Respiratory FailureNCT03742167
Pilot Simulation RCT of Telemedical Support for Paramedics
A study testing Telemedicine in people with Respiratory Failure and Status Epilepticus, run by Boston Medical Center at 1 site in United States.
Trial summary
This study evaluates the impact of video communication via telemedicine on the quality of emergency care provided to children by paramedic teams supported by a remote physician in a simulated out-of-hospital setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure, Status Epilepticus, Status Asthmaticus
- What is being tested?
- Telemedicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2018to 12 Jul 2022
- 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
- Certified paramedics from three EMS systems in the Boston metropolitan area (Boston EMS, South Shore EMS, and Lahey Medical Center EMS)
- Attending physicians and clinical fellows with expertise in pediatric emergency medicine and pediatric resuscitation from 2 pediatric referral centers (Boston Medical Center and Boston Children's Hospital)
Who cannot join
- -Prehospital providers without paramedic level certification (e.g. BLS certification only)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Randomized Control Trial of Telemedical Support for Paramedics in Simulated Pre-hospital Pediatric Emergencies
This study evaluates the impact of video communication via telemedicine on the quality of emergency care provided to children by paramedic teams supported by a remote physician in a simulated out-of-hospital setting. Half of the paramedic teams will use a video telemedicine platform for communication with a physician, while the other half will use an audio-only platform.
Read the detailed description
In the United States, the current standard of pre-hospital (out-of-hospital) emergency care for children with life-threatening illnesses in the community includes remote physician medical direction for paramedics providing life-saving therapies while transporting the child to the hospital. Most pre-hospital emergency medical service (EMS) agencies use radios systems for audio communication between paramedics and physicians. This communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment.
The purpose of this pilot study is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life-threatening illnesses. Paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction.
Because real pediatric life-threatening illnesses are rare, high-stakes events and involve a vulnerable population (children), this pilot randomized control trial will provide early data on the efficacy of this intervention in simulated cases of pediatric medical emergencies. The primary outcome is "paramedic resuscitation performance" measured by a checklist of observable critical actions by independent reviewers during live observation and video review. The results of this study will provide important pilot data to estimate the clinical effect of this intervention and the sample size needed for a future definitive trial with children, a vulnerable population.
- Being tested
- Telemedicine
- Keywords
- Prehospital emergency care, Paramedic performance, Telemedicine, Medical control physician, Infant mannequin smulation, Pediatric life threatening illness
- Medical subject headings
- Respiratory Insufficiency, Status Epilepticus, Status Asthmaticus, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
The mobile, HIPAA-compliant, video-conferencing platform, Zoom Pro, will be used on tablet computers as a low-cost telemedicine platform for the intervention group. This platform uses Wi-Fi or cellular data connection for video streaming. The investigators will use the telephone communication on this platform for control scenarios, to mimic the current standard for audio-only consultation. A web-based software platform (WireCast®) will capture video recordings over a secure wireless network.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Experimental | The telemedicine arm will have 2-way audiovisual connection with a pediatric medical control physician. Receives: Other: Telemedicine |
| Control | No intervention | The control arm will receive pediatric medical control physician consultation via telephone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paramedic Team Performance score
The paramedic team performance score is generated from a 64-item checklist of observable actions for pediatric assessment and resuscitation that are scored dichotomously (observed/not observed). The composite performance score is calculated as the number of observed actions divided by the total number of expected actions per case, and reported as a percentage of completed observed actions. This checklist is validated for simulation-based assessment of paramedic performance using three simulated cases of pediatric pre-hospital emergencies. Paramedic team performance will be rated by 1 live and 2 video raters. The final performance score for each team will be reported as an average score for all three raters.
Measured: 9 months
Secondary outcomes (7)
NASA Task load Index
This is an extensively validated measure of perceived workload of individuals. It is a multidimensional scale where individuals estimate workload during or after completing a task. It contains 7 domains (mental demand, physical demand, temporal demand, performance, effort, frustration, and anxiety) which are evaluated on a 20-point Likert scale. Study participants will complete this questionnaire immediately after completing the simulation modules.
Measured: 9 months
Telemedicine Platform Usability
This 14-item questionnaire is a validated measure of all the usability of telehealth platforms (usefulness, ease of use, effectiveness, reliability, and satisfaction). The investigators modified this questionnaire to specifically address the usability of a prehospital telemedicine platform. Study participants will complete this questionnaire immediately after completing the simulation modules.
Measured: 9 months
Error in medication choice
This will be any incorrect type of medication utilized by a team during each simulation resuscitation. This includes unanticipated medication choices which the study raters feel was not indicated or potentially harmful by consensus opinion. This data is collected in the paramedic performance checklist.
Measured: 9 months
Error in weight-based medication dosing
This will include any errors in pediatric weight-based dose calculation, including errors in volume of drug administered during each simulated case. This data is collected in the paramedic performance checklist.
Measured: 9 months
Equipment size error
This includes errors in equipment size during each simulated resuscitation. This data is collected in the paramedic performance checklist.
Measured: 9 months
Equipment use errors
This includes errors in equipment usage (e.g. depth of endotracheal tube insertion, rate of bag-valve-mask ventilation, location of intraosseous needle insertion) during each simulated resuscitation. This data is collected in the paramedic performance checklist.
Measured: 9 months
EMS protocol error
This will be defined as any error in offline and online EMS treatment protocols that is observed during each simulated resuscitation. This data is collected in the paramedic performance checklist.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2018
- Study start18 Dec 2018
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tehnaz Boyle, MD PhD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03742167
- Sponsor's protocol ID
- H-37817
- Other IDs
- K23HL145126-01A1
- Status last verified
- Jul 2022
- First submitted
- 13 Nov 2018
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lammers RL, Byrwa MJ, Fales WD, Hale RA. Simulation-based assessment of paramedic pediatric resuscitation skills. Prehosp Emerg Care. 2009 Jul-Sep;13(3):345-56. doi: 10.1080/10903120802706161.
PubMed 19499472Butler L, Whitfill T, Wong AH, Gawel M, Crispino L, Auerbach M. The Impact of Telemedicine on Teamwork and Workload in Pediatric Resuscitation: A Simulation-Based, Randomized Controlled Study. Telemed J E Health. 2019 Mar;25(3):205-212. doi: 10.1089/tmj.2018.0017. Epub 2018 Jun 29.
PubMed 29957150Parmanto B, Lewis AN Jr, Graham KM, Bertolet MH. Development of the Telehealth Usability Questionnaire (TUQ). Int J Telerehabil. 2016 Jul 1;8(1):3-10. doi: 10.5195/ijt.2016.6196. eCollection 2016 Spring.
PubMed 27563386
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Control Trial of Telemedical Support for Paramedics in Simulated Pre-hospital Pediatric Emergencies
- ClinicalTrials.gov ID
- NCT03742167
- Acronym / sponsor ID
- H-37817
- Keywords
- Prehospital emergency care, Paramedic performance, Telemedicine, Medical control physician, Infant mannequin smulation, Pediatric life threatening illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Boston Children's Hospital
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 15 Nov 2018 (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.
This study evaluates the impact of video communication via telemedicine on the quality of emergency care provided to children by paramedic teams supported by a remote physician in a simulated out-of-hospital setting. Half of the paramedic teams will use a video telemedicine platform for communication with a physician, while the other half will use an audio-only platform.
Detailed description
In the United States, the current standard of pre-hospital (out-of-hospital) emergency care for children with life-threatening illnesses in the community includes remote physician medical direction for paramedics providing life-saving therapies while transporting the child to the hospital. Most pre-hospital emergency medical service (EMS) agencies use radios systems for audio communication between paramedics and physicians. This communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment.
The purpose of this pilot study is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life-threatening illnesses. Paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction.
Because real pediatric life-threatening illnesses are rare, high-stakes events and involve a vulnerable population (children), this pilot randomized control trial will provide early data on the efficacy of this intervention in simulated cases of pediatric medical emergencies. The primary outcome is "paramedic resuscitation performance" measured by a checklist of observable critical actions by independent reviewers during live observation and video review. The results of this study will provide important pilot data to estimate the clinical effect of this intervention and the sample size needed for a future definitive trial with children, a vulnerable population.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Experimental | Other: TelemedicineThe telemedicine arm will have 2-way audiovisual connection with a pediatric medical control physician. |
| Control | No intervention | –The control arm will receive pediatric medical control physician consultation via telephone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Certified paramedics from three EMS systems in the Boston metropolitan area (Boston EMS, South Shore EMS, and Lahey Medical Center EMS)
- Attending physicians and clinical fellows with expertise in pediatric emergency medicine and pediatric resuscitation from 2 pediatric referral centers (Boston Medical Center and Boston Children's Hospital)
Key exclusion criteria (1 listed)
- -Prehospital providers without paramedic level certification (e.g. BLS certification only)
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 |
|---|---|---|
| TelemedicineThe mobile, HIPAA-compliant, video-conferencing platform, Zoom Pro, will be used on tablet computers as a low-cost telemedicine platform for the intervention group. This platform uses Wi-Fi or cellular data connection for video streaming. The investigators will use the telephone communication on this platform for control scenarios, to mimic the current standard for audio-only consultation. A web-based software platform (WireCast®) will capture video recordings over a secure wireless network. | Other | Telemedicine |
Primary outcome
Paramedic Team Performance score
Time frame: 9 months
The paramedic team performance score is generated from a 64-item checklist of observable actions for pediatric assessment and resuscitation that are scored dichotomously (observed/not observed). The composite performance score is calculated as the number of observed actions divided by the total number of expected actions per case, and reported as a percentage of completed observed actions. This checklist is validated for simulation-based assessment of paramedic performance using three simulated cases of pediatric pre-hospital emergencies. Paramedic team performance will be rated by 1 live and 2 video raters. The final performance score for each team will be reported as an average score for all three raters.
7 secondary outcomes
NASA Task load Index
Time frame: 9 months
Telemedicine Platform Usability
Time frame: 9 months
Error in medication choice
Time frame: 9 months
Error in weight-based medication dosing
Time frame: 9 months
Equipment size error
Time frame: 9 months
Equipment use errors
Time frame: 9 months
EMS protocol error
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Background: PubMed 19499472Lammers RL, Byrwa MJ, Fales WD, Hale RA. Simulation-based assessment of paramedic pediatric resuscitation skills. Prehosp Emerg Care. 2009 Jul-Sep;13(3):345-56. doi: 10.1080/10903120802706161.
- Background: PubMed 29957150Butler L, Whitfill T, Wong AH, Gawel M, Crispino L, Auerbach M. The Impact of Telemedicine on Teamwork and Workload in Pediatric Resuscitation: A Simulation-Based, Randomized Controlled Study. Telemed J E Health. 2019 Mar;25(3):205-212. doi: 10.1089/tmj.2018.0017. Epub 2018 Jun 29.
- Background: PubMed 27563386Parmanto B, Lewis AN Jr, Graham KM, Bertolet MH. Development of the Telehealth Usability Questionnaire (TUQ). Int J Telerehabil. 2016 Jul 1;8(1):3-10. doi: 10.5195/ijt.2016.6196. eCollection 2016 Spring.
- 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.
Tehnaz Boyle, MD PhD principal investigator
Boston 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 Telemedicine in people with Respiratory Failure and Status Epilepticus, run by Boston Medical Center 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 2 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: finished, as of the sponsor's last update on 28 Jul 2022. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Paramedic Team Performance score (time frame: 9 months). 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 NCT03742167, which also lists 3 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 28 Jul 2022.