- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05917652
The Actuate-CBC Study (ACTUATE)
July 25, 2025 updated by: Amanda Bettencourt, University of Pennsylvania
THE Actuate-CBC Study: Accelerating the Uptake of Telemedicine for Crisis Burn Care
The study team will use implementation science to accelerate the uptake of teleconsultationfor burn patients by 1) examining the relationships between clinician perceptions of acceptability, feasibility, intention to use, and actual use of burn teleconsultation 2) identifying the optimal process for burn teleconsultation and the barriers and facilitators for its use during a crisis or prolonged care situation, and 3) designing and testing the effectiveness of a specific, tailored burn teleconsultation toolkit intervention to increase burn teleconsultation use.
Study Overview
Detailed Description
The principal investigator's central hypothesis is that a tailored implementation intervention (toolkit) that integrates the known advantages of using telemedicine for burn consultation with new knowledge regarding clinician perceptions and the setting in which they work will improve the feasibility, acceptance, intention to use, and uptake of burn teleconsultation.
The implementation intervention will enable rapid burn teleconsultation implementation under crisis circumstances and assist clinicians to virtually connect the person caring for a burn patient anywhere to the entire burn team's expertise.
The study results will lead to more robust national crisis, wartime, and disaster response plans, improve quality of burn care, and decrease morbidity and mortality from serious burn injury, regardless of injury location.
Study Type
Observational
Enrollment (Estimated)
2183
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kelly E Farraday, MSOD
- Phone Number: 2152793718
- Email: kellyfar@nursing.upenn.edu
Study Contact Backup
- Name: Amanda Bettencourt, PhD
- Email: paamanda@nursing.upenn.edu
Study Locations
-
-
California
-
Orange, California, United States, 92868
- Recruiting
- UCI Health Regional Burn Center
-
Contact:
- Victor Joe, MD
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Not yet recruiting
- Massachusetts General Hospital Sumner Redstone Burn Center
-
Contact:
- John Schulz, MD
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan
-
Contact:
- Gary Verycruysse, MD
-
-
Minnesota
-
Saint Paul, Minnesota, United States, 55101
- Recruiting
- Regions Hospital Burn Center
-
Contact:
- Mark Johnston, RN
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
physicians and other staff members treating burn patients
Description
Inclusion Criteria:
- 18 years of age or older and
- are providing burn care to patients at the 4 burn centers and the non-burnhospitals are eligible for inclusion.
Exclusion Criteria:
- do not meet inclusion criteria,
- decline to participate or do not give consent to participate in the study, •
- directly express uneasiness about the participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
RedCap surverys
The study team will use REDCap to send an IRB approved secure electronic survey
|
The study team will develop and design key elements of the implementation intervention (toolkit) among a small group of burn and non-burn clinician stakeholders (4-6 total).
The study team will use in-person interviews with stakeholders and a semi-structured interview guide to elicit feedback and assess face and content validity of the toolkit elements prior to deployment across the study hospitals.
For those who consent to participation, the study team will conduct virtual teleconference interviews in-person using a secure videoconferencing platform while the person is not working, at a time convenient for them.
Interviews will last between 45 and 60 minutes.
The study team anticipates conducting 4-6 interviews to finalize toolkit elements prior to implementation.
|
|
Interviews
The study team plans to do about 18-23 one-on-one interviews with clinicians (burn care nurses, physicians, advanced practice providers, therapists) or will progress until data saturation is reached.
|
The study team will develop and design key elements of the implementation intervention (toolkit) among a small group of burn and non-burn clinician stakeholders (4-6 total).
The study team will use in-person interviews with stakeholders and a semi-structured interview guide to elicit feedback and assess face and content validity of the toolkit elements prior to deployment across the study hospitals.
For those who consent to participation, the study team will conduct virtual teleconference interviews in-person using a secure videoconferencing platform while the person is not working, at a time convenient for them.
Interviews will last between 45 and 60 minutes.
The study team anticipates conducting 4-6 interviews to finalize toolkit elements prior to implementation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Examine the relationships between clinician perceptions of feasibility, acceptability, intention to use, and the actual use of acute burn teleconsultation.
Time Frame: 4 years
|
The study team will look at the differences in opinions between the Aim 1 and 2 interviews and surveys as well as the referral numbers being collected and compare that to the Aim 3 data from interviews and surveys as well as actual referral data to see if there is an increase in the use of telemedicine.
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 4, 2023
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 15, 2027
Study Registration Dates
First Submitted
January 20, 2023
First Submitted That Met QC Criteria
June 14, 2023
First Posted (Actual)
June 26, 2023
Study Record Updates
Last Update Posted (Actual)
July 30, 2025
Last Update Submitted That Met QC Criteria
July 25, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 850877
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Telemedicine
-
Michigan State UniversityUniversity of Michigan; Wake Forest University Health Sciences; Babes-Bolyai...CompletedUsual Care | Telemedicine: Smoking Cessation App Only | Telemedicine: Smoking Cessation Counseling | Telemedicine: App + CounselingRomania
-
Attune Health Research, Inc.Rheumatology Research FoundationRecruiting
-
University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyCompleted
-
Wake Forest University Health SciencesCompleted
-
National University Health System, SingaporeCompletedTelemedicineSingapore
-
CochlearCompletedTelemedicineUnited States
-
The Hong Kong Polytechnic UniversityCompleted
-
Wake Forest University Health SciencesCompleted
-
Buzzi Children's HospitalCompleted
Clinical Trials on Tool kit
-
University of California, San DiegoRecruitingType 2 Diabetes | Diabetes DistressUnited States
-
Deborah Wexler, MDNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2United States
-
University of Alabama at BirminghamNational Institute of Mental Health (NIMH); Massachusetts General Hospital; Beth...CompletedHIV-infection/AIDSUnited States
-
Brigham and Women's HospitalMassachusetts General Hospital; Robert Wood Johnson Foundation; North Shore Medical...Completed
-
Vanderbilt UniversityCompletedVentilator Associated Pneumonia | Central Line-associated Bloodstream Infection (CLABSI)United States
-
Vertos Medical, Inc.Completed
-
Joshua M HareCompletedHypoplastic Left Heart SyndromeUnited States
-
University of MichiganCompleted
-
University of California, San FranciscoNational Institute of Mental Health (NIMH); Muhimbili University of Health...Not yet recruiting
-
Merck KGaA, Darmstadt, GermanyCompleted