Alcohol Screening and Pre-Operative Intervention Research Study (ASPIRE)
Primary Purpose
Alcohol Drinking
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief advice
Health coaching
Sponsored by

About this trial
This is an interventional health services research trial for Alcohol Drinking focused on measuring Elective Surgery
Eligibility 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
Sites / Locations
- The University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Brief advice
Health coaching
Arm Description
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.
Two health coaching sessions, resource brochure, standard of care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Acceptability of Intervention as Measured by the Post-intervention Evaluation.
Interventions will be considered 'acceptable' if the average acceptability rating reaches a threshold of 3 or more on a 4-point Likert scale where a score of 4 is most acceptable.
Satisfaction
Quite dissatisfied
Mildly dissatisfied
Mostly satisfied
Very satisfied
Full Information
NCT ID
NCT03929562
First Posted
April 24, 2019
Last Updated
October 24, 2022
Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT03929562
Brief Title
Alcohol Screening and Pre-Operative Intervention Research Study
Acronym
ASPIRE
Official Title
Alcohol Screening and Pre-Operative Intervention Research Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
August 20, 2019 (Actual)
Primary Completion Date
July 19, 2021 (Actual)
Study Completion Date
August 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
Keywords
Elective Surgery
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brief advice
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Health coaching
Arm Type
Experimental
Arm Description
Two health coaching sessions, resource brochure, standard of care
Intervention Type
Behavioral
Intervention Name(s)
Brief advice
Intervention Description
One 10-minute brief advice session
Intervention Type
Behavioral
Intervention Name(s)
Health coaching
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Alcohol Weekly Use
Description
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.
Time Frame
Baseline through 4 months
Secondary Outcome Measure Information:
Title
Acceptability of Intervention as Measured by the Post-intervention Evaluation.
Description
Interventions will be considered 'acceptable' if the average acceptability rating reaches a threshold of 3 or more on a 4-point Likert scale where a score of 4 is most acceptable.
Satisfaction
Quite dissatisfied
Mildly dissatisfied
Mostly satisfied
Very satisfied
Time Frame
Weeks 1-6, Immediately following intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Fernandez
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication.
IPD Sharing Access Criteria
Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.
Learn more about this trial
Alcohol Screening and Pre-Operative Intervention Research Study
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