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

January 28, 2015 updated by: Jose R Maldonado, MD, Stanford University

The "Prediction of Alcohol Withdrawal Severity Scale" (PAWSS): Development and Psychometric Characteristics of a New Scale for the Prediction of Complicated Alcohol Withdrawal Syndrome.

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

409

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the first 72 hours after admission.

Secondary Outcome Measures

Outcome Measure
Time Frame
Amount of benzodiazepines administered
Time Frame: During the first 72 hours after admission.
During the first 72 hours after admission.
Transfer to ICU due to severe AWS
Time Frame: During the first 5 days after admission.
During the first 5 days after admission.
Development of delirium
Time Frame: During the first 72 hours after admission.
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.
Participants will be followed for the duration of hospital stay, an expected average of 7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Jose R Maldonado, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

June 21, 2012

First Submitted That Met QC Criteria

July 6, 2012

First Posted (Estimate)

July 11, 2012

Study Record Updates

Last Update Posted (Estimate)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 28, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22731

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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