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Completed

NCT Number: NCT03502759

Improving Patient Communication About SUDEP

Children with generalized tonic-clonic seizures (GTCS) have about a 1 in 4500 of succumbing to sudden unexpected death in epilepsy (SUDEP). For that reason, the American Academy of Neurology recommends that clinicians caring for these children make their families aware of this small but important risk and provide appropriate supportive follow-up resources. Moreover, existing evidence suggests that children with poorly controlled GTCS have a strikingly increased odds of SUDEP, 3-24 fold, raising the importance of improving seizure control.

Clinicians caring for these patients have multiple issues to address in the typical visit. The investigators propose to use information technology to help providers assure that addressing SUDEP is incorporated into their routine care. The investigators have developed the Child Health Improvement through Computer Automation system (CHICA), a computer based clinical decision support system for pediatric care. CHICA captures patient reported data in the waiting room and prioritizes clinical advice to the physician through the electronic health record (EHR).

CHICA is used in five primary care clinics in the Eskenazi health system where it supports general pediatric care. The goal of this project is to test the effectiveness of a SUDEP module in this setting where CHICA is already in use - with a future goal of developing a full suite of CHICA modules for child neurologists.

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Key information

Conditions

SUDEP Brain Diseases Central Nervous System Diseases Death Death, Sudden Epilepsy Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Sudden Unexpected Death in Epilepsy

Age range

0 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University - Children's Health Services Research

Indianapolis, Indiana, 46202, United States

About this study

Specifically, the investigators propose the following:

Aim 1: Add a "SUDEP module" to CHICA to identify children at increased risk of SUDEP, provide patient education materials that the clinician can share with the families, and recommend timelier follow-up with a child neurologist. The SUDEP module will be added to the existing installation of CHICA in the Eskenazi Health System in Indianapolis, IN so that SUDEP risk screening and advice are generated automatically in the setting of routine primary care in the 5 Eskenazi clinics.

Aim 2: Interview families of patients with epilepsy to determine if their pediatricians shared the SUDEP information and/or referred them to their neurologist. Families whose children are at risk for SUDEP will be identified through CHICA. The investigators will utilize the Pediatric Practice-based Research Network (PResNet) to follow-up these families by phone after their visits with the pediatrician. PResNet will determine if SUDEP was discussed, if a handout was provided, and if SUDEP has been discussed previously by their pediatrician or neurologist.

Aim 3: The investigators will assess physician and staff satisfaction regarding the SUDEP module of CHICA. Each year, PResNet will conduct a satisfaction survey among the clinic physicians and staff that use CHICA. The survey consists of general questions about CHICA that are asked every year and module-specific questions about new functionality that has been added.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Parent or Guardian of a child seen at one of five clinics in the Eskenazi health care system for which the child has had at least 2 lifetime motor seizures.

Exclusion criteria

Inability of the subject to understand the survey

Treatment and study plan

CHICA SUDEP module

Behavioral

CHICA reminds physicians to counsel patients/families about the risk of SUDEP.

Primary outcomes

  1. Parent recall of SUDEP counseling

    Time frame: within 2 weeks of a clinical encounter

    Parents will be contacted by phone and answer survey questions about SUDEP counseling during their child's most recent pediatric visit.

Secondary outcomes

  1. Knowledge and comfort in taking care of child's epilepsy

    Time frame: within 2 weeks of a clinical encounter

    Parents will be contacted by phone and answer survey questions about their knowledge and comfort in taking care of their child's epilepsy

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Child Neurology Foundation
  • Greenwich Biosciences

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 19, 2018
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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