- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05173506
Child Health Improvement Through Computer Automation - Child Neurology (CHICA-CN) Evaluation
CHICA-CN Evaluation - Evaluation of a Computer Decision Support System in Child Neurology
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jaclyn M Martindale, DO
- Phone Number: 336- 716-4101
- Email: jmartind@wakehealth.edu
Study Contact Backup
- Name: Stephen M Downs, MD
- Phone Number: 336.716.2588
- Email: sdowns@wakehealth.edu
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest University Health Sciences
-
Contact:
- Stephen M Downs, MD
- Phone Number: 336.716.2588
- Email: sdowns@wakehealth.edu
-
Contact:
- Jacyln M Martindale, DO
- Phone Number: 336-716-4101
- Email: jmartind@wakehealth.edu@wakehealth.edu
-
Principal Investigator:
- Jacyln M Martindale, DO
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Must be patients in the participating clinical practices meeting inclusion criteria for one of the four cohorts
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Adolescent Depression Screening
Computer assistant depression screening and management |
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.
|
Genetic Testing
Computer reminders to test for genetic disorders |
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.
|
Rescue seizure therapy
Computer reminders to prescribe and adjust rescue anti-seizure medications |
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.
|
Adolescent Transition
Computer supported screening and counseling regarding transition to adult care |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
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
|
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
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
|
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
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
|
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
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.
|
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
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.
|
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
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.
|
After one year of of clinicians using CHICA-CN
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jaclyn M Martindale, DO, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00078610
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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