Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

— COPD Readmit  

Official title:

The Impact of Early Diagnosis and Treatment of OSA on Hospital Readmission in Hospitalized Chronic Obstructive Pulmonary Disease Patients: the COPD Readmit Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03647462
• Other study ID #: KPSleep-004
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: April 2025

Study information

• Verified date: July 2022
• Source: Kaiser Permanente
• Contact: Dennis Hwang, MD
• Phone: 909-427-4432
• Email: dennis.x.hwang[@]kp.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Obstructive Sleep Apnea
• Pulmonary Disease, Chronic Obstructive
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Continuous Positive Airway Pressure
CPAP is an FDA approved therapy machine for patients diagnosed with OSA. CPAP provides positive air pressure to the patients throat to ensure the patients airway stays open during sleep. CPAP is the gold standard treatment for OSA, but there is limited research that demonstrates whether CPAP can improve clinical outcomes in patients with COPD. Therefore, our investigators want to initiate CPAP therapy in patients hospitalized for COPD to investigate whether there is an improvement in cardiac function and clinical outcomes (i.e. mortality).

Locations

Country	Name	City	State
United States	Sleep Center; San Bernardino County Medical Center, Kaiser Permanente	Fontana	California

Sponsors (1)

Lead Sponsor	Collaborator
Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital readmission and mortality rates	Number of occasions patient has been admitted to the hospital and number of patients who have died	30 days
Secondary	Clinic and urgent care visits	Appointments with any medical providers (sleep, cardiac, primary) at a clinic or urgent care facility	30 days
Secondary	Off work orders	Note from provider ordering/requesting patient to be dismissed from work for medical reasons (sick, injured, etc.)	30 days
Secondary	STOP BANG	Snoring, tiredness, observed apnea, blood pressure, body mass index, age, neck circumference, and gender (STOP BANG) is the name of a OSA screening questionnaire. Questionnaire contains 8 "Yes/No" questions and the number of "Yes" answers provide a total score (range 0-8). Patients that answer "Yes" to 3-4 questions are typically considered to be at intermediate risk of OSA.	30 days
Secondary	Epworth Sleepiness Scale (ESS)	Epworth Sleepiness Scale measures degree of sleepiness. 8 scenarios are described and the responder indicates their likelihood of dozing unintentionally (range 0-3). A total of the scores are added (range 0-24) and typically scores of at least 11 indicate excessive sleepiness.	30 days
Secondary	Patient Reported Outcome Measurement Information System (PROMIS)	Patient Reported Outcome Measurement Information System is a 10 item questionnaire that measures physical, mental, and social health in adults. It can be used on the general population and patients with chronic conditions. Patients rate their health based on a severity scale of 1-5 (1 indicates poor health) and the scoring system allows each question/item to be evaluated separately.	30 days
Secondary	Chronic Obstructive Pulmonary Disease Assessment Tool (CAT)	Chronic Obstructive Pulmonary Disease (COPD) Assessment Tool is a questionnaire that measures the impact the disease has on patients well being and daily life. There are 8 questions that ask about common symptoms COPD patients experience and the patient indicates their severity (range 0-5). A total of the scores are added (range 0-40) and scores of at least 30 indicate that their COPD has a very high level of impact on their daily lives.	30 days
Secondary	Comparing inpatient portable monitor versus 30-day follow up portable monitor results in usual care group	Evaluating the change of sleep diagnostic test results from the hospital to 1-month after being discharged (only for patients enrolled in the Usual Care pathway)	30 days