Alcohol Screening and Pre-Operative Intervention Research Study
Phase: NA
Conditions: Alcohol Drinking
Sponsor: University of Michigan

 
 
Alcohol Screening and Pre-Operative 
Intervention Research Study (ASPIRE) 
 
NCT03929562 
 
IRB Approval Date: May 7, 2021 

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Alcohol Screening and Pre-Operative Intervention Research 
Study 
 
ASPIRE 
National Clinical Trial Number: (TBD) 
Principal Investigator: 
Anne Fernandez, Ph.D., University of Michigan 
 
Supported by: 
National Institute of Alcohol Abuse and Alcoholism: K23 AA023869 
Version Number: 1 
 
12.14.18 
 
 

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TABLE OF CONTENTS 
Page 
PREFACE ........................................................................... Error! Bookmark not defined. 
Considerations for use ..................................................... Error! Bookmark not defined. 
Version control .................................................................. Error! Bookmark not defined. 
FULL PROTOCOL TITLEct.gov; eRsch ................................... Error! Bookmark not defined. 
TABLE OF CONTENTS ................................................................................................... i 
Protocol summaryct.gov ................................................................................................. iv 
1 
BAckground & Rationale ....................................................................................... 6 
1.1 
BackgroundeRsch ................................................................................................ 6 
1.2 
Study Rational ................................................................................................... 6 
2 
Outcomesct.gov;eRsch................................................................................................. 6 
2.1 
Primary Outcome .............................................................................................. 6 
2.2 
Secondary Outcomes ....................................................................................... 7 
2.3 
Other Pre-Specified Outcomes ......................................................................... 7 
3 
STUDY DESIGN ...................................................................................................... 7 
3.1 
Study Design ..................................................................................................... 7 
3.2 
Study flow ......................................................................................................... 8 
4 
Selection and enrollment of participants ............................................................. 9 
4.1 
Inclusion Criteriact.gov;eRsch  ................................................................................ 9 
4.2 
Exclusion Criteriact.gov;eRsch ................................................................................ 9 
4.3 
RecruitmenteRsch ................................................................................................ 9 
4.4 
EnrollmenteRsch;ct.gov ......................................................................................... 10 
5 
STUDY INTERVENTIONSct.gov  ............................................................................. 10 
5.1 
Delivery and Duration ....................................... Error! Bookmark not defined. 
5.2 
Handling of Study Interventions ...................................................................... 12 
5.3 
Concomitant Treatment .................................................................................. 12 

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5.3.1 Allowed Interventions .................................................................................. 12 
5.3.2 Prohibited Interventions ............................................................................... 12 
5.4 
Lifestyle Considerations .................................................................................. 12 
5.5 
Intervention Discontinuation ............................................................................ 12 
5.6 
Treatment Fidelity ........................................................................................... 12 
5.6.1 Overall compliance ...................................................................................... 12 
5.6.2 Treatment Design ........................................................................................ 13 
5.6.3 Interventionist or Provider Training .............................................................. 13 
5.6.4 Delivery of Treatment .................................................................................. 13 
5.6.5 Receipt of Treatment ................................................................................... 13 
5.6.6 Enactment of Treatment .............................................................................. 13 
6 
STUDY PROCEDURESeRsch ................................................................................. 13 
6.1 
Schedule of Activities ...................................................................................... 17 
6.2 
Description of Activities ................................................................................... 18 
6.2.1 Pre-consent activities .................................................................................. 18 
6.2.2 Post-consent activities & Outcome Assessments ........................................ 18 
6.2.3 Randomization ............................................................................................ 19 
6.2.4 Control & Experimental Interventions .......................................................... 19 
6.2.5 Outcome Assessments................................................................................ 19 
6.2.6 Withdrawal ................................................................................................... 20 
7 
safeTy .................................................................................................................... 20 
7.1 
Potential Risks ................................................................................................ 20 
7.2 
Potential Benefits ............................................................................................ 21 
7.3 
Assessment of Potential Risks & Benefits ...................................................... 21 
7.4 
Event Reporting ScheduleeRsch ........................................................................ 21 
7.5 
Safety Monitoring ............................................................................................ 23 
7.6 
Definitions for Adverse Events and Serious Adverse Eventsct.gov;eRsch ............ 22 
7.7 
Classification of Adverse Events ..................................................................... 21 
7.7.1 Severity of Event ......................................................................................... 23 
7.7.2 Relationship to Participation ........................................................................ 22 
7.7.3 Expectedness .............................................................................................. 23 
8 
STATISTICAL CONSIDERATIONSeRsch ............................................................... 26 
8.1 
Sample Size .................................................................................................... 26 
8.2 
Data Analysesct.gov .......................................................................................... 26 
8.2.1 General Approach ....................................................................................... 26 
8.2.2 Primary Outcome ........................................................................................ 26 

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8.2.3 Secondary Outcome ...................................... Error! Bookmark not defined. 
9 
Regulatory, ethical and study oversight considerations .................................. 27 
9.1 
Informed Consent ProcesseRsrch ...................................................................... 27 
9.2 
Confidentiality and PrivacyeRsrch ...................................................................... 27 
9.3 
Future Use of Stored Specimens and Data .................................................... 27 
9.4 
Data Handling & Record Keeping ................................................................... 27 
9.4.1 Quality Assurance & Quality Control ........................................................... 27 
9.4.2 Training ....................................................................................................... 28 
9.4.3 Protocol Deviations ..................................................................................... 29 
9.4.4 Monitoring .................................................................................................... 29 
10 COMMITTEES ....................................................................................................... 29 
11 REFERENCES....................................................................................................... 29 
12 APPENDICES .............................................................. Error! Bookmark not defined. 
 
 

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PROTOCOL SUMMARYCT.GOV 
 
Title: 
Alcohol Screening and Pre-operative Intervention Research 
(ASPIRE) study 
Study Description: 
The present study aims to conduct a randomized pilot test of two 
intervention conditions for risky alcohol use prior to elective surgery: 
Brief Advice and Health Coaching. This study builds on existing 
research indicating that moderate alcohol use (>2 drinks/day) prior 
to surgery increases the risk of postoperative morbidity, and heavy 
alcohol use (>4 drinks/day) increases the risk of postoperative 
mortality. This study will enhance our knowledge of how health 
coaching can influence problematic alcohol use, improve patient 
health, bolster hospital outcomes, and reduce the cost of 
postoperative care. 
Outcomes: 
 
The primary goal of this trial is to develop and examine the initial 
efficacy and acceptability of the health coaching intervention relative 
to brief advice with regards to reducing alcohol use prior to surgery. 
The primary outcome is change in alcohol use (average weekly 
drinking) and the secondary outcome is acceptability (perception of 
the interventions personal relevance). This trial has the following 
hypotheses but is likely under-powered to detect statistically 
significant differences. 
Hypothesis 1: Relative to the Brief Advice group, the Health 
Coaching group will experience greater reductions in average 
monthly alcohol use (quantity by frequency) based on the time line 
follow back. 
Intervention 
Information: 
 
The health coaching session will include two in-person individual 
sessions that will provide information about alcohol use reduction 
before and after surgery, delivered in a motivational interviewing 
format.  Patients will have the choice of in-person or virtual meetings 
(via encrypted, university-supported virtual meeting platform).  Brief 
advice will include a single 10-minute individual session of alcohol 
use reduction advice delivered virtually via encrypted, university-
supported virtual meeting platform. The objective of both 
interventions is to motivate participants to maintain abstinence from 
alcohol for 4 weeks before and 6 weeks after surgery. 
Study Population: 
The study population will be approximately 90 elective or semi-
elective surgical patients recruited from Michigan Medicine pre-
operative clinics.  Patients will be 18 to 75 years old and can identify 
as any gender or race/ethnicity.  
Locations:eRsch 
Patients will predominantly be recruited over the phone and online, 
after being identified by medical chart review.  They may also be 
recruited in-person from outpatient Michigan Medicine clinics that 
evaluate patients for surgical candidacy at numerous locations 

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including, but not limited to, Taubman Clinic, Domino’s Farms, West 
Ann Arbor, and Northville.  
Estimated Study 
Start Date: 
March 1st, 2019. 
Study Duration: 
Two years and four months. 
 

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1 
BACKGROUND & RATIONALE 
1.1 BackgroundeRsch 
 
Pre-operative alcohol use is one of the most common surgical risk factors and is one of the few 
that is modifiable1. A meta-analysis of 55 studies (combined N = 1,234,923) indicates pre-
operative alcohol consumption (> 2 standard drinks/day) is associated with an increased risk of 
various postoperative complications including general morbidity, infections, wound 
complications, pulmonary complications, prolonged hospital stay, and admission to intensive 
care unit2. Heavier alcohol consumption (> 4 standard drinks/day) is associated with increased 
risk of postoperative mortality These risks are not specific to certain surgeries or 
subpopulations, they are evident across all surgeries2 even after controlling for covariates such 
as gender and past year smoking status3,4. Importantly, short-term abstinence prior to elective 
surgery can reduce postoperative risks in as little as four to eight weeks (or less)5. Every 
additional point scored on the AUDIT-C increases the expected number of post-surgical 
complications by 29%6 Pre-operative alcohol use is linked to longer hospital stays, admission to 
the intensive care unit (ICU), and increased probability of returning to the operating room7. All 
told, pre-operative risky drinking leads to numerous health consequences for individuals and 
increased costs to the healthcare system and society.  
There is a scarcity of treatment and prevention research focused on pre-operative risky drinking. 
This is striking given the that the vast majority of hospital patients, including surgical inpatients, 
accept alcohol screening and BMI when it is offered8–10. Brief interventions are a recommended 
way to reduce risky drinking prior to surgery5,6; There remains a critical need for research to 
develop and evaluate the impact of pre-operative brief interventions on alcohol use and 
postsurgical outcomes. This study aims to take the initial steps to address this research gap. 
1.2 Study Rational 
There has been a call for additional research and development of behavioral interventions for 
alcohol use during the pre-operative period. However, these practice and research 
recommendations have not been implemented. At this time, there is a great need for research to 
identify and reduce alcohol use prior to elective surgery in order to improve patient health 
outcomes and reduce unnecessary healthcare utilization and costs. Therefore, this study will 
conduct a randomized pilot trial to evaluate initial efficacy of two interventions aimed at reducing 
alcohol use. Pre-operative patients (N = 90) will be recruited from University of Michigan 
Healthy System clinics and randomized to receive either a 2-session health coaching 
intervention (n = 45) or brief advice (n= 45). 
2 
OUTCOMESCT.GOV;ERSCH 
2.1 Primary Outcome 
The primary goal of this trial is to test initial efficacy of health coaching relative to brief advice. 
The primary outcome that this trial is powered to detect is change in alcohol use (defined as 
average weekly drinking) from baseline to one month follow-up (pre-operative outcome) and 
from baseline to the four month follow-up (post-operative outcome) in the Health Coaching 
condition relative to the brief advice condition.  

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2.2 Secondary Outcomes 
The secondary outcome of this trial is acceptability of the two interventions.  
Acceptability is defined as the extent to which participant’s perceive the intervention as 
personally relevant. We will consider the interventions acceptable based on post-
intervention evaluations.  Specifically, interventions will be considered ‘acceptable’ if the 
average acceptability rating reaches a threshold of 4 or more on a 5-point Likert scale.    
2.3 Other Pre-Specified Outcomes 
All other outcome measures will be exploratory. 
3 
STUDY DESIGN 
3.1 Study Design 
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 feasibility, fidelity, appropriateness, and 
acceptability. Study subjects will be outpatients at the University of Michigan Health System and 
fulfill the study’s inclusion criteria (see Section 4.1 below).  Subjects will be randomized to one 
of two intervention conditions: Health Coaching or Brief Advice (See Section 5 below).   
 
 

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3.2 Study flow 
 
 
Eligibility 
Screening 
Consent and baseline 
assessment  
Urn randomization  
N = 90 
 Session 1 
Surgery 
1 month Follow up  
(pre-op) 
4 month Follow up 
(post-op) 
Collect alcohol and drug 
biomarkers   
Medical Chart Review 
Week 1 
Week 5 
Week 6 (day 
of surgery 
Week 18  
Week 0:  Pre-enrollment 
Brief Advice 
Exit Interview 
N = 10 
Health Coaching 
Exit Interview 
N = 10 
Week 19 
Session 2 
Health Coaching (n =45) 
 Session 1 
Brief Advice (n = 45) 
Week 3 

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4 
SELECTION AND ENROLLMENT OF PARTICIPANTS 
4.1 Inclusion Criteriact.gov;eRsch  
Patients will be eligible for participation if they are: 1) 18 - 75 years of age, 2) referred for 
elective or semi-elective surgery or pre-operative assessment in the next 120 days, and 3) Meet 
criteria for “risky drinking,” scoring ≥ 5 on the first 3-items of Alcohol Use Disorders Identification 
Test (AUDIT). These cutoffs are associated with increased rates of postoperative complications 
among pre-operative patients following elective surgeries. 
4.2 Exclusion Criteriact.gov;eRsch  
Exclusion Criteria.  
Patient is… 
1) unable to provide voluntary informed consent for any reason (including incompetency);  
2) substantially cognitively impaired as evidenced by lack of orientation to person, place, or time 
or lack of ability to repeat back and answer screening questions 
3) Displays or shows evidence of psychotic symptoms 
4) Unable to read or understand English 
5 ) Undergoing surgeries that commonly require local anesthesia only (e.g. cataracts surgery, 
dental surgery, or other minor surgeries) 
4.3 RecruitmenteRsch 
Given the different structure and patient flow at various pre-operative clinics within Michigan 
Medicine, participants (N = 90) will be recruited using several methods designed to minimize 
disruption to patient care. We will seek a waiver of informed consent to identify potentially 
eligible patients from the medical chart. This waiver will only apply to the initial medical pre-
screen for eligibility criteria.  
1. In-person recruitment: We will recruit patients in-person from the pre-operative and surgical 
clinics at Michigan Medicine. Research staff will be given tablets to consent to screening and to 
complete the screening through Qualtrics. Paper study screening questionnaires will be used as 
backup and may be distributed by research or clinic staff. The screening assessment will 
determine patient eligibility to participate in the Phase 3 randomized control trial. The participant 
will be assigned a random screen ID number. If the participant is eligible and is interested in 
participating, we conduct the consent process at that time.  If this cannot be done right then, 
eligible subjects will be contacted by study research staff to schedule.  
2. Phone recruitment: Patients who have appointments at Michigan Medicine surgical or pre-
operative clinics will be identified through MiChart/medical record review. In clinics where we do 
not recruit in person, the clinics staff will provide patients with a letter at their clinic visit 
informing (see Phase 3 Patient Invitation Letter) them that they may be contacted by a member 
of the research team for study participation and give them the option to call the study to ‘opt-
out.’ If the clinic cannot provide a letter, we will mail a letter to the patient at least 3 days prior to 
our recruitment contacts. We are seeking a waiver of consent for this initial medical record 
screen. Those patients who appear to meet study inclusion/exclusion criteria through MiChart 
medical review will be contacted by telephone for recruitment (see Study Screening 
Questionnaire) by study research assistants. They will also be contacted through text or e-mail 
(see text and e-mail recruitment scripts). The text and e-mail will simply inform them they may 
be eligible for a research study and include a link to the screening consent form and screening 

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questions.  Those who are eligible will be asked to enter their contact information if they are 
interested in participating and the research assistant will reach out to them for consent and 
scheduling.  Research assistants will make up to eight contact attempts by phone, text, and e-
mail before indicating the patient was “unable to be reached.”  We will leave a maximum of 
three voicemails. 
All patients approached either in-person or by phone will be tracked in an Excel spreadsheet. 
Identifiable information will only be retained for patients that enroll in the study.  We will save 
only medical record numbers (MRNs) for all patients to ensure we do not attempt to recruit them 
more than once (e.g. if a patient has another surgery and enters into our recruitment list again 
MRN cross check will allow us to ensure we don’t contact them again). Recruitment outcomes 
will also be tracked in the Excel spreadsheet to document eligibility, refusals and those the 
research assistant is unable to reach.  Reasons for refusal or ineligibility will also be 
documented in the Excel spreadsheet. 
4.4  EnrollmenteRsch;ct.gov 
When the screening survey is administered, the staff member administering the screen will 
obtain verbal consent (when recruitment by phone) or patients will be asked to agree to the 
consent on the tablet (if recruiting online). For phone screening the staff member will read aloud 
the verbal consent script, and obtain verbal consent from the participant before beginning the 
survey. The oral consent script will contain all information typically included in a written consent 
document including risk, benefits, and security procedures. Following screening, staff will 
document the outcome of the call, including: eligible, ineligible, refused, reason for refusal etc.  
Participants who meet study eligibility criteria and have not met any of the exclusion criteria, will 
be given the option to participate in the study. Interested participants will either complete the 
consent form online or in-person and in all cases will be given the opportunity to ask questions 
prior to signing the consent.  Eligible participants who complete the informed consent in-person 
will review it with the study research assistant and be given time to read the consent and ask 
any questions.  Patients can also complete the informed consent online, which will contain all of 
the same information as the paper consent, before an intervention appointment.  In all cases 
participants will be given the opportunity to ask questions before signing the consent.  Reasons 
for refusal will be documented.   
Completion of informed consent will be documented and tracked in REDCap. Informed consent 
documents will be stored in locked files as well as linked to the patient’s data in REDCap.  Each 
participant will be a given unique patient identifier in REDCap.  Enrolled patients will be tracked 
in REDCap for surgery details, demographics, recruitment site, randomized intervention type, 
withdrawals, and intervention completion, and assessment completion.   
At the time of the intervention, the research assistant will confirm that the patient is scheduled 
for surgery and the surgery date.  
5 
STUDY INTERVENTIONSCT.GOV  
The ASPIRE study will offer two conditions that will occur before the patient’s scheduled 
surgery.  The conditions are (1) Health Coaching and (2) Brief Advice. Both 
interventions will be delivered by a trained member of the research team. 
Brief Advice 
 

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The Brief Advice session will take place once at least four (4) weeks before the patient’s 
surgery.  The Brief Advice session will last approximately 10 minutes. Before the 
session, the patient will receive the study infographic that visually summarizes the 
effects of alcohol on surgical health, study recommendations of healthy behaviors, and 
alcohol use resources. During the session, the patient and trained research team 
member will refer to the study infographic and discuss alcohol use and health during the 
pre-operative period.  If a participant cannot complete all study activities during one 
visit, we will allow participants to set an appointment to complete these activities within 
three days. A staff member at the pre-operative clinic will also give patient’s an 
infographic about alcohol and surgical health during their clinic visit approximately two 
weeks prior to surgery. 
 
Delivery: The Brief Advice session will be delivered by a trained member of the 
research team via telehealth or a telephone call, if the patient does not have access to a 
computer.  In both cases, the research team will be using encrypted, university-
supported virtual meeting platform with HIPAA-compliant conferencing services to 
contact the patient.  Brief Advice sessions will be audio-recorded for quality assurance 
purposes. The infographic will be provided at the patient’s pre-existing pre-operative 
clinical visit. 
 
Health Coaching 
Health Coaching will consist of two (2) sessions beginning four (4) weeks before the 
patient’s surgery.  The sessions will be spaced two (2) weeks apart to accommodate 
patient response to the intervention. Each Health Coaching session will last 
approximately 50 minutes. During the Health Coaching sessions, a trained research 
team member will discuss alcohol use and health during the pre-operative period by 
using motivational enhancement therapy techniques to improve the patient’s motivation 
to change.  Additionally, the research team will provide the patient with alcohol use 
resources during the Health Coaching sessions.  If a participant cannot complete all 
study activities during one visit, we will allow participants to set an appointment to 
complete these activities within three days. Follow-up surveys will take place at one-
week prior to surgery and one-month post-surgery.  A staff member at the pre-operative 
clinic will also give patient’s an infographic about alcohol and surgical health during their 
clinic visit approximately two weeks prior to surgery. 
 
Delivery: All Health Coaching sessions will be delivered by a member of the research 
team trained in motivational interviewing. The research team will give patients the option 
of in-person meetings, or virtual meetings via encrypted, university-supported virtual 
meeting platform .  The Health Coaching sessions will be audio-recorded for quality 
assurance purposes encrypted, university-supported virtual meeting platform with 
HIPAA-compliant conferencing services will be used for the videoconferencing or phone 
meetings. In-person meetings will take place at UM or a building within the UMHS, or a 
mutually agreed upon location within the community. The infographic will be provided at 
the patient’s pre-existing pre-operative clinical visit. 
Intervention Targets (mechanistic and clinical outcomes): 

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The goal of the pilot trial is to assess the initial efficacy of health coaching relative to 
brief advice and determine the acceptability and feasibility of both interventions.  This 
study is underpowered to assess mechanisms of change. 
Supportive Theories 
Supportive theories include social learning theory and motivational interviewing 
 
5.1 Handling of Study Interventions 
N/A 
5.2 Concomitant Treatment 
We will not exclude participants enrolled in other studies and/or health programs.  
5.3.1 Allowed Interventions – N/A 
5.3.2 Prohibited Interventions – N/A 
5.3 Lifestyle Considerations 
None. 
5.4 Intervention Discontinuation 
Withdrawal of consent will result in true study discontinuation with no interview or assessment 
performed.  Any information collected before withdrawal will be kept as part of the subject’s 
record. The study will document the patient’s reason for withdrawal, if available, to track for 
study purposes.     
Patients can also be withdrawn by the study if they become ineligible after consent.  These 
reasons include (1) surgery cancelation or rescheduling with a greater than 6-month delay, (2) 
demonstrating substantial cognitive impairment at two time points as evidenced by lack of 
orientation to person, place, or time or lack of ability to repeat back and answer questions; or (3) 
displays or shows evidence of psychotic symptoms, (4) fails to follow instructions of the 
researchers. 
5.5 Treatment Fidelity 
Fidelity to session content will be evaluated after each study session using a content checklist 
designed to ensure central elements of the health coaching and brief advice sessions are 
delivered. Motivational interviewing competence and adherence will be evaluated using the 
Motivational Interviewing Treatment Integrity (MITI) measure. All health coaching and brief 
advice sessions will be audio-taped, coded using the MITI, and evaluated using the fidelity 
checklist to ensure they adhere to protocol.  Bi-weekly supervision will take place to provide 
fidelity feedback to interventionists and ensure quality and consistency of intervention delivery.  
 
5.5.1 Overall compliance 
A participant will have completed the brief advice intervention after receiving the 10-
minute brief advice session.  A participant will complete health coaching after receiving 

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the two 50-minute health coaching sessions. We will track intervention completion in 
REDCap.  
5.5.2 Treatment Design 
The treatment is designed to provide health education, psychoeducation and increase 
motivation to change using a motivational interviewing framework.  
5.5.3 Interventionist or Provider Training 
All staff delivering sessions will take part in a two-day motivational interviewing training 
and weekly meetings with the study PI (a licensed clinical psychologist) to learn both 
specific intervention content, and MI delivery. They will also listen to audio-recordings of 
completed sessions from the refinement trial.  After training, interventionists will need to 
complete at least three practice sessions. One of these sessions must be audio-
recorded and coded with the MITI and our fidelity checklist and meet an 80% 
competency to MI, as well as deliver 90% of elements from the content checklist.  
5.5.4 Delivery of Treatment 
See above 
5.5.5 Receipt of Treatment 
See above 
5.5.6 Enactment of Treatment 
See above 
6 
STUDY PROCEDURESERSCH 
For Phase 3 we will conduct a randomized pilot trial test of Health Coaching and Brief 
Advice interventions to reduce alcohol use prior to elective surgery. The goal of the pilot 
trial is to assess the initial efficacy of Health Coaching relative to the Brief Advice 
Intervention and determine initial acceptability, feasibility, and fidelity of both conditions. 
Participants have a choice of intervention modality and they will either take place in-
person or as a virtual meeting using an encrypted, university-supported virtual meeting 
platform. The in-person meetings will take place at either the Rachel Upjohn Building, in 
MCRU research space, or at a building within UM or UMHS, or a mutually agreed upon 
location within the community. If a participant cannot complete all study activities during 
one visit or virtual visit, we will allow participants to set an appointment to complete 
these activities within three days. This study has one baseline assessment. Follow-up 
surveys will take place at one-month post-baseline (Follow up 1; one week pre-surgery) 
and at four-months post-baseline (Follow-up 2; 3-months post-surgery).   
Randomization 
Participants will be urn randomized to study condition using computerized random 
number generator. Groups will be balanced based on gender.  
Assessment and Measures 
Baseline assessment will take place at least four weeks prior to surgery. The baseline 
assessment will take approximately 40 minutes to complete. Thus, the first appointment 
will take up to 120 minutes for those randomized to health coaching (15 minutes to 

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review the consent form; 40 minutes for baseline assessment; 50 minutes for the 
intervention; 10 minutes for the post-intervention feedback; and 5 minutes to provide the 
incentive) or 75 minutes for those assigned to receive brief advice (15 minutes to review 
the consent form; 40 minutes for baseline assessment; and 10 minutes for the brief 
advice intervention and 10 minutes for intervention feedback evaluation). 
All baseline and follow-up assessments will be designed and administered using the 
Qualtrics Research Suite (http://www.qualtrics.com). The project-specific Qualtrics site 
is protected with a researcher-designated login name and password. The site houses 
the surveys and compiles data that staff will then transfer to a password protected 
Access database on the Department of Psychiatry secure network. For the web-based 
follow-up surveys, participants receive an email invitation inviting them to take the 
survey on-line and directing them to the Qualtrics site. An additional password may be 
given to participants in order for them to access to the site. There are systems in place 
that prevent the survey from being taken by the same user more than once. No 
identifying information is linked to the participants. There are security precautions in 
place to protect against unauthorized access, but there is a small risk of unauthorized 
access. Information regarding Qualtrics security and privacy statements can be found at 
http://www.qualtrics.com/security-statement and http://www.qualtrics.com/privacy-
statement. 
Baseline and Follow-up assessment. Baseline and Follow-up assessments will be 
completed by participants online (via tablet or home computer) at baseline, at 1-month 
follow-up (approximately one-week pre-surgery), and at 4-months follow-up 
(approximately three months’ post-surgery). The schedule of assessments is indicated 
in the Schedule of Study Activities. Participants will be notified by e-mail or text 
message when they are scheduled to complete follow-up.  If participants do not have 
internet access or do not want to complete the baseline or follow-up assessment online, 
research staff will conduct the follow-up assessment over the telephone, reading the 
questions from Qualtrics.  
Self-Report Measures 
Alcohol use assessments administered at baseline and follow-up include the Alcohol 
Use Disorders Identification Test (AUDIT)11, the Alcohol Timeline Followback (TLFB)12, 
the Severity of Alcohol Dependence Questionnaire (SADQ-C)13. The primary outcome 
(average weekly drinking using the TLFB) is gathered here. All other self-report 
measures are exploratory. 
Measures of alcohol use problems, behaviors, and cognitions include the Short 
Inventory of Problems (SIP)14, the Penn Alcohol Craving Scale (PACS)15, the 
Readiness-to-Change Ruler16, Situational Confidence Questionnaire (SCQ)17. 
Drug use assessments include the NIDA modified Alcohol, Smoking, and Substance 
Involvement Screening Test (ASSIST)18 and the Current Opioid Misuse Measure 
(COMM-8)19. Health and functioning assessments include Patient-Reported Outcomes 
Measurement Information System (PROMIS-29)20. 
Other measures related to treatment mediators and moderators include assessments of 
Social Support21,22, Health Service Utilization23,24,  Pre-operative Surgical Anxiety25, 
knowledge of surgical risk factors, pain management practices, and healthcare surgical 

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risk assessment.  
Alcohol and Drug Use biomarkers. On the day of surgery, a urine and blood sample will 
be collected and alcohol and drug screening labs ordered through the electronic health 
record.  The lab order will include ethyl glucuronide, phosphatidylethanol, and gas 
chromatography. The results will be shared with the research team and not affect the 
patient’s current surgical candidacy. This measure is exploratory. 
Medical Chart Review. The research team will extract and analyze de-identified data 
from patient’s medical records to evaluate the impact of the alcohol brief intervention on 
perioperative morbidity and mortality. No HIPAA identifiers will be collected from the 
patient medical record, except dates of treatment and dates of death (if applicable). The 
dataset will not be linked to patient identifying information. This measure is exploratory. 
Post-Intervention Assessment. Participants will also complete brief assessments 
following intervention completion regarding 4 domains: (1) perceived clinical usefulness 
(2) personal relevance, and (3) level of engagement, and (4) areas in need of 
adaptation. The secondary outcome (perception of interventions personal relevance) is 
gathered here.  
Qualitative Exit Interview: After the study is complete (N = 20) participants that indicated 
willingness to be re-contacted (in consent form) will be asked to complete an exit 
interview (open-ended researcher-delivered questions) about why they did or did not 
change their alcohol use, and what the role of the intervention was in that decision 
making process. The purpose is to further refine the intervention conditions for further 
development and dissemination. This measure is exploratory. 
Intervention Conditions 
Health Coaching:  Participants randomized to the health coaching condition will be 
scheduled for two in-person sessions, which will take place approximately 4 weeks prior 
to surgery. Health coaching will be delivered in person or through an encrypted, 
university-supported virtual meeting platform, depending on participant preference. 
Health coaching 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. All in-person sessions will be digitally audio-recorded 
and reviewed to ensure the core elements of MI are maintained. The patient will also 
continue with standard care through the UMHS surgical department. This includes the 
routine pre-operative assessments, medical appointments, and medical procedures. An 
infographic about alcohol and surgical health will also be given to participant’s at the 
patient’s pre-existing pre-operative clinical visit.  
Brief Advice:  Patients randomized to the brief advice condition will receive one brief 
advice session where the patient will receive health information and a resource 
brochure, but not additional material or motivational interviewing.  The patient will also 
continue with standard care through the UMHS surgical department. This includes the 
routine pre-operative assessments, medical appointments, and medical procedures.  An 

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infographic about alcohol and surgical health will also be given to participant’s at the 
patient’s pre-existing pre-operative clinical visit. 
Health Information and Resource Brochure. All randomized participants will receive a 
brochure including basic information on health behaviors regarding alcohol use, medical 
misuse of prescription drugs, and information on how to get help for substance use 
disorders. Women of childbearing age may be included in this study therefore 
information regarding the risks of alcohol use during pregnancy will be included in the 
brochure.  

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6.1 Schedule of Activities 
Table 1. Example of a Schedule of Activities (template) 
Note. All self-report measures are listed in the assessment section
 
Pre-screening 
(Pre-consent) 
 
Baseline 
Week 1, Day 1 
Intervention1 
Week 3 
Intervention 
Week 5 
Intervention 
Week 6 (day 
or surgery) 
Intervention 
Week 18 
Intervention 
Week 19 
Withdrawal8 
EMR Review eligibility 
X 
 
 
 
 
 
 
 
 
Eligibility confirmation 
X 
 
 
 
 
 
 
 
 
Informed consent 
 
 
X 
 
 
 
 
 
 
Demographics 
 
 
X 
 
 
 
 
 
 
Outcome Evaluation 
 
 
 
 
 
 
 
 
 
Self-report Alcohol Use 
 
 
X 
 
X 
 
X 
 
 
Alcohol and drug use 
biomarkers (Urine drug screen 
and blood draw) 
 
 
 
 
 
X 
 
 
 
Self-report Drug use  
 
 
X 
 
X 
 
X 
 
 
Mediators and moderators 
 
 
X 
 
X 
 
X 
 
 
Self-report Health and 
functioning assessment  
 
 
X 
 
X 
 
X 
 
 
Randomization 
 
 
X 
 
 
 
 
 
 
Experimental Interventions and 
intervention evaluations 
 
 
X 
X 
 
 
 
 
 
EMR review 
 
 
 
 
 
 
X 
 
 
Qualitative Exit Interview 
 
 
 
 
 
 
 
X 
 
Event reporting 
 
X 
X 
X 
X 
X 
X 
X 
X 

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6.2 Description of Activities 
6.2.1 Pre-consent activities 
We will be screening medical records to determine some patient eligibility criteria such 
as age, and surgery candidacy. We are requesting a waiver of consent for recruitment 
purposes. Due to the large number of patients receiving surgical care in the health 
system, it would be difficult to obtain consent from each patient prior to screening. The 
risk to patients is minimal in order to allow staff to pre-screen medical records. Patients 
who are interested in participating will provide informed consent before study activities 
begin. 
 
Participants who appear eligible after medical record screening will be approached in 
person or by phone, text or e-mail to complete a short screening survey; participants will 
provide screening consent prior to the screening survey. Participants eligible after the 
screening survey will provide informed consent before baseline assessment.  
 
Screen by tablet/online: The screening survey will be administered online using the 
Qualtrics survey platform. Prior to completing the screening survey, participants will be 
presented with an online consent form that contains all information typically included in 
a written consent document including risk, benefits, and security procedures. Before 
continuing to the survey, participants will provide consent by checking a box.  
 
Screen on the phone: When the screening survey is administered by phone, the staff 
member administering the screen will obtain telephonic consent from the participant by 
reading aloud the verbal consent script, and obtaining verbal consent from the 
participant before beginning the survey. The oral consent script will contain all 
information typically included in a written consent document including risk, benefits, and 
security procedures. 
 
6.2.2 Post-consent activities & Outcome Assessments 
Outcome assessments are performed three times across an individual’s time in the 
study: baseline, one-month post-baseline (one week prior to surgery, which will be 
completed online by participants), and four-months post-baseline (3 months after 
surgery). At approximately 3- months post-surgery, staff will perform a medical chart 
review (See 6.2.2.1 below).  Following brief advice and health coaching sessions, 
patients will be asked to complete a brief intervention assessment on acceptability and 
relevance of intervention content. 
 
6.2.2.1 
Medical Chart Review. The research team will extract and analyze de-
identified data from patient’s medical records to evaluate the impact of the two 
intervention conditions on perioperative morbidity and mortality. We are underpowered 
to detect potential between group effects of interventions on these outcomes, thus they 
are not part of our primary aims/hypotheses. No HIPAA identifiers will be collected from 

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the patient medical record, except dates of treatment and dates of death (if applicable). 
The dataset will not be linked to patient identifying information. 
6.2.3 Randomization and Retention 
Computer-generated urn randomization26 will ensure balanced groups based on gender. 
Research staff will be blind to participant study condition (with the except of those 
delivering interventions).  We will track participant retention as a measure of study 
feasibility. Retention strategies include, collecting multiple forms of participant and 
collateral contact information and sending reminders by e-mail, phone, and text. We aim 
to retain 80% of patients (72/90) using these strategies and those used in mentors’ past 
research that achieved similar rates of retention. 
6.2.4 Control & Experimental Interventions 
Intervention and Control Conditions.  
See section 5 
 
6.2.5 Outcome Assessments 
The change alcohol use and acceptability assessments will occur at three times 
throughout the study: baseline, one-month post-baseline, and four-months post-
baseline. See List of Study Activities Table. We will verify alcohol and drug use reports 
through a blood draw and urine drug screen conducted on the day of surgery that will 
undergo lab testing for drug/alcohol biomarkers. 
Qualitative Interviews  
 
A total of 20 patients, 10 from each intervention condition, will be selected (based on 
response vs. non-response to intervention.  Response is defined as an alcohol use 
reduction of greater than one standard deviation from the mean between baseline and 
final follow-up.  Non-response is defined as any increase in alcohol use between 
baseline and final follow-up or no change in alcohol use. These participants will be 
asked to complete exit interviews regarding their experience. Qualitative interviews with 
patients occur during a single interaction with research staff. Qualitative interviews will 
be audio recorded.  We will initially focus our patient interviews on what factors led to 
change or lack of change in alcohol use, and how the intervention played a role in these 
changes, and how the intervention could be improved. 
 
 

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6.2.6 Withdrawal 
If subjects withdraw or decline to finish treatment, we will make every effort to gather 
primary outcome data at regularly scheduled follow-ups. We will also query for an 
adverse event over the phone or in person. For subjects who wish to withdraw 
completely from the study, we will make every effort to collect the data as soon as 
possible – i.e. when the individual lets you know of their decision to withdraw. We will 
continue to use data that was obtained prior to withdrawal date unless the participant 
asks for it to be destroyed. The data will be kept secure until it is destroyed. 
7 
SAFETY 
7.1 Potential Risks 
The risk of violation of confidentiality exists because human participants are giving 
personal information. This risk is related to the damage that could be caused by an 
inadvertent release of sensitive information. Risk of a breach of confidentiality is 
minimal. Participants will be informed of the procedures taken to protect their 
confidentiality.  Questions will be asked about alcohol, prescribed opioid and sedative 
medications, depression, and physical health.  Prior to participating in the study, the 
consent form will contain a statement explaining mandatory reporting requirements for 
information reported regarding intention to harm self or imminent harm to others. 
Participants could become upset during the intervention or may become uncomfortable 
as a result of being asked personal questions.  All participants, of course, are free to 
terminate any portion of the study at any time or refuse to respond to any questionnaire 
item. Information about protecting against this risk are outlined in the next section. The 
investigators of this project will establish protocols for both research staff to guide them 
in responding to any crisis or harm situations (see Data Safety and Monitoring Plan). 
We will not screen participants for suicidality but if it is mentioned in an interview or 
intervention, further clinical assessment and individualized referral will be provided 
according to a detailed risk management plan. Note that Dr. Fernandez, Principal 
Investigator, is a licensed clinical psychologist who will be available to research staff to 
assist with determination of risk level. Procedures are consistent with those used in prior 
work in the psychiatry department that have been successfully implemented. 
Participants with alcohol dependence could experience withdrawal syndrome if they 
stop drinking abruptly. We will make every effort to identify patients at risk for alcohol 
withdrawal at baseline and encourage them to taper alcohol (and drug) use rather than 
stop abruptly should they chose to reduce or stop use. The pre-operative surgical and 
anesthesia team also assesses alcohol and drug use for every patient as part of 
standard care at several time points and enacts the Michigan Alcohol Withdrawal 
protocol for post-operative withdrawal prophylaxis. Thus patients will be encouraged to 
share accurate information about alcohol and drug use with their health care providers 
prior to surgery. We will also encourage admission to substance abuse treatment and/or 

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use of pharmacology when appropriate. If a patient has symptoms of alcohol 
dependence or reports past alcohol withdrawal symptoms we will consult with our 
consulting psychiatrist with expertise in withdrawal management for additional guidance. 
If we are still concerned about a patient’s safety related to alcohol or drug withdrawal, 
we would inform their surgical/anesthesia healthcare provider of this risk so that proper 
treatment can be offered perioperatively, and make every effort to let the patient know 
that we are communicating this information to their provider. 
Because some women may not know that they are pregnant or may not disclose their 
pregnancy, the health brochure given to all randomized participants will include 
information regarding the risks of alcohol use during pregnancy.  In addition, all 
pregnant women who are using substances will be encouraged to take part in a 
substance use treatment program.   
7.2 Potential Benefits 
Participants may benefit from participation in Health Coaching or Brief Advice sessions 
through alcohol use reduction and improved health. In addition, participants may benefit 
from the satisfaction of knowing they are contributing to a scientific experiment aimed at 
gaining knowledge that may help others. Others could benefit from the proposed 
research to the extent that the information on health services, alcohol screening, and 
alcohol brief intervention is disseminated and utilized towards prevention and treatment 
efforts. 
 
7.3 Assessment of Potential Risks & Benefits 
The degree of risk to which study participants will be exposed in the proposed protocol 
is low. By contrast, the potential benefits to the individual and society are substantial, 
insofar as the results of this study will be used to develop and implement interventions 
for pre-operative alcohol use. The interventions have the potential to successfully 
identify and reduce risky drinking prior to life-threatening surgical procedures. They also 
have the potential to reduce utilization of postoperative healthcare services.  When 
considering the minimal risks entailed with the data collection and tests proposed, in 
combination with the extensive efforts to limit/eliminate these risks, we feel that the 
potential benefits to the research community and future interventions far outweigh the 
potential minimal risks.  
7.4 & 7.5 
Event Reporting ScheduleeRsch  and Classification of Adverse Events 
Project staff will notify PI of SAEs immediately. All adverse events will be reported to the 
Institutional Review Board (IRBMED) per standard reporting guidelines; and an annual 
report will be submitted to the NIAAA Project Officer summarizing all adverse events. 
Per standard reporting guidelines, related and unexpected SAEs will be reported as 
soon as possible but within 7 calendar days, related and expected SAEs will be 
reported within 14 calendar days, unrelated and unexpected SAEs will be reported 
annually, and expected and unrelated SAEs will not be reported unless they exceed the 
rate expected for the study population. Dr. Fernandez will be responsible for 

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determining the severity of an event, and whether such adverse events were expected 
(i.e. listed as expected in the DSMP or included in the informed consent). The person 
responsible for reporting adverse events will be Dr. Fernandez; she will also be 
responsible for reporting amendments to the protocol to IRBMED prior to implementation 
of any changes. 
In the event that a participant either withdraws from the study or the PI decide to 
discontinue a participant due to an AE or SAE, the participant will be monitored by Dr. 
Fernandez, PI, via ongoing status assessment until (a) a resolution is reached (e.g., the 
problem has resolved or stabilized with no further change expected), (b) the SAE is 
determined to be clearly unrelated to the study intervention, or (c) the SAE results in 
death. Actions taken by the IRB in response to adverse event will also be reported to 
the funding agency, as will reports of changes or amendments to the protocol resulting 
from an adverse event. Outcomes of AEs and SAEs will be regularly reported to NIH 
and IRB (as outlined above). A summary of the AEs and SAEs that occurred during the 
previous year will be included in the annual progress report to NIH and the annual IRB 
renewals at the University of Michigan. Events that do not meet the criteria of an AE or 
SAE will also be included in the project’s annual progress reports to NIH and the 
University of Michigan IRB. 
7.5 Definitions for Adverse Events and Serious Adverse Eventsct.gov;eRsch  
Monitoring, Grading, Documentation, and Reporting of Adverse Events. It is 
unlikely that the study protocol will lead to an adverse event (AE) or serious adverse 
event (SAE). However, we have established procedures for dealing with these events. 
In the proposed study we will use the FDA definition of adverse events (AE) and serious 
adverse events (SAE). An adverse event is any undesirable experience, serious and 
non-serious, in a participant that may have a causal relationship with study participation. 
Symptoms or conditions present at or before the study that manifest themselves with 
the same intensity or frequency after study participation will not be recorded as adverse 
events. At the time of each contact, all participants will be monitored for the 
development of adverse experiences. Any concerns will be immediately reported to the 
PI who will review the information.  
7.5.1 Relationship to Participation –  
The PI will classify the relationship of the study protocol to the event as: 
• Definitely Not Study-Related: There is a 0% chance the event is related to the 
study.  It is clear that the participant’s clinical state fully explained the event, and not 
the study protocol.    
• Possibly Study-Related: There is a 1-49% chance the event is related to the study.  
The participant’s clinical state can explain the event; however, the study protocol 
could possibly have influenced the event.  
• Probably Study-Related:  There is a 50-99% chance the event is study related.  The 
event follows a reasonable temporal sequence associated with participating in the 
study and cannot be fully explained by the participant’s clinical state. 
• Definitely Study-Related. There is a 100% chance the event is study-related.  The 

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event follows a reasonable temporal sequence associated with participating in the 
study and cannot be explained by the participant’s clinical state. 
 
7.5.2 Severity of Event 
 
The scale below will be used to estimate the grade of severity of the adverse event: 
• Grade 1 Mild: Transient or mild discomfort, no limitation of activity, no or minimal 
intervention/therapy required. 
• Grade 2 Moderate: Mild to moderate limitation in activity; some assistance may be 
needed; no or minimal intervention/therapy required. 
• Grade 3 Severe: Marked limitation in activity; some assistance usually required; 
intervention/therapy required; hospitalization possible. 
• Grade 4 Life –threatening: Extreme limitation in activity; significant assistance 
required; significant intervention/therapy required; hospitalization probable (SAE) 
 
7.5.3 Expectedness 
Expected adverse events: Given that the population for this study consists of pre-
operative patients experiencing varying levels of pre-operative risk, we expect morbidity 
or mortality from surgical complications, as well as serious and non-serious surgical 
complications at a rate consistent with the general surgical patient population. Study 
staff may become aware of these complications during review of medical charts, or from 
participant self-report during follow up assessments.  
7.6 Safety Monitoring 
Responsibility for Data and Safety Monitoring. The PI, Dr. Fernandez, with 
assistance from the mentoring team, will be primarily responsible for monitoring 
participant safety. The primary concern will be the appropriate referral for patients who 
experience distress during assessment as well as the protection of client confidentiality. 
The PI will meet weekly with staff on the project, at which time they will evaluate the 
progress of the project, including issues regarding data management and participant 
risk. The PI will meet with mentors at monthly (e.g. Dr. Frederic Blow) to review study 
progress and any issues that arise. Urgent issues will be addressed immediately.  
Data Management. Project staff will be educated on the latest policies regarding the 
ethical treatment of participants and the protection of confidentiality. Several procedures 
will be utilized to guarantee the validity, integrity, accuracy and completeness of the 
data. Data files are accessible only to project personnel and are password protected. 
Finally, the project database will also be password protected and accessible only to 
research staff. Files used in data analysis will not have any identifying information in 
them – just randomly assigned ID numbers. All identifying information will be kept in a 
separate password protected file. All paper data will be filed in locked cabinets inside 
locked rooms that only the PI and research staff will have access to. No patient 
identifiable information will be released or published without written permission unless 

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required to do so by law.   
Entities conducting monitoring. The Michigan Medicine IRB (IRBMED) will review this 
protocol and all procedures and will provide oversight.  Monitoring will be done by the 
PI, mentors, and IRBMED. 
What is monitored? Monitoring is done of all procedures to ensure that they conform to 
approved protocol; of unforeseen circumstances that might arise and affect safety; of all 
reports of serious adverse events as defined in 38 CFR 46 (death, new prolonged 
hospitalization, persistent or significant disability/incapacity, or congenital anomaly/birth 
defect); of other significant adverse events (adverse events that lead to drop out by 
participant, termination by the investigator, termination or reduction of treatment); of 
unexpected adverse events resulting from the study; and of expected adverse events. 
Data and Safety Monitoring Plan   
Safety Monitoring  
The Principal Investigator, Dr. Fernandez, will ultimately be responsible for monitoring 
the data safety and quality of the study with involvement from the study coordinator. It 
should be noted that all research projects involving human participants, including the 
proposed one, require approval from the Institutional Review Board (IRBMED). A 
Certificate of Confidentiality will be provided for this study from the National Institute 
on Health (NIH). 
Dr. Fernandez will ensure that all relevant IRB policies, procedures and stipulations are 
being followed. Dr. Fernandez also will be responsible for ensuring that project staff 
adhere to the IRB policies including: (1) all participants will understand, agree to, and 
sign a written consent form before participating; (2) strict adherence to a participant’s 
right to withdraw or refuse to answer questions will be maintained; (3) the assessments 
will be completely confidential and no names will be associated with the assessment 
data; (4) consent forms and identifying information will be kept separately from the 
participant data; (5) all identifying information (consents, tracking data) will be kept 
locked at all times and computer files will have restricted access; (6) participants will be 
informed in writing in the consent form how to contact the PI, the project manager, and 
IRB office with any questions and/or concerns. 
 
Crisis Assessment: Dr. Fernandez will be responsible for providing training to all 
research staff regarding procedures for identifying, managing, and responding 
appropriately to acute warning signs of distress that could occur as a result of the 
assessments. Such strategies include maintaining an empathic response, 
acknowledging the distress through reflection, and eliciting or encouraging use of 
relaxation and cognitive calming strategies. Study staff will receive training from Dr. 
Fernandez in crisis assessment and management procedures in the event that 
participants reveal suicidal or homicidal ideation, child physical/sexual abuse, or 
concerns about safety. These crisis procedures will include a review of the study 
protocol regarding the limits of confidentiality, how to liaison with study site staff (i.e., in-
patient psychiatry, emergency department) to arrange for an assessment, circumstances 

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in which it may be necessary to notify authorities regarding intent to harm self or others 
(i.e. participant provider, child protective services), and the development of safety plans 
and resources. Study procedures also will include immediately paging/contacting Dr. 
Fernandez in cases in which this may become necessary (or contacting the assigned 
backup clinician during designated time periods). Dr. Fernandez will be responsible for 
providing regular supervision to research staff having direct contact with participants 
including crisis procedures for assessment and referral procedures for participants who 
meet criteria for suicidality. Supervision will focus on procedures for managing issues 
that could arise. 
In the case that a participant indicates any level of suicidal ideation or recent attempt 
during encounters with any study staff a suicide risk management protocol will be used. 
The protocol utilizes an algorithm of scripted risk assessment questions and “action 
steps” dependent on the participant responses. Based on the level of risk determined by 
the algorithm, study staff may perform one or more of the following: a) recommend the 
participant call or be transferred to the national suicide crisis hotline, the University of 
Michigan’s Psychiatric Emergency Services (PES), or the nearest emergency 
department to immediately address suicide risk and determine whether emergency 
medical services or police should be activated to conduct a wellness check in the 
patient’s home or community, b) notify a designated on-call study team clinician when 
the suicide risk management algorithm has been activated, and when any questions 
arise regarding risk management.   
Data Monitoring Plan 
The Principal Investigator (PI) ultimately will be responsible for monitoring the data 
safety and quality with involvement from study coordinator. Data will be collected using 
the Qualtrics survey platform and or/standardized paper forms and will only be identified 
with the study ID of the participant. The codes that link the name of the participant and 
the study ID will be kept separately and securely, along with any signed consent forms 
obtained. Quality control and reliability of screening, baseline and follow-up assessments 
will be monitored by Dr. Fernandez throughout the trial via regular meetings and 
observation of the research staff conducting standardized assessments. Additional data 
will be stored in a study database created within the REDCap application. The quality of 
the data will be monitored throughout the study. Data will be analyzed using a data 
analysis program such as SAS software. Data quality will be monitored by random 
inspection of the completed forms by the research staff and any problems detected will 
be discussed with the PI. 
Qualitative interviews will be conducted by trained research staff. The qualitative 
interviews will be audio-recorded. The audio-recordings of the sessions and 
interviews will be uploaded to a secure network server with restricted access. Once 
collected, participant data will remain confidential. 
 

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8 
STATISTICAL CONSIDERATIONSERSCH 
8.1 Sample Size 
 
Sample Size and Power Considerations. The sample size (N = 90) was primarily 
chosen to facilitate conclusions regarding study feasibility, acceptability, and provide 
experience with study protocol (e.g. recruitment, retention, assessment, and analysis). 
Participant retention (n = 72; 80%) is achievable using methods utilized in mentor’s past 
research27,28 and described in the retention section. A final sample of 72 participants will 
provide power of .80 to detect a medium effect (f2 = .20) using the proposed analyses. 
Based on meta-analyses of MI for excessive drinking, medium effects are expected 
within a 4-month follow up period29,30. Between group differences in post-operative 
morbidity, mortality, and healthcare utilization will likely be ‘very small’ based on base-
rates of postoperative complications. This study is underpowered to detect small effects. 
For this reason, hypothesis testing is considered ‘exploratory.’ Therefore, this study will 
primarily provide pragmatic information and experience with the study protocol to inform 
a fully-powered RCT. 
 
8.2 Data Analysesct.gov 
8.2.1 General Approach 
 
Data Preparation. Prior to analyses, we will examine patterns of missing data, research 
dropout, intervention fidelity, distributional properties of measures, correlations among 
outcome measures31. Given the small sample, we will pay particular attention to data 
distribution and use transformations when appropriate.   
Data Analysis. We will examine between group effects on alcohol use using General 
Estimated Equations (GEE).  We expect balanced groups on key variables as a result of 
urn randomization but will test the following covariates for systematic effects on 
outcome; gender, age, race/ethnicity, surgery type, and drug use. These analyses will 
use regression modeling using GEE due to the correlated structure of our data from 
repeated measures at baseline and follow-up. The GEE methodology properly 
estimates the regression coefficient and variance of the regression coefficient when 
correlated data are used in regression analysis will use all data available for participants 
including those subjects lost to attrition. Appropriate distributions will be use used based 
on the nature and distribution of the response variable. Relevant covariates will be 
included such as gender, age, race/ethnicity, surgery type, smoking status, and drug 
use. 
8.2.2 Primary Outcome 
The primary outcome of this study is between group differences in change in alcohol 
use from baseline to follow-up. This is defined as change in average weekly alcohol use 
(quantity by frequency) as measured by the Time Line Follow Back. Our hypothesis is: 
Relative to the brief advice group, the health coaching group will experience greater 
reductions in average weekly alcohol use between baseline and follow-up. This 

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hypothesis is considered exploratory given the low power to detect significant 
differences. 
Qualitative Analysis: 
All qualitative interviews will be digitally audio-recorded and transcribed verbatim using 
a HIPAA-compliant transcription service. Transcripts and codes will be analyzed using 
Nvivo software. We will analyze data using applied thematic analysis.  Emerging 
themes and data interpretations will be used for intervention refinement. 
 
9 
REGULATORY, ETHICAL AND STUDY OVERSIGHT CONSIDERATIONS 
9.1 
Informed Consent ProcesseRsrch 
Except for when identifying potential participants through MiChart, data will be accessed and 
collected only with informed consent. Consent will be obtained either in writing, over the phone, 
or online. Signed paper consents will be filed in a locked, confidential research file, or 
electronically on study provided tablet computers and stored in a secure database. Copies of 
consent forms will be given to the participant. Unique identification numbers will be assigned to 
participants who consent. All data forms will be coded with this number rather than with a name. 
Computer data files will be saved with passwords. Consent forms will be stored separately from 
other study data because they contain identifying information. Only the participant code number 
will be entered with the study data. Furthermore, we will receive a Certificate of Confidentiality 
from the NIH to protect the confidentiality of our data from legal requests.  
 
9.2 
Confidentiality and PrivacyeRsrch 
To minimize the risk of breaches of confidentiality, every effort is made to ensure that study data 
are always confidential, and web- and paper-based data are never stored so that data can be 
linked to a particular person. Training of research staff will include information about the 
importance of confidentiality and techniques to maintain confidentiality of all information 
reported by research participants. In addition, all research personnel will complete the required 
UM confidentially certification training. 
9.3 Future Use of Stored Specimens and Data 
9.4 Data Handling & Record Keeping  
9.4.1 Quality Assurance & Quality Control 
Throughout the proposed research investigation, participants’ names and contact 
information will be stored in a secure, password-protected database, separate from their 
study data. Names will be linked to individual ID numbers only in a study database, 
which will be kept in a restricted access folder on a secure server. Patient audio from 
intervention sessions and exit surveys will also be kept in a restricted access folder on a 
secure server.  All information collected will be accessible only to research staff who 
have completed and maintain mandatory training in the protection of human subjects 
(see 9.4.2) 

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REDCap will be used to track subject demographics, surgery details, screening scores, 
and level of study completion.  REDCap uses several methods to protect data from 
vulnerability and exploitation.  Incoming REDCap data gets filtered, sanitized and 
escaped as part of REDCap’s security procedures. The study investigators will ensure 
that Research Assistants (RAs) and other study staff will only have access to the 
REDCap data and information they need to complete their work by creating and 
updating user rights in REDCap.   
Qualtrics: The project-specific Qualtrics site is protected with a researcher-designated 
login name and password. The site houses the surveys and compiles data that staff will 
then transfer to a password protected Access database on the Department of 
Psychiatry secure network. For the web-based follow-up surveys, participants receive 
an email invitation inviting them to take the survey on-line and directing them to the 
Qualtrics site. An additional password may be given to participants in order for them to 
access to the site. There are systems in place that prevent the survey from being taken 
by the same user more than once. No identifying information is linked to the 
participants. There are security precautions in place to protect against unauthorized 
access, but there is a small risk of unauthorized access. Information regarding Qualtrics 
security and privacy statements can be found at http://www.qualtrics.com/security-
statement and http://www.qualtrics.com/privacy-statement. 
An encrypted, university-supported virtual meeting platform (e.g., , Zoom) will be used 
for delivering ASPIRE interventions via telephone or tele-video.  The plaform has a 
highly secure infrastructure that includes network and application firewalls, DOS 
protection, and penetration testing. The encrypted, university-supported virtual meeting 
platforms do not record or store patient information.  It encrypts and transmits content 
via phone that supports HIPAA privacy rules.  The ASPIRE study will not keep any 
patient video, only audio for quality assurance purposes, and transcription and coding in 
the case of qualitative exit surveys.  
Training 
All hired members of the research team will complete training and receive certification in 
Human Subjects Research Protection and HIPAA regulations, and the investigators will 
keep current certifications up to date.  All members of the research team will also 
complete PEERRS training.  All staff shall attend and successfully complete the 
University of Michigan Recipient Rights training within the first 90 days of employment. 
All staff delivering sessions will take part in a two-day motivational interviewing training 
and weekly meetings with the study PI (a licensed clinical psychologist) to learn both 
specific intervention content, and MI delivery. They will also listen to audio-recordings of 
completed sessions from the refinement trial.  Interventionists will need to complete at 
least three practice sessions with other staff. One of these sessions must be audio-
recorded and coded with the MI treatment integrity checklist and meet an 80% 
competency to MI, as well as deliver 90% of elements from the content checklist.  
Dr. Fernandez will ensure that all relevant IRB policies, procedures and stipulations are 
being followed and she will be responsible for ensuring that project staff adhere to the 
UM IRB policies including the following: (1) All participants will understand, agree to, 

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and provide consent before participating;  (2) Strict adherence to a participant’s right to 
withdraw or refuse to answer questions will be maintained; (3) Assessments and 
interventions will be completely confidential within intervention groups and no names 
will be associated with the obtained data; (4) Identifying information will be kept 
separate from the coded participant data;  (5) All identifying information will be kept 
locked at all times and computer files will be saved with passwords on secure servers; 
and (6) Participants will be informed in the consent form on how to contact the PI and 
IRB office with any questions and/or concerns.  Any serious unexpected and study 
related adverse events will be reported within 48 hours of learning of the event to the 
Project Officer and to UM within UM IRB reporting guidelines by Dr. Fernandez in 
directly supervising research staff, the investigators will be responsible for monitoring 
these confidentiality procedures.  Quality control and reliability of screening, baseline 
and follow-up data will be monitored via regular meetings where data frequencies are 
examined. Dr. Fernandez will also monitor the quality of the data files via supervision of 
the coordinator and data manager. 
The investigators will be responsible for providing training to all research staff who are 
interacting with participants via the intervention regarding procedures for identifying, 
managing, and responding appropriately to acute warning signs of distress.  Staff will 
receive training in risk assessment as outlined in previous sections. 
Management of AEs (See section 7) 
9.4.2 Protocol Deviations 
Study protocol deviations are not expected and will not be allowed.  Any protocol 
deviations will be addressed, tracked, and reported per the procedure below.    
 
It will be the responsibility of the site investigator to use continuous vigilance to identify 
and report deviations within 7 working days of identification of the protocol deviation, or 
within 7 working days of the scheduled protocol-required activity. All deviations will be 
addressed in study source documents, reported NIAAA Program Official. Protocol 
deviations will be sent to the reviewing Institutional Review Board (IRB) per their 
policies. The site investigator will be responsible for knowing and adhering to the 
reviewing IRB requirements.  
9.4.3 Monitoring 
We will monitor through routine data monitoring, weekly review meetings, staff training 
and annual re-training, and regular record reviews for assuring protocol compliance, 
and data quality, including regular record review and data double-entry to test for errors 
in data entry. 
10 
COMMITTEES 
N/A 
11 
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