Clinical trial NCT03353064: Telemedicine for Improving Outcome in Inner City Patient Population With Hypercapneic Respiratory Failure
Official title: Telemedicine as a Proposed Solution Towards Efficiency of Healthcare Delivery for Einstein Pulmonary Patients on PAP/NIPPV for Hypercapnia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypercapnic Respiratory Failure
Chronic Obstructive Pulmonary Disease
Obesity Hypoventilation Syndrome
Sleep Disordered Breathing
Neuromuscular Diseases
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Hypercapnia Telemedicine Outreach Program (E-TOUCH Study) aims to utilize telemedicine technology, as well as emergency medical services (EMS) home visits to address the problem with poor follow-up and compliance among Einstein's hypercapnic patients.

The hypothesis is that reaching out to the subjects' homes will allow more consistent healthcare delivery, increase healthcare efficiency and compliance with therapy, and overall decrease acute decompensated states / hypercapnic respiratory failure, decreasing ED visits and hospitalization.

Detailed description: Hypercapnic respiratory failure is a prevalent medical problem, comprising a substantial number of ED visits and readmissions. The target population that are at high risk for developing hypercapnia are patients with obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), sleep disordered breathing (SDB) overlapping with COPD, and patients with neuromuscular disorders. These patients are commonly managed in the progressive care units or the intensive care unit for extended periods of time, which can over-utilize health systems resources. Einstein Medical Center's patient population includes multiple low-income communities / neighborhoods. Their educational background varies and constant education and counseling is an integral part of the treatment plan. These patients are particularly vulnerable due to a lack of geographic access and difficulty contacting healthcare providers via phone. Some of the patients may not be able to afford co-pays for clinic visits or are not able to follow up with a physician. In addition, patients treated with non-invasive ventilation in the hospital and require home therapy either never receive the device or are sub-optimally trained in its appropriate utilization. These patients may also be morbidly obese with mobility issues, which is another obstacle preventing patients from following up with their providers.

Positive airway pressure (PAP) therapy/ non-invasive positive pressure ventilation (NIPPV) are effective treatments to avoid acute hypercapnic respiratory failure; however, low compliance and poor follow-up are often recurring issues. These high-risk patients present in the emergency department acutely hypercapnic and encephalopathic with subsequent ICU admission and mechanical ventilation.This Telemedicine Outreach Program aims to utilize E-touch devices (Vivify-Go) in collaboration with home visits by EMS (Emergency medical services) to improve compliance and the efficiency of healthcare delivery. These efforts will hopefully lead to a decrease in acute decompensated respiratory states and hospital readmission rates.

Eligibility criteria: Inclusion Criteria:

* Adult patients \> 18 years of age
* Evidence of hypercapnia (PCO2 ≥ 45mmHg) secondary to COPD-OSA overlap, OHS, Neuromuscular disease / weakness
* Requiring NIV / NIPPV outpatient
* Ability to operate a smart device / tablet
* Informed consent

Exclusion Criteria:

* Non-English or Non-Spanish- speaking (device videos and surveys are available in English or Spanish only)
* Patients unable to give consent
* Pregnant women
* Prisoners
* Patients \<18 years of age
* Patient already on NIPPV/ CPAP at home and compliant on therapy
* Significant non-pulmonary conditions (CHF with EF \< 40%), Pulmonary hypertension with PASP\> 60 mmGH, severe valvular heart disease, end-stage renal disease or end-stage liver disease.
* Patients without health insurance
* Residing out of state (Pennsylvania)
* Patients with current or history of drug / narcotic dependence

Primary outcomes:
measure: 30-day ED and Hospital readmission Rate
timeFrame: 30 days
Secondary outcomes:
measure: SF-12 questionnaire
timeFrame: every 2 weeks for duration of 6 weeks
measure: NIV compliance
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Albert Einstein Healthcare Network
state: Pennsylvania
Study officials:
affiliation: Albert Einstein Medical Center
name: Sunil Sharma
role: PRINCIPAL_INVESTIGATOR
References:
citation: D'Cruz,Rebecca, Harman Saman, Olliver O'Sullivan, Norashikin Amran, Jumaa Bwika, Ben Beauchamp, Rahul Mukherjee. "Readmission and mortality after first hospital admission with acute hypercapnic respiratory failure (AHRF) requiring non-invasive ventilation (NIV)" European Respiratory Journal (2013) 42:P2490
citation: Konikkara J, Tavella R, Willes L, Kavuru M, Sharma S. Early recognition of obstructive sleep apnea in patients hospitalized with COPD exacerbation is associated with reduced readmission. Hosp Pract (1995). 2016;44(1):41-7. doi: 10.1080/21548331.2016.1134268. Epub 2016 Jan 20.
citation: Riachy M, Najem S, Iskandar M, Choucair J, Ibrahim I, Juvelikian G. Factors predicting CPAP adherence in obstructive sleep apnea syndrome. Sleep Breath. 2017 May;21(2):295-302. doi: 10.1007/s11325-016-1408-y. Epub 2016 Sep 16.
citation: Taylor Y, Eliasson A, Andrada T, Kristo D, Howard R. The role of telemedicine in CPAP compliance for patients with obstructive sleep apnea syndrome. Sleep Breath. 2006 Sep;10(3):132-8. doi: 10.1007/s11325-006-0059-9.
citation: Turino C, de Batlle J, Woehrle H, Mayoral A, Castro-Grattoni AL, Gomez S, Dalmases M, Sanchez-de-la-Torre M, Barbe F. Management of continuous positive airway pressure treatment compliance using telemonitoring in obstructive sleep apnoea. Eur Respir J. 2017 Feb 8;49(2):1601128. doi: 10.1183/13993003.01128-2016. Print 2017 Feb.
citation: Bruyneel M. Technical Developments and Clinical Use of Telemedicine in Sleep Medicine. J Clin Med. 2016 Dec 13;5(12):116. doi: 10.3390/jcm5120116.