RecruitingACTRN12620000835943

Incidence of vocal cord paresis and evaluation of a multi-modal education program and structured multidisciplinary pathway in patients after congenital heart surgery


Sponsor

University of Queensland

Enrollment

60 participants

Start Date

Sep 2, 2019

Study Type

Interventional

Conditions

Summary

This project aims to study the incidence of vocal cord paresis and evaluate implementation of a multi-modal education program and structured multidisciplinary pathway in patients after congenital heart surgery.


Eligibility

Sex: Both males and femalesMin Age: 0 YearssMax Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Congenital heart surgery in children sometimes involves the aortic arch or nearby blood vessels. One potential complication of this surgery is vocal cord paresis — partial weakness or paralysis of the vocal cords — which can cause a hoarse, weak voice and problems with swallowing and feeding. This complication is not always detected promptly because routine screening is not always in place, and families may not know what to watch for. This study has two goals: first, to find out how often vocal cord paresis occurs after congenital heart surgery involving the aortic arch, patent ductus arteriosus, or left pulmonary artery; and second, to evaluate whether a structured education program and a multidisciplinary care pathway can improve early identification and management of this complication. Your child may be eligible if they are aged 0 to 18 years and have undergone congenital heart surgery involving the aortic arch, the patent ductus arteriosus (a blood vessel that normally closes after birth), or the left pulmonary artery. Children with a pre-existing diagnosis of vocal cord paresis before their surgery would not be enrolled.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

A collaborative working group comprising nurses, speech pathologists, dietitians and cardiac surgeons developed an easy-to-follow guide to managing nasogastric feeding. The pathway seeks to prime infa

A collaborative working group comprising nurses, speech pathologists, dietitians and cardiac surgeons developed an easy-to-follow guide to managing nasogastric feeding. The pathway seeks to prime infants for success in safely commencing and transitioning to oral feeds in the following key ways: 1. Patients are not considered suitable for an initial oral feeding trial prior to clearing 4 criteria related to underlying known risk factors for feeding dysfunction or aspiration. 2. Patients are assessed by experienced speech pathologists who are able to identify additional risk factors for, or clinical signs of, swallowing difficulty and aspiration. Crucially, the speech pathologist can then immediately implement clinical strategies and modifications (therapeutic or prophylactic) to prevent aspiration and improve swallowing safety. 3. Patients are concurrently referred to Paediatric Otorhinolaryngologists for assessment of vocal cord function via naso-endoscopy. Diagnosis of potential vocal cord palsy, along with other incidental observations of the upper airway, aid in the interpretation of the clinical feeding evaluation and team decision making regarding the progression of oral feeds. 4. Once considered safe for progressing with oral feeds without direct speech pathology supervision (with safety modifications or precautions in place as required), the frequency and duration of oral feeds are increased as tolerated by the patient, with ongoing close monitoring by the medical and feeding teams. 5. Where clinical signs of swallowing difficulty or suspicion of aspiration persist despite clinical intervention, the patient is referred for further evaluation and medical imaging as clinically indicated. A six-month multi-modal, multi-disciplinary education program will be used to implement the feeding pathway. The education program is guided by the Knowledge-to-Action (KTA) Framework and the Consolidated Framework for Implementation Research (CFIR). Investigators will use the frameworks to assist with identification of gaps in knowledge, adaptation of evidence to context, assessment of barriers and facilitators to knowledge use, selection and implementation of interventions, monitoring knowledge use, and outcomes evaluation. Semi-structured interviews of staff involved in managing vocal cord paresis will be conducted in the month before implementation to identify barriers and enablers to adoption. Staff knowledge will also be assessed. Interviews will be repeated post implementation. Interviews will be completed by the ward educator for cardiology. The education program will comprise of short education sessions (maximum 5 mins) and will include a summary of vocal cord palsy and its diagnosis and management, discussion of the care pathway, and a real-life surgical scenario to analyse in tandem with the pathway. Sessions will be conducted on an ad hoc opportunistic basis over a six-month period and will be led by the clinical educator with the goal of running 20 sessions in total for the participating ward and the speech pathology team. Information will also be distributed in the ward newsletter and on education boards in the clinical area. To ensure ongoing translation of the pathway and integration into routine clinical practice, education sessions will be continued every month and audit of use of the pathway will be integrated into routine quality assurance practices within the ward. Facilitators will be engaged by expression of interest to consolidate education and reinforce use of the framework. An information sheet will also be provided to all families with children that have a diagnosis of vocal cord palsy. The sheet will be provided by either the cardiac surgical care coordinators or cardiac surgery fellows at the time of diagnosis of VCP.


Locations(1)

Queensland Children's Hospital - South Brisbane

QLD, Australia

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