Child Health Improvement Through Computer Automation - Child Neurology (CHICA-CN) Evaluation

April 23, 2024 updated by: Wake Forest University Health Sciences

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.

Study Overview

Status

Recruiting

Conditions

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:

  1. 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.
  2. 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.
  3. 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

Observational

Enrollment (Estimated)

640

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

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
  • > 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

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
  • > 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

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
  • > 3 visits to clinic
  • Age > 13 years at last visit (before CHICA-CN)

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jaclyn M Martindale, DO, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2022

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

December 13, 2021

First Posted (Actual)

December 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00078610

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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