AppendicitisAppy-CDSNCT02633735
EHR-based Decision Support for Pediatric Acute Abdominal Pain in Emergency Care
A study testing Appy CDS in people with Appendicitis, run by HealthPartners Institute at 2 sites in United States.
Trial summary
Although appendicitis is the most common surgical emergency in children, its diagnosis remains a challenge and thus, emergency department (ED) providers increasingly rely on computed tomography to distinguish appendicitis from other conditions. Read more about this study
- Who is it for?
- Ages 5 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Appendicitis
- What is being tested?
- Appy CDS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,940 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2017to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- children and adolescents ages 5-20 years with abdominal pain
- internal med, family med, or emergency med trained providers at participating EDs
Who cannot join
- select comorbid conditions
- previous abdominal surgery
- treated for select comorbid conditions
Trial locations and contacts
2 sites in 1 country.
United States2 sites
HealthPartners Medical Group
Minneapolis, Minnesota, 55440
Kaiser Permanente Northern California
Oakland, California, 94612
About this study
Although appendicitis is the most common surgical emergency in children, its diagnosis remains a challenge and thus, emergency department (ED) providers increasingly rely on computed tomography to distinguish appendicitis from other conditions. This project (a) uses electronic health record (EHR) technology to deliver patient-specific clinical decision support to ED providers at the point of care, (b) assesses the impact of this intervention on the use of diagnostic imaging and clinical outcomes, and (c) assesses the impact of the intervention on the costs of care delivered. This innovative project will be a template for extending EHR-based clinical decision support to other domains of emergency care to ultimately improve a broad range of pediatric acute care outcomes.
The proposed intervention, referred to as appy-CDS, is specifically designed for widespread use in EDs and could reduce reliance on advanced diagnostic imaging for pediatric and adolescent patients with acute abdominal pain while maintaining or improving clinical outcomes. Investigators aim to develop and implement an interactive, evidence-based clinical decision support tool to optimize care for children and adolescents presenting to a general or non-pediatric ED with acute abdominal pain.
Read the detailed description
Abdominal pain is one of the most common reasons for children and adolescents to seek care in the emergency department (ED). Computed tomography (CT) has been promoted as a method to improve diagnostic accuracy when evaluating patients with acute abdominal pain. In the past 20 years, CT use has increased dramatically, especially for children receiving care in general ED settings. Although in some adult cohorts, increased CT use has been associated with decreased rates of negative appendectomies, similar improvements in health outcomes among children with acute abdominal pain have not occurred. Negative consequences of CT include increased costs and substantial exposure to ionizing radiation.
Although appendicitis is the most common surgical emergency in children, its diagnosis remains a challenge and thus, emergency department (ED) providers increasingly rely on computed tomography to distinguish appendicitis from other conditions. This project (a) uses electronic health record (EHR) technology to deliver patient-specific clinical decision support to ED providers at the point of care, (b) assesses the impact of this intervention on the use of diagnostic imaging and clinical outcomes, and (c) assesses the impact of the intervention on the costs of care delivered.
The proposed intervention, referred to as appy-CDS, is specifically designed for widespread use in EDs and could reduce reliance on advanced diagnostic imaging for pediatric and adolescent patients with acute abdominal pain while maintaining or improving clinical outcomes. This cluster randomized trial builds on more than 10 years of work on derivation and validation of ED-based clinical decision rules, previous successful outpatient and emergency department clinical decision support interventions, and complex economic and statistical analyses of risk assessment and ED resource use. In this project, the investigators aim to extend the benefits of previous efforts by developing and implementing an interactive, evidence-based clinical decision support tool to optimize care for children and adolescents presenting to a general or non-pediatric ED with acute abdominal pain. The results of this project will extend the understanding of how to maximize the clinical return on massive public and private sector investments being made in sophisticated EHR systems. If successful, this flexible decision support tool could be adapted and implemented broadly in a range of acute care settings to both standardize and personalize care delivered to pediatric patients.
- Conditions
- Appendicitis
- Being tested
- Appy CDS
- Keywords
- Clinical Decision Support
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Appy CDSOther
See description under arm/group section
| Study group | Role | What they receive |
|---|---|---|
| Appy CDS | Experimental | The Appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The intervention is administered to providers in this arm. Receives: Other: Appy CDS |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre to Post Ratio of Image Use
First, we evaluated whether patient characteristics (age, sex, race/ethnicity) differed by study arm and phase using frequency distributions, means and standard deviations. Second, we estimated use of imaging for CT, US and CT or US by study arm and phase. We evaluated the effectiveness of AppyCDS by estimating the ratio of ratios (ROR) and 95% confidence intervals (CI) of intervention arm, from pre-intervention phase to intervention phase as compared to UC arm over the two study phases, for all imaging outcomes.
Measured: pre-intervention of 8 months (average), and post intervention of 23 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study start1 Jun 2017
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AppendicitisStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel cluster-randomized clinical trial at 14 general EDs in two large care system to evaluate the impact of appy-CDS intervention with a pre and post intervention phases
- Masking
- None (open label)
- Enrolment
- 5,940 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, Children's Hospitals and Clinics of Minnesota
- Responsible party
- Sponsor
- Investigators
- Elyse O Kharbanda, MD, MPH, Principal investigator, HealthPartners InstituteAnupam B Kharbanda, MD, MSc, Principal investigator, Children's Hospital and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633735
- Sponsor's protocol ID
- 14-025
- Acronym
- Appy-CDS
- Status last verified
- Sep 2019
- First submitted
- 24 Nov 2015
- Last updated
- 9 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kharbanda AB, Vazquez-Benitez G, Ballard DW, Vinson DR, Chettipally UK, Dehmer SP, Ekstrom H, Rauchwerger AS, McMichael B, Cotton DM, Kene MV, Simon LE, Zhu J, Warton EM, O'Connor PJ, Kharbanda EO; Clinical Research on Emergency Services and Treatments Network (CREST) and the Critical Care Research Center, HealthPartners Institute. Effect of Clinical Decision Support on Diagnostic Imaging for Pediatric Appendicitis: A Cluster Randomized Trial. JAMA Netw Open. 2021 Feb 1;4(2):e2036344. doi: 10.1001/jamanetworkopen.2020.36344.
PubMed 33560426Cotton DM, Vinson DR, Vazquez-Benitez G, Margaret Warton E, Reed ME, Chettipally UK, Kene MV, Lin JS, Mark DG, Sax DR, McLachlan ID, Rauchwerger AS, Simon LE, Kharbanda AB, Kharbanda EO, Ballard DW; Clinical Research on Emergency Services and Treatments (CREST) Network. Validation of the Pediatric Appendicitis Risk Calculator (pARC) in a Community Emergency Department Setting. Ann Emerg Med. 2019 Oct;74(4):471-480. doi: 10.1016/j.annemergmed.2019.04.023. Epub 2019 Jun 19.
PubMed 31229394
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EHR-based Decision Support for Pediatric Acute Abdominal Pain in Emergency Care
- ClinicalTrials.gov ID
- NCT02633735
- Acronym / sponsor ID
- Appy-CDS / 14-025
- Conditions
- Appendicitis
- Keywords
- Clinical Decision Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,940 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Kaiser Permanente, Children's Hospitals and Clinics of Minnesota
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Posted 9 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although appendicitis is the most common surgical emergency in children, its diagnosis remains a challenge and thus, emergency department (ED) providers increasingly rely on computed tomography to distinguish appendicitis from other conditions. This project (a) uses electronic health record (EHR) technology to deliver patient-specific clinical decision support to ED providers at the point of care, (b) assesses the impact of this intervention on the use of diagnostic imaging and clinical outcomes, and (c) assesses the impact of the intervention on the costs of care delivered. This innovative project will be a template for extending EHR-based clinical decision support to other domains of emergency care to ultimately improve a broad range of pediatric acute care outcomes.
The proposed intervention, referred to as appy-CDS, is specifically designed for widespread use in EDs and could reduce reliance on advanced diagnostic imaging for pediatric and adolescent patients with acute abdominal pain while maintaining or improving clinical outcomes. Investigators aim to develop and implement an interactive, evidence-based clinical decision support tool to optimize care for children and adolescents presenting to a general or non-pediatric ED with acute abdominal pain.
Detailed description
Abdominal pain is one of the most common reasons for children and adolescents to seek care in the emergency department (ED). Computed tomography (CT) has been promoted as a method to improve diagnostic accuracy when evaluating patients with acute abdominal pain. In the past 20 years, CT use has increased dramatically, especially for children receiving care in general ED settings. Although in some adult cohorts, increased CT use has been associated with decreased rates of negative appendectomies, similar improvements in health outcomes among children with acute abdominal pain have not occurred. Negative consequences of CT include increased costs and substantial exposure to ionizing radiation.
Although appendicitis is the most common surgical emergency in children, its diagnosis remains a challenge and thus, emergency department (ED) providers increasingly rely on computed tomography to distinguish appendicitis from other conditions. This project (a) uses electronic health record (EHR) technology to deliver patient-specific clinical decision support to ED providers at the point of care, (b) assesses the impact of this intervention on the use of diagnostic imaging and clinical outcomes, and (c) assesses the impact of the intervention on the costs of care delivered.
The proposed intervention, referred to as appy-CDS, is specifically designed for widespread use in EDs and could reduce reliance on advanced diagnostic imaging for pediatric and adolescent patients with acute abdominal pain while maintaining or improving clinical outcomes. This cluster randomized trial builds on more than 10 years of work on derivation and validation of ED-based clinical decision rules, previous successful outpatient and emergency department clinical decision support interventions, and complex economic and statistical analyses of risk assessment and ED resource use. In this project, the investigators aim to extend the benefits of previous efforts by developing and implementing an interactive, evidence-based clinical decision support tool to optimize care for children and adolescents presenting to a general or non-pediatric ED with acute abdominal pain. The results of this project will extend the understanding of how to maximize the clinical return on massive public and private sector investments being made in sophisticated EHR systems. If successful, this flexible decision support tool could be adapted and implemented broadly in a range of acute care settings to both standardize and personalize care delivered to pediatric patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel cluster-randomized clinical trial at 14 general EDs in two large care system to evaluate the impact of appy-CDS intervention with a pre and post intervention phases
| Arm | Type | Receives |
|---|---|---|
| Appy CDS | Experimental | Other: Appy CDSThe Appy-cds intervention is a point of care clinical decision support system designed to identify pediatric patients at risk for appendicitis using EHR and supplemental data. The intervention is administered to providers in this arm. |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 5 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children and adolescents ages 5-20 years with abdominal pain
- internal med, family med, or emergency med trained providers at participating EDs
Key exclusion criteria (3 listed)
- select comorbid conditions
- previous abdominal surgery
- treated for select comorbid conditions
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 |
|---|---|---|
| Appy CDSSee description under arm/group section | Other | Appy CDS |
Primary outcome
Pre to Post Ratio of Image Use
Time frame: pre-intervention of 8 months (average), and post intervention of 23 months
First, we evaluated whether patient characteristics (age, sex, race/ethnicity) differed by study arm and phase using frequency distributions, means and standard deviations. Second, we estimated use of imaging for CT, US and CT or US by study arm and phase. We evaluated the effectiveness of AppyCDS by estimating the ratio of ratios (ROR) and 95% confidence intervals (CI) of intervention arm, from pre-intervention phase to intervention phase as compared to UC arm over the two study phases, for all imaging outcomes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33560426Kharbanda AB, Vazquez-Benitez G, Ballard DW, Vinson DR, Chettipally UK, Dehmer SP, Ekstrom H, Rauchwerger AS, McMichael B, Cotton DM, Kene MV, Simon LE, Zhu J, Warton EM, O'Connor PJ, Kharbanda EO; Clinical Research on Emergency Services and Treatments Network (CREST) and the Critical Care Research Center, HealthPartners Institute. Effect of Clinical Decision Support on Diagnostic Imaging for Pediatric Appendicitis: A Cluster Randomized Trial. JAMA Netw Open. 2021 Feb 1;4(2):e2036344. doi: 10.1001/jamanetworkopen.2020.36344.
- Derived from this study: PubMed 31229394Cotton DM, Vinson DR, Vazquez-Benitez G, Margaret Warton E, Reed ME, Chettipally UK, Kene MV, Lin JS, Mark DG, Sax DR, McLachlan ID, Rauchwerger AS, Simon LE, Kharbanda AB, Kharbanda EO, Ballard DW; Clinical Research on Emergency Services and Treatments (CREST) Network. Validation of the Pediatric Appendicitis Risk Calculator (pARC) in a Community Emergency Department Setting. Ann Emerg Med. 2019 Oct;74(4):471-480. doi: 10.1016/j.annemergmed.2019.04.023. Epub 2019 Jun 19.
- Individual participant dataSharing planned: No
Related trials for Appendicitis
RecruitingObservational study
Prospective Comparison of Pro-Adrenomedullin, C-Reactive Protein, and Neutrophil-to-Lymphocyte Ratio for Diagnosing Acute Appendicitis
Acute Appendicitis
Active, not recruiting
PAINED: Project Addressing INequities in the Emergency Department
Pain, Appendicitis
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Recruiting
Feasibility and Safety of a Pediatric ERAS Protocol for Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Acute Appendicitis
RecruitingPhase 3
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis
Complicated Appendicitis, Intra-Abdominal Abscess
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.
Elyse O Kharbanda, MD, MPH principal investigator
HealthPartners Institute
Anupam B Kharbanda, MD, MSc principal investigator
Children's Hospital and Clinics of Minnesota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Appy CDS in people with Appendicitis, run by HealthPartners Institute at 2 sites 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 9 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 2 sites 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?
Yes. Results are posted in the registry (first posted 9 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pre to Post Ratio of Image Use (time frame: pre-intervention of 8 months (average), and post intervention of 23 months). 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 NCT02633735, which also lists 2 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 9 Jul 2020.