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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; SUDEP
• Intervention / Treatment: Behavioral: CHICA SUDEP module

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University - Children's Health Services Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-intervention; Seizure patients receive usual care.
Experimental: Post-intervention; Physicians provide care enhanced by computer based clinical decision support about SUDEP.	Behavioral: CHICA SUDEP module; CHICA reminds physicians to counsel patients/families about the risk of SUDEP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parent recall of SUDEP counseling	Parents will be contacted by phone and answer survey questions about SUDEP counseling during their child's most recent pediatric visit.	within 2 weeks of a clinical encounter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge and comfort in taking care of child's epilepsy	Parents will be contacted by phone and answer survey questions about their knowledge and comfort in taking care of their child's epilepsy	within 2 weeks of a clinical encounter

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Greenwich Biosciences; Child Neurology Foundation
• Investigators: Principal Investigator: Randall W Grout, MD, Indiana University - Ped Health Services

Publications and helpful links

General Publications

• Grout RW, Buchhalter J, Patel AD, Brin A, Clark AA, Holmay M, Story TJ, Downs SM. Improving Patient-Centered Communication about Sudden Unexpected Death in Epilepsy through Computerized Clinical Decision Support. Appl Clin Inform. 2021 Jan;12(1):90-99. doi: 10.1055/s-0040-1722221. Epub 2021 Feb 17.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2018
• Primary Completion (Actual): March 5, 2019
• Study Completion (Actual): March 30, 2019

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 11, 2018
• First Posted (Actual): April 19, 2018

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Epilepsy; SUDEP
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Death, Sudden; Death; Epilepsy; Sudden Unexpected Death in Epilepsy
• Other Study ID Numbers: 1803547954

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No