Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized COPD Patients
Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized COPD Patients
The purpose of this study is to determine whether early diagnosis of OSA and initiation of
 and adherence to CPAP therapy in patients hospitalized for chronic obstructive pulmonary
 disease reduce 30-day hospital readmission rates.
Our investigators propose a randomized clinical trial to test hospitalized patients (due to
 chronic obstructive pulmonary disease, COPD) for obstructive sleep apnea, then randomizing
 the patients with OSA into CPAP versus usual care. This study is designed to target a high
 risk population (hospitalized patients) and early initiation of therapy. Our investigators
 intend to enroll all consenting participants hospitalized with a primary COPD diagnosis. Our
 study is unique and the answer to its question - whether early diagnosis of OSA and
 initiation of and adherence to CPAP therapy in hospitalized COPD patients will reduce 30-day
 readmission rates - is unknown. The objective is twofold: to improve quality of care and
 decrease preventable hospitalizations through early diagnosis and implementation of this
 early diagnosis and intervention model for this subset of patients may slow progression of
 COPD, offset a large public health and financial burden, and improve overall outcomes.

 Our investigators believe that our study, which involves human subjects, is in accordance
 with general ethical principles. It should be noted that the diagnosis and subsequent
 treatment of OSA during hospitalization is not part of routine practice, and that the control
 group truly would follow "usual care". Moreover, patients who are deemed very sick (as
 outlined in the exclusion criteria) will be excluded from the study. Finally half of enrolled
 participants will receive early CPAP therapy which may potentially benefit those patients
 beyond what is currently "usual care".

 Study Design

 Our study is a single-center, randomized control trial designed to evaluate the impact of
 early diagnosis and treatment of obstructive sleep apnea (OSA) in hospitalized chronic
 obstructive pulmonary disease (COPD) patients on hospital readmission, symptoms, and
 healthcare utilization. Consecutive patients who meet inclusion criteria hospitalized with a
 primary diagnosis of COPD will be asked to participate in the study. Patients who agree and
 sign consent will undergo a portable sleep study to diagnose OSA-predominant sleep disordered
 breathing. Patients will also complete a questionnaire packet consisting of the following
 standardized questionnaires: sleep history questionnaire, Epworth Sleepiness Scale (ESS),
 Patient Recorded Outcome Measurement Information System (PROMIS), Chronic Obstructive
 Pulmonary Disease Assessment Tool (CAT), and STOP-BANG questionnaire. Each patient who meets
 inclusion criteria and consents to the study will undergo an inpatient portable sleep study
 (ApneaLink, Resmed Corp). This is a Type III study which is an unattended study that measures
 nasal pressure, respiratory effort, oxygen saturation, and body position. A study
 investigator will apply the portable device, and a board-certified sleep medicine physician
 (co-investigators) will interpret these studies. The study will be performed while the
 patient is on room air (not on oxygen), thus the study may not be applied on the first
 hospitalized night (if oxygen therapy is required) but delayed until the patient is
 appropriate to be off oxygen.

 A diagnosis of OSA will be made if the apnea-hypopnea index with 4% oxygen desaturation is
 greater than 5 (AHI4%≥5) with at least 50% of events consistent with obstructive rather than
 central physiology. Study participants with OSA will then be randomized into one of two
 pathways: Intervention Pathway and Usual Care Pathway.

 Intervention Pathway Patients will receive CPAP therapy in the hospital followed by home CPAP
 therapy. A sleep center respiratory therapy/sleep technologist case manager will perform a
 bedside mask fit, CPAP education, and set up their outpatient follow-up appointments with the
 sleep center. Their home CPAP therapy will be a loaner from the sleep medicine department
 that includes wireless connectivity so that adherence data is available to the investigators
 throughout the duration of the study. Furthermore, the patients will be entered into our
 usual automated platform (USleep; ResMed Corp) in which patients with suboptimal CPAP use
 will be sent messages (email or text based on patient preference) in order to ensure
 adherence to therapy. This platform is already a standard part of our usual care.

 The patients will receive CPAP in addition to the contemporary standard of care
 pharmacotherapy for their underlying cardiac condition(s). They will be asked to follow up at
 the Fontana Sleep Center within 1 month after discharge for assessment of CPAP use and asked
 to complete the aforementioned questionnaire packet (with the exception of the STOP BANG
 questionnaire). Patients will also be asked to follow up within 30 days after discharge for
 assessment of CPAP use and asked to complete the aforementioned questionnaire packet.
 Patients will be followed during the 30-day period and assessed for readmission rates, time
 to readmission, adherence to CPAP therapy, and presence of symptoms. During the 1 month
 follow-up appointment, the sleep center will troubleshoot CPAP use when appropriate;
 otherwise, requests for additional troubleshooting will be at the discretion of the patient
 (as is currently our usual care).

 Usual Care Pathway Patients will receive contemporary standard of care pharmacotherapy for
 their underlying cardiac condition(s) and will not receive CPAP therapy for the duration of
 the study. They will be asked to follow up at the Fontana Sleep Center within 1 month after
 discharge for a repeat outpatient portable sleep study and asked to complete the
 aforementioned questionnaire packet (with the exception of the STOP BANG questionnaire). The
 results of the outpatient portable sleep studies will be compared with the in-patient
 portable sleep study. Patients will also be asked to follow up with the Fontana Sleep Center
 within 30 days after discharge for assessment of primary and secondary outcomes. Patients
 will be followed during the 30-day period and assessed for readmission rates, time to
 readmission, adherence to CPAP therapy, and presence of symptoms.
Inclusion Criteria:

 -  Kaiser Permanente member

 -  Males or females, any race, and age 18 and older

 -  OSA-predominant (AHI at or above 5) sleep disordered breathing

 -  Primary diagnosis upon admission of chronic obstructive pulmonary disease

 -  Appropriate to perform portable sleep study while on room air (no oxygen)

 -  Patients who are able and willing to give informed consent

 Exclusion Criteria:

 -  Use of CPAP within 6 months of enrollment

 -  Patients with CSA-predominant sleep disordered breathing

 -  Patients who are "sleepy": ESS at or above 11

 -  Commercial driver's license or other occupational hazards (operating heavy machinery)

 -  Non-English speaking (validated questionnaires are currently limited to English)

 -  Patients with chronic respiratory failure requiring oxygen therapy or non-invasive
 ventilation.

 -  Patients requiring tracheostomy

 -  Pregnant patients