Cystic Fibrosis, Lung Transplant; Complications
Conditions
Brief summary
Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis
Detailed description
The aim of this project is to implement a clinical tool utilizing predictors of mortality for patients with Cystic Fibrosis (CF) on the waiting list to identify candidates that should present for urgent medical care and, if appropriate, will prompt clinicians to update a candidate's lung allocation score (LAS), the score used to prioritize lung transplant candidates for transplant by medical urgency, and avoid undetected decline. The clinical tool consists of home spirometry measures and patient reported outcomes that is completed weekly on a mobile application device used clinically to track spirometry.
Interventions
OTHERClinical Tool (Mobile Spirometry and Survey)
The clinical tool is a combination of home spirometry measurements and a patient survey measuring patient reported outcomes including the Cystic Fibrosis Respiratory Symptom Diary (CFRSD) and Chronic Respiratory Infection Symptom Score (CRISS©), with permission from the Seattle Quality of Life Group.
Sponsors
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Cystic Fibrosis * To be listed for lung transplant * Has purchased home spirometer
Exclusion criteria
* Diagnosis other than Cystic Fibrosis * Unable to read * Unable to use computer or smartphone device to access mobile application
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lung Allocation Score (LAS) | Through study completion, an average of 3-6 months (time spent on the lung transplant waiting list). | Change in LAS value at the first clinic visit triggered by the clinical tool |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to transplant | Through study completion, up to 1 year | Measured in days (time spent on the lung transplant waiting list) |
| Survival to transplant | Through study completion, up to 1 year | Binary outcome measure to indicate if individual survived to transplant |
Countries
United States
Outcome results
None listed