Alcohol Screening and Pre-Operative Intervention Research Study

NCT ID: NCT03929562

Last Updated: 2022-11-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-20

Study Completion Date

2021-08-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Brief advice

Intervention Type BEHAVIORAL

One 10-minute brief advice session

Health coaching

Two health coaching sessions, resource brochure, standard of care

Group Type EXPERIMENTAL

Health coaching

Intervention Type 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.

Interventions

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Brief advice

One 10-minute brief advice session

Intervention Type BEHAVIORAL

Health coaching

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Anne Fernandez

Assistant Professor of Psychiatry, Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Fernandez

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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The University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 37494103 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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5K23AA023869

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00156743

Identifier Type: -

Identifier Source: org_study_id

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