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Implementation of a Clinical Tool to Improve Waitlist Mortality in Patients With Cystic Fibrosis
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical Tool (Mobile Spirometry and Survey) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical Tool (Mobile Spirometry and Survey) | Other | 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. |
| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
| Through study completion, up to 1 year |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |