Telemedicine for Improving Outcome in Inner City Patient Population With Hypercapneic Respiratory Failure

Chronic Obstructive Pulmonary Disease Clinical Trial

— ETOUCH  

Official title:

Telemedicine as a Proposed Solution Towards Efficiency of Healthcare Delivery for Einstein Pulmonary Patients on PAP/NIPPV for Hypercapnia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03353064
• Other study ID #: ETOUCH Study
• Status: Terminated
• Phase: N/A
• Start date: October 18, 2017
• Est. completion date: October 26, 2018

Study information

• Verified date: October 2018
• Source: Albert Einstein Healthcare Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 26, 2018
• Est. primary completion date: October 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Hypercapnia
• Hypercapnic Respiratory Failure
• Hypoventilation
• Lung Diseases
• Lung Diseases, Obstructive
• Neuromuscular Diseases
• Obesity Hypoventilation Syndrome
• Pulmonary Disease, Chronic Obstructive
• Respiratory Insufficiency
• Sleep Disordered Breathing

Intervention

Other:
• Vivify
A telemedicine kit will (Vivify) which will obtain daily biometrics (vital signs) and care plans. These are all monitored by the Pulmonary team remotely via an online portal. The telemedicine system has a set-up for alerts whenever there are clinical concerns (vital signs out of parameters), or non-use of the Non-invasive positive pressure ventilation (NIPPV). This system allows for video conferencing between the Pulmonary team (physician, respiratory therapist, nurse) to troubleshoot issues, and increase NIPPV compliance.
• EMS
Emergency medical service scheduled home visits for face to face troubleshooting of the NIPPV, environmental check and end-tidal CO2.

Locations

Country	Name	City	State
United States	Albert Einstein Healthcare Network	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein Healthcare Network

Country where clinical trial is conducted

United States, 

References & Publications (6)

Bruyneel M. Technical Developments and Clinical Use of Telemedicine in Sleep Medicine. J Clin Med. 2016 Dec 13;5(12). pii: E116. Review. — View 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

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. — View 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. — View 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. — View Citation

Turino C, de Batlle J, Woehrle H, Mayoral A, Castro-Grattoni AL, Gómez S, Dalmases M, Sánchez-de-la-Torre M, Barbé F. Management of continuous positive airway pressure treatment compliance using telemonitoring in obstructive sleep apnoea. Eur Respir J. 2017 Feb 8;49(2). pii: 1601128. doi: 10.1183/13993003.01128-2016. Print 2017 Feb. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day ED and Hospital readmission Rate	Patients are followed from enrollment for the next 30 days. We will compare rate of re-admissions between the 2 parallel intervention arms, and check the p-value	30 days
Secondary	SF-12 questionnaire	The SF-12 questionnaire gives an assessment score of subject's mental and physician functioning and overall health-related quality of life. We will compare scores of subjects in the parallel intervention groups	every 2 weeks for duration of 6 weeks
Secondary	NIV compliance	This is a YES or NO determination of NIV compliance using the CMS (Centers of Medicare and Medicaid) criteria of at least 4hrs use of NIV per day, at least 70% of a 30-day period. We will compare the number of compliant against non-compliant subjects in the 2 parallel intervention groups	6 weeks