RESUMO
BACKGROUND: People with cystic fibrosis are required to adhere to a burdensome daily treatment regimen. Comprehensive adherence protocols can support more consistent use of adherence interventions and improve treatment adherence rates. This study aimed to explore the feasibility, acceptability, and appropriateness of implementing an adherence protocol into the outpatient cystic fibrosis clinic of a tertiary, paediatric hospital. METHODS: This implementation study employed a pre-post observation design, using multiple methods. Focus groups and semi-structured interviews were conducted pre-implementation to understand clinician and consumer perspectives on adherence care. A multicomponent adherence protocol (including multidisciplinary written treatment plans, digital mental health screening and customised communication tools) was then implemented as standard care for a three-month implementation phase. Quantitative data was collected throughout using purpose-designed audit tools and surveys. The Replicating Effective Practice (REP) Framework guided the implementation process. Analysis was informed by The Consolidated Framework for Implementation Research (CFIR) to identify factors that support or challenge the integration of adherence protocols into standard care. RESULTS: Thirteen clinicians, eight parents and two adolescents participated in focus groups or interviews that informed development of the tailored multicomponent adherence protocol for implementation. Medical chart audits demonstrated that the protocol was used with 44-57% of eligible consumers three months after introduction. Eighteen clinicians and five consumers participated in post-implementation phase questionnaires. The protocol was considered acceptable and appropriate to clinicians and consumers. Changes in clinicians' practice behaviour were short-lived peaks in response to targeted intervention strategies throughout the implementation phase, such as audit and feedback. CONCLUSIONS: An adherence protocol is not an "off the shelf" solution to the adherence challenge in a hospital outpatient setting. Despite the tailored adherence protocol being considered appropriate and acceptable to clinicians and consumers, low fidelity indicates limited feasibility in the outpatient clinic setting, where multi-disciplinary members are all considered responsible for adherence care interventions. Key implementation factors and strategies to consider prior to introducing an adherence protocol are described. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12619001730190 (Retrospectively registered).