Randomized Trial on Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial
Phase: NA
Conditions: Abuses Over-The-Counter/Prescription Medications, Pain, Postoperative, Opioid Use, Physical Activity, Patient Dependence on
Sponsor: University of New Mexico

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PROTOCOL TITLE: 
Randomized trial on Expectations and Pain control Advancement In surgeRy: The 
REPAIR Trial 
PRINCIPAL INVESTIGATOR: 
Tasha Serna-Gallegos, MD 
Assistant Professor 
Department of Obstetrics & Gynecology 
University of New Mexico Health Sciences Center 
VERSION NUMBER: 
Version 8 
DATE: 
February 17, 2023 
REGULATORY FRAMEWORK: 
Please indicate all that apply: 
 
 
DOD (Department of Defense) 
 
DOE (Department of Energy) 
 
DOJ (Department of Justice) 
 
ED (Department of Education) 
 
EPA (Environmental Protection Agency) 
 
FDA (Food and Drug Administration) 
 
HHS (Department of Health and Human Services) 
 
VA 
 
Other: 
 
Is this a clinical trial under ICH-GCP E6?  
 Yes  
 No 
If yes, please confirm that the research team is familiar with and agrees to comply 
with the investigator requirements cited in ICH-GCP E6. 
 Yes 
 No 
ICH-GCP E6 can be accessed by copying and pasting this URL into your 
browser: http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf 

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Table of Contents 
1. 
Objectives .................................................................................................................... 4 
2. 
Background .................................................................................................................. 4 
3. 
Study Design ................................................................................................................ 4 
4. 
Inclusion and Exclusion Criteria .................................................................................. 4 
5. 
Number of Subjects...................................................................................................... 4 
6. 
Study Timelines ........................................................................................................... 5 
7. 
Study Endpoints ........................................................................................................... 5 
8. 
Research Setting .......................................................................................................... 5 
9. 
Resources Available..................................................................................................... 5 
10. 
Prior Approvals ........................................................................................................ 6 
11. 
Multi-Site Research .................................................................................................. 6 
12. 
Study Procedures ...................................................................................................... 7 
13. 
Data Analysis ........................................................................................................... 8 
14. 
Provisions to Monitor the Data to Ensure the Safety of Subjects ............................ 8 
15. 
Withdrawal of Subjects ............................................................................................ 8 
16. 
Data Management/Confidentiality ............................................................................ 9 
17. 
Data and Specimen Banking .................................................................................. 10 
18. 
Risks to Subjects .................................................................................................... 11 
19. 
Potential Benefits to Subjects ................................................................................. 11 
20. 
Recruitment Methods ............................................................................................. 11 
21. 
Provisions to Protect the Privacy Interests of Subjects .......................................... 12 
22. 
Economic Burden to Subjects ................................................................................ 12 
23. 
Compensation ......................................................................................................... 13 
24. 
Compensation for Research-Related Injury ........................................................... 13 
25. 
Consent Process ..................................................................................................... 13 
26. 
Documentation of Consent ..................................................................................... 16 
27. 
Study Test Results/Incidental Findings .................................................................. 16 
28. 
Sharing Study Progress or Results with Subjects .................................................. 17 
29. 
Inclusion of Vulnerable Populations ...................................................................... 18 
30. 
Community-Based Participatory Research ............................................................ 19 
31. 
Research Involving American Indian/Native Populations ..................................... 19 
32. 
Transnational Research .......................................................................................... 19 
33. 
Drugs or Devices .................................................................................................... 20 
Checklist Section ............................................................................................................... 21 

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1. Objectives 
There are two specific objectives. First, assess and incorporate patients’ post-operative 
pain experiences related to pelvic floor surgeries and identify what patients feel is 
important regarding pain experiences and expectations, their management and pre- 
operative education. Second, based on patient identified themes, assess the impact of 
patient-centered pre-operative education on 1) post-operative narcotic use and return to 
activities and function 2) patient preferences regarding amounts of post-operative 
narcotics prescribed and 3) to assess the impact on patient satisfaction and preparedness. 
The central hypothesis is that the development of patient-centered, pre-operative 
education specifically addressing pain issues and narcotic prescribing practices will 
decrease post-operative narcotic use without curtailing return to normal activity or 
function. The rationale for this hypothesis is that existing evidence-based, post-operative 
pain guidelines lack requisite patient input and that aligning patient and surgeon goals 
prior to surgery will help manage post-operative pain expectations, reduce number of 
opioids prescribed, decrease risk of opioid dependence and improve patient satisfaction 
and preparedness. Obtaining proof that this approach is clinically feasible and beneficial 
would positively influence patient care. The central hypothesis will be tested with the 
following specific aims: 
Specific Aim 1. 1a: To identify patient post-operative pain concerns surrounding pelvic 
floor surgery utilizing qualitative methodology through focus group sessions. 1b: To 
develop and implement pre-operative patient education based on the domains identified 
in specific aim 1a. Patient-centered education will address concerns regarding post- 
operative pain expectations and preferences regarding the amount of opioid prescribed at 
hospital discharge. Hypothesis: Patients are concerned and apprehensive about post- 
operative pain related to surgery. The conceptual themes regarding pain issues can be 
incorporated into pre-operative patient education, expanding the patient role in decision- 
making regarding narcotics supplied at hospital discharge. 
Specific Aim 2. 2a: To randomize women undergoing pelvic floor surgery to standard 
pre-operative education versus patient-centered education (as determined by Aim 1) and 
evaluate whether patient-centered education, compared to routine education, decreases 
narcotic consumption without interfering with return to regular activity following hospital 
discharge. 2b: To test whether patient-centered education decreases the quantity of 
narcotics prescribed and/or increases patient satisfaction and preparedness. Hypothesis: 
Patients exposed to patient-centered pre-operative education that includes pain 
expectations and patient preference, will decrease quantities of post-operative narcotics 
consumed and prescribed without interfering with return to activities, improving patient 
satisfaction and preparedness for surgery. 
Expected outcomes: Investigation of post-operative pain experiences in women who have 
undergone pelvic floor surgery will allow creation of patient-centered pre-operative 
educational material and allow inclusion of patients in the shared decision-making 
process. The resulting positive impact will be an improved approach to pre-operative 
education and management of post-operative pain in women undergoing pelvic floor 
surgery. 

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2. Background 
Opioid use disorder has reached epidemic proportions in the United States. Opioid 
prescriptions per capita increased 7% from 2007-2012, with concomitant increases in 
narcotic associated emergency room visits and opioid-related deaths.1 A Center for 
Disease Control (CDC) review reported that long-term opioid use disorder was 
commonly associated with narcotics prescribed for acute pain and that greater quantities 
at initial exposure were associated with greater risk of long-term use. Based on these 
findings, the CDC recommended limiting narcotic use for acute, non-surgical pain to ≤ 3 
days.1 
There is currently no clear consensus regarding how narcotics should be prescribed for 
pain, including post-operative pain, which has resulted in over 800 pain-management 
guidelines.2 Among these are two comprehensive, evidence-based documents cited by the 
CDC1 that specifically address post-operative pain management.3,4 Those guidelines 
emphasize judicious post-operative narcotic prescribing practices, discouraging opioid 
misuse while encouraging return to function. The Washington Medical Directors Group4 
provides particularly useful recommendations (Table 1). Perhaps the most important of 
which are 1) thorough pre-operative counseling, including setting realistic pre-operative 
expectations regarding post-operative pain and activity, and 2) optimizing non-narcotic 
analgesics allowing use of the lowest narcotic dose for the shortest duration of time 
(usually < 14 days). 
There has been an absence of significant improvement in opioid prescribing practices 
despite increased attention to pain addiction issues.2,5 The large number of proposed 
guidelines and lack of consensus regarding their use, may contribute to inconsistent 
implementation of post-operative pain protocols in clinical practice.6,7 As surgeons, 
urogynecologists routinely prescribe narcotics for post-operative pain control. 
Consequently, we can play an important role in curbing the opioid epidemic in the 
patients we serve. 
Urogynecologists lack a standardized approach to post-operative pain management. The 
ideal method to develop a standardized approach would be to bridge the gap between 
existing post-operative pain management options using a patient-centered approach. Our 
overarching goal is to provide pragmatic and replicable methods for post-operative pain 
management that can be disseminated for use by the urogynecologic community with 
potential use by the surgical community at large. 
3. Study Design 
This is a single-site mixed methods (qualitative and quantitative components) comprised 
of patient focus groups as well as a randomized control trial. 
Aim 1 - Substantive data are lacking regarding patient experience and recommendations 
surrounding post-operative pain. In instances where little literature exists, utilizing 
qualitative methods can help identify and address patient concerns. We will create a 
semi-structured interview guide based on existing literature with known and perceived 
gaps. We will then conduct a minimum of four focus groups, recruiting patients who have 
undergone pelvic reconstructive surgery in the past 6 months to a year. Given our patient 
population, we will plan for 2-3 focus groups conducted in English and 1-2 focus groups 
conducted in Spanish. Based on internal practice data, approximately 15% of our patients 

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are primarily Spanish speaking. Including Spanish-speaking patients will improve the 
generalizability of this study since approximately 25% of Spanish-speakers in the US 
report that they speak minimal to no English.19 Based on prior experience we will recruit 
enough women to ensure each focus group has 5-10 participants per session. Our research 
team is bilingual with vast experience conducting and completing qualitative work. 
Qualitative Analysis. According to the principals of grounded theory methodology, 
focus groups should be iterative, conducting additional sessions until saturation is 
reached. Saturation is met when no new concepts or themes are identified. Based on 
these principals and our past qualitative work, we will conduct a minimum of 4 focus 
group sessions and will continue to conduct sessions until saturation regarding post- 
operative themes is reached.20-22 We will audio record each session. The recordings will 
then be de-identified, transcribed, reviewed, and coded to identify key words and phrases, 
which will then be grouped to form preliminary themes. Following each focus group 
session, the transcript will be reviewed and analyzed to identify additional themes and 
emerging concepts. We will revise the interview guide as needed prior to each successive 
focus group to ensure that all significant patient themes are identified and explored. 
Following completion of the sessions, identified themes will be organized into domains 
and used to create patient-centered education for Aim 2. 
Aim 2 - This clinical trial will randomize women undergoing pelvic floor surgery to 
standardized routine pre-operative education versus standardized patient-centered pre- 
operative education (as identified in Aim 1) and will compare group differences for the 
following: 
Outcome Measures 
Primary Outcome: 1.Opioid Consumption -- Opioid consumption determined by pill 
counts and translated into Morphine Milligram Equivalents (MMEs), within 2 weeks of 
hospital discharge. Patients will be required to bring their narcotic medications for pill 
counts at their routine 2-week follow-up appointment, since this is the most reliable 
method for checking opioid use. A medication diary will document pattern of opioid and 
non-narcotic use and may potentially serve as a behavioral modification tool for narcotic 
consumption. 
Important Secondary Outcomes: 1. Opioids prescribed at hospital discharge and Opioids 
consumption at 6-week follow-up. 2. Patient Reported Outcomes Measurement 
Information Systems (PROMIS)29 Physical Function SF & Pain Interference 
Questionnaires -- at baseline, 2 and 6 week follow-up. These validated questionnaires 
(available in English and Spanish) measure patient-reported physical activity and pain in 
the preceding 7 days.30 Raw scores are translated into standardized scores; mean T-score 
represents the average score of the general population and a difference of 10 points 
represents 1 SD away from the mean. 
Other Secondary Outcomes: Patient Satisfaction and Preparedness for Surgery: We will 
administer Global Questionnaires assessing (1) satisfaction with pre-operative education 
and care and (2) assessing patient’s perceptions regarding preparedness for surgery. 
These will be administered to both Spanish and English speaking patients. Questionnaires 
will be scored on a 1-5 Likert scale (Strongly disagree to Strongly agree). (Other 
validated post-operative satisfaction and preparedness questionnaires are not readily 
available in Spanish; existing Spanish questionnaires are condition-specific -- general or 
urogynecologic post-operative questionnaires are not currently validated.) 

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4. Inclusion and Exclusion Criteria 
We will recruit women cared for by the University of New Mexico Urogynecology 
practice at UNMH Women’s Care Clinic or Sandoval Regional Medical Center 
undergoing pelvic floor surgery. Patients who have elected to proceed will be offered 
study enrollment if they meet the inclusion and do not meet the exclusion criteria. 
The inclusion criteria are: 
1. Subjects are ≥ 18 years of age 
2. English or Spanish speaking 
3. Patient scheduled for pelvic floor surgery 
Exclusion criteria are as follows: 
1. Unable to speak English or Spanish 
2. Using long acting opioids (e.g. MS Contin, Fentanyl patch) 
3. Primary or Pain Healthcare Provider recommends against study participation 
(eg. If the patient has a history of opioid use disorder or other confounding 
problems, we will contact the Primary Care Provider or Pain Healthcare 
Provider for their recommendations regarding study participation) 
4. Undergoing surgeries that involve: Neuro/Interstim, Cysto/hyrdro distension, 
vaginal botox, mesh excision/complications 
 
Special populations such as adults unable to consent, individuals who are not yet adults, 
pregnant women, and prisoners will not be included in this study. 
We will be excluding women who are unable to speak and understand either 
English or Spanish. The justification for this is the satisfaction surveys are only 
available in English and Spanish and include the majority of the patients care by our 
group. Because these are our secondary objectives, it is important to use these 
standardized surveys. Additionally, we can only conduct focus groups in English or 
Spanish given our qualitative team is bilingual only in English and Spanish. 
 
5. Number of Subjects 
This a qualitative and randomized control trial at a single site – the University of New 
Mexico’s Urogynecology department. 
Up to 60 participants will be recruited for the focus groups and up to 198 people will be 
recruited for the randomized controlled trial at UNM. 
Power Calculation & Statistical Analysis: 
Based on our prior qualitative experience; approximately 10-12 participants must be 
recruited to have 6-8 attend the focus group. We plan to conduct 4 focus groups; and 
need to recruit 48 subjects. Given it is possible thematic saturation will not be 
achieved after 4 focus groups; we will recruit additional subjects and complete 
additional focus group until saturation is obtained. Although a few studies describe 

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opioid prescribing practices following Ob-Gyn surgery, we could not find any studies 
that reported opioid consumption following gynecologic or urogynecologic surgery. 
In order to perform the power calculations necessary for Specific Aim 2 (comparing 
opioid use between groups), because the actual number of opioids consumed 
following urogynecologic surgery is unknown, we will assume that patient-centered 
pre-operative education will result in a 33% decrease in narcotic consumption 
following hospital discharge compared to the control group. If we assume that 
controls consume a mean of fifteen 5 mg oxycodone pills (SD of +/-11 pills), and if 
we assume that the patient-centered group consumes 33% fewer pills (i.e. 10 pills in 
the modified education group), we would need a total of 152 participants (76 per 
group) to complete treatment and follow-up for a two-tailed t-test to have 80% power 
at α=0.05. Assuming approximately 30% of patients will cancel surgery after 
randomization (including medical or insurance issues or change their mind) or will be 
lost to follow-up; we would need to enroll up to 198 women (99 per group) or until 
our designated power is met. We will perform between group comparisons using Chi- 
squared tests for categorical variables and t-tests for continuous variables. We 
anticipate that specific covariates (e.g. baseline questionnaire results, and narcotic use 
in last 3 months) may be confounders and that multivariable analyses will be required 
to evaluate the between group differences in outcomes. Note 1: When studies involve 
consent, an individual is considered a research subject once they have provided 
consent. If the research includes screening procedures after consent, please indicate 
the number of subjects that need to be recruited and the number that will actually 
participate in the research post-screening. 
6. Study Timeline 
Subjects in Aim 1 will participate in one focus group. Subjects in Aim 2 will 
participate up to the 6 week post-operative visit. This could occur within a window 
up of up to 8 weeks past their surgery. 
We will be able to complete this project within the planned timeframe outlined below. 
The UNM Urogynecology Division performed approximately 230 major pelvic floor 
operations last year (average of 19/month). We will create the database, standardize 
current pre-operative sessions, and prepare the manual of operations and focus group 
script for Specific Aim 1 over the next 3 months. We will identify patients for 
enrollment in the focus groups during this initial period. This preparation will then 
allow us to successfully execute specific Aim 1 over the subsequent 3 months. We 
will have biweekly to weekly focus group meetings during the start-up period of the 
grant cycle. This allows 8-10 weeks to review our findings and develop a patient- 
centered educational plan. We will then enroll up to 198 women or until our specified 
power is met over the next 1-4 years given the halt of all elective surgeries with the 
Covid pandemic(averaging 11 participants/month). We anticipate finishing 
recruitment by October 2021 and follow up for those randomized by December 
2021We, thus, expect to meet our recruitment goals. The last 3 months of the grant 
cycle will be dedicated to statistical analysis and abstract and manuscript preparation. 
As all patients receive pre-operative education and have scheduled 2 and 6-week 
post-operative visits, we anticipate that the vast majority of our patients will be 

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willing and able to participate in this study. Experience indicates that our patients 
have willingly participated in previous RCTs with high retention rates. We expect 
that this pattern will continue. We will continuously evaluate our recruitment 
numbers. 
 
 
 
Timeline 
March-May 
2018 
June-August 2018 
Sept 2018-December 2021 
(3 years, 3 months) 
December 2021- 
February 2022 
IRB submission, Database creation, 
Focus group recruitment planned, 
Standardize patient-centered pre- 
operative education 
 
Conduct focus group sessions, 
Standardize patient-centered pre- 
operative education 
 
 
Recruit & follow 180 patients until 
6-weeks after surgery 
 
Data analysis, manuscript 
preparation 
 
 
7. Study Endpoints 
Investigation of post-operative pain experiences in women who have undergone pelvic 
floor surgery will allow creation of patient-centered pre-operative educational material 
and allow inclusion of patients in the shared decision-making process. The resulting 
positive impact will be an improved approach to pre-operative education and 
management of post-operative pain in women undergoing pelvic floor surgery. 
Primary Outcome: 1.Opioid Consumption -- Opioid consumption determined by pill 
counts and translated into Morphine Milligram Equivalents (MMEs), within 2 weeks of 
hospital discharge. Patients will be required to bring their narcotic medications for pill 
counts at their routine 2-week follow-up appointment, since this is the most reliable 
method for checking opioid use. A medication diary will document pattern of opioid and 
non-narcotic use and may potentially serve as a behavioral modification tool for narcotic 
consumption. 
Important Secondary Outcomes: 1. Opioids prescribed at hospital discharge and Opioids 
consumption at 6-week follow-up. 2. Patient Reported Outcomes Measurement 
Information Systems (PROMIS)29 Physical Function SF & Pain Interference 
Questionnaires – at baseline, 2 and 6 week follow-up. These validated questionnaires 
(available in English and Spanish) measure patient-reported physical activity and pain in 
the preceding 7 days.30 Raw scores are translated into standardized scores; mean T-score 
represents the average score of the general population and a difference of 10 points 
represents 1 SD away from the mean. 
Other Secondary Outcomes: Patient Satisfaction and Preparedness for Surgery: We will 
administer Global Questionnaires assessing (1) satisfaction with pre-operative education 
and care and (2) assessing patient’s perceptions regarding preparedness for surgery. 

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These will be administered to both Spanish and English speaking patients. Questionnaires 
will be scored on a 1-5 Likert scale (Strongly disagree to Strongly agree). (Other 
validated post-operative satisfaction and preparedness questionnaires are not readily 
available in Spanish; existing Spanish questionnaires are condition-specific -- general or 
urogynecologic post-operative questionnaires are currently unavailable.) 
 
8. Research Setting 
The study will be performed at the University of New Mexico (UNMH) Women’s Care 
Clinic and Sandoval Regional Medical Center (SRMC). Potential subjects will be 
recruited in the UNMH and SRMC clinics. After recruitment, they will undergo the 
consent process (written or verbally), and fill out initial questionnaires in the outpatient 
offices, by phone, email link to REDCap or HIPAA compliant zoom, whichever works 
best for the participant. There are no laboratory tests in this trial other than what would 
be routinely collected for standard of care. There will be no involvement of any 
community advisory board. There will not be any research conducted outside of the 
UNM HSC. 
9. Resources Available 
The previous PI, Dr. Jeppson joined UNM in 2013 with an impressive pedigree and 
research experience from his residency at Cleveland Clinic and his FPMRS Fellowship at 
Brown University in Providence. During his tenure at UNM he has already significantly 
contributed to the scientific knowledge in our field. As his CV and publication record 
demonstrate he is clearly committed to an academic research career. He has led and 
conducted a wide variety of research, including systematic reviews that have fostered 
changes to medical practice with high quality evidence. He is skilled at leading a research 
team and is meticulous with deadlines. He is extremely committed and gets things done. 
This study is a natural extension of his work to improve patient care and clinical 
outcomes. Dr. Jeppson is an astute, driven, clinical researcher who is already becoming a 
leader in our field. 
Dr. Jeppson’s research proposal will pragmatically study and implement an educational 
intervention to decrease post-operative narcotic use. This research augments his 
experience and interest in improving clinical care and patient education. Dr. Jeppson’s 
thesis project during fellowship, “Improving patient knowledge about sacral nerve 
stimulation using a patient based educational video” (published in the Journal of 
Urology), clearly demonstrates his commitment to patient education. Although that 
research study evaluated different outcomes, it is similar to this study in that it was a 
mixed methods project that incorporated patient preferences into educational material. 
Dr. Tasha Serna-Gallegos will take over as PI as this was her thesis project as a fellow 
and Dr. Peter Jeppson has lowered his FTE with UNM as he has moved to a practice out 
of state. 
The University of New Mexico (UNM) urogynecology division operates at two main 
locations. UNMH Women’s Care Clinic located in northeast Albuquerque provides a full 

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range of services for women with pelvic floor disorders. The clinic consists of eight exam 
rooms and two treatment rooms. Our second location is at Sandoval Regional Medical 
Center (SRMC), a community based facility located in Rio Rancho, New Mexico, a large 
suburb located outside of Albuquerque. 
Research Experience: The Urogynecology Division at UNM has a strong history of 
conducting high quality research and collaboration with other investigators in the US and 
abroad and has consistently met or exceeded recruitment goals on time. We were 
members of the NICHD-sponsored PFDN in the last grant cycle, and have met 
recruitment goals with high rates of follow-up and accurate data collection. 
 
Our group is well versed in the importance of adherence to protocols, timely completion 
of regulatory requirements, effective recruitment strategies, and the importance of the 
inclusion of minority subjects. Research is integral to all aspects of Divisional work; 
importantly, all members of the clinical team participate in research efforts. There are 
weekly research meetings to discuss the progress of the ongoing studies within the 
department, and it is an excellent forum to ensure that all involved are adequately 
informed of their duties, of the protocol, and of the procedures. 
We do not anticipate that emergency care will be needed for this study, however the 
urogynecology physicians are available on a 24-hour basis, 7 days per week for their 
patients requiring emergency care. 
10. Prior Approvals 
There will not be any approvals obtained prior to commencing the research. The study 
was presented for approval by the Department Chair or Vice Chair of Research. The 
signed Departmental Review form can be found in the “supporting documents”. 
This study does not include any ionizing radiation, biologic specimens, or drugs. 
Medications prescribed to participants will be part of their standard of care. 
11. Multi-Site Research 
N/A this is not a multi-site study or a FDA regulated trial. 
12. Study Procedures 
The only procedures subjects will undergo are those that are needed as part of their 
routine preoperative, intraoperative and postoperative care. There are no procedures 
related to the study. 
All surgeries will take place at UNM Main, OSIS or SRMC operating rooms. 
Questionnaires and data collection will occur in the Urogynecology clinics at UNM or 
SRMC, by phone, HIPAA compliant Zoom or email link to REDCap, whichever is best 
for the participant. All data will be collected prospectively. 
Participant Flow through the Study: Figure 1 (N range pending funding) 

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Surgery 
Pre-Op NSAID, Acetaminophen, & Gabapentin (Unless contraindicated) 
Post-Op Hospital: Encourage Oral Opioids 
Pt Centered Pre-Op Education (N=45-99) 
Routine Pre-Op Education (N=45-99) 
Enroll Patients Scheduled for Pelvic Floor Surgery (N=90-198) 
Baseline: Demographics, Opioid History, Physical Function & Pain Questionnaires 
Randomize to: 
Enroll Patients in a One-Time Focus Group (N=40-60) 
6 Week Post-Op 
Medication Diary, Physical Function & 
Pain Questionnaires, Opioid Pill 
Counts, Preparedness for Surgery & 
Satisfaction Questionnaires 
6 Week Post-Op 
Medication Diary, Physical Function & 
Pain Questionnaires, Opioid Pill 
Counts, Preparedness for Surgery & 
Satisfaction Questionnaires 
Discharge 
Modified # Opioid (Pt Preference-See 
Text) & Non-Opioid Medications 
Discharge 
Routine # Opioid & Non-Opioid 
Medications 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
2 Week Post-Op 
Opioid Pill Counts & Medication Diary, 
Physical Function & Pain 
Questionnaires 
2 Week Post-Op 
Opioid Pill Counts & Medication Diary 
Physical Function & Pain 
Questionnaires 
 
 
 
 
13. Data Analysis 
Power Calculation & Statistical Analysis: Although few studies describe opioid 
prescribing practices following Ob-Gyn surgery, we could not find any studies that 
reported opioid consumption following gynecologic or urogynecologic surgery. In order 
to perform the power calculations necessary for Specific Aim 2 (comparing opioid use 
between groups), because the actual number of opioids consumed following 
urogynecologic surgery is unknown, we will assume that patient-centered pre-operative 
education will result in a 33% decrease in narcotic consumption compared to the control 
group. If we assume that controls consume a mean of fifteen 5 mg oxycodone pills (SD 
of +/-11 pills), and if we assume that the patient-centered group consumes 33% fewer 
pills (i.e. 10 pills in the modified education group), we would need a total of 152 
participants (76 per group) to complete treatment and follow-up. Assuming 
approximately 30% of patients will cancel surgery after randomization or will be lost to 
follow-up; we would need to enroll 198 women (99 per group). We will perform between 
group comparisons using Chi-squared tests for categorical variables and t-tests for 
continuous variables. We anticipate that specific covariates (e.g. baseline questionnaire 
results, and narcotic use in last 3 months) may be confounders and that multivariable 
analyses will be required to evaluate the between group differences in outcomes. 
 
14. Provisions to Monitor the Data to Ensure the Safety of Subjects 
Subjects will participate in focus groups and then receive preoperative education and 
shared decision making on quantity of opioid prescribed postoperatively. Therefore the 
risks inherent to participation in the study are only minimal. As this is a minimal risk 
study, our Data Safety Monitoring Plan will entail the review of data monthly by staff 
and the PI or a mentoring co-investigator. We will assess for harm such as over treatment 

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of pain, which is highly unlikely as we are complying with our standard of care. It would 
be unlikely that the study would require suspension as patients in the intervention arm are 
actually having less exposure to harm than the standard of care arm. Specific findings we 
will be looking for are adverse events, serious adverse events and reportable new 
information. 
15. Withdrawal of Subjects 
Any participant may withdraw from the study at any time without penalty and will 
continue to receive the clinical standard of care. A subject may be withdrawn from the 
study without her consent at the discretion of the physician and study staff if they believe 
she no longer meets study inclusion criteria or if she meets exclusion criteria, or if they 
believe that it is not in her best interest to continue study participation. Investigators may 
withdraw a subject if the subject is not following the study protocol. If a woman is 
withdrawn from the study either at her own discretion or that of the research staff, she 
may continue with the planned surgical procedure performed in the usual fashion. 
To minimize withdrawal from the study, patients will be randomized at their pre- 
operative visit. According to the 2010 CONSORT guidelines, we will analyze all 
participants assessed for eligibility within the study. We will document reasons for 
withdrawal from the study including failure to meet eligibility criteria or participant 
declining enrollment into the study. We will report eligibility criteria not met or reasons 
for declining participation in the study. The withdrawal procedure is clearly documented 
in the study consent. 
16. Data Management/Confidentiality 
Randomization assignment will be generated by a computer based randomization table 
and assigned by a research coordinator. Assignments will be kept in sealed opaque 
envelopes numbered sequentially, and on the day of the patient’s pre-operative visit, the 
surgeon will call a research coordinator who will open the next envelope in the sequence. 
All data collection sheets and questionnaires will contain the subject number and day of 
the clinic visit or day of completion. No other patient identifiers will be collected. PHI 
including patient name, date of birth, phone number, and medical record number will 
need to be collected to track for appointments. 
The data collection, HIPAA and consent forms will be maintained in a locked file cabinet 
in the OBGYN administrative area. A separate folder will be designated for each 
participant. The offices have the additional security of being badge-access only for 
OBGYN department employees. A key matching study number to subject’s name will be 
in a spreadsheet secured on a password protected computer. 
The only PHI collected will be patient name, date of birth, medical record number and 
telephone number for site use only and to ensure patient follow up. This will not be 
entered into the database, but it will be kept with the other identifying information. 
The data does not include sensitive information or information requiring additional 
protection. 

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Electronic data entry will be performed in the OBGYN administrative offices, using the 
de-identified subject study number. The electronic data will be encrypted, password 
protected, and stored on the secure UNM OBGYN department server. This server’s 
electronic security is monitored / maintained by the Health Sciences Library and 
Informatics Center (HSLIC). A REDCap database will be created to collect, store and 
manage the data. REDCap databases are reposed securely. The REDCap database is only 
accessible using a individual unique login and password and access is only provided to 
co-investigators. Access is restricted to co-investigators and will be protected using the 
unique REDCap login and password provided to each co-investigator. 
Access to the files and REDCap will be restricted to research personnel and Investigators 
and will be locked or protected using the unique REDCap login and password provided to 
each co-investigator. The data will be stored for 5 years after completion of analysis and 
then will be destroyed. 
A Certificate of Confidentiality will not be used to protect data from forced release. No 
data will be transported to outside locations or shared with external institutions. Focus 
groups will be audio-recorded; the transcriptions will be de-identified and the original 
audio-recordings will be destroyed following manuscript publication. There will be no 
video recordings or photographs taken. 
17. Data and Specimen Banking 
As stated above, the data collection, HIPAA and consent forms will be maintained in a 
locked file cabinet in the OBGYN administrative area. A separate folder will be 
designated for each participant. A key matching study number to subject’s name will be 
stored on a password protected computer on a secure UNM OBGYN department server. 
In order to further ensure patient confidentiality, the identifying information will be kept 
separately from the numbered study files in a locked cabinet. The data will be maintained 
for 5 years after completion of the study and then destroyed. 
 
No specimens will be archived for future use. Additionally, this is neither a multi-center 
study nor will any information be banked or archived elsewhere. 
18. Risks to Subjects 
Focus groups by their nature cannot be anonymous. However, participants will be asked 
to keep what was discussed in the focus groups confidential and will be asked to use their 
first names only. The focus group transcripts will be de-identified. Risks of enrollment 
in the study include the risk of breach of confidentiality. We will take every measure to 
try to ensure the security and confidentiality of participants. This may result in 
stigmatization or hardship. Participants will be recruited in a private room and will have 
ample time to consider whether they want to participate in the study. Also, locked filing 
cabinets will be used to protect patient consent information and collected data. The link 
identifying patients and their study numbers will be also be stored on a password 
protected computer on a secure UNM OBGYN department server. There are risks of 
stress, emotional distress, and inconvenience. 

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Pregnant women will not be included in the study, so there is no risk to embryos/fetuses. 
19. Potential Benefits to Subjects 
Participation in this study may provide information that may help other people who have 
a similar medical problem in the future. 
 
20. Recruitment Methods 
We will recruit women from our urogynecology clinical practice at UNM and SRMC. 
The urogynecology clinics at UNM and SRMC have a large referral population of 
patients who undergo pelvic floor surgery. Participants will be identified in the clinics at 
UNM/HSC and Sandoval Regional Medical Center by investigators. All patients 
scheduled for surgery will be approached for recruitment for the RCT portion of this 
study. The focus group participants will be identified through previous study consents 
that said they would be willing to be contacted for future research. Additionally, the 
urogynecolgy division keeps a computer record of the patients that had urogynecologic 
surgery over the past year as part of our standard care and scheduling. These patients 
may also be contacted by their surgeon to see if they are interested in participating in a 
focus group. Subjects are encouraged to consult with family, friends, and primary health 
care providers, as well as communicate any questions they may have before beginning 
the consent process. 
 
If a woman is withdrawn from the study either by her desire or that of the research staff, 
or does not desire to participate, she will be offered the same treatment options. 
There will be no other additional materials to recruit subjects. 
21. Provisions to Protect the Privacy Interests of Subjects 
Focus groups by their nature cannot be anonymous. However, participants will be asked 
to keep what was discussed in the focus groups confidential and will be asked to use their 
first names only. The focus group transcripts will be de-identified. 
Privacy concerns are taken into account with every patient seen at the UNM and SRMC. 
Participants approached and/or interviewed in the clinic setting will be in private offices 
or examination rooms in the UNM or SRMC clinic, where all staff, including research 
staff, are well-versed in sensitive health care discussions and procedures. Telephone 
interviews for recruitment and study data gathering are conducted in the research staff 
area or private physician offices, where all staff have received CITI Training. The office 
area designated for the entire urogynecology research staff is isolated from the clinical 
administrative staff area, providing protection for participants and potential participants 
during screening, recruitment, study-designated calls, and data entry. 
 
All study sheets used to collect patient information will be de-identified. 

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At all times throughout the clinical investigation confidentiality will be observed by all 
parties involved. All data will be secured against unauthorized access. Privacy and 
confidentiality of information about each subject will be preserved in study reports and in 
any publication. Each subject participating in this study will be assigned a unique 
identifier. HIPAA authorization is within the consent. All documents containing personal 
health information (screening logs, consent documents, data forms) are maintained in 
locked file cabinets with access available only to research staff and investigators. Data is 
entered into a password-protected system. No individual identifiers are entered into the 
system. The sole link with personal information is maintained by the research team on a 
password protected computer on a secure UNM OBGYN department server with access 
limited to authorized research staff and investigators. This information is only to be used 
at the study center. 
22. Economic Burden to Subjects 
 
 
Research Procedures 
Number of 
Samples/Procedures 
Responsible Party 
Study 
3rd Party Payer 
or Participant 
Focus Group – Aim 1 
1 
 
Demographic Form 
1 
 
PROMIS Physical Function SF 
3 
 
PROMIS Pain Interference SF 
3 
 
Patient Satisfaction and Preparedness for 
Surgery Questionnaire 
1 
 
Medication Diaries 
2 
 
Opioid History 
1 
 
 
 
 
Standard of Care Procedures 
Number of 
Samples/Procedures 
Responsible Party 
Study 
3rd Party Payer 
or Participant 
Urogynecology Clinic Visits pre-op, 2 & 6 
week post-op 
3 
 
 
Pelvic Floor Surgery 
1 
 
Pain medication post-op 
Varies per patient 
 
 
 
 
 
 
 
 
 
 
 
23. Compensation 
Pending funding - For enrollment in Aim 1, participants will receive a $50 merchandise 
card for their participation in one focus group. For enrollment in Aim 2, participants will 
receive a $10 at their initial visit, $20 at their 2-week post-operative visit and $20 at their 
6-week post-operative visit for a total of $50 in merchandise cards for their participation 
in the study. This incentive will offset the cost of subject’s time and transportation while 
participating in the study. 

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24. Compensation for Research-Related Injury 
If participants are injured or become sick as a result of this study, UNM HSC or SRMC 
will provide emergency treatment at the study participant’s cost. No commitment is made 
by the University of New Mexico Health Sciences Center to provide free medical care or 
money for injuries to participants of the study. Reimbursement for treatment for all 
related costs of care will be sought from the participant insurer, managed care plan, or 
other benefits program. The participant will be responsible for any associated co- 
payments or deductibles required by the insurance. Participants will be asked to report 
any illness or injury they believe to be related to the study to the investigator or research 
staff. Participants will be given telephone contact information for the urogynecology 
office for the purpose of asking any questions or stating any concerns about the study or 
treatment as a research subject. They may also be directed toward the HRPO. This 
language will be stated in the consent document and reviewed during the informed 
consent process. There is no additional risk to participate in this study. 
 
25. Consent Process 
Patients will be approached about the research study at the urogynecology clinics at 
UNM and SRMC, as well as on phone and by HIPAA compliant Zoom, after the patient 
has decided to have surgery. The study consent will be obtained by one of the research 
team members. Verbal consent will be noted on the updated consent form with a space to 
also sign if the patient has an office visit in person. Due to the pandemic, research 
coordinators are mainly working from home and going through the consent with 
participants by phone for the safety of everyone. Privacy is still maintained as the 
coordinator ensures they have a place they can talk privately by phone. Additionally, 
care will not be withheld if they decide not to participate. 
They will have multiple opportunities to ask any questions that they may have, and they 
will also be provided with the clinic’s contact information to get in touch with research 
investigators to address any additional questions or concerns. 
Subjects will be reassured that participation is completely voluntary and does not affect 
their treatment, their relationship with their providers, or the university to minimize the 
possibility of coercion or undue influence. The patients will be asked that they 
understand the opportunity to participate and their complete freedom to decline. This 
will also be asked if they understand and if they have any questions. There is no 
minimum time period needed between informing the patient of the study and time of 
consent. Subject will be encouraged to take as much time as they need. 
This study will obtain HIPAA authorization prior to enrollment. HIPAA authorization is 
embedded within the study consent form, which will be reviewed with all participants by 
the physician or research coordinator obtaining consent. Specific information that will be 
obtained includes prior medical history, surgical history, reproductive health history 
including child bearing, drug allergies, age, and ethnicity. This information will be 
obtained by health care providers, not research coordinators, as deemed necessary for a 

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more complete and accurate medical history of the patient and is part of the standard of 
care during preoperative assessment. 
Spanish speaking patients will be included. We will submit the translated documents 
once the study is approved by the IRB. 
Cognitively Impaired Adults will not be included in the study. 
All subjects will be 18 years of age or older. No infants, children or teenagers will be 
enrolled in the study. 
26. Documentation of Consent 
We plan to document consent, and the Consent form is attached. We do not plan on 
collecting/storing tissue samples. We will have the option to consent verbally. We will 
not be using a script, information sheet, or other mechanism. 
 
27. Study Test Results/Incidental Findings 
We do not intend to share study test or procedure results with study participants. 
Additionally, we do not anticipate that the research being conducted will result in 
incidental findings. Every patient will receive the practice’s standard of care regarding a 
pre-operative work up, which may include different laboratory tests and imaging studies, 
as determined by their other active medical issues. These results are not part of the 
research being conducted and will hence be disclosed to the patient as appropriate for 
standard of care. 
 
28. Sharing Study Progress or Results with Subjects 
The patients will not be masked to their study arm. We do not intend to seek out study 
participants to disseminate information once the study is complete. Women who are 
interested in the results will be provided the information where to read the manuscript 
once it is published. Study results for individual participants will not be shared. 
29. Inclusion of Vulnerable Populations 
There will not be any vulnerable populations included in this study. Those electing for 
surgery will not be coerced into doing so, nor will they be coerced into participating in 
this trial. 
 
30. Community-Based Participatory Research 
NA. There will be no involvement of the community in this research. 
31. Research Involving American Indian/Native Populations 
NA. This research does not specifically target this population. If a Native American 
woman is a candidate for this study, she will be offered participation. 

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32. Transnational Research 
NA. This study is not transnational. 
33. Drugs or Devices 
NA. This research does not involve drugs or devices. 

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Checklist Section 
This section contains checklists to provide information on a variety of topics that require special 
determinations by the IRB. Please complete all checklists relevant to your research. 
 
I. Waivers or Alterations of Consent, Assent, and HIPAA Authorization 
A. Partial Waiver of Consent for Screening/Recruitment 
We are not requesting a partial waiver of consent 
Partial Waiver of HIPAA Authorization for Screening/Recruitment 
We are requesting a partial waiver of HIPAA authorization to prescreen participants. 
Investigators will review the medical records of potential participants in PowerChart 
to determine if they are a good candidate for participation. They may review 
information such as medical history including surgeries and medications. 
The protected health information will not be reused or disclosed to any other person 
or entity, except as required by law, for authorized oversight of the research study, or 
for other research for which the use or disclosure of protected health information for 
which an authorization or opportunity to agree or object is not required by 45 CFR 
164.512. 
We will be using PowerChart to screen potential participants who have already had 
surgery at UNMH or SRMC. We will review their medical records through 
PowerChart to ensure they meet the inclusion/exclusion criteria. PHI that will be 
reviewed in PowerChart will include information such as date of birth, gender 
identity, and diagnoses. The only PHI that will be stored will be the patient’s name, 
MRN, and the reason they were not approached or included in the study. This 
spreadsheet is an encrypted document and will be destroyed at the conclusion of the 
study. 
 
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