NCT05173506

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
455

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

August 18, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2024

Completed
Last Updated

October 17, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

November 17, 2021

Last Update Submit

October 16, 2024

Conditions

Keywords

Quality of CareChild Health Improvement

Outcome Measures

Primary Outcomes (7)

  • 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

    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

    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

    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

    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.

    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.

    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.

    After one year of of clinicians using CHICA-CN

Study Arms (4)

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

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

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

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

Other: Computer decision support for physician

Interventions

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 Depression ScreeningAdolescent TransitionGenetic TestingRescue seizure therapy

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Nervous System Diseases

Interventions

Physicians

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Jaclyn M Martindale, DO

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2021

First Posted

December 30, 2021

Study Start

August 18, 2022

Primary Completion

August 30, 2024

Study Completion

September 17, 2024

Last Updated

October 17, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

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

Locations