Post-RAMPART Implementation of Midazolam in EMS (PRIME) . A retrospective, observational study of the use of IM midazolam . Study Rationale.
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There is a need to understand the process of implementation of clinical trial findings in the prehospital setting. In the absence of such understanding the use of effective prehospital treatments may be delayed, increasing morbidity.
There is a need to understand the effectiveness of pre-hospital treatment of status epilepticus and to identify factors that predict treatment failure/success.
Completion of the RAMPART trial provides a unique opportunity and environment to examine prehospital convulsive seizure therapy and changes in treatment.
Objective 1: Publication of the RAMPART trial results did not influence IM midazolam use between the 12 months preceding publication and the post-publication follow-up period.
Objective 2: IM midazolam administered according to local protocols following RAMPART trial completion was inferior to IM midazolam and IV lorazepam administered during the RAMPART trial in terminating convulsive seizure/status epilepticus prior to emergency department arrival.
Objective 1: The primary outcome measure is the proportion of EMS transported patients treated with benzodiazepines for convulsive seizure who received intramuscular midazolam, evaluated monthly
Objective 2: Termination of convulsive seizure activity prior to arrival in the emergency department after an initial prehospitaldose of midazolam without the need for a second “rescue” dose of any benzodiazepine by EMS
Treatment concordance with RAMPART clinical trial results. Treatment is considered concordant if 1) adults and those children with an estimated body weight of more than 40 kg received 10 mg of midazolam intramuscularly or 2) children with an estimated body weight of 13 kg to 40 kg received 5 mg of midazolam intramuscularly.
Frequency of acute recurrence of seizure (either in EMS or ED)
Frequency and duration of hospitalization
Frequency and duration of ICU admission
Frequency of acute endotracheal intubation
Clinical, spatial and demographic characteristics of patients without termination of seizures prior to arrival in the ED and those with recurrent seizures in the prehospital or ED setting (treatment failures).
IRB review at each participating institution is required to demonstrate compliance with the conditions set out for the protection of human subjects as compiled in the “Common Rule”, 45 CFR 46 subparts A-D.
Given the retrospective, observational nature of the study we plan to conduct it under a waiver of informed consent.
The research involves no more than minimal riskto the subjects (i.e., the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests);
The waiver or alteration will not adversely affect the rights and welfare of the subjects;
The research could not practicably be carried out without the waiver or alteration; and
Whenever appropriate, the subjects (including their physicians, as applicable) are provided with additional pertinent informationafter participation.
An important objective of the PRIME study is to characterize treatment resistant seizures.
It is therefore necessary to evaluate specific elements of protected health information. These include: subject age, treatment date and location, and hospital length of stay information, in order to identify characteristics associated with treatment failures.
HIPAA requires that the IRB or a Privacy Board find and document the following when a waiver of authorization will result in use or disclosure of protected health information (“PHI”) in connection with a research project:
No more than a minimal risk to the privacy of individuals;
Plan to protect the identifiers;
Plan to destroy the identifiers; and
Written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required;
The waiver will not adversely affect the privacy rights and the welfare of the individuals;
The research could not practicably be conducted without the waiver; and
The research could not practicably be conducted without use of the PHI
The study will be conducted in accordance with the ICH Guidelines for Good Clinical Practice and all relevant local, national and international regulations.
Hub investigators will provide quality assurance within their Hub spoke complex in a process called Verification. This is independent of Monitoring, whichis used to mean only independent external monitoring by the NETT Project Monitor of the Clinical Coordinating Center.
Data quality monitoring is performed continuously. Out of range and logical errors are identified at the time of data entry.
Site visits may be conducted periodically by the Project Monitor(s).
At site visits, the records of a sample of subjects will be reviewed against source documents. The proportion of records to be reviewed will be determined by the Statistical and Data Management Center.
$1,500 start up payment for participating HUB/Spoke Complexes
$160 / completed CRF, paid quarterly
In RAMPART, each Hub/Spoke complex averaged 96 PRIME subjects per year
Worth additional $15,360/year, on average, for each Hub/Spoke complex
Large variation in screening between complexes, therefore reimbursement will have to be reviewed quarterly to ensure balance in enrollment and ability to complete needed duration of study for time series analysis