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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jose R Maldonado, MD, Stanford University
ClinicalTrials.gov Identifier:
NCT01637415
First received: June 21, 2012
Last updated: January 28, 2015
Last verified: January 2015
  Purpose

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
Alcohol Withdrawal Syndrome

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Complicated alcohol withdrawal [ Time Frame: During the first 72 hours after admission. ] [ Designated as safety issue: Yes ]
    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:
  • Amount of benzodiazepines administered [ Time Frame: During the first 72 hours after admission. ] [ Designated as safety issue: No ]
  • Transfer to ICU due to severe AWS [ Time Frame: During the first 5 days after admission. ] [ Designated as safety issue: No ]
  • Development of delirium [ Time Frame: During the first 72 hours after admission. ] [ Designated as safety issue: Yes ]
  • Length of hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 7 days. ] [ Designated as safety issue: Yes ]

Enrollment: 409
Study Start Date: May 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637415

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

Publications:
Responsible Party: Jose R Maldonado, MD, Associate Professor of Psychiatry; Chief, Psychosomatic Medicine Service, Stanford University
ClinicalTrials.gov Identifier: NCT01637415     History of Changes
Other Study ID Numbers: 22731
Study First Received: June 21, 2012
Last Updated: January 28, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
alcohol withdrawal syndrome
prediction
severity
alcohol use disorder
complicated alcohol withdrawal
alcohol withdrawal seizures
delirium tremens
PAWSS

Additional relevant MeSH terms:
Substance Withdrawal Syndrome
Syndrome
Chemically-Induced Disorders
Disease
Mental Disorders
Pathologic Processes
Substance-Related Disorders

ClinicalTrials.gov processed this record on February 27, 2015