Discussion
anxiety, psychosis, bipolar disorder, depression, schizophrenia
SECONDARY, RECRUITMENT
The PARTNERS2 study is the first definitive, randomised controlled trial of a coaching-enhanced collaborative care intervention for individuals with SMI. A majority of recruited participants had significant needs and were not receiving expert mental health support. The PARTNERS intervention was established in low-income urban, coastal and rural communities, and maintained in pandemic conditions. Although 91% of participants in the intervention group received at least one contact with a care partner and 87% had goals assessed, there were five practices where care partners were present for <70% of the intervention period. Outcome measures were analysed for the 174 participants (88%) with follow-up data, much of which were collected by remote means because of the COVID-19 pandemic. No differences were found between control and intervention groups for the primary outcome measure (MANSA), the secondary outcomes or the planned sensitivity analyses. There were no observable differences between groups for key safety data.The strengths of the trial included its pragmatic real-life design, with high proportions of individuals from areas of deprivation. We achieved high levels of follow-up and no reduction in contact rate during the pandemic. Although the number of participants recruited was less than originally planned, the revised recruitment target, despite being calculated for 80% power, gave data from a sufficient number of participants to enable between-group differences to be estimated with high levels of precision. The PARTNERS intervention was informed by existing literature, expert interviews, input from patients and the public, and a formative evaluation during the feasibility phase.There are limitations in trial design and delivery. The cluster randomised controlled trial design resulted in an uneven allocation of individuals. There was more variation in practice cluster size than anticipated, and although practice size was used as a minimisation factor, it was less correlated with the number of individuals recruited than expected. There were significant recruitment challenges at the start of the trial, with enhancements made to recruitment protocols to allow practices to engage more easily in the research and to increase the opportunities for individuals who might otherwise not have been reached. The high proportion of participants with a diagnosis of bipolar disorder rather than schizophrenia in this sample contrasts with proportions of those in mental health services;Outcome selection was based on an analysis of the intervention theory and predicted stages of change. However, selection of a primary outcome was not straightforward because of the wide range of different outcomes the intervention was designed to have the potential to change. Although mean baseline scores of outcomes indicate significant need, the absence of a maximum MANSA score for inclusion in the study meant that some individuals had relatively positive MANSA scores at baseline, potentially making improvements more difficult to detect in the primary outcome. Additionally, there was difficulty collecting two of the planned outcome measures. The Brief INSPIRE measure, aiming to examine experience of recovery orientated care, was not formally analysed because of substantial between-site differences in rates of missing data. Key physical healthcare monitoring data were unable to be collected from health records because of reductions in researcher presence in practices during pandemic conditions. Notably, with person-centred interventions, goals and changes are individual and idiosyncratic and, however important to the individual, may not be picked up by standard outcome measures. Alternatively, it could be argued that asking care partners – who provide relatively low-intensity care, albeit with the support of a wider team – to address physical, social and psychological needs that may have accrued over years is too great a challenge. This is, however, an aim of care coordination and community mental health team care, and a key outcome of the Community Mental Health Framework policy.Difficulties with intervention delivery, imbalance in numbers of individual participants randomised, a heterogeneous group of participants and potential lack of sensitivity of standard outcome measures to the often unpredictable path to recovery makes full interpretation complex. However, a shift from usual to PARTNERS care in England in the period 2017–2020 did not result in a clinically significant improvement in standard outcome measures. Although the study was not designed as a non-inferiority trial, the lack of difference in outcomes, measured to a high degree of precision, and lack of significant imbalance in safety data suggest that the shift to PARTNERS care is not likely to be harmful. This is important, given the current policy direction of more integrated, primary care-based, person-centred care across the UK and in many other countries globally.There are few other comparable studies. There are no published trials of coaching alone for psychosis, rather than as part of collaborative care, and studies of motivational practices tend to focus on medication adherence. Collaborative care for individuals with depression and anxiety is associated with a modest but significant improvement in outcomes compared with usual care.In conclusion, this was the first definitive randomised controlled trial of a coaching-based collaborative care intervention for people with SMI. It was completed in a challenging health system and pandemic context. No improvements in standard outcome measures were seen, but the shift to primary care-based care did not lead to increased mental health crises. The qualitative process evaluation analyses will cast more light on how best to target and support implementation of coaching-based collaborative care. For system leaders redesigning services, the message is that the PARTNERS collaborative care model (including for those currently receiving low-intensity secondary care) is likely to be safe, but in its current intensity, is unlikely to generate major improvements in quality of life within a year.