Three Strategies for Implementing Motivational Interviewing on Medical Inpatient Units: See One, Do One, Order One
Phase: NA
Conditions: See One, Do One, Order One
Sponsor: National Institute on Drug Abuse (NIDA)

Page 1 of 36 
 
 
YALE UNIVERSITY 
 
                                  HUMAN INVESTIGATION COMMITTEE 
 
                                     Application to Involve Human Subjects in Biomedical Research 
100 FR1 (2011-6) 
 
 
 
SECTION I: ADMINISTRATIVE INFORMATION 
 
Title of Research Project:   Three Strategies for Implementing Motivational Interviewing on Medical Inpatient 
Units:  See One, Do One, Order One 
 
Principal Investigator: Steve Martino PhD 
 
Yale Academic Appointment: Professor 
 
Campus Address: 142 Temple St, Suite 301, New Haven, CT  06510 
 
Campus Phone: 46621 
Fax: 46766 
Pager:  
E-mail: steve.martino@yale.edu 
Protocol Correspondent Name & Address (if different than PI): 
 Monica Canning-Ball 
Campus Phone: 203-812-
0126 
Fax: 203-764-
6766 
E-mail: monica.canning-ball@yale.edu 
Yale Cancer Center CTO Protocol Correspondent Name & Address (if applicable): 
 
Campus Phone:  
Fax:  
E-mail:  
Faculty Advisor:(required if PI is a student, 
resident, fellow or other trainee)           
 NA 
 
Yale Academic Appointment: 
 
Campus Address:  
 
Campus Phone:  
Fax:  
Pager:  
E-mail:  
DATE STAMPED-RECEIVED 
PROTOCOL NUM 
 
1205010234 
Please refer to the HIC website for application 
instructions and information required to complete 
this application.  The Instructions are available at 
http://www.yale.edu/hrpp/forms-
templates/biomedical.html  
Submit the original application and two (2) copies 
of all materials including relevant sections of the 
grant which funds this project (if applicable) to 
the HIC.   
HIC OFFICE USE ONLY 

Page 2 of 36 
 
 
Investigator Interests: 
Does the principal investigator, co-investigator, or any other responsible research team member, or any of 
their family members (spouse, child, domestic partner) have an incentive or interest, financial or otherwise, 
that may be viewed as affecting the protection of the human subjects involved in this project, the scientific 
objectivity of the research or its integrity? See Disclosures and Management of Personal Interests in Human 
Research http://www.yale.edu/hrpp/policies/index.html#COI  
ο  Yes  
ο  No  
 
 
If yes, list names of the investigator or responsible person: 
 
The Yale University Principal Investigator and all Yale University and Yale New Haven Hospital 
individuals who are listed as co-investigators on a protocol with a Yale University Principal 
Investigator must have a current financial disclosure form on file with the University’s Conflict 
of Interest Office. If this has not been done, the individual(s) should follow this link to the COI 
Office Website to complete the form:  http://www.yale.edu/coi/   
 
NOTE: The requirement for maintaining a current disclosure form on file with the University’s 
Conflict of Interest Office extends primarily to Yale University and Yale-New Haven Hospital 
personnel.  Whether or not they are required to maintain a disclosure form with the 
University’s Conflict of Interest Office, all investigators and individuals deemed otherwise 
responsible by the PI who are listed on the protocol are required to disclose to the PI any 
interests that are specific to this protocol. 
 
SECTION II: GENERAL INFORMATION 
 
1. Performing Organizations:  Identify the hospital, in-patient or outpatient facility, school or 
other agency that will serve as the location of the research.  Choose all that apply: 
  
a. Internal Location[s] of the Study: 
 Magnetic Resonance Research Center  
 
 Yale University PET Center 
     (MR-TAC)    
 
 
 
 
 YCCI/Church Street Research Unit (CSRU) 
 Yale Cancer Center/Clinical Trials Office (CTO)     
 YCCI/Hospital Research Unit (HRU) 
 Yale Cancer Center/Smilow 
 
 
 
 YCCI/Keck Laboratories 
 Yale-New Haven Hospital  
 
 
 Cancer Data Repository/Tumor Registry 
 Specify Other Yale Location: 
 
 
 
 
 
b. External Location[s]: 
 APT Foundation, Inc. 
 
 
 
 Haskins Laboratories 
 Connecticut Mental Health Center 
 
 John B. Pierce Laboratory, Inc. 
 Clinical Neuroscience Research Unit (CNRU) 
Veterans Affairs Hospital, West Haven 
 
 Other Locations, Specify:  
 
 
 International Research Site  
(Specify location(s)): 
 
 
c. Additional Required Documents (check all that apply): 
 N/A 
*YCCI-Scientific and Safety Committee (YCCI-SSC)  
Approval Date:  

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*Pediatric Protocol Review Committee (PPRC) 
 
Approval Date:  
*YCC Protocol Review Committee (YRC-PRC) 
 
Approval Date: 
 
*Dept. of Veterans Affairs, West Haven VA HSS 
 
Approval Date:  
*Radioactive Drug Research Committee (RDRC) 
 
Approval Date:  
 YNHH-Radiation Safety Committee (YNHH-RSC) 
 
Approval Date:  
 Magnetic Resonance Research Center PRC (MRRC-PRC) 
Approval Date:  
 YSM/YNHH Cancer Data Repository (CaDR)  
 
Approval Date:  
 Dept. of Lab Medicine request for services or specimens form 
*Approval from these committees is required before final HIC approval is granted. See instructions 
for documents required for initial submission and approval of the protocol. Allow sufficient time for 
these requests. Check with the oversight body for their time requirements. 
 
2. Probable Duration of Project: State the expected duration of the project, including all 
follow-up and data analysis activities. 9/1/2012-8/31/2017 
 
3. Research Type/Phase: (Check all that apply) 
a. Study Type 
   
 Single Center Study 
   
 Multi-Center Study 
Does the Yale PI serve as the PI of the multi-site study? Yes 
 
No 
 
  
 Coordinating Center/Data Management 
  
 Other:  
 
 
b. Study Phase 
 N/A 
    
 Pilot  
 Phase I 
 Phase II 
 Phase III 
 Phase IV 
    
 Other (Specify)  
 
 
4. Area of Research: (Check all that apply) Note that these are overlapping definitions and 
more than one category may apply to your research protocol. Definitions for the following 
can be found  in the instructions section 4c: 
 Clinical Research: Patient-Oriented 
   
 
 Clinical Research: Outcomes and  
 Clinical Research: Epidemiologic and Behavioral  
                 Health Services 
 Translational Research #1 (“Bench-to-Bedside”)      
 Interdisciplinary Research 
 Translational Research #2 (“Bedside-to-Community”)  
 Community-Based Research 
 
 
5.   Is this study a clinical trial? Yes 
 
No 
 
NOTE the current ICMJE (International Committee of Medical Journal Editors) definition of a 
clinical trial: “any research study that prospectively assigns human participants or groups of humans 
to one or more health-related interventions to evaluate the effects on health outcomes.” Health-related 
interventions include any intervention used to modify a biomedical or health-related outcome (for 
example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and 
process-of-care changes). Health outcomes include any biomedical or health-related measures 
obtained in patients or participants, including pharmacokinetic measures and adverse events” 

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If yes, where is it registered? 
  
 
Clinical Trials.gov registry 
  Will be registered promptly upon HIC approval and 
receipt of funding. 
  
 
Other (Specify)  
 
Registration of clinical trials at their initiation is required by the FDA, NIH and by the ICMJE. 
  
 
If this study is registered on clinicaltrials.gov, there is new language in the consent form and compound 
authorization that should be used. 
For more information on registering clinical trials, including whether your trial must be 
registered, see the YCCI webpage, http://ycci.yale.edu/researchers/ors/registerstudy.aspx  or 
 contact YCCI at 203.785.3482) 
 
6. Will this study have a billable service as defined by the Billable Service Definition? 
Yes 
 No
 
If you answered "yes", this study will need to be set up in Patient Protocol Manager (PPM) 
http://medicine.yale.edu/ymg/systems/ppm/index.aspx  
 
7. Are there any procedures involved in this protocol that will be performed at YNHH or one of 
its affiliated entities?  Yes _X__ No ___  If Yes, please answer questions a through c and note 
instructions below.  If No, proceed to Section III. 
a. Does your YNHH privilege delineation currently include the specific procedure that you will 
perform? 
b. Will you be using any new equipment or equipment that you have not used in the past for 
this procedure? 
  
c. Will a novel approach using existing equipment be applied? 
  
If you answered “no” to question 7a, or "yes" to question 7b or c, please contact the YNHH 
Department of Physician Services (688-2615) for prior approval before commencing with your 
research protocol. 
 
SECTION III: FUNDING, RESEARCH TEAM AND TRAINING 
 
1. Funding Source: Indicate all of the funding source(s) for this study. Check all boxes that apply. 
Provide information regarding the external funding source.  This information should include 
identification of the agency/sponsor, the funding mechanism (grant or contract), and whether 
the award is pending or has been awarded. Provide the M/C# and Agency name (if grant-
funded).  If the funding source associated with a protocol is “pending” at the time of the 
protocol submission to the HIC (as is the case for most NIH submissions), the PI should note 
“Pending” in the appropriate section of the protocol application, provide the M/C# and 
Agency name (if grant-funded) and further note that University (departmental) funds support 
the research (until such time that an award is made).   
 

Page 5 of 36 
 
 
 
 
 
 
PI  
Title of Grant 
Name of Funding Source  
Funding 
Funding Mechanism 
Martino 
 
Three Strategies 
for Implementing 
Motivational 
Interviewing on 
Medical Inpatient 
Units: See One, Do 
One, Order One 
NIDA - 1R01DA034243 
  Federal 
  State 
  Non Profit 
  Industry 
  Other For 
Profit  
  Other 
 
Grant-M# 150452           
Contract#  
Contract Pending 
  Investigator/Department 
Initiated 
  Sponsor Initiated 
  Other, Specify: 
 
 
 
 
 
  Federal 
  State 
  Non Profit 
  Industry 
  Other For 
Profit  
  Other 
 
Grant-M#            
Contract#  
Contract Pending 
  Investigator/Department 
Initiated 
  Sponsor Initiated 
  Other, Specify: 
 
 
 
 
 
  Federal 
  State 
  Non Profit 
  Industry 
  Other For 
Profit  
  Other 
 
Grant-M#            
Contract#  
Contract Pending 
  Investigator/Department 
Initiated 
  Sponsor Initiated 
  Other, Specify:  
 
 
IRB Review fees are charged for projects funded by Industry or Other For-Profit Sponsors.  
Provide the Name and Address of the Sponsor Representative to whom the invoice should be 
sent.  Note: the PI’s home department will be billed if this information is not provided. 
 
Send IRB Review Fee Invoice To: 
 
Name: 
 
Company: 
Address: 
  
2. Research Team:  List all members of the research team. Indicate under the affiliation column whether 
the investigators or study personnel are part of the Yale faculty or staff, or part of the faculty or staff 
from a collaborating institution, or are not formally affiliated with any institution. ALL members of 
the research team MUST complete Human Subject Protection Training (HSPT) and Health 
Insurance Portability and Accountability Act (HIPAA) Training before they may be listed on the 
protocol.  See NOTE below. 
 

Page 6 of 36 
 
 
 
 
 
NOTE: The HIC will remove from the protocol any personnel who have not completed required training. 
A personnel protocol amendment will need to be submitted when training is completed. 
 
 
Name 
Affiliation: Yale/Other 
Institution (Identify) 
 
NetID 
Principal Investigator  
Steve Martino, PhD   
Yale 
sm25 
Role: Co-Investigator 
  Kimberly A Yonkers, MD 
Yale 
kay5 
Role: Co-Investigator 
Paul Desan, MD 
Yale 
Phd6 
Role: Biostatistician 
Ralitza Gueorguieva 
Yale 
Rg268 
Role: Psychologist 
Joy Kaufman 
Yale 
Jk26 
Role: Psychiatrist 
Paula Zimbrean 
Yale 
Pz36 
Role: Co-Investigator 
William Cushing 
Yale 
Wlc22 
Role: Social Worker 
Heather Howell 
Yale 
Hbh9 
Role: Project Director 
Ashley McCaherty 
Yale 
Ar578 
Role: Research Assistant 
Monica Canning-Ball 
Yale 
Mac6 
Role: Co-Investigator 
Ariadna Forray 
Yale 
Af343 
Role: Research Assistant  
Jessica Katon 
Yale  
Jk954 
Role: Biostatistician 
Brian Merry 
Yale 
Bcm6 
Role: Other personnel 
Junemarie Rosner 
Yale 
Jr662 
Role: Other personnel 
Steven L Bernstein 
Yale 
Slb4 
Role: Other personnel 
Teresa Kenyon 
Yale 
Tk378 
Role: Other personnel 
Timothy Pham 
Yale 
Tlp24 
Role: Other personnel 
Rachel Ramirez 
Yale 
Rr497 
Role: Student 
Isabella Hermantin 
Yale 
Ih77 
Role: Student 
Mollie Rich 
Yale 
Mr2243 
Role: Research Assistant 
Rebecca Aldi 
Yale 
Ra497 
Role: Other personnel 
Jose Salvana 
Yale  
Jas343 
Role: Student 
Sahar Amjad 
Yale 
Sa829 
Role: Student 
Tulasikrishna Kadiyla 
Yale 
Tk534 
Role: Research Assistant 
Jonathan Ryan 
Yale 
Jr963 
Role: Data Manager 
Kate Gilstad-Hayden 
Yale 
Krg24 
Role: Study personnel 
Virginia Otero-Santos 
Yale 
Vo48 
Role: Study personnel 
Rebecca Tutino 
Yale 
Rt466 
Role: Study personnel 
Lilit Kazazian 
Yale 
Lk527 
Role: Study personnel 
Eva Jones 
Yale 
Emj28 

Page 7 of 36 
 
SECTION IV: 
 PRINCIPAL INVESTIGATOR/FACULTY ADVISOR/ DEPARTMENT CHAIR 
AGREEMENT 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
As the principal investigator of this research project, I certify that: 
 The information provided in this application is complete and accurate. 
 I assume full responsibility for the protection of human subjects and the proper conduct of the 
      research. 
 Subject safety will be of paramount concern, and every effort will be made to protect subjects’ 
      rights and welfare. 
 The research will be performed according to ethical principles and in compliance with all federal, 
      state and local laws, as well as institutional regulations and policies regarding the protection of   
      human subjects. 
 All members of the research team will be kept apprised of research goals. 
 I will obtain approval for this research study and any subsequent revisions prior to my initiating the 
      study or any change and I will obtain continuing approval of this study prior to the expiration date      
      of any approval period. 
 I will report to the HIC any serious injuries and/or other unanticipated problems involving risk to 
      participants. 
 I am in compliance with the requirements set by the University and qualify to serve as the 
      principal investigator of this project or have acquired the appropriate approval from the  
      Dean’s Office or Office of the Provost, or the Human Subject Protection Administrator at 
      Yale-New Haven Hospital, or have a faculty advisor. 
 I will identify a qualified successor should I cease my role as principal investigator and facilitate a 
smooth transfer of investigator responsibilities. 
 
_____ 
 
 
 
 
 
 
 
 
11/16/15 
 
  
PI Name (PRINT) and Signature 
 
 
 
 
Date 

Page 8 of 36 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Department Chair’s Assurance Statement 
Do you know of any real or apparent institutional conflict of interest (e.g., Yale ownership of a 
sponsoring company, patents, licensure) associated with this research project? 
 Yes (provide a description of that interest in a separate letter addressed to the HIC.) 
 No 
 
As Chair, do you have any real or apparent protocol-specific conflict of interest between yourself and 
the sponsor of the research project, or its competitor or any interest in any intervention and/or method 
tested in the project that might compromise this research project? 
Yes (provide a description of that interest in a separate letter addressed to the HIC) 
No 
 
I assure the HIC that the principal investigator and all members of the research team are qualified by 
education, training, licensure and/or experience to assume participation in the conduct of this research 
trial. I also assure that the principal investigator has departmental support and sufficient resources to 
conduct this trial appropriately. 
 
   ____________________________  
 
 
 
 
 
 
   Chair Name (PRINT) and Signature   
     
 
 
 Date 
 
   _________________________________ 
   Department 
 
 
 
 
 
 
As the faculty advisor of this research project, I certify that: 
 The information provided in this application is complete and accurate. 
 This project has scientific value and merit and that the student or trainee investigator has the  
      necessary resources to complete the project and achieve the aims. 
 I will train the student investigator in matters of appropriate research compliance, protection of 
      human subjects and proper conduct of research. 
 The research will be performed according to ethical principles and in compliance with all federal, 
      state and local laws, as well as institutional regulations and policies regarding the protection of   
      human subjects. 
 The student investigator will obtain approval for this research study and any subsequent revisions 
      Prior to initiating the study or revision and will obtain continuing approval prior to the expiration 
      of any approval period. 
 The student investigator will report to the HIC any serious injuries and/or other unanticipated  
      problems involving risk to participants.  
 I am in compliance with the requirements set forth by the University and qualify to serve as 
      the faculty advisor of this project. 
 
 
 
 
___________  
______ 
 
 
 
_____ 
    Advisor Name (PRINT) and Signature 
 
 
 
 
Date 

Page 9 of 36 
 
YNHH Human Subjects Protection Administrator Assurance Statement 
Required when the study is conducted solely at YNHH by YNHH health care providers. 
 
 
As Human Subject Protection Administrator (HSPA) for YNHH, I certify that: 
 I have read a copy of the protocol and approve it being conducted at YNHH. 
 I agree to notify the IRB if I am aware of any real or apparent institutional conflict of interest. 
 The principal investigator of this study is qualified to serve as P.I. and has the support of the hospital 
for this research project. 
 
  ______________________________________ 
 
 
 
 
 
 
 
 
    YNHH HSPA Name (PRINT) and Signature         
 
 
Date 
 
 
 
 
For HIC Use Only 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Date Approved  
 
 
 
Human Investigation Committee Signature 
 
This protocol is valid through ______________________________________________ 
 
 
 
SECTION V: RESEARCH PLAN 
 
1. Statement of Purpose: State the scientific aim(s) of the study, or the hypotheses to be tested.  
 
General medical hospitals provide care for a disproportionate share of patients who abuse or are 
dependent upon substances.1,2 This group is among the most costly to treat and has the poorest medical 
and substance use outcomes.3,4 Motivational interviewing5 (MI) is a well-recognized, evidenced-based 
substance abuse treatment that has been adapted for use as a brief intervention in health care settings.6 MI 
is applicable to many health-related behavioral problems, and can be taught to a broad range of health 
care clinicians.7 However, it is unclear which implementation strategies will lead to the efficient and 
proficient uptake of MI in general medical settings, such as medical inpatient units.  
     Primary care clinicians have multiple practice demands and time constraints. New practices have the 
greatest chance of being implemented if they are simple and compatible with existing workflows and 
systems.8-12 Two widely used strategies to bring specialized practices into use within general hospital 
settings are the “see one, do one” apprenticeship model of training13-16 and use of consultation-liaison 
(CL) services.17 “See one, do one” has been a modus operandi in medical education for centuries and 
relies upon a competency-based supervision training approach.  While it has been empirically validated in 
the specialty addiction field, less controlled testing of this implementation strategy is available in general 
medical settings. The apprenticeship approach requires that appropriate patients and trainers are available 
with high flexibility for teaching and supervision; when applied to behavioral counseling approaches, this 
may be seen as incompatible with the medical role and time constraints of clinicians.6 In contrast, 

Page 10 of 36 
 
ordering MI through CL is a relatively simple, minimally burdensome process and highly compatible with 
the way clinicians secure other specialist services for their patients in the hospital.  
We propose to conduct a randomized controlled trial using mixed quantitative and qualitative 
methods to examine the effectiveness of three different strategies for integrating MI into the practice of 
healthcare providers  working within Yale New Haven Hospital’s internal medicine hospitalist service 
and other general medical inpatient units. Specifically, we will randomize 30 healthcare providers  to one 
of three conditions: (1) a continuing medical education workshop that provides background and “shows” 
healthcare providers how to conduct MI (the control condition, called SEE ONE); (2) a “see one, do one” 
apprenticeship model involving workshop training plus live supervision of bedside practice (DO ONE); 
and (3) ordering MI from CL after learning about it in a workshop (ORDER ONE).  Following the 
respective MI trainings, each healthcare provider will be assessed for the provision of MI to 40 study-
eligible inpatients, recruited by the research team after admission to our general medical units.  
 
Our Primary Aims are: 
1. To assess the uptake of MI by Healthcare providers on the medical units.  
H1a.  The percentage of MI interviews in the first 40 consecutive, study-eligible inpatients identified 
by the research team will be higher in the “DO ONE” than “SEE ONE” group;  
H1b.  The percentage of MI interviews in the first 40 consecutive, study-eligible inpatients identified 
by the research team will be higher in the “ORDER ONE” than “SEE ONE” group.  
2. To assess the integrity of MI when Healthcare providers use it on the medical units.  
H2a.  DO ONE will result in more proficiently conducted MI sessions than SEE ONE;  
H2b.  ORDER ONE will result in more proficiently conducted MI sessions than SEE ONE. 
3. To assess the cost-effectiveness of the three strategies.   
H3a.  SEE ONE will be the most cost-effective implementation strategy when the threshold value to 
decision makers of inpatients receiving an additional MI session to a criterion level of adequate 
performance is relatively low;  
H3b.  DO ONE and ORDER ONE will be more cost-effective than SEE ONE when the threshold 
value is relatively high. 
 
The primary outcome for MI uptake will be the percentage of MI sessions conducted for study-eligible 
inpatients as verified by audio recordings.  For MI proficiency, primary outcomes will be 1) 
independently rated MI adherence and competence ratings of the sessions, and 2) the percentage of 
sessions achieving a criterion level of adequate MI performance used in MI effectiveness18-20 and clinician 
training trials.21,22  In addition, we will calculate the relative costs and cost-effectiveness of the three MI 
implementation strategies. Secondary outcomes across the three conditions will be 1) independently rated 
strength and frequency of patient statements that favor change in the sessions (called change talk) as a 
proxy for patient outcomes,23,24 and 2) themes related to implementation facilitators and barriers identified 
through qualitative assessment. 
 
2. Background: Describe the background information that led to the plan for this project. 
Provide references to support the expectation of obtaining useful scientific data. 
 
Substance abuse and dependence are among the most prevalent and costly health problems in the United 
States.  Individuals who abuse substances are seven times more likely than non-substance using 
individuals to be admitted to a hospital for medical care secondary to complications that are caused by 
their substance use.  Hence, inpatient hospitals provide care for a disproportionate share of patients who 
abuse or are dependent on substances- patients who are disproportionately costly to treat and at risk for 
poor health outcomes.3,4 On the other hand, hospitalization provides a unique opportunity to identify and 
motivate patients to address their substance use problems in that patients are: 1) accessible; 2) have time 

Page 11 of 36 
 
for an intervention; and 3) are often admitted for complications related to substance use that renders 
hospitalization a “teachable moment”.43,44  
 
MI has a strong evidence-base in the treatment of substance abuse (alcohol, drugs, smoking), 
reducing risky behaviors (e.g., unsafe sex or needle sharing), increasing healthy behaviors (e.g., improved 
diet, increased exercise), and engaging patients in treatment; it consistently demonstrates small to 
moderate and clinically significant effects across targeted behaviors.45-47 As a brief intervention for 
primary care patients, MI has its most consistent support with non-dependent unhealthy alcohol use,48-52 
though recent studies suggest that MI is more effective than expected with dependent drinkers in hospitals 
and other primary care settings.53-55 MI also has promise for addressing medical patients’ illicit drug 
use.56,57 The strength and frequency of in-session patient change talk is highly correlated with improved 
substance use outcomes post-treatment and at follow-up points.58-63 Moreover, clinicians who use MI 
proficiently (i.e., adhere to MI-consistent strategies and use them competently) are significantly more 
likely to elicit patient change talk in their sessions.23,58,62,64 These findings have led Miller and 
colleagues23,24 to recommend client change talk as a good proxy for patient outcomes in clinician training 
studies. Thus, the evaluation of successful MI implementation should include the clinicians’ adherence 
and competence in using the newly introduced practice, with the frequency and strength of change talk 
within sessions as a proxy for the effectiveness of the practice as delivered. 
 
Importantly, MI can be taught to a broad range of health care providers via a one-time workshop 
training, especially in health care where formal continuing medical education or CME events such as one-
day workshops are common and acceptable venues.7,70,71 MI workshop training alone consistently 
produces small increases in MI integrity immediately following training; however, without subsequent 
training, these gains diminish in as little as 2-3 months.23,59,72,73 In contrast, numerous studies in the mental 
health and addiction fields show significantly increased competency when  a workshop is followed by 
direct observation and supervision coupled with formal treatment integrity ratings.21,23,64,72,74 The purpose 
of this research is to subject this training approach to a randomized controlled trial for implementation of 
a substance abuse intervention into primary care settings.      
 
Integration of substance abuse interventions into primary care could improve health outcomes and 
reduce health care costs.51,52,57,75,76 However, this is contingent upon effective implementation strategies.  
Implementation theories identify two important components for consideration when crafting strategies: 
complexity and compatibility. The more complex a strategy, the greater the difficulty in implementation.8-
10,12 Similarly, if a strategy is not compatible with the existing workflows and systems of the setting, 
implementation is likely to fail.8,9,11,12 In short, implementation strategies that are straightforward and fit 
into existing practices of primary care clinicians and their workplaces are most likely to succeed.77 This 
principle of “keeping it simple” is particularly salient for primary care clinicians who would require 
between 3.5 – 10.6 hours per day if they were to follow all recommended guidelines for screening and 
behavioral management of the top 10 chronic diseases.78 
 
Traditionally, an apprenticeship model has been used to instruct inpatient medical clinicians in 
bedside procedures,13-16 but this model has not been applied to promoting the use of behavioral counseling 
techniques in primary care.  Commonly referred to as “see one, do one”, the instructor explains the theory 
and techniques of a practice and demonstrates it in a simulated scenario (e.g., manikin) or directly with 
patients. Subsequently, trainees practice the approach under the supervision of an expert clinician who 
provides live performance feedback and coaching to improve the technique. Eventually, these clinicians 
will “teach one” to others when they have mastered the practice. This form of learning on the job has been 
a modus operandi in medical education for centuries16,79 and is analogous to the competency-based 
supervision approach noted above. The ultimate aim of “see one, do one” is to have clinicians implement 
the procedure proficiently with their patients. While incorporating familiar and efficacious teaching 
methods (direct observation, feedback, coaching), a potential caveat is that “see one, do one” is somewhat 

Page 12 of 36 
 
complex in that it requires appropriate patients and a trainer to be available for teaching.  Moreover, when 
applied to behavioral counseling approaches like MI, it may be seen as potentially incompatible with the 
clinicians’ medical role and time constraints.6  
 
     Another common practice in general hospitals is the use of psychiatry consultation-liaison (CL) 
services. The main function of CL is to provide assessment and specialty guidance on the management of 
patients with mental health and addiction problems.17 Inpatient clinicians request a CL consult by 
ordering it through the electronic medical record.  CL provides the relevant service on the same day or 
day thereafter, depending on the urgency of the request (e.g., concerns about risk for deliberate self-
harm). About 20% of CL consultations typically involve the assessment, treatment recommendations and 
referrals for patients who have substance abuse/dependence problems.80-85 The ultimate aim of CL is to 
have highly trained specialists implement the procedure proficiently with patients, rather than having the 
referring clinicians conduct it themselves. The use of CL as a vehicle for implementing specialized 
behavioral counseling approaches such as MI in primary care has never been tested. From the perspective 
of inpatient clinicians, using CL is a simple, minimally burdensome process (i.e., order one) and highly 
compatible with the way they secure other specialist services (e.g., neurology consult) for their patients. 
The provision of MI by CL clinicians upon request is a very promising implementation strategy for 
integrating substance abuse treatment into inpatient medical care.  The potential problems with this 
approach are: 1) it requires clinicians to recognize and order the service, 2) patients must accede to a 
consultation with a substance abuse expert, 3) it may be more expensive since it requires additional staff 
time from individuals who have expert training and work on a specialty service, and 4) the treatment 
would be delivered by providers who are not central to the overall care of the patient, thus potentially 
reducing the potency of the intervention  Given the possible pros and cons of these approaches, we 
currently lack information about the most effective and cost effective strategies by which to implement 
MI into a general inpatient medical setting. 
 
3. Research Plan: Summarize the study design and research procedures using non-technical 
language that can be readily understood by someone outside the discipline. Be sure to 
distinguish between standard of care vs. research procedures when applicable, and include 
any flowcharts of visits specifying their individual times and lengths.  
 
The proposed project will evaluate the effectiveness of three different implementation strategies for 
integrating MI into the YNHH’s internal medicine hospitalist service and other general medical inpatient 
units. Specifically, we will randomize 30 Healthcare providers to one of three conditions: (1) a continuing 
medical education workshop that “shows” the healthcare providers MI (the control condition, referred to 
as SEE ONE); (2) a ‘see one, do one” apprenticeship model involving workshop training plus live 
supervision of bedside practice (DO ONE); and (3) ordering MI from CL after learning about it in a 
workshop (ORDER ONE). After receiving the respective MI training, each Healthcare provider will be 
followed for provision of MI to study-eligible/consented patients. In ORDER ONE, healthcare providers 
may elect to conduct MI themselves or order it to be conducted by Psychiatrists from the CL service. 
 
     After the Healthcare providers have attended their respective workshops, research staff will identify 
substance using patients in need of a MI intervention. Research staff will independently screen, assess and 
obtain consent from eligible patients who are admitted to the internal medicine hospitalist service  and 
other general medical inpatient units. Patients will be potentially included if they are  assigned to a 
participating Healthcare provider according to the hospital’s usual clinical administrative procedures. 
Thus, patients will follow the randomization condition of their Healthcare provider, though Healthcare 
provider will not know which patients on their caseloads have enrolled in the study. This approach will 
permit a naturalistic test of the Healthcare provider’ ability to identify and intervene using MI with 
patients who have substance use problems.  Each Healthcare provider will be followed until he or she has 

Page 13 of 36 
 
cared for 40 study-enrolled patients, whether or not the Healthcare provider has recognized the patient as 
a substance user and/or provided a MI intervention.  These patients will be the first 40 patients 
administratively assigned to the Healthcare provider who are screened, consented and enrolled into the 
study.  Screening and consent of inpatients will be done in the “background” and Healthcare provider will 
not be told in advance that a patient has been enrolled since this may “cue” their behavior.  We will not 
tell the Healthcare provider of our target enrollment but rather will tell them when they have reached our 
“target” number.  In this way, we will enroll 1200 medical inpatients who may potentially receive a MI 
intervention.  
 
After completion of their caseload, Healthcare provider will have a post-trial assessment to evaluate their 
reaction to their assigned condition, including a qualitative interview that will determine implementation 
facilitators and barriers.  This post-trial conversation will also debrief Healthcare provider on the overall 
aims of the study, individual and group performance and success in administering motivational 
interviewing (both in terms of the quality of individual sessions, the use of MI in appropriate cases, as 
well as an overview of “missed opportunities” for pts who clinically warranted the MI services but were 
not provided with it by their healthcare provider).  This debriefing will be provided in an MI-consistent 
manner, supporting strengths and successes of the providers while pushing them to improve technique 
and accuracy. 
 
Primary outcomes will be 1) the percentage of MI sessions, as verified by audio recordings, conducted 
among each Healthcare provider 40 consecutively enrolled study patients, 2) independently rated MI 
adherence and competence ratings of the sessions, and 3) the percentage of sessions conducted that meet a 
criterion level of adequate MI performance used in MI effectiveness18-20 and clinician training trials.21,22 In 
addition, we will calculate the relative costs and cost effectiveness of the three conditions. Secondary 
outcomes will be 1) independently rated strength and frequency of patient statements that favor change in 
the sessions (called change talk) as a proxy for patient outcomes,23,24 and 2) themes related to 
implementation facilitators and barriers identified through qualitative interviews. The YNHH hospitalist 
and the psychiatric CL services will work closely with research staff to implement all aspects of this 
project. 
 
Initially our main unit of randomization was the PAs within the YNHH hospitalist service. The director of 
the hospitalist service, Dr. Victor Morris, and Will Cushing, Chief PA of the hospitalist service, both co-
investigators on this proposal, have committed the participation of the PAs on the service to the protocol. 
The service includes 33 PAs who work during days Mon-Fri on non-critical care general medical units.  
There is a turnover rate of about 2 per year that nets 40 PAs during the 4-year data collection phase of the 
project.  Prior to randomization, Dr. Morris, Will Cushing and other members of the study team will meet 
with the PAs during staff meetings, wherein we will describe the project and elicit interest. Thereafter, we 
will screen PAs for eligibility and obtain written consent for their participation. PAs will next complete 
baseline assessment, including an audio recorded sample of their usual manner of interviewing an 
inpatient with a substance use problem. Following baseline assessments, a restricted randomization 
procedure will be used to allocate an equal number of PAs to the three conditions (10 PAs per condition).   
 
Originally this study focused on training PAs because they have become very prevalent and important 
midlevel providers in all practice settings in U.S. medicine. PAs have been used to address current health 
system and societal needs for primary care105 and to reduce service costs106 and house staff hours as 
mandated by the Accreditation Council of Graduate Medical Education.107,108 Moreover, they spend more 
time interacting with their patients than physicians within the YNHH hospitalist system, and recent work 
has shown PAs have the interest and capacity to learn behavioral intervention strategies such as MI.69 
 

Page 14 of 36 
 
While our initial goal was to randomize and enroll PAs only in this study, other healthcare providers have 
shown interest, ability to incorporate MI into their daily schedule and proven to be ideal candidates to 
include as a part of our cohort.   
       
C. Study Setting 
 
The study will take place on the general medical inpatient units of YNHH.  The internal medicine 
hospitalist service (where we will be recruiting PA participants) consists of 8 teams, each comprised of an 
attending physician and 2-5 PAs. PAs typically see patients on more than one unit and see each assigned 
patient 1-2 times per day.  Hospitalist patients are followed by one PA and one MD from the service. The 
hospitalist teams cover about 160 beds/day (range = 130-210) on 13 different units excluding intensive 
care units.  In 2010, the service was responsible for approximately 9,900 discharges. The average length 
of stay for patients is 4 days.  The psychiatric CL is available to all attending MDs and PAs for the 
assessment and initiation of treatment for mental health and addiction problems.  Attendings and PAs 
order CL services via entry into the electronic medical record, which are viewed by a CL administrative 
assistant and CL staff throughout the day.  Consultations are typically seen within 4-8 hours of placement, 
depending upon the acuity and time sensitivity of the requested consult. Non-urgent consults may be seen 
the next day if the caseload is high. 
 
General medical inpatient units have a patient population characterized by very high rates of co-morbid 
substance use disorders typically in excess of rates found in other primary care settings.1 Moreover, large 
numbers of hospitals have adopted the hospitalist model for inpatient care on medical units,109 and almost 
all hospitals have psychiatric CL services for addressing mental health and addiction problems that fall 
outside the expertise of medical providers.17,1110  This study has the potential to identify highly 
disseminative strategies for integrating substance abuse services into primary care in a major sector of the 
U.S. health care system. 
 
The practice under study for implementation is a single 20-min MI session that we have used to train 
medical students and physicians21,89 and are currently comparing to a computerized MI approach with 
substance using women in outpatient primary care treatment.87 The MI session includes six steps: (1) 
understand patient’s view of his/her substance use and motivations for change; (2) discuss reasons for 
using vs. not using/cutting down; (3) provide personalized feedback about patient’s substance use; (4) 
continue handling resistance skillfully and draw out change talk; (5) develop a change plan or present 
change options for later consideration; and (6) summarize and support what the patient has decided to do.  
Clinicians ask key questions at the conclusion of steps 2-4 to ascertain the patient’s commitment to 
change.  If the patient endorses a goal of quitting or cutting back substance use, the clinician immediately 
proceeds to Step 5. Thus, clinicians adapt MI to their specific patient’s readiness to change, giving the 
manualized treatment flexibility to avoid a rigid application of MI that might undermine its effectiveness 
and acceptability to clinicians.24,46 
 
Healthcare providers will each receive the MI implementation strategy offered within their assigned 
condition. Separate workshop trainings will occur for Healthcare providers within conditions. Additional 
workshops will be conducted as needed if new Healthcare providers are recruited into the study. In each 
condition, all Healthcare provider as well as the Psychiatrists from CL in ORDER ONE will audio record 
their MI interviews to confirm the interviews have occurred and to permit MI integrity rating. 
 
1. 
Workshop (See One) 
Healthcare providers in this condition will participate in a 1-day skill-building workshop. Dr. Martino, a 
member of the Motivational Interviewing Network of Trainers (MINT) and a highly experienced MI 
workshop trainer, will conduct the workshop per MINT recommendations, giving the Healthcare 
providers an opportunity to “see” the MI intervention and learn how to conduct it through expert and 

Page 15 of 36 
 
video demonstrations and experiential activities.  He also will teach the Healthcare providers how to 
screen patients for risky substance use with NIAAA Guidelines, the CAGE Questionnaire and Heaviness 
of Smoking Index114 (described below). A 2-hr “booster” session will be provided to Healthcare providers 
once they have reached their halfway point of the trial phase (20 eligible patients), consistent with the 
common practice of requiring annual refresher training for critical procedures used by staff in hospitals.  
     2.  Workshop plus live supervision (Do One) 
Healthcare providers will participate in a 1-day skill-building workshop conducted by Dr. Martino, 
including  halfway point booster sessions, as outlined above.  Following the workshop, the Healthcare 
providers will each “do one” MI intervention under the live supervision of a Psychiatrist from CL. Dr. 
Martino will have taught the CL psychiatrists to conduct MI and will have trained them in the supervisory 
practices developed in our prior MI training work (See Appendix B).21,89,90 Healthcare providers can 
request additional live supervision at any point during the trial, consistent with the apprenticeship 
model.13-16  Additionally, once the Healthcare provider in this condition reaches their halfway point of the 
trial phase (20 eligible patients), they will be offered another bedside supervision as a refresher of their 
MI skills.  
     3.  Workshop plus consultation-liaison service (Order One) 
Healthcare providers will participate in a 1-day skill-building workshop and annual booster sessions 
conducted by Dr. Martino. The Healthcare providers in this condition will be instructed that they may 
either administer MI or they may “order” a MI interview to be delivered by a Psychiatrist from CL with 
specialty MI training. This is the only group that may “order” a MI interview.  
     Before Healthcare providers can “order” MI from CL, Dr. Martino will train and supervise the CL 
Psychiatrists in MI, who will provide adequate coverage for administration of MI during the data 
collection period of the project. Training will follow a clinical trials training approach used in efficacy 
and effectiveness trials:115,116 1) a 2-day skill-building workshop; 2) three post-workshop supervised 
practice cases based on review of audio recorded sessions using the NIDA-SAMHSA MI supervision 
blending product, MIA: STEP,86,94; and 3) follow-up monthly individual supervision to maintain and 
monitor the CL experts’ MI practice. 
     4.  Rationale for implementation strategy choice and study design 
     Continuing medical education workshop/seminar training plus booster sessions is the usual approach 
for teaching medical professionals new or unfamiliar clinical practices70,71 and will serve as our control 
condition. By holding this training constant across conditions, we can isolate the effects of live-
supervision in DO ONE and ability to order MI from CL in ORDER ONE that exceed those which occur 
in primary care training-as-usual efforts. We considered a two cell design that would compared DO ONE 
and ORDER ONE.  However, to our knowledge neither DO ONE or ORDER ONE have been tested in 
primary care settings. Given this, we felt that a true “control condition” by which to compare uptake, MI 
proficiency, and cost effectiveness is required. 
 
5.  Rationale for sample choice: 
We are recruiting a heterogeneous sample of substance using patients to test the implementation strategies 
in clinical circumstances typically seen by Healthcare providers on general medical inpatient units. 
Finally, most Healthcare providers and all MI integrity raters are mono-lingual English speakers. We 
therefore do not have the capacity to include Spanish-only speaking patients in the study.  
 
     G. Procedures for monitoring Healthcare provider-patient assignments and audio 
recording MI interventions 
Research assistants will be hired and will review a list of patients  assigned to PA study providers who are 
part of the internal medicine hospitalist service.   PA staff members from the Hospitalist Service at 
YNHH, will generate a daily list for review by research assistants/ study personnel.  This list, will be 
furnished to the Project Director and research assistants via  YNHH email to Yale University email 
accounts, for the sake of security and confidentiality.  For other Healthcare providers working in general 
medical inpatient units and participating in the study, (i.e. RNs) patient lists will be obtained via the 
Project Director and/or research assistants logging into EPIC and sorting all the current YNHH patients 

Page 16 of 36 
 
by Registered Nurse. The RAs also visit each applicable unit and asking an appropriate staff member or 
reviewing the patient list book to ensure EPIC was accurate.  Permission to review books on the unit has 
been given by the Managers on each unit from which we are currently recruiting This list and 
corresponding admission notes will be preliminarily reviewed by the research assistant for the exclusive 
purpose of ruling OUT subjects 1) who do not speak English, 2) who have pre-existing diagnoses 
indicating cognitive impairment (ie dementia) such that consideration for enrollment in a research trial 
would be inappropriate, and 3) who have already been previously enrolled in this research protocol. Only 
relevant admission documents will be reviewed in the electronic record to determine these exclusionary 
criteria.  We plan to do a brief review of admission notes because the project will entail screening 
thousands of individuals. Given the volume of inpatients at YNHH, it is impractical for research staff to 
approach every patient, nor is it an efficient use of their time.  Review of the medical admission 
documents will guide research staff to offer study participation to those who are not obviously ineligible. 
It would enhance feasibility greatly to be able to know whether someone meets these basic potential 
exclusionary criteria.  However, no data will be saved about the patient; instead the name of patients who 
are not eligible for screening will be removed from our list.  The remaining individuals from the daily list 
will be approached by study personnel, namely Research Assistants, who will offer and administer written 
and verbal informed consent.   After patients are consented, screened and assessed, the Research Assistant 
may collect data from the participant (see assessments outlined below) and the electronic medical record 
(concurrent medical conditions, number of previous admissions and admission medications).  The 
Healthcare provider will not be informed by research staff about the use of substances by the patient but 
must rely on usual procedures and their workshop training to identify risky substance use and the need for 
a MI intervention. It should be noted that information about risky substance use is often noted in the 
patients’ electronic medical records. However, lack of direct disclosure to the Healthcare provider allows 
us to assess the implementation of drug use detection strategies and maintains the confidentiality of 
information that we collect. Ideally, our training will augment information that ideally, is routinely 
collected. We will use the audio recording of the MI interview as evidence the intervention or referral 
occurred. 
 
     All Healthcare providers and Psychiatrists from CL will be issued a digital recording device.  They 
will audio record their own MI sessions and personally consent patients for such recordings and give the 
recordings to the research assistant, along with identifying information that will enable the research 
assistant to check the patients’ study enrollment status. If recordings are obtained from non-study 
participants (e.g., someone that was deemed ineligible or who did not provide consent), they will be 
immediately erased.  Otherwise, they will be downloaded for storage on a secure server for later analysis. 
 
     As part of a research assistant’s job, he or she will regularly send messages to all of the Healthcare 
providers reminding them to record any MI interventions (or CL referrals) they conduct with patients on 
the unit. As a back-up, additional recording devices will be conveniently placed on the units, and the 
administrative assistant on the CL service and research assistants will have additional recording devices 
that can be given to Healthcare providers and Psychiatrists from CL on demand. Dr. Morris and Mr. 
Cushing will be apprised of the overall success of obtaining audio recorded MI interviews, although they 
will not be told of the success for each of the Healthcare providers or their assigned conditions. They will 
assist with compliance for obtaining recorded sessions if there are problems.  
 
     H.  Assessments: 
Data will be collected by self-report, interview questionnaires and audio recordings.  The Healthcare 
providers will complete structured questionnaires and qualitative interviews.  All of this will be coded by 
a subject ID rather than the individual’s name.  Similarly, the audio recordings will be stored as computer 
files on a secure server and only include subject IDs to label the interview. 
 

Page 17 of 36 
 
The proposed project will evaluate training effects using mixed methods to gather both quantitative and 
qualitative data122,123 and be organized according to the basic structure of Kirkpatrick’s widely applied 
four level training evaluation model.124 Given space limitations, only instruments central to our primary 
and secondary outcomes or that are less familiar are described in more detail. Healthcare provider 
assessments will occur at baseline, during the trial, and post-trial (i.e., after their 40th assigned study-
enrolled patient has been discharged from the unit).  Patient assessments will occur only at baseline. Of 
importance, we will have several research staff trained in the ITRS and MISC 2.1 Client Language 
Coding System (both described below) rating MI proficiency throughout the trial to accommodate the 
large number of recorded sessions generated in this study. 
1. Reaction level (reactions to the different implementation strategies) 
• 
Workshop Evaluation Form and Supervision Evaluation Forms21,22,91 will evaluate the 
Healthcare providers’ satisfaction with the workshops and supervision provided in the study.  
• 
Facilitators and Barriers Qualitative Interview will be used to assess the Healthcare provider 
and \ perception of the facilitators and barriers of their assigned implementation strategy post-
trial.  Focus groups consisting of approximately 8-12   Healthcare providers and  that will target 
the five broad domains from the Consolidated Framework for Implementation Research:8 (1) 
characteristics of the MI intervention; (2) external pressures to provide a substance abuse 
intervention, and specifically MI, to medical inpatients; (3) internal medical unit factors (e.g., fit 
within usual care, incentives, prioritization of tasks, leadership engagement, available resources); 
(4) characteristics of the patients; and (5) implementation processes used in the conditions 
including training, supervision, and availability of the CL service will be conducted immediately 
following their MI training. These focus groups will be audio-recorded for the purpose of 
utilizing information gathered for the qualitative data analysis of this study. In addition, we will 
assess characteristics of the health care professional (e.g., attitude, peer influence, openness to 
change) that have been found to impact implementation.125-127 We will also conduct key 
informant focus groups and/or interviews throughout the study with the Chief PA, the Director of 
Hospitalist Services, Unit Chiefs, and hospital clinical staff to further assess organizational 
barriers and facilitators. These interviews will ask many of the same questions that facilitate and 
impede the use of Motivational Interviewing within the Hospitalist Service and other general 
medical inpatient units in the hospital. These interviews will also be audio-recorded for 
qualitative analysis purposes. 
• 
 
      2.  Learning level (changes in knowledge and attitudes) 
• 
Beliefs about MI128 will assess the  Healthcare providers’ personal experiences with and beliefs 
about MI and perceived barriers to implementing it. 
• 
Motivational Interviewing Questionnaire89,129 assesses  Healthcare provider knowledge of MI 
principles. 
• 
Clinician Rulers89 assesses  Healthcare provider  interest, confidence, and commitment in using 
MI. 
      3.  Behavior level (changes in behavior) 
• 
MI Uptake will be based on the number of MI intervention sessions audio recorded by  
Healthcare providers and Psychiatrists from CL. 
• 
Independent Tape Rater Scale (ITRS) will assess the integrity of MI delivery and the criterion 
level of adequate MI performance within each session collected at baseline and during the trial.  
The ITRS includes items that cover therapeutic strategies that are MI consistent (e.g. reflections) 
or inconsistent (e.g., unsolicited advice). It also has items detailing general counseling strategies 
(e.g., assessment of substance use) that are not unique to MI, nor antithetical to it, and 
interventions particular to other substance abuse treatment approaches (e.g., coping skill 
development). For each item, raters evaluate the practitioners for adherence (i.e., the extent of 
intervention delivery) and competence (i.e., the skill/quality of intervention delivery) along 7-

Page 18 of 36 
 
point Likert scales. For our primary outcomes, we will: 1) calculate mean adherence and 
competence scores for the two factors (fundamental and advanced MI strategies) identified in 
prior psychometric analyses;91-93 and 2) determine if sessions achieve our criterion level for 
adequately performing MI,18-22 namely, at least half the MI consistent items rated average or 
above for both adherence and competence. Descriptive analysis of other specific and general 
substance abuse interventions that do not involve MI will permit identification of how  Healthcare 
providers and Psychiatrists from CL deviate from or modify the MI intervention for the inpatient 
setting, an important issue when studying the implementation of evidence-based treatments in 
real world settings.125,126 We have extensive experience training ITRS raters to perform very 
reliable MI session process ratings.21,22,91,93 
      4.  Results level (results that occurred from the application of the new practice) 
• 
Motivational Interviewing Skills Code 2.1 Client Language Coding System130 will obtain 
frequency counts and strength indices of positive (change talk) and negative (sustain talk) 
language categories in four categories: reason (includes desire, ability, and need statements as 
subcategories), other (hypothetical advice to others, if-then statements about the possibility of 
changing, foretelling of future problems if change does not occur, problem recognition), taking 
steps, and commitment.  
      5.   Healthcare provider, patient, and work environment characteristics 
• 
Clinician Survey127 collects baseline  Healthcare provider demographics and background.   
• 
Confusion Assessment Method (CAM) will be used to assess patients’ cognitive impairment 
(i.e. delirium).  
• 
Time Line Follow Back118,131 assesses patients’ past month self-reported substance use.  
• 
Heaviness of Smoking Index114 assesses 2 items from the Fagerström Test for Nicotine 
Dependence questionnaire133 regarding amount smoked and time-to-first-cigarette of the day as a 
means to screen patients for smoking and likely nicotine dependence. 
• 
Mini-International Neuropsychiatric Inventory 5.0.0 Clinician-Rated119 will be used only to 
generate patient drug or alcohol use diagnoses (abuse and dependence).  
• 
Addiction Severity Index Alcohol/Drug Section120 will assess the frequency, duration, and 
severity of alcohol and drug problems over the patients’ lifetime and in the past 28 days. 
• 
Patient Health Questionnaire (PHQ-9) will be used to measure patients’ level of depression.  
• 
SF-12 will measure a patient’s overall health and functioning both now and during the last 4 
weeks.  
• 
Medical Chart Review will be conducted to 1) obtain admission and discharge diagnoses, 2) 
confirm self -report of substance misuse (e.g., labs), and 3) identify possible barriers to receipt of 
MI that may occur after consent or assessment, e.g., onset of delirium, cardiac arrest, early release 
from hospital.     
• 
The Motivation for Change Scale135 uses 3 items (analogue scale coded from 1 to 100) tapping 
patient drug, alcohol or tobacco use likelihood problem recognition, and treatment motivation.  
These types of ruler-based assessments of motivation have performed as well or better than more 
elaborate readiness to change questionnaires in predicting behavioral intentions.136 
• 
Medical Inpatient Work Index-Revised137 is a 15-item scale that will be adapted for use by  
Healthcare providers and nursing staff to access their perception of the YNHH work environment 
in terms of: (1) autonomy in making patient care decisions; (2) control  Healthcare providers and 
nursing staff have over others to promote high-quality patient care; (3) collegiality with other 
medical staff; and (4) administrative/managerial support. The scale has been found to be a 
reliable and valid index of organizational traits in U.S. general medical hospitals.138,139 
     6. Additional assessments 
• 
For Healthcare providers, we will track time in hours to MI implementation per patient (starting 
from the patient’s admission to the unit) and, for DO ONE, the number of live supervisions 

Page 19 of 36 
 
received.  For patients, we will track length of stay on unit and CL services received other than 
“ordered” MI.  
• 
For CL experts we will track how sleepy a patient is that they need to conduct a Motivational 
Interview with as a result of an order placed in EPIC by a Healthcare provider in the Order One 
Condition. This will be done using the Stanford Sleepiness Scale. The Stanford Sleepiness 
Scale (SSS) is a widely used instrument to assess subjective sleepiness with good validity 
(1). Respondents select which of seven statements best reflects their level of sleepiness; 
higher scores indicate greater sleepiness. The SSS predicts performance decrements 
following acute sleep deprivation (2).  
 
 
 Table 1: Assessments for  Healthcare provider and patient participants 
Participant 
    Assessment Name 
Data Type 
Assessor 
Baseline 
Tria
l 
Post-
Trial 
 
 Healthcare 
provider 
Clinician Survey 
Self-report 
 Healthcare 
provider 
x 
 
x 
 
Medical Inpatient Work 
Index – Revised  
Self-report 
 Healthcare 
provider / nursing 
staff 
x 
 
 
 
Workshop and 
Supervision Evaluation 
Form 
Self-report  
 Healthcare 
provider 
 
x 
 
 
Beliefs about MI Survey 
Self-report 
 Healthcare 
provider 
x 
 
x 
 
Motivational Interviewing 
Questionnaire 
Self-report 
 Healthcare 
provider 
x 
 
x 
 
Clinician Rulers 
Self-report 
 Healthcare 
provider 
x 
 
x 
 
MI Uptake 
Audio recording 
RA 
 
x 
 
 
Live Supervision 
Evaluation Form 
Self-report 
Healthcare 
provider (Do One) 
 
x 
 
 
ITRS 
Independent 
rating 
Raters 
x 
x 
 
 
MISC 2.1 Client Language 
Coding System 
Independent 
rating 
Raters 
 
x 
 
 
Facilitators and Barriers 
Qualitative Interview 
Interview 
Raters 
 
 
x 
Patient 
 Cage Questionnaire 
Interview 
RA 
x 
 
 
 
NIAAA Guidelines 
Interview 
RA 
x 
 
 
 
Confusion Assessment 
Method 
Interview 
RA 
x 
 
 
 
Heaviness of Smoking 
Index 
Interview 
RA 
x 
 
 
 
Timeline Follow-back 
Interview 
RA 
x 
 
 
 
Mini-International 
Neuropsychiatric 
Inventory 
Interview 
RA 
x 
 
 
 
Addiction Severity Index 
Interview 
RA 
x 
 
 

Page 20 of 36 
 
Alcohol/Drug Section 
 
Patient Health 
Questionnaire (PHQ-9)  
Interview 
RA 
x 
 
 
 
SF-12 
Interview 
RA 
x 
 
 
 
Medical Chart Review 
Chart Abstraction 
RA 
 
x 
 
 
Motivation for Change 
Scale 
Self-report 
RA 
x 
 
 
CL Expert 
Stanford Sleepiness Scale 
Self-report 
CL Expert 
 
x 
 
      7.  Cost estimates 
• 
As in previous economic studies conducted by Dr. Olmstead,95,140-144 including the economic 
study of our three-arm clinician training trial describe above,95 the methodology we will use to 
estimate the costs of the three MI implementation strategies will be from the perspective of the 
provider (i.e., hospital) to increase the real-world usefulness of the cost estimates outside of this 
research protocol.145  We will not include research costs (e.g., participant reimbursements, 
assessment measurement) but rather restrict cost estimates to those  associated with implementing 
the three MI implementation strategies.  Our cost methodology will follow the micro-costing 
steps recommended by Yates 146 and Zarkin et al.147 We will first delineate relevant non-research 
activities (e.g., MI workshop training, MI interventions, supervision (including expert review of 
audio recorded Psychiatrists from CL sessions)) and, for each identified activity, we will gather 
data on both the time spent by personnel in the activities and, as relevant, the space associated 
with each activity using a modified version of the Resource Allocation Worksheet (RAW) 
developed for Project COMBINE.145  This form will collect data on the total labor hours spent on 
each activity by the trainer,  Healthcare providers, and Psychiatrists from CL and the space used 
in conducting the activity.  The labor costs of each activity will be equal to the product of the 
amount of time spent by each person on the activity and their fully-loaded wage (i.e., including 
fringe and overhead).  To estimate space costs, the research assistant will measure in square feet 
the size of the rooms used for training, MI interventions, and supervision.  We will calculate an 
average space estimate per medical unit for the main activity domains (workshop training, MI 
intervention, supervision) and multiply these domains by the annual rent per square foot for the 
hospital.  We will obtain salary data (actual wage plus fringe rate for salary staff and hourly 
contract rate for contract staff) for  Healthcare providers and Psychiatrists from CL and annual 
rent per square foot from YNHH administrators.  We also will record all the direct material 
expenses (e.g., manuals, rating forms, recording devices, audiotapes) of conducting the MI 
training workshops and supervisions. 
   
4. Genetic Testing    N/A 
 
A. Describe 
i. the types of future research to be conducted using the materials, specifying if 
immortalization of cell lines, whole exome or genome sequencing, genome wide 
association studies, or animal studies are planned 
ii. the plan for the collection of material or the conditions under which material will 
be received 
iii. the types of information about the donor/individual contributors that will be 
entered into a database 
iv. the methods to uphold confidentiality 
 
B. What are the conditions or procedures for sharing of materials and/or distributing for 
future research projects? 
C. Is widespread sharing of materials planned? 

Page 21 of 36 
 
D. When and under what conditions will materials be stripped of all identifiers? 
E. Can donor-subjects withdraw their materials at any time, and/or withdraw the identifiers 
that connect them to their materials? 
i. How will requests to withdraw materials be handled (e.g., material no longer 
identified: that is, anonymized) or material destroyed)? 
 
F. Describe the provisions for protection of participant privacy 
G. Describe the methods for the security of storage and sharing of materials  
 
 
5. Subject Population: Provide a detailed description of the types of human subjects who will 
be recruited into this study. 
 
Eligible for study participation will be PA’s working in the general hospitalist service, other Healthcare 
providers on general medical inpatient units of the hospital and patients with any drug, alcohol, or 
nicotine abuse or dependence disorders admitted to the general medical units at YNHH.  Study staff will 
screen all patients admitted to the medical inpatient service of YNHH unless deemed otherwise ineligible 
for screening, as outlined in procedures section G above.  Research staff will approach all admitted 
patients assigned to the hospitalist service study providers or providers on other general medical inpatient 
units who speak English, who do not immediately evidence cognitive limitations and who have not been 
previously enrolled in this study.  Given the volume of inpatients at YNHH, it is impractical for 
research staff to approach every patient, nor is it an efficient use of their time.  Review of the 
medical admission documents will guide research staff to offer study participation to those who 
are not obviously ineligible. 
 
6. Subject classification: Check off all classifications of subjects that will be specifically 
recruited for enrollment in the research project. Will subjects who may require additional 
safeguards or other considerations be enrolled in the study? If so, identify the population of 
subjects requiring special safeguards and provide a justification for their involvement. 
 
 Children 
 
 
 Healthy  
 
Fetal material, placenta, or dead fetus 
 Non-English Speaking 
 Prisoners  
 Economically disadvantaged persons 
 Decisionally Impaired 
 Employees  
 Pregnant women and/or fetuses 
 Yale Students  
 
Females of childbearing potential 
 
NOTE: Is this research proposal designed to enroll children who are wards of the state as 
potential subjects? 
 Yes  
 No (If yes, see Instructions section VII #4 for further 
requirements) 
 
 
7. Inclusion/Exclusion Criteria: What are the criteria used to determine subject inclusion or    
exclusion? 
 
1.  Inclusion criteria for   Healthcare provider participants : 
•  Assignment to one of the general medical inpatient units at YNHH during day-time shifts; 
intensive care units will be excluded given the morbidity of patients in this setting.  
• Volunteer to serve as study clinicians, attend a workshop about MI, and possibly receive live 
supervision. 

Page 22 of 36 
 
• Agree to all procedures of this trial (randomization to training condition and of assigned patients, 
audio recording MI sessions, and completing assessments). 
2. Exclusion criteria for  Healthcare provider participants: 
• Have been formally supervised to use MI with patients on the units. 
• Intend to give notice to YNHH that they plan to leave the hospital or are scheduled for medical 
or family leave such that they will not be able to interview 40 patients during the study period. 
 
 
1.  Inclusion criteria for patients are: 
• Are 18 years of age or older. 
• Acknowledge use of a substance within past 28 days and meets screening criteria consistent with 
substance (illicit drugs, licit drugs that are used in a non-medically indicated fashion, alcohol, or 
nicotine) use disorder. 
• Are willing to consent to audio recording of interview with the Healthcare provider or  CL 
psychiatrist. 
   2.  Exclusion criteria for patients 
• Have an altered mental status such as delirium, encephalopathy, dementia or mental retardation 
or a score on the Confusion Assessment Method > 0 since this would impair provision of 
consent and ability to participate 
• Inability to speak English.  Most of the Healthcare providers are mono-lingual English speakers, 
and all MI integrity raters only speak English.  We therefore do not have the capacity to include 
Spanish-only speaking patients in the study.  
• Stroke (that precludes participation) 
• Resides in a nursing home, skilled nursing facility or Hospice Care 
• Receiving palliative care 
• Deaf 
• Unable to speak lucidly    
• Previous participation in the protocol. 
 
8. How will eligibility be determined, and by whom?  
 
Research staff will need to review admission notes from hospital medical charts of patients admitted the 
previous day, as indicated from the admission list provided by PAs on the Hospitalist Service at YNHH . 
Given the volume of inpatients at YNHH, it is impractical for research staff to approach every patient, nor 
is it an efficient use of their time.  Review of the medical admission documents will guide research staff 
to offer study participation to those who are not obviously ineligible Staff will be reviewing patients’ 
electronic admission documents in a limited fashion to determine the purpose, length of stay, primary 
language and any indicator for delirium or dementia. Research staff will destroy names and any other 
identifying information on said list of patients who are deemed inappropriate to be screened for the study. 
After determining initial eligibility to be screened, research staff will explain the study procedures and 
obtain written consent.  Individuals who provide consent, will be administered three items from the 
Confusion Assessment Method.117   A score of 1 (yes) on any item will trigger an evaluation by a 
psychiatric investigator to determine if the patient has the capacity to provide consent. If they score 0 
screening will continue. Next, researchers will collect the Heaviness of Smoking Index,114 demographic 
information and will administered the Time Line Follow Back118 for the past month. After these 
procedures are completed and eligibility is confirmed, patients will be informed that they are eligible to 
participate. They will then be asked to complete a computer intake that includes, questions about primary 
substance of misuse, the MINI International Diagnostic Interview,119 a functional impairment measure 
(Short Form 12; SF 12) and sections of the Addiction Severity Index120 that relate to medical 
complications of substance use. Research staff will also request permission to contact patients in the 

Page 23 of 36 
 
future to clarify any unresolved data issues if needed. They will be told that a  Healthcare provider may 
approach them on the unit to discuss their health habits, which might be audio recorded as part of the 
study.  
 
 
9. Risks: Describe the reasonably foreseeable risks, including risks to subject privacy, 
discomforts, or inconveniences associated with subjects participating in the research.  
 
The potential risks in this study are related to psychiatric interviewing and loss of confidentiality for medical 
inpatients and for  Healthcare provider participants. 
 
10. Minimizing Risks: Describe the manner in which the above-mentioned risks will be 
minimized. 
 
For the  Healthcare provider participants, a Research Assistant, Project Director, or Investigator will 
obtain written consent from  Healthcare providers.  Medical information will not be collected from  
Healthcare providers but we will collect information on attitudes, experience and demographic 
background.  This will all be coded under a subject ID and kept on password protected data bases and in 
double locked files in the offices of research staff.  Any information that is collected from subjects who 
are not eligible to participate (including screening information from those who have not provided consent 
or audiotapes from those who have not consented to participate in the study), will be destroyed. 
 
For potentially eligible medical inpatients, information will be kept in a research chart that is not available 
to non-research staff unless safety issues mandate disclosure (e.g., risk of self harm or harm to others).  In 
this case, the subject will be apprised of safety concerns and the need to inform his or her primary 
clinician about psychiatric or behavioral health concerns.  Only the minimal necessary information will be 
disclosed. We have obtained a Certificate of Confidentiality that will facilitate frank sharing of 
information between the researchers and the patients.  However, the patient subjects will also be apprised 
of the limitations of the certificate which, as above, include risk of self harm or harm to others. 
 
11. Data and Safety Monitoring Plan: Include an appropriate Data and Safety Monitoring Plan 
(DSMP) based on the investigator’s risk assessment stated below. (Note: the HIC will make 
the final determination of the risk to subjects.) For more information, see the Instructions, 
page 24. 
 
a.  
What is the investigator’s assessment of the overall risk level for subjects 
participating in this study?  Minimal 
b. 
If children are involved, what is the investigator’s assessment of the overall risk 
level for the children participating in this study?  N/A 
c. 
Copy, paste, and then tailor an appropriate Data and Safety Monitoring Plan  
from  http://www.yale.edu/hrpp/forms-templates/biomedical.html  for 
i. Minimal risk 
ii. Greater than minimal/moderate risk 
iii. High risk 
 
The principal investigator, Dr. Yonkers is responsible for monitoring the data, assuring protocol 
compliance, and conducting the safety reviews. She and Dr. Martino will review entrance criteria of 
all inpatient subjects at a weekly meeting.   
 

Page 24 of 36 
 
The principal investigator, the Institutional Review Board (IRB) or NIDA have the authority to 
stop or suspend the study or require modifications. 
 
This protocol presents minimal risks to the subjects and Unanticipated Problems Involving Risks 
to Subjects or Others (UPIRSOs), including adverse events, are not anticipated. In the unlikely 
event that such events occur, Reportable Events (which are events that are serious or life-
threatening and unanticipated (or anticipated but occurring with a greater frequency than 
expected) and possibly, probably, or definitely related) or Unanticipated Problems Involving 
Risks to Subjects or Others that may require a temporary or permanent interruption of study 
activities will be reported immediately (if possible), followed by a written report within 5 
calendar days of the Principal Investigator becoming aware of the event to the IRB (using the 
appropriate forms from the website) and any appropriate funding and regulatory agencies. The 
investigator will apprise fellow investigators and study personnel of all UPIRSOs and adverse 
events that occur during the conduct of this research project.  All serious adverse effects will be 
reported to the Yale IRB in compliance with University and Medical School research review boards’ 
protocols. The protocol’s research monitor(s), e.g., study sponsors, funding and regulatory 
agencies, and regulatory and decision-making bodies will be informed of serious adverse events 
within 5 days of the event becoming known to the principal investigator. 
 
 
d. For multi-site studies for which the Yale PI serves as the lead investigator:  N/A 
i. How will adverse events and unanticipated problems involving risks to subjects or 
others be reported, reviewed and managed? 
ii. What provisions are in place for management of interim results? 
iii. What will the multi-site process be for protocol modifications? 
 
12. Statistical Considerations: Describe the statistical analyses that support the study design.  
     I.  Data Management and Analysis 
     1.  Data management 
Procedures for highly efficient, real-time managing, monitoring, and analysis of data have been developed 
and refined by our research group.   We are using OnCore, Yale's new Clinical Trials Management 
System (CTMS), to track procedures and data entry for patient characteristics and outcomes.  Participants 
enter data directly into the computer via CASI.   All computers are encrypted and password protected.  
Identifying data are not kept on the computer. For office PCs where data that were collected on paper is 
entered, we use a double entry method (staff data) and regular data checks to assess the integrity of the 
data base and missing data. After data entry and cleaning, de-identified data are moved to SAS databases 
for analysis. 
     2.  Data analysis for quantitative primary and secondary outcomes 
Outlined below is the general strategy for data analyses which will address each of our specific aims:  (1) 
assess the uptake of MI by  Healthcare providers on the medical units; (2) assess the integrity of MI when  
Healthcare providers use it on the medical units; (3) assess the cost-effectiveness of the three strategies; 
(4) determine how long the initial training effects endure across the study period. 
• 
Data reduction:  Primary outcome variables have been defined a priori to reduce the risk of Type 
I error.  Preparatory analyses will include evaluation of baseline equivalence of groups on 
demographic and comparability of rates of data availability across conditions. If imbalances exist 
we will enter the unbalanced variables as covariates in the models below. Descriptive statistics 
for all outcome variables will be calculated prior to statistical analysis. Continuous outcome 

Page 25 of 36 
 
variables will be evaluated for normality and transformations will be applied as necessary. Two-
sided tests and overall alpha level of 0.05 for all primary hypotheses will be used. 
• 
Strategies for management of differential attrition: We do not expect differential attrition across 
conditions in that the rate of  Healthcare provider job turnover is very low and their activities in 
the study overlap considerably with their normal duties. However, in the event of  Healthcare 
provider discontinuation in the trial, we will recruit new  Healthcare provider hires to maintain a 
balanced design. 
• 
Evaluation of effects at implementation strategies:  The principal strategy for assessing the 
effectiveness of the study implementation conditions on outcome will be mixed effects general 
linear models for continuously measured primary (e.g., MI integrity) and secondary (e.g., strength 
and frequency of patient change talk) outcomes variables, and generalized linear mixed models 
for binary outcomes (e.g. meets criterion MI performance threshold). In both types of models we 
will have training condition as the main predictor variable and will include random effects for  
Healthcare providers to account for clustering of observations within  Healthcare providers. Our 
main hypotheses involve group comparisons with the SEE IT group as the reference condition. 
We will consider significant comparisons of the DO IT and ORDER IT conditions to the SEE IT 
condition as supportive of our hypotheses. Comparisons of DO IT with ORDER IT will be 
conducted for exploratory purposes only.   
• 
Adequacy of sample size for primary hypotheses:  Effect sizes for power estimation for the 
continuous outcomes were based on studies by Miller et al.23 (d=0.4 to 0.8) and Martino et al.21 
(d=0.4 to 1.2). A review article by Apodaca and Longabaugh148 also suggests that at least medium 
effect sizes are expected for the between-group comparisons. Martino et al. 21 observed large 
effect sizes for the binary outcome comparison (meets criterion MI performance threshold, 53% 
vs. 18%); however, we conservatively assume a medium effect size for this comparison as well. 
Intra-class correlations accounting for expected within clinician variance were estimated based on 
Imel et al149 and are expected to be small (in the 0.05 to 0.10 range). Feasibility constraints (i.e., 
10  Healthcare providers per condition) limited the number of clusters ( Healthcare providers) that 
we could consider. Finally, because we do not expect all  Healthcare providers to identify 
substance using patients and use MI with them (i.e., our 1st hypothesis about MI uptake), we will 
require a larger sample size of study-enrolled patients to reach our targeted number of audio 
recorded MI sessions for hypothesis testing purposes. We estimate 80% of patients across 
conditions will receive MI.  Based on these estimates and constraints, alpha level of 0.05 and 
power of 80%, 30  Healthcare providers and 40 patients per  Healthcare provider will be 
sufficient for testing the primary hypotheses of the study. Table 2 shows the actual total sample 
size for the cluster-randomized design for continuous and binary outcomes, adjusted for a 
conservative estimate of MI uptake.  
 
Table 2: Sample size estimates for the primary aims of the study based on alpha=0.05 for the pairwise 
comparisons of each condition to the control condition and 80% power.  
Effect size 
Total sample 
size for an 
ordinary 
RCT (3 arms)  
ICC 
Number 
of  
Healthcare 
provider  
Average 
number of 
patients per  
Healthcare 
provider 
Total sample size for a 
cluster RCT 
unadjusted for 
estimated MI uptake 
Total sample size for 
a cluster RCT 
adjusted for estimated 
MI uptake 
d=0.4 
300 
0.07 
31 
31 
930 
1116 
40% vs 18% 
195 
0.1 
30 
17 
510 
765 
 
     3.  Incremental cost-effectiveness analyses 
The relative cost-effectiveness of the three MI implementation strategies will be assessed using both 
incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves (CEACs).  

Page 26 of 36 
 
Incremental cost-effectiveness analysis is the appropriate approach to use in this study inasmuch as Do 
One and Order One both add clear and certain costs to See One.150,151  ICERs and CEACs will be 
calculated from the provider (i.e., hospital) perspective.  Using the cost estimates described in the 
Assessment subsection, we will calculate ICERs for multiple outcome measures, including (a) the number 
of MI sessions delivered (a measure of uptake of MI by  Healthcare providers on the medical units), and 
(b) the number of MI sessions delivered to criterion (a measure of the integrity of MI delivered to patients 
on the medical units).  The ICERs measure the incremental cost of using a given integration strategy, 
compared to the next-least-costly strategy, to produce an extra unit of effect for each of the outcomes.  
The most cost-effective integration strategy is then the strategy with the largest ICER that falls below the 
threshold value placed by decision makers on an additional unit of effect for a given outcome.152 Because 
no threshold values exist for any outcomes used in the substance abuse treatment field, we will present 
ranges of values, defined by the ICERs for each patient outcome, over which each integration strategy 
would be considered cost-effective compared to the others.  Decision makers can use these ranges in 
combination with their own evaluation of the value of outcomes to make policy decisions.  By using 
multiple outcomes, we can determine the robustness of our cost-effectiveness findings and provide a more 
fine-grained cost-effectiveness analysis to address different priorities (e.g., uptake of MI by  Healthcare 
providers on medical units, integrity of MI delivered to patients) that stakeholders may have.153,154   
     To illustrate the uncertainty associated with the ICER point estimates, costs and effects for each 
integration strategy will be bootstrapped (with 2,000 replicates) to produce confidence intervals around 
the ICERs and to produce CEACs for each of the outcome measures.155 CEACs quantify the uncertainty 
in the cost-effectiveness analysis by showing the probability that each strategy is the most cost-effective 
for any given threshold value.152,155,156 Intuitively, as the threshold value of an additional unit of a given 
outcome increases, the strategy that produces the largest effect becomes increasingly more likely to be 
the most cost effective, even though it adds incremental costs.  Similarly, as the threshold value of an 
additional unit of a given outcome decreases, the strategy that has the lowest cost becomes increasingly 
more likely to be the most cost-effective.  Finally, sensitivity analyses will be conducted to determine the 
robustness of the cost-effectiveness results to alternative assumptions about a wide variety of 
implementation parameters (e.g., cost of inputs).  Dr. Todd Olmstead will conduct these cost-
effectiveness analyses; he has extensive experience in this area. 95,140-144 
  
     4.  Qualitative data analyses 
Each key informant interview will be will be audio recorded, transcribed, and independently coded by Dr. 
Kaufman and a member of her research team who will utilize debriefing to discuss and challenge 
findings.157 Dr. Kaufman and her team will utilize grounded theory methods developed by Strauss and 
Corbin158,159 to identify themes related to implementation facilitators and barriers across informants. The 
collection of data from multiple informants, iterative process of data collection and analysis, use of two 
researchers to code each transcript and work to consensus, keeping an audit trail of the data analysis 
process, and the theoretical sampling of themes and concepts will increase creditability, transferability, 
dependability, and confirmability of the findings.157 We will identify the barriers and facilitators that are 
1) unique to and 2) common across the conditions. Dr. Kaufman will oversee the qualitative analyses; she 
has extensive experience in this area.96-100 
 
 
SECTION VI: RESEARCH INVOLVING DRUGS, BIOLOGICS, RADIOTRACERS, PLACEBOS AND 
DEVICES 
 
 
If this section (or one of its parts, A or B) is not applicable, state N/A and delete the rest of the 
section. 
 
A.  DRUGS, BIOLOGICS and RADIOTRACERS 
 
N/A 

Page 27 of 36 
 
 
SECTION VII: RECRUITMENT/CONSENT AND ASSENT PROCEDURES  
1. 
Targeted Enrollment: Give the number of subjects: 
a.  targeted for enrollment at Yale for this protocol__see below_ 
b.    If this is a multi-site study, give the total number of subjects targeted across all 
sites_n/a__  
 
Participants will bePhysician Assistants (PAs) who work at the Yale New Haven Hospital (YNHH) 
Internal Medicine Hospitalist service and 1200-1600 inpatients who are being cared for by a PA from the 
Hospitalist Service.  All PAs on the Internal Medicine Hospitalist service are eligible to participate.  We 
will obtain written informed consent from all the PAs who express interest in participation and MI 
training.  The PAs will be randomized to one of three conditions that are outlined below.  The inpatients 
who may be eligible subjects will be followed for inpatient care by one of the Internal Medicine 
hospitalist service PAs.  While they will not be randomized, they will follow the randomization condition 
of their PA. Additionally, we have expanded our target for enrollment to other Healthcare providers (i.e. 
nursing staff, physician, etc.) who work at Yale New Haven Hospital (YNHH) within general medical 
inpatient units.  Between the PAs and other healthcare providers we intend to enroll 30-40 participants.  
 
2. 
Indicate recruitment methods below.  Attach copies of any recruitment materials that will 
be used. 
 
 Flyers 
 
 
 
 
 Internet/Web Postings 
 
 
 Radio 
 Posters  
 
 
 
 Mass E-mail Solicitation  
 
 Telephone 
 Letter 
 
 
 
  
 Departmental/Center Website 
 
 Television 
 Medical Record Review  
 
 Departmental/Center Research Boards 
 Newspaper 
 Departmental/Center Newsletters 
 Web-Based Clinical Trial Registries 
 
  YCCI Recruitment database 
 
 Clinicaltrials.gov Registry (do not send materials to HIC) 
 Other (describe): please see below 
 
3. 
 Recruitment Procedures:  
a. Describe how potential subjects will be identified. 
b. Describe how potential subjects are contacted.  
c. Who is recruiting potential subjects?  
 
The PAs will be recruited from the Internal Medicine Hospitalist Service.  All PAs will be encouraged to 
participate. Other Healthcare providers will be recruited from their general medical inpatient units.  
 
The medical inpatients will be recruited from the inpatient Internal Medicine Internal medicine hospitalist 
service and other general medical inpatient units. The research assistant will review a list of patients 
either assigned to PAs working onthe internal medicine hospitalist service or those assigned to Healthcare 
providers working in other general medical inpatient units of the hospital. After patients are consented, 
screened and assessed, the research assistant will have access to the electronic medical chart and will 
identify which PA was assigned to a given patient.   
 
 
4. 
Screening Procedures 
a. Will email or telephone correspondence be used to screen potential subjects for eligibility 
prior to the potential subject coming to the research office? 
 Yes  
 No 

Page 28 of 36 
 
b. If yes, identify below all health information to be collected as part of screening and 
check off any of the following HIPAA identifiers to be collected and retained by the 
research team during this screening process.  
 
HEALTH INFORMATION TO BE COLLECTED: 
 
Medical inpatients will undergo face-to face screening after providing consent.  If eligible, they will 
undergo a comprehensive evaluation by computer and by Research Assistants, several of whom will be 
hired to work on this project.  This will include medical, psychiatric and drug use histories.  Standardized 
psychosocial assessments and self-report rating forms are administered via self-report on a computer or in 
limited instances (e.g., substance use calendar) on paper. All of this will be coded by a subject ID rather than 
the individual’s name. 
 
  
HIPAA identifiers:  
 Names  
 All geographic subdivisions smaller than a State, including: street address, city, county, precinct, zip codes and their 
equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly-available data from 
the Bureau of the Census: (1) the geographic unit formed by combining all zip codes with the same three initial digits 
contains more than 20,000 people, and (2) the initial three digits of a zip code for all such geographic units containing 
20,000 or fewer people is changed to 000.  
  Telephone numbers 
 Fax numbers  
 E-mail addresses 
 Social Security numbers  
 Medical record numbers 
 Health plan beneficiary numbers  
 Account numbers  
  All elements of dates (except year) for dates related to an individual, including: birth date, admission date, discharge 
date, date of death, all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages 
and elements may be aggregated into a single category of age 90 or older  
 Certificate/license numbers  
 Vehicle identifiers and serial numbers, including license plate numbers  
 Device identifiers and serial numbers  
 Web Universal Resource Locators (URLs)  
 Internet Protocol (IP) address numbers  
 Biometric identifiers, including finger and voice prints (audio-recording of MI session) 
 Full face photographic images and any comparable images  
5. 
 Any other unique identifying numbers, characteristics, or codes Assessment of Current Health 
Provider Relationship for HIPAA Consideration: 
Does the Investigator or any member of the research team have a direct existing clinical 
relationship with any potential subject?  
 Yes, all subjects 
 Yes, some of the subjects 
 No 
 
If yes, describe the nature of this relationship. 
 
 
 

Page 29 of 36 
 
6. 
Request for waiver of HIPAA authorization: (When requesting a waiver of HIPAA 
Authorization for either the entire study, or for recruitment purposes only.  Note: if you are collecting 
PHI as part of a phone or email screen, you must request a HIPAA waiver for recruitment purposes.) 
 
Choose one: For entire study: ______ For recruitment purposes only: _X_____ 
i. Describe why it would be impracticable to obtain the subject’s authorization for 
use/disclosure of this data;  
 
We request a waiver to conduct a brief and limited review of admission documents to 
determine patients who are not eligible for screening because they do not speak 
English, have an organic brain syndrome such as dementia or encephalopathy, or who 
have already been previously enrolled in this research protocol. Those who are not 
immediately excluded will be approached to request participation and informed 
consent will be obtained.  Given the volume of inpatients at YNHH, it is impractical 
for research staff to approach every patient, nor is it an efficient use of their time.  
Review of the medical admission documents will guide research staff to offer study 
participation to those who are not obviously ineligible.   
ii. If requesting a waiver of signed authorization, describe why it would be 
impracticable to obtain the subject’s signed authorization for use/disclosure of this 
data. 
1. We estimate that we will have to screen over 5000 medical inpatients for 
participation.  We further estimate that 20% will be ineligible for screening 
given the basic exclusion parameters outlined above.  The cost and work will 
be substantially reduced by the initial waiver to determine preliminary 
ineligibility.  Further, it reduces the risk of loss of confidentiality for data 
collected from subjects who have a planned short hospitalization or have a 
medical condition that would preclude participation (eg dementia).  
Information on patients who either are not eligible for screening or refuse 
participation is immediately destroyed. 
 
By signing this protocol application, the investigator assures that the protected 
health information for which a Waiver of Authorization has been requested will not 
be reused or disclosed to any person or entity other than those listed in this 
application, except as required by law, for authorized oversight of this research 
study, or as specifically approved for use in another study by an IRB. 
 
Researchers are reminded that unauthorized disclosures of PHI to individuals outside of the Yale 
HIPAA-Covered entity must be accounted for in the “accounting for disclosures log”, by subject 
name, purpose, date, recipients, and a description of information provided.  Logs are to be 
forwarded to the Deputy HIPAA Privacy Officer. 
 
7. Required HIPAA Authorization: If the research involves the creation, use or disclosure of 
protected health information (PHI), separate subject authorization is required under the 
HIPAA Privacy Rule. Indicate which of the following forms are being provided: 
 
  
 Compound Consent and Authorization form 
 
  
 HIPAA Research Authorization Form 

Page 30 of 36 
 
 
 
8. Consent Personnel: List the names of all members of the research team who will be obtaining 
consent/assent.  
Research assistants will be hired to work on this project, and their names and copies of training 
certificated will be provided to the HRPP before study procedures begin. 
 
 
9. Process of Consent/Assent: Describe the setting and conditions under which consent/assent will 
be obtained, including parental permission or surrogate permission and the steps taken to ensure 
subjects’ independent decision-making.  
 
Consent of Healthcare providers:  Healthcare providers will be consented primarily by study Principal 
Investigator and his Co-Investigator Kimberly Yonkers, MD, as part of outlining the MI Training 
offering.  This will occur in a staff meeting group setting, with opportunity for individual questions in a 
one:one manner with the PI.  The nature of randomization will be made clear to personnel, as well as the 
requirements of their participation (ie attending training and possible follow-up).  Of particular 
importance to us is the risk for supervisory coercion to recruit PAs in particular into the study. Dr. Victor 
Morris, Director of the Hospitalist Services, and Will Cushing, Chief PA, have supervisory responsibility 
over the PAs.  They are Co-Investigators for the proposed study and fully supportive of absolute 
voluntary PA consent for initial and ongoing study participation.  They will provide research and 
supervisory support to the fact that the decision of any PAs to not participate in the study will not 
influence their job or performance appraisal.  As an added protection, neither Dr. Morris nor Mr. Cushing 
will personally consent any PAs.     
 
Consent of hospital patient study subjects: The procedure for obtaining informed consent entails a 
face-to-face discussion between the potential subject and a trained research assistant who will attend HIC 
training specific to obtaining informed consent.  For medical inpatients, we will consent preliminarily 
eligible inpatients, then verbally administer a de-identified screening battery.  Those who are 
preliminarily eligible will be invited to complete a full intake.  Medical inpatients are encouraged to ask 
questions about any confusing points, and to consider carefully their choice to participate in this, or any, 
research protocol.  Significant conversation will cover the fact that the decision to decline study 
participation will in no way affect their medical care.   
All study data will be kept in a research chart.  Medical inpatients will be told through the informed 
consent process that if they express suicidal or homicidal intent, this would incur assessment for 
voluntary or involuntary hospitalization, or a loss of some confidentiality.  All subjects will be informed 
about the limits of confidentiality concerning suicidal intent and homicidal intent.  Suicidal or homicidal 
attempts or completions, and hospitalizations, will be monitored as serious adverse events, and will be 
reported to the Human Research Protection Program (HRPP) at the Yale School of Medicine and other 
clinic research review boards.   
 
Consent of Hospital Clinical Staff:  Hospital Clinical Staff will be consented by study Principal 
Investigator, his Co-Investigator Kimberly Yonkers, MD and/or Project Director, Ashley McCaherty as 
part of describing the focus groups and/or interviews that will be conducted throughout the course of the 
study. This will take place in a scheduled meeting group setting, with opportunity for individual questions 
in a one:one manner with the PI, Co-Investigator and/or Project Director.   All Hospital Clinical Staff will 
be given the choice to sign-up for these focus groups and /or interviews and will be fully informed that 
their participation is completely voluntary.   
 
Consent for audio recording:   Healthcare provider’s will independently consent their own patients 
throughout the course of their work day for the process of audio-recording MI sessions, being blind to 

Page 31 of 36 
 
who is or is not a subject in the study and recognizing that the mere act of recording a clinical session 
requires patient permission.  Such recordings will only be retained for patients who in fact are matched up 
with consented study subjects.  In the event that a  Healthcare provider records an MI session with a non-
study subject, that recording will be immediately deleted from the digital recorder (ie never downloaded 
to the hard drive server).  A de-identified copy of the consent for audio-recording will be maintained in 
research files for the sake of documentation. 
 
10. Evaluation of Subject(s) Capacity to Provide Informed Consent/Assent: Indicate how the 
personnel obtaining consent will assess the potential subject’s ability and capacity to consent to the 
research being proposed.  
 
Healthcare providers will be able to provide consent, given the nature and sophistication of their 
employment and level of education.  However, it is important to ensure that hospital patients possess the 
capacity to provide informed consent.  Capacity to consent will be assessed in a systematic format.  
Immediately excluded from consideration will be new admissions of patients with obvious diagnoses 
indicating cognitive impairment, ie dementia.  To ensure that the respondent has the capacity to provide 
consent, the study personnel will assess orientation to person, place and date.  They will also be 
administered 3 questions for the Confusion Assessment Method.  A positive score on any of these items 
will trigger an evaluation by an attending psychiatrist who is part of the study team.  The evaluation will 
determine the patient’s capacity to provide informed consent.   Cases will be treated on a case-by-case 
basis, and at no point will research assistants make a final decision on cases of questionable capacity to 
consent.  Patients that are determined by a study investigator to not possess the capacity to provide consent 
will be provided with information on community resources for support and treatment.   
 
A waiver of signed consent will be needed for a subset of patient subjects. This is due to the study being 
conducted within an acute medical inpatient unit, where conditions that might limit a person’s 
ability to sign the consent form may occasionally occur. This subset of patients will include: 
patients that are physically unable to write (i.e. hand tremors, spinal cord injury, broken hand, 
broken shoulder, muscular dystrophy and other physical ailments preventing a patient from 
physically signing), unable to see (i.e. legally blind, uncontrolled type 2 diabetes mellitus which 
led to blurred vision), unable to read (i.e. patient does not have their glasses on them).  
 
 
11. Documentation of Consent/Assent: Specify the documents that will be used during the 
consent/assent process. Copies of all documents should be appended to the protocol, in the same 
format that they will be given to subjects.  
 
Compound authorizations attached. 
 
12. Non-English Speaking Subjects: Explain provisions in place to ensure comprehension for 
research involving non-English speaking subjects. Translated copies of all consent materials must 
be submitted for approval prior to use.   N/A.  Only English-speaking subjects will be enrolled in 
this trial. 
 
13. Consent Waiver: In certain circumstances, the HIC may grant a waiver of signed consent, or 
a full waiver of consent, depending on the study. If you will request either a waiver of consent, 
or a waiver of signed consent for this study, complete the appropriate section below.   
 
 Not Requesting a consent waiver  

Page 32 of 36 
 
 
 Requesting a waiver of signed consent 
       
 Requesting a full waiver of consent 
    
 
A. Waiver of signed consent: (Verbal consent from subjects will be obtained. If PHI is 
collected, information in this section must match Section VII, Question 6) 
 Requesting a waiver of signed consent for Recruitment/Screening only  
If requesting a waiver of signed consent, please address the following: 
a. Would the signed consent form be the only record linking the subject and the research? 
 Yes  
 No 
b. Does a breach of confidentiality constitute the principal risk to subjects?  
 Yes  
 No 
 
 
 
 
 
OR 
 
c. Does the research activity pose greater than minimal risk?  
 Yes If you answered yes, stop. A waiver cannot be granted.  Please note: 
Recruitment/screening is generally a minimal risk research activity   
 No  
  AND 
d. Does the research include any activities that would require signed consent in a non-
research context? 
 Yes  
 No 
 
 Requesting a waiver of signed consent for the Entire Study (Note that an information 
sheet may be required.) 
 
  
If requesting a waiver of signed consent, please address the following: 
a. Would the signed consent form be the only record linking the subject and the research? 
 Yes  
 No 
b. Does a breach of confidentiality constitute the principal risk to subjects?  
 Yes  
 No 
 
 
 
 
 
OR 
 
c. Does the research pose greater than minimal risk? 
 Yes If you answered yes, stop. A 
waiver cannot be granted.    
 No  
AND 
d. Does the research include any activities that would require signed consent in a non-
research context? 
 Yes  
 No 
 
  
As mentioned in section 10, a waiver of signed consent will be needed for subjects that 
are physically unable to provide a signature (i.e. hand tremors, spinal cord injury, broken 
hand, broken shoulder, muscular dystrophy and other physical ailments preventing a 
patient from physically signing) or are unable to see (i.e. legally blind, uncontrolled type 
2 diabetes mellitus which led to blurred vision), unable to read (i.e. patient does not have 
their glasses on them). We currently have an information sheet that is provided to this 
subset of patient subjects.  

Page 33 of 36 
 
 
 B. Full waiver of consent: (No consent from subjects will be obtained for the activity.)  
 Requesting a waiver of consent for Recruitment/Screening only  
a. Does the research activity pose greater than minimal risk to subjects?   
 Yes  If you answered yes, stop. A waiver cannot be granted. Please note: 
Recruitment/screening is generally a minimal risk research activity  
 No 
 
  
b. Will the waiver adversely affect subjects’ rights and welfare? 
 Yes  
 No 
 
  
c. Why would the research be impracticable to conduct without the waiver?  
 
We estimate that we will have to screen over 5000 medical inpatients for participation.  
We further estimate that 20% will be ineligible for screening given the basic exclusion parameters 
outlined above.  The cost and work will be substantially reduced by the initial waiver to determine 
preliminary ineligibility.  Further, it reduces the risk of loss of confidentiality for data collected 
from subjects who have a planned short hospitalization or have a medical condition that would 
preclude participation (eg dementia).  Information on patients who either are not eligible for 
screening or refuse participation is immediately destroyed. 
 
 
d. Where appropriate, how will pertinent information be returned to, or shared with 
subjects at a later date?  
 
 
 Requesting a full waiver of consent for the Entire Study (Note: If PHI is 
collected, information here must match Section VII, question 6.) 
 
  
 
If requesting a full waiver of consent, please address the following: 
 
 
  
a. Does the research pose greater than minimal risk to subjects?   
 Yes  If you answered yes, stop. A waiver cannot be granted.   
 No 
 
  
b. Will the waiver adversely affect subjects’ rights and welfare? 
 Yes  
 No 
 
  
c. Why would the research be impracticable to conduct without the waiver?  
 
d. Where appropriate, how will pertinent information be returned to, or shared with 
subjects at a later date?  
 
SECTION VIII: PROTECTION OF RESEARCH SUBJECTS 
 
    Confidentiality & Security of Data: 
a.    What protected health information (medical information along with the HIPAA identifiers) 
about subjects will be collected and used for the research?    
       Interview dates, dates of birth, subject names & addresses & contact information, hospital 
Medical Record Numbers, voice recording. 
 
b.    How will the research data be collected, recorded and stored?    
 

Page 34 of 36 
 
All data obtained via paper and pencil, or by digital recordings, will be coded by a unique study number 
and will be stored in locked filing cabinets in locked research offices.  For medical inpatients, all data 
entered via the computer will also be coded by a unique study identification number.  In the event that  
Healthcare provider’s ambitiously record a patient MI session with a non-study subject, the recording will 
be immediately destroyed from the digital recorded without ever being downloaded to our ITS server.  
However, this person’s de-identified audio-recording consent will be maintained for paper files.  
   
c.    How will the digital data be stored? 
 CD  
 DVD  
 Flash Drive  
 Portable Hard    
       Drive  
 Secured Server  
 Laptop Computer  
 Desktop Computer  
 Other 
d.    What methods and procedures will be used to safeguard the confidentiality and security of     
the identifiable study data and the storage media indicated above during and after the 
subject’s participation in the study?  
Data stored on the computer will not contain any identifiable Personal Health Information (PHI). 
Interview dates, schedules, outcomes, and study progress will be stored in a de-identified tracking 
database stored on a secure server at Information Technology Services’ Data Warehouse Center at Yale 
University.  Contact information and other PHI will be kept in a separate database also located on the 
secure server at the Data Warehouse Center which is backed-up daily. Access to the server is double 
password-protected and limited to a select number of authorized Yale staff.  All staff accessing the server 
must use a Yale-managed and owned administrative desktop computer located in the Department of 
Psychiatry.  Similarly, authorized study personnel will be able to access the server via Virtual Private 
Networks (VPN) configured on Yale-managed and owned laptop computers. Yale VPN provides a 
method for using a public network (e.g. internet) to securely access a private network (e.g. server). Lastly, 
Yale University passwords must be changed at least once per calendar year to a different password. This 
includes primary and responsible Yale-issued NetIDs.  Access to Yale’s network and affiliated servers 
will be denied to any staff member who fails to change their password annually. Each year's password 
must be unique and cannot be similar to previous year's passwords or the new password will not be 
accepted.  Yale's password must have 8-14 characters; must contain at least 2 letters; must contain at least 
2 non-letters; must NOT contain Illegal characters < > & \ , ' " : (less than, greater than, ampersand, 
backslash, comma, apostrophe and quotation marks). 
 
Do all portable devices contain encryption software? 
 Yes   
 No 
         If no, see http://hipaa.yale.edu/guidance/policy.html 
  
e. 
What will be done with the data when the research is completed? Are there plans to 
destroy the identifiable data? If yes, describe how, by whom and when identifiers will be 
destroyed. If no, describe how the data and/or identifiers will be secured.  
 
Upon completion of the study, files will be destroyed in a manner consistent with HIC policy at that date. 
 
f.   Who will have access to the protected health information (such as the research sponsor, the  
investigator, the research staff, all research monitors, FDA, Yale Cancer Center Data and Safety 
Monitoring Committee (DSMC), SSC, etc.)? (please distinguish between PHI and de-identified 
data)  
 
The databases are stored on an “exclusive” data drive that can only be accessed by authorized Yale-issued 
NetIDs who work on this study, including the PI, Project Director, and Research Assistants.  As an extra 
safe guard, we will create a “strong” password on the Access study database which is at least 8 characters 
with at least one uppercase and lowercase letter and one number or symbol.  Individual computers that 
have access to PHI have Pretty Good Privacy (PGP) whole disk encryption installed on them as well as 

Page 35 of 36 
 
MXI Security.  Therefore, at the time of initial login to the desktop you need to enter your Yale NetID 
and password and you also need to logon to MXI Security which also requires a password. Failure to 
logon to MXI Security will prohibit anyone from accessing any of the files on that desktop computer.  
 
g.   If appropriate, has a Certificate of Confidentiality been obtained?   
 
A COC has been obtained and copy has been provided for the HIC. 
 
h.   Are any of the study procedures likely to yield information subject to mandatory reporting   
requirements? (e.g. HIV testing – reporting of communicable diseases; parent interview -
incidents of child abuse, elderly abuse, etc.). Please verify to whom such instances will need to 
be reported.   No. 
 
 
 
 
 
 
SECTION IX: POTENTIAL BENEFITS 
 
 
Potential Benefits: Identify any benefits that may be reasonably expected to result from the 
research, either to the subject(s) or to society at large. (Payment of subjects is not considered a 
benefit in this context of the risk benefit assessment.)  
 
Integrating substance abuse interventions into primary care could improve health outcomes and reduce 
health care costs.51,52,57,75,76 However, this is contingent upon effective implementation strategies. We will 
compare and estimate the cost effectiveness of three implementation strategies that have the ability to 
interdigitate well into a general medical inpatient setting. 
 
This study proposes great value in service delivery and increased medical knowledge to individual 
patients and their healthcare providers.  Substance use increases general medical and psychiatric 
morbidity. Knowledge about the best methods for implementing evidence-based practices such as 
motivational interviewing into general medical settings is sorely needed.  
 
Medical inpatients who have a substance use problem may receive a motivational intervention that may 
enhance their interest in substance use treatment.  
 
Healthcare providers who participate may benefit in the receipt of additional training for motivational 
interviewing.  In addition, they will receive CMEs for didactic training.   
 
 
         SECTION X: RESEARCH ALTERNATIVES AND ECONOMIC CONSIDERATIONS 
 
1.     Alternatives: What other alternatives are available to the study subjects outside of the research? 
 
Participation in this study is voluntary for Healthcare providers, Hospital Clinical Staff, and hospital 
inpatients alike and the quality of or general provision of their healthcare is in no way related to their 

Page 36 of 36 
 
choice to enroll or not enroll in this RCT.  Treatment alternatives include receipt of usual services from 
hospital social work of CL services.   
 
2.  
Payments for Participation (Economic Considerations): Describe any payments that will be 
made to subjects, the amount and schedule of payments, and the conditions for receiving this 
compensation.  
 
Study subjects (patients) will be paid $30 for their full participation in this study.  If a patient prefers not 
to be paid in cash, they can be reimbursed with a $30 gift card instead.  
 
Healthcare provider participants will be reimbursed $350 for baseline assessments, attendance at our 
high-quality Motivational Interviewing training, and attendance at our baseline focus group. Additionally 
they will be reimbursed $50 for completing post-trial assessments and attending a post-trial focus group. 
Hospital Clinical Staff will be paid $20 for their participation in focus groups or interviews in this study.  
These focus groups or interviews may occur up to 3 times throughout the study and therefore they will be 
paid up to $60.  
 
3. 
Costs for Participation (Economic Considerations): Clearly describe the subject’s costs 
associated with participation in the research, and the interventions or procedures of the study that 
will be provided at no cost to subjects.   
    
There are no costs to any study subjects incurred as part of participation in the research. 
 
4. 
In Case of Injury: This section is required for any research involving more than minimal risk.  
N/A 
 
a.     Will medical treatment be available if research-related injury occurs?  
 
b.     Where and from whom may treatment be obtained?  
 
c.     Are there any limits to the treatment being provided?  
 
d.     Who will pay for this treatment?  
 
e.     How will the medical treatment be accessed by subjects?  
 
This study does not entail physical procedures that may cause injury.  No compensation is available for 
emotional injury.  All patients enrolled in study are currently receiving health care at the study-sponsoring 
hospital.