Telehealth Support for Artificial Respiration

(TEACH Trial)

Recruiting at 12 trial locations

Overseen By Colin Grissom, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Intermountain Health Care, Inc.

Disqualifiers: Brain death, Died within 24 hours

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

13400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding telehealth support (remote healthcare using technology) can improve care for patients on mechanical ventilation in the ICU. The researchers aim to determine if this additional telehealth support facilitates more effective administration of breathing breaks, known as spontaneous awakening and breathing trials, and enhances overall recovery. The trial includes two groups: one will receive usual care with added telehealth support (Telehealth-enabled support for SAT/SBT adherence), and the other will receive usual care without the extra support. It is suitable for ICU patients aged 16 or older who are currently on a breathing machine. As an unphased trial, this study allows patients to contribute to innovative care improvements in the ICU setting.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that telehealth-enabled support for SAT/SBT adherence is safe for mechanically ventilated patients?

Research has shown that telehealth support is generally safe for patients. It ensures that important hospital procedures, such as waking patients and assisting them in breathing independently, are properly followed. This method provides healthcare teams with immediate feedback, enhancing patient care without adding extra risks. So far, studies have not identified any major negative effects from using telehealth in this manner. The primary goal is to improve patient outcomes by ensuring that care plans are closely followed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the telehealth-enabled support for SAT/SBT adherence because it introduces a new way to enhance patient care remotely. Unlike traditional methods that rely solely on in-person audits and feedback, this approach integrates telehealth technology to provide continuous support and monitoring. This could lead to improved adherence to SAT/SBT protocols, potentially resulting in better patient outcomes and more efficient healthcare delivery. By leveraging telehealth, the approach offers a promising solution to bridge gaps in care, especially in settings with limited resources or for patients who are geographically distant from healthcare facilities.

What evidence suggests that telehealth-enabled support is effective for improving outcomes in mechanically ventilated patients?

Research has shown that telehealth support can help healthcare providers better adhere to daily routines for patients on ventilators. This trial will compare two approaches: one group will receive telehealth-enabled support along with the usual audit and feedback for SAT/SBT adherence, while the other group will receive only the usual audit and feedback. Sticking to routines, such as waking patients and testing their breathing, can lead to better outcomes. Studies have found that adding telehealth to regular care helps maintain these routines. Early findings suggest this approach might lead to benefits like shorter time on ventilators and possibly better recovery. Real-time feedback and support through telehealth can significantly improve patient care. ^{1 2 3 5 6}

Who Is on the Research Team?

Colin Grissom, MD

Principal Investigator

Intermountain Health Care, Inc.

Are You a Good Fit for This Trial?

This trial is for patients aged 16 or older who are in the ICU and on artificial breathing support. It's not for those who passed away within a day of being put on a ventilator or were already brain dead when admitted for organ donation.

Inclusion Criteria

I am on a breathing machine.

I am 16 or older and currently in the ICU of the study hospital.

Exclusion Criteria

Patient who died within 24 hours of intubation

Patient with pre-existing brain death admitted to study hospital for organ donation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive coordinated spontaneous awakening and breathing trials with telehealth-enabled support or usual audit and feedback

5 days

Daily monitoring during intubation

Follow-up

Participants are monitored for ventilator-free days and other clinical outcomes

28 days

What Are the Treatments Tested in This Trial?

Interventions

• Telehealth-enabled support for SAT/SBT adherence
• Usual audit and feedback for SAT/SBT adherence

Trial Overview The study is testing if adding telehealth support to regular check-ups improves how well clinicians stick to protocols for waking up and breathing trials, which could lead to better outcomes for patients on ventilators.

How Is the Trial Designed?

Group I: Intervention - Telehealth- enabled support plus usual audit and feedback for SAT/SBT adherence Experimental Treatment 2 Interventions

Usual audit and feedback + telehealth-enabled support

Group II: Control - Usual audit/feedback for SAT/SBT adherence only Active Control 1 Intervention

Usual audit and feedback

Who Is Running the Clinical Trial?

Intermountain Health Care, Inc.

Lead Sponsor

Trials

142

Recruited

1,965,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Published Research Related to This Trial

The Adherence Enhancement Internet Program (AEIP) was developed to improve long-term adherence to home monitoring among lung transplant recipients, addressing the common decline in adherence over time.

A feasibility trial with 12 lung transplant recipients showed that participants found the AEIP easy to use and acceptable, indicating it could be an effective tool for maintaining adherence to monitoring protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The design of an Internet-based system to maintain home monitoring adherence by lung transplant recipients. Karl, BC., Finkelstein, SM., Robiner, WN.[2019]

A web-based automated telehealth messaging program for patients with obstructive sleep apnea (OSA) showed similar adherence and effectiveness to standard care, with no significant differences in CPAP usage or apnea-hypopnea index between the two groups.

The telehealth program significantly reduced the coaching labor required by 59%, indicating a more efficient approach to patient support without compromising treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A telehealth program for CPAP adherence reduces labor and yields similar adherence and efficacy when compared to standard of care. Munafo, D., Hevener, W., Crocker, M., et al.[2022]

Home telemonitoring technology significantly improved patient satisfaction and empowerment among patients with chronic obstructive pulmonary disease (COPD), as shown in a study comparing 23 telemonitoring patients to 23 traditional homecare patients.

While telemonitoring positively impacted patients' quality of life, it did not lead to expected savings in healthcare resources, indicating that simply implementing technology is not enough; a more comprehensive reorganization of care practices is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of home telemonitoring to support improved care for chronic obstructive pulmonary diseases. Sicotte, C., Paré, G., Morin, S., et al.[2019]

A home-based interactive telehealth program for patients with chronic obstructive pulmonary disease (COPD) enhances access to pulmonary rehabilitation, making it easier for patients to participate in necessary care.

This telehealth approach also helps reduce travel costs for patients, making treatment more affordable and convenient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Pulmonary Rehabilitation for Patients With Severe Chronic Obstructive Pulmonary Disease. Bryant, MS., Bandi, VD., Nguyen, CK., et al.[2020]

The study involved 10 pediatric patients with persistent asthma who used an Internet-based telehealth system to monitor their medication adherence and asthma control, showing significant improvement in inhaler technique scores during the second study period.

Caregivers reported improved quality of life for patients in the virtual education group, and the telehealth system effectively reduced emergency department visits and hospital admissions, indicating its efficacy and acceptance among users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Internet-based store-and-forward video home telehealth system for improving asthma outcomes in children. Chan, DS., Callahan, CW., Sheets, SJ., et al.[2019]

A scoping review of 15 articles identified various care technologies aimed at improving medication adherence in organ transplant patients, with a focus on post-transplant settings.

The study highlights the need for patient-specific adaptations and training for these technologies, emphasizing that successful adherence interventions should also consider other aspects of post-transplant care beyond just medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Care Technologies to Improve Treatment Adherence in Patients Undergoing Organ Transplant: A Scoping Review. da Silva, AM., Knihs, NS., Sens, S., et al.[2022]

The pilot study involving 10 adolescent heart transplant recipients showed that an asynchronous Directly Observed Therapy (DOT) mHealth application was highly acceptable and feasible, with 90.1% of medication adherence videos submitted by patients.

Although the study indicated a 21.7% decrease in medication non-adherence after 12 weeks, the results were not statistically significant due to the small sample size, suggesting that further research is needed to confirm the effectiveness of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Directly observed therapy to promote medication adherence in adolescent heart transplant recipients. Killian, MO., Clifford, S., Lustria, MLA., et al.[2022]

Self-testing spirometry by asthma patients at home is valid and produces results comparable to those obtained under professional supervision, indicating that patients can effectively monitor their condition independently.

Despite many patients lacking computer experience, a significant majority found the telemonitoring system easy to use and expressed strong interest in continuing its use for asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-based home asthma telemonitoring: can patients handle the technology? Finkelstein, J., Cabrera, MR., Hripcsak, G.[2019]

The use of an interactive phone telesystem significantly improved adherence to Written Action Plans in COPD patients, leading to faster recovery from exacerbations, as shown in a study involving 40 patients over one year.

A larger implementation of the telesystem with 256 patients resulted in a notable reduction in respiratory-related emergency room visits and COPD-related hospitalizations, indicating enhanced self-management and reduced healthcare utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovating the treatment of COPD exacerbations: a phone interactive telesystem to increase COPD Action Plan adherence. Farias, R., Sedeno, M., Beaucage, D., et al.[2020]

Telehealth is generally well-received by patients with amyotrophic lateral sclerosis (ALS) and their caregivers, particularly for monitoring respiratory function, as indicated by a review of 16 studies.

However, healthcare professionals face barriers such as negative attitudes towards telehealth due to lack of personal contact and technical issues, along with financial challenges like reimbursement and cost-effectiveness, which may hinder its broader implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current use of telehealth in ALS care and the barriers to and facilitators of implementation: a systematic review. Helleman, J., Kruitwagen, ET., van den Berg, LH., et al.[2021]

Counties with limited access to liver disease specialty care experience higher liver-related mortality rates, particularly in rural areas that are far from transplant centers and lack local gastroenterology services.

Many residents in these high-need areas also lack access to necessary technology, such as devices and high-speed internet, which could hinder the effectiveness of telehealth strategies aimed at improving care access.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Access to technology to support telehealth in areas without specialty care for liver disease. Henson, JB., Wegermann, K., Patel, YA., et al.[2023]

A new Internet-based self-management program called 'Teens Taking Charge: Managing My Transplant Online' was developed for adolescents with solid organ transplants (SOT) to improve medication adherence and self-management skills, based on feedback from 21 participants aged around 15 years.

The initial usability testing showed that participants found the program's content trustworthy and helpful, particularly the peer experience videos, although they suggested improvements for easier navigation, indicating the program's potential to enhance self-management among teens with SOT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability testing of the Internet program: "Teens Taking Charge: Managing My Transplant Online". Korus, M., Cruchley, E., Stinson, JN., et al.[2019]

In a study of 269 lung transplant recipients, 59.4% were found to be non-adherent to regular self-monitoring of lung function, with forgetfulness, lack of time, and a good self-perception of health being the main reasons for this non-adherence.

Factors contributing to non-adherence included low perceived support from the transplant center and patient organizations, as well as a history of infections and rejections, highlighting the need for improved support systems to enhance patient compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significance of patient self-monitoring for long-term outcomes after lung transplantation. Kugler, C., Gottlieb, J., Dierich, M., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05141396

NCT05141396 | Telehealth-Enabled, Real-time Audit and ... This cluster-randomized hybrid implementation/effectiveness trial will compare C-SAT/SBT adherence and clinical outcomes in the presence of traditional audit ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37735443/

Implementation of coordinated spontaneous awakening and ... The TEACH study aims to improve coordinated spontaneous awakening and breathing trials in ICU patients using telehealth-enabled real-time audit ...

3. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-023-01303-1

Implementation of coordinated spontaneous awakening and ... The telehealth-enabled, real-time audit and feedback for clinician adherence (TEACH) study will determine whether adding a telehealth augmented ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10559139/

Awakening and Breathing Coordination: A Mixed-Methods ... The purpose of this study was to measure variation in adherence to consistent daily coordinated SAT/SBT use across 15 ICUs in an integrated, community- based ...

5. researchgate.net researchgate.net/publication/372163724_Awakening_and_breathing_coordination_A_mixed-methods_analysis_of_determinants_of_implementation

A Mixed-Methods Analysis of Determinants of Implementation ... (SAT/SBT) improves outcomes for mechanically ventilated patients, but adherence varies. ... The telehealth-enabled support (TEACH) intervention in ...

6. journals.lww.com journals.lww.com/ccmjournal/fulltext/2025/01001/413__active_telemedicine_feedback_enhances.366.aspx

413: active telemedicine feedback enhances spontaneous ... A telemedicine feedback intervention enhanced SBT adherence selectively in ICUs that did not have a bedside intensivist.