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Alcohol Screening and Preoperative Intervention Research Study - 2 (ASPIRE-2)

Primary Purpose

Alcohol Drinking

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Usual Care (pre-operative)
Preoperative Virtual Health Coaching
Usual surgical care (post-operative)
Postoperative Virtual Health Coaching
On-Track (Post-operative)
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Drinking focused on measuring Surgery

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Completed consent form, baseline survey, and enrollment phone call Willingness to comply with all study procedures and availability for the duration of the study Scheduled for select major elective surgery (non-cancer) in the next 5-12 weeks Score ≥ 5 on the Alcohol Use Disorders Identification Test-Concise (AUDIT-C) based on research linking this score with increased risk of surgical complications Access to a smart device or computer access with internet or wi-fi connection throughout the study period Exclusion Criteria: Exclude participants enrolled in another research study focused on alcohol use History of severe alcohol withdrawal Unable to speak, understand, or read English

Sites / Locations

  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Other

Experimental

Experimental

Experimental

Experimental

Other

Arm Label

Enhanced Usual Care then Usual Surgical Care

Enhanced Usual Care then Post-operative Health Coaching

Enhanced Usual Care then On-Track

Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track)

Enhanced Usual Care alone

Preoperative Virtual Health Coaching then Usual Surgical Care

Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching

Preoperative Virtual Health Coaching then On-Track

Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track)

Preoperative Virtual Health Coaching only

Arm Description

Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care

Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care

Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care

Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care

Only completed first randomization. Study withdrawal prior to re-randomization

Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching

Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching

Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching

Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching

Only completed first randomization. Study withdrawal prior to re-randomization.

Outcomes

Primary Outcome Measures

Alcohol consumption as measured by the timeline follow-back
Alcohol consumption will be assessed using the 30-day Timeline Follow-Back (TLFB). The TLFB will capture information on the frequency and quantity of alcohol use including average drinks/day.

Secondary Outcome Measures

World Health Organization Drinking (WHO) Risk Level
WHO drinking risk levels derived from patient reports of the number of standard drinks (defined as 0.6 ounces of absolute alcohol) consumed, converted to grams of pure alcohol (0.6 ounces = 14 grams). Ranging from abstinence (0 grams) to very high risk (101+ males / 61+ females grams).
Alcohol Use Disorder Identification test (AUDIT)
We will calculate participant's total score on the AUDIT measure. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use and presence of more alcohol use disorder symptoms.

Full Information

First Posted
March 13, 2023
Last Updated
April 21, 2023
Sponsor
University of Michigan
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT05783635
Brief Title
Alcohol Screening and Preoperative Intervention Research Study - 2
Acronym
ASPIRE-2
Official Title
Reducing Alcohol Use Among Elective Surgical Patients Using Adaptive Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2023 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

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 sequential, multiple assignment, randomized trial will test treatments designed to reduce alcohol use before and after surgery to promote surgical health and long-term wellness.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
Keywords
Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
The proposed study will achieve this using a Sequential Multiple Assignment Randomized Trial (SMART) design.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Usual Care then Usual Surgical Care
Arm Type
Experimental
Arm Description
Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care
Arm Title
Enhanced Usual Care then Post-operative Health Coaching
Arm Type
Experimental
Arm Description
Randomized two times (2 possible randomization groups each time). Responder to Enhanced Usual Care
Arm Title
Enhanced Usual Care then On-Track
Arm Type
Experimental
Arm Description
Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care
Arm Title
Enhanced Usual Care then Combine (Postoperative Health Coaching + On-track)
Arm Type
Experimental
Arm Description
Randomized two times (2 possible randomization groups each time). Non-responder to Enhanced Usual Care
Arm Title
Enhanced Usual Care alone
Arm Type
Other
Arm Description
Only completed first randomization. Study withdrawal prior to re-randomization
Arm Title
Preoperative Virtual Health Coaching then Usual Surgical Care
Arm Type
Experimental
Arm Description
Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching
Arm Title
Preoperative Virtual Health Coaching then Postoperative Virtual Health Coaching
Arm Type
Experimental
Arm Description
Randomized two times (2 possible randomization groups each time). Responder to Preoperative Virtual Health Coaching
Arm Title
Preoperative Virtual Health Coaching then On-Track
Arm Type
Experimental
Arm Description
Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching
Arm Title
Preoperative Virtual Health Coaching then Combine (Postoperative Virtual Health Coaching + On-track)
Arm Type
Experimental
Arm Description
Randomized two times (2 possible randomization groups each time). Non-responder to Preoperative Virtual Health Coaching
Arm Title
Preoperative Virtual Health Coaching only
Arm Type
Other
Arm Description
Only completed first randomization. Study withdrawal prior to re-randomization.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Usual Care (pre-operative)
Intervention Description
The enhanced usual care will receive standard surgical care, and a resource brochure including basic information on health, alcohol use withdrawal risks, and treatment/emergency resources. The resource brochure will be e-mailed to patients or sent via postal mail.
Intervention Type
Behavioral
Intervention Name(s)
Preoperative Virtual Health Coaching
Intervention Description
Preoperative Virtual Coaching is based on principles of health coaching, collaborative care, and motivational interviewing. Health and educational content is framed using the Health Belief Model. During two sessions, that take place approximately 3 and 5 weeks prior to surgery, the health coach presents alcohol use reduction/abstinence as important for surgical health (rather than addiction or chronic health reasons) and engages participants in discussion and patient-centered goal-setting. Participants will also receive a brochure including basic information on health, alcohol use withdrawal risks, and treatment/emergency resources.
Intervention Type
Behavioral
Intervention Name(s)
Usual surgical care (post-operative)
Intervention Description
This group will receive standard post-operative care.
Intervention Type
Behavioral
Intervention Name(s)
Postoperative Virtual Health Coaching
Intervention Description
Postoperative Virtual Coaching uses the same framework and structure as Preoperative Virtual Coaching. These sessions will be delivered by a health coach using a collaborative, and motivational interviewing-based approach. The goal of these sessions is to promote well-being and help participants maintain alcohol abstinence or reduction long-term (or initiate change in alcohol use if they have not already). These sessions promote low-risk alcohol use, provide education on chronic health effects of heavy alcohol use, and teach skills for coping with or avoiding triggers for alcohol use including coping with stress and mood challenges. These sessions introduce skills to help participants manage alcohol, stress, and mood as they recover from surgery.
Intervention Type
Behavioral
Intervention Name(s)
On-Track (Post-operative)
Intervention Description
On-Track is a mobile and web-accessible health tool that uses self-monitoring and provision of feedback on progress towards goals to engage participants in self-management of alcohol use and motivate behavior change through increased self-awareness and accountability for health. The On-Track application includes a) daily tracking of alcohol and other substance use; b) daily tracking of stress, mood, and pain; c) personalized health goals; and d) visual displays of alcohol use, stress, mood, pain, and goal achievement including graphs of trends over time. On-Track also uses novel monetary and non-monetary incentives to encourage utilization including an escalating monetary incentive schedule for self-monitoring.
Primary Outcome Measure Information:
Title
Alcohol consumption as measured by the timeline follow-back
Description
Alcohol consumption will be assessed using the 30-day Timeline Follow-Back (TLFB). The TLFB will capture information on the frequency and quantity of alcohol use including average drinks/day.
Time Frame
10 months after surgical discharge
Secondary Outcome Measure Information:
Title
World Health Organization Drinking (WHO) Risk Level
Description
WHO drinking risk levels derived from patient reports of the number of standard drinks (defined as 0.6 ounces of absolute alcohol) consumed, converted to grams of pure alcohol (0.6 ounces = 14 grams). Ranging from abstinence (0 grams) to very high risk (101+ males / 61+ females grams).
Time Frame
10 months after surgical discharge
Title
Alcohol Use Disorder Identification test (AUDIT)
Description
We will calculate participant's total score on the AUDIT measure. Scores on the AUDIT range from 0 to 40 with higher numbers indicating greater problematic alcohol use and presence of more alcohol use disorder symptoms.
Time Frame
Up to 10 months after surgical discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed consent form, baseline survey, and enrollment phone call Willingness to comply with all study procedures and availability for the duration of the study Scheduled for select major elective surgery (non-cancer) in the next 5-12 weeks Score ≥ 5 on the Alcohol Use Disorders Identification Test-Concise (AUDIT-C) based on research linking this score with increased risk of surgical complications Access to a smart device or computer access with internet or wi-fi connection throughout the study period Exclusion Criteria: Exclude participants enrolled in another research study focused on alcohol use History of severe alcohol withdrawal Unable to speak, understand, or read English
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Fernandez
Phone
734-232-0313
Email
acfernan@med.umich.edu
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
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Fernandez, PhD
Phone
734-232-0313
Email
acfernan@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Anne Fernandez, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded investigators conducting applicable human subjects research are expected to submit de-identified, individual-level data to this data archive. The data generated in this grant will also be presented at national or international meetings (e.g., Research Society on Alcoholism, Addiction Health Services Research, etc.) and published in a timely fashion. All final peer-reviewed manuscripts that arise from this proposal will be submitted to the digital archive in PubMed Central.
IPD Sharing Time Frame
The research team will share data with NIAAA data archive (NIAAADA) biannually per funder requirements. The data in the NIAAADA are catalogued and made available to the general research community at the time of an associated publication or end of the award/support period, whichever comes first. Data in the NIAAADA is available indefinitely.
IPD Sharing Access Criteria
Community of scientists interested in the study of alcohol use and related interventions. Additionally, data submitted to National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) will be accessible by the general research community via NIAAADA.
IPD Sharing URL
https://nda.nih.gov/niaaa

Learn more about this trial

Alcohol Screening and Preoperative Intervention Research Study - 2

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