The Impact of Mobile Education Delivery on Postoperative Pain Outcomes
Phase: NA
Conditions: Total Joint Arthroplasty, Pain, Postoperative
Sponsor: Mayo Clinic

 
 
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The Impact of Mobile Education Delivery on Postoperative Pain Outcomes 
Study Protocol  
 
IRB Number: 17-04771 
 
NCT number: NA 
 
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IRB Minimal Risk Protocol Template  
 
General Study Information 
 
Principal Investigator: Amber Stitz        
 
 
 
 
 
 
 
 
Study Title: The Impact of Mobile Education Delivery on Postoperative Pain Outcomes     
Protocol version number and date: Version #1 May 2, 2017      
 
Research Question and Aims 
 
Hypothesis: It is hypothesized that a real-time, interactive, mobile education system will demonstrate improved 
pain associated outcomes, and higher patient participation when compared to the current standard education 
delivery method. 
 
Aims, purpose, or objectives: This study seeks to understand the difference between two different education 
delivery methodologies and the effect on the postoperative pain experience, including participation in treatment 
plan, knowledge, pain outcomes, and opioid requirements.  
 Evaluate the difference in patients’ self-reported pain experience according to the type of education 
delivery methods. 
 Determine if there are significant differences in patients’ knowledge of pain, medications, and side 
effects according to the type of education delivery methods. 
 Evaluate the difference in patients’ self-reported participation in pain management according to the type 
of education delivery methods. 
 Determine if there is a significant difference in opioid requirements in the first 48 hours according to the 
type of education delivery methods. 
Note: If this study establishes a human specimen repository (biobank) for research 
purposes, do not use this template. Use the Mayo Clinic Human Specimen Repository 
Protocol Template found on the IRB home page under Forms and Procedures at 
http://intranet.mayo.edu/charlie/irb/ 
 
First-time Use: Use this template to describe your study for a new IRB submission. 
1. Complete the questions that apply to your study. 
2. Save an electronic copy of this protocol for future revisions.    
3. When completing your IRBe application, you will be asked to upload this document to the protocol 
section. 
Modification:  To modify this document after your study has been approved: 
1. Open your study in IRBe. Click on the study ‘Documents’ tab and select the most recent version of the 
protocol. Save it to your files. 
2. Open the saved document and activate “Track Changes”.  
3. Revise the protocol template to reflect the modification points , save the template to your files 
4. Create an IRBe Modification for the study and upload the revised protocol template. 

 
 
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Background (Include relevant experience, gaps in current knowledge, preliminary data, etc.):   
Despite all the available analgesic, modern devices, and nonpharmacological interventions, pain in the 
acute post-surgical period remains a prominent issue and effective management has remained elusive with 
significant gaps in care. Early estimates suggest that anywhere from 50% to 75% of surgical patients experience 
inadequate pain relief (Huang et al., 2001), often due to delayed intervention (Sinatra, Torres, & Bustos, 2002).  
A National Survey of patients who had undergone non-specific surgical care demonstrated occurrence of acute 
pain in 80% of patients and moderate to severe pain in approximately 86% of those who experienced acute pain 
(Apfelbaum, Chen, Mehta, & Gan, 2003). A 2008 study of 1,490 surgical inpatients, 41% of patients reported 
severe pain in the first 24 hours after surgery (Sommer, de Rijke, van Kellef, et al., 2008). Watt-Watson, 
Stevens, Garfunkel, Steiner, & Gallop (2001) found severe pain in 86% of coronary artery bypass patient 24 
hours after surgery. A chart review revealed that 80% of these patients experiencing severe pain received ˂16 
mg of morphine over the previous 24 hours and two had no analgesia orders in the medical record (Watt-
Watson eat al., 2001). Ineffective pain management effects recovery, complications, cost (Gordon, Dahl, & 
Stevenson, 2000), patient satisfaction (Garimella & Cellini, 2013), length of stay (Joshi, Beck, Emerson, et al., 
2014), readmissions (ASA, 2012), quality of life (Ersek, 2001), and chronic postsurgical pain (O’Brien, 
Pergolizzi, van de Laar, et al, 2103; Barrington, Halaszynski, & Sinatra, 2014). 
Effective pain management is the use of appropriate pain modalities to improve the pain experience 
while balancing the goal of optimal pain relief with patient safety to prevent adverse outcomes (Hayes & 
Gordon, 2015). In the surgical setting, effective and safe pain management poses significant challenges for 
nurses, providers, and healthcare organizations. This is due in part to the multifactorial influences that result in 
inadequate pain management including substandard assessment of pain (Michales, Hubbartt, Carroll, & 
Hudson-Barr, 2006), limited clinician knowledge to manage pain effectively, and poor patient engagement 
(Innis, Bikaunieks, Petryshen, Zellermeyer, & Ciccarelli, 2004). From the patient perspective, effective pain 
management is reliant on their knowledge, engagement, and the ability to effectively report pain symptoms 
(The Joint Commission, 2009). Patient reported dissatisfaction and poor pain outcomes have been linked to 
insufficient education and limited patient-provider communication (Subramanian, Ramasamy, Hoong, Chinna, 
&Rosli, 2016; Smith, Rhodes, Paciotti, et al., 2015; Helfand & Freeman, 2009). These gaps faced by patients 
result in misconceptions about pain, opioid use, and side effects (Helfand & Freeman, 2009; Morrison RS, 
Meier DE, Fischberg et al., 2006). Clinical outcomes, including pain reporting, opioid management, pain scores, 
and satisfaction may be improved with focused patient education and knowledge acquisition (Mularski, White-
Chu, Overbay, Miller, Asch, & Ganzini, 2006). The literature suggests that patients lack the needed knowledge 
to effectively manage opioid analgesic medications safely and effectively (Horwitz et al., 2013; AJN, 2015). 
Lack of knowledge, medication safety concerns (misuse), and risk for adverse effects are most prominent in the 
opioid naïve patient experiencing acute pain (AJN, 2015). A panel of clinical experts from the APS and the 
American Anesthesia Association made the following recommendations “clinicians provide patient and family-
centered, individually tailored education to the patient (and/or responsible caregiver), including information on 
treatment options for management of postoperative pain, and document the plan and goals for postoperative 
pain management” (Chou et al., 2016, pg. 133) followed by an adjustment by the clinician in the “pain 
management plan on the basis of adequacy of pain relief and presence of adverse events” (Chou et al., 2016, pg. 
135). 
In 2016, the NIH and the American Pain Society (APS) both issued gaps in research to guide clinical 
practice. Research gaps exist in nearly every aspect of pain management. One gap of note is the role of pain 
management patient education and engagement on recovery, pain relief, adverse effects, safety, and long term 
outcomes in patients undergoing major joint arthroplasty (TJA) (NIH, 2016; Gordon, Leon-Casasola, Wu et al., 
2016). Research is needed to understand the effectiveness of educational methods, delivery mechanisms, and 

 
 
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intervention timing to determine the impact on pain outcomes, patient engagement in the shared-decision 
making process, safety, and post-discharge medication management.  
Significance 
The available research indicates a strong positive correlation between patient education and outcomes. 
However, there is limited literature on the direct influence of pain management education on patients’ recovery, 
engagement, pain relief, adverse effects, safety, and long term outcomes. These gaps are consistent with the 
identified research gaps from the NIH and APS. The use of technology in clinical practice and patient 
education, such as mobile applications, patient portals, and iPads, are only just beginning to be explored in the 
last five to ten years. Further research is needed to understand the effectiveness, barriers, and use of eHealth 
delivery models. One barrier to eHealth delivery is adoption and use of technology in the elderly populations. 
The elderly population has lagged in the acceptance and adaptation to technology. Only 59% of seniors use the 
internet and computer, compared to 86% of all adults (Smith, 2014). The adoption of technology in this 
population is potentiated by physical challenges (arthritis, and vision changes), skeptical attitudes about the 
benefits of technology, and difficulty with learning how to use digital devices. However, a paradigm shift is 
occurring with a 6% annual increase in the number of seniors using technology (Smith, 2014). This trend is 
anticipated to continue, making technology less of a challenge in health information delivery. The average age 
of patients undergoing TJA surgery is 67years of age. As such, consideration and further research into the 
adoption of eHealth delivery in this population is necessary. Additionally, each education delivery method 
poses several advantages and disadvantages. Verbal 1:1 education is patient centered and allows for direct 
interaction and questions yet is costly, time consuming, and is associated with limited memory recall (Knowles, 
Holton, Swanson, 2011). This style of education is often used in conjunction with written text in the form of 
booklets or pamphlets. Written education allows for mass distribution of educational content but is associated 
with printing expenses and low patient compliance (Knowles, Holton, Swanson, 2011). Conversely, internet 
based education is interactive, easily accessible, simple, and visually appealing (Knowles, Holton, Swanson, 
2011). Depending on an organization’s technological capabilities, internet based education may not be 
attainable due to technical limitations and cost (Knowles, Holton, Swanson, 2011). The research study proposed 
here seeks to understand the difference and effectiveness of educational methods and delivery mechanisms 
using mobile applications compared to standard education delivery (verbal and written) to determine the impact 
on pain outcomes, pain experience, patient participation, and opioid requirements. 
 
Study Design and Methods 
 
Methods:  Describe, in detail, the research activities that will be conducted under this protocol:   
Variables 
The independent variable is the type of patient education deliverable given to the two study arms, group 
A (experimental group, real-time, interactive, mobile education system) and group B (control group, standard of 
care). The dependent variables are 1) patient knowledge, 2) patient perceived participation in pain management, 
3) high and low pain scores, and 4) total opioid consumption. A simple table of the independent, dependent, and 
additional variables are presented in Appendix B. A detailed accounting of all data points including variable 
type, theoretical definitions, and operational definitions can be found in the detailed code book.   

 
 
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Method 
Design 
This prospective study has been designed as quasi-experimental study. This study design was selected 
for several reasons. This study seeks to explore both a treatment and control group in efforts to compare 
outcomes which are dependent on the type of intervention. To control for fidelity of the intervention and avoid 
cross over, behavior changes from nurses providing the intervention, the intervention the patient receives will 
be determined by the location they are bedded in hospital. Orthopedic TJA patients are assigned at random and 
based on bed availability to one of two patient care units. One of the two patient care units will offer standard 
education the other unit will offer the mobile, iPad based education. The patient care unit to offer the mobile, 
iPad based education will be selected at random. This study design will help minimize will reduce the risk of 
selection bias, increase fidelity of the intervention, and increases the probability that the differences 
demonstrated between the study groups will be attributed to the actual intervention under study.   
Study participants will be assigned into one of two study arms, intervention or control, based on random 
assignment to the two designated units. At the time of consent, patients will be informed that there are two 
study arms and that some subjects will receive enhanced pain management education; however, subjects will 
not explicitly be informed if they are in the intervention or control arm of the study. Participants who have 
verbally consented will receive a HIPAA authorization form accompanied by a letter reminding them of the 
study and their consent to participate at the time of the preoperative visit. This typically occurs one to two days 
before surgery. Participants will be asked to sign the HIPAA authorization form and return the clinical staff. 
Participants will be provided an extra copy for their records. No Patient data will be collected prior to this. Once 
HIPAA has been signed participants will complete the intake survey provided with the packet of information.  
Researchers are blinded to the study arm the participant was enrolled in until after consent has been 
obtained, the patient is enrolled in the study, and has been admitted to the hospital and assigned a bed. Once 
enrolled and consented, bed control will be notified to assign the patient(s) to one of the two designated patient 
care units with no specific direction offered on which unit the patient(s) should be assigned to. The only 
direction provided will be to split the patients evenly between the two units. Only ten study arm participants 
may be enrolled and active at one time. This is limited based on the number of available iPad devices for the 
purposes of this study.  
Study Population 
The target population is adult patients undergoing elective, lower extremity total joint arthroplasty 
(TJA). Candidates for inclusion are adult patients over the age of 18 years undergoing surgical intervention and 
inpatient care for one of the following procedures, total hip arthroplasty (THA) (primary, bilateral, and revision) 
and total knee arthroplasty (TKA) (primary, bilateral, unicompartmental, and revision). Patients must be fluent 
in the English language. Patients will be excluded if they are undergoing more complex hip and knee 
procedures such as implant resections with or without spacer placement, liner exchange, or THA or unipolar hip 
arthroplasty related to repair of hip fracture. Patients will also be excluded if there are preexisting physical or 
cognitive limitations that would hinder their ability to use the mobile application. 
Sample Size  
Assuming a moderate effect size 0.50 (Cohen’s d), a power of 80% (0.80), and an alpha of 0.05, 64 
participants are needed in each study arm (Polit, 2010). Due to limited time scope, a minimum of 150 patients 
will be approached for potential participation. If time allows and additional subjects are needed to achieve the 
desired sample size, additional candidates will be approached to reach the recommended total of 128 patients, 
divided between the two study arms.  

 
 
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Recruitment and Consent 
 
Eligible patients will be identified using surgeon referral and/or electronic surgical listing reports. 
Enrollment into the study is completely voluntary. Patients will be recruited at the time of perioperative phone 
consultation with nursing. This consultation occurs approximately two weeks prior to their scheduled surgical 
procedure. At this time patients will be introduced to the study by the RN or APRN. If the patient expresses 
interest, verbal consent will be obtained and documented at the time of the call by the IRB approved consent 
designees. Consent designees will read the consent script and provide any necessary time to answer the patients’ 
questions. At the time of consent, patients will be informed that there are two study arms and that some subjects 
will receive enhanced pain management education; however, subjects will not explicitly be informed if they are 
in the intervention or control arm of the study.  
Enrollment into the study is completely voluntary. Participating in this study poses minimal risk to the 
participants; all patients will receive the necessary education to meet their care needs and the minimum standard 
of practice. The potential for risk is that the mode of information/education delivery does not meet the patients’ 
needs and the risk of low acceptance of technology use. In this case, patients in the study arm would be 
removed from the study and would receive standard education. Pain management in both arms will remain the 
same; no changes will be made to the process for treating pain using either non-pharmacologic or 
pharmacologic interventions. Medication orders, medication administration, and pain treatment plans will not 
be affected by participation in study. As care is today, pain management will be customized to meet the needs 
of the individual patient.  
Oral consent will be obtained, documented, and maintained as part of the research records. No 
identifiable patient information will be maintained. The only identifiable information collected will be the 
patients’ clinic number. It will be used for tracking purposes only until the data collection process is complete. 
When the chart audit is complete, the clinic numbers will be removed from the data set and only the 
predesignated subject number will be used and maintained. At the start of the study the patient will be asked to 
complete the HIPAA Authorization to Use and Disclose Protected Health Information. The researcher will 
remain blinded to the type of education delivery that the patient will receive until after enrolment and bed 
assignment. This will prevent potential bias with inadvertently assigning patients to groups based on 
characteristics, like age. 
There is a risk for disclosure of personal protected information. The electronic data will be stored on an 
internal secure server. If transport of electronic data is necessary for any reason an encrypted storage device will 
be used. Paper and pencil surveys will be stored in a locked cabinet, in a locked and secure office. The 
researcher and the RN will be responsible to data entry into SPSS. The RN will be trained by the researcher on 
SPSS data entry. Access to the data will be restricted to only research personnel approved on the IRB 
application. The RNs will complete the institution’s IRB education requirements for staff assisting with 
research data. Limiting the number of staff involved will reduce the potential for data entry errors.   
Setting  
The intervention and data collection will be collected on orthopedic patients admitted to two orthopedic 
inpatient care units who have undergone major joint replacement surgery at a large academic medical center in 
the upper Midwest. Between the two units there are 50 dedicated orthopedic beds that admit more than 9,000 
orthopedic patients annually. Included in the annual orthopedic admits are approximately 4,000 major total joint 
arthroplasties. Based on historical admission data and patient volumes the desired sample size is feasible. 
Patients relocated to non-orthopedic units due to high patient census will not be included in the study. The goal 
is to recruit 20 patients on a weekly basis, ten in each arm of the study. Due to the restricted number of iPads 

 
 
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available, only ten patients may be enrolled in the study arm at any point in time. The total divided sample of 
124 patients should be achievable within ten weeks from the start of the study.  
Intervention  
Study group. The participants in the study arm will receive comprehensive pain management education 
delivered using mobile iPads at the point of care. The mobile based education modules will be inclusive of the 
use of the pain rating scale and assessment of pain; communication with healthcare providers; daily 
expectations for pain and pain management; pharmacologic and non-pharmacologic treatment options; 
medication side effects and safety; and discharge instructions including safe handling of opioids, disposal, 
tapering, and when to call the provider. It will also include an interactive pain and discomfort menu, knowledge 
based questions, and medication tracking log. The content has been developed using existing Mayo Clinic 
patient education materials (videos and written text) developed by the Department of Anesthesia and Pain 
Service in conjunction with the Department of Patient Education. The mobile application covers a curriculum of 
the most common concerns and questions individual experiencing pain have as presented by Gifford (2014), 
Horwitz et al. (2013), AJN (2015), and Chou et al. (2016). The content presented in the application is 
comprehensive, compiling the content of several standard Mayo Clinic education pamphlets and videos in an 
easily accessible, comprehensive, and convenient way. The mobile application uses multiple teaching 
methodologies to accommodate different learning needs, including written text; short videos; illustrated 
graphics, pictures, and guides; interactive checklists; knowledge based questions; and frequently asked 
questions. The program was developed using Mayo Clinic Care Connect as the build platform in collaboration 
with the Department of Social Media. The Web-based platform where this pain program is housed was 
successfully trialed in 2016 by providing perioperative education to TJA patients. The iPads for use in the 
hospital have been configured and secured in such a way that patients will only have access to this program.  
Patients enrolled in the study arm will be given an iPad on admission to the post-surgical unit. The RN 
will instruct the patient on how to use the iPad and the program. The device will remain with the patient until 
discharge. The patient, independently or with the nurse, may use the program at any point during the inpatient 
care experience. The RN will use the iPad to engage patients in their pain management and care. Intervention 
fidelity will be monitored by requiring the RN to indicate when and how often they observed and/or directly 
engaged the patient in pain education using the mobile device. A checklist will be available on the patients chart 
for the RN to complete at the end of each shift through the duration of the patients hospital stay.  
Control group. The control group will receive the current standard of care which consists of verbal 
instruction and pain management pamphlets. At a minimum, the patients will receive two educational pamphlets 
titled Your Pain and Discomfort Management Menu and Communicating About Your Pain. The pain 
management menu is designed to provide the patient with basic pain information with a focus on non-
pharmacologic pain interventions. The pain communication pamphlet offers a more comprehensive explanation 
about pain, assessment of pain (0-10 scale), communicating with the healthcare providers, and pain 
management options. The content of these two documents is a portion of the education the study patients will 
receive using the mobile application. These two documents are existing educational material available through 
the Department of Patient Education. These educational materials were developed by the Department of 
Anesthesia and Pain Service in conjunction with the Department of Patient Education. Verbal instruction is 
inconsistent and is nurse dependent. At a minimum the nurse is instructed to provide the two pamphlets to the 
patient and follow-up with the patient to address any questions. Additional printed education materials are 
available through the department of patient education and verbal instruction may be tailored based on nursing 
assessment and patient need. It is important to note that all educational content available to the study 
participants is available to the control group in different forms or functions. Fidelity to standard of care will be 

 
 
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monitored by requiring the RN to indicate when and how often they observed and/or directly engaged the 
patient in pain education using standard pamphlet educational material. A checklist will be available on the 
patients chart for the RN to complete at the end of each shift through the duration of the patients hospital stay.     
Management of interventions and study participants. The implementation of the interventions in the 
study and control arm will be closely monitored by the researcher. Educational in-services for all shifts will be 
held on various days. Education will include the research protocol, goals of the study, use of the mobile iPad 
patient education in practice, and data collection procedures. To ensure all staff have access to the education, a 
brief video will be disseminated via e-mail to be viewed at staff convenience prior to the start of the study. 
Participants in the study will be denoted by a specific color coded label at the door. This will notify and flag 
direct care staff to ensure that the appropriate study protocol is followed. The research protocol for each arm of 
the study and instructions for the mobile education application will be placed in the research reference book, 
located at each nursing sub-station. For participants whom are enrolled in the study arm, the researcher will 
deliver the iPad either directly to the patient or to the bedside RN caring for the patient. The RN will receive 
one-on-one, just in time education at the point of device delivery. The researcher will also make daily rounds 
and random care observations with nurses caring for participants enrolled in the study. Additional education and 
reminders will be offered at the point of care and as needed.  
Instruments 
Patient demographics and clinical characteristics. Patient demographics and past medical history will 
be collected as part of the study (Appendix D). Patient demographic variables to be collected include age, race, 
education level, marital status, and employment status. Specific confounding variables associated with the type 
of intervention and outcome will be collected including patients’ preferred learning style, comfort level with 
technology, and anxiety. Preferred learning style will be assessed using the three styles of learning reading, 
seeing, doing, or listening (Bastable, 2008). Comfort level with technology will be assessed using a five-point 
Lickert scale with zero being, “not comfortable at all” and five being “very comfortable.” Anxiety associated 
with anticipated pain will be assessed on ten-point. Relevant past medical and surgical history will also be 
collected including past major orthopedic surgeries, chronic pain, preoperative use of opioids, and mental health 
conditions. The patient demographic collection form will be administered using paper and pencil survey. The 
patient will be given the form when they arrive to the ambulatory orthopedic clinic for their perioperative visit, 
one to two days prior to their scheduled surgery. It will take participants approximately five minutes to 
complete the survey.  
Pain outcomes. The Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) will 
be used to evaluate the patients’ perception of their pain management experience and outcomes (Appendix E). 
The APS-POQ-R is a 23-item, two-page questionnaire measuring five subscales of the patient experience and 
one aspect measuring non-pharmacologic management. These 6 aspects include (1) pain severity and relief; (2) 
impact of pain on activity, sleep, and negative emotions; (3) side effects of treatment; (4) helpfulness of 
information about pain treatment; (5) ability to participate in pain treatment decisions; and (6) use of 
nonpharmacological strategies (Gordon, Polomano, Pellino et al., 2010). There are 14 symptom-based questions 
to indicate symptom severity using a ten-point scale (0-10). The higher the score, the more severe the symptom 
experience. Two additional symptom-based questions explore severity of pain over time and pain relief using a 
ten-point scale with a range of 0% to 100%. For pain severity over time, a higher score indicates a higher 
incidence of severe pain in 24 hours. For pain relief, a higher score indicates a more positive response to pain 
relief. These data points will help determine the effectiveness of the intervention on pain outcomes (pain 
scores). Three questions are associated with the pain education experience. Using a ten-point scale (0-10), the 
higher response scores indicate a more positive experience rating. Pain experience here is assessed by 

 
 
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generalized satisfaction with pain relief and participation in treatment decisions. These data points will help 
determine the influence of pain education on satisfaction with educational material/delivery and participation. 
The reported participation score will be used to measure the degree to which the patient is engaged by a means 
of active participation in care and treatment. The remainder of the survey questions use a single word 
association to answer the question rather than a measurable scale. The APS-POQ-R has demonstrated adequate 
psychometrics, construct validity, reliability, and clinical feasibility. Internal consistency reliability was 
acceptable with a Cronbach α of 0.86. The individual subscales were also assessed for reliability with the 
resulting Cronbach α as follows affective subscale, α = 0.82; pain severity and sleep interference subscale, α = 
0.83; perceptions of pain care subscale, α = 0.70; interference with activity, α = 0.82; and adverse effects 
subscale, α = 0.63 (Gordon, Polomano, Pellino et al., 2010). This tool is open source and available for 
application without further permission (Gordon, Polomano, Pellino et al., 2010). 
Pain knowledge. The Patient Pain Questionnaire (PPQ) will be used to evaluate pain knowledge post 
intervention (Appendix F). The PPQ is a 16-item questionnaire measuring both pain knowledge and actual 
experiences with pain. This study will use only nine of the items targeted at pain knowledge and beliefs. The 
nine knowledge-based questions use a ten-point (0-10) ordinal scale to assess patients’ agreement or 
disagreement with statements about pain relief, medication administration, addiction, dosing, timing, non-
pharmacologic management, side effects, beliefs about pain medications, and changes in the pain experience. 
Depending on the statement a higher score may indicate either agreement or disagreement with the statement. 
All items have been formatted so that zero indicates the most positive outcome and a ten indicates the most 
negative outcome. These nine items are primarily used for chronic cancer pain; however the PPQ has been and 
can be adapted to assess general pain knowledge and experiences. Psychometric analysis of the PPQ 
demonstrated content validity of 0.90 (content validity index), construct validity of <0.05 variance, concurrent 
validity (r=0.60; p <0.05), test-retest reliability (r=0.80), and internal consistency with a Cronbach α of 0.71 
(Ferrel & Rivera, 1997). The language will also be revised, as in the study conducted by Reynolds (2009) and 
reference to chronic cancer pain will be removed from the original question. This tool is open source and 
available for application without further permission and may be utilized by clinicians or researchers (City of 
Hope Pain and Palliative Care Resource Center, 2017; MIDSS, n.d.).  
At the start of the study and at the time of discharge the patient will complete the APS-POQ-R and the 
revised knowledge-based PPQ surveys. It will take participants approximately 10 minutes to complete the two 
surveys. The use of these two widely used instruments will ensure that the information being collected is highly 
reliable and valid, truly measuring what the study is seeking to evaluate. These paper and pencil surveys will be 
provided to the patient prior to discharge and collected from the patient by the staff registered nurse (RN) and/or 
charge nurse.  In addition to training and education on the intervention, staff will receive direction on the data 
(survey) collection process and requirements. 
Chart audits. Chart audits of the electronic health record will be conducted after discharge to collect the 
remaining clinical data. Data to be collected will include total opioid requirements as indicated by the 
medication administration record; primary surgical procedure as reported in the surgical listing and the 
operative report; type of regional anesthesia as indicated in the anesthesia record; length of stay; and discharge 
disposition as reported in the hospital dismissal summary. Additionally, the past medical history will be 
reviewed to confirm patient reported history of chronic pain, preoperative use of opioids, and mental health 
conditions. The researcher and a staff RN will conduct these chart audits.  
Limitations 
 
The design of this study does present some limitations. Participants in the study group will receive 
enhanced pain content that is delivered using an alternative method, ultimately testing both the delivery method 
and the content. The duality of the study intervention is a confounding variable and may make differentiating 

 
 
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the cause of the outcome difficult. Another limitation is that preoperative educational classes are available to 
patients to attend if they choose. All patients receive the same pamphlets and information in the mail when 
surgery is scheduled. An in-person didactic class is optional for patients. Some pain education is offered in this 
class. Currently only 49% of patients attend these classes. It is anticipated that some patients enrolled in the 
study will have received varying levels of education prior to their hospital admission. This is an antecedent 
variable that will be collected as part of the chart audit and accounted in the data analysis. The two nursing units 
involved in the study are located within the same hospital. It is possible that nursing staff from the intervention 
unit may float to the control unit and educate study patients using content from the expanded education from the 
intervention on the iPads. Pre-testing knowledge of pain and measured again at the end of the intervention 
(prepost) using a paired t-test analysis will strengthen the design of the study. Only opioid use for pain control is 
being measured. 
Data Management 
Data Collection Procedure 
Data will be collected at three points in time using paper and pencil survey’s and chart audits. The data 
collection protocol can be found in Appendix G. After completion of the HIPAA form, demographic and past 
medical history information and pain knowledge survey will be administered in the ambulatory clinic at the 
time of the perioperative surgical visit. A paper and pencil survey/form will be provided to the patient when 
they arrive in the clinic for their perioperative appointment and returned to the desk staff when completed. 
The intervention will occur on the postoperative inpatient care unit (PCU) starting at the time the patient 
arrives on the unit from the post anesthesia care unit (PACU). The intervention will continue through the course 
of care until discharge. At the time of discharge the patient will complete the Revised American Pain Society 
Patient Outcomes Questionnaire (APS-POQ-R) (Gordon et al., 2010) and the revised knowledge-based Patient 
Pain Questionnaire (PPQ) (Ferrell &Rivera, 1997; Reynolds, 2009). The use of these two widely used 
instruments will ensure that the information being collected is highly reliable and valid, truly measuring what 
the study is seeking to evaluate. These paper and pencil survey’s will be provided to the patient prior to 
discharge and collected from the patient by the staff registered nurse (RN) and/or charge nurse.  In addition to 
training and education on the intervention, staff will receive direction on the data (survey) collection process 
and requirements. The administration of the post-intervention surveys at the point of care, before the patient has 
left the study environment, will help to prevent the loss of study participants due to non-response or failure to 
complete follow-up surveys.  
After discharge the researcher will conduct a chart review to collect clinical data including opioid 
consumption totals, past medical history, anesthesia type, and length of stay. The researcher in addition to one 
RN will be responsible for chart audit data collection. The RNs will be trained by the researcher on chart audit 
processes. The RNs will complete the institutions IRB education requirements for staff assisting with research 
data. A tentative timeline has been developed as a GNATT chart in Appendix H. All collected data from the 
paper surveys’ and chart audits will be entered in to SPSS for analysis. Data storage and management is 
discussed further under ethical considerations.  
 
Resources:  Describe the available resources to conduct the research (personnel, time, facilities, mentor 
commitment, etc.):  

 
 
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This study has no financial implications or budget associated with implementation or data analysis. 
Equipment being used in this study was paid for using previous allocated grant funds. Statistical analysis will be 
conducted by the primary investigator with assistance from program advisor listed in the IRB application.   
The primary researcher will have at a minimum a 0.1 - 0.2 FTE to dedicate towards research activities. 
An additional 0.1 - 0.2 FTE of staff RN time will be dedicated towards research activities once the data 
collection and intervention implementation is underway. The RNs to assist is an inpatient staff RN, Erin 
Verdoorn and Ben Schmidt. The process of identifying patients and consent will be built into the ambulatory 
nurses existing work at the time of the preoperative phone consultation. Ten iPads have been purchased and the 
platform setup to conduct this study using grant funds from the Center for Innovation.         
  (1a)  This is a multisite study involving Mayo Clinic and non Mayo Clinic sites. When checked, describe in 
detail the research procedures or activities that will be conducted by Mayo Clinic study staff. 
 
  (1b)  Mayo Clinic study staff will be engaged in research activity at a non Mayo Clinic site.  When checked, 
provide a detailed description of the activity that will be conducted by Mayo Clinic study staff. 
 
Subject Information 
Target accrual is the proposed total number of subjects to be included in this study at Mayo Clinic. A “Subject” 
may include medical records, images, or specimens generated at Mayo Clinic and/or received from external 
sources.    
 
Target accrual: Due to limited time scope, a minimum of 150 patients will be approached for potential 
participation. If time allows and additional subjects are needed to achieve the desired sample size, additional 
candidates will be approached to reach the recommended total of 128 patients, divided between the two study 
arms. 
 
Subject population (children, adults, groups):  adult patients undergoing elective lower extremity total joint  
arthroplasty (TJA). 
 
Inclusion Criteria: Adult patients over the age of 18 years undergoing surgical intervention and inpatient care 
for one of the following procedures, total hip arthroplasty (THA) (primary, bilateral, and revision) and total 
knee arthroplasty (TKA) (primary, bilateral, unicompartmental, and revision). Patients must be fluent in the 
English language. 
 
Exclusion Criteria: Pediatric patients under the age of 18; undergoing more complex hip and knee procedures 
such as implant resections with or without spacer placement, liner exchange, or THA or unipolar hip 
arthroplasty related to repair of hip fracture; preexisting physical or cognitive limitations that would hinder their 
ability to use the mobile application. 
 
Research Activity 
 
Check all that apply and complete the appropriate sections as instructed.  
  
1. 
  Drug & Device:  Drugs for which an investigational new drug application is not required. Device for 
which (i) an investigational device exemption application is not required; or the medical device is 

 
 
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cleared/approved for marketing and being used in accordance with its cleared/approved labeling. (Specify in 
the Methods section) 
 
2. 
  Blood:  Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture.  
 
3. 
  Biological specimens other than blood:  Prospective collection of human biological specimens by 
noninvasive means that may include: urine, sweat, saliva, buccal scraping, oral/anal/vaginal swab, sputum, 
hair and nail clippings, etc. 
 
4. 
  Tests & Procedures:  Collection of data through noninvasive tests and procedures routinely employed 
in clinical practice that may include: MRI, surface EEG, echo, ultrasound, moderate exercise, muscular 
strength & flexibility testing, biometrics, cognition testing, eye exam, etc.  (Specify in the Methods section) 
 
5. 
  Data (medical record, images, or specimens):  Research involving use of existing and/or prospectively 
collected data. 
 
6. 
  Digital Record:  Collection of electronic data from voice, video, digital, or image recording. (Specify in 
the Methods section) 
 
7. 
  Survey, Interview, Focus Group:  Research on individual or group characteristics or behavior, survey, 
interview, oral history, focus group, program evaluation, etc.  (Specify in the Methods section) 
 
 NIH has issued a Certificate of Confidentiality (COC).  When checked, provide the institution and 
investigator named on the COC and explain why one was requested. ________________________ 
 
Biospecimens – Categories 2 and 3 
 
(2)  Collection of blood samples. When multiple groups are involved copy and paste the appropriate section 
below for example repeat section b when drawing blood from children and adults with cancer.  
 
a. From healthy, non-pregnant, adult subjects who weigh at least 110 pounds. For a minimal risk 
application, the amount of blood drawn from these subjects may not exceed 550ml in an 8-week period 
and collection may not occur more frequently than 2 times per week. 
Volume per blood draw: _____ml   
Frequency of blood draw (e.g. single draw, time(s) per week, per year, etc.) ___________ 
 
b. From other adults and children considering age, weight, and health of subject. For a minimal risk 
application, the amount of blood drawn from these subjects may not exceed the lesser of 50 ml or 3 ml 
per kg in an 8-week period, and collection may not occur more frequently than 2 times per week.   
Volume per blood draw: _____ml 
Frequency of blood draw (e.g. single draw, time(s) per week, per year, etc.) ___________  
 
(3)  Prospective collection of biological specimens other than blood: ______________________________ 

 
 
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Review of medical records, images, specimens – Category 5 
 
For review of existing data: provide a date range or an end date for when the data was generated. The end date 
can be the date this application was submitted to the IRB.  Example: 01/01/1999 to 12/31/2015 or all records 
through mm/dd/yyyy.  
Date Range: 
 
Check all that apply (data includes medical records, images, specimens).  
 
  (5a)  Only data that exists before the IRB submission date will be collected.   
 
 
  (5b)  The study involves data that exist at the time of IRB submission and data that will be generated after 
IRB submission. Include this activity in the Methods section.  
Examples 
 The study plans to conduct a retrospective chart review and ask subjects to complete a questionnaire.  
 The study plans to include subjects previously diagnosed with a specific disease and add newly 
diagnosed subjects in the future.  
 
  (5c)  The study will use data that have been collected under another IRB protocol. Include in the Methods 
section and enter the IRB number from which the research material will be obtained. When appropriate, note 
when subjects have provided consent for future use of their data and/or specimens as described in this protocol.  
 
Enter one IRB number per line, add more lines as needed 
 
 Data    
 Specimens  
 Data & Specimens  ______________________________________ 
 
 Data    
 Specimens  
 Data & Specimens  ______________________________________ 
 
 Data    
 Specimens  
 Data & Specimens  ______________________________________ 
 
 
  (5d)  This study will obtain data generated from other sources. Examples may include receiving data from 
participating sites or an external collaborator, accessing an external database or registry, etc.  Explain the source 
and how the data will be used in the Methods section.  
 
  (6)  Video audio recording: Describe the plan to maintain subject privacy and data confidentiality, 
transcription, store or destroy, etc.  
 
 
HIPAA Identifiers and Protected Health Information (PHI) 
 

 
 
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Protected health information is medical data that can be linked to the subject directly or through a combination 
of indirect identifiers.  
 
Recording identifiers (including a code) during the conduct of the study allows you to return to the medical 
record or data source to delete duplicate subjects, check a missing or questionable entry, add new data points, 
etc. De-identified data is medical information that has been stripped of all HIPAA identifiers so that it cannot be 
linked back to the subject. De-identified data is rarely used in the conduct of a research study involving a chart 
review.   
 
Review the list of subject identifiers below and, if applicable, check the box next to each HIPAA identifier 
being recorded at the time of data collection or abstraction.  Identifiers apply to any subject enrolled in the 
study including Mayo Clinic staff, patients and their relatives and household members.  
 
Internal refers to the subject’s identifier that will be recorded at Mayo Clinic by the study staff. 
External refers to the subject’s identifier that will be shared outside of Mayo Clinic. 
 
Check all that apply: 
INTERNAL 
EXTERNAL 
Name 
 
 
Mayo Clinic medical record or patient registration number, lab accession, 
specimen or radiologic image number  
X 
 
Subject ID, subject code or any other person-specific unique identifying 
number, characteristic or code that can link the subject to their medical data   
X 
 
Dates: All elements of dates [month, day, and year] directly related to an 
individual, their birth date, date of death, date of diagnosis, etc.   
Note: Recording a year only is not a unique identifier.  
 
 
Social Security number 
 
 
Medical device identifiers and serial numbers 
 
 
Biometric identifiers, including finger and voice prints, full face photographic 
images and any comparable images 
 
 
Web Universal Resource Locators (URLs), Internet Protocol (IP) address 
numbers, email address 
 
 
Street address, city, county, precinct, zip code, and their equivalent geocodes 
 
 
Phone or fax numbers 
 
 
Account, member, certificate or professional license numbers, health 
beneficiary numbers 
 
 
Vehicle identifiers and serial numbers, including license plate numbers 
 
 
Check ‘None’ when none of the identifiers listed above will be recorded, 
maintained, or shared during the conduct of this study.  (exempt category 4) 
 None 
 None 
 
 
Data Analysis 
 
Power analyses and study endpoints are not required for minimal risk research, pilot or feasibility studies.  

 
 
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  No statistical information. If checked, please explain: 
 
 
Power Statement:  N/A 
 
Data Analysis Plan  
The pre-intervention and post-intervention, paper surveys’ will be returned to the researcher for data 
entry and storage. The collected data will be collated and entered by the researcher into SPSS for data analysis. 
A detailed code book has been developed to include specific information on the type of variable and the 
theoretical and operational definitions. Data entry will be double-checked for accuracy by one of the staff 
trained staff RNs participating in data collection and chart audits. Descriptive statistics will be performed on 
each study variable. Continuous variables, including pain scores, pain knowledge, and opioid requirements, will 
be reported using a mean and standard deviation. Categorical variables, including patient characteristics and 
education engagement, will be reported as frequencies and percent occurrence. The data will be examined for 
any baseline differences between the groups to identify characteristics that may confound results and require 
control in the analysis. Data will  be examined to assure that it meets the assumptions of normality required for 
parametric analysis. If data does not meet normality assumptions, nonparametric analyses will be used. This 
study uses a revised adaption of the Patient Pain Questionnaire (PPQ) survey. For this reason, the reliability and 
validity of the nine knowledge based questions will be evaluated using Cronbach’s alpha and factor analysis.   
This study will explore the difference between two types of education delivery methods and the effect 
on pain scores, participation, knowledge, and opioid requirements. The difference amongst the two study groups 
will be analyzed using an independent t-test. Using the population mean of each group a t statistic will be 
computed. The independent t-test was selected because this statistical test is appropriate when there are two 
groups that are not the same people and are not connected to one another in any other systematic way (Polit, 
2010). Additionally, the requirements for the t-test fit with the design of the study and variables. The 
independent variable must be dichotomous nominal level indicating a participants’ status in one of the two 
groups and the dependent variable must maintain the characteristics of interval-scale or ratio (Polit, 2010). 
 
 
Endpoints 
Primary:   N/A 
Secondary: N/A