Riding the wave of change: Providing solid ground to support nursing with patient transitions to novel haemophilia therapies
Abstract
Introduction
Haemophilia nursing practice has experienced a shift in the past decade, as the historic chief focus on factor infusions shifted to extended half-life products, bispecific antibody therapies and other non-replacement therapies. This evolution has driven a need for changes in nursing practice in many haemophilia treatment centres.
Aim
This article intends to provide insights to the haemophilia nurse to champion practice changes at their haemophilia treatment centres.
Methods
Two popular change theories, Lewin's three-step change model and Kotter's eight-step change model are discussed as a framework for haemophilia nurses to think, structure and be leaders in change.
Conclusion
Examples of these models in practice could give guidance and examples to reflect on for haemophilia nurses needing to make changes in their practice settings. These models of change, alongside existing haemophilia nurse competencies and tools such as the shared decision-making tool from the World Federation of Hemophilia, can assist the nurse to be a capable change agent to usher in these new innovations.
1 INTRODUCTION
In recent years, the haemophilia nursing role has enjoyed a strong undercurrent of change, with many of the baseline competencies of this role, and much of the work based on the teaching and training of patients for intravenous home infusions.1 The shift to long-acting, and non-replacement therapies has brought about a need to re-evaluate prior nursing practice and embrace the change that has come with this evolution in medications, treatments and therapy (MTT). In the haemophilia treatment centre (HTC), nurses have had a central role in the coordination and delivery of comprehensive care,1 which puts the nurse in an ideal position to champion practice changes due to their depth of understanding of this complex system, however, implementing innovations in practice could be considered an advanced competency for the haemophilia nurse,1 so not all nurses may be prepared to facilitate the change needed for this evolution in MTT. Fortunately, knowledge to bring about change for even the novice haemophilia nurse can be guided by two popular models of change theory and supported with their existing practice competencies and experience. In this article, Lewin's three-step change model2 and Kotter's eight-step change model3 will be discussed as a framework for haemophilia nurses to think, structure and be leaders in change. Due to the limited commercial availability and use at the time of publication, a specific focus on haemostatic rebalancing therapies and gene therapies will not be specifically addressed, although this framework could be useful for their introduction in the future.
2 MODELS FOR CHANGE IMPLEMENTATION
Change management models may be useful guides to facilitate change and adaptations of new MTT in complex healthcare systems. These models can provide a framework to ensure that the stakeholder's experiential knowledge is respected and incorporated into the change process, and the change is generated with clinician engagement and contributions. Change models also provide clarity to those indirectly and directly affected by change and help with commitment to the process required for the change to occur.4 This framework is valuable for the haemophilia nurse, who may be keen to initiate innovations in the HTC in response to the introduction of a novel MTT.
Two popular change models which have been used in healthcare are Lewin's change theory,2 and Kotter's eight-step change model.3 Lewin's change theory is a well-known change theory in healthcare, which has been utilised across many clinical areas for nurse leaders to understand and guide practice changes.2, 4, 5 Lewin's theory is rooted in the belief that there are forces or factors influencing the present situation that hold it in its current state. Identifying these forces in their totality can then allow an understanding of how to drive change forward or lessen restraining forces that keep practice entrenched in old ways of working. After finding these forces, targeted interventions can begin the first phase of change, ‘Unfreezing’.2 This stage should focus on planning interventions to lessen the restraining forces and strengthen driving forces to drive forward into the next phase.2 The second phase of the model, ‘Moving’2, includes executing interventions that are initiated with the goal of moving to the final stage. The final phase, ‘Refreezing’,2 should acknowledge and support the new care paradigm. Supporting forces and behaviours that maintain this paradigm are essential at this point to maintain the new regimen and not revert to old practice patterns.2
Kotter's eight-step change model is another popular model that has been used for leading change in healthcare settings and is structured around a series of sequential steps to facilitate and sustain change.3 In his article outlining this model, Kotter3 emphasised that for change to be successful, it must move through a sequential progression; skipping steps or making mistakes in a step can slow momentum and negate gains. His steps include 1) establishing a sense of urgency; 2) forming a powerful guiding coalition; 3) creating a vision; 4) communicating the vision; 5) empowering others to act on the vision; 6) planning for and creating short-term wins; 7) consolidating improvements and producing still more change; and 8) institutionalizing new approaches.3 This model has proven useful in healthcare where change is needed, especially in the areas of changing practices and protocols.6
2.1 Example one: Using Lewin's theory for the introduction of MTT
The introduction in the last decade of novel MTTs in the haemophilia practice setting has led to clinical advantages for some patients. These advantages may include improved bleed control in patients with inhibitors, easier administration than intravenous access for young children and elderly, higher trough and more consistent factor levels, decreased frequency of infusions for prophylaxis, less episodic treatment and less treatment for surgical procedures.7 The identification of patients in which new treatments could bring improvements is the first step in the initiation of the World Federation of Haemophilia (WFH) shared decision-making tool.8 This tool can be an excellent resource alone, and with the application of Lewin's model.2 A force field analysis of learning about, and defining the current ways of working within a HTC can be done alongside of this identification process. The haemophilia nurse could also then build a care pathway for patients switching or starting on a novel MTT.
The first step of Lewin's change model is unfreezing.2 This is the primary step needed to facilitate change, and for unfreezing to occur, the nurse needs to recognise forces at play and find a method to drive change forward while decreasing old behaviours and perceptions that negatively impact movement.5 Creating emphasis on both clinical and quality of life (QOL) improvements could be key considerations for nurses and affected individuals. In a series of studies focused on decisions to switch from intravenous (IV) to subcutaneous (SQ) therapy in patients with chronic inflammatory bowel disease, the main reasons for a therapeutic change were related to decreased hospital visits and time related to therapy.9 Subcutaneous administration is an easier and quicker parenteral access route than IV administration, and can potentially improve adherence, treatment burden and increase QOL. These can be elements to target during the unfreezing phase2 to advocate for novel MTT to be considered on a hospital or regional drug formulary. This could bring about the change to systems serving patients and decrease the resistant forces helping to drive toward eventual adoption.
Identifying driving forces can come from the analysis of patient engagement during the SDM process as laid out by the WFH tool.8 In reflection of the impact of the patients’ current treatments on their daily life systems, such as work, education and family, nurses can gain a deeper appreciation of forces outside the health system that may also facilitate or resist movement. Younger patients, those with personal experience with SQ therapies or those patients with more disease-related symptoms may have situations where driving forces are present to facilitate unfreezing. While resisting forces such as fear of change, required effort to engage and make the change, satisfaction with current therapy or prohibitive cost of change may be forces resisting change. The haemophilia nurse can understand these driving and resisting forces and use them as guides in the development of patient programmes and educational materials related to the novel MTTs. It may help identify potential early adopters of new therapies, who can then share their experiences with others making similar decisions which may help with patient reflection and decision making in the SDM process.8
Nurses have the unique ability to develop patient care programmes and education focused on areas that take into consideration the specific needs of patients.1 Using their understanding of the restraining and driving change forces, programmes which help with movement should have targeted patient interventions to build or diminish barriers supporting moving forward.1 Items unique to the HTC patient population may not be obvious to those without the history and perspective that a haemophilia nurse has developed over time.1 Many older patients may have personal experience with or have family members who developed infectious diseases that were associated with early adoption of treatments. Those who underwent early hepatitis C treatment may associate SQ therapies with the side effects experienced related to interferon. Patients that may have a history of bad outcomes or unmet expectations following adoption of new therapies, may be less willing to change. In the paediatric setting, the emotional pressure on parents to make the best decision for their child may delay decision making. It is also important to develop opportunities to engage the child in SDM that is right for their developmental level.
A focus on the enabling forces by the nurse should revolve around the expectation of health improvement. Nurses play a central role during the change process by addressing and presenting patient views, teaching the practicalities related to product storage, dosing and ensuring follow-up occurs1, 10, 11 They may also dedicate time to developing treatment schedules focused on historic adherence patterns of each patient. In a study by de Dycker et al.,12 the willingness to change therapies was greatly enhanced when face-to-face education was held. This was found to be superior to digital engagement alone. The availability of technology that allow for face to face via a video platform should be considered for patients with barriers to in-person appointments.
The final component of Lewin's change theory2 is ‘Refreezing’; establishing the new habits and aiming to avoid falling back into old ones. Careful planning should focus on methods to support patients once the transition to a new product is adopted. Developing short and long-term goals, incorporating attributes of the new treatment and the uniqueness of each patient is important. This is key to the SDM8 process but also helps support patients during the change to be successful in the new normal. Attention to adapting HTC workflows will also optimise refreezing. This practice can be reinforced by the haemophilia nurse with frequent checkpoints during the initial transition to a new treatment, including assessment of the skills taught and knowledge of the MTT. Unanticipated barriers and emerging questions as the patient gains experience with the new treatment may be present and should be considered, as some of these may impact adherence with the novel MTT. For example, SQ may seem less invasive than IV access, but there is now the added layer of pain related to the presence of the SQ medicine during administration. Pain as a side effect of SQ drugs was found to be underestimated. It may decrease adherence and affect the patients’ quality of life due to the anxiety around administration.13 Assuring that systems and resources to obtain medication and administer medications at home are in place may need to involve developing a system of reminders for the patient to stay on schedule. In some cases, intermittent or long-term assistance for the medication administration in the home may be required.
2.2 Example two: Using Kotter's theory for the introduction of MTT
Utilising Kotter's eight-step model3 as a framework for the introduction of novel MTT can support the planning and visualisation of the developing pathway through a different lens. The first step in the pathway, creating urgency, can start with the haemophilia nurse identifying the need for change and beginning initiation. Urgency can occur organically in several ways such as, with an imminent approval of a MTT, problems with an existing MTT, changes in funding or change in the circumstance for the patient. Nurses are often the first to identify focus areas of change. Other stakeholders involved with the usage, supply and funding need to understand why this change is important and warrants urgency and may need to be alerted. Patients with minimal bleeding concerns and/ or those who have normalised their medication treatment regimen with factor concentrates may not be a priority for urgent changes in MTTs. Building awareness, understanding and advocating for access for patients is a key task of this stage. Pollard et al.11 highlighted the role of the haemophilia nurse with formulary switches in the past where urgency was mandated due to timelines for national therapy framework changes. Haemophilia nurses could use skills developed from past switches in MTT during this initial phase. Kotter3 emphasised the importance of motivation being crucial to having others help with change so the effort can go forward, and the difficulty of driving people from their comfort zones when things are well established. Highlighting possible areas, of improvement such as, the potential change in patient outcomes, decreases in annual bleeding rate, decreased treatment burden and potential increased QOL is important.7 Sharing the numbers of regions or other countries who have already successfully introduced this MTT may help to create ‘urgency’ raising an awareness amongst stakeholders regarding the standard of care offered in comparable regions.
The second step is creating a powerful coalition among leaders.3 In the HTC, all multi-disciplinary members should be a part of this change but also should believe that the change is important and urgent to put energy and effort into. The haemophilia nurse core competencies of communication/support and collaborative practice allow for the creation of partnerships with non-nurse colleagues to work towards the change.1 These changes within the healthcare system may include supply chain, monitoring, space allocation, staffing needs and planning for home support. Working closely with the local national haemophilia member organisations (NMOs) is also critical, as this will ensure that key opinion leaders can help with advocacy and be a powerful voice for the urgency of the need for change. Local NMOs may also have skills and expertise with advocacy. The haemophilia nurse can use this connection to create a coalition that may help connect patients with other local NMOs members.
The third and fourth steps of Kotter's change theory3 are creating a vision and communicating this vision quickly afterwards. The haemophilia nurse and participants of the coalition formed in step two, must share a specific and measurable vision. A clear, specific workflow for all involved is key. Communicating the vision through multiple channels, assigning responsibility for follow up and regularly providing education is important for success.3 The haemophilia nurse should create a pathway for switching patients, validating this with HTC team members and then communicating this to all stakeholders to ensure that a clear vision is communicated and not muddied with adapted changes and rebroadcast. This could include sharing information with patients at an NMO local meeting, sharing information via newsletter, or to patient individually at appointments. Sharing projected switch numbers and MTT stock projections with the laboratory or pharmacy can ensure the supply of MTT is smooth and the capacity to monitor therapeutic responses is adequate.
The fifth step in Kotter's steps of change3 is removing obstacles to accomplish this vision. Since the haemophilia nurse may be planning and executing the switch from factor concentrates to novel MTT, current experiences and knowledge may bring forth an understanding of barriers easily. Examples of obstacles to consider may be timing of finishing existing home stock not coinciding with timing of the patient availability for attending training, predicting stock levels for loading doses and those to continue maintenance schedules, and finding a suitable time to schedule training for patients that does not interrupt school or work. Other barriers to starting a novel MTT, such as patient perceived safety of the new MTT, efficacy of old MTT, eligibility and laboratory studies may also need to be considered in the planning process. Planning how to remove or navigate around these obstacles will help this stage go smoothly for the haemophilia nurse.
Creating short-term wins for the healthcare team and building on the change are the sixth and seventh steps in Kotter's change model.3 Kotter3 highlights that ‘creating short-term wins is different from, hoping for short term wins’ and actively showing progress versus passively hoping for the best is important. The strong undercurrent of change that many nurses in HTCs have been experiencing should be shared back to all stakeholders as well as through formal channels such as publications and academic meetings. Building in and considering metrics to understand gains in measures such as patient-reported outcomes pre and post change, decreased bleeding or annual bleeding rates, decreased hospitalisations and increased participation in sport, work or school are all examples of useful measures to build into the planning process. Protected time to reflect on the change process and make modifications in the path would also ensure that the quality in care delivery is maintained throughout the switch and beyond. This can also help to ensure that the change is sustained long term. Switching all interested and eligible patients to novel MTT can take more time than anticipated; celebrating short-term wins will maintain the urgency, dedication to the vision and continue to keep the coalition engaged with measurable successes. Declaring the change successful and well established too soon may limit further innovation.3 EHL and BSA therapies are the most commercially available novel MTT, but the haemophilia nurse may need to adapt and refine the pathway as more novel MTT become accessible. Maintaining the momentum that was created to switch patients to these initial novel MTT may need to be maintained and renewed to continue to innovate practice.
This leads to the final step of Kotter's model,3 anchoring the change, which has strong similarities to the refreezing stage of Lewin's model.2 Healthcare is a constantly changing environment, but many healthcare practices are rooted in tradition and established practices. For the haemophilia nurse, the prior established role may need to be re-imagined and solidified. The past intensity of the nurse-patient relationship, including time involved for intravenous skills, may change with a shift in route of novel MTT.
3 CONCLUSION
Haemophilia nurses are uniquely positioned to be the change agents in many HTCs. With specialised clinical knowledge and skill,1 they understand the potential that a novel MTT can bring to their practice area. Haemophilia nurses can develop education and care programs to best support patient success with transitions to MTT based on each patient's unique needs and challenges. They can also utilise models of change,2, 3 alongside existing haemophilia nurse competencies and tools such as the SDM tool from the WFH.8 By carefully planning for the wave of change washing over many HTCs worldwide, utilising the grounding guidance of a model of change, such as Lewin change theory of planned change2 or Kotter's3 stages of change; the introduction of novel haemophilia MTT into the HTC can be successful and support patient-centred, individualised care with the possibility of improved health outcomes for patients.
AUTHOR CONTRIBUTIONS
Erica Crilly wrote the body of the article and was responsible for all submission details. Jennifer Maahs wrote additions the body of the article and the majority of example one. Jennifer Maahs also provided review and corrections. Cathy Harrison constructed the figure and provided review and corrections. Marlene Beijlevelt, Brian Ramsay, Cyrus Githinji, Marcela Sisdelli and Anjalin Dsouza were involved in conceptualisation of topic and review.
CONFLICT OF INTEREST STATEMENT
Erica Crilly has received meeting sponsorship/consultation fees from Sanofi, Pfizer, Takeda, Bayer. Cathy Harrison has received meeting sponsorship/ consultation/speaker fees from CSL, Pfizer, Roche, Sanofi, Sobi, Takeda, Novo Nordisk.
DATA AVAILBILITY STATEMENT
The data that supports the findings of this study are available from the corresponding author upon reasonable request.
ETHICS STATEMENT
This is a review and comprises data retrieved from the public domain. Therefore, no ethics approval was obtained prior to conducting the literature search.
