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

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ClinicalTrials.gov Identifier: NCT03353064
Recruitment Status : Terminated (inability to recruit subjects)
First Posted : November 27, 2017
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Sunil Sharma, Albert Einstein Healthcare Network

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.


Condition or disease Intervention/treatment Phase
Hypercapnic Respiratory Failure Chronic Obstructive Pulmonary Disease Obesity Hypoventilation Syndrome Sleep Disordered Breathing Neuromuscular Diseases Other: Vivify Other: EMS Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Single (Outcomes Assessor)
Masking Description: Statisticians will be receiving de-identified data
Primary Purpose: Health Services Research
Official Title: Telemedicine as a Proposed Solution Towards Efficiency of Healthcare Delivery for Einstein Pulmonary Patients on PAP/NIPPV for Hypercapnia
Actual Study Start Date : October 18, 2017
Actual Primary Completion Date : October 26, 2018
Actual Study Completion Date : October 26, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Vivify + EMS
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
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.

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

Active Comparator: Vivify Only

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
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.




Primary Outcome Measures :
  1. 30-day ED and Hospital readmission Rate [ Time Frame: 30 days ]
    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 :
  1. SF-12 questionnaire [ Time Frame: every 2 weeks for duration of 6 weeks ]
    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

  2. NIV compliance [ Time Frame: 6 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353064


Locations
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United States, Pennsylvania
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, United States, 19140
Sponsors and Collaborators
Albert Einstein Healthcare Network
Investigators
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Principal Investigator: Sunil Sharma Albert Einstein Medical Center
Publications of Results:
Other Publications:
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Responsible Party: Sunil Sharma, Division Chair and Program Director of Pulmonary, Critical Care, Allergy and Sleep Medicine, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT03353064    
Other Study ID Numbers: ETOUCH Study
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity Hypoventilation Syndrome
Obesity
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Insufficiency
Sleep Apnea Syndromes
Hypoventilation
Neuromuscular Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Overnutrition
Nutrition Disorders