Patient Outcomes Collection: How Can we do Better? A Randomized Trial to Determine Factors Which May Affect Patient Compliance.
Phase: NA
Conditions: Shoulder Pain
Sponsor: Rush University Medical Center

NCT03653455 
Patient Outcomes Collection: How can we do better? A Randomized Trial to Determine 
Factors Which May Affect Patient Compliance. 
 09/27/2022 

Title: Patient Outcomes Collection: How can we do better? A Randomized Trial to Determine Factors 
Which May Affect Patient Compliance. 
PI: Nikhil Verma, MD
Version Date:  9/21/2022
Page 1 of 11
Purpose: 
The purpose of this study is to identify factors that will increase completion rates of post-operative patient 
reported outcome surveys (PROs).  Specifically, we will compare completion rates of PRO surveys from three 
groups of participants.  Group one (Arm 1) will receive no pre-operative or post-operative PRO instruction, 
Group 2 (Arm 2) will receive PRO instruction pre-operatively and 6 month post-operatively and Group 3 (Arm 
3) will receive low-value monetary incentives for completion of their 6 month and 1 year PRO surveys.  This 
group will receive no pre-operative or post-operative PRO instruction.
Background and Significance: 
Patient reported outcome surveys (PROs) are widely used by clinical providers as important tools to help inform 
their clinical and research practice, and to improve quality of care for patients.  In addition, PROs are 
increasingly cited as a tool in measuring surgical performance and the value of health care services being 
delivered. The Center for Medicare and Medicaid Services (CMS) is intending to adopt an expanding array of 
PROs to help determine physician reimbursement rates. In the field of orthopedic surgery, PROs are routinely 
used to help surgeons deliver quality care to patients and to demonstrate the value of such care to payors and 
other stakeholders8, 9. 
For PROs to adequately and reliably assess the success of a medical intervention, it is imperative that the data 
collected accurately represent the entire patient cohort and how they respond to a given treatment.  The failure 
to do so increases the risk of collecting data that are biased or skewed, and may misrepresent the outcomes of 
the entire cohort.  For example, patients who do not complete their surveys may be younger with better clinical 
outcomes. Factors such as age, language, socioeconomic status and technological literacy can adversely affect 
patient response rates.  Alternatively, patients who are undergoing prolonged care due to poor outcome or 
complication may be more likely to complete post-operative outcomes.  These forms of selection bias can 
significantly impact the validity of the scores. 
ORA: 18041709-IRB01   Date IRB Approved: 12/8/2021   Amendment Date: 9/27/2022

Title: Patient Outcomes Collection: How can we do better? A Randomized Trial to Determine Factors 
Which May Affect Patient Compliance. 
PI: Nikhil Verma, MD
Version Date:  9/21/2022
Page 2 of 11
In the absence of high response rates, such results might falsely lead to the conclusion that responders must 
therefore be older and sicker, or have experienced a complication. To mitigate the effects of such bias, higher 
response rates must be achieved.10  The rate at which patients complete and return surveys (response or 
compliance rate) is widely used to evaluate the quality of survey data11, both pre-and post-operatively. This, in 
turn, decreases confidence in validity and interpretation of results11.  
The utility and quality of data captured by PROs is largely dependent on patients’ response rates, both pre- and 
post-operatively.  For pre-operative surveys, higher response rates may be achieved if patients are reminded to 
complete their surveys at an office visit or prior to surgery.  However, patient non-compliance presents a major 
challenge post-operatively, undermining PRO data integrity.1-3 
To help with PRO response rate compliance, electronic and web-based platforms have been used successfully, 
and effectively, to administer and collect PRO data.2   Automating PRO administration saved time for patients 
and providers in the office, post-operative compliance rates remained low in this study.  According to another 
study, electronic (as opposed to paper) administration of PROs only modestly improved follow-up compliance 
rates14. In an attempt to improve response rates, efforts have been made to reduce patient burden (by reducing 
the number of questions asked, for example), to regularly remind patients to complete their forms (either by 
email or telephone), or even offer patients monetary or non-monetary incentives.2-5 A comprehensive review of 
literature conducted by Edwards et al. showed that patients were more likely to complete their surveys if they 
were offered monetary incentives4.
Study Hypothesis:
We hypothesize that participant PRO instruction and low-value monetary incentives will result in an increase 
PRO completion rates.  
Study Design and Subject Selection: 
This is a prospective, comparative cohort study comparing how active participant engagement through PRO 
instruction and education or monetary incentives may improve PRO compliance.  These PRO compliance rates 
ORA: 18041709-IRB01   Date IRB Approved: 12/8/2021   Amendment Date: 9/27/2022

Title: Patient Outcomes Collection: How can we do better? A Randomized Trial to Determine Factors 
Which May Affect Patient Compliance. 
PI: Nikhil Verma, MD
Version Date:  9/21/2022
Page 3 of 11
will be compared with participants that receive no PRO instruction and education or monetary incentives to 
complete PRO surveys.
The participants will be recruited from 5 practices at Midwest Orthopedics at Rush, and enrollment is expected 
to be completed 1 year after the initiation of the study. 
Inclusion Criteria:
Patients scheduled to undergo shoulder arthroscopy for rotator cuff condition (sub-acromial decompression, 
distal clavicle resection, biceps tenodesis, partial or full thickness rotator cuff tear repair or debridement) will be 
eligible for enrollment in the appropriate cohort. There will be no restrictions to this enrollment apart from that 
presented in the exclusions below.  
Exclusion Criteria: 
1. Minors or those over the age of 80
2. Subjects lacking English proficiency to complete the PROs of interest.
3. Past or current medical history that would preclude patients from undergoing surgery. 
Consent process:
Potential participants will be identified by medical chart review and eligibility requirements.  Study staff will 
call potential participants to inform them about the study and invite them to participate.  The potential 
participant must be made fully aware of the protocol requirements and s/he must acknowledge his/her 
understanding and agreement prior to signing the informed consent. 
Informed consent will be obtained via eConsent through potential subject email via Rush approved, secured 
electronic platform, Patient IQ.  Once the participant has consented, a study staff member will call the 
participant to schedule their study visit.
ORA: 18041709-IRB01   Date IRB Approved: 12/8/2021   Amendment Date: 9/27/2022

Title: Patient Outcomes Collection: How can we do better? A Randomized Trial to Determine Factors 
Which May Affect Patient Compliance. 
PI: Nikhil Verma, MD
Version Date:  9/21/2022
Page 4 of 11
During the consent process, patients will be notified that we are evaluating outcomes collection.  However, an 
in depth discussion of randomization and collection of compliance data will be avoided in an attempt to avoid 
bias in results. 
Using an internet-based random number generator, consented participants will be block-randomized to avoid 
substantial imbalances in the number of patients assigned to each group. There will be 33 patients per study 
arm, with a final allocation ratio of 1:1:1.
Participants will be randomized to one of 3 groups: Group one (Arm 1) will receive no pre-operative or post-
operative PRO instruction or education, Group 2 (Arm 2) will receive PRO instruction/education pre-
operatively and 6 month post-operatively and Group 3 (Arm 3) will receive low-value monetary incentives in 
the form of 3-10$ Amazon gift cards.  One gift card will be given to participants in Group 3 (Arm 3) after 
verified completion of their preoperative, 6-month and 12-month PRO surveys, respectively. The gift cards will 
be sent to the participant’s home address after the survey is verified completed in Patient IQ.  Group 3 (Arm3) 
participants will receive no pre-operative or post-operative PRO instruction/education to complete their PRO 
surveys. 
Study Endpoints:
Primary Endpoint:
The primary endpoint will measure whether patient engagement affects PRO compliance.  Specifically, 
compliance will be measured for the PROs listed below at preoperatively, as well as 6 months and 1-year post 
shoulder arthroplasty:
o
American Shoulder and Elbow Surgeons (ASES) Shoulder Assessment Form
o
Single Assessment Numeric Evaluation Score (SANE)
o
Veterans Rand (VR)/Short Form (SF)-12
ORA: 18041709-IRB01   Date IRB Approved: 12/8/2021   Amendment Date: 9/27/2022

Title: Patient Outcomes Collection: How can we do better? A Randomized Trial to Determine Factors 
Which May Affect Patient Compliance. 
PI: Nikhil Verma, MD
Version Date:  9/21/2022
Page 5 of 11
Secondary Endpoint:
o
Assess what effects age, English proficiency, and technological literacy have on PRO compliance.  
Patients will be asked to complete a short custom survey (Appendix 2), administered via Patient IQ, to 
help measure how the above-mentioned factors might affect compliance rate.
o
Assess what effect the length of survey and time will have on compliance rate.
Study Interventions 
Group 1 (Arm 1)
33 patients undergoing arthroscopic shoulder surgery will be randomly chosen to receive a set of PROs through 
an electronic data collection system (Patient IQ), and will be asked to complete their forms prior to surgery, as 
well as at 6-months and 1-year after surgery. We will administer a short form (Appendix 2), just once at the 
start of the study to help assess whether language, age, and/or technological literacy might affect compliance. 
No additional contact by clinical or research staff will be made with Group 1 (Arm 1) participants for post-
operative form collection.  
Group 2 (Arm 2)
33 patients undergoing arthroscopic shoulder surgery will be randomly chosen to have a discussion with the 
physician or physician assistant regarding what PROs are, and how they can help both the patient and physician 
make informed decisions about a specific medical intervention.  A checklist of discussion points will be 
available to providers to ensure all key elements are reviewed with patients (see appendix 1).  This discussion 
will be included at the time of surgical scheduling, alongside other routine discussion points such as informed 
consent process, surgical scheduling information, and peri-operative instructions. 
Participants will be assigned a set of PROs through an electronic data collection system (Patient IQ), and will be 
asked to complete their forms prior to surgery, as well as at 6-months and 1-year after surgery.  In addition, we 
will ask patients to complete a short form (Appendix 2), just once at the start of the study to help assess whether 
language, age, and/or technological literacy might affect compliance. 
ORA: 18041709-IRB01   Date IRB Approved: 12/8/2021   Amendment Date: 9/27/2022

Title: Patient Outcomes Collection: How can we do better? A Randomized Trial to Determine Factors 
Which May Affect Patient Compliance. 
PI: Nikhil Verma, MD
Version Date:  9/21/2022
Page 6 of 11
Group 3 (Arm 3)
33 randomly selected participants undergoing arthroscopic shoulder surgery will be assigned PROs through 
Patient IQ.  They will be asked to complete their forms prior to surgery, as well as at 6-months and 1-year after 
surgery.  We will administer a short form (Appendix 2), just once at the start of the study to help assess whether 
language, age, and/or technological literacy might affect compliance. Participants in Group 3 (Arm 3) will be 
told they will receive a $10 Amazon gift card if they complete their pre-operative forms, a $10 Amazon gift 
card if they complete their forms 6-months post surgery, and a $10 Amazon gift card if they complete their 
forms 1-year post surgery. The gift card will be sent to the participant’s home address after the survey is 
verified completed in Patient IQ.
For all Groups, we will monitor the patient compliance rate for the following questionnaires: ASES shoulder 
assessment form, Single Assessment Numeric Evaluation (SANE), and VR/SF12.  All groups will be asked to 
respond to the short form (Appendix 2), just once at the start of the study to help assess whether language, age, 
and/or technological literacy might affect compliance.
Automatic email reminders will be sent to patients every 5 days, starting 60 days before forms expire until the 
forms are completed.
 Participant compliance will be documented at preoperatively, 6 months and 1-year post shoulder arthroplasty.
Data analysis:
We anticipate that patient education, as well as providing low-value monetary incentives, will overall enhance 
patient participation and that these strategies will increase post-operative survey completion and rate of return.  
We further predict that patient education may have an equal or more significant impact on patient compliance to 
financial compensation, and avoid additional expenditure. We will monitor patient compliance using tools 
available in Patient IQ, which, allow determination of form completion for each patient.
ORA: 18041709-IRB01   Date IRB Approved: 12/8/2021   Amendment Date: 9/27/2022

Title: Patient Outcomes Collection: How can we do better? A Randomized Trial to Determine Factors 
Which May Affect Patient Compliance. 
PI: Nikhil Verma, MD
Version Date:  9/21/2022
Page 7 of 11
Based on our statistical power analysis using a chi-squared test of proportions, we plan to enroll 100 patients 
per study arm.  This is sufficient to show a difference of 20% in the PRO completion rate with a beta of 0.80 
and an alpha of 0.05.  As historical research data analytics have noted that a 70% response rate is required to 
minimize potential forms of bias in report results of a given procedure, we believe a 20% increase in response 
rate is reasonable to assess whether it is possible to reach the 70% threshold.
While we expect response rates to increase in the treatment (patient engagement plus email reminders) vs. 
control (email reminders only) groups, it is possible that we might not observe a statistically significant 
difference among our treatment groups. This notwithstanding, our data will help provide important information 
as to which strategy might be more pragmatic to ensue.  
Long Term Aims:
Given the increasing importance of PROs in both clinical practice and research, and concerns overpatient 
compliance, we believe the proposed research will enhance our understanding of strategies that may be 
employed to increase response rates and, hence, data quality. Long term, the information gained in this proposal 
will help set realistic expectations and benchmarks in the orthopedic community in regard to PRO 
administration, data collection, and patient compliance rates.
Risks and Benefits:
The risk to the subject for participating in this study is loss of patient confidentiality. To
minimize this risk, data will be kept on a secure, password-protected server at Midwest Orthopedics at Rush 
University Medical Center.  
There is no direct benefit to the participant. The benefit is to identify factors that will increase completion rates 
of post-operative patient reported outcome surveys (PROs) in order to improve patient care.
ORA: 18041709-IRB01   Date IRB Approved: 12/8/2021   Amendment Date: 9/27/2022

Title: Patient Outcomes Collection: How can we do better? A Randomized Trial to Determine Factors 
Which May Affect Patient Compliance. 
PI: Nikhil Verma, MD
Version Date:  9/21/2022
Page 8 of 11
Data & safety monitoring:
There is minimal risk to the participants except for the potential for loss of privacy and confidentiality, but 
every reasonable effort will be made to protect the patient’s information while their data is used as part of this 
study.
Data storage & confidentiality:
The data is maintained on a secure at Midwest Orthopedics at Rush and Patient IQ.  Participants’ identities will 
be coded via the use of a separate key Excel document correlating participants’ medical record numbers with a 
study ID assigned for the sole purpose of this study.
Upon publishing of the study’s results, study data held on the excel spreadsheet and data key will be securely 
deleted from the Midwest Orthopedics at Rush computer. No social security numbers, names, addresses, phone 
numbers, or other personal information beyond what is mentioned in this submission will be recorded.  Files 
will not be shared with non-study personnel. Any presentations or publications that result from this study will 
not identify any participants individually and may present the data results in an aggregated form. 
REFERENCES:
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2.
Makhni EC, Higgins JD, Hamamoto JT, Cole BJ, Romeo AA, Verma NN: Patient Compliance With  
            Electronic Patient Reported Outcomes Following Shoulder Arthroscopy. Arthroscopy : the journal of 
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3.
Cotter EJ, Hannon CP, Locker P, et al.: Male Sex, Decreased Activity Level, and Higher BMI     
            Associated With Lower Completion of Patient-Reported Outcome Measures Following ACL 
            Reconstruction. Orthop J Sports Med 2018;6:2325967118758602.
4.
Edwards PJ, Roberts I, Clarke MJ, et al.: Methods to increase response to postal and electronic 
            questionnaires. The Cochrane database of systematic reviews 2009:MR000008.
5.
Brealey SD, Atwell C, Bryan S, et al.: Improving response rates using a monetary incentive for patient 
            completion of questionnaires: an observational study. BMC Med Res Methodol 2007;7:12.
6.
Makhni EC, Meadows M, Hamamoto JT, Higgins JD, Romeo AA, Verma NN: Patient Reported 
ORA: 18041709-IRB01   Date IRB Approved: 12/8/2021   Amendment Date: 9/27/2022

Title: Patient Outcomes Collection: How can we do better? A Randomized Trial to Determine Factors 
Which May Affect Patient Compliance. 
PI: Nikhil Verma, MD
Version Date:  9/21/2022
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            Outcomes Measurement Information System (PROMIS) in the upper extremity: the future of outcomes 
            reporting? Journal of shoulder and elbow surgery / American Shoulder and Elbow Surgeons  [et al] 
            2017;26:352-357.
7.
Black N: Patient reported outcome measures could help transform healthcare. Bmj 2013;346:f167.
8.
Brook EM, Glerum KM, Higgins LD, Matzkin EG: Implementing Patient-Reported Outcome Measures 
            in Your Practice: Pearls and Pitfalls. Am J Orthop (Belle Mead NJ) 2017;46:273-278.
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CMS Quality Measure Development Plan: Supporting the Transition to the Merit-based Incentive 
            Payment System (MIPS) and Alternative Payment Models (APMs). Available at: 
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            Programs/MACRA-MIPS-and-APMs/Final-MDP.pdf.
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Fogliani M: Low Response Rates and Their Effects on Survey Results, in  Methodology Advisory 
            Committee Meeting, 1999.
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Johnson TP, Wislar JS: Response rates and nonresponse errors in surveys. Jama 2012;307:1805-1806.
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Zuke WA, Leroux TS, Gregory BP, et al.: Establishing Maximal Medical Improvement After 
            Arthroscopic Rotator Cuff Repair. Am J Sports Med 2017:363546517707963.
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Patel J, Lee JH, Li Z, SooHoo NF, Bozic K, Huddleston JI, 3rd: Predictors of Low Patient-Reported 
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Bojcic JL, Sue VM, Huon TS, Maletis GB, Inacio MC: Comparison of paper and electronic surveys for 
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Glassman J, Unti, L: Patient-Reported Functional Outcomes: How to Collect and Report Risk-Adjusted 
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ORA: 18041709-IRB01   Date IRB Approved: 12/8/2021   Amendment Date: 9/27/2022

Title: Patient Outcomes Collection: How can we do better? A Randomized Trial to Determine Factors 
Which May Affect Patient Compliance. 
PI: Nikhil Verma, MD
Version Date:  9/21/2022
Page 10 of 11
Appendix 1
Discussion points:
 What are Patient Reported Outcome Forms?
•
Clinician’s perspective
o
help gauge patient’s progress with respect to normative data for the same procedure
o
use as a research tool
o
help patients like you!
•
Patient’s perspective
o
help gauge patient’s progress with respect to normative data for the same procedure
o
Identify patients at risk for poor outcome early
o
use as a research tool
o
help patients like me!
 Why are you (the patient) being asked to complete these forms?
•
utility
•
generalizability
 Do these forms directly affect you (the patient)?
 Do you (the patient) have any questions or concerns?
ORA: 18041709-IRB01   Date IRB Approved: 12/8/2021   Amendment Date: 9/27/2022

Title: Patient Outcomes Collection: How can we do better? A Randomized Trial to Determine Factors 
Which May Affect Patient Compliance. 
PI: Nikhil Verma, MD
Version Date:  9/21/2022
Page 11 of 11
Appendix 2
Custom Survey
1) How old are you?
o
18-24
o
25-34
o
35-44
o
45-54
o
55-64
o
65+
2) What is your primary language?
o
English
o
Spanish
o
Other (please specify) ------------
3) How comfortable do you feel using a computer or a smart device (for example an iPad, smart phone, etc)?
o
Very comfortable
o
Somewhat comfortable
o
Not at all comfortable
ORA: 18041709-IRB01   Date IRB Approved: 12/8/2021   Amendment Date: 9/27/2022