NCT03929562: ASPIRE

Alcohol Screening and Pre-Operative Intervention Research Study

Completed NA Results posted Last updated 15 November 2022

What this trial tests

NA trial testing Brief advice in Alcohol Drinking in 65 participants. Completed in 17 August 2021.

Timeline

20 August 2019

Primary endpoint
19 July 2021

17 August 2021

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	65
Start date	20 August 2019
Primary completion	19 July 2021
Estimated completion	17 August 2021
Sites	1 location across United States

Drugs / interventions tested

• Brief advice
• Health coaching

Conditions studied

• Alcohol Drinking — all drugs for Alcohol Drinking →

Sponsor

University of Michigan

Who can join

Adults 18 to 75, any sex, with Alcohol Drinking. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Alcohol Weekly Use Primary · Baseline through 4 months

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.

1-Month Follow Up

Group	Value	95% CI
Brief Advice	7.01	± 3.12
Health Coaching	6.07	± 2.13

4-Month Follow Up

Group	Value	95% CI
Brief Advice	8.15	± 3.08
Health Coaching	6.44	± 1.91

Acceptability of Intervention as Measured by the Post-intervention Evaluation. Secondary · Weeks 1-6, Immediately following intervention

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 1. Quite dissatisfied 2. Mildly dissatisfied 3. Mostly satisfied 4. Very satisfied

Group	Value	95% CI
Brief Advice	8
Health Coaching Session 1	4
Health Coaching Session 2	1
Brief Advice	15
Health Coaching Session 1	20
Health Coaching Session 2	23

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 Months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Brief Advice

Serious: 1/26 (4%)

Deaths: 0/26

Health Coaching

Serious: 3/25 (12%)

Deaths: 0/25

Serious adverse events (1 terms)

Reaction	System	Brief Advice	Health Coaching
Post-op Surgical complications, Surgical and Medical Procedures	Injury, poisoning and procedural complications	—	—

Most-reported serious reactions: Post-op Surgical complications, Surgical and Medical Procedures.

Data from ClinicalTrials.gov NCT03929562 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Preoperative alcohol interventions for elective surgical patients: Results from a randomized pilot trial.
   Fernandez AC, Chapman L, Ren TY, Baxley C, et al · · 2022 · cited 9× · PMID 36283843 · DOI 10.1016/j.surg.2022.09.012
2. Beliefs About Perioperative Opioid and Alcohol Use among Elective Surgical Patients Who Report Unhealthy Drinking: A Qualitative Study.
   Fernandez AC, Lin LA, Bazzi AR, Boissoneault J, et al · · 2021 · cited 2× · PMID 33892495 · DOI 10.1093/pm/pnab104
3. Reducing Alcohol Use Before and After Surgery: Qualitative Study of Two Treatment Approaches.
   Chapman L, Ren T, Solka J, Bazzi AR, et al · · 2023 · cited 1× · PMID 37494103 · DOI 10.2196/42532