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

NCT01637415 | Completed

• 1 other identifier: 22731
• Study Type: observational
• Target: 409
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Withdrawal Syndrome

Keywords

alcohol withdrawal syndrome; prediction; severity; alcohol use disorder; complicated alcohol withdrawal; alcohol withdrawal seizures; delirium tremens; PAWSS

Outcome Measures

Primary Outcomes (1)

• Complicated alcohol withdrawal

  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 Outcomes (4)

• Amount of benzodiazepines administered

  During the first 72 hours after admission.

• Transfer to ICU due to severe AWS

  During the first 5 days after admission.

• Development of delirium

  During the first 72 hours after admission.

• Length of hospital stay

  Participants will be followed for the duration of hospital stay, an expected average of 7 days.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospitals and Clinics

Stanford, California, 94305, United States

Location

Related Publications (4)

• Maldonado JR, Sher Y, Ashouri JF, Hills-Evans K, Swendsen H, Lolak S, Miller AC. The "Prediction of Alcohol Withdrawal Severity Scale" (PAWSS): systematic literature review and pilot study of a new scale for the prediction of complicated alcohol withdrawal syndrome. Alcohol. 2014 Jun;48(4):375-90. doi: 10.1016/j.alcohol.2014.01.004. Epub 2014 Feb 19.

  PMID: 24657098 RESULT

• Maldonado JR, Nguyen LH, Schader EM, Brooks JO 3rd. Benzodiazepine loading versus symptom-triggered treatment of alcohol withdrawal: a prospective, randomized clinical trial. Gen Hosp Psychiatry. 2012 Nov-Dec;34(6):611-7. doi: 10.1016/j.genhosppsych.2012.06.016. Epub 2012 Aug 13.

  PMID: 22898443 RESULT

• Maldonado JR. An approach to the patient with substance use and abuse. Med Clin North Am. 2010 Nov;94(6):1169-205, x-i. doi: 10.1016/j.mcna.2010.08.010.

  PMID: 20951277 RESULT

• Stern TA, Gross AF, Stern TW, Nejad SH, Maldonado JR. Current approaches to the recognition and treatment of alcohol withdrawal and delirium tremens: "old wine in new bottles" or "new wine in old bottles". Prim Care Companion J Clin Psychiatry. 2010;12(3):PCC.10r00991. doi: 10.4088/PCC.10r00991ecr. No abstract available.

  PMID: 20944765 RESULT

MeSH Terms

Conditions

Alcoholism; Alcohol Withdrawal Seizures; Alcohol Withdrawal Delirium

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Seizures; Neurologic Manifestations; Nervous System Diseases; Alcohol-Induced Disorders, Nervous System; Neurotoxicity Syndromes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Poisoning; Alcohol-Induced Disorders; Substance Withdrawal Syndrome

Study Officials

• Jose R Maldonado, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry; Chief, Psychosomatic Medicine Service

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: July 11, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 30, 2015

Record last verified: 2015-01

Locations

US (1)