Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese)NCT03501667
Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use
A study testing Use of decision support tool and Use of UpToDate in people with Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese), run by Boston Children's Hospital at 1 site in United States.
Trial summary
Boston Children's Hospital resources include SimulConsult which is a decision support tool available for use of BCH provider through the library portal. It is offered along other resources on that webpage (UpToDate, Micromedex, and VisualDx). See addendum 1. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese)
- What is being tested?
- Use of decision support tool and Use of UpToDate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 31 Dec 2020
- 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A trainee at Boston Children's residency program (pediatrics, emergency medicine, pediatric emergency medicine, pediatric rheumatology)
Who cannot join
- Opting out of the study (optional at any stage)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Lauren Robertson, 617-919-1526, lauren.robertson@childrens.harvard.edu
Lindsey Rice, 6179196160, lindsey.rice@childrens.harvard.edu
About this study
Official title: Boston Children's Hospital
Boston Children's Hospital resources include SimulConsult which is a decision support tool available for use of BCH provider through the library portal. It is offered along other resources on that webpage (UpToDate, Micromedex, and VisualDx). See addendum 1.
Recently, a pediatric rheumatology arm was added to the expertise of SimulConsult, guided by our co-PI, Dr. Robert Sundel. As this tool is being offered and used, the investigators would like to assess metric of performance of this tool in enhancing participant trainees knowledge about the work up of patients with a potential rheumatologic disorder. See also www.ncbi.nlm.gov/pubmed/27964737 The investigators are conducting a clinical research to assess improvement in the clinical performance of study participants evaluating patients with a potential rheumatologic disorder. The intervention involved in using a computerized decision support tool already available in the Boston Children's Hospital domain. The outcome will be comparing this performance to that of an attending physician as the gold standard. We will assess the study participants performance across two locations: Emergency Department and Rheumatology clinic. Care to patients remains unchanged, as the workup plan and care is provided by an attending across both domains.
The investigators main hypothesis is that using a decision support tool will result in a higher agreement rate between study participants' differential diagnosis and work up plan compared with the gold standard (attending differential diagnosis and research plan).
Read the detailed description
Boston Children's Hospital resources include SimulConsult which is a decision support tool available for use of BCH provider through the library portal. It is offered along other resources on that webpage (UpToDate, Micromedex, and VisualDx). See addendum 1.
Recently, a pediatric rheumatology arm was added to the expertise of SimulConsult, guided by our co-PI, Dr. Robert Sundel. As this tool is being offered and used, the investigators would like to assess metric of performance of this tool in enhancing study participants (trainees) knowledge about the work up of patients with a potential rheumatologic disorder. See also www.ncbi.nlm.gov/pubmed/27964737 The investigators are conducting a clinical research to assess improvement in the clinical performance of trainees evaluating patients with a potential rheumatologic disorder. The intervention involved in using a computerized decision support tool already available in the Boston Children's Hospital domain. The outcome will be comparing this performance to that of an attending physician as the gold standard. The investigators will assess the study participants performance across two locations: Emergency Department and Rheumatology clinic. Care to patients remains unchanged, as the workup plan and care is provided by an attending across both domains.
Our main hypothesis is that using a decision support tool will result in a higher agreement rate between study participants' differential diagnosis and work up plan compared with the gold standard (attending differential diagnosis and research plan).
- Being tested
- Use of decision support tool, Use of UpToDate
- Medical subject headings
- Arthritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of decision support toolOther
Also called Use of SimulConsult
use of a decision support software during clinical assessment of a case
Use of UpToDateOther
Also called Use of current literature
Control group, participants using current literature prior to assessing a clinical case. Allowing 10 minutes to read on a topic during clinical care is an active intervention in the study participant fund of knowledge.
| Study group | Role | What they receive |
|---|---|---|
| Use of decision support tool | Active comparator | Trainee using decision support tool while assessing a clinical case. This intervention will affect the study participant fund of knowledge on the case. Receives: Other: Use of decision support tool |
| Use of UpToDate | Active comparator | Control group, participants using current literature prior to assessing a clinical case. Allowing 10 minutes to read on a topic during clinical care is an active intervention in the study participant fund of knowledge. Receives: Other: Use of UpToDate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing DDx with that of the attending physician (gold standard)
Comparing DDx provided by the trainee with that of the attending physician (gold standard)
Measured: through study completion, an average of 1 year
Comparing evaluation plan with that of the attending physician (gold standard)
Comparing evaluation plan laid out by the trainee with that of the attending physician (gold standard)
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2018
- Study start1 Jan 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese)Studies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparing use of deision support group (intervention group) to use of common literature (control group) among pediatric trainees treating patients with possible rheumatologic disorder
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Kimia, Boston Children's Hospital
- Investigators
- Amir A Kimia, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03501667
- Sponsor's protocol ID
- IRB-P00027105
- Status last verified
- Jul 2020
- First submitted
- 4 Apr 2018
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Segal MM, Athreya B, Son MB, Tirosh I, Hausmann JS, Ang EY, Zurakowski D, Feldman LK, Sundel RP. Evidence-based decision support for pediatric rheumatology reduces diagnostic errors. Pediatr Rheumatol Online J. 2016 Dec 13;14(1):67. doi: 10.1186/s12969-016-0127-z.
PubMed 27964737
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Boston Children's Hospital
- ClinicalTrials.gov ID
- NCT03501667
- Acronym / sponsor ID
- IRB-P00027105
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 18 Apr 2018 (actual)
- 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.
Boston Children's Hospital resources include SimulConsult which is a decision support tool available for use of BCH provider through the library portal. It is offered along other resources on that webpage (UpToDate, Micromedex, and VisualDx). See addendum 1.
Recently, a pediatric rheumatology arm was added to the expertise of SimulConsult, guided by our co-PI, Dr. Robert Sundel. As this tool is being offered and used, the investigators would like to assess metric of performance of this tool in enhancing participant trainees knowledge about the work up of patients with a potential rheumatologic disorder. See also www.ncbi.nlm.gov/pubmed/27964737 The investigators are conducting a clinical research to assess improvement in the clinical performance of study participants evaluating patients with a potential rheumatologic disorder. The intervention involved in using a computerized decision support tool already available in the Boston Children's Hospital domain. The outcome will be comparing this performance to that of an attending physician as the gold standard. We will assess the study participants performance across two locations: Emergency Department and Rheumatology clinic. Care to patients remains unchanged, as the workup plan and care is provided by an attending across both domains.
The investigators main hypothesis is that using a decision support tool will result in a higher agreement rate between study participants' differential diagnosis and work up plan compared with the gold standard (attending differential diagnosis and research plan).
Detailed description
Boston Children's Hospital resources include SimulConsult which is a decision support tool available for use of BCH provider through the library portal. It is offered along other resources on that webpage (UpToDate, Micromedex, and VisualDx). See addendum 1.
Recently, a pediatric rheumatology arm was added to the expertise of SimulConsult, guided by our co-PI, Dr. Robert Sundel. As this tool is being offered and used, the investigators would like to assess metric of performance of this tool in enhancing study participants (trainees) knowledge about the work up of patients with a potential rheumatologic disorder. See also www.ncbi.nlm.gov/pubmed/27964737 The investigators are conducting a clinical research to assess improvement in the clinical performance of trainees evaluating patients with a potential rheumatologic disorder. The intervention involved in using a computerized decision support tool already available in the Boston Children's Hospital domain. The outcome will be comparing this performance to that of an attending physician as the gold standard. The investigators will assess the study participants performance across two locations: Emergency Department and Rheumatology clinic. Care to patients remains unchanged, as the workup plan and care is provided by an attending across both domains.
Our main hypothesis is that using a decision support tool will result in a higher agreement rate between study participants' differential diagnosis and work up plan compared with the gold standard (attending differential diagnosis and research plan).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparing use of deision support group (intervention group) to use of common literature (control group) among pediatric trainees treating patients with possible rheumatologic disorder
| Arm | Type | Receives |
|---|---|---|
| Use of decision support tool | Active comparator | Other: Use of decision support toolTrainee using decision support tool while assessing a clinical case. This intervention will affect the study participant fund of knowledge on the case. |
| Use of UpToDate | Active comparator | Other: Use of UpToDateControl group, participants using current literature prior to assessing a clinical case. Allowing 10 minutes to read on a topic during clinical care is an active intervention in the study participant fund of knowledge. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A trainee at Boston Children's residency program (pediatrics, emergency medicine, pediatric emergency medicine, pediatric rheumatology)
Key exclusion criteria (1 listed)
- Opting out of the study (optional at any stage)
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 |
|---|---|---|
| Use of decision support toolAlso: Use of SimulConsultuse of a decision support software during clinical assessment of a case | Other | Use of decision support tool |
| Use of UpToDateAlso: Use of current literatureControl group, participants using current literature prior to assessing a clinical case. Allowing 10 minutes to read on a topic during clinical care is an active intervention in the study participant fund of knowledge. | Other | Use of UpToDate |
Primary outcome
Comparing DDx with that of the attending physician (gold standard)
Time frame: through study completion, an average of 1 year
Comparing DDx provided by the trainee with that of the attending physician (gold standard)
Comparing evaluation plan with that of the attending physician (gold standard)
Time frame: through study completion, an average of 1 year
Comparing evaluation plan laid out by the trainee with that of the attending physician (gold standard)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Background: PubMed 27964737Segal MM, Athreya B, Son MB, Tirosh I, Hausmann JS, Ang EY, Zurakowski D, Feldman LK, Sundel RP. Evidence-based decision support for pediatric rheumatology reduces diagnostic errors. Pediatr Rheumatol Online J. 2016 Dec 13;14(1):67. doi: 10.1186/s12969-016-0127-z.
- 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.
Amir A Kimia, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of decision support tool and Use of UpToDate in people with Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese), run by Boston Children's Hospital 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 7 Jul 2020. 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?
Contact Lauren Robertson ((617)-919-6160, lauren.robertson@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparing DDx with that of the attending physician (gold standard) (time frame: through study completion, an average of 1 year). The study lists 2 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 NCT03501667, which also lists 1 linked publication.
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 7 Jul 2020.