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

Primary Purpose

Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vivify
EMS
Sponsored by
Albert Einstein Healthcare Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Hypercapnic Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Albert Einstein Healthcare Network

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Vivify + EMS

Vivify Only

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
November 5, 2017
Last Updated
October 26, 2018
Sponsor
Albert Einstein Healthcare Network
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1. Study Identification

Unique Protocol Identification Number
NCT03353064
Brief Title
Telemedicine for Improving Outcome in Inner City Patient Population With Hypercapneic Respiratory Failure
Acronym
ETOUCH
Official Title
Telemedicine as a Proposed Solution Towards Efficiency of Healthcare Delivery for Einstein Pulmonary Patients on PAP/NIPPV for Hypercapnia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
inability to recruit subjects
Study Start Date
October 18, 2017 (Actual)
Primary Completion Date
October 26, 2018 (Actual)
Study Completion Date
October 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein Healthcare Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome, Sleep Disordered Breathing, Neuromuscular Diseases

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Outcomes Assessor
Masking Description
Statisticians will be receiving de-identified data
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vivify + EMS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Vivify Only
Arm Type
Active Comparator
Arm Description
This group will receive the telemedicine tablet and kit, with the same protocol as defined above. No EMS home visits will be set up
Intervention Type
Other
Intervention Name(s)
Vivify
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
EMS
Intervention Description
Emergency medical service scheduled home visits for face to face troubleshooting of the NIPPV, environmental check and end-tidal CO2.
Primary Outcome Measure Information:
Title
30-day ED and Hospital readmission Rate
Description
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
Time Frame
30 days
Secondary Outcome Measure Information:
Title
SF-12 questionnaire
Description
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
Time Frame
every 2 weeks for duration of 6 weeks
Title
NIV compliance
Description
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
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunil Sharma
Organizational Affiliation
Albert Einstein Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein Healthcare Network
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
Results Reference
background
PubMed Identifier
26691510
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.
Results Reference
background
PubMed Identifier
27638725
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.
Results Reference
background
PubMed Identifier
16565867
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.
Results Reference
background
PubMed Identifier
28179438
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.
Results Reference
background
PubMed Identifier
27983582
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.
Results Reference
result

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

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