SUDEPNCT03502759
Improving Patient Communication About SUDEP
A study testing CHICA SUDEP module in people with SUDEP and Epilepsy, run by Indiana University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 21 years
- What is being tested?
- CHICA SUDEP module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2018to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Inability of the subject to understand the survey
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University - Children's Health Services Research
Indianapolis, Indiana, 46202
About this study
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.
Read the 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.
- Being tested
- CHICA SUDEP module
- Keywords
- SUDEP, Epilepsy
- Medical subject headings
- Sudden Unexpected Death in Epilepsy, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHICA SUDEP moduleBehavioural
CHICA reminds physicians to counsel patients/families about the risk of SUDEP.
| Study group | Role | What they receive |
|---|---|---|
| Pre-intervention | No intervention | Seizure patients receive usual care. |
| Post-intervention | Experimental | Physicians provide care enhanced by computer based clinical decision support about SUDEP. Receives: Behavioral: CHICA SUDEP module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 2 weeks of a clinical encounter
Secondary outcomes (1)
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
Measured: within 2 weeks of a clinical encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start14 Jun 2018
- Primary completion5 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SUDEPStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Child Neurology Foundation, Greenwich Biosciences
- Responsible party
- Principal investigator, Randall Grout, Indiana University
- Investigators
- Randall W Grout, MD, Principal investigator, Indiana University - Ped Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502759
- Sponsor's protocol ID
- 1803547954
- Status last verified
- Jan 2022
- First submitted
- 11 Apr 2018
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33598905
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Patient Communication About SUDEP
- ClinicalTrials.gov ID
- NCT03502759
- Acronym / sponsor ID
- 1803547954
- Keywords
- SUDEP, Epilepsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Child Neurology Foundation, Greenwich Biosciences
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-intervention | No intervention | –Seizure patients receive usual care. |
| Post-intervention | Experimental | Behavioral: CHICA SUDEP modulePhysicians provide care enhanced by computer based clinical decision support about SUDEP. |
Who may qualify
- Ages
- 0 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Inability of the subject to understand the survey
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHICA SUDEP moduleCHICA reminds physicians to counsel patients/families about the risk of SUDEP. | Behavioural | Post-intervention |
Primary outcome
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.
1 secondary outcome
Knowledge and comfort in taking care of child's epilepsy
Time frame: within 2 weeks of a clinical encounter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Results publication: PubMed 33598905Grout 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall W Grout, MD principal investigator
Indiana University - Ped Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHICA SUDEP module in people with SUDEP and Epilepsy, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent recall of SUDEP counseling (time frame: within 2 weeks of a clinical encounter). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03502759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.