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).

Background: In cystic fibrosis care, patients are required to adhere to a burdensome daily treatment regimen. The outpatient cystic fibrosis clinic presents an opportunity for multidisciplinary healthcare teams to monitor disease progression, support daily treatment adherence, address adherence challenges and improve health outcomes. However, the complexity of adherence care, and inconsistencies in methods and delivery of adherence interventions may impact the effectiveness of healthcare teams changing adherence outcomes. Comprehensive adherence protocols have been proposed (CF My Way) to increase the visibility, consistency and efficacy of adherence work. Barriers in the clinic environment have been implicated in their unsuccessful translation into standard care. The aim of this study was to explore the feasibility, acceptability and appropriateness of implementing the ‘CF My Way’ protocol into the outpatient cystic fibrosis clinic of a tertiary, paediatric hospital Methods: This implementation study employed a pre-post observational study design using mixed methods. A four-phased implementation framework guided the implementation plan. Prior to the program introduction, qualitative data was collected from 23 clinicians, adolescents and parents using focus groups and interviews to identify barriers and enablers to implementation. Quantitative data was collected using purpose-designed audit tools and surveys throughout the implementation and analysed to inform modifications and support translation to standard care. Discussion: Theoretically and conceptually-derived implementation science frameworks can inform the process of translating an adherence protocol into an existing CF healthcare setting. Results indicate that while using an adherence protocol is acceptable and appropriate according to the perspectives of clinicians and parents, ‘CF My Way’ is not yet an “off the shelf” solution to the adherence challenge. Modifications were required to the original adherence protocol to support integration. Implementation strategies such as pilot testing, systems analysis and team cultural interventions are indicated to support effective and consistent adherence care pathways in the CF clinic. Trial registration number: ACTRN12619001730190 Trial web address: http://www.ANZCTR.org.au/ACTRN12619001730190.aspx