EHR-Based Medication Complete Communication Strategy to Promote Safe Opioid Use
Phase: NA
Conditions: Opioid Use, Unspecified
Sponsor: Northwestern University

EHR-Based Medication Complete Communication (EMC2) Strategy to Promote Safe 
Opioid Use: A Physician Randomized Trial 
 
 
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PROTOCOL TITLE: 
 
EHR-Based Medication Complete Communication (EMC2) Strategy to Promote 
Safe Opioid Use: A Physician Randomized Trial 
 
PRINCIPAL INVESTIGATOR: 
 
Danielle M. McCarthy, MD MS 
Assistant Professor  
Department of Emergency Medicine 
Northwestern University Feinberg School of Medicine 
211 East Ontario Suite 200 
Chicago, IL 60611 
d-mccarthy2@northwestern.edu 
 
VERSION NUMBER: 
Version 1.4 
VERSION DATE: 
7/11/2016 

EHR-Based Medication Complete Communication (EMC2) Strategy to Promote Safe 
Opioid Use: A Physician Randomized Trial 
 
 
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Table of Contents 
1.0 
Objectives ................................................................................................................ 3 
2.0 
Background .............................................................................................................. 3 
3.0 
Inclusion and Exclusion Criteria .............................................................................. 4 
4.0 
Study-Wide Number of Subjects ............................................................................. 6 
5.0 
Study-Wide Recruitment Methods .......................................................................... 6 
6.0 
Multi-Site Research ................................................................................................. 6 
7.0 
Study Timelines ....................................................................................................... 6 
8.0 
Study Endpoints ....................................................................................................... 7 
9.0 
Procedures Involved ................................................................................................. 8 
10.0 Data and Specimen Banking .................................................................................... 8 
11.0 Data and Specimen Management ........................................................................... 12 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 12 
13.0 Withdrawal of Subjects* ........................................................................................ 16 
14.0 Risks to Subjects* .................................................................................................. 17 
15.0 Potential Benefits to Subjects ................................................................................ 17 
16.0 Vulnerable Populations .......................................................................................... 18 
17.0 Community-Based Participatory Research ............................................................ 18 
18.0 Sharing of Results with Subjects ........................................................................... 18 
19.0 Setting .................................................................................................................... 18 
20.0 Resources Available ............................................................................................... 18 
21.0 Prior Approvals ...................................................................................................... 19 
22.0 Recruitment Methods ............................................................................................. 19 
23.0 Local Number of Subjects ..................................................................................... 20 
24.0 Confidentiality ....................................................................................................... 20 
25.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 20 
26.0 Compensation for Research-Related Injury ........................................................... 21 
27.0 Economic Burden to Subjects ................................................................................ 21 
28.0 Consent Process ..................................................................................................... 21 
29.0 Process to Document Consent in Writing .............................................................. 22 
30.0 Drugs or Devices .................................................................................................... 22 
 

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1.0 
Objectives 
 
1.1 
The overall objectives of the research grant are listed below; patients and 
providers will be involved in the data collection for Aims 1 & 2 whereas Aim 3 & 
4 will not have any patient involvement and will assess costs of implementation 
from a system standpoint and plans for dissemination: 
 
Aim 1: Test the effectiveness of an EHR-based Medication Complete 
 
Communication (EMC2) strategy, with and without SMS text reminders to 
 
 improve patient understanding and use of opioid medications. 
 
Aim 2: Evaluate the fidelity of the EMC2 Strategies and explore patient, 
provider, and health system barriers to the implementation and 
effectiveness of either intervention. 
 
Aim 3: Assess the costs required to deliver the interventions, exclusive of 
system design.  
 
Aim 4: Develop a dissemination plan for the EMC2, with any necessary  
modifications, to other emergency departments and relevant medical 
practices. 
 
1.2  
Related to Aim 1 above, we hypothesize that leveraging an electronic 
health record (EHR) based Medication Complete Communication (EMC2) 
strategy will reduce medication errors with newly prescribed opioid 
medications demonstrated by patient use compared to usual care. 
Compared to those receiving usual care, patients receiving the EMC2 
strategies will:  
 
H1 Report higher rates of provider (physician and 
pharmacist) counseling 
H2 Have a greater understanding of risks associated with 
newly prescribed opioid medications  
H3 demonstrate more appropriate safe use of prescribed 
high-risk opioid medications 
2.0 
Background 
2.1 
Research has repeatedly demonstrated that individuals lack 
 
essential information on how to safely take medication they are 
 
prescribed.1-6  Knowledge deficits are greatest for information 
 
pertaining to risks and warnings.7 This general lack of awareness is 
 
 a leading root cause of the many cases of misuse that have 
 
translated to serious adverse events.   
2.2 
Neither physicians nor pharmacists routinely counsel patients to 
 
ensure  understanding, leaving patients to rely on product labeling, 
 
such as the package insert, container label, or medication 

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Opioid Use: A Physician Randomized Trial 
 
 
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leaflets.8-12 These existing tools that have been designed to inform 
 
individuals on the safe, appropriate use of a prescribed(Rx) 
 
medication - including risks and warnings – are limited in their 
 
 effectiveness. Even when evidence-based practices are employed 
 
 to develop these written communications, those with limited 
 
literacy and numeracy skills - and older adults - may remain at 
 
greater risk for poor understanding and medication errors.13-15    
Poor understanding of medication risks is particularly concerning 
 
for opioid pain relievers. In the past decade, there has been a 
 
marked increase of opioid prescriptions and a corresponding 
 
 increase in the number of deaths from both opioid abuse and 
 
unintentional misuse.16-20 In 2008, opioid pain relievers were 
 
involved in 74% of all deaths from prescription drug overdose.16 
 
Widely variable and often inadequate patient counseling about this 
 
class of medications may contribute to this, especially in the 
 
Emergency Department (ED) where pain is the most 
 
common complaint and opioid pain relievers the most commonly 
 
prescribed medication.21-26 39% of all opioids are prescribed in the 
 
ED, yet both spoken and written counseling is minimal.27-29 
At the national level, the Food and Drug Administration (FDA) 
 
and Drug Enforcement Agency (DEA) endorse health system 
 
interventions targeting long-acting and extended release opioids 
 
and have focused many efforts on the physician prescriber.17,30 
 
To date, the ED response has also been to focus on the prescriber 
 
by trying to reduce inappropriate opioid prescribing.31-36 Yet 
 
interventions are also needed to improve the prevalence and 
 
quality of patient education and counseling at the time of 
 
appropriate prescribing.  
2.3 
With the increasing adoption of EHRs and mobile technologies, we 
now have the ability to impart risk information to individuals at 
multiple time  points  and via multiple modalities. We will 
implement an EHR-based, Medication Complete Communication 
(EMC2) strategy, wherein 1)  emergency physicians adequately 
counsel patients at the time of prescribing, 2) tangible tools 
reinforce counseling, and 3) a mechanism for follow-up engages 
additional providers to reinforce education and confirm 
understanding. 
 
3.0 
Inclusion and Exclusion Criteria 
 
3.1 
Screening for eligibility for study 
Emergency Department Providers. The research study will be described 
to providers by the emergency department leadership and study leadership, 
both via email and at in-person business meetings. All ED providers 

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Opioid Use: A Physician Randomized Trial 
 
 
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(attending MD, resident MD, NP, PA) with the exception of study 
investigators will be eligible. Providers will be asked to complete a written 
consent form if they choose to be involved in the study.  
 
Patients. During the patient recruitment period, the RA will make 
frequent rounds through the ED and ask physicians to identify potentially 
eligible patients who will be discharged home on opioid pain relievers.  
The RA also will carry a pager so that physicians can notify the RA if they 
have an eligible patient.  This method of patient identification has a well-
established track record within our ED for maximizing enrollment while 
minimizing RA downtime. If the patient is interested in participating or 
learning more about the study, the RA will obtain verbal permission to ask 
the patient a brief series of questions to determine eligibility (see criteria 
below).  If the patient is eligible for the study, the RA will proceed with 
obtaining written informed consent. 
 
Follow-up Providers. Certain providers will interact with consented 
patients after the intervention takes place (e.g. Primary care physicians 
(PCP) and outpatient pharmacists).  These providers will have no required 
role in carrying out the intervention (which is carried out by the EHR 
enhancements).  These providers will be identified by chart review (PCP) 
and pill bottle review (pharmacists) at the time of patient follow-up.  
<30% of ED patients have on-staff PCP and there is no way to predict 
where the patients will fill their prescriptions (e.g., on-site Walgreens or 
another pharmacy).  After identifying these providers at the time of 
follow-up, we will contact them via email or mail to participate in a 
survey.  Both types of surveys will be offered to accommodate providers’ 
busy schedules and because the pharmacists are located at diverse 
locations across the across the city of Chicago.   The survey will assess the 
implementation of the EHR interventions and the providers’ reactions to 
receiving additional information about their patients who were prescribed 
opioids in the ED.   
 
3.2 
ED Provider Inclusion Criteria. 1) Resident, Attending Physician or 
Mid-level provider (NP, PA) working in the Northwestern Emergency 
Department during study dates. 
 
ED Provider Exclusion Criteria. 1) Study investigator. 
 
Patient Inclusion Criteria. To be eligible to enroll and remain in the 
study, patient subjects must meet all of the following criteria: 1) Patient 
age 18 years and older, 2) English language speaking  3) prescribed pill 
form of hydrocodone-acetaminophen opioid pain reliever 4) the patient is 
the person primarily responsible for administering medication  
 
Patient Exclusion criteria.  Subjects will be excluded from the study if 
any of the following conditions are met: 1) Aged <18, 2) non-English 

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Opioid Use: A Physician Randomized Trial 
 
 
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speaking, 3) clinically unstable, psychologically impaired or intoxicated as 
judged by research staff member or emergency physician, 4) chronic 
opioid use, defined as daily or near daily use of opioid pain relievers for 
the past 90 days 5) admitted to hospital 6) unable to complete follow up 
phone interviews 7) pregnant 
 
Follow-up Provider Inclusion Criteria: 1) Primary care physician within 
Northwestern system who has seen patient enrolled in study as part of 
routine ED follow-up or 2) Pharmacist who filled opioid prescriptions for 
study participant. 
 
Follow-up Provider Exclusion Criteria: none 
 
 
3.3 
Special Populations 
No special or vulnerable populations will be included. 
 
4.0 
Study-Wide Number of Subjects 
4.1 
Number of Emergency Department Physicians and Mid-Level providers to  
be enrolled.  N=150 
Number of Patients to be Enrolled. N=1500 
 
 
Number of follow up providers to be enrolled (PCP/Pharmacists) N=50 
 
5.0 
Study-Wide Recruitment Methods 
N/A 
 
6.0 
Multi-Site Research 
N/A 
 
7.0 
Study Timelines 
An individual ED physician or mid-level provider will be involved in this study 
for a maximum of two years of patient enrollment.   
 
An individual patient subject will be involved in the study for a total of 1 month.  
They will complete a baseline enrollment interview, a phone interview at 2-4 
days, a phone interview at 7-14 days, and a final phone interview at 1 month.  
 
An individual PCP or pharmacist will be involved in the study for the amount of 
time it takes to complete the survey questionnaire (estimated at approx. 5-10 
minutes). 
 
We anticipate that patient enrollment will actively take place for 1.5 years to 
reach the target N above; however if accrual occurs at a slower rate we have 
allowed 2 years.  The estimated date to complete primary analyses is May 2017. 
 
 

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8.0 
Study Endpoints 
 
8.1 
Covariates.  Baseline assessment will include a sociodemographic and 
 
health questionnaire and questions about previous use of opioids.  A 
 
literacy assessment using the Newest Vital Sign (NVS) will be performed.   
 
Primary Endpoint. Demonstrated understanding of how to properly dose 
the opioid medication as measured by participants’ ability to correctly 
dose their prescription regimen using a demonstrated dosing exercise 
previously used in studies by both Drs. McCarthy and Wolf.  Primary 
endpoint will be assessed at the 7-14 day phone interview.  
 
Secondary Endpoint. Actual use of the opioid medication as measured 
through the review of the medication diary, participant report of refills and 
new opioid prescriptions received patient opinion of the intervention as 
measured by both closed and open-ended questions at the time of follow-
up phone interview; patient risky-behaviors while on opioids, as measured 
by patient self-report. Other aspects of safe use related to risk awareness 
will be assessed using a questionnaire, as will beliefs about medication 
use.  The questionnaire will assess topics including safe storage of opioids, 
sharing of opioids, disposal on completion of the prescription, and 
questions related to possible dangerous behaviors. Secondary endpoints 
will be assessed with phone interviews . 
 
Tertiary Endpoints. The identification of medication names, dosage, risks, 
warnings, and benefits will be assessed through a structured questionnaire 
that has been developed and used extensively by Dr. Wolf and colleagues 
in multiple studies and current NIH-funded grants.  The self-report of 
provider counseling will also be measured. Tertiary endpoint assessments 
will be assessed via phone interviews.  
 
Exploratory Endpoint. A subset of analyses will examine return visits to 
the ED (obtained via EDW query) and admission to the hospital for a 
complaint related to opioid pain reliever (ranging from mild, e.g., 
constipation to severe, e.g., respiratory depression). Additional analyses 
will be conducted to evaluate for possible misuse or inappropriate 
prescribing.  Outcome indicators include: 1) opioid overlap (defined as 
opioid prescriptions that overlap by 7 or more days, including refills), 2) 
opioid and benzodiazepine overlap, 3) long acting/extended release opioid 
prescription written for acutely painful conditions 4) high daily opioid 
dosage (defined as a prescribed daily dose of 100 morphine milligram 
equivalents (MME) or greater) and 5) opioid dose escalation (measured as 
having a 50% or greater increase in mean MME per month twice during 
the year).91,92 These data will be obtained by a data pull via the Illinois 

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Opioid Use: A Physician Randomized Trial 
 
 
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Prescription Monitoring Program (ILPMP) at 1-year post initial ED 
prescription.  Drs. McCarthy and Lank will conduct this data-pull.  
Patients PHI will not be sent to the ILPMP or any other state or pharmacy 
governing body to obtain these data. 
 
9.0 
Procedures Involved 
9.1 
We will conduct a three arm physician randomized study trial in the 
 
emergency department at Northwestern to measure the effect of an EHR-
 
based, Medication Complete Communication (EMC2) and EMC2+SMS 
 
text reminder strategies on increasing provider counseling, increasing 
 
patient understanding of risks associated with newly prescribed opioid 
 
medications, and demonstrating more appropriate, safe use of prescribed 
 
high-risk opioid medications.  English speaking patients who are 
 
prescribed hydrocodone-acetaminophen will be recruited and assessed 
 
with phone interviews at 2-4 days, 7-14 days and 1 month. 
 
9.2 
Provider Randomization. To optimize the likelihood of obtaining similar 
 
populations in each intervention arm, providers that have consented to 
 
participation in the study will be placed into 4 strata depending on their 
 
role (attending versus resident) and historical volume of opioids 
 
prescribed. Dr. Kim, blinded to provider identity will randomly assign 
 
providers within each stratum to each of three study arms using a random 
 
number generator.  We will reveal provider identities after randomization 
 
is complete.   
 
Provider role and training. All providers will be informed of the possible 
interventions that their patients may receive (e.g., Universal Medication 
Schedule sig codes (See below on page 9), Medication Sheet, Text 
reminders, and emails to PCP as well as any changes such randomization 
may cause to the providers workflow (i.e, for some providers, intermittent 
pop-ups reminding them to counsel patients).  Providers will be told that 
they will be assigned to either the usual care or one of two intervention 
groups. The providers who are assigned to the intervention groups will be 
trained on how to 1) prescribe medications with the EMS instructions 
from the “favorites” list and 2) how the other components of the 
intervention will automatically generate (MedSheet, emessage to PCP).  
 
The initial study visit (baseline) will be conducted at the time of patient 
enrollment.  Following this baseline interview, RAs will conduct three 
telephone interviews (at 2-4 days post-baseline, 7-14 days post-baseline 
and at one month post-baseline).  The first two assessments (at enrollment 
and 2-4day follow-up call) have been included to closely track patient 
recall of counseling and knowledge, while the latter two assessments (7-14 
day follow-up call and 1 month follow-up call) are included to assess 
decay of knowledge, safe use, storage of medications and demonstrated 
dosing.  The final call (one month post-baseline) will assess disposal of 

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Opioid Use: A Physician Randomized Trial 
 
 
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medications and determine if patients have received additional opioid pain 
relievers from other providers. 
 
Baseline Interview. At the time of enrollment, the RA will ask the 
participant to indicate the best days and times to call within a 2-4 day 
range. A $5 Gift card given to the participant for completion of enrollment 
tasks. 
 
First Study (2-4 Day) Phone Call. The study phone call will be conducted 
at a time of convenience for the patient, however still within a 2-4 day 
range post-baseline. Additionally during this phone call, the RA will either 
confirm or schedule the 7-14 day follow-up call. A $10 Gift card will be 
mailed to the participant for completion of first phone call. 
 
Second Study (7-14 Day) Phone Call . The second phone call will be 
conducted at a time of convenience for the patient, however still within 7-
14 day range post-baseline. Patients will be compensated for their time to 
complete the call with a$20 gift card which will be mailed to the 
participant upon completing the call. Patients will also be asked to mail 
back their de-identified medication diary using the prepaid envelope 
provided at baseline.  
 
Third/Final Study (1 Month) Phone Call. The final study phone call will 
be conducted at a time of convenience for the patient, however still within 
1-month post-baseline. (See Attached Interview script) 
 
Intervention Patients with physicians randomized to the EMC2 arm will 
receive the 5-part EMC2 intervention.   
 
[1] Funded by AHRQ [R18HS17220], we created single-page, plain 
language medication information sheets with content appropriately 
sequenced from a patient’s perspective (drug name, indication, 
purpose/benefit, how to take, for how long, when to call your doctor, when 
to stop taking and call your doctor, important information) and following 
other health literacy best practices.  
 
[2] The medication sig (‘sig’ is short for signa, which in Latin means 
“write”) contains directions to the patient (e.g.: “take one pill every 8 
hours). We have shown that we are able to replace existing EHR default 
sigs for the top 300 medicines prescribed in primary care with UMS 
instructions [R21CA132771] and have evaluated the use of UMS sigs in 
actual pharmacy practice [R01HS017687] for non-PRN medications.  The 
UMS sig for PRN medications has been evaluated in two studies 
(California Healthcare Foundation, McNeil Consumer Healthcare), and we 
have found that patients with the UMS sig for PRN dosing (Take-Wait-
Stop label) were less likely to exceed the maximum daily recommended 

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Opioid Use: A Physician Randomized Trial 
 
 
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dose of their opioid prescription.  The UMS Sig for the opioids in question 
in this study will change the text on the prescription bottle as demonstrated 
in Figure 1 
 
 
 
 
 
 
 
 
 
 
 
 
 
[3] In addition to the tools that the patient receives, the EHR will automate 
communication to the patient’s prescribing ED physician, reminding them 
to counsel the patient with a pop-up window.   
 
[4] Additionally, there will be communication to the dispensing 
pharmacist by making a note on the paper-prescription requesting the 
pharmacist consider counseling the patient. 
 
[5] Finally, there will be a notification to the primary care physician (PCP) 
if the patient has a PCP in the Northwestern system.  This notification was 
initially conceptualized as being automated when the inpatient and 
outpatient Cerner systems were compatible.  Since the switch of the 
outpatient Northwestern Medicine offices to the EPIC EHR, this 
automated function is not longer available.  Therefore, the RAs enrolling 
the subjects will note if the patient has a Northwestern Medicine 
physician.  If the patient enrolled for follow-up has a physician in the 
system, the RA will manually log-in to the outpatient EPIC interface (with 
write functionality) and send the PCP an inbox message with the 
following sample text: “Your patient NAME, DOB was seen in the 
Northwestern Emergency Department on MONTH DATE, 20XX.  They 
received a prescription for Hydrocodone-Acetaminophen (DOSE, 
TIMING, NUMBER OF TABS).  When you see this patient for a follow-
up appointment, please consider counseling them about the safe use of this 
medication.  For additional information about your patient’s visit to the 
Emergency Department, you may access the Emergency Department Note 
and Depart Summary.  The Depart Summary will also contain a copy of 
the information sheet that your patient received about their new 
prescription pain medication.”   
 
Figure 1: Standard label (left), UMS Take-Wait-Stop label (right) 

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[Note: Neither the Pharmacist nor the PCP receiving the messages to 
“consider counseling the patient” are required to take any action as part of 
the intervention.  The study is designed with the ED as point of care and 
we will be assessing implementation to gauge the response to these 
messages among those PCPs and pharmacist who received them; however, 
these providers are not required to do anything as part of the study or 
intervention.] 
 
Patients with ED physicians randomized to the EMC2 +SMS Text 
reminder arm will receive the above-described 5 components of the EMC2 
intervention, and also will receive daily text reminders for one week (7 
messages) following the new prescription for an opioid pain reliever (only 
consented patients).  The premise for the 1-week timeframe is to help 
patients remember precautions regarding safe use during the time they are 
taking the medication (average ED Rx for opioids is from pilot data is 18 
tabs). Furthermore, SMS text reminders that would continue indefinitely 
are at risk for either being ignored, irritating patients, and/or adding an 
unnecessary expense to patients (i.e., patient does not have an unlimited 
texting plan, further challenging sustainability). Messages sent early in the 
week will focus on topics such as safe storage and use; those sent near the 
end of the week will focus on topics such as disposal and pill sharing.  We 
will schedule EMC2 text messages to arrive mid-day (12:00pm to 
5:00pm), based on patient preference. (See appendix for sample text 
messages) 
 
9.3 
Procedures to monitor safety and minimize risk. 
As a part of all of the time points of follow-up, the RAs will have a 
checklist of potentially dangerous behaviors related to opioids and if these 
items are noted in the course of data collection the RAs have a set protocol 
to follow.  (see safety protocol attached) 
9.4  The drug hydrocodone-acetaminophen is the topic of the research; 
however it is not being used in the research—the intervention is 
focused on education about this medication and the study will not 
change the drug, dose, frequency, quantity or refills that the ED 
physician selects in the course of their normal clinical care.   
 
 
Sources of Materials:  
Electronic Health Record (EHR): Patient information and outcomes will 
be extracted from the EHR (demographics, ED return visits and re-
admissions).  Re-admissions and re-visits to the hospital and ED data will 
be abstracted from medical records for all patients enrolled into the study, 
as well as all patients prescribed an opioid during the recruitment period of 
18-months. 
 

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Illinois Prescription Monitoring Program (ILPMP): We will obtain data 
from the ILPMP on medication fill date, subsequent refills of the 
prescribed opioid, and new prescriptions for other controlled substances.  
 
All personal health information will be kept behind organizations’ 
firewalls.  Analytic databases will be created with removal of all personal 
health information; these will then be sent to Northwestern investigators 
for analysis. 
 
Patient in-person enrollment & follow-up phone interviews:  Interviews 
include assessments of health literacy skills, safe medication use, and 
medication understanding, among others. 
 
Provider surveys: Both the ED providers and the follow-up providers 
(PCP and Pharmacists) will be surveyed to assess their reactions to the 
intervention via electronic and mail survey. 
 
10.0 Data and Specimen Banking 
10.1 Data will be stored for up to 5 years after study completion for data 
analysis and publication of study results.  At that time, all identifiers 
will be destroyed, but de-identified data will be retained.  Data will 
be stored on Northwestern encrypted servers and access will be 
granted through the PI.  
10.2 The clinical data, interview data and prescription refill data noted 
above will be stored. 
10.3 Data will not be released. 
11.0 Data and Specimen Management 
11.1 AIM 1 Analysis Plan. The proposed trial uses a cluster-randomized 
design where the prescribing physician is the unit of randomization. 
We will randomize approximately 150 physicians (50 attending 
physicians, 100 EM resident physicians and mid-level providers) to 
three intervention arms (usual care, EMC2, and EMC2 + SMS text 
reminders).  The estimate of 150 includes a base of 100 providers 
with an estimate of approximately 50 new providers over the course 
of the 18 months of recruitment (e.g. 15 new residents in 2015, 15 
new residents in 2016 and new attending hires). At any given time, 
we estimate that 100 providers will be actively involved in the study, 
resulting in approximately 33-34 physicians per arm. Physicians will 
be stratified by provider role (i.e., attending vs. resident) and 
randomly assigned to one of the three arms with an equal number 
assigned to each.  We will accrue approximately 12 patients per 
physician; we conservatively anticipate at least 54% retention for the 
phone call follow-up 7-14 days post prescription.  These estimates 
will result in 1500 participants recruited with an anticipated 

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minimum of 816 patients at in-person follow-up (272 per arm, 8 per 
physician) available for primary data analysis.   
 
To ensure adequate balance across the 3 arms, potential confounders 
including socio-demographic characteristics, comorbidities, regimen 
complexity (i.e., # of medications, total pills taken daily), health literacy 
level, and history of opioid use) will be compared using one-way ANOVA 
models and χ2 tests, as appropriate. Covariates with significant differences 
(p-value < .05) across treatment groups will be included in the generalized 
linear mixed models (GLMMs) to adjust for the group differences as 
described below. We note that detected differences may be physician-
specific, so if we observe differences across the treatment arms, we will 
explore whether the difference might be attributable to individual 
physicians.  
 
Demonstrated safe use by not exceeding the maximum dose is the primary 
outcome of interest for Aim 1 (H3), with higher reported rates of provider 
counseling and greater understanding of risks relevant to hypotheses of 
secondary interest for Aim 1 (H1, H2). We will use GLMMs for analyses of 
the data, specifying the logit link function for the binary outcomes using 
xtmixed in Stata (v.12.1). The 3-category treatment group variable will be 
the independent variable of primary interest and modeled as a fixed effect 
with the usual care group specified as the reference. We will also include 
fixed effects for any potential confounding covariates noted in the 
descriptive studies that were not accounted for in randomization. Random 
effects will be included for each physician to account for intra-physician 
correlation among participants. For all GLMM analyses we will report point 
estimates and corresponding 95% confidence intervals.  We will examine 
and report the extent to which the random effects suggest correlation of 
outcomes within physicians.  
 
Measures taken to minimize bias. For the randomization scheme of this 
study, physician is the unit of randomization rather than patient. With 
healthcare interventions and quality improvement projects, such as the one 
proposed herein, there are no other ways to evaluate an automated EHR 
process than to “turn them on.”  This is why the randomization will occur at 
the physician level rather than the patient level.  This process will result in 
trickle down of aspects of the EMC2 intervention (but not SMS texting) to 
patients seen by the consented provider, but not enrolled in the study for 
follow-up purposes (e.g., on overnight shifts).  
 
Level of significance to be used. We will use a two-sided 5% significance 
test 
 
Stopping rules. We will stop enrollment once we have reached the 1500 
patient enrolled maximum. 

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Procedures for reporting deviations from the original plan.  Any deviations 
involving human subjects will be submitted to the IRB for review before 
being implemented. 
 
Selection of subjects for inclusion in the analysis. All subjects with complete 
information (e.g., at least 80% completion of interview instrument) will be 
used in the analysis. 
 
AIM 2 Analysis Plan. Following completion of enrollment, we will 
determine the extent to which the interventions were implemented as 
planned (a process evaluation) in the two intervention arms. In the EMC2 
and EMC2 + SMS text reminder arms, we will collect EHR data on 
prescriptions and discharge summaries to assess if patients actually received 
the new prescriptions with the UMS (Take-Wait-Stop) sig, and review pill 
bottle information during the 7-14 day phone call to determine if the sigs 
were translated accordingly onto patients’ drug labels. For the EMC2 + SMS 
text reminder arm, we will ask patients at all follow-up intervals if they 
received the text messages. For those electing to turn off the service, we will 
qualitatively explore and code reasons why.   
 
Usability of the EHR interventions will be assessed among the ED 
physicians and follow-up providers (PCPs and pharmacists) via survey. 
 
AIM 3 Analysis Plan.  We will directly measure and assess the provider 
perspective costs of running the two EMC2 interventions. Specifically, we 
will estimate the incremental cost of the interventions relative to usual care 
from the perspective of the ED implementing these systems. The primary 
costs of running the EMC2 intervention involve the limited expenses around 
printing (printer ink, paper, staff time).  However, we will include estimates 
for minimal programming maintenance and will test the sensitivity of results 
to changes in the maintenance requirements in terms of programmer hours. 
We also will separately track development costs for software and other 
programming requirements based on programmer hours.  The greater cost, 
in terms of running the program, will be that for the SMS text services, 
which will include the nominal monthly cost as well as staff time to 
schedule the SMS text reminders after the initial ED visits. For study 
purposes, the RA will do this task; however, we will have record on a daily 
basis in a study database (Microsoft Office Access, Microsoft Corp.) the 
number of minutes spent programming the SMS text reminders. This record 
will allow us to estimate the direct staff costs of this component by 
combining time with wage estimates.  We will test the sensitivity of costs to 
different assumptions about the potential use of variable staff (nurse, clerk, 
medical assistant) using different salaries but assuming the same proficiency 
in terms of time required.  Further we will assess the sensitivity of the 

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estimates to different proficiency levels that could arise from learning by 
doing. 
 
To achieve Aim 3, Surrey Walton, at UIC, will help in analyzing time and 
resource use related to the intervention.  Any data that he would receive 
would be anonymous and would not contain any patient PHI.  Instead, the 
data would involve counts of hours spent, and materials used, in creating 
and implementing the intervention. 
 
11.2  Rationale for choice of sample size, power considerations. The sample size 
for this study was based on pairwise comparisons between the two 
intervention arms compared to usual care (i.e., usual care vs. EMC2 and 
usual care vs. EMC2 + SMS). This calculation was based on the primary 
outcome of demonstrating safe use by not exceeding the maximum 
recommended dose at the 7-14 day phone follow-up interview.  
 
Conservatively estimating 54% retention rate for 7-14 day follow-up call, 
we will have 82% to detect a difference of 11.8% between each intervention 
and the usual care arm assuming a Type I error of 2.5% to account for the 
two comparisons.  An intraclass correlation coefficient (ICC) of 0.001 was 
used because we do not expect patient outcomes to be influenced by the 
clustering of physicians due to patients being randomly assigned a physician 
upon ED entrance and physicians typically working a random assortment of 
shifts.  
 
With the sample size set by the primary outcome of demonstrated safe use 
by not exceeding the maximum dose, we also show detectable effects for the 
secondary outcomes in Table 3, assuming at least 80% power, a Type 1 
error rate of 2.5%, an ICC of 0.001, and usual care estimates from prior 
studies.  
 
11.3 
Data Safeguarding Procedures. Any information that could allow 
identification of individual patients, including the master list, will 
be kept strictly confidential. In order to preserve participants’ 
confidentiality rights, research subjects will be assigned study ID 
numbers that will be used to identify all the information collected. 
A master study tracking database will contain information linking 
participants to their study ID numbers. This database will be on 
RedCap and is both encrypted and password protected and only 
accessible by approved study personnel at Northwestern. Grant file 
access permissions will only be given to specific approved 
research personnel, as designated by the PI. 
 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 

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Data Safety and Monitoring Board. The Data Safety and Monitoring 
Board (DSMB) will be formed in the early months of the project and be 
given responsibility to review and approve the study methods and analysis 
plan for all research aims. The DSMB members will be recruited by Dr. 
McCarthy and will include 4 local health services researchers, 
methodologists, and biostatisticians with related expertise. DSMB 
members will meet in person once a year. At these meetings the study 
protocol, procedures, and any issues of concern related to research 
integrity will be discussed. Additional meetings may be arranged for late-
breaking issues. (See Appendix for DSMB protocol) 
 
Adverse event monitoring.  This is a behavioral interventional study.  No 
individual administration of any therapeutic or prophylactic agent is 
required in this protocol and there are no procedures required by the 
protocol. However, because this study does involve interview questions 
related to the use of a medication, namely hydrocodone/acetaminophen, 
safety measures will be in place to detect any unsafe medication use by the 
patients at home. These adverse events may occur during the course of the 
study period from overdose (whether accidental of intentional), from 
abuse, from concomitant use with other products (sedatives or 
acetaminophen) and from withdrawal.  The research assistants conducting 
the phone interviews and completing review of the medication diaries will 
have a protocol in place to identify any concerning medication use 
patterns with an action plan outlined if events are detected.  (See 
attachment)  
 
It is the expectation of the investigator that because this study is a non-
invasive behavioral intervention that most, if not all, adverse events are 
unlikely or definitely not related to study participation or the intervention.  
These adverse events will be reported annually as part of regular data 
reporting. If any adverse events are serious or potentially study related, 
they would be reported as required in the time period required by the IRB. 
 
13.0 Withdrawal of Subjects 
13.1 In the case that subjects do not complete their follow-up phone 
interviews and do not respond to 3 calls attempting to re-schedule, 
they will be withdrawn from the study.  Additionally, if subjects 
exhibit inappropriate or violent behavior towards research personnel, 
they will be withdrawn from the study.   
13.2 If a subject decides to withdraw from the study, there will be 
instructions in the consent document (all patients provided signed 
copy) with information regarding contacting the study coordinator or 
PI to withdraw their consent.  

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13.3 If a subject withdraws from the study the data collected to that time 
point will be retained to assess for bias in the final sample.  They 
will not be contacted further for interviews.   
14.0 Risks to Subjects 
14.1 
Patients who receive care at the participating Emergency 
Department during this study will be subject to minimal risk 
through their participation. It is possible that subjects may feel 
shame and/or some emotional discomfort when taking the literacy 
and medication use assessments, and performing medication 
related tasks. We will also be making changes to how their 
medication instructions are written, and learning through follow-up 
interviews how they are implementing regimens. If we find that 
patients in any study arm are misusing medications, we will have a 
structure in place to address these concerns. This will be 
documented accordingly within internal study documents; however 
will not become a part of the medical record unless patients require 
acute care for their drug misuse or abuse. Consent forms will also 
acknowledge this disclosure. 
Patients in one study arm will receive automated text messages that some 
could view as intrusive; however they will have the ability to opt-out of 
the messages at any time.  With SMS texting via cell phones, only the 
phone number is entered into the automated texting system, and no other 
patient information. We will uphold patient confidentiality and respect any 
requests to turn off this function during the study. 
 
Subjects will be informed that participation in any part of this research 
study may result in a loss of privacy, since persons other than the 
investigators may view their study records if deemed necessary for 
oversight purposes. However, they will be identified by a unique 
identification number (“study number”), not by name, and any other 
identifying information (e.g. personal and/or contact information) will be 
kept separate from the other data; All information will be kept in secure, 
password protected files. Further, subjects will be told that unless required 
by law, only the study investigators, members of the project staff, and 
representatives of the Northwestern University or clinic Institutional 
Review Boards will have the authority to review any study records. In 
such case, they too will be required to maintain confidentiality.  
 
15.0 Potential Benefits to Subjects 
15.1 It is possible that subjects enrolled in the two intervention study arms 
may directly benefit in that they may have, as a result of this study, a 
better functional understanding of their opioid medication. The 
results of this study may provide important information regarding 
how strategies can be implemented via mobile technologies and the 

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EHR to support safe and appropriate opioid use. Findings of the 
ED’s ability to implement this intervention (and the cost associated) 
can help similar organizations improve patient education about the 
safe use of opioids in the future. 
16.0 Vulnerable Populations 
N/A 
17.0 Community-Based Participatory Research 
N/A 
18.0 Sharing of Results with Subjects 
18.1 No results will be shared with subjects.  Patients’ primary care 
providers may become aware that they are enrolled in a study 
through an EHR-notification, however this will not contain any 
study results—simply a note that the patient received a prescription 
for Norco and was counseled about it in the ED using the MedSheet. 
19.0 Setting 
19.1 Patients will be identified, consented and all procedures will be 
performed in either the Northwestern Emergency Department or 
over the phone with the participant. 
20.0 Resources Available 
20.1 The research team is comprised of has 5 PhD level researchers, 3 
Physician-researchers (all of whom hold research masters degrees), a 
research-pharmacist, and a group of research assistants and statistical 
analysts (who have 2-10 years of experience working on similar 
projects).  We have significant experience in recruiting patients from 
the emergency department, conducting studies related to medications 
(including the medication being studied), consenting patients to 
follow-up, and conducting multi-part follow-up with both in-person 
and telephone interviews. Additionally, the team has experience in 
managing data in accordance with the best-practices of the IRB to 
protect patients’ confidentiality.   
20.2 Initial estimates suggest that approximately 9,000 subjects will be 
potentially eligible for follow-up annually (representing 16% of 
discharged patients from the ED).   
The PI has 30% protected time for this study throughout the study 
duration and full support of the Department of Emergency Medicine.  
The Co-Is have ample time supported to assist in weekly meetings, 
data analysis, DSMB review, and other study operational tasks.  The 
three physician-researchers will be available at all hours for the RAs 
to contact if there are any concerns related to the safety protocol (see 
attached).   

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The study team will have 2 full-time RAs dedicated to enrolling and 
completing follow-up on the study with support from a team of other 
RAs to cover evening and weekend hours.   
 
Facilities: The patients will be approached and consented for 
participation while in the Emergency Department.  Follow-up calls 
by the RAs will occur at a time of convenience for the patient and 
the RAs have access to closed offices wherein to conduct the calls 
and record data.   
 
All persons assisting in the project will be adequately informed 
about the research protocol, the research procedures, and their duties 
and functions. We will ensure this by conducting weekly research 
meetings (already in-place) and by reviewing key concepts and 
conducting practice sessions for the consent process and interviews. 
21.0 Prior Approvals 
21.1 We have received funding from the Agency for Healthcare Research 
and Quality.   
22.0 Recruitment Methods 
22.1 Patients will be recruited during daytime and evening hours in the 
Northwestern Emergency Department after being identified by the 
procedures outlined above in section 3.1. 
22.2 Patients will be recruited in the Emergency Department at 
Northwestern. 
22.3 During the patient recruitment period, the RA will make frequent 
rounds through the ED and ask physicians to identify potentially 
eligible patients who will be discharged home on opioid pain 
relievers.  The RA also will carry a pager so that physicians can 
notify the RA if they have an eligible patient.  This method of patient 
identification has a well-established track record within our ED for 
maximizing enrollment while minimizing RA downtime. If the 
patient is interested in participating or learning more about the study, 
the RA will obtain verbal permission to ask the patient a brief series 
of questions to determine eligibility (see criteria below).  If the 
patient is eligible for the study, the RA will proceed with obtaining 
written informed consent. 
22.4 The RA will explain the study to the patient.  There are no 
advertisements.  
22.5 Patients will receive a $5 gift card at the time of enrollment, $10 gift 
card will be mailed after completion of the 2-4 day phone call and 

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they will then receive a $20 gift card upon completion of the 7-14 
day phone interview.   
23.0 Local Number of Subjects 
N/A 
 
24.0 Confidentiality 
24.1 Patients. After identifying eligible subjects, a member of the research staff 
will approach the patient and obtain written informed consent. Written 
consent  will consist of permission to be contacted for the future phone 
interviews, permission for possible receiving additional information about 
their medication, and permission for medical record review. The research 
assistant will review the consent with participants. He/she will provide 
participants with information on the study plan and their rights as research 
participants.  Participants’ consent will be documented by their signatures. 
Subjects will be provided with a copy of the consent. They may withdraw at 
any time during the study without penalty or loss of any healthcare benefit 
or service to which they are entitled. 
 
Patients who state that they do not want to receive further communication 
via SMS text-messaging will have the opportunity to cancel the text 
messages and not receive further outreach; they will be included in outcome 
assessments.  
 
Data from the Illinois Prescription Monitoring Database will be obtained via 
individual patient record query for the enrolled patients.  No protected 
health information will not be sent outside of Northwestern or to the State 
for a database query.   
 
Patients will be assigned a unique identification number; The research 
database will be password protected and accessible only to the research 
team. Information linking subjects with their unique identifier will be kept 
on a separate password-protected desktop computer in a locked office within 
the Department of Emergency Medicine. We believe that in using these 
methods we will be compliant with the “Standards for Privacy of Individual 
Identifiable Health Information” under the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) Privacy Rule. 
 
ED physicians, mid-level providers and follow-up providers 
All participants will be told that their participation is voluntary; they can 
stop at any time, and whether they participated or not will not be disclosed 
to their superiors. 
 
25.0 Provisions to Protect the Privacy Interests of Subjects 

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25.1 Only patients consenting to participate in study follow-up will be 
asked to interact with study personnel at future dates (follow-up 
calls). 
25.2 We will also attempt to reduce shame and performance anxiety as a 
result of interviews about compliance with screening and 
assessments through extensive training of the research assistants. If 
any misuse of the medication is discovered during the interviews, 
there will be a process in-place to connect them to further medical 
care if required (see appendix). 
25.3 Stephanie Gravenor will conduct the EDW data pull to access the 
data elements from the medical record.  The remainder of the RA 
staff will only access the chart if a patient had a return visit to the ED 
within 30 days of enrollment.  In that case, a chart review of that 
visit will be performed by the RA.  Two of the study co-Is will 
access the information in the Illinois Prescription Monitoring 
Database directly (Drs. McCarthy and Lank).   
26.0 Compensation for Research-Related Injury 
N/A 
 
27.0 Economic Burden to Subjects 
27.1 Patients in one study arm who receive text messages could have to 
pay at a maximum $0.70-$1.75 cents over the course of the project, 
assuming charges of 10-25 cents per text message received 
(depending on the cell phone company and receipt of 7 text 
messages).  We believe this expense is justified because the 
intervention should aide in preventing misuse of the medication and 
the re-imbursement for study participation was created with this cost 
built-in. 
28.0 Consent Process 
28.1 ED Providers.  We will ask providers to consent to be part of the 
study, which includes consenting to be randomized to one of the 
three study arms.  We are asking for provider consent to allow any 
providers who are uncomfortable with the study to opt out.  As noted 
in recruitment, providers will be informed of the nature and details 
of the study via email and a brief overview at a monthly business 
meeting.  Thus they will be asked to sign a written consent to be a 
part of the study, which includes their consent to allow their patients 
to be randomized to condition, as well as their willingness to allow 
us to contact them for feedback via survey.  
 
Patients. Subjects will be informed about the nature of the study by a CITI 
certified RA and asked to provide consent.  Specifically, they will be told 
that depending on the doctor they see, they may be given additional 

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educational materials and tools to help them better understand their 
medication.  They will also be told that additional providers, including their 
primary physician and pharmacist, will be informed about their prescription 
and may provide them with additional education.  Additionally they will be 
notified that only those contents of their medical record that are necessary to 
evaluate the effectiveness of the intervention will be released to the research 
team at Northwestern.  Finally, they will be informed about the follow-up 
components for the study, consisting of 3 phone calls (at 2-4 days, 7-14 days 
and 1 month).  The patients will complete a written informed consent 
document and will be given a copy of the consent document.  See consent 
document. They will be informed that they may withdraw from the study at 
any time and given contact information for the PI and study coordinator.   
 
Non-consenting patients.  Subjects in this study are consenting to follow-up; 
however, as mentioned above, because of the nature of implementing the 
EHR-based intervention at the system level, it is possible that patients who 
are seen after hours (outside of RA availability) will receive the EHR 
components of the intervention without being approached for consent or 
enrolled in the study. Note, that any patient not enrolled in the study and not 
providing written consent will not be called to ask to participate in follow-
up visits or phone calls.  We believe that were a patient to see an enrolled 
physician and thus potentially receive the EHR-components of the 
intervention, that the patient would not be exposed to any additional risk as 
the physician-facing interventions (e.g. EHR alert) are educational and do 
not change the prescribing practices of the physician. 
 
Changes to the care delivery of the ED as a result of the intervention should 
be perceived as an exploratory quality improvement activity, and therefore 
reasonable that some patients may be exposed to new, available services as 
part of the study.  We will only examine data on outcomes that can be 
collected in aggregate and not from patient interviews (specifically, we will 
examine, via the EDW, return visits to the emergency department).  There is 
no collection of PHI, rather a comparison of already available ED data 
between study arms.  
 
Follow-up providers. The PCPs and pharmacists identified by chart review 
and pill bottle review during patient follow up will be asked to consent to 
complete a survey gauging their responses to the intervention which their 
patients received. These providers will be asked to document their consent 
by clicking an “I agree” box (on the electronic version of the survey) or by 
returning the survey (paper version of the survey). (See survey attachments 
with consent statements) 
  
29.0 Process to Document Consent in Writing 
29.1 
ED physicians being randomized to study arms 

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Written informed consent will be obtained from ED physicians 
(both attending and resident physicians). All participants will be 
told that their participation is voluntary; they can stop at any time, 
and whether they participated or not will not be disclosed to their 
superiors.  Their participation in the EHR-based intervention will 
be kept confidential and made anonymous in reports.  If the 
physician does not want to participate or decides to stop before 
completing the 18-month patient enrollment period, this will not be 
disclosed to any superiors.   
 
Patients 
The intervention is implemented at the physician level.  Therefore patients 
will be recruited for follow-up purposes only, rather than for consent to 
the EHR portion of the intervention.  For patients consenting to follow-up, 
the consent will be documented in writing. 
 
For those patients receiving the intervention on the basis of having a 
consented provider, but not approached or consented for follow-up, we 
request a waiver of informed consent because: 1) this is a low-risk study, 
in particular, it is research designed to evaluate an educational strategy, 2) 
it would not be feasible to conduct the study as intended if obtaining 
individual informed consent were necessary (in this case because patients 
do not become eligible until a prescription is written for an opioid—but a 
key component of the intervention is the text on the prescription), 3) 
informed consent from each participant would threaten the scientific 
validity of the study (in this case it would be impossible to evaluate real-
world dissemination and implementation of the intervention if the EHR 
automations needed to be turned on and off at the individual patient level) 
and 4) for the patients receiving the intervention, but not completing 
follow-up, no patient data are collected that would not be routinely 
collected in usual care without consent. Specifically, the only data that 
will be accessed on this sample of patients is demographic data from the 
electronic medical record and data on return visits to the emergency 
department and re-admission to the hospital for problems related to pain 
and/or opioid use.   
 
As detailed above, this specific strategy of “turning on” an EHR 
intervention with physician or clinic level randomization has been 
previously approved by the IRB at Northwestern University for three other 
AHRQ funded grants (P01HS021141-01, 1U19HS021093-01 & 
1R18HS017220-01).   
 
Follow-up providers. Follow-up providers will document their consent to 
completing the survey as detailed above: by clicking an “I agree” button 
(electronic version of survey) or returning the survey (paper version of the 
survey). 

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30.0 Drugs or Devices 
N/A 
 
ATTACHMENTS:  
a. Interview battery 
b. Patient Consent 
c. ED Provider Consent 
d. ED Provider draft survey  
e. Follow-up provider (PCP & pharmacist) draft survey 
f. Safety Protocol 
g. MedSheet (health literacy format) 
h. Medication Diary 
i. Sample Text Messages 
j. DSMB Protocol 
k. Appointment Reminder Card 
l. Mini Mental Status Exam supplements