Reducing the frequency of outpatient review in people with cystic fibrosis on high-efficacy modulator therapy – a non-inferiority, randomised controlled trial (REFORM).

This study is a multicentre, randomized, non-inferiority trial. It is not blinded. This pragmatic trial investigating the safety and acceptability of reducing the frequency of outpatient reviews will leverage off normal clinical practice. Participants will be randomised to standard interval (3 monthly) vs. extended interval (6 monthly - intervention group) outpatient review. Patients in the intervention group (i.e. extended interval) will receive 6 monthly review for 2 years from time of enrolment. The enrolment, 12 month and 24 month appointments will be in-person appointments with in-laboratory spirometry. Other appointments can be in-person or via telehealth at the discretion of the Cystic Fibrosis (CF) service and participant (per usual practice in CF clinics). All clinic visits will occur as per standard practice otherwise. Participants will be asked to complete an online survey every 3 months independent of the arm they are enrolled in (please see below). During outpatient review, data will be collected per usual clinical practice including: lung function (in-laboratory or home spirometry), symptoms, exacerbations, hospitalisations, weight, sputum microbiology and medications. The data will be entered into the Australian Cystic Fibrosis Data Registry (ACFDR) as per usual practice. No additional data will be collected at clinic visits. Participants will receive a brief electronic survey via REDCap every 3 months to assess whether they have had any pulmonary exacerbations, additional clinic appointments or medication changes. Participants will complete a patient satisfaction questionnaire and the Cystic Fibrosis questionnaire-revised respiratory domain questionnaire at baseline, 12 and 24 months in REDCap. As per usual practice, if participants are experiencing increased symptoms or have other concerns between routine appointments, they will contact the nurses at their CF service and receive additional appointments if necessary. This will not be a protocol violation and we are collecting information about additional appointments. Data regarding the number of routine and additional attendances (including outpatient and inpatient attendances) will be collected. The study will be administered by the study investigators which include members of the CF clinic team at each site and 1 CF coordinator (member of the CF team) at each site. The coordinator will monitor clinic attendance and any unplanned clinic visits.