Testing Delivery Channels of Brief Motivational Alcohol Intervention

Hazardous Drinking Clinical Trial

— PECO  

Official title:

Testing Delivery Channels of Brief Motivational Alcohol Intervention Among General Hospital Inpatients With Risky Drinking: Personal Counseling Versus Computer-generated Feedback Letters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01291693
• Other study ID #: 108376
• Secondary ID: DM8-IESO03108376
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 4, 2011
• Last updated: December 1, 2015
• Start date: February 2011
• Est. completion date: November 2014

Study information

• Verified date: December 2015
• Source: University Medicine Greifswald
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate whether motivation-tailored alcohol interventions are more effective when delivered by person or by computer-generated feedback letters. A sample of 920 general hospital inpatients with risky drinking will be recruited through a computerized screening procedure. Patients with more severe alcohol problems will be excluded from the study. Participants will be allocated by time frame randomization to one of three study arms: (1) personal counseling based on Motivational Interviewing, (2) computer-expert system intervention that generates individualized feedback-letters, and (3) control group (treatment-as-usual). The interventions differ in their channel of delivery, but not regarding their content. Both intervention groups receive interventions at three time points: directly after the baseline-assessment at the general hospital, and 1 and 3 months later by mail and phone, respectively. Outcome will be assessed six, 12, 18 and 24 months after baseline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 975
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• General hospital inpatients with risky drinking (AUDIT-C >= 4/5 (women/men) and AUDIT < 20)

Exclusion Criteria:

• Patients already recruited during an earlier hospital stay

• Patients physically and mentally not capable of participating in the study

• Patients with a hospital stay of less than 24 hours

• Patients with insufficient language/ reading skills

• Patients employed at one of the departments participating in the study or conducting the study

• Patients with more severe alcohol problems (AUDIT >= 20)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hazardous Drinking

Intervention

Behavioral:
• Personal Counseling
At three time-points, participants receive counseling by health professionals trained in Motivational Interviewing based counseling. To assure that both interventions do not differ in their content, individual manuals generated by a software program are used. Counseling will be face-to-face during the hospital stay, and by phone one and three months later.
• Computer-generated feedback letters
At three time points, participants receive feedback letters, tailored to the stages of change according to the TTM, and generated by a computer software program. The first letter is handed out during their hospital stay and includes normative feedback. One and three months later, participants receive ipsative feedback letters by mail.

Locations

Country	Name	City	State
Germany	Institute of Social Medicine and Prevention, University Medicine Greifswald	Greifswald	Mecklenburg-Western Pomerania

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	German Cancer Aid

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risky drinking	Determined by using average alcohol consumption per day, heavy occasional drinking, highest blood alcohol concentration, the Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) score	6, 12, 18, 24 months	No
Secondary	Motivation to reduce drinking	Assessed by a stages of change-algorithm	6, 12, 18, 24 months	No
Secondary	Attempts to reduce drinking		6, 12, 18, 24 months	No
Secondary	Knowledge about drinking limits		6, 12, 18, 24 months	No
Secondary	Self-efficacy scores	Assessed by a modified short-form of the Alcohol-Abstinence-Self-Efficacy-Scale (AASE). The modified form assesses self-efficacy regarding compliance with drinking limits.	6 months	No
Secondary	Decisional balance scores	Assessed by a short form of the Alcohol Decisional Balance Scale (ADBS)	6 months	No
Secondary	Self-rated health		6, 12, 18, 24 months	No
Secondary	Health care utilization		6, 12, 18, 24 months	No

External Links

•   Homepage Institute of Social Medicine and Prevention, University Medicine Greifswald