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

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ClinicalTrials.gov Identifier: NCT03929562
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Anne Fernandez, University of Michigan

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

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.




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03929562


Contacts
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Contact: Lyndsay Chapman 734-232-0360 lych@umich.edu

Locations
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United States, Michigan
The University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Lyndsay Chapman    734-232-0360    lych@umich.edu   
Principal Investigator: Anne Fernandez         
Sponsors and Collaborators
University of Michigan
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Anne Fernandez University of Michigan

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Responsible Party: Anne Fernandez, Assistant Professor of Psychiatry, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT03929562     History of Changes
Other Study ID Numbers: HUM00156743
5K23AA023869 ( U.S. NIH Grant/Contract )
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: July 2019
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.

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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:
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Alcohol Drinking
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs