Nudging Primary Care Providers Toward Guideline-Recommended Opioid Prescribing Through Easier and More Convenient EHR Information Design
Phase: NA
Conditions: Chronic Pain
Sponsor: Indiana University

 
 
 
PROTOCOLS 
 
 
Nudging Primary Care Providers toward Guideline-Recommended Opioid 
Prescribing through Easier and More Convenient EHR Information Design 
 
R33 Clinical Trial 
MPIs: Chris Harle and Olena Mazurenko 
 
NCT04295135 
 
IRB #1911922583 
Jan 9, 2024 
 
 
 

 
 
Organizations: 
 
Indiana University 
Regenstrief, Inc.  
Eskenazi Health 
 
 
Funding Sources: 
 
National Institute on Drug Abuse 
National Institutes of Health 
 
 
A-Level of Review 
 
q720 
Does any research activity in this study present more than minimal risk to human 
subjects? 
No.The research may qualify for Expedited review if all research procedures fall into one of the 
categories below. 
 
q721 
Check all category(ies) which apply to this research. Category 5 - Research involving 
materials (data, documents, records, or specimens) that have been collected, or will be 
collected solely for nonresearch purposes 
Category 7 - Research on individual or group characteristics or behavior, or research employing 
survey, interview, oral history, focus group, program evaluation, human factors evaluation, or 
quality assurance methodologies 
 
q724 
Will the researchers be using a data collection form? 
No 
 
q725 
List all data points that will be recorded or collected. 
The data points that will be collected will all be participating provider behavior within Epic 
during qualifying patient visits. These data points will be the following: • Daily MMEs 
(Morphine Milligram Equivalents) of opioid medications being prescribed • Retrieval of 
Prescription Drug Monitoring Program (PDMP/INspect) reports (not the results of the reports) 
• Urine toxicology screens being ordered (not the results of the screens) • Goal- setting - 
using the goal-setting feature already in Epic • Pain and function measurement using PEG 

 
 
scale instrument already in Epic 
 
q23340 
Would identification of subjects and/or their responses reasonably place them at risk for 
any of the following (check any that apply): 
None 
 
 
B-Lay Summary Research Design 
 
 
q22122 
Describe the purpose of this study in lay terms, including research question(s) 
and hypothesis. 
The Chronic Pain OneSheet (OneSheet) is a dashboard that was developed at Eskenazi, 
and built in Epic at Eskenazi Health and at Wake Forest Baptist Health, in close 
collaboration with the Primary Care leadership and clinics at both institutions. The 
Dashboard does not provide new information to providers, but rather works by aggregating 
and structuring information that is already being collected, and that is available in other 
places in the medical record. By aggregating and structuring this information in a more 
convenient manner, the goal of the OneSheet is to make the information that is important in 
clinical decision-making more readily available, and to reduce the amount of time that 
providers need to spend locating this information. 
The purpose of the study is to determine whether and how having access to the Chronic 
Pain OneSheet activity in Epic affects the ordering, prescribing, goal-setting, risk 
monitoring, and outcome measuring behavior of participating providers in visits with 
patients with chronic pain. We will also assess whether access to the Chronic Pain 
OneSheet results in primary care providers making chronic pain treatment decisions that 
are more concordant with the CDC Guideline for Prescribing Opioids for Chronic Pain. 
 
q22123 
List and describe all research interactions and/or interventions, including the frequency 
and duration of procedures, and length of participation for individual subjects. 
The Chronic Pain OneSheet (OneSheet) is a dashboard that was developed and built in Epic 
at Eskenazi Health, in close collaboration with the Eskenazi Health Clinical Information 
Technology Governance committee, and Eskenazi Health Primary Care leadership and 
clinics. It was subsequently built into Epic at Wake Forest Baptist Health primary care clinics, 
in close collaboration with WFBH Primary Care leadership. The Dashboard does not provide 
new information to providers, but rather works by aggregating and structuring information that 
is already being collected, and that is available in other places in the medical record. By 
aggregating and structuring this information in a more convenient manner, the goal of the 
OneSheet is to make the information that is important in clinical decision making more readily 
available, and to reduce the amount of time that providers need to spend locating this 

 
 
information. Qualifying providers will be recruited for the study and will be formally consented. 
The enrolled providers will be randomized to treatment and control groups (using the 
OneSheet vs. NOT using the OneSheet). The participating providers that have been 
randomized to the treatment group will be given instructions on how to access and use the 
OneSheet when treating patients' chronic pain. These providers will also be given ongoing 
technical support and assistance with integrating the OneSheet into their clinical workflows. 
Those participating providers who have been randomized to the control group will not be 
given any information or instructions on accessing and using the OneSheet. At Eskenazi, 
when a qualifying patient, identified by Regenstrief through an algorithm developed in 
collaboration with the researchers, comes to a visit with a participating provider in the 
treatment group, a BPA will appear in the patient’s record, alerting the provider to consider 
utilizing the OneSheet for that patient’s chronic pain management during the visit. Eskenazi 
will share the MRNs of qualifying patients, and dates of qualifying visits with Regenstrief Data 
Core, who will collect outcome measure data, remove patient identifiers (with the exception of 
dates), and share this limited data set with the research team for analysis. At Wake Forest, 
when a qualifying patient, identified through the same process, comes to a visit with a 
participating provider in the treatment group, a BPA will appear in the patient's record, alerting 
the provider to consider utilizing the OneSheet for the patient's chronic pain management 
during the visit. Wake Forest Baptist Health will share the MRNs of qualifying patients, and 
dates of qualifying visits with an honest broker, who will collect outcome measure data, 
remove patient identifiers (with the exception of dates), and share this limited data set with the 
research team for analysis. At both sites, formal informed consent and HIPAA authorization 
will not be obtained from qualifying patients being treated by participating providers. 
 
q23358 
Will any non-English study documents be uploaded? 
No 
 
q24919 
Is this research funded by, or has a funding application been submitted to, a federal 
agency? This includes federal pass- through funding. 
Yes 
 
q23234 
List inclusion criteria - eligibility criteria for subjects. 
Inclusion criteria for provider participants: 1. Primary care provider (including Family 
Medicine, Internal Medicine, Med-Peds, and General Medicine) 2. Is able to prescribe 
medication (i.e., MD, NP, PA) 3. Sees patients at an Eskenazi or Wake Forest Baptist Health 
primary care clinic. Data will only be collected from visits that participating providers have 
with patients who meet the following criteria: 1. 18+ years old 2. No cancer diagnosis in the 
prior 3 years. 3. Meet the following indications of chronic pain over the most recent 24 
months: a. 3+ unique* instances of a qualifying pain diagnosis (either billed diagnosis or 

 
 
problem list) OR b. 3+ unique* prescriptions for one or more of the following drugs: an opioid 
(“opioid agonist,” “opioid partial agonist,” “opioid combinations”), Tramadol, Nortriptyline, 
Amitriptyline, Gabapentin, Pregabalin, Duloxetine, desipramine, milnacipran, tapentadol OR 
c. 2 unique* instances of a qualifying pain diagnosis AND 2+ unique* pain medication 
prescriptions containing one or more of the drugs listed in b. * To count as unique, diagnoses 
or prescriptions should be separated by at least 30 days from any previous qualifying 
diagnosis or prescription. **Qualifying pain diagnoses and prescriptions listed separately. - 
Because chronic pain treatment is often discussed during visits not identified as chronic pain 
visits, any visit that a qualifying patient has with a participating primary care provider will be a 
qualifying visit for the purposes of the trial. 
 
q23235 
List exclusion criteria (any criteria which would exclude otherwise acceptable subjects). 
The following are exclusion criteria for providers: 1. Does not practice primary care 2. Does 
not regularly see patients at an Eskenazi or Wake Forest Baptist Health Primary Care clinic 3. 
Is not able to prescribe medication 
 
q23346 
Will subjects be paid for their participation in the 
study? Payment includes reimbursement of expenses (other than compensation for 
injury). 
Yes 
 
q23347b 
Describe the payment arrangement, including amount and timing of disbursement. 
No payments 
 
q23348 
Justify the proposed payment arrangement described above, specifically why payment does 
not provide undue influence for subject participation. 
No payments 
 
 
q23349 
Will partial payment be provided if the subject withdraws prior to completion of the study? 
No 
 
 
q23350 
Explain why failure to offer partial payment will not unduly influence subjects to complete 
the study. 

 
 
Primary care providers are highly paid individuals, so we do not think $25 gift card will be a 
high enough amount to unduly incentivize completion. 
 
q23352 
Does this research involve (choose all that apply): 
• the STUDY of any of the following products (regardless of FDA approval status). “The study 
of” means at least one objective of the study is related to obtaining data about the 
product 
• USE of any of the following products which have not been cleared or approved by the 
FDA for use in the US 
• USE of any of the following products for open label extension, treatment, or compassionate 
use 
None apply 
 
q25049a 
Is this research considered a prospective clinical study? 
Yes - This study may require entry in OnCore. 
 
q30000a 
Is this community-engaged research? 
No 
 
C-Sites and Collaborations 
 
q700 
Are there additional locations of research, not already listed? 
Yes 
 
q701c 
Provide the name of the site, including city and state. 
Wake Forest University and Wake Forest Baptist Health; Winston-Salem, NC. 
 
q702 
Is any research taking place outside the United States? 
No 
 
q704 
Are you requesting that IU provide IRB approval for any researchers who are NOT IU 

 
 
affiliates? 
Yes 
 
q25332 
Please choose the option which best describes the role of the non-affiliated 
investigators in the research. 
Non-affiliated investigators are conducting only some of the procedures specified in the 
protocol. 
 
q25334 
Please choose the research activities being conducted by the non-affiliated 
investigators. 
Collection or analysis of identifiable data or identifiable biospecimens 
 
 
q25335 
Please list the non-affiliated investigator(s) and the name(s) of the institution(s) with 
which they are affiliated (e.g. name of academic institution, academic medical center, 
corporation or other entity). 
Wake Forest University and Wake Forest Baptist Health; Winston-Salem, NC.  
 
q25336 
Please choose the best description of the non-affiliated investigator’s role at their own 
institution. 
Faculty or staff 
 
 
q25338 
Please describe the plan for management and communication of IRB-related 
information to sites and/or non-affiliated investigators, including ensuring that non-
affiliated investigators are familiar with and will follow IU HRPP policies and 
procedures, that required reporting and requests for amendments by non-affiliated 
investigators are submitted to the IU IRB, and that IRB decisions and approved 
documents are communicated. Alternatively, attach a document describing this plan. 
The lead investigator and the site-specific PI for the study at Indiana University will be responsible 
for ensuring that all non-affiliated investigators complete all training and tasks required by IU 
HRPP policies, and follow the protocol that is approved by the IU IRB. All study personnel will meet 
regularly to communicate any decisions by the IRB, and to ensure that all policies and procedures 
are being followed at all sites. All IRB approved, and stamped documents will be circulated to 
study personnel. 
 
 

 
 
q710a 
Is this a multi-center study or multi-site clinical trial? 
Yes 
 
q711a 
State the number of subjects to be enrolled in the study at all sites. 
250 
 
q712a 
Is the Lead investigator at IU? 
Yes 
 
q714 
Describe the plan for the management and communication of multi-site information 
that may be relevant to the protection of participants. 
The study teams at all sites have a standing biweekly meeting to manage the study and 
communicate information between sites. Data Use Agreements between the sites will protect the 
sharing of participant information among the study team. Files with participant information will be 
shared between the sites only when necessary and then only via secure electronic shared drives. 
 
 
D-Recruitment Methods 
 
q23236 
Describe how potential subjects will be initially identified. Potential subjects will be initially 
identified through the listing of primary care providers at each of Eskenazi's or Wake Forest's 
primary care clinics on their 
website. Other providers will by identified by having previously collaborated on prior projects 
with the research team. Additionally, at both sites, researchers will identify potential subjects 
at presentations at clinic meetings, after receiving approval from the clinic's management. 
Eligible clinic visits at Eskenazi Health clinics will be identified by Regenstrief Institute Data 
Core and Eskenazi Health. The researchers will provide criteria for eligibility, and Regenstrief 
and Eskenazi will work together to identify them. Eligible clinic visits at Wake Forest Baptist 
Health clinics will be identified by Wake Forest Baptist Health working with an honest broker 
similar to the Regenstrief Institute Data Core. The researchers will provide criteria for 
eligibility, and the health system (WFBH) and the honest broker will work together to identify 
them. The researchers will not be privy to the list of eligible patients or clinic visits at either 
trial site. 
 
q30002 

 
 
Check any of the following sources of information which will be used to identify potential 
subjects. 
Subject self-referral in response to recruitment materials 
 
 
q30003 
Describe how potential subjects will be initially contacted. Researchers will visit primary 
care clinics and present the research project to all primary care providers there through a 
powerpoint presentation and handouts/flyers. Interested eligible providers identified at the 
clinic presentations will be followed up with by e-mail by research staff. Providers who have 
previously collaborated with the research team will also be contacted by e-mail, and asked to 
refer other providers in their clinic who may be interested in participating. Because of 
operations changes related to covid-19, if visiting the clinic in person is not acceptable, 
researchers may also work with the primary care clinics to present the powerpoint 
presentation through a teleconference or a virtual meeting with a software like Zoom. The 
powerpoint and handouts will be shared through email. 
 
q23237 
Check any of the following recruitment materials which will be used to contact potential 
subjects. 
Direct 
 
Mail/Email 
Flyers/Brochures Verbal Scripts 
 
q25426b 
Select any of the following circumstances which apply to this research. 
None of the above. 
 
q23245 
Would participation in this study preclude subjects from participating in other research 
studies? 
No 
 
 
E-Risks Benefits Protections 
 
 
q23296 
List and describe (in lay terms) the potential risks to which subjects may be exposed 
as a result of their participation in the research. 
Because we will be collecting data on provider behavior, there is a risk that if a breach of 
confidentiality were to occur, and the provider's clinical behavior was criminal or otherwise 

 
 
objectionable, they would be at risk for criminal liability, loss of ability to be employed, and 
damage to reputation. However, because this data is already routinely collected in the Epic 
Electronic Health Record (EHR) system, they are already subject to these risks, and 
participation in this research does not increase these risks. Patients encounter the same level 
of risk that their identifiable data may be breached by simply being a patient in the hospital 
records systems. We will work with an honest broker who can act as a firewall between 
personally identifiable health data and the researchers, ensuring that the risk of loss of 
confidentiality is not greater than minimal. Eskenazi will share the MRNs of qualifying patients, 
and dates of qualifying visits with Regenstrief Data Core, who will collect outcome measure 
data, remove patient identifiers (with the exception of dates), and share this limited data set 
with the research team for analysis. Wake Forest Baptist Health will share the MRNs of 
qualifying patients, and dates of qualifying visits with an honest broker at Wake Forest 
University, who will collect outcome measure data, remove patient identifiers (with the 
exception of dates), and share this limited data set with the research team for analysis. Use 
of the OneSheet does not increase the risk of viewing incorrect or incomplete data because 
the OneSheet functions by gathering relevant information directly from other parts of the 
electronic medical record (EMR) in one place. Therefore, the data in the OneSheet are as 
accurate, valid, and complete as any other information in the electronic medical record. 
 
q23297 
Describe procedures for protecting against, or minimizing, the potential risks listed 
above. Include any procedures that are already being performed on subjects for 
diagnostic, treatment, or standard purposes. 
Participants' names will not be attached to their data. We will work with Regenstrief and 
another honest broker at Wake Forest who can act as a firewall between personally 
identifiable health data and the researchers, ensuring that the risk of loss of confidentiality is 
not greater than minimal. The researchers will obtain a limited dataset containing dates of 
qualifying visits, but patient identifiers (with the exception of dates) will be removed by the 
honest brokers. Furthermore, all information collected will be stored in locked filing cabinets 
or password protected secure network drives on encrypted devices. Data will continue to be 
protected on secure network drives throughout the analysis and accessed only by members of 
the research team. All study dissemination activities, such as presentations and journal 
articles, will report data in the aggregate and not identify individuals. Use of the OneSheet 
does not increase the risk of viewing incorrect or incomplete data because the OneSheet 
functions by gathering relevant information directly from other parts of the electronic medical 
record (EMR) in one place. Therefore, the data in the OneSheet are as accurate, valid, and 
complete as any other information in the electronic medical record. 
 
q23299 
Explain how research data will be protected so that only approved persons have access 
to subjects’ identifiable data (i.e. confidentiality of data). 
Participants' names will not be attached to their data. We will work with Regenstrief and 
another honest broker at Wake Forest who can act as a firewall between personally 

 
 
identifiable health data and the researchers, ensuring that the risk of loss of confidentiality 
is not greater than minimal. The researchers will obtain a limited dataset containing dates of 
qualifying visits, but patient identifiers (with the exception of dates) will be removed by the 
honest brokers. Furthermore, all information collected will be stored in locked filing cabinets 
or password protected secure network drives. Data will continue to be protected on secure 
network drives throughout the analysis and accessed only by members of the research team. 
All study dissemination activities, such as presentations and journal articles, will report data 
in the aggregate and not identify individuals. All study dissemination activities, such as 
presentations and journal articles, will report data in the aggregate and not identify 
individuals. 
 
q23300 
Explain how subjects’ physical privacy will be protected, both during 
recruitment/screening and during participation in the research. 
For each participants' privacy, the consent process will be conducted privately. 
 
q23301 
Is there a potential for subjects to benefit directly from participation in the study? 
Yes 
 
q23302 
Describe the potential benefits to be gained by the individual SUBJECT. Please note that 
payment for participation is not considered a benefit. 
The participants who are randomly assigned to have access to the Chronic Pain Onesheet 
may be able to access relevant medical record information more efficiently than they would 
otherwise. 
 
q23303 
State the potential benefits or information which may accrue to SCIENCE or SOCIETY in 
general as a result of this work. 
This research will lead to an increased understanding of the impact that a decision support 
tool has on physician behavior and interaction with their electronic health record system. 
This may result in a clinician decision support system that benefits both clinicians and 
patients in terms of improved quality and improved outcomes associated with pain 
management in primary care. 
 
 
F-Data Safety Monitoring 
 
q23304 
Describe the provisions for monitoring the data to ensure the safety of subjects. 

 
 
Research staff will monitor (at least weekly) subject withdrawals and any complaints to 
ensure that study procedures are not harming the safety of participants. As part of this 
monitoring, this information will be shared with the PI for determination of any safety risks. 
We are in the process of forming a 3-person DSMB. These members are colleagues at 
current or former institutions. However, they do not stand to gain scientifically from 
participating (e.g., through publication or grant funding). Further, they do not have a financial 
interest in the study outcome. Because the CT is low risk, DSMB members will meet at least 
annually, by teleconference call. The DSMB will also have the option of expedited meetings to 
review unexpected SAEs or other urgent issues that arise over the course of the CT. Any 
recommendations related to the CT will be made in writing by the Board’s Chairperson to the 
Principal Investigator in a report. The report will also include meeting minutes summarizing 
the discussions held during DSMB meetings. The DSMB members are of multidisciplinary 
backgrounds and have the necessary expertise in clinical medicine and pain management to 
serve on the DSMB for this CT. Additionally, because this is a multi-site CT, the DSMB is 
composed of one member from each site, as well as a third member, who is not affiliated with 
either study site. This ensures that decisions will be made impartially. 
 
 
H-Informed Consent 
 
q901 
Will all or some subjects consent to participate in the research? Some subjects (or their 
legally authorized representative) will consent to participate in the research, and some 
subjects will not. 
 
q902 
Explain which subjects will consent to the research, and which subjects will not. 
The patients on which we are pulling clinical outcome data will not consent to research. The 
physicians, on whom we are collecting data, will consent to research. 
 
q909 
For those subjects who will consent to participate, explain how subjects (or subjects’ 
legally authorized representative) will be presented with the information needed to 
decide to participate, including all elements of informed consent. 
All subjects will be presented with a copy of the informed consent statement. A researcher 
will walk through the consent form with the subject and answer any questions that the 
subject might have regarding the study. 
 
q903 
Describe any informed consent tools which will be used to present information to 
potential subjects (i.e. consent documents, videos, brochure, drug/device information, 

 
 
etc) and how they will be used. 
An informed consent statement will be used to explain all the risks, benefits, and time 
commitments, and provide a description of how to stop participating in the study. All subjects 
will be walked through the consent form with a member of the research team. A Recruitment 
Handout will be given that contains a link to the REDCap consent form if subjects prefer to 
sign the consent at a later time after hearing about the study. 
 
q925 
Describe the timing of the informed consent process, including how you will ensure 
potential subjects have sufficient opportunity to discuss and consider participation before 
agreeing to participate in the research. 
Clinician participants will be informed about the study, and provided a copy of the consent 
statement. A member of the research team will go over the sections of the informed 
consent statement with the potential subject and then allow time for questions and 
clarifications. The potential subject may sign the informed consent statement at that time, 
or they may complete it electronically (via REDCap) at a later time. The content of the 
electronic consent form will match the paper consent form. 
 
q30127a 
Will you include all required elements of consent in your consent process? 
Yes 
 
q921 
Indicate in what language(s) the consent conversation will be conducted. 
English 
 
q926 
Explain how you will ensure potential subjects understand the information you have presented 
to them before they agree to participate in the study. 
The potential subjects are highly educated medical clinicians who participate in many trials 
and are familiar with the language of informed consent statements. To ensure potential 
subjects understand the specifics of this study, after reviewing the informed consent 
statement with participants, staff will prompt the potential subject for any questions that may 
have arisen during the review and provide any clarifications necessary. 
 
q929 
Briefly describe any training provided to investigators who are obtaining informed consent. 
Investigators will undergo CITI training for social behavioral research practices. They will also 
be taught how to go through a consent form and prompt for questions that arise. 
Investigators will have a thorough working knowledge of the research study and will be able 

 
 
to answer subjects' questions. Any questions they are not able to answer, the investigator will 
refer the subject to the PI. 
 
q931 
Does the research include any minimal risk procedures to which subjects will not consent? 
No 
 
q23678a 
For those subjects who will consent to participate, choose whether the consent process 
will be documented by a written signature from subjects. 
All consented subjects will provide a written signature as documentation of consent. 
 
q30129a 
Will subjects participate in any study activity prior to physically signing a consent document? 
No 
 
q940a 
Explain the process for obtaining a written signature from subjects. 
Clinician participants will be informed about the study, and provided a copy of the consent 
statement. A member of the research team will go over the sections of the informed 
consent statement with the potential subject and then allow time for questions and 
clarifications. If this occurs in person, the potential subject may choose to sign the paper 
informed consent statement at that time. If this occurs remotely, the potential subject will 
be directed to the REDCap form where they may choose to electronically sign the consent 
statement. For clinicians who do not sign the consent statement at the initial contact, the 
study team will attempt to contact to recruit and consent a potential participant no more 
than 5 times, or until they state they do not want to participate. 
 
q23764 
Since some subjects will not consent to participation in the research, a waiver of consent 
is required. Choose the appropriate reason for waiving consent. 
Research is minimal risk and obtaining consent is not practicable. 
 
q904b 
Explain how the research involves no more than minimal risk to the subjects. 
The collection of outcome data is only meant to identify physicians who will be the subjects 
on whom we are actually collecting data. The physicians will be consented. 
 
q906b 

 
 
Explain how the waiver will not adversely affect the rights and welfare of subjects. 
The identify of the patients will not be known by the study team. It is only meant to identify 
physicians. Data will not be used in any other way. 
 
q907b 
Explain how the research could not be practicably carried out if informed consent were 
required. 
The research is concerned with the clinical behaviors of primary care providers when they 
are treating patients with chronic pain and using their EHR in daily practice. Because primary 
care providers see many patients with chronic pain on a daily basis, it would be impractical for 
researchers or clinic staff collaborators to intervene in each of these visits to obtain consent. 
 
q30004d 
Explain why the research could not be practicably carried out without identifiers. 
The identity of the patients will not be known to the study team. They will be known by the 
hospital pulling the records. We will work with an honest broker who can act as a firewall 
between personally identifiable health data and the researchers, ensuring that the risk of loss 
of confidentiality is not greater than minimal. 
 
q908b 
Explain how subjects will be informed of pertinent results at the conclusion of the study, 
if appropriate. If subjects will not be informed, enter N/A. 
N/A -- there not by any pertinent results for the patients because their data is only be used to 
identify the relevant physicians or OneSheet uses. 
 
 
K-HIPAA 
 
q23253 
Are you part of a covered entity (health care provider that transmits health information 
electronically) or are you receiving information from a covered entity as part of your 
research? 
Yes 
 
q23254 
Will protected health information be utilized, accessed, collected, or generated as 
part of the study? 
Yes 
 
 
q30347a 

 
 
Select the electronic systems to be used for the collection and/or storage of protected 
health information (ePHI). Choose all that apply. 
REDCap 
Microsoft Teams 
IU Box Health Data Account 
 
q23257 
Will you be accessing or collecting protected health information for RECRUITMENT 
purposes? 
No 
 
q23277 
HIPAA applies to your study, and requires that you obtain authorization for 
PARTICIPATION in research, or that you request a waiver. Check all that apply. 
I will not obtain authorization prior to their participation 
 
q23650 
List all data elements to be used or disclosed (do not refer to an attachment). 
Patient demographics, Healthcare encounter location, type, provider, and date Chronic pain 
diagnosis and date Patient goal type and date Pain and function assessment (PEG) results 
and date of assessment PDMP check completion date Laboratory, procedure, medication, 
and referral orders Opioid risk tool results and date of assessment 
 
 
q23651 
A waiver of the requirement for a written signature must be approved by the IRB. Explain 
how this research involves no more than minimal risk of loss of confidentiality to the 
subject. 
Because we will be collecting data on provider behavior, there is a risk that if a breach of 
confidentiality were to occur, and the provider's clinical behavior was criminal or otherwise 
objectionable, they would be at risk for criminal liability, loss of ability to be employed, and 
damage to reputation. However, because this data is already routinely collected in the Epic 
Electronic Health Record (EHR) system, they are already subject to these risks, and 
participation in this research does not increase these risks. Patients encounter the same level 
of risk that their identifiable data may be breached by simply being a patient in the hospital 
records systems. We will work with an honest broker who can act as a firewall between 
personally identifiable health data and the researchers, ensuring that the risk of loss of 
confidentiality is not greater than minimal. The health system will share the MRNs of 
qualifying patients, and dates of qualifying visits with the honest broker, who will collect 
outcome measure data, remove patient identifiers (with the exceptions of dates), and share 
this limited data set with the research team for analysis. 
 
q23652 

 
 
Describe the plan for protecting identifiers from improper use and disclosure. 
We will work with an honest broker who can act as a firewall between personally identifiable 
health data and the researchers, ensuring that the risk of loss of confidentiality is not greater 
than minimal. 
 
q23653 
Describe the plan to destroy identifiers at the earliest opportunity appropriate for the 
research, considering the purpose of the research and local data retention 
requirements.  
Neither provider or patient names will be attached to their data. We will work with 
Regenstrief Data Core who can act as a firewall between personally identifiable health data 
and the researchers, ensuring that the risk of loss of confidentiality is not greater than 
minimal. The researchers will obtain a limited dataset containing dates of qualifying visits, 
but patient identifiers (with the exceptions of dates) will be removed by the honest broker. 
 
q23654 
Confirm that the study team will assure identifiable PHI will not be re-used or disclosed to 
individuals outside the study team, except as required by law. 
The members of the study team conducting the analysis will access the limited dataset 
through a secure network drive, specifically created for that purpose. Only the members of 
the study team who are involved with the analysis will be granted access to the secure 
folder. Furthermore, all information collected will be stored in locked filing cabinets or 
password protected secure network drives on encrypted devices. Data will continue to be 
protected on secure network drives throughout the analysis and accessed only by members 
of the research team. All study dissemination activities, such as presentations and journal 
articles, will report data in the aggregate and not identify individuals. 
 
q23655 
Explain how the research could not be practicably conducted without waiver of 
authorization or alteration of authorization requirements. 
The research is concerned with the clinical behaviors of primary care providers when they 
are treating patients with chronic pain and using their EHR in daily practice. Because primary 
care providers see many patients with chronic pain on a daily basis, it would be impractical for 
researchers or clinic staff collaborators to intervene in each of these visits to obtain HIPAA 
authorization. 
 
q23656 
Explain how the research could not be practicably conducted without access to and use of 
identifiable PHI. 
Regenstrief Data Core will require MRNs and dates of qualifying visits to create the limited 
dataset that will be shared with the study team. The limited dataset will include dates of 

 
 
healthcare services provided. The limited dataset is required to complete our analysis 
determining if access to the OneSheet changes clinician behavior regarding pain medication 
prescriptions, treatment referrals, the setting of pain and function goals, and the assessment 
of opioid related risks (PDMP checks, urine drug screens, and PEG scores). Specifically, dates 
are required to analyze the effect of the OneSheet over time, and to measure guideline-
concordance of clinician behavior (e.g., was the PDMP checked within the time span required 
by guidelines). 
 
 
IRB Amendments  
   
Approval date  
Summary of changes  
7/8/20 
Added WF as a site, Dr. Mazurenko named PI, Dr. Hurley as site specific PI, 
Limited dataset instead of deidentified, updated recruitment process, added 
demographic survey, ICF edited, e-Consent added - a003   
7/29/20 
Updated recruitment talking points - a004  
9/16/20 
Individual randomization instead of clinic level, updated ICF total number of 
participants - a005  
8/6/21 
Adding second recruitment at both sites to increase sample size due to 
provider turnover-v5  
  

 
 
Administrative Details Form 
 
 
 
Protocol Details 
 
 
9031 
Protocol Type 
Expedited 
 
Billing Account # 
 
 
Study Status 
 
 
 
Submission Details 
 
 
9000 
Submission Review Level 
Expedited 
 
 
9030 
Expedited Category. 
Category 5: Data or specimens that have been or will be collected for 
nonresearch purposes 
Category 7: Survey, interview, focus groups, human factor, group behavior or 
characteristics 
 
 
9002 
Criteria for Approval. Select to confirm. 
Approved: The criteria for approval of the research are satisfied in accordance 
with IU HRPP Policies, and applicable federal regulations. 
 
 
 

 
 
Protocol Determinations 
 
 
9003 
Protocol Level of Risk. 
Minimal risk 
 
9020 
Is renewal required for this research? 
No 
 
9004 
Check all determinations that need to be made. 
Informed Consent Waiver 
HIPAA Waiver 
Certificate of Confidentiality 
 
 
9005 
Informed Consent Waivers 
Waiver of informed consent granted in accordance with IU HRPP Policies 
 
 
9006 
HIPAA Waivers 
Participation 
 
9010 
Brief description of PHI - Participation 
Patient demographics Healthcare encounter location, type, provider, and date 
Chronic pain diagnosis and date Patient goal type and date Pain and function 
assessment (PEG) results and date of assessment PDMP check completion 
date Laboratory, procedure, medication, and referral orders Opioid risk tool 
results and date of assessment Patient MRN 

 
 
 
 
9009 
Participation HIPAA Waiver 
Waiver of authorization criteria satisfied in accordance with 45 CFR 164.512(i) 
(2)(ii). Waiver of authorization approved in accordance with 45 CFR 
164.512(i). 
 
 
9025 
Certificate of Confidentiality. 
The research is subject to the NIH Policy for Issuing Certificates of 
Confidentiality and therefore has been issued a Certificate. 
 
9028 
Other Determinations.