BurnsNCT02607852
Feedback System of PROMS in Children With Burns
A study testing iPads in people with Burns, run by Stephanie Romo at 1 site in United States.
Trial summary
The primary objective of the overall study is to determine the feasibility and usefulness of a feedback system that delivers BOQ results to physicians in "real time" during outpatient encounters using iPads. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Burns
- What is being tested?
- iPads
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2015to 31 Dec 2017
- 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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children between the ages of 0 and 18 years of age, receiving outpatient burn care at Shriners Hospitals for Children - Boston with total body surface area burn of ≥ 5% and/or a burn injury to face, hands, feet or genitalia. English or Spanish speaking and literate
Who cannot join
- Clinician overriding a patient to serve on the study because of medical/psychiatric problems that might in the opinion of the clinician overwhelm the goals/purposes of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children- Boston
Boston, Massachusetts, 02114
About this study
Official title: System for Feedback of Patient Reported Outcomes in Children With Burns
The primary objective of the overall study is to determine the feasibility and usefulness of a feedback system that delivers BOQ results to physicians in "real time" during outpatient encounters using iPads.
Read the detailed description
The primary objective of this pilot study is to ascertain the feasibility and usefulness of a feedback system that provides clinicians with parent-proxy reported outcomes measure data during routine outpatient encounters for burn treatment.
The secondary objective of this first phase of the study is to determine clinicians' and parents perception of the experience of completing the BOQ+P and/or the usefulness of the information that was provided to the clinician and parent/guardians(s). For this reason we will collect a brief debriefing questionnaire from physicians and another from parents.
- Conditions
- Burns
- Being tested
- iPads
- Keywords
- Patient Reported Outcomes Measure, Burns
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPadsDevice
The current study will help determine if using Burn Outcomes Questionnaire and 17- item Pediatric Symptom Checklist (PSC-17) feedback data, collected on iPads or online, over the course of patient treatment will be useful for the physicians and ultimately impact the recovery of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Other | Patients between the ages of 5-18 years. They will complete the 5-18 version of the BOQ on iPads or through the HTTPS Tonic link. Receives: Device: iPads |
| Arm B | Other | Patients between the ages of 0-4 years. They will complete the 0-4 version of the BOQ and appropriate Pediatric Symptom Checklists (i.e. baby or preschool) on iPads or through the HTTPS Tonic link. Receives: Device: iPads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responses to Clinician Debriefing Questionnaires
After viewing the BOQ feedback and seeing the patient, the clinicians will rate whether or not they found the BOQ+P data useful. The measure includes 5 Likert-Scale questions and 1 open-ended question that asks for their feedback about the system.
Measured: Participants will participate for the duration of one outpatient visit, an expected average of 3 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study start8 Apr 2015
- Primary completion31 Dec 2016
- Study completion31 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Arm A: Patients 5-18 years old Arm B: Patients 0-4 years old
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stephanie Romo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stephanie Romo, Shriners Hospitals for Children
- Investigators
- Robert L Sheridan, MD, Principal investigator, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607852
- Sponsor's protocol ID
- BOS1501
- Other IDs
- 20170611
- Status last verified
- Jun 2017
- First submitted
- 17 Aug 2015
- Last updated
- 22 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- System for Feedback of Patient Reported Outcomes in Children With Burns
- ClinicalTrials.gov ID
- NCT02607852
- Acronym / sponsor ID
- BOS1501
- Conditions
- Burns
- Keywords
- Patient Reported Outcomes Measure, Burns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Stephanie RomoUniversity, hospital or other
- Study start
- 8 Apr 2015 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2017 (estimated)
- First posted
- 18 Nov 2015 (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 primary objective of the overall study is to determine the feasibility and usefulness of a feedback system that delivers BOQ results to physicians in "real time" during outpatient encounters using iPads.
Detailed description
The primary objective of this pilot study is to ascertain the feasibility and usefulness of a feedback system that provides clinicians with parent-proxy reported outcomes measure data during routine outpatient encounters for burn treatment.
The secondary objective of this first phase of the study is to determine clinicians' and parents perception of the experience of completing the BOQ+P and/or the usefulness of the information that was provided to the clinician and parent/guardians(s). For this reason we will collect a brief debriefing questionnaire from physicians and another from parents.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm A: Patients 5-18 years old Arm B: Patients 0-4 years old
| Arm | Type | Receives |
|---|---|---|
| Arm A | Other | Device: iPadsPatients between the ages of 5-18 years. They will complete the 5-18 version of the BOQ on iPads or through the HTTPS Tonic link. |
| Arm B | Other | Device: iPadsPatients between the ages of 0-4 years. They will complete the 0-4 version of the BOQ and appropriate Pediatric Symptom Checklists (i.e. baby or preschool) on iPads or through the HTTPS Tonic link. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children between the ages of 0 and 18 years of age, receiving outpatient burn care at Shriners Hospitals for Children - Boston with total body surface area burn of ≥ 5% and/or a burn injury to face, hands, feet or genitalia. English or Spanish speaking and literate
Key exclusion criteria (1 listed)
- Clinician overriding a patient to serve on the study because of medical/psychiatric problems that might in the opinion of the clinician overwhelm the goals/purposes of the study.
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 |
|---|---|---|
| iPadsThe current study will help determine if using Burn Outcomes Questionnaire and 17- item Pediatric Symptom Checklist (PSC-17) feedback data, collected on iPads or online, over the course of patient treatment will be useful for the physicians and ultimately impact the recovery of the patient. | Device | Arm A, Arm B |
Primary outcome
Responses to Clinician Debriefing Questionnaires
Time frame: Participants will participate for the duration of one outpatient visit, an expected average of 3 hours.
After viewing the BOQ feedback and seeing the patient, the clinicians will rate whether or not they found the BOQ+P data useful. The measure includes 5 Likert-Scale questions and 1 open-ended question that asks for their feedback about the system.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2017.
- 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.
Robert L Sheridan, MD principal investigator
Shriners Hospitals for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iPads in people with Burns, run by Stephanie Romo 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 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: status not confirmed, as of the sponsor's last update on 22 Jun 2017. 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?
Results are not available in the source record.
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?
Responses to Clinician Debriefing Questionnaires (time frame: Participants will participate for the duration of one outpatient visit, an expected average of 3 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2017.