Diagnostic Skills for Rheumatologic ConditionsNCT04856956
Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use
A study testing Diagnostic decision support software in people with Diagnostic Skills for Rheumatologic Conditions, run by PhenoSolve, LLC at 1 site in United States.
Trial summary
This study is designed to test the helpfulness of a diagnostic tool, SimulConsult, when clinicians are diagnosing pediatric rheumatic diseases. Trainees and nurse practitioners will use the software or not use it, and their differential diagnoses will be compared to those of attending physicians in the same clinical… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diagnostic Skills for Rheumatologic Conditions
- What is being tested?
- Diagnostic decision support software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2021to 31 Dec 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
The subjects are trainees (rheumatology and rotating fellows) and nurse practitioners, not patients. The Attendings participate in their supervisory role, and their clinical judgments are recorded as a preliminary "gold standard", but they are not research subjects.
- Trainees seeing new pediatric patients with a potential rheumatologic disorder are eligible. They will be drawn from the pool of Rheumatology fellows (3), Allergy/Immunology fellows (6), rotating pediatric and occasional adult residents (1 - 2) per month)
- Nurse practitioners in Rheumatology (2).
- Rheumatology Attendings for these new patient visits will also be asked to participate but will be supervisory participants in the study, not subjects.
We anticipate 15 trainees plus nurse practitioners will participate. There are no exclusion criteria, and we do not anticipate screen failures; however, trainees and nurse practitioners may decline to participate for individual patients or the entire study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
This study is designed to test the helpfulness of a diagnostic tool, SimulConsult, when clinicians are diagnosing pediatric rheumatic diseases. Trainees and nurse practitioners will use the software or not use it, and their differential diagnoses will be compared to those of attending physicians in the same clinical encounter, and then to definitive diagnoses weeks later after testing, if one is reached.
Read the detailed description
The study aims to assess improvement in the clinical performance of trainees evaluating patients with a suspected rheumatologic disorder. The Intervention is the use of Diagnostic Decision Support Software (DDSS) already available as a Boston Children's Hospital resource.
- Main objective: To assess if the use of the DDSS by trainees and nurse practitioners can improve their diagnostic performance in developing a differential diagnosis and plan in real clinical use. (Studies have shown in prior research that the use of the DDSS does so for case vignettes, lowering diagnostic errors of trainees by 75%). The study will compare how closely the differential diagnosis and plan of the trainees and nurse practitioners approximate those of their senior Pediatric Rheumatology attending physician colleagues.
- Secondary objective: To assess how frequently the differential diagnosis of the trainees and nurse practitioners includes the definitive diagnosis by doing a manual chart review weeks after the visit. (Studies have shown in prior research that if the definitive diagnosis is in the initial differential diagnosis, the right tests get ordered, and diagnostic errors are avoided.)
The design is a parallel one, comparing subjects (trainees and nurse practitioners) using the DDSS (Intervention Arm) to subjects who do not use the DDSS (Control Arm). In both study arms, subjects may use all other traditional resources. Arm assignment will be by patient case rather than trainee / nurse practitioner to reduce variation due to each subject's different capabilities (years of training and familiarity with pediatric rheumatology).
- Being tested
- Diagnostic decision support software
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic decision support softwareOther
Comparing use of decision support group (intervention group) to use only of common literature (control group) among pediatric trainees diagnosing patients with possible rheumatologic disorder
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Use of diagnostic decision support software) | Experimental | Trainee or nurse practitioner sees patient and uses diagnostic decision support software in developing their differential diagnosis and plan Receives: Other: Diagnostic decision support software |
| Control (Current process) | No intervention | Trainee or nurse practitioner sees patient but doesn't use diagnostic decision support software in developing their differential diagnosis and plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance against Gold Standard: Presence of Gold standard #1 diagnosis in trainee list
The study will compare the trainee's differential diagnosis and workup plan to those of the attending physician seeing the same patient. The Attending is considered at this stage as the "gold standard" and we aim to answer the question "how well does a trainee with a DDSS (and traditional resources) approximate an experienced, specialist Attending vs. a trainee with access only to more traditional resources?".
Measured: 1 day
Secondary outcomes (1)
Performance against definitive diagnosis: Presence of definitive diagnosis in trainee list
The study will do a manual chart review of the cases to find the definitive diagnosis (where available) to measure the frequency with which the definitive diagnosis was in the trainee's initial DDx.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start20 Apr 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diagnostic Skills for Rheumatologic ConditionsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a parallel-design, randomized, controlled study.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PhenoSolve, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boston Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Michael M Segal, MD PhD, Study chair, PhenoSolve, LLCRobert P Sundel, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856956
- Sponsor's protocol ID
- BCH.SC.02
- Status last verified
- Sep 2022
- First submitted
- 17 Mar 2021
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The results will be shared.
Publications
Segal MM. Mobile medical computing driven by the complexity of neurologic diagnosis. J Child Neurol. 2006 Jul;21(7):595-9. doi: 10.1177/08830738060210071601.
PubMed 16970851Segal 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 27964737Staffa SJ, Zurakowski D. Strategies in adjusting for multiple comparisons: A primer for pediatric surgeons. J Pediatr Surg. 2020 Sep;55(9):1699-1705. doi: 10.1016/j.jpedsurg.2020.01.003. Epub 2020 Jan 23.
PubMed 32029234Segal MM, Williams MS, Gropman AL, Torres AR, Forsyth R, Connolly AM, El-Hattab AW, Perlman SJ, Samanta D, Parikh S, Pavlakis SG, Feldman LK, Betensky RA, Gospe SM Jr. Evidence-based decision support for neurological diagnosis reduces errors and unnecessary workup. J Child Neurol. 2014 Apr;29(4):487-92. doi: 10.1177/0883073813483365. Epub 2013 Apr 10.
PubMed 23576414
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Pediatric Rheumatology Diagnostic Decision Support in Clinical Use
- ClinicalTrials.gov ID
- NCT04856956
- Acronym / sponsor ID
- BCH.SC.02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- PhenoSolve, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Boston Children's Hospital
- Study start
- 20 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 23 Apr 2021 (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.
This study is designed to test the helpfulness of a diagnostic tool, SimulConsult, when clinicians are diagnosing pediatric rheumatic diseases. Trainees and nurse practitioners will use the software or not use it, and their differential diagnoses will be compared to those of attending physicians in the same clinical encounter, and then to definitive diagnoses weeks later after testing, if one is reached.
Detailed description
The study aims to assess improvement in the clinical performance of trainees evaluating patients with a suspected rheumatologic disorder. The Intervention is the use of Diagnostic Decision Support Software (DDSS) already available as a Boston Children's Hospital resource.
- Main objective: To assess if the use of the DDSS by trainees and nurse practitioners can improve their diagnostic performance in developing a differential diagnosis and plan in real clinical use. (Studies have shown in prior research that the use of the DDSS does so for case vignettes, lowering diagnostic errors of trainees by 75%). The study will compare how closely the differential diagnosis and plan of the trainees and nurse practitioners approximate those of their senior Pediatric Rheumatology attending physician colleagues.
- Secondary objective: To assess how frequently the differential diagnosis of the trainees and nurse practitioners includes the definitive diagnosis by doing a manual chart review weeks after the visit. (Studies have shown in prior research that if the definitive diagnosis is in the initial differential diagnosis, the right tests get ordered, and diagnostic errors are avoided.)
The design is a parallel one, comparing subjects (trainees and nurse practitioners) using the DDSS (Intervention Arm) to subjects who do not use the DDSS (Control Arm). In both study arms, subjects may use all other traditional resources. Arm assignment will be by patient case rather than trainee / nurse practitioner to reduce variation due to each subject's different capabilities (years of training and familiarity with pediatric rheumatology).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a parallel-design, randomized, controlled study.
| Arm | Type | Receives |
|---|---|---|
| Intervention (Use of diagnostic decision support software) | Experimental | Other: Diagnostic decision support softwareTrainee or nurse practitioner sees patient and uses diagnostic decision support software in developing their differential diagnosis and plan |
| Control (Current process) | No intervention | –Trainee or nurse practitioner sees patient but doesn't use diagnostic decision support software in developing their differential diagnosis and plan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Diagnostic decision support softwareComparing use of decision support group (intervention group) to use only of common literature (control group) among pediatric trainees diagnosing patients with possible rheumatologic disorder | Other | Intervention (Use of diagnostic decision support software) |
Primary outcome
Performance against Gold Standard: Presence of Gold standard #1 diagnosis in trainee list
Time frame: 1 day
The study will compare the trainee's differential diagnosis and workup plan to those of the attending physician seeing the same patient. The Attending is considered at this stage as the "gold standard" and we aim to answer the question "how well does a trainee with a DDSS (and traditional resources) approximate an experienced, specialist Attending vs. a trainee with access only to more traditional resources?".
1 secondary outcome
Performance against definitive diagnosis: Presence of definitive diagnosis in trainee list
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Background: PubMed 16970851Segal MM. Mobile medical computing driven by the complexity of neurologic diagnosis. J Child Neurol. 2006 Jul;21(7):595-9. doi: 10.1177/08830738060210071601.
- 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.
- Background: PubMed 32029234Staffa SJ, Zurakowski D. Strategies in adjusting for multiple comparisons: A primer for pediatric surgeons. J Pediatr Surg. 2020 Sep;55(9):1699-1705. doi: 10.1016/j.jpedsurg.2020.01.003. Epub 2020 Jan 23.
- Background: PubMed 23576414Segal MM, Williams MS, Gropman AL, Torres AR, Forsyth R, Connolly AM, El-Hattab AW, Perlman SJ, Samanta D, Parikh S, Pavlakis SG, Feldman LK, Betensky RA, Gospe SM Jr. Evidence-based decision support for neurological diagnosis reduces errors and unnecessary workup. J Child Neurol. 2014 Apr;29(4):487-92. doi: 10.1177/0883073813483365. Epub 2013 Apr 10.
- Individual participant dataSharing planned: Yes. The results will be shared.
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.
Michael M Segal, MD PhD study chair
PhenoSolve, LLC
Robert P Sundel, 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 Diagnostic decision support software in people with Diagnostic Skills for Rheumatologic Conditions, run by PhenoSolve, LLC 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?
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 4 Oct 2022. 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?
Performance against Gold Standard: Presence of Gold standard #1 diagnosis in trainee list (time frame: 1 day). 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 NCT04856956, which also lists 4 linked publications.
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 4 Oct 2022.