SBIR-STTR Award

Reducing Heart Failure Re-Admissions by Enhancing Sleep Apnea Treatment Adherence
Award last edited on: 3/1/22

Sponsored Program
SBIR
Awarding Agency
NIH : NHLBI
Total Award Amount
$1,264,187
Award Phase
2
Solicitation Topic Code
837
Principal Investigator
Eric M Heil

Company Information

AirCare Labs LLC

3641 Locust Walk 205 Colonial Penn Center
Philadelphia, PA 19104
   N/A
   info@aircareapp.com
   N/A
Location: Single
Congr. District: 03
County: Philadelphia

Phase I

Contract Number: 1R44HL124923-01
Start Date: 8/1/14    Completed: 1/31/15
Phase I year
2014
Phase I Amount
$148,972
Hospital re-admission can be devastating for patients and carries significant financial burdens for health care systems. In 2013, the recently implemented Medicare Hospital Readmissions Reduction Program imposed $227 million in penalties on 2,225 hospitals. Medicare has focused on heart failure diagnoses because it is one of the most common causes of admission and has the highest re-admission rate of any medical diagnosis. A growing body of research suggests that sleep apnea is a major predictor of heart failure re-admission; it is present in 50-80 percent of heart failure patients. Furthermore, preliminary research gathered by the University of Pennsylvania Sleep Center suggests that positive airway pressure (PAP) treatment of sleep apnea is associated with significantly reduced re-admission rates. However, adherence to sleep apnea treatment with PAP is poor, with only 30-40 percent of patients having adequate hours of use. This finding has led the study investigators to conclude that patients with heart failure recently discharged from the hospital are at increased risk of re-admission due to non-adherence with PAP. A potential solution for this major problem facing hospitals can be found in the AirCareLabs system. It offers an integrated care approach that includes telemedicine with video conferencing features delivered via tablet based communication that is initiated promptly in the peri-discharge period and continued at home. The study team proposes modifying this system for targeted care of sleep apnea patients through wireless real-time monitoring of pulse oximetry and PAP adherence, along with additional educational content, in order to significantly reduce readmission rates during the first month post discharge for patients with heart failure that are starting PAP therapy Key innovations include the ability for patients to receive at-home, night-time assistance with their PAP (remarkably, this is currently unavailable to patients), and a financial model in which costs for the application are covered by the health system as it seeks to avoid Medicare penalties, thus bypassing the limited fee-for-service approach that has curtailed innovation in the sleep apnea field. The proposed project includes a Phase I component that consists of modifying the AirCareLab system to integrate wireless pulse oximetry data, structured interviews to identify the optimal treatment approach to resolve patient care concerns, development of educational material for patients to access at home via the AirCareLab system, and a pilot clinical study in 20 study participants. The Phase II component includes further refining the oximetry data and integrating with PAP device data to create interpretive risk classification algorithms, and a large randomized controlled trial of 240 subjects to confirm efficacy. If successful, this project will create a new scalable model which can substantially reduce hospital readmission rates for heart failure.

Thesaurus Terms:
Acute;Adherence (Attribute);Admission Activity;Adopted;Algorithms;Base;Benchmarking;Breathing;Businesses;Bypass;Cardiovascular System;Care Delivery;Caring;Classification;Clinical Research;Commercialization;Communication;Communities;Compliance Behavior;Computer Software;Continuous Positive Airway Pressure;Cost;Data;Data Collection;Development;Devices;Diagnosis;Durable Medical Equipment;Educational Materials;Effectiveness;Elements;Equipment;Fee-For-Service Plans;Financial Incentive;Follow-Up;Goals;Health Personnel;Health System;Healthcare Systems;Heart Failure;Heart Function;Home Environment;Hospital Readmission;Hospitals;Hour;Humidifier;Improved;Innovation;Internet;Intervention;Interview;Investments;Link;Masks;Measures;Medical;Medicare;Modeling;Monitor;Novel;Oxygen Saturation Measurement;Oxyhemoglobin;Participant;Pathway Interactions;Patient Care;Patient Discharge;Patient Education;Patient Monitoring;Patients;Pennsylvania;Phase;Philadelphia;Physiologic Pulse;Pilot Projects;Point Of Care;Pressure;Process;Programs;Provider;Public Health Relevance;Pulse Oximetry;Randomized Controlled Trials;Research;Research Personnel;Risk;Services;Sleep;Sleep Apnea Syndromes;Sleep Disorders;Small Business Innovation Research Grant;Solutions;Structure;System;Tablets;Telehealth;Telehealth Systems;Telemedicine;Testing;Time;Treatment Adherence;Universities;Wireless Technology;

Phase II

Contract Number: 6R44HL124923-02
Start Date: 8/1/14    Completed: 1/31/15
Phase II year
2014
(last award dollars: 2016)
Phase II Amount
$1,115,215

Hospital re-admission can be devastating for patients and carries significant financial burdens for health care systems. In 2013, the recently implemented Medicare Hospital Readmissions Reduction Program imposed $227 million in penalties on 2,225 hospitals. Medicare has focused on heart failure diagnoses because it is one of the most common causes of admission and has the highest re-admission rate of any medical diagnosis. A growing body of research suggests that sleep apnea is a major predictor of heart failure re-admission; it is present in 50-80 percent of heart failure patients. Furthermore, preliminary research gathered by the University of Pennsylvania Sleep Center suggests that positive airway pressure (PAP) treatment of sleep apnea is associated with significantly reduced re-admission rates. However, adherence to sleep apnea treatment with PAP is poor, with only 30-40 percent of patients having adequate hours of use. This finding has led the study investigators to conclude that patients with heart failure recently discharged from the hospital are at increased risk of re-admission due to non-adherence with PAP. A potential solution for this major problem facing hospitals can be found in the AirCareLabs system. It offers an integrated care approach that includes telemedicine with video conferencing features delivered via tablet based communication that is initiated promptly in the peri-discharge period and continued at home. The study team proposes modifying this system for targeted care of sleep apnea patients through wireless real-time monitoring of pulse oximetry and PAP adherence, along with additional educational content, in order to significantly reduce readmission rates during the first month post discharge for patients with heart failure that are starting PAP therapy Key innovations include the ability for patients to receive at-home, night-time assistance with their PAP (remarkably, this is currently unavailable to patients), and a financial model in which costs for the application are covered by the health system as it seeks to avoid Medicare penalties, thus bypassing the limited fee-for-service approach that has curtailed innovation in the sleep apnea field. The proposed project includes a Phase I component that consists of modifying the AirCareLab system to integrate wireless pulse oximetry data, structured interviews to identify the optimal treatment approach to resolve patient care concerns, development of educational material for patients to access at home via the AirCareLab system, and a pilot clinical study in 20 study participants. The Phase II component includes further refining the oximetry data and integrating with PAP device data to create interpretive risk classification algorithms, and a large randomized controlled trial of 240 subjects to confirm efficacy. If successful, this project will create a new scalable model which can substantially reduce hospital readmission rates for heart failure.

Public Health Relevance Statement:


Public Health Relevance:
Sleep apnea, characterized by abnormal breathing at night, is often untreated in patients with heart failure. Helping patients to effectively use the most common form of treatment for sleep apnea, positive airway pressure therapy, can improve their heart function. This can reduce the likelihood that the patient will be re- admitted to the hospita. AirCareLabs has developed an innovative solution that allows patients to communicate with health care providers 24 hours a day, thus allowing them to get the help they need to effectively use positive airway pressure and thereby reduce the risk of being re-admitted to the hospital.

Project Terms:
No Project Terms available.