Alcohol Withdrawal SyndromePAWSSNCT01637415
The "Prediction of Alcohol Withdrawal Severity Scale" (PAWSS)
An observational study of Alcohol Withdrawal Syndrome, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alcohol Withdrawal Syndrome
- How many people
- 409 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Hospitals and Clinics
Stanford, California, 94305
About this study
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.
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.
Read the 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.
- Conditions
- Alcohol Withdrawal Syndrome
- Keywords
- alcohol withdrawal syndrome, prediction, severity, alcohol use disorder, complicated alcohol withdrawal, alcohol withdrawal seizures, delirium tremens, PAWSS
- Medical subject headings
- Alcoholism, Alcohol Withdrawal Seizures, Alcohol Withdrawal Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the first 72 hours after admission.
Secondary outcomes (4)
Amount of benzodiazepines administered
Measured: During the first 72 hours after admission.
Transfer to ICU due to severe AWS
Measured: During the first 5 days after admission.
Development of delirium
Measured: During the first 72 hours after admission.
Length of hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol Withdrawal SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose R Maldonado, MD, Stanford University
- Investigators
- Jose R Maldonado, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01637415
- Sponsor's protocol ID
- 22731
- Acronym
- PAWSS
- Status last verified
- Jan 2015
- First submitted
- 21 Jun 2012
- Last updated
- 30 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24657098Maldonado 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.
PubMed 22898443Maldonado 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.
PubMed 20951277Stern 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.
PubMed 20944765
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01637415
- Acronym / sponsor ID
- PAWSS / 22731
- Conditions
- Alcohol Withdrawal Syndrome
- Keywords
- alcohol withdrawal syndrome, prediction, severity, alcohol use disorder, complicated alcohol withdrawal, alcohol withdrawal seizures, delirium tremens, PAWSS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 11 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Amount of benzodiazepines administered
Time frame: During the first 72 hours after admission.
Transfer to ICU due to severe AWS
Time frame: During the first 5 days after admission.
Development of delirium
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2015.
- Results publication: PubMed 24657098Maldonado 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.
- Results publication: PubMed 22898443Maldonado 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.
- Results publication: PubMed 20951277Maldonado 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.
- Results publication: PubMed 20944765Stern 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose R Maldonado, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Withdrawal Syndrome, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complicated alcohol withdrawal (time frame: During the first 72 hours after admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01637415, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2015.