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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
RedCap surverys
The study team will use REDCap to send an IRB approved secure electronic survey
Behavioral: Tool kit
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.
Behavioral: Tool kit
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 26, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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