Alcohol Screening and Pre-Operative Intervention Research Study

NCT03929562 | Completed Results

• 2 other identifiers: HUM001567435K23AA023869
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking

Keywords

Elective Surgery

Outcome Measures

Primary Outcomes (1)

• Mean Alcohol Weekly Use

  Average (i.e. mean) weekly alcohol use was assessed using the timeline followback measure. The timeline followback assesses alcohol use using a calendar format on which participants report the number of standard drinks they consumed each day during the assessment period. In the United States, one standard drink (or one alcoholic drink equivalent), is defined as any beverage containing 0.6 oz or 14 grams of pure alcohol.

  Baseline through 4 months

Secondary Outcomes (1)

• Acceptability of Intervention as Measured by the Post-intervention Evaluation.

  Weeks 1-6, Immediately following intervention

Study Arms (2)

Brief advice

ACTIVE COMPARATOR

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

Health coaching

EXPERIMENTAL

Two health coaching sessions, resource brochure, standard of care

Behavioral: Health coaching

Interventions

Brief advice BEHAVIORAL

One 10-minute brief advice session

Brief advice

Health coaching BEHAVIORAL

Two 45-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.

Health coaching

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Displays or shows evidence of psychotic symptoms
• Undergoing surgeries that commonly require local anesthesia only

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Chapman L, Ren T, Solka J, Bazzi AR, Borsari B, Mello MJ, Fernandez AC. Reducing Alcohol Use Before and After Surgery: Qualitative Study of Two Treatment Approaches. JMIR Perioper Med. 2023 Jul 26;6:e42532. doi: 10.2196/42532.

  PMID: 37494103 DERIVED

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Anne C. Fernandez
• Organization: University of Michigan

acfernan@med.umich.edu

734-232-0521

Study Officials

• Anne Fernandez

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Psychiatry, Medical School

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: April 29, 2019
• Study Start: August 20, 2019
• Primary Completion: July 19, 2021
• Study Completion: August 17, 2021
• Last Updated: November 15, 2022
• Results First Posted: November 15, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)