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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jose R Maldonado, MD, Stanford University
ClinicalTrials.gov Identifier:
NCT01637415
First received: June 21, 2012
Last updated: February 28, 2014
Last verified: February 2014
  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 (i.e., 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 (i.e., autonomic instability). The goal of this study is to evaluate the psychometric properties (e.g., predictive validity) of the new tool, the Prediction of Alcohol Withdrawal Severity Scale (PAWSS), on identifying which patients are at risk for developing moderate to severe AWS (i.e., seizures, hallucinosis, delirium tremens) during admission to a medical unit.


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 Moderate to Severe Alcohol Withdrawal Syndrome.

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Moderate to severe alcohol withdrawal [ Time Frame: During the first 72 hours after admission. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Amount of benzodiazepines administered [ Time Frame: During the first 72 hours after admission. ] [ Designated as safety issue: No ]
  • Development of delirium tremens (DT's) [ Time Frame: During the first 72 hours after admission. ] [ Designated as safety issue: Yes ]
  • Development of seizures (in absence of underlying seizure disorder) [ Time Frame: During the first 72 hours after admission. ] [ Designated as safety issue: Yes ]
  • 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
Estimated Study Completion Date: September 2014
Estimated 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 moderate to severe AWS in hospitalized medical 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 3 or greater will be associated with a high risk for the development of moderate to severe AWS.

Patients will be undergo examination with the PAWSS within 24 hours of admission. Thereafter, all patients will undergo daily examinations with the Clinical Institute Withdrawal Assessment (CIWA) and Alcohol Withdrawal Severity scale (AWSS) 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 SIPAT-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 moderate-severe AWS it will enable them to prophylax (i.e., preventively treat) patients at risk and thus decrease patients' morbidity and mortality, length of hospital stay, and minimize the significant burden on the nursing and medical staff.

  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 the Stanford Hospital and Clinics B2 and B3 inpatient units, admitted directly from either Stanford ED or from any community or outpatient setting.

Criteria

Inclusion Criteria:

  • All patients admitted to the B2 and B3 Stanford Hospital inpatient units, directly from the Stanford ED, other Stanford Hospital units, or outpatient/community settings.
  • Ability to communicate in English.
  • Ability to understand our questionnaire.
  • Willingness to consent and participate.

Exclusion Criteria:

  • Patients transferred from outside hospitals.
  • Inability to understand our questionnaire.
  • Unwilling to consent and participate.
  • Patients in active alcohol withdrawal, as defined by CIWA > 20 on admission.
  • Patients with uncontrolled seizure disorder.
  • Patients with severe personality disorder.
  • Patients with an imminent discharge plan (within 48 hours of study screening).
  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

No publications provided

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: February 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
alcohol withdrawal
prediction
severity
use disorder

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

ClinicalTrials.gov processed this record on August 19, 2014