Improving Patient Communication About SUDEP

NCT03502759 | Completed

• 1 other identifier: 1803547954
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

SUDEP; Epilepsy

Keywords

SUDEP; Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Knowledge and comfort in taking care of child's epilepsy

  within 2 weeks of a clinical encounter

Study Arms (2)

Pre-intervention

NO INTERVENTION

Seizure patients receive usual care.

Post-intervention

EXPERIMENTAL

Physicians provide care enhanced by computer based clinical decision support about SUDEP.

Behavioral: CHICA SUDEP module

Interventions

CHICA SUDEP module BEHAVIORAL

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

Post-intervention

Eligibility Criteria

• Age: 0 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Inability of the subject to understand the survey

Sponsors & Collaborators

• Indiana University: lead
• Child Neurology Foundation: collaborator
• Greenwich Biosciences: collaborator

Study Sites (1)

Indiana University - Children's Health Services Research

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

• 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.

  PMID: 33598905 RESULT

MeSH Terms

Conditions

Sudden Unexpected Death in Epilepsy; Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Randall W Grout, MD

  Indiana University - Ped Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Faculty, Ped Health Services

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 19, 2018
• Study Start: June 14, 2018
• Primary Completion: March 5, 2019
• Study Completion: March 30, 2019
• Last Updated: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)