Improving Patient Communication About SUDEP

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03502759
Recruitment Status : Recruiting
First Posted : April 19, 2018
Last Update Posted : November 2, 2018
Child Neurology Foundation
Greenwich Biosciences
Information provided by (Responsible Party):
Randall Grout, Indiana University

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.

Condition or disease Intervention/treatment Phase
SUDEP Epilepsy Behavioral: CHICA SUDEP module Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Patient Communication About SUDEP
Actual Study Start Date : June 14, 2018
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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.

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03502759

Contact: Randall W Grout, MD 3172780552

United States, Indiana
Indiana University - Children's Health Services Research Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Randall W Grout, MD    317-278-0552   
Sponsors and Collaborators
Indiana University
Child Neurology Foundation
Greenwich Biosciences
Principal Investigator: Randall W Grout, MD Indiana University - Ped Health Services

Responsible Party: Randall Grout, MD, Faculty, Ped Health Services, Indiana University Identifier: NCT03502759     History of Changes
Other Study ID Numbers: 1803547954
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Randall Grout, Indiana University:

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases