Hypercapnic Respiratory FailureETOUCHNCT03353064
Telemedicine for Improving Outcome in Inner City Patient Population With Hypercapneic Respiratory Failure
A study testing Vivify and EMS in people with Hypercapnic Respiratory Failure and Chronic Obstructive Pulmonary Disease, run by Albert Einstein Healthcare Network at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome
- What is being tested?
- Vivify and EMS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2017to 26 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, 19140
About this study
Official title: Telemedicine as a Proposed Solution Towards Efficiency of Healthcare Delivery for Einstein Pulmonary Patients on PAP/NIPPV for Hypercapnia
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.
Read the 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.
- Conditions
- Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome, Sleep Disordered Breathing, Neuromuscular Diseases
- Being tested
- Vivify, EMS
- Medical subject headings
- Respiratory Insufficiency, Pulmonary Disease, Chronic Obstructive, Obesity Hypoventilation Syndrome, Sleep Apnea Syndromes, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VivifyOther
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.
EMSOther
Emergency medical service scheduled home visits for face to face troubleshooting of the NIPPV, environmental check and end-tidal CO2.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Vivify |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (2)
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
Measured: every 2 weeks for duration of 6 weeks
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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start18 Oct 2017
- Primary completion26 Oct 2018
- Study completion26 Oct 2018
Why it stopped: inability to recruit subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hypercapnic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein Healthcare Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunil Sharma, Albert Einstein Healthcare Network
- Investigators
- Sunil Sharma, Principal investigator, Albert Einstein Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353064
- Sponsor's protocol ID
- ETOUCH Study
- Acronym
- ETOUCH
- Status last verified
- Oct 2018
- First submitted
- 5 Nov 2017
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26691510Riachy 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.
PubMed 27638725Taylor 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.
PubMed 16565867Turino 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.
PubMed 28179438Bruyneel M. Technical Developments and Clinical Use of Telemedicine in Sleep Medicine. J Clin Med. 2016 Dec 13;5(12):116. doi: 10.3390/jcm5120116.
PubMed 27983582
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine as a Proposed Solution Towards Efficiency of Healthcare Delivery for Einstein Pulmonary Patients on PAP/NIPPV for Hypercapnia
- ClinicalTrials.gov ID
- NCT03353064
- Acronym / sponsor ID
- ETOUCH / ETOUCH Study
- Conditions
- Hypercapnic Respiratory Failure, Chronic Obstructive Pulmonary Disease, Obesity Hypoventilation Syndrome, Sleep Disordered Breathing, Neuromuscular Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inability to recruit subjects
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Albert Einstein Healthcare NetworkUniversity, hospital or other
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 26 Oct 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Vivify + EMS | Active comparator | Other: Vivify, Other: EMSThis 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. |
| Vivify Only | Active comparator | Other: VivifyThis group will receive the telemedicine tablet and kit, with the same protocol as defined above. No EMS home visits will be set up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VivifyA 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 | Vivify + EMS, Vivify Only |
| EMSEmergency medical service scheduled home visits for face to face troubleshooting of the NIPPV, environmental check and end-tidal CO2. | Other | Vivify + EMS |
Primary outcome
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
2 secondary outcomes
SF-12 questionnaire
Time frame: every 2 weeks for duration of 6 weeks
NIV compliance
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: inability to recruit subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- BackgroundD'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: PubMed 26691510Konikkara 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.
- Background: PubMed 27638725Riachy 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.
- Background: PubMed 16565867Taylor 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.
- Background: PubMed 28179438Turino 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 publication: PubMed 27983582Bruyneel M. Technical Developments and Clinical Use of Telemedicine in Sleep Medicine. J Clin Med. 2016 Dec 13;5(12):116. doi: 10.3390/jcm5120116.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil Sharma principal investigator
Albert Einstein Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivify and EMS in people with Hypercapnic Respiratory Failure and Chronic Obstructive Pulmonary Disease, run by Albert Einstein Healthcare Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: inability to recruit subjects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day ED and Hospital readmission Rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03353064, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.