RT Journal Article
SR Electronic
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
FD British Thoracic Society
SP e001381
DO 10.1136/bmjresp-2022-001381
VO 9
IS 1
A1 Jane Lowers
A1 Elisabeth P Dellon
A1 Anne Stephenson
A1 Robert Arnold
A1 Andrew Althouse
A1 Kwonho Jeong
A1 Ethan Dubin
A1 Jesse Soodalter
A1 Cade Hovater
A1 Marie Bakitas
A1 Jessica Goggin
A1 William Hunt
A1 Sigrid Ladores
A1 Kimberly Curseen
A1 Gretchen Winter
A1 George Solomon
A1 Jonathan Ailon
A1 Douglas Conrad
A1 Dio Kavalieratos
YR 2022
UL http://bmjopenrespres.bmj.com/content/9/1/e001381.abstract
AB 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.