Respiration, ArtificialTEACHNCT05141396
Telehealth-Enabled, Real-time Audit and Feedback for Clinician AdHerence (TEACH)
A study testing Telehealth- enabled support for SAT/SBT adherence and Usual audit and feedback for SAT/SBT adherence in people with Respiration, Artificial, run by Intermountain Health Care, Inc. at 11 sites in United States.
Trial summary
The purpose of this trial is to evaluate if augmenting a usual audit and feedback implementation approach with telehealth-enabled support improves coordinated spontaneous awakening/breathing trials and patient outcomes for mechanically ventilated patients. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Respiration, Artificial
- What is being tested?
- Telehealth- enabled support for SAT/SBT adherence and Usual audit and feedback for SAT/SBT adherence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,400 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Sep 2022to 15 Oct 2026
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient age >=16 years admitted to study hospital ICU
- Intubated and mechanically ventilated
Who cannot join
- Patient with pre-existing brain death admitted to study hospital for organ donation
- Died within 24 hours of intubation
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
American Fork Hospital
American Fork, Utah, 84003
David Guidry, MD
David Guidry, MD
- Recruiting
Cedar City Hospital
Cedar City, Utah, 84721
David Guidry, MD
David Guidry, MD
- Recruiting
Layton Hospital
Layton, Utah, 84041
David Guidry, MD
David Guidry, MD
- Recruiting
Logan Regional Hospital
Logan, Utah, 84341
David Guidry, MD
David Guidry, MD
- Recruiting
Intermountain Medical Center
Murray, Utah, 84107
Andrew Knighton, 801-507-8714, Andrew.Knighton@imail.org
Colin Grissom, MD
- Recruiting
Mckay Dee Hospital
Ogden, Utah, 84403
Colin Grissom, MD
Colin Grissom, MD
- Recruiting
Utah Valley Hospital
Provo, Utah, 84604
Colin Grissom, MD
Colin Grissom, MD
- Recruiting
Riverton Hospital
Riverton, Utah, 84065
David Guidry, MD
David Guidry, MD
- Recruiting
LDS Hospital
Salt Lake City, Utah, 84143
Colin Grissom, MD
Colin Grissom, MD
- Recruiting
Alta View Hospital
Sandy City, Utah, 84094
David Guidry, MD
David Guidry, MD
- Recruiting
St. George Regional Hospital
St. George, Utah, 84790
Colin Grissom, MD
Colin Grissom, MD
About this study
Official title: Implementation of Coordinated Spontaneous Awakening and Breathing Trials Using Telehealth-Enabled, Real-Time Audit and Feedback for Clinician Adherence: A Type II Hybrid Effectiveness-Implementation
The purpose of this trial is to evaluate if augmenting a usual audit and feedback implementation approach with telehealth-enabled support improves coordinated spontaneous awakening/breathing trials and patient outcomes for mechanically ventilated patients.
Read the detailed description
Sedation and analgesia are utilized with invasive mechanical ventilation (IMV) to improve patient comfort and synchrony with the mechanical ventilator. Prolonged sedation, however, may result in increased time on IMV and increased risk for ventilator associated pneumonia, delirium, and poor long-term cognitive outcomes. Daily interruptions in sedation [spontaneous awakening trials (SAT)] coordinated with daily spontaneous breathing trials (SBT) reduce mortality, increase ventilator free days, decrease intensive care unit (ICU) length of stay, and reduces ventilator-associated events. Coordination of spontaneous awakening and breathing trials (C-SAT/SBT), however, are underutilized due to significant barriers to implementation and adherence. This cluster-randomized hybrid implementation/effectiveness trial will compare C-SAT/SBT adherence and clinical outcomes in the presence of traditional audit and feedback implementation strategies alone or augmented with a novel Telehealth-Enabled, real-time Audit and feedback for Clinician adHerence ("TEACH") implementation strategy.
- Conditions
- Respiration, Artificial
- Being tested
- Telehealth- enabled support for SAT/SBT adherence, Usual audit and feedback for SAT/SBT adherence
- Keywords
- Invasive Mechanical Ventilation, Coordinated Spontaneous Awakening and Breathing Trials
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth- enabled support for SAT/SBT adherenceOther
Telehealth-enabled support over and above usual audit and feedback includes identifying candidates for spontaneous awakening and breathing trials, prompting bedside providers and guiding execution of the coordinated spontaneous awakening and breathing trials as needed.
Usual audit and feedback for SAT/SBT adherenceOther
Usual audit and feedback
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Telehealth- enabled support plus usual audit and feedback for SAT/SBT adherence | Experimental | Usual audit and feedback + telehealth-enabled support Receives: Other: Telehealth- enabled support for SAT/SBT adherence; Other: Usual audit and feedback for SAT/SBT adherence |
| Control - Usual audit/feedback for SAT/SBT adherence only | Active comparator | Usual audit and feedback Receives: Other: Usual audit and feedback for SAT/SBT adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to C-SAT/SBT
Fraction of eligible days on which coordinated spontaneous awakening trial and spontaneous breathing trial completed.
Measured: intubation to extubation - an average of 5 days
Ventilator-free days to day 28
ventilator-free days to day 28
Measured: 28 days
Secondary outcomes (7)
30-day Mortality
Measured: 30 days
Hospital Length of Stay
Measured: Through hospital discharge, an average of 10 days
90-day Mortality
Measured: 90 Days
New ventilator-associated pneumonia
Measured: Through hospital discharge, an average of 10 days
ICU Length of Stay
Measured: Through hospital discharge, an average of 10 days
Reintubation
Measured: intubation to extubation - an average of 5 days
Unintentional Extubation
Measured: intubation to extubation - an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start1 Sep 2022
- Primary completion31 Aug 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiration, ArtificialStudies 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
- Masking
- None (open label)
- Enrolment
- 13,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colin Grissom, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141396
- Sponsor's protocol ID
- 1051681
- Other IDs
- U01HL159878
- Acronym
- TEACH
- Status last verified
- Jun 2023
- First submitted
- 19 Nov 2021
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In order to protect patient privacy and comply with relevant regulations, identified data will be unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.
Publications
Grissom CK, Holubkov R, Carpenter L, Hanna B, Jacobs JR, Jones C, Knighton AJ, Leither L, Lisonbee D, Peltan ID, Winberg C, Wolfe D, Srivastava R. Implementation of coordinated spontaneous awakening and breathing trials using telehealth-enabled, real-time audit and feedback for clinician adherence (TEACH): a type II hybrid effectiveness-implementation cluster-randomized trial. Implement Sci. 2023 Sep 21;18(1):45. doi: 10.1186/s13012-023-01303-1.
PubMed 37735443
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Coordinated Spontaneous Awakening and Breathing Trials Using Telehealth-Enabled, Real-Time Audit and Feedback for Clinician Adherence: A Type II Hybrid Effectiveness-Implementation
- ClinicalTrials.gov ID
- NCT05141396
- Acronym / sponsor ID
- TEACH / 1051681
- Conditions
- Respiration, Artificial
- Keywords
- Invasive Mechanical Ventilation, Coordinated Spontaneous Awakening and Breathing Trials
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13,400 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- University of Utah, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 2 Dec 2021 (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 purpose of this trial is to evaluate if augmenting a usual audit and feedback implementation approach with telehealth-enabled support improves coordinated spontaneous awakening/breathing trials and patient outcomes for mechanically ventilated patients.
Detailed description
Sedation and analgesia are utilized with invasive mechanical ventilation (IMV) to improve patient comfort and synchrony with the mechanical ventilator. Prolonged sedation, however, may result in increased time on IMV and increased risk for ventilator associated pneumonia, delirium, and poor long-term cognitive outcomes. Daily interruptions in sedation [spontaneous awakening trials (SAT)] coordinated with daily spontaneous breathing trials (SBT) reduce mortality, increase ventilator free days, decrease intensive care unit (ICU) length of stay, and reduces ventilator-associated events. Coordination of spontaneous awakening and breathing trials (C-SAT/SBT), however, are underutilized due to significant barriers to implementation and adherence. This cluster-randomized hybrid implementation/effectiveness trial will compare C-SAT/SBT adherence and clinical outcomes in the presence of traditional audit and feedback implementation strategies alone or augmented with a novel Telehealth-Enabled, real-time Audit and feedback for Clinician adHerence ("TEACH") implementation strategy.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - Telehealth- enabled support plus usual audit and feedback for SAT/SBT adherence | Experimental | Other: Telehealth- enabled support for SAT/SBT adherence, Other: Usual audit and feedback for SAT/SBT adherenceUsual audit and feedback + telehealth-enabled support |
| Control - Usual audit/feedback for SAT/SBT adherence only | Active comparator | Other: Usual audit and feedback for SAT/SBT adherenceUsual audit and feedback |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patient age >=16 years admitted to study hospital ICU
- Intubated and mechanically ventilated
Key exclusion criteria (2 listed)
- Patient with pre-existing brain death admitted to study hospital for organ donation
- Died within 24 hours of intubation
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 |
|---|---|---|
| Telehealth- enabled support for SAT/SBT adherenceTelehealth-enabled support over and above usual audit and feedback includes identifying candidates for spontaneous awakening and breathing trials, prompting bedside providers and guiding execution of the coordinated spontaneous awakening and breathing trials as needed. | Other | Intervention - Telehealth- enabled support plus usual audit and feedback for SAT/SBT adherence |
| Usual audit and feedback for SAT/SBT adherenceUsual audit and feedback | Other | Control - Usual audit/feedback for SAT/SBT adherence only, Intervention - Telehealth- enabled support plus usual audit and feedback for SAT/SBT adherence |
Primary outcome
Adherence to C-SAT/SBT
Time frame: intubation to extubation - an average of 5 days
Fraction of eligible days on which coordinated spontaneous awakening trial and spontaneous breathing trial completed.
Ventilator-free days to day 28
Time frame: 28 days
ventilator-free days to day 28
7 secondary outcomes
30-day Mortality
Time frame: 30 days
Hospital Length of Stay
Time frame: Through hospital discharge, an average of 10 days
90-day Mortality
Time frame: 90 Days
New ventilator-associated pneumonia
Time frame: Through hospital discharge, an average of 10 days
ICU Length of Stay
Time frame: Through hospital discharge, an average of 10 days
Reintubation
Time frame: intubation to extubation - an average of 5 days
Unintentional Extubation
Time frame: intubation to extubation - an average of 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 37735443Grissom CK, Holubkov R, Carpenter L, Hanna B, Jacobs JR, Jones C, Knighton AJ, Leither L, Lisonbee D, Peltan ID, Winberg C, Wolfe D, Srivastava R. Implementation of coordinated spontaneous awakening and breathing trials using telehealth-enabled, real-time audit and feedback for clinician adherence (TEACH): a type II hybrid effectiveness-implementation cluster-randomized trial. Implement Sci. 2023 Sep 21;18(1):45. doi: 10.1186/s13012-023-01303-1.
- Individual participant dataSharing planned: Yes. In order to protect patient privacy and comply with relevant regulations, identified data will be unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.
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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.
Colin Grissom, MD principal investigator
Intermountain Health Care, Inc.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth- enabled support for SAT/SBT adherence and Usual audit and feedback for SAT/SBT adherence in people with Respiration, Artificial, run by Intermountain Health Care, Inc. at 11 sites 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Barbagelata (8015074607, carlos.barbagelata@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to C-SAT/SBT (time frame: intubation to extubation - an average of 5 days). The study lists 2 primary outcomes in all. 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 NCT05141396, which also lists 1 linked publication.
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 3 Jul 2023.