Testing Delivery Channels of Brief Motivational Alcohol Intervention (PECO)

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

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.

Study Overview

• Status: Completed
• Conditions: Hazardous Drinking
• Intervention / Treatment: Behavioral: Personal Counseling; Behavioral: Computer-generated feedback letters

• Study Type: Interventional
• Enrollment (Actual): 975
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Germany
  • Mecklenburg-Western Pomerania
    • Greifswald, Mecklenburg-Western Pomerania, Germany, 17475
      • Institute of Social Medicine and Prevention, University Medicine Greifswald

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Treatment as usual
Experimental: Personal counseling	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.
Experimental: Computer generated feedback letters	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation to reduce drinking	Assessed by a stages of change-algorithm	6, 12, 18, 24 months
Attempts to reduce drinking		6, 12, 18, 24 months
Knowledge about drinking limits		6, 12, 18, 24 months
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
Decisional balance scores	Assessed by a short form of the Alcohol Decisional Balance Scale (ADBS)	6 months
Self-rated health		6, 12, 18, 24 months
Health care utilization		6, 12, 18, 24 months

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Collaborators: German Cancer Aid
• Investigators: Principal Investigator: Jennis Freyer-Adam, PhD, Institute of Social Medicine and Prevention, University Medicine Greifswald; Principal Investigator: Beate Gaertner, PhD, Department of Epidemiology and Health Monitoring, Robert Koch-Institute Berlin; Principal Investigator: Ulrich John, Prof PhD, Institute of Social Medicine and Prevention, University Medicine Greifswald

Publications and helpful links

General Publications

• Freyer-Adam J, Baumann S, Bischof G, Staudt A, Goeze C, Gaertner B, John U. Social Equity in the Efficacy of Computer-Based and In-Person Brief Alcohol Interventions Among General Hospital Patients With At-Risk Alcohol Use: A Randomized Controlled Trial. JMIR Ment Health. 2022 Jan 28;9(1):e31712. doi: 10.2196/31712.
• Freyer-Adam J, Noetzel F, Baumann S, Aghdassi AA, Siewert-Markus U, Gaertner B, John U. Behavioral health risk factor profiles in general hospital patients: identifying the need for screening and brief intervention. BMC Public Health. 2019 Nov 29;19(1):1594. doi: 10.1186/s12889-019-7931-6.
• Freyer-Adam J, Baumann S, Haberecht K, Tobschall S, Bischof G, John U, Gaertner B. In-person alcohol counseling versus computer-generated feedback: Results from a randomized controlled trial. Health Psychol. 2018 Jan;37(1):70-80. doi: 10.1037/hea0000556. Epub 2017 Oct 2.
• Baumann S, Gaertner B, Haberecht K, Meyer C, Rumpf HJ, John U, Freyer-Adam J. Does impaired mental health interfere with the outcome of brief alcohol intervention at general hospitals? J Consult Clin Psychol. 2017 Jun;85(6):562-573. doi: 10.1037/ccp0000201. Epub 2017 Mar 23.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: February 4, 2011
• First Submitted That Met QC Criteria: February 7, 2011
• First Posted (Estimate): February 8, 2011

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Motivational Interviewing; brief intervention; general hospital; Hazardous drinking; computer-generated feedback; stage-tailored; delivery channel
• Other Study ID Numbers: 108376 (Other Grant/Funding Number: German Cancer Aid); DM8-IESO03 (Registry Identifier: University Medicine Greifswald); DM8-IESO04 (Registry Identifier: University Medicine Greifswald); 109737 (German Cancer Aid); 110676 (Other Grant/Funding Number: German Cancer Aid); 110543 (Other Grant/Funding Number: German Cancer Aid); 111346 (Other Grant/Funding Number: German Cancer Aid)