the case manager. I think I saw a letter or two, but no sort of telephone or e-mail or anything of that sort.

GP007

Either way, the limited communication reported by some GPs may account for their lack of awareness of the involvement of the care managers in the trial and the work that was being carried out with their patients.

Researcher:

You said that there would be someone with more specialist interest might be involved, erm, did you know who else was going to be involved?

GP014:

Recruiting patients?

Researcher:

Erm, so the person you would be collaborating with?

GP014:

No.

Researcher:

No. OK. Erm, and so, are you aware now about the case managers that were involved in the study? That was involved in seeing the patient therapeutically?

GP014:

No.

The lack of GP involvement is supported by some care managers’ reports that, although GPs were helpful once they had managed to contact them, GPs rarely initiated contact, which left care managers feeling that communication was one-sided:

[S]ince I’ve been working here, and that’s been 2 years now, I think I’ve only ever had GPs initiate contact with me twice. Yep. It’s really, really rare, which is a shame really.

CM105

Despite the difficulties identified in contacting GPs, care managers reported improved relationships with participating GPs, along with identifying the benefits of this:

Yeah, I think, I mean there are some GPs who are really difficult to get hold of or, you do write to them and you don’t get a response and you have to try to chase them up, but a lot of the time what I have found is that they are quite helpful, you know, certain GPs are very easy to talk to on the phone, or make appointments with, so that’s been quite helpful, and erm, yeah, kind of discussing the patient as well, it’s, you know, I can suggest something, they can give me their side of what they’re doing, again, come to some sort of conclusion.

CM104

Some care managers suggested that co-location within GP practices could bring more opportunities for collaboration with GPs because of the increased possibility of informal communication and they compared this with their previous ways of working:

[I]n the old days if we worked at a surgery, based there, it’s that relationship building that you have a chance to do, erm, and so at the moment we don’t do that as part of normal care, it’s harder to do, I think it’s impossible to do really, so what we get is, we’re based at one health centre and we get people from all different surgeries being referred through to that one health centre so we don’t get a chance to build those relationships.

CM102

Supervisors recognised the difficulty experienced in achieving true collaboration between care managers and GPs:

I mean you’ve got to have people together to collaborate, you know, I just wonder to what extent this really is collaboration, because it’s only collaboration in name, in a way and the interested parties don’t really get down and talk to each other very much . . . It’s such a big problem . . . I’m not blaming anybody because GPs don’t have the time. . . . You could try to make it happen, it would be nice just to see that, increasing that contact . . . it sounds like a very desirable thing that would be helpful for everybody . . . I think collaborative is too strong a word for collaborative care, it’s not truly collaborative in my opinion, but that’s my opinion.

S105

The supervisors recognised that the collaborative care framework did not seem to fit within existing working practices of GPs.

Probably because of the set-up and frequency of supervision, supervisors and care managers reported good professional relationships with each other. Supervisors and care managers reported being impressed with each other’s skills, suggesting confidence in each other’s abilities. More specifically, supervisors reported satisfaction with the care managers’ skills for delivering behavioural activation within a collaborative care framework, even to those patients identified as complex:

I’ve been pretty impressed by the ability of the case managers to assess and manage some people who have not always been that straightforward, by any means, and these are people who are supposed to have, you know, these are people who have I suppose moderate degrees of depression, but they’ve got complicated life problems as well, some of them have been in crisis, and they’ve managed them. I think it’s gone pretty well.

S102

Likewise, care managers were enthusiastic about what they considered to be enhanced supervision, because of its increased frequency and the supervisors’ wealth of experience and knowledge:

[T]hey might point stuff out to me or they might anticipate problems before they arrived which in my lesser experience maybe wouldn’t have foreseen so therefore they gave me some advice about how I might manage certain situations or what I might say to prepare a patient for something, erm, so yeah, it was fantastic, really, really good.

CM105

There was little evidence in the GP data that the work conducted by the care managers and supervisors had any impact on GPs’ routine consultations or their work with patients:

[A]s far as the CADET study is concerned, we’ve not . . . it’s happened alongside us really, it hasn’t had . . . it certainly hasn’t been detrimental to anything that we’ve been doing, but that’s not really what I mean. What I mean is that we identified patients but then didn’t need to change what we were doing very much.

GP007

Care managers reported that they had taken or planned to take many elements from collaborative care (such as increased collaboration with GPs and medication management, as well as the behavioural activation psychosocial intervention) back into their routine work, which demonstrates that this approach is acceptable to care managers and has the potential to become normalised within their routine practice:

What I will probably take back is a lot more information on medication . . . when I was working prior to that [CADET], the focus wasn’t so much on the medication, yeah, and I don’t think that I had much idea of medication, and I think now, there was a time when I wasn’t too keen on medication myself, I wasn’t too sure if medication really worked, whereas now I’ve seen that it is quite helpful so I would probably emphasise the medication with my patients, yeah, and I probably will take the whole BA [behavioural activation] in terms of being active and how that helps with the depression, so yeah, as a whole, the whole thing, but if there’s one thing I’m going to focus on more it’ll be the medication, yeah.

CM104

Our data suggest that organisational changes within practices would be required to establish relationships between care managers and GPs and facilitate successful collaboration, such as integrated information technology systems and enhanced opportunities for GP/care manager communication and possibly co-location of professionals. Collaborative care would need to be seen as fitting in with the routine work of the practice for GPs to make changes to accommodate the work involved.

Evaluating collaborative care (reflexive monitoring)

The weekly supervision presented regular opportunities for care managers and supervisors to reflect on patients and monitor their progress jointly. Collaborative care and the psychosocial intervention were described as effective and acceptable by care managers and supervisors, although it seems that care managers reflected on the perceived effectiveness of the psychosocial intervention (which formed the majority of their work with individual patients) rather than the collaborative care framework as a whole. The care managers described how they monitored patients through the collection of routine data (HADS), their own perceptions of patients’ progress and discussions within supervision:

[A] couple of people who, especially one, he’s had long-standing social anxiety so a bit more of a complicated problem, but also depression, and we just worked away on the depression and we saw an improvement, so just by doing that behavioural activation, so sometimes even though someone’s got more complex problems, for some people behavioural activation just saw quite an improvement, you know.

CM102

I think it’s effective . . . I think that has been the most satisfying part, that I know it can work, I’ve seen BA [behavioural activation] work.

CM105

Although care managers and supervisors identified some problems around delivering the trial psychological intervention (behavioural activation) in line with the protocol for those with comorbid mental health and complex social problems, the principles of intervention were still perceived to be acceptable in reducing symptoms of depression:

I think I would’ve liked to work on anxiety a bit more, but at the same time . . . we’ve watched those depression scores come down.

CM101

Some GPs did report receiving positive feedback from patients about their experiences with the care managers and of the intervention, which led the GPs to believe that there was some value in the intervention. This ‘second-hand’ knowledge was the only evidence on which GPs could reflect on the intervention, or on the collaborative care framework:

A significant amount of them have reported personally that they have felt better after participating in the trial, in the study and then whatever the numbers there is some benefit in it.

GP002

I think certainly with a number of patients they did seem to gain considerable benefit and their depression was improved and their general social functioning seemed to be improved . . . I didn’t get any negative feedback about the process.

GP006

In contrast to the care managers’ reports, GPs reported that they did not actively seek feedback from patients regarding their experience of collaborative care, and feedback was received only when volunteered by the patients:

Generally from the patients we have had very positive feedback, and often our patients are generally kind of if there is something they don’t like they will come and tell us.

GP009

Similarly, some GPs suggested that the results of the trial rather than their views would determine their opinion on the future possibility of working in a new way:

[O]ne of my managers doesn’t see how, if CADET really works, so, and at the same time I’m not sure because I’m waiting, I look for the actual, you know sometimes I think it hasn’t worked, sometimes I think it has worked . . . I suppose that’s where the results will show, whether that’s worked.

CM101

[W]e’re talking small numbers and I think we need to see some outcome data rather than just my anecdotal subjective views of possibilities.

GP010

The supervisors raised concerns about who would take on the responsibility of supervision of the care managers if collaborative care was implemented into routine practice, because of both the expertise and the time required to deliver supervision to the same standard and frequency as was delivered in the trial. Care managers also identified time as the biggest resource necessary to implement collaborative care, which included the time needed to maintain the prompt commencement of the intervention following referral, the time required for the administration involved in communicating with GPs and the time invested in supervision:

I think the collaborative care part of it, because, writing a letter after assessment and then keeping a GP updated with letters, often what happens at [names team], the GPs are sent a letter on discharge with a summary of what happened, so that’s kind of like no collaboration at all, for a lot of people there’s absolutely no collaboration, and that’s just down to time really and just the number of patients that everybody has.

CM106

However, GPs felt that the main obstacle to implementing collaborative care would be the financial cost of commissioning collaborative care services, which they perceived would be more expensive than current care:

Researcher:

What are your views on whether collaborative care should be commissioned as a service for management of people with depression in primary care?

GP005:

I would say it is an excellent way forward. However, it couldn’t really have come at a worse time could it?

Researcher:

Could you explain that?

GP005:

Well in terms of all the financial restrictions and all the changes that are going to be happening at the moment.

Thus, care managers and supervisors valued the care manager role encompassing expert supervision as well as the specific psychological intervention, including the behavioural activation and medication management components. Care managers placed less emphasis on the liaison between care manager and GP. GPs did not report actively reflecting on and monitoring the collaborative aspect of collaborative care, between care managers and GPs, but care managers described examples of liaison and how it might be facilitated. Care managers were positive about implementing collaborative care into routine practice, although possibly the emphasis was on the psychosocial intervention rather than the broader collaborative care framework; however, lack of time, concerns over supervisory arrangements in routine practice and the perceived cost of implementation were identified by all participants as barriers to this.

Results of the analysis of therapy recordings

Our analysis of the 30 session tapes sampled led to three emergent themes describing the process of treatment delivery: (1) engaging the patient, (2) adopting a counselling model and (3) variations in the delivery of behavioural activation. We describe these in the following sections.

Engaging the patient

The theme ‘engaging the patient’ describes the efforts and strategies employed by care managers to develop a therapeutic relationship with participants. The theme covers not only these strategies and skills but also communication examples in which care managers failed to connect with participants before trying to engage in the more functional aspects of the CADET clinical protocol.

In terms of achieving engagement, care managers would use scripts, not necessarily those provided in the CADET treatment manual, but rather from a routine framed by the organisation in which they worked. Care managers were not directly employed by the trial team but were working with CADET participants alongside their other responsibilities in the provider organisation for whom they worked. As such, their ‘script’ could represent standard introductory information that they were required to give as part of their usual clinical practice. In most cases, this made specific reference to the limits of confidentiality:

OK so I’ve got a bit of a script to read out first but the rest of it is just completely free-flowing conversation. It’s just to make sure I give you the information I need to begin with so I don’t miss anything out.

Care manager, assessment T4

It was clear, however, that one of the difficult tasks for the care managers was to merge the script described above with the need to address the immediate needs of the participant and to engage them in the CADET clinical protocol. Non-specific therapeutic skills such as simply providing encouragement and positive feedback seemed to help with achieving and maintaining engagement. A key skill that we observed here was the verbal expression of empathy:

Participant:

Oh, I don’t really have much confidence in myself let’s put it that way, I just plod on, I just keep going through it.

Care manager:

You’ve obviously had a struggle for quite some time but somehow you have managed to keep going.

Assessment T3

Care managers did not always demonstrate engagement with participants and a number of examples of styles of communication that seemed to result in a failure of engagement could be identified in the sessions. There were examples of the care manager almost having a parallel dialogue in which the cues provided by the participant were not picked up on, because of the need to progress with the CADET interview task. One task, collecting factual assessment information, sometimes resulted in prolonged interrogative sequences in which the opportunity to pick up on key emotional cues was lost. Likewise, premature reassurance without understanding, acknowledging and empathising with the nature of the problems was not a successful intervention in achieving engagement:

Participant:

I feel useless, like I’m a bad mother.

Care manager:

And what makes you say that?

Participant:

I don’t know.

Care manager:

Because it seems like, although it is really hectic, it seems like there is a routine there and there is control and just having a routine is a base for children, because they come home and –

Participant:

They’re always playing up and that so I just think I don’t have that much control over them that way, sometimes I just sit there and cry for nothing, I just feel like this is all there is to life, what happened to me basically, because I used to be such a bubbly, outgoing person.

Assessment T2

Adopting a counselling model

The theme ‘adopting a counselling model’ describes two particular types of interaction that moved beyond simply being empathic to engage the participant and towards something more recognisable as counselling. The first (delivered in response to life events/emotional cues from the participant) involved offering not simple empathic comments but explanatory hypotheses as a response to the participant talking about life difficulties, an approach more associated with psychodynamic therapies. The second counselling focus was when care managers talked about relationships rather than exploring the impact of depression on behaviours, triggers and consequences, and working towards goals. In several of the recordings, open-ended discussions of relationship issues rather than a focus on strategies to manage and address low mood were observed:

Participant:

I all too easily see the negative side in me, what I, what’s wrong with me and what I haven’t done or what I did or shouldn’t have done or –

Care manager:

Sounds like you’re very hard on yourself.

Participant:

I am yeah.

Care manager:

Well that’s going to have an impact on your confidence isn’t it? You know if, again if you’re seeing the redeeming features in everybody then perhaps any situation that comes up you might be more likely to take that on as if something bad happens then that’s something that you’ve done rather than –

Participant:

Yes, yes, like it couldn’t be their fault because they’re not like that it must be me.

Care manager:

Yeah, ok, so you recognise that yet you still find that this has impacted on you in certain ways. Well you’re not alone with that, certainly and it sounds again like I mean how long were you with your wife for?

Assessment T4

This discussion topic could then become a primary feature of the shared problem statement, making it difficult to move on to functional aspects of the CADET protocol such as symptom monitoring, medication management, behavioural activation and GP liaison.

Variations in the delivery of behavioural activation

The theme ‘variations in the delivery of behavioural activation’ describes how care managers explained and delivered behavioural activation, a core element of the CADET clinical protocol. Behavioural activation was clearly described in the manual provided to the care managers and they received 5 days of training in how to deliver it. Nonetheless, we observed differing approaches from care managers in terms of initial explanations, identification of behavioural exercises and goal setting with participants. We also identified care managers focusing on the content of participants’ cognitions, a cognitive treatment strategy not part of the CADET clinical protocol.

In terms of explaining behavioural activation, some of the care managers managed a reasonably accurate explanation of it. In some sessions the explanation was brief and reduced simply to the idea of ‘getting going and doing things again’, with quite cursory reference to it during later sessions. In a similar way to the behaviours that we observed in the theme ‘engaging the patient’, this sometimes sounded rather like a one-way preprescribed ‘script’, with little opportunity for the participant to ask questions:

Care manager:

The idea is that depression leads to changes in how we behave, our routines change, we withdraw from things that we enjoy and we tend to avoid doing necessary and important things, so the idea is that by setting goals we act our way out of depression rather than waiting until we think that we’re ready to think our way out of depression. So behavioural activation is a structured and active method of helping yourself and it focuses on re-establishing daily routines, increasing the pleasurable activities that we do and addressing necessary issues so we’ll help you to regain the functions that may have been lost or reduced since you felt low. Does that make sense or –

Participant:

Yeah, of course, get my brain back and functioning again, I’d appreciate that!

Assessment T5

There were examples of conversations in which care managers focused on the therapeutic effect of increasing physical activity or exercise, whereas the behavioural activation protocol instructed care managers to help participants increase a much broader range of personally relevant activities with the objective of re-establishing routines that had been reduced or disturbed during their depression. Likewise, we did observe variation in the way that care managers helped participants to set personal goals, another key element of the behavioural activation protocol. Some care managers left goals rather vague whereas others helped participants narrow down to specifics:

Care manager:

OK, what are your expectations and your ideas of what you’d like to achieve in the time that we’ve got together?

Participant:

Just to be what people call normal, I suppose.

Care manager:

What does normal mean? What are you not doing now that you’d like to do by the time we’re finished working together?

Assessment T9

We saw how care managers could help participants to translate overall goals into specific activities. Planning of activities could be detailed to help participants know what activity they were going to do and how and when they were going to try and carry out the activity. The next two extracts show this variation clearly; in the first extract the first care manager tries to establish clear procedural detail whereas, in the second extract, the details remain somewhat vague and after cursory attention being paid to the detail of how a goal was to be achieved the interview moves on to the care manager’s own agenda:

Care manager:

Yeah, so what do you think you want to do over the next week to look at that, do you think there’s anything you could change to put that in your diary or?

Participant:

Yeah, I think the first thing I should do is clean myself up really. I mean I’m not dirty or anything like that, don’t get me wrong, but my hygiene has gone out of the window looking at this, it really has.

Care manager:

So if you just look at the personal hygiene in a morning and work on that bit first that sounds reasonable doesn’t it, so what are your aims there, is it a wash or a shower or a wash one day and a shower the next?

Follow-up T7 (3)

Yeah, I think maybe make that as a goal for this week or the next time we speak, maybe to contact the Citizens Advice Bureau and see what you could do there, that’s quite an important thing to do at the moment. Well that’s good, excellent. I am going to go on to the HADS scale, the HADS questionnaire, do you have the paper in front of you?

Care manager, follow-up T2 (1)

In terms of care managers’ fidelity to the CADET clinical protocol, we did observe some use of clinical strategies that we had not included in the manualised protocol. As noted previously in this section, our care managers had established NHS clinical roles and were used to using a range of approaches as part of their work. One common element of their established working practices – addressing cognitions directly and using cognitive therapy concepts – could be seen to creep into their work with CADET participants even though this was not in the CADET clinical protocol:

[W]hen we’re feeling low we have those automatic negative thoughts and if you’re a person who tends to actually personalise things which is a thought bias then sometimes we can beat ourselves up about it. I’m certainly not thinking this is your fault, I’m thinking oh a sinus infection, that’s terribly painful.

Care manager, follow-up T4 (2)

Copyright © Queen’s Printer and Controller of HMSO 2016. This work was produced by Richards et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK344160

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