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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05173506
Other study ID # IRB00078610
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 18, 2022
Est. completion date August 2024

Study information

Verified date August 2023
Source Wake Forest University Health Sciences
Contact Jaclyn M Martindale, DO
Phone 336- 716-4101
Email jmartind@wakehealth.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 640
Est. completion date August 2024
Est. primary completion date August 2024
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria: - Must be patients in the participating clinical practices meeting inclusion criteria for one of the four cohorts Exclusion Criteria: - N/A

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Computer decision support for physician
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.

Locations

Country Name City State
United States Wake Forest University Health Sciences Winston-Salem North Carolina

Sponsors (4)

Lead Sponsor Collaborator
Wake Forest University Health Sciences Child Neurology Foundation, Indiana University, Norton Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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