This is the first study using a theoretically and conceptually-derived implementation strategy, underpinned by implementation science, to introduce an adherence protocol into a CF outpatient clinic. Through a rich exploration of the structures and processes of the outpatient CF clinic, factors that impact adherence care provision and influence whether clinics are able to change towards more uniform approach to adherence management were uncovered. The ‘CF My Way’ protocol was designed to embed adherence interventions into outpatient CF clinic encounters however, this protocol required extensive modification and planning to support compatibility to the local environment in this study. Audit results showed that the modified protocol components were used with up to 65% of eligible families, with the use of a screening tool and commencement of a written treatment plan the most successfully implemented components. Whilst both clinicians and parents indicated via survey that they considered the Modified CF My Way protocol both appropriate and acceptable, the rates of clinician use suggest inconsistent clinical utilization over the three-month observation period. These findings, like the original ‘CF My Way’ study, bring into question the feasibility of integrating an adherence protocol into standard care in an outpatient setting [17]. Factors that likely influenced uptake were identified and, if addressed, may allow greater implementation success in future studies.
Clinical teams in the CF clinic have become more multi-disciplinary to deliver high quality, family-centred care. As the clinical team has expanded, there has become a greater need for strong coordination and communication networks to integrate care as each team member is likely to address their discipline specific piece of the adherence puzzle [36, 37]. Adequate team coordination is required to avoid the pitfalls of the “too many cooks in the kitchen” effect where clinics become repetitive, unhelpful or inefficient [36, 37]. Results from this study support that clinicians experience an overlap of professional roles regarding adherence and poor visibility of what other members of the team are doing with the family regarding adherence. Without clear allocation of roles, many clinicians expressed concerns about the risks of providing contrary recommendations to families or overloading the young person or family with too many recommendations or expectations. This was confirmed by parent and adolescent participants who described care provision that was often repetitive, especially in the area of adherence assessment, and acknowledged the negative impact of receiving different advice on sustaining their child’s care at home. This phenomenon has been described in multidisciplinary clinic care more widely, where overlap of professional roles can both be a strength when the team reinforces the health message but also lead to confusion for families when recommendations vary or change according to practitioner, leaving parents to decide how to interpret the recommendations themselves [36, 37, 38].
Beyond the impact that the structure and communication channels of the CF clinical team on clear team messaging, team communication and networks were observed to be a dominant factor on the implementation of the modified adherence protocol. Post implementation survey results highlighted that 10–30% of surveyed staff had low awareness of some of the adherence protocol components. A contributing factor may have been the diffusion of education and training to the local clinical team through clinical meetings and communication networks. Communication was identified at pre- implementation as an existing challenge likely to impact implementation and it appears that this was not sufficiently considered in the training design in this study. Training delivered to clinicians in existing team meetings, via email and informally during the outpatient CF clinic was selected to reduce the time burden to clinicians. This appeared insufficient to result in coordinated change and achieve sufficient awareness across the large clinical team. Other communication strategies are indicated. The introduction of an implementation team in this study increased team communication. This group represented key members of various disciplines who provided feedback from their team regarding the implementation progress and championed the diffusion of training and information back to their clinical area. It is suggested that future adherence protocol projects select additional communication and education interventions to coordinate care and diffusion of information including implementation teams that cross multiple health disciplines.
The level of compatibility between the clinic workflows and systems and the new protocol was identified by clinicians as impacting the protocol’s acceptability and appropriateness. The highest number of modifications were required to the written treatment plan, due to its digitization and need for multiple team members to contribute their recommendations. Digitization offered benefits in terms of data storage, accessibility and team collaboration. However, it also introduced a higher training requirement as the digital systems were not familiar to the large healthcare team (as existing systems were not suitable to serve the requirements of the protocol components) [33]. Clinicians identified that the components added additional paperwork and time burden. The technical logs displayed ongoing modifications were underway until the last week of the implementation period, as a result of organizational efforts to address clinical governance. As a result, changes to the originally launched protocol were necessary throughout the 3-month implementation period which likely impacted upon the quality of training and clinician’s understanding of the digital components of the protocol. It is recommended that a higher training budget be considered when introducing digital adherence resources as well as use of adequate pilot testing to ensure compatibility with local systems [33]. The benefits of digital transformations often take longer timeframes to be realised due to both training requirements and their increased value when the data collected can be harnessed for other purposes [33].
An unexpected finding of medical chart audits was that the number of monthly annual reviews relative to the total clinic population was lower than anticipated by clinicians. In effect, there were low numbers of eligible consumers for the ‘Modified CF My Way’ protocol as four of the five core components were linked with this timepoint. Despite annual review being considered standard care [39], it was identified that consistent processes were not well established or understood by the team. Subsequently, the annual review processes were reviewed and formalized to support compatibility between a consistent structured adherence protocol and a similarly consistent annual review structure. As annual review numbers increased significantly between month one and three, this may have impacted the adherence protocol completion rates as clinicians adjusted to greater number of eligible patients per clinic than previously experienced. Systems analysis practices could be utilised to observe how clinic processes work prior to implementing an adherence protocol to ensure underlying process barriers are addressed before introducing new processes [40]. In this study, use of systems analysis in the pre-condition phase of planning may have uncovered the low annual review numbers. When adherence protocol processes are designed to be linked with clinic flow processes, it is imperative that these underlying systems are optimised.
Future teams implementing the ‘CF My Way’ protocol should consider modification, adaptation, and implementation strategies to increase compatibility with CF outpatient clinics. Using a small clinic pilot group is recommended to allow implementation teams to refine the protocol and troubleshoot issues prior to scaling up. As evidenced by this study and the original randomized control trial [17], significant modification and localization is required to align within clinic adherence protocols with existing clinic work flows. Initial modification alone did not sufficiently support compatibility. Using a pilot clinic with a small group of patients/ clinicians would facilitate ‘on the ground’ learnings to inform changes to the protocol before scaling up. This would also reduce the need for clinician retraining.
An unexpected finding of this study was the significant impact of culture on adherence care provision. The pre-implementation results brought organisational culture and underlying clinician beliefs into view. In implementation literature, culture has been identified to play a significant role in organisational change [41, 42]. At the time of this study, the approach to adherence management by the CF team was typified by high levels of decentralization and flexibility for clinicians. Adherence care provision was highly oriented towards the users (i.e., parents and young people) of the service, rather than explicit rules or formal processes. This is characteristic of a “humanistic” organizational culture [41]. Humanistic organisations rely on shared values and allow employees a high level of individual decision making to govern behaviour and place limited structures in place to control these processes. It is considered that this culture impacted upon adherence protocol implementation in this study in two distinct ways. Firstly, as the intervention was considered family-centred (according to post implementation clinician survey results), this positively impacted clinician acceptability of the protocol. Secondly, as adherence care falls to a large group of clinicians within a humanistic, decentralized workplace culture, it was not surprising that underlying process gaps and variability in practices were identified in the local setting when the modified adherence protocol was introduced. Maintaining a balanced culture is perceived optimal, which supports both flexibility and structure as well as greater consistency of care [42].
Clinician’s beliefs and the underlying workplace ethos around adherence were uncovered to be an important factor in understanding CF adherence practices. Clinicians discussed in the pre-implementation focus groups that they held an underlying belief that “adherence” is an unattainable target. Team members reported that they believed prescribed treatment plans are unrealistic and place a high level of burden on families. The way that clinicians deliver family-centred care was influenced by this belief. Clinicians reported they act in a protective way to reduce overwhelm and change their adherence targets and recommendations according to their perception of the family’s capacity to manage. In contrast, parents reported that they would prefer their team to equally discuss more treatments options with them rather than assuming the family’s burden. Some parents spoke to a feeling of having to ask for additional treatments that they had read about online or feeling their care team was holding back in their recommendations.
When teams rely on a humanistic culture, equity of care may be compromised by the paternalistic instincts and best intentions of clinicians. Where clear organisational policy or structure is not available to guide clinician’s delivery of care, a high level of flexibility and variation in the provision of care is likely to be observed. Although this places families at the fore, it raises a question of whether clinicians and families differ in their interpretation of family centred care and whether the introduction of systems that outline basic roles and responsibilities around adherence would increase the equity and predictability of multidisciplinary care.
An opportunity is presented here for families to be engaged actively and openly in co-designing their optimal treatment plan. Consumers who are well engaged are more likely to seek help when needed, ask for and follow advice, are more satisfied with their care and have improved adherence and health outcomes [43]. Parent participants discussed a desire to be an active participant in care planning as well as in planning how they use their clinic appointment (e.g., requesting multidisciplinary team members as their needs indicated). From this study, it would appear that parents, particularly parents of teenagers, want more opportunities to be a key member in treatment decisions and have insight into which clinicians they wish to see in their clinic appointment to support their care.
Limitations of the study should be noted. The purposive recruitment of clinicians and families to the study may have introduced respondent bias, as interested parties were more likely to allocate time to discussing the subject matter of the study. Therefore, views of stakeholders with low interest or investment in adherence service redesign may be under-represented. Also, the implementation of the problem-solving component of the original protocol was not observed in this study due to considerations of the number of sustainable changes that could be managed and availability of training materials. However, following service evaluation using the key factors outlined in this paper, the implementation of a collaborative problem-solving intervention is recommended.
In summary, adherence protocols show promise in their ability to define professional’s roles and care pathways in an area of practice that has previously been relatively undefined. Currently the ‘CF My Way’ protocol and the modified version observed in this study are not “off the shelf” solutions to this problem. However, lessons can be learnt from observing their implementation using an implementation science approach. When improving adherence care, attention should be directed at strategies that support effective interprofessional collaboration to address the underlying fragmentation and role overlaps in adherence care. Further exploration is indicated regarding how multi-disciplinary teams can collaborate or utilize care coordinators to increase integration of adherence care and clarity of treatment recommendations for families.
The use of objective assessment data to direct adherence care also showed potential in this study. The screening of adherence related factors and inclusion of family preferences in appointment planning were observed to assist clinicians to allocate clinical time and support families demonstrating risk of adherence deterioration, rather than clinicians relying on intuition. Objective screening data may support more effective allocation of resources and prioritization of patients requiring timely adherence intervention. For example, the use of preclinic family communication or screening (via digital automation) could be used to enhance pre-appointment planning. This may be especially valuable for teenagers with CF and their families where clinic reviews are seen to add less value [44] and where families are more confident and comfortable to manage how they use their appointment. Bringing the child, adolescent or their family into care planning decisions would represent a directional shift away from traditional paternalistic approaches to adherence management towards family demand driven care [45, 46]. Further research should explore pathways for family data (including communication of their preferences) to have a more active role in directing the allocation of health professional time in the CF clinic. Predictive analytics using objective adherence data could also be used to streamline timing of review appointments or target group programs or resources towards families with similar needs to increase efficiency of health care.