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Respiratory TherapyNCT05661695

Evaluation of Clinical Tool to Improve Adherence to Ventilator Management at UM

A study testing RT Assistant in people with Respiratory Therapy, run by Convergent Engineering, Inc. at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Respiratory Therapists (RTs) have difficulty maintaining compliance with protocols and making efficient handoff communication. This project will evaluate the effectiveness of an electronic tool that will display a dashboard of key information on all the RTs patients and provide reminders that indicate whether… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Respiratory Therapy
What is being tested?
RT Assistant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
31 Mar 2024to 31 May 2024
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Practicing RTs are eligible to participate in this study

Who cannot join

  • non-RTs or those who refuse to participate

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Miami Health

    Miami, Florida, 33136

    Andrea Gabrielli, MD, 305-689-1227, ag@maimi.edu

Other trials in United States

About this study

Official title: Evaluation of Clinical Tool to Improve Adherence to Ventilator Management Protocols and Standardized Shift Reports at UM

Respiratory Therapists (RTs) have difficulty maintaining compliance with protocols and making efficient handoff communication. This project will evaluate the effectiveness of an electronic tool that will display a dashboard of key information on all the RTs patients and provide reminders that indicate whether evidence-based practice protocols are being followed. In addition, it will collect data from medical devices and the EMR and outline key information in the appropriate format to help standardize and improve handoff communication. The study will first collect blind baseline data for comparison with protocol adherence and silently evaluate shift change handoffs. In the second stage, the electronic tool will be installed and used to evaluate whether protocol compliance and shift change handoff is improved.

Read the detailed description

Background:

Respiratory Therapists (RTs) face challenges to provide high quality patient care including maintaining compliance with evidence-based practice protocols using lung protective ventilation (LPV) (tidal volume [VT] 4 to 8 ml predicted body weight and plateau pressure [Pplt] < 30 cm H2O), efficient communication during patient handoffs at shift changes and maintaining situational awareness amidst a high patient-to-clinician ratio and elevated acuity of patient care. Lung-protective ventilation (LPV) guidelines, initially published by ARDS Net and supported by the American Thoracic Society, Society of Critical Care Medicine and European Society of Intensive Care Medicine. LPV guidelines recommend use of low tidal volume (VT) (6 to 8 ml predicted body weight [PBW]) and inspiratory plateau pressure (Pplt) (≤ 30 cm H2O), proven to lower mortality in patients with adult respiratory distress syndrome (ARDS). However, several studies revealed that many clinicians and institutions are not effectively implementing LPV guidelines many years after their publication in the New England Journal of Medicine in 2000. Clinicians who are unable and/or unwilling to apply low VT and Pplt as defined above jeopardize patient safety and risk increased mortality. One study found only 27% of patients received low VT and Pplt within 48 hours of the onset of ARDS. It was also found that ". . . adoption of evidence-based mechanical ventilation in real world practice has been disturbingly slow."

Another daily challenge faced by an RRT is the transfer of vital patient information during shift changes. A less than optimal "patient hand-off" or communication of relevant patient care information during shift changes appears to be a major factor in preventable medical errors directly affecting patient safety. The primary objective of a patient hand-off is to provide accurate information about the patient's care, treatment and services, current condition and any recent or anticipated changes. While appearing to be relatively easy task, a comprehensive, high-quality patient hand-off can be a complex communication procedure. One study found that patient hand-off communication failures were responsible for 30% of malpractice claims in U.S. hospitals, resulting in 1,744 deaths and $1.7 billion in malpractice costs over five years. While the use of computerized patient handoff methods are likely to promote improved information transfer during patient hand-offs, there is a dearth of such easy-to-use, portable communication tools available for RTs. Other contributing factors adversely affecting patient hand-off communication appear to be unrecognized patient needs due to lack of accurate and real time electronic monitoring, task interruption from nuisance alarms and inability to quickly determine the correct clinical decision.

RT Assistant, a bedside, portable and hand-held electronic tool, was designed to help the RT with these challenges.

Goals:

Evaluate the clinical effectiveness of RT Assistant software for the following:

Maintaining patients according to established LPV guidelines for ventilator-dependent patients Maintaining established low oxygen therapy guidelines Improving patient shift report communication Collect baseline data from the selected ICU passively through the SickBay data aggregator, including percentage of time patients are within the LPV and oxygenation guidelines.

Collect baseline data on shift report quality by passively monitoring shift reports between RTs during the above baseline data collection Install the RT Assistant software, train participating RTs, and compare baseline data with the same data collected in the same ICU during the use of the RT Assistant software

Being tested
RT Assistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RT AssistantDevice

    RRT's will be given the RT Assistant to use during a regular ICU shift to make patient care decisions.

Study groups in NCT05661695
Study groupRoleWhat they receive
RT's in ICUOtherWe will collect ventilator pressure, flow, volume, oxygen and breathing pattern data, etc, as well as arterial blood-gas exchange and hemodynamic data of adults attached to ventilators. the RRT's will treat patients as normal without the assistance of the RT Assistant for the pre-intervention phase and will be observed collecting the same data and performing patient care with the assistance of the RT Assistant during the intervention phase. The RRTs will then be given a likert scale questionnaire on the use of the RT Assistant.
Receives: Device: RT Assistant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Respiratory Therapist Likert Scale Questionnaire

    Questionnaire, score 1-10 (1 being the worst, 10 being the best)

    Measured: through study completion, an average of 60 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2022
  2. Study start31 Mar 2024 (estimated)
  3. Primary completion31 May 2024 (estimated)
  4. Study completion31 May 2024 (estimated)

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignment RTs will be observed during patient care without the use of the RT Assistant during the non-interventional phase and with the use of the RT Assistant during the interventional phase. RTs will be observed by highly trained RTs during both phases. RTs will answer a likert scale questionnaire about the use of the RT Assistant used to make clinical decisions.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05661695
Sponsor's protocol ID
RTA 11-02
Status last verified
Aug 2023
First submitted
14 Dec 2022
Last updated
14 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Any paper data, such as checklists, informed consents, and surveys will be maintained in locked cabinets in Department of Surgery offices. Electronic copies of such data will be stored in password protected, secure computer resources at UF and the sponsor, Convergent Engineering. Electronic data collected through the data aggregator will be stored on a secure, HIPAA certified, cloud-based server. Access to the server data is provided only via the web application protected by the UFHealth secure login system. Aggregated data will be extracted from the system by Convergent Engineering personnel and provided to a 3rd party statistician for analysis.

Questions about this trial

What is this clinical trial studying?

A study testing RT Assistant in people with Respiratory Therapy, run by Convergent Engineering, Inc. 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 1 inclusion and 1 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 14 Feb 2024. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Neil R Euliano, PhD (3523784899 ext. 107, neil@conveng.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory Therapist Likert Scale Questionnaire (time frame: through study completion, an average of 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 14 Feb 2024.

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