Telehealth Support for Artificial Respiration

(TEACH Trial)

Recruiting at10 trial locations

Overseen by Colin Grissom, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Intermountain Health Care, Inc.

Disqualifiers: Brain death, Died within 24 hours

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a telehealth system called 'TEACH' to help doctors and nurses better manage the process of waking up and helping patients on ventilators breathe on their own. The goal is to improve patient outcomes by making it easier for healthcare providers to follow best practices.

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 data supports the effectiveness of the treatment Telehealth-enabled support for SAT/SBT adherence?

Research shows that telehealth technologies can improve adherence to treatment plans, as seen in studies with lung transplant recipients and COPD patients. These technologies help maintain high levels of adherence by providing immediate feedback, reminders, and simplifying communication between patients and healthcare providers. ^{1 2 3 4 5}

Is telehealth support for artificial respiration generally safe for humans?

The research on telehealth systems for managing conditions like asthma and transplant adherence shows that these systems are generally well-accepted and safe, with participants finding them helpful and easy to use. No significant safety concerns were reported in the studies, and participants often experienced improved adherence and satisfaction with the telehealth interventions. ^{1 6 7 8 9}

How is the Telehealth-enabled support for SAT/SBT adherence treatment different from other treatments for artificial respiration?

The Telehealth-enabled support for SAT/SBT adherence treatment is unique because it uses telehealth technology to enhance adherence to artificial respiration protocols by providing immediate feedback, reminders, and educational support, which can help maintain high adherence levels over time, unlike traditional methods that may not offer such interactive and continuous support. ^{1 10 11 12 13}

Research Team

Colin Grissom, MD

Principal Investigator

Intermountain Health Care, Inc.

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Telehealth-enabled support for SAT/SBT adherence (Behavioural Intervention)
• Usual audit and feedback for SAT/SBT adherence (Behavioural Intervention)

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.

Participant Groups

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+

Brent James

Intermountain Health Care, Inc.

Chief Medical Officer since 2010

MD from University of Utah

Rob Allen

Intermountain Health Care, Inc.

Chief Executive Officer since 2022

Bachelor's degree in Business Administration

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Dr. Gary H. Gibbons

National Heart, Lung, and Blood Institute (NHLBI)

Chief Executive Officer since 2012

MD from Harvard Medical School

Dr. James P. Kiley

National Heart, Lung, and Blood Institute (NHLBI)

Chief Medical Officer since 2011

MD from University of California, San Francisco

University of Utah

Collaborator

Trials

1,169

Recruited

1,623,000+

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The design of an Internet-based system to maintain home monitoring adherence by lung transplant recipients. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Effects of home telemonitoring to support improved care for chronic obstructive pulmonary diseases. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Care Technologies to Improve Treatment Adherence in Patients Undergoing Organ Transplant: A Scoping Review. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Innovating the treatment of COPD exacerbations: a phone interactive telesystem to increase COPD Action Plan adherence. [2020]

5. Denmark pubmed.ncbi.nlm.nih.gov

Significance of patient self-monitoring for long-term outcomes after lung transplantation. [2019]

6. Denmark pubmed.ncbi.nlm.nih.gov

Usability testing of the Internet program: "Teens Taking Charge: Managing My Transplant Online". [2019]

7. England pubmed.ncbi.nlm.nih.gov

An Internet-based store-and-forward video home telehealth system for improving asthma outcomes in children. [2019]

8. Denmark pubmed.ncbi.nlm.nih.gov

Directly observed therapy to promote medication adherence in adolescent heart transplant recipients. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Internet-based home asthma telemonitoring: can patients handle the technology? [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Telehealth Pulmonary Rehabilitation for Patients With Severe Chronic Obstructive Pulmonary Disease. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Access to technology to support telehealth in areas without specialty care for liver disease. [2023]

12. Germany 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. [2022]

13. England pubmed.ncbi.nlm.nih.gov

The current use of telehealth in ALS care and the barriers to and facilitators of implementation: a systematic review. [2021]