Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis

Study Overview
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Brief Summary
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Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis

Detailed Description
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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.

Official Title
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Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis

Conditions
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Cystic Fibrosis, Lung Transplant; Complications

Intervention / Treatment
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* Other: Clinical Tool (Mobile Spirometry and Survey)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical Tool (Mobile Spirometry and Survey)<br>All subjects enrolled will be placed into the clinical tool arm. The clinical tool is comprised of a mobile application based assessment of home spirometry and a survey measuring patient reported outcomes. | Other: Clinical Tool (Mobile Spirometry and Survey)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Allocation Score (LAS) | Change in LAS value at the first clinic visit triggered by the clinical tool | Through study completion, an average of 3-6 months (time spent on the lung transplant waiting list). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to transplant | Measured in days (time spent on the lung transplant waiting list) | Through study completion, up to 1 year | 
| Survival to transplant | Binary outcome measure to indicate if individual survived to transplant | Through study completion, up to 1 year |