Clinical trial NCT03647891: Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized Cardiac Patients
Official title: The Impact of Early Diagnosis and Treatment of Obstructive Sleep Apnea on Hospital Readmission in Hospitalized Cardiac Patients: the CV Readmit Clinical Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: OSA
Heart Failure
Myocardial Infarction
Arrhythmia, Cardiac
Keywords: obstructive sleep apnea
CPAP
hospital readmission
heart failure
myocardial infarction
cardiac arrhythmia
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether early diagnosis of obstructive sleep apnea and initiation of and adherence to CPAP therapy in hospitalized cardiac patients would impact 30-day hospital readmission rates.

Detailed description: Study investigators have designed a single-center, randomized control trial to evaluate the impact of early diagnosis and treatment of obstructive sleep apnea (OSA) in hospitalized cardiac patients on hospital readmission, symptoms, and healthcare utilization. This study targets a high risk population (hospitalized cardiac patients) and targets early initiation of continuous positive airway pressure (CPAP) therapy in patients diagnosed with OSA. Investigators intend to enroll all consenting participants hospitalized with a primary cardiac diagnosis, which include congestive heart failure, arrhythmia's, and acute coronary syndromes. The study is unique and the answer to its question - whether early diagnosis of OSA and initiation of and adherence to CPAP therapy in hospitalized cardiac 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 cardiac disease, offset a large public health and financial burden, and improve overall outcomes.

Study investigators believe that the study, which involves human subjects, is in accordance with general ethical principles. It should be noted that 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

The 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 cardiac patients on hospital readmission, symptoms, and healthcare utilization. Consecutive patients who meet inclusion criteria hospitalized with a primary diagnosis of heart failure, arrhythmia, or acute coronary syndrome 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), EQ5D-5L, and PROMIS 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). During the 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). In addition, patients will receive a $50 stipend for participation in the study. Patients will be assessed for readmission rates, time to readmission, adherence to CPAP therapy, and presence of symptoms at the 1-month period

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. At the one-month follow up appointment, patients will receive a $50 stipend for participation in the study. Patients will be assessed for readmission rates, time to readmission, adherence to CPAP therapy, and presence of symptoms at the 1-month period

Eligibility criteria: Inclusion Criteria:

* Kaiser Permanente member
* Males or female, any race, and age 18 and older
* OSA-predominant (AHI at or above 5) sleep disordered breathing
* Primary diagnosis upon admission of congestive heart failure, acute coronary syndrome, or arrhythmias
* Congestive heart failure (Acute or acute on chronic systolic heart failure, Acute or acute on chronic diastolic heart failure)
* Acute coronary syndrome (ST segment elevation myocardial infarction, Non-ST segment myocardial infarction, Unstable angina)
* Arrhythmias (Tachyarrhythmias, Atrial fibrillation, Atrial flutter, Bradyarrhythmias, Sinus bradycardia, 2nd degree atrioventricular block, Complete heart block)
* 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

Primary outcomes:
measure: Hospital readmission
timeFrame: 30 days
measure: Mortality rates
timeFrame: 30 days
Secondary outcomes:
measure: Clinic and urgent care visits
timeFrame: 30 days
measure: Off work orders
timeFrame: 30 days
measure: STOP BANG
timeFrame: 30 days
measure: Epworth Sleepiness Scale (ESS)
timeFrame: 30 days
measure: EQ5D-5L
timeFrame: 30 days
measure: PROMIS
timeFrame: 30 days
measure: Comparing inpatient portable monitor versus 30-day follow up portable monitor results in usual care group
timeFrame: 30 days
Other outcomes:
Locations:
city: Fontana
country: United States
facility: Sleep Center; San Bernardino County Medical Center, Kaiser Permanente
state: California
Study officials:
affiliation: Fontana Medical Center, Kaiser Permanente
name: Dennis Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References: