The "Prediction of Alcohol Withdrawal Severity Scale" (PAWSS) (PAWSS)
|ClinicalTrials.gov Identifier: NCT01637415|
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : January 30, 2015
|Condition or disease|
|Alcohol Withdrawal Syndrome|
The investigators plan to study the psychometric properties of a new tool, the "Prediction of Alcohol Withdrawal Severity Scale" (PAWSS) on predicting the risk for the development of complicated AWS (i.e., seizures, delirium tremens) in hospitalized medically ill patients. This tool was developed through an extensive literature review which identified evidence-based predictors for AWS.
The scale consists of three portions relating to 1) an initial screening (threshold items), 2) patient's history of alcohol use and its consequences, and 3) measures of BAL and autonomic function. The investigators predict that a scale score 4 or greater will be associated with a high risk for the development of complicated AWS.
Patients will undergo examination with the PAWSS within 24 hours of hospital admission. Thereafter, all patients will undergo daily examinations with the Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA) and the Alcohol Withdrawal Severity scale (AWS scale) in order to measure the primary outcomes of the study, that is, the development and severity (i.e., moderate to severe) of AWS during the first 72-hours after admission. The study is designed to study the tool's psychometric properties including its validity and inter-rater reliability.
By providing clinicians with a tool (i.e., PAWSS) that allows them to correctly predict who will develop complicated AWS it will enable them to prophylax (i.e., preventively treat) patients at risk and thus decrease patients' morbidity and mortality, shorten length of hospital stay, minimize the significant burden on the nursing and medical staff, and improve overall patient care.
|Study Type :||Observational|
|Actual Enrollment :||409 participants|
|Official Title:||The "Prediction of Alcohol Withdrawal Severity Scale" (PAWSS): Development and Psychometric Characteristics of a New Scale for the Prediction of Complicated Alcohol Withdrawal Syndrome.|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
- Complicated alcohol withdrawal [ Time Frame: During the first 72 hours after admission. ]Complicated withdrawal will be defined as patients meeting criteria for complicated or severe withdrawal according to DSM-IV-Tr, a CIWA-Ar score > or = to 15, or experiencing severe symptoms requiring the use of benzodiazepine agents for symptom management.
- Amount of benzodiazepines administered [ Time Frame: During the first 72 hours after admission. ]
- Transfer to ICU due to severe AWS [ Time Frame: During the first 5 days after admission. ]
- Development of delirium [ Time Frame: During the first 72 hours after admission. ]
- Length of hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days. ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01637415
|United States, California|
|Stanford Hospitals and Clinics|
|Stanford, California, United States, 94305|
|Principal Investigator:||Jose R Maldonado, MD||Stanford University|