Critical IllnessNCT02877810
Evidence-Based Tele-Emergency Network Grant Program
A study testing Telemedicine and Telephone in people with Critical Illness, run by University of California, Davis at 1 site in United States.
Trial summary
The purpose of this study is to determine the impact of an existing tele-emergency care network on quality of care, appropriateness of care utilization, patient safety (medication errors), and cost effectiveness compared to telephone consultations from a healthcare system prospective. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Telemedicine and Telephone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 696 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Aug 2019
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children younger than or equal to 14 years of age at the time of their ED visit.
Who cannot join
- Children evaluated at the ED for non-medical reasons such as elective surgeries and social reasons (i.e., cases of possible endangerment) and other non-medical reasons.
- Children evaluated at the ED preoperatively, for elective surgical procedures.
- Children transferred to the ED from another hospital ED.
- Children transiently "held" in the ED in the process of a direct admission to the ward.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis, Medical Center
Sacramento, California, 95817
About this study
The purpose of this study is to determine the impact of an existing tele-emergency care network on quality of care, appropriateness of care utilization, patient safety (medication errors), and cost effectiveness compared to telephone consultations from a healthcare system prospective.
Read the detailed description
The investigators will use a novel cluster randomized unbalanced crossover trial design. When a new site is enrolled, the first approximately 6 months of the project will be a "ramp-up" period during which the protocol will be re-reviewed during a site visit to the participating EDs and random block assignments will be generated and delivered. The last 6 months will be reserved for data analysis, study closeout, and manuscript preparation. An intervening 2-year period will be divided into 4 six-month calendar time periods for carrying out the protocol and data collection. For each 6-month period, each ED will have a randomized treatment assignment for pediatric emergency and critical care consultations ("M" for telemedicine and "P" for telephone.) Participating EDs (the unit of randomization) will be stratified into two strata by size of ED and geographical location. EDs will then be randomized within-strata to one of the four unbalanced (3:1) crossover treatment assignment sequences, each consisting of a 6-month period: PMMM, MPMM, MMPM, or MMMP. During these assigned periods, the type of consultation being assigned will be strongly encouraged, but deviating from protocol (i.e., using telephone consultation when randomized to telemedicine, or the vice-versa) will be allowed as needed by the physicians. Data will be collected and abstracted through retrospective chart review.
- Conditions
- Critical Illness
- Being tested
- Telemedicine, Telephone
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Telemedicine is a live, interactive, audiovisual teleconferencing system.
TelephoneOther
Consultations will be given over telephone.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Experimental | A consultation will be given for the care of a critically ill pediatric patient to a remote hospital emergency department physician by telemedicine, a live, interactive, audiovisual teleconferencing system, from a pediatric critical care physician. Receives: Other: Telemedicine |
| Telephone | Active comparator | A consultation will be given for the care of a critically ill pediatric patient to a remote hospital emergency department physician by telephone, from a pediatric critical care physician.. Receives: Other: Telephone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Care Implicit Review Instrument
The investigators hypothesize that children receiving care in EDs during periods of telemedicine use will receive higher quality of care than similar children who receive care during periods of telephone use. A previously validated 5-item implicit review instrument that measures 4 aspects of process of care in the ED, along with a fifth item assessing the overall quality of care provided to the patient will be used. The sum of the 5 item-specific scores will be aggregated from each reviewer to obtain a summary quality score for each medical record.
Measured: Year 3
Pediatric Risk of Admission (PRISA II)
The investigators hypothesize that children receiving care in EDs during randomized periods of telemedicine use will be admitted more appropriately than similar children who receive care during periods randomized to telephone use. To compare the cohort of seriously ill children treated during the telephone and telemedicine time blocks, observed to expected (O/E) ratios will be calculated using an intention-to-treat framework.
Measured: Year 3
Pediatric Emergency Assessment Tool (Re-PEAT)
The investigators hypothesize that children receiving care in EDs during randomized periods of telemedicine use will be transferred more appropriately than similar children who receive care during periods randomized to telephone use. The investigators will compare O/E ratios.
Measured: Year 3
Medication Error Rate Instrument
The investigators hypothesize that children receiving care in EDs during periods of telemedicine use will experience fewer physician-related medication errors than similar children who receive care during periods of telephone use. A previously published instrument developed specifically to evaluate medication errors among children receiving care in the ED will be used.
Measured: Year 3
Economic Efficiency Cost-Analysis
The investigators hypothesized that care provided to children in EDs during randomized periods of telemedicine use will be economically more efficient than care provided during randomized periods of telephone. Cost analysis will estimate return-on-investment indicating the cost saving amount per $1 investment in telemedicine compared to care without telemedicine.
Measured: Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study startNov 2015
- Primary completionAug 2018
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 696 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James P Marcin, MD, MPH, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02877810
- Sponsor's protocol ID
- 678668
- Other IDs
- G01RH27872
- Status last verified
- Oct 2019
- First submitted
- 3 Aug 2016
- Last updated
- 30 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Marcin JP, Lieng MK, Mouzoon J, Sauers-Ford HS, Tancredi D, Cabri A, Pandya VA, Park AS, Kuppermann N. Telemedicine vs Telephone Consultations and Medication Prescribing Errors Among Referring Physicians: A Cluster Randomized Crossover Trial. JAMA Netw Open. 2024 Feb 5;7(2):e240275. doi: 10.1001/jamanetworkopen.2024.0275.
PubMed 38421649Marcin JP, Sauers-Ford HS, Mouzoon JL, Haynes SC, Dayal P, Sigal I, Tancredi D, Lieng MK, Kuppermann N. Impact of Tele-Emergency Consultations on Pediatric Interfacility Transfers: A Cluster-Randomized Crossover Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255770. doi: 10.1001/jamanetworkopen.2022.55770.
PubMed 36780158
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-Based Tele-Emergency Network Grant Program
- ClinicalTrials.gov ID
- NCT02877810
- Acronym / sponsor ID
- 678668
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 696 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 24 Aug 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.
The purpose of this study is to determine the impact of an existing tele-emergency care network on quality of care, appropriateness of care utilization, patient safety (medication errors), and cost effectiveness compared to telephone consultations from a healthcare system prospective.
Detailed description
The investigators will use a novel cluster randomized unbalanced crossover trial design. When a new site is enrolled, the first approximately 6 months of the project will be a "ramp-up" period during which the protocol will be re-reviewed during a site visit to the participating EDs and random block assignments will be generated and delivered. The last 6 months will be reserved for data analysis, study closeout, and manuscript preparation. An intervening 2-year period will be divided into 4 six-month calendar time periods for carrying out the protocol and data collection. For each 6-month period, each ED will have a randomized treatment assignment for pediatric emergency and critical care consultations ("M" for telemedicine and "P" for telephone.) Participating EDs (the unit of randomization) will be stratified into two strata by size of ED and geographical location. EDs will then be randomized within-strata to one of the four unbalanced (3:1) crossover treatment assignment sequences, each consisting of a 6-month period: PMMM, MPMM, MMPM, or MMMP. During these assigned periods, the type of consultation being assigned will be strongly encouraged, but deviating from protocol (i.e., using telephone consultation when randomized to telemedicine, or the vice-versa) will be allowed as needed by the physicians. Data will be collected and abstracted through retrospective chart review.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Experimental | Other: TelemedicineA consultation will be given for the care of a critically ill pediatric patient to a remote hospital emergency department physician by telemedicine, a live, interactive, audiovisual teleconferencing system, from a pediatric critical care physician. |
| Telephone | Active comparator | Other: TelephoneA consultation will be given for the care of a critically ill pediatric patient to a remote hospital emergency department physician by telephone, from a pediatric critical care physician.. |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children younger than or equal to 14 years of age at the time of their ED visit.
Key exclusion criteria (4 listed)
- Children evaluated at the ED for non-medical reasons such as elective surgeries and social reasons (i.e., cases of possible endangerment) and other non-medical reasons.
- Children evaluated at the ED preoperatively, for elective surgical procedures.
- Children transferred to the ED from another hospital ED.
- Children transiently "held" in the ED in the process of a direct admission to the ward.
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 |
|---|---|---|
| TelemedicineTelemedicine is a live, interactive, audiovisual teleconferencing system. | Other | Telemedicine |
| TelephoneConsultations will be given over telephone. | Other | Telephone |
Primary outcome
Quality of Care Implicit Review Instrument
Time frame: Year 3
The investigators hypothesize that children receiving care in EDs during periods of telemedicine use will receive higher quality of care than similar children who receive care during periods of telephone use. A previously validated 5-item implicit review instrument that measures 4 aspects of process of care in the ED, along with a fifth item assessing the overall quality of care provided to the patient will be used. The sum of the 5 item-specific scores will be aggregated from each reviewer to obtain a summary quality score for each medical record.
Pediatric Risk of Admission (PRISA II)
Time frame: Year 3
The investigators hypothesize that children receiving care in EDs during randomized periods of telemedicine use will be admitted more appropriately than similar children who receive care during periods randomized to telephone use. To compare the cohort of seriously ill children treated during the telephone and telemedicine time blocks, observed to expected (O/E) ratios will be calculated using an intention-to-treat framework.
Pediatric Emergency Assessment Tool (Re-PEAT)
Time frame: Year 3
The investigators hypothesize that children receiving care in EDs during randomized periods of telemedicine use will be transferred more appropriately than similar children who receive care during periods randomized to telephone use. The investigators will compare O/E ratios.
Medication Error Rate Instrument
Time frame: Year 3
The investigators hypothesize that children receiving care in EDs during periods of telemedicine use will experience fewer physician-related medication errors than similar children who receive care during periods of telephone use. A previously published instrument developed specifically to evaluate medication errors among children receiving care in the ED will be used.
Economic Efficiency Cost-Analysis
Time frame: Year 3
The investigators hypothesized that care provided to children in EDs during randomized periods of telemedicine use will be economically more efficient than care provided during randomized periods of telephone. Cost analysis will estimate return-on-investment indicating the cost saving amount per $1 investment in telemedicine compared to care without telemedicine.
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 30 Oct 2019.
- Derived from this study: PubMed 38421649Marcin JP, Lieng MK, Mouzoon J, Sauers-Ford HS, Tancredi D, Cabri A, Pandya VA, Park AS, Kuppermann N. Telemedicine vs Telephone Consultations and Medication Prescribing Errors Among Referring Physicians: A Cluster Randomized Crossover Trial. JAMA Netw Open. 2024 Feb 5;7(2):e240275. doi: 10.1001/jamanetworkopen.2024.0275.
- Derived from this study: PubMed 36780158Marcin JP, Sauers-Ford HS, Mouzoon JL, Haynes SC, Dayal P, Sigal I, Tancredi D, Lieng MK, Kuppermann N. Impact of Tele-Emergency Consultations on Pediatric Interfacility Transfers: A Cluster-Randomized Crossover Trial. JAMA Netw Open. 2023 Feb 1;6(2):e2255770. doi: 10.1001/jamanetworkopen.2022.55770.
- Individual participant dataSharing planned: Undecided
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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.
James P Marcin, MD, MPH principal investigator
University of California, Davis
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 and Telephone in people with Critical Illness, run by University of California, Davis 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 4 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 30 Oct 2019. 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?
Quality of Care Implicit Review Instrument (time frame: Year 3). The study lists 5 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 NCT02877810, which also lists 2 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 30 Oct 2019.