Individuals with cystic fibrosis (CF) are plagued by daily respiratory symptoms such as cough and dyspnea. In spite of dramatic improvements in care, their lives are greatly shortened due to progressive respiratory failure. The course of CF is marked by recurrent pulmonary exacerbations characterized by worsened symptoms and declines in pulmonary function. CF acute pulmonary exacerbations result in more rapid decline in lung function and increased. Preliminary data from our groups suggest that delays in seeking care are associated with lack of recovery of lung function after an exacerbation. The primary goal of this proposal is to perform a clinical trial to determine the efficacy of early intervention in the treatment of adolescent and adult CF acute pulmonary exacerbation. The study will assess the integration of two novel approaches to the treatment of CF pulmonary exacerbation: 1) the use of home spirometers to identify and trigger treatment of an exacerbation;and 2) the use of home based assessment of patient symptoms to identify and trigger the treatment of a pulmonary exacerbation, both integrated into one protocolized care plan. This novel approach will be compared to usual care with the primary outcome measure being lung function as measured with forced expiratory volume in the first second (FEV1). We hypothesize that if pulmonary exacerbations are treated earlier with a multi-faceted intervention, the progression of lung disease will be slowed. This approach will utilize state of the art, telehealth equipment to improve the assessment and delivery of care to adolescents and adults with CF.

Public Health Relevance

The primary goal of this proposal is to perform a clinical trial to determine the efficacy of early intervention in the treatment of adolescent and adult CF acute pulmonary exacerbation using remote monitoring with home spirometry and respiratory symptom assessment and protocolized management of CF exacerbation. This approach will utilize state of the art, telehealth equipment to improve the assessment and delivery of care to adolescents and adults with CF.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL103965-04
Application #
8534241
Study Section
Respiratory Integrative Biology and Translational Research Study Section (RIBT)
Program Officer
Banks-Schlegel, Susan P
Project Start
2010-09-27
Project End
2015-06-30
Budget Start
2013-07-01
Budget End
2014-06-30
Support Year
4
Fiscal Year
2013
Total Cost
$706,945
Indirect Cost
$76,665
Name
University of Washington
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
605799469
City
Seattle
State
WA
Country
United States
Zip Code
98195
Ortiz, Justin R; Neuzil, Kathleen M; Shay, David K et al. (2014) The burden of influenza-associated critical illness hospitalizations. Crit Care Med 42:2325-32
Staudinger, Benjamin J; Muller, Jocelyn Fraga; Halldórsson, Skarphéðinn et al. (2014) Conditions associated with the cystic fibrosis defect promote chronic Pseudomonas aeruginosa infection. Am J Respir Crit Care Med 189:812-24
Kim, Richard; Goss, Christopher H (2014) Unintended consequences of therapy in the intensive care unit. JAMA Intern Med 174:574-6
Lechtzin, N; West, N; Allgood, S et al. (2013) Rationale and design of a randomized trial of home electronic symptom and lung function monitoring to detect cystic fibrosis pulmonary exacerbations: the early intervention in cystic fibrosis exacerbation (eICE) trial. Contemp Clin Trials 36:460-9
Goss, Christopher H; Ratjen, Felix (2013) Update in cystic fibrosis 2012. Am J Respir Crit Care Med 187:915-9
Goss, Christopher H; Tefft, Nathan (2013) Comparative effectiveness research - what is it and how does one do it? Paediatr Respir Rev 14:152-6
Goss, Christopher H; Mayer-Hamblett, Nicole (2013) The yin and yang of indoor airborne exposures to endotoxin. Am J Respir Crit Care Med 188:1181-3
Goss, Christopher H; Carson, Shannon S (2011) Is severe sepsis associated with new-onset atrial fibrillation and stroke? JAMA 306:2264-6
Goss, Christopher H (2011) Comparative effectiveness research: what happened to incorporating costs of care? Am J Respir Crit Care Med 183:973-4