Neurologic DisorderNCT05173506
Child Health Improvement Through Computer Automation - Child Neurology (CHICA-CN) Evaluation
An observational study of Neurologic Disorder, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The study will evaluate a computer decision support system for child neurology, Child Health Improvement through Computer Automation - Child Neurology (CHICA-CN) using patient chart review, family phone surveys, and physician interviews in a before-after study design. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Neurologic Disorder
- What is being tested?
- Computer decision support for physician
- How many people
- 455 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2022to 17 Sep 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult
Study population: All children under 18 years of age who attend one of two participating child neurology clinics who qualify for one of the four cohorts and who have at least three visits to that clinic and at least one visit during the study period
Who may be able to join
- Must be patients in the participating clinical practices meeting inclusion criteria for one of the four cohorts
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: CHICA-CN Evaluation - Evaluation of a Computer Decision Support System in Child Neurology
The study will evaluate a computer decision support system for child neurology, Child Health Improvement through Computer Automation - Child Neurology (CHICA-CN) using patient chart review, family phone surveys, and physician interviews in a before-after study design.
Read the detailed description
(CHICA-CN) Child Health Improvement through Computer Automation - Child Neurology is software that works with the electronic health record (EHR) to improve the efficiency and quality of care in the outpatient setting. Built in partnership with the Child Neurology Foundation, CHICA's guidance is based on authoritative guidelines from the American Academy of Neurology and others. The plan is to implement CHICA-CN in the Child Neurology Clinics at Wake Forest Baptist Health. To evaluate CHICA-CN the proposal is to look at data derived from three sources:
- Chart Review to evaluate quality of care based on measures derived from four algorithms developed from American Academy of Neurology quality measures and typically documented in the medical record. This will be a before-after study design in which measurements will be obtained before and after the installation of CHICA-CN.
- Parent Phone Surveys to Document the parent experience in terms of physician-patient communication, parent engagement, and satisfaction with use of the patient facing tablet interface. These data will be collected from families of patients identified for the chart review after the intervention.
- Physician user satisfaction measures, including perceived value of the system and ease of use in general and as regards individual clinical issues. Surveys will be administered to physicians and clinic staff who used CHICA-CN.
- Conditions
- Neurologic Disorder
- Being tested
- Computer decision support for physician
- Keywords
- Quality of Care, Child Health Improvement
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer decision support for physicianOther
The Child Health Improvement through Computer Automation - Child Neurology (CHICA-CN) system will screen patients for needed services and provide reminders to physicians to provide the needed services.
| Study group | Role | What they receive |
|---|---|---|
| Adolescent Depression Screening | * > 3 visits to clinic
* Diagnosis of epilepsy - International Classification of Diseases, Tenth Revision - Epilepsy and recurrent seizures (ICD-10:G40)
* Age > 12 years at last visit (before CHICA-CN)
Computer assistant depression screening and management Receives: Other: Computer decision support for physician | |
| Genetic Testing | * > 3 visits to clinic
* Diagnosis of global developmental delay - International Classification of Diseases, Tenth Revision - autistic disorder (ICD-10: F84)
* Age < 6 years at last visit (before CHICA-CN)
Computer reminders to test for genetic disorders Receives: Other: Computer decision support for physician | |
| Rescue seizure therapy | * > 3 visits to clinic
* Diagnosis of epilepsy - International Classification of Diseases, Tenth Revision - Epilepsy and recurrent seizures (ICD-10: G40)
* Age < 18 years at last visit (before CHICA-CN)
Computer reminders to prescribe and adjust rescue anti-seizure medications Receives: Other: Computer decision support for physician | |
| Adolescent Transition | * > 3 visits to clinic
* Age > 13 years at last visit (before CHICA-CN)
Computer supported screening and counseling regarding transition to adult care Receives: Other: Computer decision support for physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chart Abstraction Outcomes - Transitions of Care
Transitions of Care - the number of charts that document that the service was provided divided by the number of charts reviewed
Measured: Visits will be extracted for the year before implementation of CHICA-CN and for a one year period after implementation of CHICA-CN
Chart Abstraction Outcomes - Rescue Seizure Therapy for Children with Epilepsy
Rescue Seizure Therapy for Children with Epilepsy - the number of charts that document that the service was provided divided by the number of charts reviewed
Measured: Visits will be extracted for the year before implementation of CHICA-CN and for a one year period after implementation of CHICA-CN
Chart Abstraction Outcomes - Genetic Testing for Global Developmental Delay
Genetic Testing for Global Developmental Delay - the number of charts that document that the service was provided divided by the number of charts reviewed
Measured: Visits will be extracted for the year before implementation of CHICA-CN and for a one year period after implementation of CHICA-CN
Chart Abstraction Outcomes - Adolescent Depression Screening
Adolescent Depression Screening - the number of charts that document that the service was provided divided by the number of charts reviewed
Measured: Visits will be extracted for the year before implementation of CHICA-CN and for a one year period after implementation of CHICA-CN
Physician-patient communication Survey Score
Communication subscale of the Ambulatory Care Experiences (ACE) Survey - includes 4 items like "How often did your personal doctor explain things in a way that was easy to understand" or "How would you rate your personal doctor's knowledge of your medical history." - Single score (0-12), higher score indicates better communication.
Measured: Eligible patients will be identified as they have encounters, starting 6 months after implementation of CHICA-CN and continuing for 12 months, assessed for the identified visit, within 2 weeks of the visit
Patient engagement Survey Score
Patient Activation Measure Short Form (PAM) - 13 item scale assesses whether the parent believes an active role in the child's care is important; if the parent has the confidence and knowledge to take action, e.g., medications, bringing concerns to the provider; if the parent has taken action, e.g., lifestyle changes, to improve child's health; and whether the parent stays on course under stress, e.g., being able to handle child's health condition at home. 13 items, single score (0-39), higher score indicates greater patient/parent engagement.
Measured: Eligible patients will be identified as they have encounters, starting 6 months after implementation of CHICA-CN and continuing for 12 months, assessed for the identified visit, within 2 weeks of the visit
Physician Satisfaction Survey
Clinician user satisfaction measures, including perceived value of the system and ease of use in general and as regards individual clinical issues. Surveys will be administered to physicians and clinic staff who used CHICA-CN. The survey includes a series of statements with which the respondent will mark their level of agreement on a Likert scale. There is no summary score, but we will calculate and report a mean, median, and range for each item.
Measured: After one year of of clinicians using CHICA-CN
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2021
- Study start18 Aug 2022
- Primary completion30 Aug 2024
- Study completion17 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Norton Healthcare, Indiana University, Child Neurology Foundation
- Responsible party
- Sponsor
- Investigators
- Jaclyn M Martindale, DO, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05173506
- Sponsor's protocol ID
- IRB00078610
- Status last verified
- Aug 2024
- First submitted
- 17 Nov 2021
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHICA-CN Evaluation - Evaluation of a Computer Decision Support System in Child Neurology
- ClinicalTrials.gov ID
- NCT05173506
- Acronym / sponsor ID
- IRB00078610
- Conditions
- Neurologic Disorder
- Keywords
- Quality of Care, Child Health Improvement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Norton Healthcare, Indiana University, Child Neurology Foundation
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 30 Dec 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.
The study will evaluate a computer decision support system for child neurology, Child Health Improvement through Computer Automation - Child Neurology (CHICA-CN) using patient chart review, family phone surveys, and physician interviews in a before-after study design.
Detailed description
(CHICA-CN) Child Health Improvement through Computer Automation - Child Neurology is software that works with the electronic health record (EHR) to improve the efficiency and quality of care in the outpatient setting. Built in partnership with the Child Neurology Foundation, CHICA's guidance is based on authoritative guidelines from the American Academy of Neurology and others. The plan is to implement CHICA-CN in the Child Neurology Clinics at Wake Forest Baptist Health. To evaluate CHICA-CN the proposal is to look at data derived from three sources:
- Chart Review to evaluate quality of care based on measures derived from four algorithms developed from American Academy of Neurology quality measures and typically documented in the medical record. This will be a before-after study design in which measurements will be obtained before and after the installation of CHICA-CN.
- Parent Phone Surveys to Document the parent experience in terms of physician-patient communication, parent engagement, and satisfaction with use of the patient facing tablet interface. These data will be collected from families of patients identified for the chart review after the intervention.
- Physician user satisfaction measures, including perceived value of the system and ease of use in general and as regards individual clinical issues. Surveys will be administered to physicians and clinic staff who used CHICA-CN.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Adolescent Depression Screening | – | Other: Computer decision support for physician* > 3 visits to clinic * Diagnosis of epilepsy - International Classification of Diseases, Tenth Revision - Epilepsy and recurrent seizures (ICD-10:G40) * Age > 12 years at last visit (before CHICA-CN) Computer assistant depression screening and management |
| Genetic Testing | – | Other: Computer decision support for physician* > 3 visits to clinic * Diagnosis of global developmental delay - International Classification of Diseases, Tenth Revision - autistic disorder (ICD-10: F84) * Age < 6 years at last visit (before CHICA-CN) Computer reminders to test for genetic disorders |
| Rescue seizure therapy | – | Other: Computer decision support for physician* > 3 visits to clinic * Diagnosis of epilepsy - International Classification of Diseases, Tenth Revision - Epilepsy and recurrent seizures (ICD-10: G40) * Age < 18 years at last visit (before CHICA-CN) Computer reminders to prescribe and adjust rescue anti-seizure medications |
| Adolescent Transition | – | Other: Computer decision support for physician* > 3 visits to clinic * Age > 13 years at last visit (before CHICA-CN) Computer supported screening and counseling regarding transition to adult care |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children under 18 years of age who attend one of two participating child neurology clinics who qualify for one of the four cohorts and who have at least three visits to that clinic and at least one visit during the study period
Key inclusion criteria (1 listed)
- Must be patients in the participating clinical practices meeting inclusion criteria for one of the four cohorts
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Computer decision support for physicianThe Child Health Improvement through Computer Automation - Child Neurology (CHICA-CN) system will screen patients for needed services and provide reminders to physicians to provide the needed services. | Other | Adolescent Depression Screening, Adolescent Transition, Genetic Testing, Rescue seizure therapy |
Primary outcome
Chart Abstraction Outcomes - Transitions of Care
Time frame: Visits will be extracted for the year before implementation of CHICA-CN and for a one year period after implementation of CHICA-CN
Transitions of Care - the number of charts that document that the service was provided divided by the number of charts reviewed
Chart Abstraction Outcomes - Rescue Seizure Therapy for Children with Epilepsy
Time frame: Visits will be extracted for the year before implementation of CHICA-CN and for a one year period after implementation of CHICA-CN
Rescue Seizure Therapy for Children with Epilepsy - the number of charts that document that the service was provided divided by the number of charts reviewed
Chart Abstraction Outcomes - Genetic Testing for Global Developmental Delay
Time frame: Visits will be extracted for the year before implementation of CHICA-CN and for a one year period after implementation of CHICA-CN
Genetic Testing for Global Developmental Delay - the number of charts that document that the service was provided divided by the number of charts reviewed
Chart Abstraction Outcomes - Adolescent Depression Screening
Time frame: Visits will be extracted for the year before implementation of CHICA-CN and for a one year period after implementation of CHICA-CN
Adolescent Depression Screening - the number of charts that document that the service was provided divided by the number of charts reviewed
Physician-patient communication Survey Score
Time frame: Eligible patients will be identified as they have encounters, starting 6 months after implementation of CHICA-CN and continuing for 12 months, assessed for the identified visit, within 2 weeks of the visit
Communication subscale of the Ambulatory Care Experiences (ACE) Survey - includes 4 items like "How often did your personal doctor explain things in a way that was easy to understand" or "How would you rate your personal doctor's knowledge of your medical history." - Single score (0-12), higher score indicates better communication.
Patient engagement Survey Score
Time frame: Eligible patients will be identified as they have encounters, starting 6 months after implementation of CHICA-CN and continuing for 12 months, assessed for the identified visit, within 2 weeks of the visit
Patient Activation Measure Short Form (PAM) - 13 item scale assesses whether the parent believes an active role in the child's care is important; if the parent has the confidence and knowledge to take action, e.g., medications, bringing concerns to the provider; if the parent has taken action, e.g., lifestyle changes, to improve child's health; and whether the parent stays on course under stress, e.g., being able to handle child's health condition at home. 13 items, single score (0-39), higher score indicates greater patient/parent engagement.
Physician Satisfaction Survey
Time frame: After one year of of clinicians using CHICA-CN
Clinician user satisfaction measures, including perceived value of the system and ease of use in general and as regards individual clinical issues. Surveys will be administered to physicians and clinic staff who used CHICA-CN. The survey includes a series of statements with which the respondent will mark their level of agreement on a Likert scale. There is no summary score, but we will calculate and report a mean, median, and range for each item.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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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.
Jaclyn M Martindale, DO principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Disorder, run by Wake Forest University Health Sciences 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: finished, as of the sponsor's last update on 17 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Chart Abstraction Outcomes - Transitions of Care (time frame: Visits will be extracted for the year before implementation of CHICA-CN and for a one year period after implementation of CHICA-CN). The study lists 7 primary outcomes in all. 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 17 Oct 2024.