Discussion
depression, cancer, anxiety/depression, anxiety
ONCOLOGY, CANCER, SECONDARY
Our primary objective was to determine if an Enhanced, ongoing ‘active’ implementation strategy throughout the first year of implementing a clinical pathway for anxiety and depression would lead to better staff adherence to the ADAPT CP than a Core, more ‘passive’ limited implementation strategy. We found no differences between the two implementation arms in adherence when we used either a binary outcome (≥ 70% of components adhered to, versus < 70%) or a continuous outcome. Our secondary objective was to examine the effect of step allocation (overall, and by implementation support arm) on total and component adherence scores. We found that step allocation was significantly associated with adherence; adherence was lower for higher (more severe) steps of anxiety/depression. When adherence was analysed as a continuous outcome only, there was also weak evidence for a difference (Our finding that implementation strategy as a main effect did not impact adherence is in contrast to the findings of Almatar et al. [However, our cut-off for adherence, while based on similar studies, is somewhat arbitrary. When we used a continuous outcome, providing maximum power, and included the interaction term between implementation strategy and severity step, we found a marginally significant difference between arms for adherence to the ADAPT CP for patients with higher or more severe levels of anxiety and/or depression. Controlling for other potential confounders, staff in the Enhanced arm adhered to about 7.5 percentage points more components of the CP than those in the Core arm, for patients with step 3 anxiety/depression. While statistically non-significant due to considerable variability, there was a 10 percentage-point difference in adherence between arms for patients with step 4 anxiety/depression. Thus, the Enhanced implementation effort did appear to assist services to respond to patients with more severe anxiety/depression, who arguably need help more specialist care than those with minimal to mild anxiety/depression. However, this result must be interpreted with caution, given the marginally significant result.These results provide some of the first empirical data on the extent of implementation effort required to ensure success in implementing health service change in the form of a novel CP. Our study suggests that even when great care has been taken to design and launch a new CP, adhering to principles described in implementation science frameworks, ongoing assistance during implementation facilitates greater staff adherence. While frameworks such as the Consolidated Framework for Implementing Research (CFIR) [If longitudinal implementation effort is required to achieve health service change, adequate resourcing will be needed not only for initial effort, but for sustainment. Our own health economic data (paper under review) will inform appropriate planning. Unfortunately to date, it appears that health systems often fail to dedicate sufficient resourcing to integrate and sustain implementation efforts, particularly those focused on improving mental health [All patients included in this data set had completed screening at least once. Subsequent adherence was highest across both arms of the study for triage (85–100% across anxiety/depression steps). Staff followed up concerning patient scores on screening measures, by having a discussion with them to clarify their concerns and needs. Adherence to re-screening, whilst lower than for triage, was also relatively high (54–78%). Screening for distress using patient-reported outcome measures has been promoted for many years [However, adherence to interim ADAPT CP steps (tracking whether patients took up referrals, were happy with care received and improved or required re-referral, and obtaining a treatment discharge summary) was poor. These components, laid out in the ADAPT CP, are particularly important for patients with more severe morbidity who require referral. Yet we observed a highly significant difference for the main effect of anxiety/depression step on adherence, with lower adherence overall for those with greater anxiety/depression.While we did not directly assess reasons for this lower adherence to interim CP components in the current trial, we can speculate regarding causes. Oncology staff are likely less familiar with these components, than with initial screening. There may also be a lack of referral pathways, given psychosocial workforce limitations, and staff may therefore be referring out to community services with whom they have less established communication channels. Furthermore, these steps can require more time and be frustrating if the specialist staff to whom patients have been referred respond slowly or not at all to requests for information and discharge summaries. Integrating psychological care related to cancer diagnosis that occurs outside of the cancer centre could be complex and require careful planning and system changes. Staff may need targeted support in integrating these CP components within existing workflow processes.It is also possible that these steps occurred but were not well documented in either the ADAPT Portal or patient records. However, without documentation, steps to address non-uptake of referral or need for new referral may not consistently occur, impacting patient outcomes [Our study had significant strengths. We employed a cluster randomised controlled trial design, that allowed us to clearly compare two implementation strategies. We recruited diverse oncology services across urban and regional areas, and public and private health care systems. We collected detailed data on staff adherence to each of the CP components and controlled for potential site and patient confounders. Reporting complied with CONSORT reporting standards [The study also had limitations. While our study compared a Core implementation strategy with an Enhanced one that provided implementation support across one year, it is not clear what intensity of implementation support is required to achieve improved adherence. Perhaps less ongoing support may have been sufficient, or more would have achieved an even better outcome. Future studies could compare more or less intense implementation efforts, compare length of supported needed and tease out which strategies were most helpful.We were not able to obtain accurate data on the proportion of all eligible patients who were invited by staff to participate in the ADAPT CP. The implementation strategy delivered may have effected the level of staff commitment, time and energy devoted to encouraging patients to screen for anxiety and depression, and this should be explored in future trials.An important consideration is how much statistical power we had to detect an effect if one was present. This information is best captured in the bounds of the confidence intervals for the effect sizes. Although there was no effect of implementation arm on adherence as a binary outcome (Table Our focus was on services adherence to the ADAPT CP. Due to small numbers (The ADAPT Portal was not able to integrate with the electronic medical records (EMRs) used in participating hospitals, due to diversity of systems used across services. This likely reduced staff compliance in recording their actions within the Portal in line with instructions. Thus, adherence to the ADAPT CP may have been higher than we could detect. However, we did conduct exhaustive medical record reviews to supplement the portal data and ensure our adherence data was as accurate as possible. Nevertheless, future studies would benefit from integrating data collection methods within existing hospital EMR systems.