The Impact of Pre-operative Opioid Education and Opioid Disposal Following Shoulder Arthroplasty
Phase: NA
Conditions: Opioid Use
Sponsor: Brendan M. Patterson

 
Protocol Title: The Impact of Pre-operative Opioid Education and Opioid 
Disposal Following Shoulder Arthroplasty 
 
Protocol Version: 1.0 
 
Protocol Date: 7/23/22 
 
NCT05525975 
 
IRB# 202202119 
 
Principal Investigator: Brendan Patterson 
Research Team: Brady Wilkinson, Maria Bozoghlian, Natalie Glass, Katherine Hadlandsmyth, James 
Nepola 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
I. 
Abstract 
 
Opioid medications are widely used after many orthopedic procedures and are routinely 
prescribed after shoulder replacement surgery. Despite the high prevalence of opioid abuse 
and misuse, there is no standardized mechanism for patients to dispose of unused opioid 
medications safely and securely and the average number of opioid pills required after shoulder 
replacement surgery is still unknown. In a prior pilot study conducted by our group (IRB# 
202012142), we analyzed opioid consumption patterns of patients undergoing shoulder 
arthroplasty as well as their adherence to a safe and secure disposal mechanism for excess 
opioid pills. We achieved a 94% retention rate and preliminary results showed that most of the 
subjects were 60 years of age and older.  
 
The objective of the current proposal is to: (1) develop pre-operative education materials 
related to post-operative opioid use following shoulder arthroplasty; (2) pilot the impact of 
this educational intervention; (3) examine the effect of providing disposal mechanisms for 
unused opioid pain medications following shoulder arthroplasty. Our proposal is to conduct a 
single blinded randomized controlled trial of patients undergoing total shoulder replacement, 
both anatomic total shoulder arthroplasty (TSA) and reverse shoulder arthroplasty (RSA) at 
UIHC. This randomized controlled trial will compare: (1) education plus opioid disposal to 
the standard of care (SC). We hypothesize that pre-operative opioid education modules 
combined with a structured opioid disposal program will decrease opioid consumption 
following shoulder arthroplasty. 
 
 
II. 
Background and Significance/Preliminary Studies 
 
Opioid medications are involved in thousands of deaths in the United States annually (1), and 
the opioid crisis remains a major public health concern in the United States. Since 1999 
overdose deaths involving opioids, including prescription opioids, heroin, and synthetic 
opioids, have increased significantly (2). Despite the opioid epidemic being declared a public 
health emergency by the Department of Health and Human Services (HHS) in 2017, there are 
still unmet needs and therefore strategies that provide durable solutions to the opioid crisis are 
critical.  
 
According to data published by the Department of Health and Human Services, increased 
prescription of opioid medications led to widespread misuse of both prescription and non-
prescription opioids (15). The number of overdoses and deaths from prescription opioids has 
increased since 1990 and correlates with a growth in the number of opioid prescriptions (3).  
 
Opioid medications are commonly prescribed for orthopedic conditions. In addition to the risk 
of abuse, opioids carry a number of other health risks such as respiratory depression, 
confusion (5), and an increase in the risk of falls and fractures among seniors (16). The 
concern for opioid abuse and misuse is rising among the elderly population. An article 
published in the CDC’s Morbidity and Mortality weekly report showed that during 2017-2018 
even though opioid-related death rates decreased for persons aged 15-64, these rates actually 
increased among persons aged ≥ 65 years old (17). Furthermore, the HHS Office of Inspector 

General released a report based on an analysis of prescription drug event records for Medicare 
Part D which revealed that in 2016 one out of every three beneficiaries received at least one 
opioid prescription (7).   
 
The rate of shoulder arthroplasty has increased dramatically over the past 10 years (6, 12). 
Most patients undergoing shoulder arthroplasty are over the age of 60. In our pilot study we 
found that 81% of our subject population were >60 years of age. We believe that it is crucial 
to address opioid consumption patterns among this elderly population.  
 
Previous studies have tested interventions to promote disposal of excess opioids in an effort to 
address the opioid crisis (4, 8, 11). In addition, other authors have focused on opioid 
consumption after shoulder surgery (10, 13, 14). Still, there is no standardized mechanism for 
opioid disposal or postoperative opioid prescribing protocol for shoulder replacement surgery. 
We propose a new and multi-faceted approach that combines proper patient education and a 
secure disposal technique which proved to be successfully accepted in our pilot study. This 
approach will help in developing a more accurate and standardized postoperative pain 
management plan for patients undergoing shoulder arthroplasty. These same techniques can 
eventually be validated for other orthopedic surgical procedures. 
 
 
1. CDC. Drug/Overdose Deaths [Available from: 
https://www.cdc.gov/drugoverdose/deaths/index.html.  
2. Data Overview | CDC's Response to the Opioid Overdose Epidemic 2021 [Available from: 
https://www.cdc.gov/opioids/data/index.html.  
3. CDC. Drug Overdose/Deaths/Opioids 2021 [Available from: 
https://www.cdc.gov/drugoverdose/deaths/prescription/overview.html.  
4. Bettlach CLR, Hasak JM, Santosa KB, Larson EL, Tung TH, Fox IK, et al. A Simple 
Brochure Improves Disposal of Unused Opioids: An Observational Cross-Sectional Study. 
Hand (N Y). 
2020;10.1177/1558944720959898:1558944720959898.10.1177/1558944720959898.  
5. Chau D, Walker V, Pai L, Cho L. Opiates and Elderly: use and side effects. 2008 
[Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2546472/.  
6. Dillon MT, Chan PH, Inacio MCS, Singh A, Yian EH, Navarro RA. Yearly Trends in 
Elective Shoulder Arthroplasty, 2005-2013. Arthritis Care Res (Hoboken). 2017;69(10):1574-
81.10.1002/acr.23167.  
7. General. USDoHaHSOoI. Opioids in Medicare Part D: Concerns about Extreme Use and 
Questionable Prescribing 2017 [Available from: https://oig.hhs.gov/oei/reports/oei-02-17-
00250.pdf.  
8. Hasak JM, Roth Bettlach CL, Santosa KB, Larson EL, Stroud J, Mackinnon SE. 
Empowering Post-Surgical Patients to Improve Opioid Disposal: A Before and After Quality 
Improvement Study. J Am Coll Surg. 2018;226(3):235-40 
e3.10.1016/j.jamcollsurg.2017.11.023.  
9. Kumar K, Gulotta LV, Dines JS, Allen AA, Cheng J, Fields KG, et al. Unused Opioid Pills 
After Outpatient Shoulder Surgeries Given Current Perioperative Prescribing Habits. Am J 
Sports Med. 2017;45(3):636-41.10.1177/0363546517693665.  
10. Martusiewicz A, Khan AZ, Chamberlain AM, Keener JD, Aleem AW. Outpatient narcotic 
consumption following total shoulder arthroplasty. JSES Int. 2020;4(1):100-

4.10.1016/j.jses.2019.11.005.  
11. Nahhas CR, Hannon CP, Yang J, Gerlinger TL, Nam D, Della Valle CJ. Education 
Increases Disposal of Unused Opioids After Total Joint Arthroplasty: A Cluster-Randomized 
Controlled Trial. The Journal of bone and joint surgery American volume. 2020;102(11):953-
60.10.2106/JBJS.19.01166.  
12. Palsis JA, Simpson KN, Matthews JH, Traven S, Eichinger JK, Friedman RJ. Current 
Trends in the Use of Shoulder Arthroplasty in the United States. Orthopedics. 
2018;41(3):e416-e23.10.3928/01477447-20180409-05.  
13. Patel MS, Updegrove GF, Singh AM, Jamgochian GC, LoBiondo D, Abboud JA, et al. 
Characterizing opioid consumption in the 30-day post-operative period following shoulder 
surgery: are we over prescribing? Phys Sportsmed. 2020;10.1080/00913847.2020.1789439:1-
7.10.1080/00913847.2020.1789439.  
14. Sabesan VJ, Stankard M, Grauer J, Echeverry N, Chatha K. Predictors and prescribing 
patterns of opioid medications surrounding reverse shoulder arthroplasty. JSES Int. 
2020;4(4):969-74.10.1016/j.jseint.2020.08.014.  
15. Sabesan VJ, Chatha K, Koen S, Dawoud M, Gilot G. Innovative patient education and 
pain management protocols to achieve opioid-free shoulder arthroplasty. JSES Int. 
2020;4(2):362-5.10.1016/j.jseint.2020.01.005.  
16. Saunders K, Dunn K, Merril J, Sullivan M. Relationship of Opioid Use and Dosage Levels 
to Fractures in Older Chronic Pain Patients. 2010 [Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2842546/.  
17. Wilson NA, Kariisa M, Seth P, Smith HI, Davis NL. Drug and Opioid Involved Overdose 
Deaths - United States 2017-2018. MMWR Morb Mortal Wkly Rep 2020;69:290-297. 
[Available from: 
https://www.cdc.gov/mmwr/volumes/69/wr/mm6911a4.htm?s_cid=mm6911a4_w#suggestedc
itation  
 
 
 
III. 
Study Aims 
 
AIM 1: Develop pre-operative opioid educational modules for patients undergoing shoulder 
arthroplasty.  
 
AIM 2: Evaluate the impact of educational materials on opioid consumption following 
shoulder arthroplasty when compared to standard of care. Hypothesis: Pre-operative 
educational modules, developed by an interdisciplinary team, will prove to be successful in 
decreasing the amount opioid medication taken after shoulder arthroplasty.  
 
AIM 3: Evaluate a structured and streamlined disposal protocol and its effect on opioid 
disposal rates. Hypothesis: By promoting and implementing a structured and secured opioid 
disposal mechanism, patients undergoing shoulder arthroplasty will more frequently dispose 
of excess opioid medications. 
 
 
IV. 
Administrative Organization 
 

Participating units will include the University of Iowa Hospitals and Clinics located at 200 
Hawkins Dr., Iowa City, IA 52242 and UIHC  IRL shoulder surgery clinic located at 920 
East 2nd Avenue, Coralville, IA 52241. 
 
V. 
Study Design 
 
Experimental design: single-blinded randomized controlled trial of patients undergoing total 
shoulder arthroplasty.  
The study will include male and female patients ≥ 18-years-old who have been indicated for 
total shoulder arthroplasty.  The total number of subjects will be 136. Sample size 
determination and power analyses: A sample size estimate was performed based on previous 
literature and data from our pilot study that showed nearly 55% of subjects returned 10 or 
more out of 40 tablets. Assuming ~55% will return 10 or more out of 40 tablets in the control 
group, a total of 68 subjects per group (n=136 total, with calculated 10% drop out) would 
provide 80% power, with an alpha level of 0.05 (2-sided test), to detect a 25% difference in 
the proportion who return 10 or more tabs in the brochure/video intervention group (35%).  
 
a. Study outcomes/endpoints:  
 
AIM 1: Develop pre-operative opioid educational modules for patients undergoing 
shoulder arthroplasty.  
 
AIM 2: Evaluate the impact of educational materials on opioid consumption 
following shoulder arthroplasty when compared to standard of care.  
 
AIM 3: Evaluate a structured and streamlined disposal protocol and its effect on 
opioid disposal rates.  
 
 
 
 
 
 
 
 
 
 
 
 
VI. 
Study Procedures  
 
Inclusion criteria: patients who are 18 years of age and older who are indicated for primary 
total shoulder arthroplasty (both anatomic and reverse) at the Shoulder Surgery clinic at 
UIHC. All patients will be English speaking and have the ability to provide informed 
consent for the study.  Patients will be excluded if they are <18 years old, non-English 
speaking, pregnant, unable to consent for themselves, revision shoulder arthroplasty, 
arthroplasty for proximal humerus fracture, patients with a history of chronic opioid 

consumption or patients who have contraindications for opioid consumption. 
 
 
The medical records will only be accessed by the investigators for the purpose of collecting 
data pertaining solely to the study at hand and only data necessary to answer the research 
questions will be collected from the subjects' medical records. The study will involve the 
same data we would have access to in the course of our professional relationship with the 
patient. This data will only be available to the primary investigator and to the research 
coordinator. Without access to protected health information we would be unable to assess 
inclusion/exclusion criteria and the variables in study. Only members of the research team 
will have access to the protected health information. All identifying paper documents will be 
kept in locked cabinets at the research coordinator's office. All electronic information will be 
kept in password protected files. Data will be collected using REDCap. Identifying 
information will be destroyed after all analysis has been completed and it is no longer needed. 
 
Potential subjects will be approached in person during their usual visit to the Shoulder 
Surgery clinic. They will be provided a brochure with information about the research study. 
Discussion regarding the study and consent will be obtained in person in clinic.  
 
 
 
During their preoperative work-up visit, at IRL and Main Hospital, patients will be invited to 
participate in the research study. The research coordinator will discuss the study with potential 
subjects in a private office or exam room. If the patient shows interest in participating, the 
research coordinator and the patient will go through the process of consent of participants. 
Potential subjects will be explained that the purpose of the study is to assess opioid 
consumption and disposal after shoulder replacement surgery, and that after their surgery, 
they will have to answer daily questionnaires about pain management and opioid 
consumption, that will be delivered through text message only during the first 2 weeks after 
surgery.  Adequate time will be allotted to the patients in clinic to consider participating in the 
study. The study will require a waiver of an element of consent, in relation to the use of 
deception and blinding of subjects. Without the waiver of the element of consent our study 
results may be biased as subjects in the standard of care group may potentially change their 
behavior if they were aware of the information being concealed. 
 
Patients will be screened according to inclusion and exclusion criteria at their indication 
visit for total shoulder arthroplasty. Participants will receive daily text messages with a 
link to a REDCap survey during the 2 weeks following the surgery. For participants who 
did not answer the daily surveys, or for the ones who are still taking opioid medications 
after 2 weeks, a survey will be available at clinic. Subjects will be able to answer the 
survey at their scheduled postoperative visits (standard of care). Participants will not 
have to attend any visits for research purposes only.  
 
 
Patients will be randomized utilizing redcap. The randomization scheme will be performed 
in a 1:1 ratio.  
 
 

 
After signing the informed consent, participants will be randomized into one of the 2 study 
arms (Arm 1: control/SOC, Arm 2: education and disposal).   
 
Participants in Arm 1 will be the control group. These patients will undergo evaluation and 
treatment for total shoulder arthroplasty according to the current standard of care at the 
institution. This does not currently include any preoperative educational material regarding 
opioid consumption and/or disposal.  
 
Participants in Arm 2 will receive at their preoperative work-up visit a brochure and will 
watch an educational video. Both educational materials (brochure and video) will address 
information about opioid medication, pain management techniques and how to properly 
dispose of any excess opioid medication after the surgery. In addition, participants in Arm 2 
will receive an envelope in which they will be able to dispose their unused opioid pills. These 
envelopes will be the same ones used in our pilot study (IRB# 202012142). The disposal 
method consists of secured, labeled envelopes to dispose of the excess of Opioid medication. 
These envelopes will be provided by “Sharps Compliance, Inc.”, a company that manages 
pharmaceutical waste disposal programs for healthcare facilities. Through their “TakeAway 
Medication Recovery System Envelope (USPS)” they allow the collection and disposal of 
controlled substances (Schedules II-IV) and non-controlled medications. Subjects will be 
explained how to use the envelope and that since it is labeled they will not have to cover any 
charges.  
 
 
Potential subjects will be explained that the purpose of the study is to assess opioid 
consumption and disposal after shoulder replacement surgery, and that after their 
surgery, they will have to answer daily questionnaires about pain management and 
opioid consumption, that will be delivered through text message only during the first 2 
weeks after surgery. The questionnaires will be built using REDCap platform. Text 
messages will be sent using a platform built by the Mobile Technology Lab at UIHC.  
 
Participants who did not answer the daily survey, or who continue taking opioid 
medications after 2 weeks following surgery, will have the opportunity to answer the 
survey at their postoperative visit at the Shoulder Clinic, using the clinic's tablets, either 
at their 2-week or 6-week postoperative visit.  
 
Subjects lost to follow up will not be recontacted.  
Subjects will not receive monetary compensation.  
 
VII. 
Privacy and Confidentiality Protections 
 
Only members of the research team will have access to the protected health information. All 
identifying paper documents will be kept in locked cabinets at the research coordinator's office. 
All electronic information will be kept in password protected files. Data will be collected using 
REDCap.  Identifying information will be destroyed after all analysis has been completed and it 
is no longer needed. 
 

 
VIII. Risks and Benefits 
 
The only foreseeable risks of this study are loss of confidentiality, boredom or fatigue from 
filling daily surveys. 
There are no direct benefits to subjects. 
After completion of the proposed RCT, we expect to see a decrease in opioid consumption 
patterns after shoulder arthroplasty, as well as an increase in disposal of unused opioid pills. 
One of our expected outcomes is that our educational interventions will have a positive 
influence on opioid consumption after surgery. In addition, we expect that this group will be 
encouraged to use drug-free pain management techniques and find the educational materials 
satisfactory. Our second expected outcome is that the proposed disposal method will have 
high satisfaction rate for patients to dispose of unused opioid pills. The implementation of a 
secure and efficient disposal mechanism will encourage patients to remove potentially 
dangerous medications from their homes and this disposal program could become a standard 
of care practice for shoulder arthroplasty procedures. To date, there is no standardized 
educational intervention that is routinely administered preoperatively to all patients to 
approach postoperative opioid consumption, disposal, and pain management techniques. This 
proposal aims to gather the necessary information to build a larger study and eventually 
include other surgical procedures. 
 
 
IX. 
Data Analysis Plan 
 
The primary outcome measure is opioid consumption with and without pre-operative 
opioid education. By comparing the two arms we will determine the difference in opioid 
consumption between groups of patients who receive education and those who do not.  
We will also analyze opioid disposal in the two groups and compare disposal rates.  
 
Descriptive statistics (means, medians, percentages, standard deviations, and inter-
quartile ranges) for all variables will be computed overall and for each intervention 
group . The distributions of continuous variables will be evaluated for normality. If 
distributions are non-normal, continuous variables will be described as median 
(interquartile range) and compared across intervention groups using Wilcoxon-rank sum 
tests. Otherwise, continuous variables will be described as mean±standard deviation and 
compared between intervention groups using independent t-tests. Categorical variables 
will be reported as frequencies(percentages) and compared between groups using the 
chi-square or exact test, as appropriate. To account for multiple comparisons between 
the three groups, p-values will be adjusted using the stepdown Bonferroni approach. We 
will utilize the chi-square test to determine whether there is a significantly greater 
proportion who (Hypothesis 1) return more than 10 tablets in Arm 2 versus Arm 1; and 
(Hypothesis 2) properly dispose of unused tablets in Arm 2 versus control Arm 1. If 
necessary, we will adjust for potential covariates using logistic regression in place of the 
chi-square test with the control group serving as the referent group. 
 
A sample size estimate was performed based on previous literature and data from our 
pilot study that showed nearly 55% of subjects returned 10 or more out of 40 tablets. 

Assuming ~55% will return 10 or more out of 40 tablets in the control group, a total of 
68 subjects per group (n=136 total, with calculated 10% drop out) would provide 80% 
power, with an alpha level of 0.05 (2-sided test), to detect a 25% difference in the 
proportion who return 10 or more tabs in the brochure/video intervention group (35%).  
 
 
X. 
Literature Citations 
 
 
1. CDC. Drug/Overdose Deaths [Available from: 
https://www.cdc.gov/drugoverdose/deaths/index.html.  
2. Data Overview | CDC's Response to the Opioid Overdose Epidemic 2021 [Available from: 
https://www.cdc.gov/opioids/data/index.html.  
3. CDC. Drug Overdose/Deaths/Opioids 2021 [Available from: 
https://www.cdc.gov/drugoverdose/deaths/prescription/overview.html.  
4. Bettlach CLR, Hasak JM, Santosa KB, Larson EL, Tung TH, Fox IK, et al. A Simple Brochure 
Improves Disposal of Unused Opioids: An Observational Cross-Sectional Study. Hand (N Y). 
2020;10.1177/1558944720959898:1558944720959898.10.1177/1558944720959898.  
5. Chau D, Walker V, Pai L, Cho L. Opiates and Elderly: use and side effects. 2008 [Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2546472/.  
6. Dillon MT, Chan PH, Inacio MCS, Singh A, Yian EH, Navarro RA. Yearly Trends in Elective 
Shoulder Arthroplasty, 2005-2013. Arthritis Care Res (Hoboken). 2017;69(10):1574-
81.10.1002/acr.23167.  
7. General. USDoHaHSOoI. Opioids in Medicare Part D: Concerns about Extreme Use and 
Questionable Prescribing 2017 [Available from: https://oig.hhs.gov/oei/reports/oei-02-17-00250.pdf.  
8. Hasak JM, Roth Bettlach CL, Santosa KB, Larson EL, Stroud J, Mackinnon SE. Empowering Post-
Surgical Patients to Improve Opioid Disposal: A Before and After Quality Improvement Study. J Am 
Coll Surg. 2018;226(3):235-40 e3.10.1016/j.jamcollsurg.2017.11.023.  
9. Kumar K, Gulotta LV, Dines JS, Allen AA, Cheng J, Fields KG, et al. Unused Opioid Pills After 
Outpatient Shoulder Surgeries Given Current Perioperative Prescribing Habits. Am J Sports Med. 
2017;45(3):636-41.10.1177/0363546517693665.  
10. Martusiewicz A, Khan AZ, Chamberlain AM, Keener JD, Aleem AW. Outpatient narcotic 
consumption following total shoulder arthroplasty. JSES Int. 2020;4(1):100-
4.10.1016/j.jses.2019.11.005.  
11. Nahhas CR, Hannon CP, Yang J, Gerlinger TL, Nam D, Della Valle CJ. Education Increases 
Disposal of Unused Opioids After Total Joint Arthroplasty: A Cluster-Randomized Controlled Trial. 
The Journal of bone and joint surgery American volume. 2020;102(11):953-
60.10.2106/JBJS.19.01166.  
12. Palsis JA, Simpson KN, Matthews JH, Traven S, Eichinger JK, Friedman RJ. Current Trends in 
the Use of Shoulder Arthroplasty in the United States. Orthopedics. 2018;41(3):e416-
e23.10.3928/01477447-20180409-05.  
13. Patel MS, Updegrove GF, Singh AM, Jamgochian GC, LoBiondo D, Abboud JA, et al. 
Characterizing opioid consumption in the 30-day post-operative period following shoulder surgery: 
are we over prescribing? Phys Sportsmed. 2020;10.1080/00913847.2020.1789439:1-
7.10.1080/00913847.2020.1789439.  
14. Sabesan VJ, Stankard M, Grauer J, Echeverry N, Chatha K. Predictors and prescribing patterns of 
opioid medications surrounding reverse shoulder arthroplasty. JSES Int. 2020;4(4):969-
74.10.1016/j.jseint.2020.08.014.  

15. Sabesan VJ, Chatha K, Koen S, Dawoud M, Gilot G. Innovative patient education and pain 
management protocols to achieve opioid-free shoulder arthroplasty. JSES Int. 2020;4(2):362-
5.10.1016/j.jseint.2020.01.005.  
16. Saunders K, Dunn K, Merril J, Sullivan M. Relationship of Opioid Use and Dosage Levels to 
Fractures in Older Chronic Pain Patients. 2010 [Available from: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2842546/.  
17. Wilson NA, Kariisa M, Seth P, Smith HI, Davis NL. Drug and Opioid Involved Overdose Deaths 
- United States 2017-2018. MMWR Morb Mortal Wkly Rep 2020;69:290-297. [Available from: 
https://www.cdc.gov/mmwr/volumes/69/wr/mm6911a4.htm?s_cid=mm6911a4_w#suggestedcitation  
 
 
 
 

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UI IRB Protocol Outline Template (Version 2, 11/9/2021) 
 

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UI IRB Protocol Outline Template (Version 2, 11/9/2021)