The "Prediction of Alcohol Withdrawal Severity Scale" (PAWSS) (PAWSS)

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. Read our disclaimer for details. Identifier: NCT01637415
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : January 30, 2015
Information provided by (Responsible Party):
Jose R Maldonado, MD, Stanford University

Brief Summary:
Although there are several tools that can be used to evaluate the severity of ongoing alcohol withdrawal syndrome (AWS), there is no available tool that can predict which patients are at risk for developing AWS at the time admission, before the patient has developed AWS. Unfortunately, there are severe symptoms of alcohol withdrawal (e.g., seizures) which may develop early in the hospitalization, and before the development of other systemic symptoms which may warn medical personnel of the possibility of impeding alcohol withdrawal (e.g., autonomic instability, delirium). The goal of this study is to evaluate the psychometric properties (e.g., predictive validity) of a new tool, the Prediction of Alcohol Withdrawal Severity Scale (PAWSS), on identifying which patients are at risk for developing complicated AWS (i.e., seizures, hallucinosis, delirium tremens) among hospitalized, medically ill patients.

Condition or disease
Alcohol Withdrawal Syndrome

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Prospective
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Amount of benzodiazepines administered [ Time Frame: During the first 72 hours after admission. ]
  2. Transfer to ICU due to severe AWS [ Time Frame: During the first 5 days after admission. ]
  3. Development of delirium [ Time Frame: During the first 72 hours after admission. ]
  4. Length of hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days. ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients at Stanford Hospital and Clinics selected medical & surgical inpatient units (B2, B3, and C2), admitted directly from either Stanford ED or from any community or outpatient setting.

Inclusion Criteria:

  • Adult patients - defined as 18+ years of age
  • Able to understand and communicate in English.
  • Admission to the hospital within the last 24 hours to selected Stanford Hospital and Clinics inpatient units from the ED, outpatient clinics/community, or other SHC medical units.
  • Without an imminent discharge plan, (within 48 hours of study screening).
  • Willing and able to freely consent and participate.

Exclusion Criteria:

  • Unable or unwilling to consent and participate.
  • Unable to understand and communicate in English.
  • Patients transferred from outside medical facilities.
  • Patients with imminent discharge plan (i.e., not expected to remain in the hospital for at least 48 hours after enrollment into the study)
  • Uncontrolled active seizure disorder.
  • Active severe AWS (as defined by CIWA = or > 20) on initial assessment.
  • Identified by the primary team as too sick to participate.

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): NCT01637415

United States, California
Stanford Hospitals and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Jose R Maldonado, MD Stanford University

Publications of Results:
Responsible Party: Jose R Maldonado, MD, Associate Professor of Psychiatry; Chief, Psychosomatic Medicine Service, Stanford University Identifier: NCT01637415     History of Changes
Other Study ID Numbers: 22731
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: January 30, 2015
Last Verified: January 2015

Keywords provided by Jose R Maldonado, MD, Stanford University:
alcohol withdrawal syndrome
alcohol use disorder
complicated alcohol withdrawal
alcohol withdrawal seizures
delirium tremens

Additional relevant MeSH terms:
Substance Withdrawal Syndrome
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs