Alcohol Screening and Pre-Operative Intervention Research Study (ASPIRE)

• ClinicalTrials.gov Identifier: NCT03929562
• Recruitment Status: Completed
• First Posted: April 29, 2019
• Last Update Posted: August 23, 2021
• Sponsor: University of Michigan
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Information provided by (Responsible Party): Anne Fernandez, University of Michigan

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	Intervention/treatment	Phase
Alcohol Drinking	Behavioral: Brief advice; Behavioral: Health coaching	Not Applicable

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 (Clinical Trial)
• Actual Enrollment: 51 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 20, 2019
• Actual Primary Completion Date: July 19, 2021
• Actual Study Completion Date: August 17, 2021

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 Years 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

Locations

United States, Michigan

The University of Michigan

Ann Arbor, Michigan, United States, 48109

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: Anne Fernandez, Assistant Professor of Psychiatry, Medical School, University of Michigan
• ClinicalTrials.gov Identifier: NCT03929562
• Other Study ID Numbers: HUM00156743; 5K23AA023869 ( U.S. NIH Grant/Contract )
• First Posted: April 29, 2019
• Last Update Posted: August 23, 2021
• Last Verified: August 2021

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 Anne Fernandez, University of Michigan:

Elective Surgery

Additional relevant MeSH terms:

Alcohol Drinking; Drinking Behavior