Burns, Pediatric ALL
Conditions
Keywords
Pediatrics, Telemedicine, Mobile health, Burns
Brief summary
Because burn patients and their caregivers often live long distances from regional burn centers, access to expert burn care is limited, resulting in a negative effect on adherence to treatment and a higher risk of wound complication. A novel smartphone application synchronized with a web portal for providers, called the Telemedicine Optimized Burn Intervention (TOBI), was recently developed to enable burn experts to direct burn wound care while the patient and caregiver are home through text messaging, image transfer, and video-conferencing. The goal of the present study is evaluate TOBI compared to face-to-face care as usual for pediatric patients/caregivers visiting a burn center. This study will also assess the feasibility of conducting a larger-scale clinical trial in several burn centers. The app will allow the physician and patient/caregivers to make instant decisions regarding treatment, allowing for turn on a dime treatment decisions, rather than having the patients and families wait for scheduled clinic appointments, often hours away from home. This on demand medical care takes an innovative approach to increasing access to burn experts through smartphone technology and addressing adherence to prescribed treatment by increasing communication between provider and patients.
Interventions
If the participants are assigned to FTF care, they will receive standard burn care including a return follow-up in the burn clinic on a routine basis as prescribed by the clinical burn team (at least once per week) until the burn has healed.
Participants assigned to TOBI will be given instructions how to download and use TOBI on a smartphone, including how to interface with burn clinicians using text-messaging, videoconferencing, and sending photos of the child's burn(s). The participants will have scheduled video visits with the care provider at least weekly until the burn has healed. The participants will be able to use other features of the app, such as text-messaging and sending photos of the burn(s), as needed. The participants will be able to use standard FTF burn care as well. They will be given instructions how to contact the burn team through the hospital paging operator if TOBI is unavailable or there is an emergency.
Sponsors
Study design
Eligibility
Inclusion criteria
Caregiver parents and their children (patients) will be considered as participants and will be eligible for enrollment if: 1. the patient (child) is \< 18 years of age; caregiver age \>18 years of age 2. the patient is diagnosed with a partial thickness burn between \<1% TBSA - 20% TBSA by a pediatric burn surgeon; 3. the patient's burn is being treated with advanced burn dressing therapy (e.g., Silvadene™, Polysporin™, Acticoat™, Mepilex™, or Mepitel™); 4. the patient's burn is evaluated by the MUSC burn team within 48 hours of injury; 5. the patient's caregiver (parent or legal guardian) is able to speak, hear, and understand English, as determined during study recruitment procedures; 6. the caregiver owns and is capable of using a smart device (an Android or iOS smartphone) with permission to download TOBI app from the Google Store or AppStore; 7. able to comply with outpatient clinic visits.
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Agree to Participate in the Study | At enrollment | Looking at the number of participants (parents and children) who agree to enroll in the study at the time of burn injury versus the total number of participants who were approached to participate in the study. |
| Number of Participants Retained in the Study Over Time | From enrollment to 30 days after burn wound has healed (up to 35 days after enrollment). | Looking at the number of participants retained in the study versus those lost to attrition |
| Wound Care Treatment Adherence | Assessed weekly at clinic/telemedicine visit until burn wound was healed, up to 35 days after injury | Looking at the percentage of patient/caregiver dyads who adhered to prescribed burn wound care treatment protocol. A wound care fidelity checklist was used at each visit to determine the percentage of wound care adherence per visit. These percentages were then averaged for each weekly visit to give the value below. |
| Number of Child Participants That Experienced Adverse Events, Serious Adverse Events, and Unexpected Problems | Assessed weekly until burn wound was healed, up to 35 days | Looking at the number of child participants in each condition that experienced adverse events, serious adverse events, and unexpected problems. Adverse events in this study included infection, delay in wound care or non-healing wound. Adult caregivers are not included in this as they did not have burn wounds that were assesssed. |
| Number of Times Problems With Technology Happened in the TOBI Condition | Assessed weekly until burn wound was healed, up to 35 days | Looking at the number of times providers or participants experienced and reported technological problems with TOBI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Attitudes Towards Technology and Telemedicine Questionnaire | Measured at baseline and 1-month follow-up | Looking at the change in group average scores on the Attitudes Towards Technology and Telemedicine Questionnaire (caregiver-reported) from baseline to 1 month follow-up. Scores may range between 26-130, with higher scores = more positive attitudes towards technology and telemedicine. |
| Perception of Healthcare Access | Measured at baseline and 1-month follow-up | Looking at the change in group average scores on the Barriers to Care Questionnaire (BCQ), Pragmatics Subscale (caregiver-reported). Scores range from 0-100, with higher scores = fewer barriers and problems with access. |
| Positive And Negative Affect Schedule (PANAS) Scores | Measured at baseline/enrollment and 1-month follow-up. | Looking at the group average scores on the PANAS questionnaire measuring positive and negative affect (caregiver-reported). The means of the positive and negative scores for PANAS are reported below along with standard deviations. The scores range between 10-50, with higher scores = higher levels of affect (both positive and negative). For positive affect, a higher score is a better outcome and for negative affect, a lower score is a better outcome. Scores are reported for baseline and 1 month after burn wound healing. |
| Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) Scores | Measured at baseline and 1-month follow-up | Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. The raw scores on the 8 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 37.1-81.1. T scores are interpreted as follows: \<55 (none to slight depression), 55-59.9 (mild depression), 60-69.9 (moderate depression), \>70 (severe depression). T scores and standard error are reported below. |
| Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) Scores | Measured at baseline and 1-month follow-up | Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) range in score from 7 to 35 with higher scores indicating greater severity of anxiety. The raw scores on the 7 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 36.3-82.7. T scores are interpreted as follows: \<55 (none to slight anxiety), 55-59.9 (mild anxiety), 60-69.9 (moderate anxiety), \>70 (severe anxiety). T scores and standard error are reported below. |
| Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) Scores | Measured at baseline only | Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-General Self Efficacy questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) range in score from 8 to 40 with higher scores indicating greater self efficacy. The raw scores on the 7 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 22.72-64.98. A T-score value of 55 indicated that the respondent has greater self-efficacy for managing emotions. Higher scores indicating more self efficacy and lower scores with less self efficacy. T scores and standard error are reported below. |
| Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) Scores | Measured at baseline only | Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-Self-Efficacy Managing emotions questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) range in score from 4-20 with higher scores indicating greater severity of anxiety. The raw scores on the 4 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 36.3-82.7. A T-score of 55 and greater indicates that the respondent has greater self efficacy and ability to manage their emotions regarding disease. A higher score than 55 indicates even more self efficacy and lower score, less. T scores and standard error are reported below. |
| Peritraumatic Distress Inventory (PDI) Sores | Measured at baseline only | Looking at average scores on the Peritraumatic Distress Inventory (caregiver-reported). Scores range between 0-52, with higher scores = greater peritraumatic distress. An optimal cutoff score of 23 (sensitivity = 71%; specificity = 73%) is good for predicting clinically elevated PTSD 30-days post-injury. |
| Number of Days Until Wound is Healed | Measured during the treatment phase (2-4 weeks) | Looking at the number of days it takes for wound to heal following burn injury in both conditions |
| Posttraumatic Growth Inventory (PTGI) Scores | Measured at 1-month follow-up only | Average scores on the Posttraumatic Growth Inventory (caregiver-reported). Scores range from 0-105, with higher scores = greater posttraumatic growth. |
| Client Satisfaction Questionnaire-8 (CSQ-8) Scores | Measured at 1-month follow-up only | Looking at average scores on the Client Satisfaction Questionnaire-8 scores (caregiver-reported). Scores range between 8-32, with higher scores = greater satisfaction. |
| mHealth App Usability Questionnaire (MAUQ) Scores | Measured at 1-month follow-up only | Looking at average scores on the MAUQ questionnaire measuring app usability (caregiver-reported in TOBI condition only). Raw scores range between 21-147 and average scores range between 1-7, with higher overall score equivalent to higher usability of the app. The average scores and standard deviation are reported below for the TOBI group. |
| Total Number of Face-to-face Visits | Treatment phase (weeks 2-4) | Looking at the total number of face-to-face visits |
| Total Number of TOBI Visits | Treatment phase (weeks 2-4) | Looking at the total number of TOBI visits |
| Total Travel Time | From enrollment through treatment phase (weeks 1-4) | Looking at the total travel time in each condition as reported by the caregiver. |
| Direct Cost to Patient/Caregiver | From enrollment through treatment phase (weeks 1-4) | Looking at the direct cost to patient/caregiver as reported by caregiver |
| Time to Return to Work | From enrollment through the treatment phase (weeks 1-4). This included any time that the parent had was out of work because of the injury at time of occurrence or due to clinic follow up. | Looking at the average time it took patient/caregiver to return to work after burn wound injury. |
| Perceived Stress Scale (PSS) Scores | Measured at 1-month follow-up only | Looking at average scores on the Perceived Stress Scale (caregiver-reported) between two conditions. Scores on the PSS can range from 0 to 40 with higher scores = higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress. |
| Number of Unscheduled ED or Clinic Visits | Measured during the treatment phase (2-4 weeks) | Looking at the number of times participants had unscheduled visits (in the ED or the clinic) |
| Number of Wound Complications | Measured during the treatment phase (2-4 weeks) | Looking at the number of wound complications (e.g., infection, conversion to deeper burn requiring surgery, conversion to deeper burn requiring a change in therapy). |
| Patient-reported Pain Scores | Measured during the treatment phase (week 1 clinic visit) | Looking at average pain score at follow up visits between the two groups using the Wong-Baker Scale (0-10, with higher scores = more pain). Most patients only attended one follow up visit but if more than one, the average score is reported below. |
| Caregiver's Perception of Child's Pain Scores | Measured during the treatment phase (week 1 clinic visit) | Looking at average caregiver's perception of child's pain score at follow up visits between the two groups using the Wong-Baker Scale (0-10, with higher scores = more pain). Most dyads only attended one follow up visit but if more than one, the average score is reported below. |
Countries
United States
Participant flow
Recruitment details
Burn patients were recruited from burn clinic and the inpatient hospital setting to participate a study comparing face to face outpatient wound care to virtual wound care.
Pre-assignment details
Parents/caregivers \*and\* children were considered enrolled in the study as a dyad, although most of the outcomes were reported by the parent instead of the child. Since demographic data was collected on both the caregiver and the child, the Total Started number is 130 (65 caregivers AND 65 children) as there were 65 dyads enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Face-to-face Arm Standard face-to-face burn care.
Face-to-face burn care: If the participants are assigned to FTF care, they will receive standard burn care including a return follow-up in the burn clinic on a routine basis as prescribed by the clinical burn team (at least once per week) until the burn has healed. | 66 |
| TOBI Arm A novel smartphone application for burn wound care, called the Telemedicine Optimized Burn Intervention (TOBI), was recently developed to enable burn experts to direct burn wound care while the patient and caregiver are home through text messaging and video-conferencing. TOBI is synced with a portal used by providers, as an adjunct to standard therapy. This burn app provides education through frequently asked questions, instructional burn dressing change videos in addition to direct communication between patient and burn expert through store-and-forward pictures and videoconferencing.
Telemedicine enhanced burn care: Participants assigned to TOBI will be given instructions how to download and use TOBI on a smartphone, including how to interface with burn clinicians using text-messaging, videoconferencing, and sending photos of the child's burn(s). The participants will have scheduled video visits with the care provider at least weekly until the burn has healed. The participants will be able to use other features of the app, such as text-messaging and sending photos of the burn(s), as needed. The participants will be able to use standard FTF burn care as well. They will be given instructions how to contact the burn team through the hospital paging operator if TOBI is unavailable or there is an emergency. | 64 |
| Total | 130 |
Baseline characteristics
| Characteristic | TOBI Arm | Face-to-face Arm | Total |
|---|---|---|---|
| Age, Categorical Parents/Caregivers <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Parents/Caregivers >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Parents/Caregivers Between 18 and 65 years | 32 Participants | 33 Participants | 65 Participants |
| Age, Categorical Patients <=18 years | 32 Participants | 33 Participants | 65 Participants |
| Age, Categorical Patients >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Patients Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous Parents/Caregivers | 35 years | 34 years | 34 years |
| Age, Continuous Patients | 8 years | 5 years | 6 years |
| Race (NIH/OMB) Parents/Caregivers American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parents/Caregivers Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parents/Caregivers Black or African American | 13 Participants | 13 Participants | 26 Participants |
| Race (NIH/OMB) Parents/Caregivers More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parents/Caregivers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Parents/Caregivers Unknown or Not Reported | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Parents/Caregivers White | 18 Participants | 15 Participants | 33 Participants |
| Race (NIH/OMB) Patients American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Black or African American | 13 Participants | 13 Participants | 26 Participants |
| Race (NIH/OMB) Patients More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patients Unknown or Not Reported | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Patients White | 18 Participants | 15 Participants | 33 Participants |
| Region of Enrollment United States | 64 participants | 66 participants | 130 participants |
| Sex: Female, Male Parents/Caregivers Female | 32 Participants | 28 Participants | 60 Participants |
| Sex: Female, Male Parents/Caregivers Male | 0 Participants | 5 Participants | 5 Participants |
| Sex: Female, Male Patients Female | 16 Participants | 15 Participants | 31 Participants |
| Sex: Female, Male Patients Male | 16 Participants | 18 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 32 |
| other Total, other adverse events | 0 / 33 | 2 / 32 |
| serious Total, serious adverse events | 0 / 33 | 0 / 32 |
Outcome results
Number of Child Participants That Experienced Adverse Events, Serious Adverse Events, and Unexpected Problems
Looking at the number of child participants in each condition that experienced adverse events, serious adverse events, and unexpected problems. Adverse events in this study included infection, delay in wound care or non-healing wound. Adult caregivers are not included in this as they did not have burn wounds that were assesssed.
Time frame: Assessed weekly until burn wound was healed, up to 35 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Face-to-face Arm | Number of Child Participants That Experienced Adverse Events, Serious Adverse Events, and Unexpected Problems | 0 Participants |
| TOBI Arm | Number of Child Participants That Experienced Adverse Events, Serious Adverse Events, and Unexpected Problems | 0 Participants |
Number of Participants Retained in the Study Over Time
Looking at the number of participants retained in the study versus those lost to attrition
Time frame: From enrollment to 30 days after burn wound has healed (up to 35 days after enrollment).
Population: Parents/caregivers and patients were considered to be enrolled together as a dyad, but are reported here as caregiver and patient.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Face-to-face Arm | Number of Participants Retained in the Study Over Time | 36 participants |
| TOBI Arm | Number of Participants Retained in the Study Over Time | 42 participants |
Number of Participants Who Agree to Participate in the Study
Looking at the number of participants (parents and children) who agree to enroll in the study at the time of burn injury versus the total number of participants who were approached to participate in the study.
Time frame: At enrollment
Population: This includes caregivers and their children.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Face-to-face Arm | Number of Participants Who Agree to Participate in the Study | 66 participants |
| TOBI Arm | Number of Participants Who Agree to Participate in the Study | 64 participants |
Number of Times Problems With Technology Happened in the TOBI Condition
Looking at the number of times providers or participants experienced and reported technological problems with TOBI
Time frame: Assessed weekly until burn wound was healed, up to 35 days
Population: Only participants in the TOBI arm were evaluated for issues with technology as the face to face group did not interact with technology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TOBI Arm | Number of Times Problems With Technology Happened in the TOBI Condition | 1 number of technological problems |
Wound Care Treatment Adherence
Looking at the percentage of patient/caregiver dyads who adhered to prescribed burn wound care treatment protocol. A wound care fidelity checklist was used at each visit to determine the percentage of wound care adherence per visit. These percentages were then averaged for each weekly visit to give the value below.
Time frame: Assessed weekly at clinic/telemedicine visit until burn wound was healed, up to 35 days after injury
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Arm | Wound Care Treatment Adherence | 76.8 percentage of wound care adherence | Standard Deviation 40.1 |
| TOBI Arm | Wound Care Treatment Adherence | 84.9 percentage of wound care adherence | Standard Deviation 29.1 |
Attitudes Towards Technology and Telemedicine Questionnaire
Looking at the change in group average scores on the Attitudes Towards Technology and Telemedicine Questionnaire (caregiver-reported) from baseline to 1 month follow-up. Scores may range between 26-130, with higher scores = more positive attitudes towards technology and telemedicine.
Time frame: Measured at baseline and 1-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Arm | Attitudes Towards Technology and Telemedicine Questionnaire | 79.5 units on a scale | Standard Deviation 6.3 |
| TOBI Arm | Attitudes Towards Technology and Telemedicine Questionnaire | 78.0 units on a scale | Standard Deviation 8.4 |
Caregiver's Perception of Child's Pain Scores
Looking at average caregiver's perception of child's pain score at follow up visits between the two groups using the Wong-Baker Scale (0-10, with higher scores = more pain). Most dyads only attended one follow up visit but if more than one, the average score is reported below.
Time frame: Measured during the treatment phase (week 1 clinic visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Arm | Caregiver's Perception of Child's Pain Scores | 3.1 score on a scale | Standard Deviation 3 |
| TOBI Arm | Caregiver's Perception of Child's Pain Scores | 1.8 score on a scale | Standard Deviation 1.7 |
Client Satisfaction Questionnaire-8 (CSQ-8) Scores
Looking at average scores on the Client Satisfaction Questionnaire-8 scores (caregiver-reported). Scores range between 8-32, with higher scores = greater satisfaction.
Time frame: Measured at 1-month follow-up only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Arm | Client Satisfaction Questionnaire-8 (CSQ-8) Scores | 30.8 units on a scale | Standard Deviation 3 |
| TOBI Arm | Client Satisfaction Questionnaire-8 (CSQ-8) Scores | 30.5 units on a scale | Standard Deviation 3 |
Direct Cost to Patient/Caregiver
Looking at the direct cost to patient/caregiver as reported by caregiver
Time frame: From enrollment through treatment phase (weeks 1-4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Arm | Direct Cost to Patient/Caregiver | 339.10 dollars | Standard Deviation 568.14 |
| TOBI Arm | Direct Cost to Patient/Caregiver | 258.81 dollars | Standard Deviation 390.38 |
mHealth App Usability Questionnaire (MAUQ) Scores
Looking at average scores on the MAUQ questionnaire measuring app usability (caregiver-reported in TOBI condition only). Raw scores range between 21-147 and average scores range between 1-7, with higher overall score equivalent to higher usability of the app. The average scores and standard deviation are reported below for the TOBI group.
Time frame: Measured at 1-month follow-up only
Population: The face-to-face arm did not use the TOBI app at all, therefore they did not take the MAUQ to rate the app.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TOBI Arm | mHealth App Usability Questionnaire (MAUQ) Scores | 6.3 units on a scale | Standard Deviation 0.8 |
Number of Days Until Wound is Healed
Looking at the number of days it takes for wound to heal following burn injury in both conditions
Time frame: Measured during the treatment phase (2-4 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Arm | Number of Days Until Wound is Healed | 11.5 days to wound healed | Standard Deviation 4.3 |
| TOBI Arm | Number of Days Until Wound is Healed | 11.4 days to wound healed | Standard Deviation 3.9 |
Number of Unscheduled ED or Clinic Visits
Looking at the number of times participants had unscheduled visits (in the ED or the clinic)
Time frame: Measured during the treatment phase (2-4 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Face-to-face Arm | Number of Unscheduled ED or Clinic Visits | 0 number of unscheduled ED/clinic visits |
| TOBI Arm | Number of Unscheduled ED or Clinic Visits | 2 number of unscheduled ED/clinic visits |
Number of Wound Complications
Looking at the number of wound complications (e.g., infection, conversion to deeper burn requiring surgery, conversion to deeper burn requiring a change in therapy).
Time frame: Measured during the treatment phase (2-4 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Face-to-face Arm | Number of Wound Complications | 0 number of wound complications |
| TOBI Arm | Number of Wound Complications | 0 number of wound complications |
Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) Scores
Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-Anxiety questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) range in score from 7 to 35 with higher scores indicating greater severity of anxiety. The raw scores on the 7 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 36.3-82.7. T scores are interpreted as follows: \<55 (none to slight anxiety), 55-59.9 (mild anxiety), 60-69.9 (moderate anxiety), \>70 (severe anxiety). T scores and standard error are reported below.
Time frame: Measured at baseline and 1-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Face-to-face Arm | Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) Scores | Baseline | 50.7 T-score | Standard Error 9.1 |
| Face-to-face Arm | Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) Scores | 1 month follow up | 50.4 T-score | Standard Error 6.8 |
| TOBI Arm | Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) Scores | Baseline | 47.8 T-score | Standard Error 7.8 |
| TOBI Arm | Patient-Reported Outcomes Measurement Information System - Anxiety (PROMIS-Anxiety) Scores | 1 month follow up | 46.8 T-score | Standard Error 7.6 |
Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) Scores
Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of depression. The raw scores on the 8 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 37.1-81.1. T scores are interpreted as follows: \<55 (none to slight depression), 55-59.9 (mild depression), 60-69.9 (moderate depression), \>70 (severe depression). T scores and standard error are reported below.
Time frame: Measured at baseline and 1-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Face-to-face Arm | Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) Scores | Baseline | 47.5 T-score | Standard Error 7.6 |
| Face-to-face Arm | Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) Scores | 1 month follow up | 47.5 T-score | Standard Error 8 |
| TOBI Arm | Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) Scores | Baseline | 47.5 T-score | Standard Error 6.2 |
| TOBI Arm | Patient-Reported Outcomes Measurement Information System - Depression (PROMIS-Depression) Scores | 1 month follow up | 44.9 T-score | Standard Error 6.1 |
Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) Scores
Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-General Self Efficacy questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) range in score from 8 to 40 with higher scores indicating greater self efficacy. The raw scores on the 7 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 22.72-64.98. A T-score value of 55 indicated that the respondent has greater self-efficacy for managing emotions. Higher scores indicating more self efficacy and lower scores with less self efficacy. T scores and standard error are reported below.
Time frame: Measured at baseline only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Arm | Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) Scores | 53.5 T-score | Standard Error 10.1 |
| TOBI Arm | Patient-Reported Outcomes Measurement Information System - General Self-Efficacy (PROMIS-General-Self-Efficacy) Scores | 53.2 T-score | Standard Error 8.8 |
Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) Scores
Looking at the baseline and 1-month follow up scores on the Patient-Reported Outcomes Measurement Information System (PROMIS)-Self-Efficacy Managing emotions questionnaire (caregiver-reported). Each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) range in score from 4-20 with higher scores indicating greater severity of anxiety. The raw scores on the 4 items should be summed to obtain a total raw score. Next, the T-score table is used to identify the T-score associated with the individual's total raw score. The mean T-scores is 50 with a standard deviation of 10. T-scores range between 36.3-82.7. A T-score of 55 and greater indicates that the respondent has greater self efficacy and ability to manage their emotions regarding disease. A higher score than 55 indicates even more self efficacy and lower score, less. T scores and standard error are reported below.
Time frame: Measured at baseline only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Arm | Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) Scores | 50.2 T-score | Standard Error 9.1 |
| TOBI Arm | Patient-Reported Outcomes Measurement Information System - Self-Efficacy to Manage Emotions (PROMIS-Self-Efficacy-Manage-Emotions) Scores | 50.7 T-score | Standard Error 6.6 |
Patient-reported Pain Scores
Looking at average pain score at follow up visits between the two groups using the Wong-Baker Scale (0-10, with higher scores = more pain). Most patients only attended one follow up visit but if more than one, the average score is reported below.
Time frame: Measured during the treatment phase (week 1 clinic visit)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Arm | Patient-reported Pain Scores | 3.1 units on a scale | Standard Deviation 3 |
| TOBI Arm | Patient-reported Pain Scores | 1.8 units on a scale | Standard Deviation 1.7 |
Perceived Stress Scale (PSS) Scores
Looking at average scores on the Perceived Stress Scale (caregiver-reported) between two conditions. Scores on the PSS can range from 0 to 40 with higher scores = higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Time frame: Measured at 1-month follow-up only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Arm | Perceived Stress Scale (PSS) Scores | 18.6 units on a scale | Standard Deviation 2.7 |
| TOBI Arm | Perceived Stress Scale (PSS) Scores | 19.4 units on a scale | Standard Deviation 3 |
Perception of Healthcare Access
Looking at the change in group average scores on the Barriers to Care Questionnaire (BCQ), Pragmatics Subscale (caregiver-reported). Scores range from 0-100, with higher scores = fewer barriers and problems with access.
Time frame: Measured at baseline and 1-month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Arm | Perception of Healthcare Access | 64.5 units on a scale | Standard Deviation 25.5 |
| TOBI Arm | Perception of Healthcare Access | 72.6 units on a scale | Standard Deviation 20.3 |
Peritraumatic Distress Inventory (PDI) Sores
Looking at average scores on the Peritraumatic Distress Inventory (caregiver-reported). Scores range between 0-52, with higher scores = greater peritraumatic distress. An optimal cutoff score of 23 (sensitivity = 71%; specificity = 73%) is good for predicting clinically elevated PTSD 30-days post-injury.
Time frame: Measured at baseline only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Arm | Peritraumatic Distress Inventory (PDI) Sores | 11.9 units on a scale | Standard Deviation 8.1 |
| TOBI Arm | Peritraumatic Distress Inventory (PDI) Sores | 13.8 units on a scale | Standard Deviation 8.3 |
Positive And Negative Affect Schedule (PANAS) Scores
Looking at the group average scores on the PANAS questionnaire measuring positive and negative affect (caregiver-reported). The means of the positive and negative scores for PANAS are reported below along with standard deviations. The scores range between 10-50, with higher scores = higher levels of affect (both positive and negative). For positive affect, a higher score is a better outcome and for negative affect, a lower score is a better outcome. Scores are reported for baseline and 1 month after burn wound healing.
Time frame: Measured at baseline/enrollment and 1-month follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Face-to-face Arm | Positive And Negative Affect Schedule (PANAS) Scores | Baseline Positive Affect | 37 units on a scale | Standard Deviation 7 |
| Face-to-face Arm | Positive And Negative Affect Schedule (PANAS) Scores | Baseline Negative Affect | 14 units on a scale | Standard Deviation 4 |
| Face-to-face Arm | Positive And Negative Affect Schedule (PANAS) Scores | 1 month follow up Positive Affect | 35 units on a scale | Standard Deviation 8 |
| Face-to-face Arm | Positive And Negative Affect Schedule (PANAS) Scores | 1 month follow up Negative Affect | 13 units on a scale | Standard Deviation 4 |
| TOBI Arm | Positive And Negative Affect Schedule (PANAS) Scores | 1 month follow up Negative Affect | 11 units on a scale | Standard Deviation 5 |
| TOBI Arm | Positive And Negative Affect Schedule (PANAS) Scores | Baseline Positive Affect | 32 units on a scale | Standard Deviation 8 |
| TOBI Arm | Positive And Negative Affect Schedule (PANAS) Scores | 1 month follow up Positive Affect | 33 units on a scale | Standard Deviation 7 |
| TOBI Arm | Positive And Negative Affect Schedule (PANAS) Scores | Baseline Negative Affect | 13 units on a scale | Standard Deviation 5 |
Posttraumatic Growth Inventory (PTGI) Scores
Average scores on the Posttraumatic Growth Inventory (caregiver-reported). Scores range from 0-105, with higher scores = greater posttraumatic growth.
Time frame: Measured at 1-month follow-up only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Arm | Posttraumatic Growth Inventory (PTGI) Scores | 54.7 units on a scale | Standard Deviation 31.9 |
| TOBI Arm | Posttraumatic Growth Inventory (PTGI) Scores | 39.5 units on a scale | Standard Deviation 35.6 |
Time to Return to Work
Looking at the average time it took patient/caregiver to return to work after burn wound injury.
Time frame: From enrollment through the treatment phase (weeks 1-4). This included any time that the parent had was out of work because of the injury at time of occurrence or due to clinic follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Arm | Time to Return to Work | 2.0 days | Standard Deviation 2.2 |
| TOBI Arm | Time to Return to Work | 1.3 days | Standard Deviation 1.5 |
Total Number of Face-to-face Visits
Looking at the total number of face-to-face visits
Time frame: Treatment phase (weeks 2-4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Arm | Total Number of Face-to-face Visits | 2.1 number of visits | Standard Deviation 0.8 |
| TOBI Arm | Total Number of Face-to-face Visits | 1.1 number of visits | Standard Deviation 0.3 |
Total Number of TOBI Visits
Looking at the total number of TOBI visits
Time frame: Treatment phase (weeks 2-4)
Population: This outcome only pertains to the TOBI arm as the face-to-face arm did not have any TOBI visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TOBI Arm | Total Number of TOBI Visits | 1.1 number of visits | Standard Deviation 0.6 |
Total Travel Time
Looking at the total travel time in each condition as reported by the caregiver.
Time frame: From enrollment through treatment phase (weeks 1-4)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Face-to-face Arm | Total Travel Time | 4.0 hours | Standard Deviation 3.1 |
| TOBI Arm | Total Travel Time | 2.3 hours | Standard Deviation 2.5 |