Vocal cord dysfunction (VCD) is a potential complication of surgery involving the aortic arch, branch pulmonary arteries, and the ductus or ligamentum arteriosum. Reference Carpes, Kozak and Leblanc1 VCD occurs primarily due to anatomy of the recurrent laryngeal nerve which loops around the aorta and the ductus arteriosus and is at risk of damage during surgery involving these structures. VCD can be harmful and may have long-term developmental implications. Up to 60% of patients with VCD may not display obvious symptoms, meaning many children with VCD go undiagnosed with potential long-term consequences including aspiration pneumonia and repeated hospital admissions. Reference Lee, Millar and Rose2,Reference Skinner, Halstead, Rubinstein, Atz, Andrews and Bradley3
Clinical pathways are an established method of standardising care and ensuring adherence to best practice guidelines. Reference Campbell, Hotchkiss, Bradshaw and Porteous4–Reference Rotter, Kinsman and James6 They have been found to improve timeliness and quality of care in other populations and are becoming more accepted in the field of paediatric cardiac surgery. Reference Lagergren, Jensen, Beaven and Goudar7,Reference Gurria, Simpson and Tuncel-Kara8 Care pathways provide clear expectations of care, a means of measuring patient progress, and promote multi-disciplinary teamwork. Clinical pathways also reduce health care related mortality and morbidity and their respective costs. Reference Asmirajanti, Syuhaimie Hamid and Hariyati5,Reference Rotter, Kinsman and James9
A universal feeding strategy following VCD has yet to be established using an evidence-based approach. At the Queensland Children’s Hospital, we developed a multidisciplinary care pathway and embedded it into practice to improve outcomes in children at risk of VCD following surgery for congenital heart disease. In this paper we describe the implementation of this pathway.
Materials and methods
We conducted a prospective implementation evaluation of the VCD pathway (Fig 1). Data were collected from the project’s initiation in July, 2019, through the pathway’s launch in September, 2019, and during the implementation period up to September, 2020.
Figure 1.
The pathway was used to screen patients who were deemed to be at-risk of VCD after cardiac surgery and manage patients before and after screening. Children undergoing surgery involving the aortic arch, pulmonary arteries and ductus or ligamentum arteriosum were considered at risk of vocal cord dysfunction (VCD) due to the vulnerability of the recurrent laryngeal nerve in these procedures. In addition to the clinical pathway, patients underwent assessment using a new investigative modality, ultrasound of the larynx. A speech pathologist assessed the patients for signs of VCD once the patient was clinically stable and had achieved a quiet, alert state. Once patients were deemed suitable to be fed safely by the speech pathologist, feeding was commenced, however, all patients were fed as though they had VCD until their vocal cord function was determined by flexible direct laryngoscopy. The trial took place in the only tertiary metropolitan children’s hospital that manages children from Queensland and northern New South Wales.
The implementation of the structured multidisciplinary strategy for feeding was informed by research on implementing evidence-based practice. Reference Greenhalgh, Robert, Macfarlane, Bate and Kyriakidou10–Reference Pinnock and Sheikh12 This implementation process involved identifying facilitators and barriers to implementing the VCD pathway, enacting implementation strategies, and informing clinical and management staff on practical changes in the pathway.
In this implementation evaluation, we describe how the pathway was implemented, the barriers and enablers identified, and pathway adaption to address the barriers identified. The barriers and enablers to pathway implementation were examined using the consolidated framework for implementation research (CFIR), which characterises implementation as a planned and facilitated process that involves an interplay between the individuals involved, the intervention or change in practice and context. Reference Damschroder, Aron, Keith, Kirsh, Alexander and Lowery13
Document analysis of meeting minutes, process maps, and education materials was conducted. Barriers identified by the implementation team were recorded in an 'issues register'. The implementation team discussed these barriers and planned actions to address them. These planned actions were also recorded and monitored. A focus group discussion was conducted with the implementation team.
Results
In July, 2019, we established the implementation team for the VCD pathway. The team included a cardiothoracic surgeon, speech therapist, ear-nose-throat (ENT) specialist, cardiac nurse, cardiac research nurse, nurse educator and an implementation scientist. The team met weekly before launch and during initial implementation to map and plan the pathway, identify barriers, and develop implementation strategies.
The VCD pathway’s implementation occurred in four phases: mapping of the pathway; pre-launch preparation; recruitment; and monitoring of the pathway.
Mapping of the pathway
A diagram of the clinical pathway was developed and recorded before implementation (Fig 1). The purpose of this mapping was to determine stakeholders to engage; individuals to implement the pathway; stakeholders that would be affected by the pathway; and the decision points in the pathway. The pathway also indicated the roles and responsibilities of the implementation team members. All changes to the pathway and reasons for the changes were recorded to show how the pathway needed to be adapted.
Pre-launch preparation
The team examined the evidence for the management of VCD and sought input from staff across the relevant disciplines regarding information relevant to their understanding of the management of VCD. This information was synthesised and tailored to meet the wider clinical team’s needs and the patient population. The team identified knowledge deficiencies, adapted new knowledge and selected the optimal approach to knowledge translation. Reference Wilson, Brady and Lesesne14
The resulting education program consisted of short education sessions of a maximum of 15 minutes. Education sessions included a summary of the anatomy, aetiology, diagnosis, management of VCD and discussion of the care pathway. A clinical educator conducted sessions over a two-week period before the first patient was commenced on the pathway. The education sessions were staggered across nursing working shift periods. Out of 62 nurses working on the cardiac ward, 55 (89%) completed the education sessions. Information was distributed in the cardiac ward newsletter and on education boards in the clinical areas, including the cardiac ward’s high dependency bay.
Surveys were conducted before and after education sessions to identify knowledge gaps and self-assessed knowledge change. The survey included an open-ended clinical scenario question to assess understanding. The VCD clinical team reviewed the responses to the open-ended question to determine whether the responses indicated an understanding of VCD management. All 55 nurses who completed the training completed both the pre-and post-surveys. Responses to the surveys were used to improve subsequent education. The survey responses were used to identify problems in terms of knowledge gaps. By identifying the problems, it was possible to adapt the sessions to promote sustained knowledge use.
Members of the implementation team also developed an integrated electronic medical record template. The template was intended to be used in the initial and follow-up ENT consultations to encourage consistent reporting of outcomes and increased fidelity to the clinical pathway.
Recruitment
The consultant cardiac surgeon identified patients who met the inclusion criteria and informed the study research nurse. Consent was obtained by the cardiac surgeon or cardiac surgical fellows. An information sheet was provided to all families with children undergoing surgery that involved risk of injury to the recurrent laryngeal nerves and subsequent VCD at the time of obtaining consent for participation in the study. The information was re-enforced by the surgeon, fellow or cardiac nurse if the child developed VCD.
Patients were identified as being on the VCD pathway through notes on the Queensland Health integrated electronic medical record and the Patient Flow Management System. This system produces a short synopsis of the inpatient details for each ward, including age, parents' names, diagnosis, investigations, and other specialty-specific details that other treating teams can access quickly. The research nurse identified patients on the VCD pathway by attaching signage to the hospital bed. An information sheet regarding VCD was placed in the patient’s bedside chart. The purpose of these communication modalities was to identify patients on the pathway and to explain the implications for care for the treating team.
Monitoring the pathway
There was ongoing monitoring of patients following recruitment. A clinical VCD team, including speech pathology and cardiac surgery, conducted a weekly ward round to discuss the progress of each patient diagnosed with VCD. Monitoring was continued on all patients while in-patients in hospital until resolution of VCD. In patients with unresolved VCD at the time of hospital discharge, patients were managed according to usual practice including regular assessment as outpatients by a speech pathologist and ENT specialist.
Barriers, enablers and adaptations to the pathway (Table 1)
The criteria in the below context assessment are derived from the Consolidated Framework for Implementation Research (CFIR) Reference Damschroder, Aron, Keith, Kirsh, Alexander and Lowery13 and the integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework. Reference Gill and Kitson27 Evidence shows that each of these criteria is associated with implementation success.
Each criterion was rated by the implementation team using a five-point Likert scale where 1 equals “strongly disagree” and 5 equals “strong agree”. Factors are considered implementation enablers if rated 4 or 5, and implementation barriers if rated 1 or 2 (Table 1).
There were several enablers to VCD pathway implementation. The VCD pathway addressed a clinically significant problem. The use of an assessment by a speech pathologist together with a laryngeal ultrasound by radiology to detect VCD represents a non-invasive diagnostic modality compared with using flexible direct laryngoscopy by ENT to detect VCD. The pathway was developed internally and was able to be adapted over the study period. On the other hand, as this is the first study to assess this pathway’s implementation, it was necessary to conduct an ongoing assessment of available evidence. Executive leadership supported implementation of the pathway, both in terms of endorsement and financial support. The implementation team harnessed this support by obtaining formal commitments from leadership, conducting local consensus discussions, and developing the implementation blueprint.
Barriers, enablers, and adaptations to the VCD pathway.
Implementing this model of care necessitated investment in training and resources. Radiographers required additional training to perform laryngeal ultrasound for the detection of VCD. Similarly, speech pathologists required training to detect symptoms and signs of VCD. The study required all the children to also undergo a laryngoscopy, which resulted in an increased need for ENT services and funding for laryngoscopes for use on the ward. Grant funding was obtained to enable the purchase of an additional laryngoscope for the study.
The implementation team recognised that if the implementation of the pathway resulted in an increased length of hospital stay, the pathway would not be sustainable. The implementation team identified pathway points that could potentially result in a delay in hospital discharge. These points included time to be seen by speech pathologists and ENT and time to ordering and obtaining an ultrasound of the larynx. Therefore, facilitation from the implementation lead on the project was required to ensure these investigations were coordinated, performed in a timely and efficient fashion and that communication between these professional groups was maintained.
There were delays discharging children from the hospital early in the study. These delays were not due to additional workload associated with the pathway but rather because of staff uncertainty while other treating clinicians (cardiologists) became familiar with the pathway’s requirements. However, once the implementation team explained that there was no need to delay discharge due to participation in the study, the issue was resolved.
There were also concerns expressed from clinical staff that implementing the clinical pathway for the identification and management of VCD would result in delays in breastfeeding. According to the pathway, the potential benefits of early feeding outweighed the risk of aspiration without appropriate assessment in children at risk for VCD who were asymptomatic. Literature regarding asymptomatic VCD and associated health complications is currently unclear, and without adequate evidence, health professionals were reluctant to change their current practice. Concerns related to delaying feeds were multi-factorial and necessitated significant pathway implementation changes. All patients who underwent surgery where there was risk of injury to the recurrent laryngeal nerve were assumed to have developed vocal cord dysfunction postoperatively. Children were commenced on feeding using the precautions specified in the study pathway until they were evaluated by a speech pathologist. Concerns regarding delays in feeding may stem from the known advantages of early oral feeding in children. Eating can be of substantial comfort for older children after a cardiothoracic procedure as excessive thirst is often experienced after fasting for procedures. Reference Rizalar and Ozbas15 The concept of delaying oral fluids combined with the perceived higher risk of prolonged vascular access or nasogastric tube placement caused uneasiness in health care staff. In addition, a key discharge criterion for the paediatric cardiac surgical patient is evidence of adequate feeding and weight gain. Delays to instituting oral feeds may delay recovery and delay the date of discharge.
The COVID-19 pandemic had a significant impact on the provision of health care globally. The COVID-19 environment also proved to be a challenge for this trial. Challenges included maintaining social distancing, interruption to team meetings and competing clinical priorities whereby staff were required to retrain for front-line practice and discontinue non-essential project work. During mid-2020, laryngoscopy was discontinued for 3 months as part of the pathway, as it was an aerosol-generating procedure. This meant that the detection of VCD relied on speech pathology and ultrasound during that time.
Discussion
Clinical pathways are tools that are widely used in clinical practice to standardise and incorporate evidence-based guidelines into care provision. Reference Rotter, Kinsman and James6,Reference Rotter, Kinsman and James9,Reference Ronellenfitsch, Rossner, Jakob, Post, Hohenberger and Schwarzbach16 Initiation of new pathways must however be well supported in order to sustain long-term uptake and to fulfil pathway recommendations. Buy-in from all possible stakeholders is crucial in ensuring pathway implementation success. Reference Chan, Rosoklija and Meade17
The results of our study show that implementation of a multidisciplinary care pathway for the management of children at risk of VCD is safe and feasible. No patients reported any pathway related adverse effects and any delays in hospital discharge early in the project were mitigated through use of an implementation science approach.
The advantage of adopting a structured approach to implementation of the VCD pathway has been that it has allowed for the identification of barriers and enablers to improve facilitation by the implementation team, tailor implementation strategies, and adapt the pathway when necessary. Through this, processes were put into place to ensure appropriate patient flow, tailor education materials, target peer engagement, increase recruitment, and improve the identification of patients with VCD on the pathway. The tailoring of interventions to identified barriers has been suggested by other authors as a possible approach to ensure optimal outcomes, however, confirmation of this theory has yet to be established. Reference Bosch, van der Weijden, Wensing and Grol18
The implementation team applied principles of CFIR to assist with the identification of gaps in knowledge, adaptation of evidence to context, selection of implementation strategies, and evaluation. The CFIR has also been used with success in other populations including in HIV managements clinics and primary care. Reference Breimaier, Heckemann, Halfens and Lohrmann19–Reference Muddu, Tusubira and Nakirya22
There may be challenges in implementing this pathway in other hospitals. The implementation evaluation was conducted at a single site, with an implementation team and financial support from senior leadership. Successful implementation in other hospitals will require a local implementation team or facilitators and adaptation to contextualise different work environments and clinical practices. Funding may also need to be sought in order to support specific aspects of pathway implementation. Furthermore, experience with ultrasound of the larynx is not universally available and will need to be developed locally.
Success of implementation of the VCD pathway in this study was built upon the engagement of a multidisciplinary team using an iterative approach of identifying barriers and enablers, adapting implementation strategies and evaluating the implementation. However, continued work is needed to sustain the changes resulting from the implementation of the pathway at our institute. Other researchers also propose that success of pathway implementation is related to strong collaboration between specialists within the health system and that buy-in from colleagues and leadership is important to mitigate barriers of long-term standardized pathway use. Reference Chan, Rosoklija and Meade17,Reference Evans-Lacko, Jarrett, McCrone and Thornicroft23,Reference Kinsman, James and Ham24 Such an approach is gaining recognition in paediatric cardiac surgery as evidenced by two successful projects in which clinical pathways were implemented resulting in decreased length of stay and healthcare cost. Reference Lagergren, Jensen, Beaven and Goudar7,Reference Jabbour, Martin, Beste and Robey25
Acknowledgements
Authors would like to acknowledge the work of pathway stakeholders including nurses on the cardiology ward, hospital executive and cardiac surgery and cardiology team members.
Financial support
This work was supported by the Children’s Hospital Foundation (grant number #50230).
Conflicts of interest
None.
Ethical standards
The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national guidelines on human experimentation 26 and with the Helsinki Declaration of 1975, as revised in 2008, and has been approved by the Child Health Queensland Hospital and Health Service Human Research Ethics Committee (approval number HREC/18/QCHQ/49022) and the University of Queensland Human Research Ethics Committee (approval number 2019001698).
