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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/19/2021.

Alcohol Screening and Pre-Operative Intervention Research Study

Clinicaltrials.gov identifier NCT03929562

Recruitment Status Recruiting

First Posted April 29, 2019

Last update posted August 11, 2020

Study Description

Brief summary:

This study aims to learn more about how to improve patients' health before and after a scheduled surgery by examining acceptability and initial efficacy of pre-operative alcohol use reduction interventions.

  • Condition or Disease:Alcohol Drinking
  • Intervention/Treatment: Behavioral: Brief advice
    Behavioral: Health coaching
  • Phase: N/A
Detailed Description

The study is a randomized clinical pilot trial that assesses preliminary intervention efficacy of a two-session health coaching intervention relative to brief advice among pre-operative elective surgical patients and evaluates intervention acceptability. Study subjects will be outpatients at a large health system in the midwestern United States and fulfill the study's inclusion criteria. Subjects will be randomized to one of two intervention conditions: Health Coaching or Brief Advice.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 90 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Investigator, Outcomes Assessor)
  • Primary Purpose: Health Services Research
  • Official Title: Alcohol Screening and Pre-Operative Intervention Research Study
  • Actual Study Start Date: August 2019
  • Estimated Primary Completion Date: May 2022
  • Estimated Study Completion Date: May 2022
Arms and interventions
Arm Intervention/treatment
Active Comparator: Brief advice
One brief advice session, resource brochure, standard of care, and an infographic about alcohol and surgical health at patient's pre-existing pre-operative clinical visit.
Behavioral: Brief advice
One 10-minute brief advice session
Experimental: Health coaching
Two health coaching sessions, resource brochure, standard of care
Behavioral: Health coaching
Two 50-minute health coaching sessions will use a non-confrontation motivational interviewing (MI) style. Intervention delivery will include expressing concern about unhealthy drinking, providing feedback linking alcohol use and health (related to surgery and general health), advising the patient regarding abstinence or alcohol use reduction, and working with the patient to set a drinking goal if he/she is ready to change. We will also include a personalized feedback component to address the links between pre-operative alcohol use and postoperative morbidity/mortality.
Outcome Measures
  • Primary Outcome Measures: 1. Efficacy of intervention as measured by change in alcohol use as measured by the alcohol timeline follow back [ Time Frame: Baseline through 4 months ]
    Alcohol use (defined as average weekly drinking)
  • Secondary Outcome Measures: 1. Acceptability of intervention as measured by the post-intervention evaluation. [ Time Frame: Weeks 1-6, Immediately following intervention ]
    Interventions will be considered 'acceptable' if the average acceptability rating reaches a threshold of 4 or more on a 5-point Likert scale where a score of 5 is most acceptable.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Referred for elective or semi-elective surgery or pre-operative assessment in the next
120 days

- Meet criteria for "risky drinking" as defined by study staff

Exclusion Criteria:

- Displays or shows evidence of psychotic symptoms

- Undergoing surgeries that commonly require local anesthesia only

Contacts and Locations
Contacts

Contact: Lyndsay Chapman 734-232-0360 lych@umich.edu

Locations

United States, Michigan
The University of Michigan
Ann Arbor

Sponsors and Collaborators

University of Michigan

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator: Anne Fernandez University of Michigan

More Information
  • Responsible Party: University of Michigan
  • ClinicalTrials.gov Identifier: NCT03929562 History of Changes
  • Other Study ID Numbers: HUM00156743, 5K23AA023869
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: August 11, 2020
  • Last Verified: August 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Yes
  • Plan Description: The researchers will plan to share individual participant data that underlies the results reported in an article, after deidentification (text, tables, figures, and appendices), Study protocol, and Informed Consent Form.
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF)
  • Time Frame: Beginning 9 months and ending 36 months following article publication.
  • Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by University of Michigan: Elective Surgery
  • Additional relevant MeSH terms: Alcohol Drinking