Acute DiseaseNCT02915640
Use of a Mobile Remote Device to Optimize Pediatric Inter-facility Transportation: A Feasibility Study
A study testing Remote technology in people with Acute Disease, run by University of Saskatchewan at 3 sites in Canada.
Trial summary
This study compares the utilization of remote technology versus not using remote technology when triaging and managing pediatric patients in remote settings prior to pediatric specialized inter-facility transportation. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Acute Disease
- What is being tested?
- Remote technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 3 sitesCanada
- Study dates
- Mar 2015to May 2016
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Patients older than age 17.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Pelican Narrows Clinic (Angelique Canada Health Centre)
Pelican Narrows, Saskatchewan, S0P 0E0
Regina General Hospital
Regina, Saskatchewan, S4P 0W5
Royal University Hospital
Saskatoon, Saskatchewan, S7N0W8
About this study
Official title: Remote Technology for Paediatric Patient Assessment, Stabilization and Triaging Prior to Paediatric Inter-facility Transportation: A Feasibility Study
This study compares the utilization of remote technology versus not using remote technology when triaging and managing pediatric patients in remote settings prior to pediatric specialized inter-facility transportation.
Read the detailed description
Paediatric Specialized Inter-facility transport utilizes specialized teams usually made up of a respiratory therapist, paediatric critical care nurse, and paediatric intensivist as medical control. When a Nurse Practitioner or General Practitioner from a remote site has a paediatric acute care referral and wants to arrange transportation there is an initial call at which point there are two priorities: first is obtain a patient history and then provide advice to the remote caregiver to initiate specific therapies; second is to mobilize the specialized team to the patient. The period of time between giving initial advice while dispatching the team and the time when the team arrives, can often be a vulnerable period for the remote caregiver as well as the patient. The ability to directly visualize and assess the patient during this time, as well as assist the specialized team once they arrive may provide improvement in safety and care of the patient. It may also improve triaging and may make the stabilization and departure time more efficient.
Remote technology will be used for an initial patient assessment after being contacted by phone from the peripheral centre to transfer an acutely ill paediatric patient as assessed by the referral centre care provider. After assessment the patient will be triaged to either remain in the local community, transferred to a regional hospital that provides paediatric acute care (Prince Albert), or be transported to Royal University Hospital in Saskatoon for tertiary care. Data to be collected includes:
- Duration of time from the beginning of the initial phone call to the first therapeutic intervention
- Time to stabilization
- Time to decision for disposition
- The duration of contact with the health care provider and the patient
- Number of scheduled follow-up contacts for a specific patient within 24 hours
- Number of times the referring centre re-consults
- Of the patients who triaged to stay in the local community how many were transported to the tertiary care centre within 24hrs
- How many patients who arrived at the tertiary care centre were discharged within 24hrs
- How many patients on arrival were deemed to be unnecessary
The nurses and physicians who are communicating with the Intensivist about the case will complete a post-encounter survey to evaluate their experience.
- Conditions
- Acute Disease
- Being tested
- Remote technology
- Medical subject headings
- Acute Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote technologyOther
Utilization of remote technology versus not using remote technology when triaging and managing pediatric patients in remote settings prior to pediatric specialized inter-facility transportation.
| Study group | Role | What they receive |
|---|---|---|
| Remote technology | Experimental | Remote technology will be used for an initial patient assessment after being contacted by phone from the peripheral center to transfer an acutely ill pediatric patient as assessed by the referral centre care provider. Receives: Other: Remote technology |
| Control | No intervention | A Nurse Practitioner or General Practitioner from a remote site has a pediatric acute care referral and arranges a transportation. There is an initial call to obtain a patient history, to provide advice to the remote caregiver to initiate specific therapies and to mobilize the specialized team to the patient. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transport number in the cases (with the robot) versus the controls (without the robot)
Measured: One year
Secondary outcomes (2)
Tertiary care hospital length of stay in the cases versus the controls
Measured: One year
The number of patients transported to the regional hospitals in the cases (with the robot) versus the controls (without the robot)
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startMar 2015
- Primary completionFeb 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanya Holt, University of Saskatchewan
- Investigators
- Tanya Holt, MD, Principal investigator, Clinical Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02915640
- Sponsor's protocol ID
- PITROBOT-1
- Status last verified
- Sep 2016
- First submitted
- 21 Sep 2016
- Last updated
- 27 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Orr RA, Felmet KA, Han Y, McCloskey KA, Dragotta MA, Bills DM, Kuch BA, Watson RS. Pediatric specialized transport teams are associated with improved outcomes. Pediatrics. 2009 Jul;124(1):40-8. doi: 10.1542/peds.2008-0515.
PubMed 19564281Stroud MH, Prodhan P, Moss MM, Anand KJ. Redefining the golden hour in pediatric transport. Pediatr Crit Care Med. 2008 Jul;9(4):435-7. doi: 10.1097/PCC.0b013e318172da62.
PubMed 18496407Borrows EL, Lutman DH, Montgomery MA, Petros AJ, Ramnarayan P. Effect of patient- and team-related factors on stabilization time during pediatric intensive care transport. Pediatr Crit Care Med. 2010 Jul;11(4):451-6. doi: 10.1097/PCC.0b013e3181e30ce7.
PubMed 20453701Han YY, Carcillo JA, Dragotta MA, Bills DM, Watson RS, Westerman ME, Orr RA. Early reversal of pediatric-neonatal septic shock by community physicians is associated with improved outcome. Pediatrics. 2003 Oct;112(4):793-9. doi: 10.1542/peds.112.4.793.
PubMed 14523168Mendez I, Song M, Chiasson P, Bustamante L. Point-of-Care Programming for Neuromodulation: A Feasibility Study Using Remote Presence. Neurosurgery. 2013 Jan;72(1):99-108; discussion 108. doi: 10.1227/NEU.0b013e318276b5b2.
PubMed 23096417Rothenberg SS, Yoder S, Kay S, Ponsky T. Initial experience with surgical telementoring in pediatric laparoscopic surgery using remote presence technology. J Laparoendosc Adv Surg Tech A. 2009 Apr;19 Suppl 1:S219-22. doi: 10.1089/lap.2008.0133.supp.
PubMed 18976120
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Technology for Paediatric Patient Assessment, Stabilization and Triaging Prior to Paediatric Inter-facility Transportation: A Feasibility Study
- ClinicalTrials.gov ID
- NCT02915640
- Acronym / sponsor ID
- PITROBOT-1
- Conditions
- Acute Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Sep 2016 (estimated)
- 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 compares the utilization of remote technology versus not using remote technology when triaging and managing pediatric patients in remote settings prior to pediatric specialized inter-facility transportation.
Detailed description
Paediatric Specialized Inter-facility transport utilizes specialized teams usually made up of a respiratory therapist, paediatric critical care nurse, and paediatric intensivist as medical control. When a Nurse Practitioner or General Practitioner from a remote site has a paediatric acute care referral and wants to arrange transportation there is an initial call at which point there are two priorities: first is obtain a patient history and then provide advice to the remote caregiver to initiate specific therapies; second is to mobilize the specialized team to the patient. The period of time between giving initial advice while dispatching the team and the time when the team arrives, can often be a vulnerable period for the remote caregiver as well as the patient. The ability to directly visualize and assess the patient during this time, as well as assist the specialized team once they arrive may provide improvement in safety and care of the patient. It may also improve triaging and may make the stabilization and departure time more efficient.
Remote technology will be used for an initial patient assessment after being contacted by phone from the peripheral centre to transfer an acutely ill paediatric patient as assessed by the referral centre care provider. After assessment the patient will be triaged to either remain in the local community, transferred to a regional hospital that provides paediatric acute care (Prince Albert), or be transported to Royal University Hospital in Saskatoon for tertiary care. Data to be collected includes:
- Duration of time from the beginning of the initial phone call to the first therapeutic intervention
- Time to stabilization
- Time to decision for disposition
- The duration of contact with the health care provider and the patient
- Number of scheduled follow-up contacts for a specific patient within 24 hours
- Number of times the referring centre re-consults
- Of the patients who triaged to stay in the local community how many were transported to the tertiary care centre within 24hrs
- How many patients who arrived at the tertiary care centre were discharged within 24hrs
- How many patients on arrival were deemed to be unnecessary
The nurses and physicians who are communicating with the Intensivist about the case will complete a post-encounter survey to evaluate their experience.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote technology | Experimental | Other: Remote technologyRemote technology will be used for an initial patient assessment after being contacted by phone from the peripheral center to transfer an acutely ill pediatric patient as assessed by the referral centre care provider. |
| Control | No intervention | –A Nurse Practitioner or General Practitioner from a remote site has a pediatric acute care referral and arranges a transportation. There is an initial call to obtain a patient history, to provide advice to the remote caregiver to initiate specific therapies and to mobilize the specialized team to the patient. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Patients older than age 17.
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 |
|---|---|---|
| Remote technologyUtilization of remote technology versus not using remote technology when triaging and managing pediatric patients in remote settings prior to pediatric specialized inter-facility transportation. | Other | Remote technology |
Primary outcome
Transport number in the cases (with the robot) versus the controls (without the robot)
Time frame: One year
2 secondary outcomes
Tertiary care hospital length of stay in the cases versus the controls
Time frame: One year
The number of patients transported to the regional hospitals in the cases (with the robot) versus the controls (without the robot)
Time frame: One year
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 27 Sep 2016.
- Background: PubMed 19564281Orr RA, Felmet KA, Han Y, McCloskey KA, Dragotta MA, Bills DM, Kuch BA, Watson RS. Pediatric specialized transport teams are associated with improved outcomes. Pediatrics. 2009 Jul;124(1):40-8. doi: 10.1542/peds.2008-0515.
- Background: PubMed 18496407Stroud MH, Prodhan P, Moss MM, Anand KJ. Redefining the golden hour in pediatric transport. Pediatr Crit Care Med. 2008 Jul;9(4):435-7. doi: 10.1097/PCC.0b013e318172da62.
- Background: PubMed 20453701Borrows EL, Lutman DH, Montgomery MA, Petros AJ, Ramnarayan P. Effect of patient- and team-related factors on stabilization time during pediatric intensive care transport. Pediatr Crit Care Med. 2010 Jul;11(4):451-6. doi: 10.1097/PCC.0b013e3181e30ce7.
- Background: PubMed 14523168Han YY, Carcillo JA, Dragotta MA, Bills DM, Watson RS, Westerman ME, Orr RA. Early reversal of pediatric-neonatal septic shock by community physicians is associated with improved outcome. Pediatrics. 2003 Oct;112(4):793-9. doi: 10.1542/peds.112.4.793.
- Background: PubMed 23096417Mendez I, Song M, Chiasson P, Bustamante L. Point-of-Care Programming for Neuromodulation: A Feasibility Study Using Remote Presence. Neurosurgery. 2013 Jan;72(1):99-108; discussion 108. doi: 10.1227/NEU.0b013e318276b5b2.
- Background: PubMed 18976120Rothenberg SS, Yoder S, Kay S, Ponsky T. Initial experience with surgical telementoring in pediatric laparoscopic surgery using remote presence technology. J Laparoendosc Adv Surg Tech A. 2009 Apr;19 Suppl 1:S219-22. doi: 10.1089/lap.2008.0133.supp.
- 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.
Tanya Holt, MD principal investigator
Clinical Assistant Professor
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote technology in people with Acute Disease, run by University of Saskatchewan at 3 sites in Canada.
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 0 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 27 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Transport number in the cases (with the robot) versus the controls (without the robot) (time frame: One year). 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 NCT02915640, which also lists 6 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 27 Sep 2016; AzTrials last refreshed its copy on 1 Nov 2026.