Cluster randomised trial of an intervention to promote implementation of clinical guidance on the management of suspected encephalitis

Conditions

Topic: Infection

Ruth Backman, Robbie Foy, Peter J. Diggle, Rachel Kneen, Ava Easton et al. (9 authors)

PLoS ONE2018-12-069 citations

10.1371/journal.pone.0202257

The development of an intervention to promote adherence to national guidelines for suspected viral encephalitis.

Backman R, Foy R, Michael BD, Defres S, Kneen R, Solomon T.

2015-03-2022 citations

10.1186/s13012-015-0224-2

The evaluation of a tailored intervention to improve the management of suspected viral encephalitis: protocol for a cluster randomised controlled trial.

Backman R, Foy R, Diggle PJ, Kneen R, Defres S, Michael BD, Medina-Lara A, Solomon T.

2015-01-273 citations

10.1186/s13012-014-0201-1

Interventions

Package 1, there will be a series of interventions within the package that will be clinical led to help implement the national guidelines for management of suspected encephalitis patients.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Site inclusion criteria: All centres will have a consultant and all centres must be equipped with the ability to perform, or have access to CT/MRI scans and have aseptic conditions for conducting a LP to be performed. Hospitals will be randomised as a unit to either the standard care or intervention arm. Study centres will be initiated once all global (e.g. local research and development [R&D] approval) and study-specific conditions (e.g. training requirements) have been met, and all necessary documents have been returned to the Brain Infections UK coordinating centre. Within this study, any patients who have suspected encephalitis within the recruited sites will be included in the study. The inclusion criteria for suspected encephalitis are: Patients with suspected encephalitis (a) Mandatory Acute or sub-acute ( 38ºC) / prodromal illness ? acute or sub-acute 2. Seizures: new onset 3. Focal neurological signs ? acute or sub-acute onset. These include: 3.1. Focal weakness 3.2. Oromotor dysfunction 3.3. Movement disorders (chorea, athetosis, dystonia, hemiballisms, stereotypies, orolingual dyskinesia and tics) including Parkinsonism (bradykinesia, tremor, rigidity and postural instability) 3.4. Amnesia 4. Pleocytosis: cerebrospinal fluid white cell count >4 cells/ul 5. Neuroimaging: compatible with encephalitis 6. Electroencephalogram (EEG): compatible with encephalitis OR (b) Clinical suspicion of encephalitis but above investigations have not yet been completed OR (c) Clinical suspicion of encephalitis and the patient died before investigations completed Target Gender: Male & Female

Exclusion criteria

Exclusion criteria: Site exclusion criteria: Current participation in the ENCEPH UK programme Added 07/01/2015: Patient exclusion criteria Any patient aged under 28 days upon the date of admission shall be excluded

Design outcomes

Primary

Measure	Time frame
Current primary outcome measures as of 07/01/2015: The proportion of patients with suspected encephalitis whose care met all of the following criteria: 1. Aciclovir given within 6 hours of admission to hospital 2. A LP was performed within 12 hours of hospital arrival unless clinically contraindicated Previous primary outcome measures: The proportion of patients with suspected encephalitis whose care met all of the following criteria: 1. Aciclovir given within 6 hours of admission to hospital at the appropriate dose unless there was an alternative diagnosis 2. A LP was performed within 12 hours of hospital arrival unless clinically contraindicated.	—

Measure

Time frame

Current primary outcome measures as of 07/01/2015: The proportion of patients with suspected encephalitis whose care met all of the following criteria: 1. Aciclovir given within 6 hours of admission to hospital 2. A LP was performed within 12 hours of hospital arrival unless clinically contraindicated Previous primary outcome measures: The proportion of patients with suspected encephalitis whose care met all of the following criteria: 1. Aciclovir given within 6 hours of admission to hospital at the appropriate dose unless there was an alternative diagnosis 2. A LP was performed within 12 hours of hospital arrival unless clinically contraindicated.

—

Secondary

Measure	Time frame
Current secondary outcome measures as of 07/01/2015: 1. The proportion of all adults started on intravenous (IV) aciclovir within an appropriate dosage range for a neurological presentation who met the definition of suspected encephalitis 2. The proportion of all children started on intravenous (IV) aciclovir within an appropriate dosage range for a neurological presentation who met the definition of suspected encephalitis 3. The proportion of patients with suspected encephalitis who had a lumbar puncture performed within 12 hours unless there was a clinical contraindication 4. The proportion of patients with suspected encephalitis who had a lumbar puncture at any time within the index presentation 5. The proportion of patients with suspected encephalitis who had either MRI or CT scan within 24 hours of admission 6. The proportion of patients with suspected encephalitis having had a lumbar puncture, who had the following CSF investigations performed: 6.1. CSF:serum glucose ratio calculated 6.2. HSV PCR performed 7. An evaluation of the primary outcomes comparing adults and children enrolled in the RCT 8. A cost-effectiveness evaluation of the intervention Previous secondary outcome measures: 1. The proportion of all adults given intravenous (IV) aciclovir for a neurological presentation who met the definition of suspected encephalitis. 2. The proportion of all children given IV aciclovir for a neurological presentation who met the definition of suspected encephalitis. 3. The proportion of patients with suspected encephalitis who had a lumbar puncture performed within 12 hours unless there was a clinical contraindication. 4. The proportion of patients with suspected encephalitis who had a lumbar puncture after resolution of a clin	—

Measure

Time frame

Current secondary outcome measures as of 07/01/2015: 1. The proportion of all adults started on intravenous (IV) aciclovir within an appropriate dosage range for a neurological presentation who met the definition of suspected encephalitis 2. The proportion of all children started on intravenous (IV) aciclovir within an appropriate dosage range for a neurological presentation who met the definition of suspected encephalitis 3. The proportion of patients with suspected encephalitis who had a lumbar puncture performed within 12 hours unless there was a clinical contraindication 4. The proportion of patients with suspected encephalitis who had a lumbar puncture at any time within the index presentation 5. The proportion of patients with suspected encephalitis who had either MRI or CT scan within 24 hours of admission 6. The proportion of patients with suspected encephalitis having had a lumbar puncture, who had the following CSF investigations performed: 6.1. CSF:serum glucose ratio calculated 6.2. HSV PCR performed 7. An evaluation of the primary outcomes comparing adults and children enrolled in the RCT 8. A cost-effectiveness evaluation of the intervention Previous secondary outcome measures: 1. The proportion of all adults given intravenous (IV) aciclovir for a neurological presentation who met the definition of suspected encephalitis. 2. The proportion of all children given IV aciclovir for a neurological presentation who met the definition of suspected encephalitis. 3. The proportion of patients with suspected encephalitis who had a lumbar puncture performed within 12 hours unless there was a clinical contraindication. 4. The proportion of patients with suspected encephalitis who had a lumbar puncture after resolution of a clin

—

Countries

United Kingdom

Outcome results

None listed