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

NCT03353064 | Terminated

• 1 other identifier: ETOUCH Study
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercapnic Respiratory Failure; Chronic Obstructive Pulmonary Disease; Obesity Hypoventilation Syndrome; Sleep Disordered Breathing; Neuromuscular Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• SF-12 questionnaire

  every 2 weeks for duration of 6 weeks

• NIV compliance

  6 weeks

Study Arms (2)

Vivify + EMS

ACTIVE COMPARATOR

This arm will have the Telemedicine kits and get scheduled EMS home visits. The subjects will complete daily biometrics / surveys / care plans through the telemedicine kit, as specified in the activity schedule Apart from the tablet device, EMS home visits will be scheduled on Day 7, Day 21 and Day 42 from discharge. During these home visits, the EM personnel will perform a check of the NIV/NIPPV device. They are able to adjust pressures according to your Pulmonologist / Sleep doctor's prescription, and troubleshoot any issues with the mask, the humidifier, etc. They will also measure End-tidal CO2 via nasal cannula.

Other: Vivify; Other: EMS

Vivify Only

ACTIVE COMPARATOR

This group will receive the telemedicine tablet and kit, with the same protocol as defined above. No EMS home visits will be set up

Other: Vivify

Interventions

Vivify OTHER

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.

Vivify + EMS; Vivify Only

EMS OTHER

Emergency medical service scheduled home visits for face to face troubleshooting of the NIPPV, environmental check and end-tidal CO2.

Vivify + EMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, 19140, United States

Location

Related Publications (6)

• 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

  BACKGROUND

• 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.

  PMID: 26691510 BACKGROUND

• 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.

  PMID: 27638725 BACKGROUND

• 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.

  PMID: 16565867 BACKGROUND

• 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.

  PMID: 28179438 BACKGROUND

• 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.

  PMID: 27983582 RESULT

MeSH Terms

Conditions

Respiratory Insufficiency; Pulmonary Disease, Chronic Obstructive; Obesity Hypoventilation Syndrome; Sleep Apnea Syndromes; Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea, Obstructive; Apnea; Hypoventilation; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Sunil Sharma

  Albert Einstein Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statisticians will be receiving de-identified data
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chair and Program Director of Pulmonary, Critical Care, Allergy and Sleep Medicine

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: November 5, 2017
• First Posted: November 27, 2017
• Study Start: October 18, 2017
• Primary Completion: October 26, 2018
• Study Completion: October 26, 2018
• Last Updated: October 29, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)