An Evaluation of the Brief Interventional for Problem Drinkers Among Medical Inpatients (BI)

April 6, 2015 updated by: Shen-Ing,Liu, Mackay Memorial Hospital

Effects of Brief Intervention for General Hospital Inpatients With Unhealthy Alcohol Use in Taiwan: A Randomized, Controlled Trial

Compared with control participants at post-intervention follow-ups, unhealthy drinkers who receive the screening and brief intervention will (1) report reduced alcohol consumption among all patients, and (2) report reduced alcohol-related problems and health care utilization.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Alcohol use is associated with a number of adverse health and economic effects. Problem drinking is associated with increased mortality rates and with premature mortality. As a result of these findings, the testing of the effectiveness of alcohol abuse prevention strategies has become an important national research priority. Secondary prevention of alcohol problems covers the methods used for early detection and treatment of people with excessive alcohol consumption. These preventive methods are referred to as brief interventions. Brief intervention is a short-term counseling strategy based on motivational enhancement therapy that concentrates on changing patient behavior and increasing patient compliance with therapy. It has been shown to be effective for helping socially stable problem drinkers to reduce or stop drinking, for motivating alcohol-dependent patients to enter long-term alcohol treatment, and for treating some alcohol-dependent patients for whom the goal is abstinence. The aims of this study are to examine the outcomes of a brief intervention to reduce alcohol consumption by problem drinkers among medical inpatients in general hospital setting. The study design is a randomized controlled clinical trial. Patients will be recruited from adult patients who are admitted to medical or surgical wards of a general hospital. All adult inpatients of a general hospital, aged 18 to 65 years, will be consecutively screened with the Alcohol Use Disorders Identification Test for identifying the problem drinkers. All patients who screen positive and who have signed a consent form will be contacted by a researcher and invited to participate in a face-to-face interview to determine their eligibility for the trial. The inclusion criteria are problems drinkers, defined as men who drank more than 21 units a week and women who drank more than 14 units a week. Patients will be excluded from participation in the study if they are younger than 18 years or older than 65 years, and have attended an alcohol treatment program in the last 3 months. Screened positives will then be interviewed using the instrument of SCAN to confirm the diagnosis of alcohol use disorders. The patients who fulfill the criteria will be randomized into one of the three following groups: (1) control group will be provided with routine inpatient usual care; (2) experimental group 1: physicians and nurses in charge will be informed of the results of alcohol consumption screening, in addition to providing routine inpatient usual care; (3) experimental group 2 will receive brief intervention, in addition to treatment protocols provided for experimental group 1. Brief intervention, offered twice by well-trained therapists, is 15-minute short-term individual consultation, giving alcohol health education, increasing their motivation to alcohol abstinence, teaching alcohol abstinence principle, and in order to ameliorate the over-drinking problems in these cases. The main outcome measures are alcohol use measures, which will be evaluated at 12-week after the study recruitment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Taiwan
      • Taipei, Taiwan, 251
        • Mackay Memorial Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • men aged 18-65 admitted to medical or surgical wards in a medical center in Taipei;
  • Unhealthy alcohol users defined as men who currently (past 3 months) drank risky amounts, > 168 g alcohol per week or usually drank more than 32 g/ occasion.
  • Patients provide written informed consent

Exclusion Criteria:

  • Psychotic disorders or symptoms, bipolar disorder, major suicide risk,
  • serious medical illness, or currently being treated in psychiatric clinics/or alcohol treatment program.

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: BI
Behavioral: Motivational enhancement therapy
Motivational enhancement therapy begins with the assumption that the responsibility and capacity for change lie within the client. The therapist begins by providing individualized feedback about the effects of the patient's drinking. Working closely together, therapist and patient explore the benefits of abstinence, review treatment options, and design a plan to implement treatment goals.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The primary outcome was the number of drinks per week
Time Frame: 4-, 9- and 12-month
4-, 9- and 12-month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
included days abstinent, the number of heavy drinking episodes (> 5 drinks/ occasion); the proportions of patients with risky drinking (> 14 drinks per week) , heavier drinking (> 20 drinks per week), alcohol-related problems and health care utilization.
Time Frame: 4-, 9 and 12-month
4-, 9 and 12-month

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mackay Memorial Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Science Council, Taiwan

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2004

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2005

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2005

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 28, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DOH93-TD-1050

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings