TY - JOUR T1 - Integrating specialist palliative care to improve care and reduce suffering: cystic fibrosis (InSPIRe:CF) – study protocol for a multicentre randomised clinical trial JF - BMJ Open Respiratory Research JO - BMJ Open Resp Res DO - 10.1136/bmjresp-2022-001381 VL - 9 IS - 1 SP - e001381 AU - Jane Lowers AU - Elisabeth P Dellon AU - Anne Stephenson AU - Robert Arnold AU - Andrew Althouse AU - Kwonho Jeong AU - Ethan Dubin AU - Jesse Soodalter AU - Cade Hovater AU - Marie Bakitas AU - Jessica Goggin AU - William Hunt AU - Sigrid Ladores AU - Kimberly Curseen AU - Gretchen Winter AU - George Solomon AU - Jonathan Ailon AU - Douglas Conrad AU - Dio Kavalieratos Y1 - 2022/09/01 UR - http://bmjopenrespres.bmj.com/content/9/1/e001381.abstract N2 - Introduction Cystic fibrosis (CF) is a life-limiting genetic disorder estimated to affect more than 160 000 individuals and their families worldwide. People living with CF commonly experience significant physical and emotional symptom burdens, disruptions to social roles and complex treatment decision making. While palliative care (PC) interventions have been shown to relieve many such burdens in other serious illnesses, no rigorous evidence exists for palliative care in CF. Thus, this study aims to compare the effect of specialist palliative care plus usual CF care vs usual CF care alone on patient quality of life.Methods and analysis This is a five-site, two-arm, partially masked, randomised superiority clinical trial. 264 adults with CF will be randomly assigned to usual CF care or usual CF care plus a longitudinal palliative care intervention delivered by a palliative care specialist. The trial’s primary outcome is patient quality of life (measured with the Functional Assessment of Chronic Illness Therapy-Palliative care instrument). Secondary outcomes include symptom burden, satisfaction with care and healthcare utilisation. Outcomes will be measured at 12 months (primary endpoint) and 15 months (secondary endpoint). In addition, we will conduct qualitative interviews with patient participants, caregivers, and palliative care and CF care team members to explore perceptions of the intervention’s impact and barriers and facilitators to dissemination.Ethics and dissemination Human subjects research ethics approval was obtained from all participating sites, and all study participants gave informed consent. We will publish the results of this trial in a peer-reviewed journal.Trial registration number ISRCTN53323164.Data are available in a public, open access repository. Trial results will be published in the Palliative Care Research Cooperative Group’s deidentified data repository. ER -