Older Adult Safety in Surgery (OASIS) - Can a Preoperative Self-Reported Functional Status Information Improve Prediction of Cardiac Mobility Related Complications That Threaten Patient Safety In Older Adult Surgical Patients?
Phase: NA
Conditions: Frail Elderly Syndrome
Sponsor: University of Massachusetts, Worcester

 
 
Older Adult Safety in Surgery (OASIS) IV 
Study Protocol with Statistical Analysis Plan 
March 7, 2019 

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1. TITLE 
Older Adult Safety in Surgery (OASIS) IV 
 
 
2. EXTERNAL IRB REVIEW HISTORY* 
N/A 
 
 
3. PRIOR APPROVALS: 
N/A 
 
 
4. OBJECTIVES* 
Surgery is a life-saving procedure for patients with cancer and can enhance quality of life 
for patients with intractable abdominal or thoracic disease. Although most patients tolerate 
the procedure well, frail older adults have as much as a threefold increase in the risk of adverse 
outcomes after surgery.1  
In response to this risk, some investigators
2-4 have studied 
preoperative exercise interventions (a.k.a. pre-habilitation). 
So far, pre-habilitation studies2,4 
have shown improvement in endurance but not a 
reduction in adverse outcomes such as medical complications, discharge to nursing home, or 
readmission. Potential explanations are that these studies were too small to show a difference 
but also they did not focus on frail older adults who 
could benefit most from prehabilitation. A final explanation is that they relied on clinic visits 
with physical therapists or kinesiologists which can add to the stress and cost of surgery for 
patients already burdened with appointments in the short preoperative period. 
A home walking prescription self-monitored with a modern pedometer (e.g. Fitbit type 
wristband) provides a convenient and cost-effective method for prehabilitation. Despite the 
apparent advantages of a home walking program, no one has demonstrated that such a 
program can reduce the incidence of adverse outcomes or improve physical status assessments 
such as endurance, balance, gait speed, strength, and self-reported function. If our 
investigative group establishes that a walking prescription supported by pedometer improves 
these assessments, we would be in a favorable position to embark on a larger study to 
demonstrate a reduction in adverse clinical outcomes. 
There are other data that would be helpful to collect prior to embarking on the larger 
study. These include the role of varying duration of the walking regimen. Given the rush to 
proceed with surgery in anxious patients, it would be important to know how well the 
intervention works over the range of times available and if there exists a threshold of duration 
(e.g. 1-2 weeks) below which a walking prescription would have no effect. 
Additionally, it would be important to analyze step counts from the pedometer and the 
percentage of days in which individual patients achieved prescribed targets. This would 
permit assessing whether any improvements in physical status resulted from the walking 
intervention. Conversely, if there is no improvement in physical status assessments, we 
could diagnose if nonadherence with the walking prescription was the reason. Finally, it 
would be helpful in guiding future research to calculate the time and cost required to recruit 
eligible patients as well as to assess patient satisfaction with the walking prescription. 

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We therefore propose a study of 400 older adults scheduled for surgery with the 
following aims which will prepare us to conduct a larger trial focused on clinical outcomes.   
 
Aim 1: To assess the impact of a walking prescription intervention on outcomes of 
endurance, balance, gait speed, strength, and self-reported function in patients with frailty. 
Aim 1a: To estimate improvement in outcomes as a function of duration of the 
walking intervention.  
Aim 1b: To re-estimate the effect of the intervention adjusting for the percentage of 
days each patient met his/her walking goal. 
Aim 1c: To measure patient satisfaction with the walking intervention. 
 
Aim 2: To measure the average time and cost required to recruit and follow up each patient. 
 
Aim 3: Postoperative outcomes:  we may also measure several postoperative outcomes  
Change in six-minute walk distance from baseline 
The number of steps per day in the hospital  
Time to 100 steps at the day of discharge. 
Discharge to skilled nursing facility 
Length of stay 
Thirty-day outcomes including serious complication, readmission, and death  
 
Aim 4: Measure the performance of Edmonton frailty score for predicting 30 day outcomes 
including serious complication, readmission, death. 
 
 
5. BACKGROUND* 
Frail older adults are at elevated risk for adverse postoperative outcomes. With aging, 
impairments underlying physical function emerge, such as muscular weakness, decreased lower 
extremity proprioception/balance, and visual deficits. These impairments limit walking ability 
which in-turn limits participation in daily life activities. A more sedentary lifestyle ensues 
leading to further lower extremity weakness which becomes manifest in slow gait speed.5  These 
sedentary individuals also undergo significant loss of endurance/exercise capacity as their bodies 
becomes less efficient at using oxygen.6  This is significant given the stress on the body during 
surgery. Frail older adults are also at risk for delayed mobilization which can lead to multiple 
other medical complications. Afilalo et al.1 found that cardiac surgery patients with slow gait 
speed, a good single marker of frailty, had more than a threefold increase in morbidity and 
mortality (odds ratio= 3.05 95% CI 1.23-7.54) 
In that study, the authors used gait speed < 0.83 m/s which is a relatively stringent criterion for 
slow speed. Using a more liberal gait speed criterion (≤ 1.0 m/s), our research group still found a 
1.7 fold increased risk (hazard ratio=1.71 95% CI 0.67-4.31) of developing an adverse 
postoperative course for older adults.7 
 A pure walking intervention (without resistance or other exercise components) can lead to 
improved physical status in frail older adults but it has not been tested previously in the surgical 
setting. Investigators have shown that long term care residents (typically frail) can participate 
and benefit from regular walking.8  Similarly, investigators with the COPD Seat study9 have 

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proposed looking at whether a two-week movement intervention (i.e. essentially a walking 
program) titrated to step count can improve balance, gait speed, and strength in patients 
discharged after hospitalization for COPD. 
  
Our proposal will assess the role of a walking intervention in the surgical context assessed over 
multiple dimensions of physical status-endurance, balance, gait speed, strength, and self-reported 
function. 
 
The gains we achieve with the walking intervention will pay dividends in terms of clinical 
endpoints. We hypothesize that a preoperative walking intervention will lead to improvement in 
physical status by the time of surgery. 
 
Prior studies did not use pedometers and also did not isolate the most vulnerable participants like 
frail older adults. Gillis et al.2 studied 77 patients of varying physical status (i.e. all comers) 
scheduled in a randomized control trial. In this trial the authors compared a tri-modal 
intervention administered 4 weeks preoperatively and 8 weeks postoperatively for improving 
endurance, nutrition, and anxiety compared with a group that received this only postoperatively. 
At the end of the preoperative phase, patients receiving pre-habilitation walked on average 
41.6m more during six minute walk distance (6MWD) testing than controls. However, the rate of 
postoperative complications did not differ significantly between groups and the cost and 
convenience of that intervention were unfavorable. 
 
Dronkers et al.4 had both clinic-based and home-based exercise components in their preoperative 
intervention (with multiple trainers enlisted at presumed great cost). As part of their intervention 
they tracked patients with traditional pedometers. Despite these comprehensive efforts, they did 
not find any significant differences in endurance or clinical complications. One explanation for 
the lack of effect may be that the investigators did not use the pedometer for goal setting. Goal 
setting has proven itself when it comes to pedometers increasing physical activity / number of 
steps.10 In addition, neither the Dronkers nor Gillis study isolated frail older adults whose 
elevated baseline risk provides an increased opportunity for preventing adverse events.  
 
 
Impact  
We target frail older adults. Unlike prior prehabilitation studies, we focus on frail older 
adults. Working with this group provides a unique opportunity to make big gains in 
endurance and other aspects of physical status (relative to baseline status). In future work 
we can assess whether these relative gains translate into significant clinical outcome 
reduction. 
 
Our intervention is low-cost and convenient. The convenience to patients of a home 
walking intervention will pay dividends in terms of adherence. Given the low baseline 
physical status of the patients we are recruiting, walking is the intervention that makes the 
most sense. 
 
We are goal setting with a modern pedometer. Goal setting with a modern pedometer will 

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overcome the shortcomings of the prior studies2,4 
that either did not use a pedometer or only 
used it for research staff tracking steps. By having the user pay close attention to the steps 
being walked, we anticipate they will walk more than other patients not using a pedometer, 
consistent with the literature.10 
 
We are collecting more comprehensive physical status data than prior studies. Prior 
studies collected endurance but other dimensions of physical status are also important to 
consider. Improvements in balance and strength can lead to better and earlier postoperative 
mobilization. Similarly, improved function can predict increased independence with 
activities of daily living reducing the need for skilled nursing. 
 
 
6. INCLUSION AND EXCLUSION CRITERIA* 
 
Inclusion criteria for screening - We will enroll participants age 50 and older undergoing any 
abdominal or thoracic surgery.  
 
Inclusion criteria for randomized controlled trial - We will enroll participants age 50 and 
older undergoing any abdominal or thoracic surgery.  
 
 
Exclusions for screening – non-adults, prisoners, Non-English language speaker for whom 
short form consent is not available. 
 
Exclusions for randomized controlled trial - The exclusions we will apply pertain mainly to 
the measurement of 6MWD – (1) unstable angina or stable angina with minimal exertion or at 
rest (2) visual impairment such that walking impairs safety (3) fall within previous three months, 
(4) resting heart rate of more than 120, a systolic blood pressure of more than 180 mm Hg, or a 
diastolic blood pressure of more than 100 mm Hg (5) patient who does not walk independently 
(e.g. wheel chair; cane walking is ok)  
 
 
Individuals who are not yet adults (infants, children, teenagers)  
This study excludes anyone who is less than 50 years old; no children will be included in this 
study. 
 
Pregnant women  
Pregnant women will not be included. 
 
Prisoners  
Prisoners will not be included in the study.   
 
Non-English language speaking subjects 

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Non-English language speaking subjects for which an IRB approved short form is available will 
be included; patients speaking a language for which the UMass IRB does not have a short form 
consents available will not be included.  
 
Adults unable to consent (adults lacking capacity) 
Adults who are deemed cognitively impaired or unable to consent will be included; given 
the topic of study and the inclusion/exclusion criteria, it is possible that potential 
participants with impaired decisional competency will be identified for this study.   If 
substantial cognitive impairment is indicated through the use of the MiniCog test, we will 
implement consent procedures consistent with those recommended for patients with 
cognitive impairment. This includes reviewing consent with a legally authorized 
representative and close monitoring of patients. If patients appear unduly distressed, they 
will be withdrawn from the study.  Please see section # 30. Consent Process for 
additional details.    
*See also section #18. 
 
7. STUDY-WIDE NUMBER OF SUBJECTS* 
N/A; this is not a multi-site study. 
 
8. STUDY-WIDE RECRUITMENT METHODS* 
N/A; this is not a multi-site study. 
 
 
9. STUDY TIMELINES* 
 
The overall study timeline is two years from start of recruitment. The first year will focus on 
preparation (training on frailty measurement, scripting interviews, and testing the questions we 
ask) and recruitment of study subjects. Individual subjects will be actively involved for 30 
minutes during their first appointment (not including time spent in clinic appointment), 
approximately 15 minutes during the day of their surgery, and potentially approximately ten 
additional minutes on their day of discharge from the hospital, though patient data collection will 
continue for up to one year after the day of surgery.  
 
10. STUDY ENDPOINTS* 
 
Aim 1a: Endurance: For endurance, we will measure 6MWD following the American 
Thoracic Society (ATS) guideline.15  Briefly, we will establish an unimpeded 20m course 
within the colorectal surgery office. Studies have varied with the length of course but a 
multicenter study mentioned in the guideline statement
15 
suggested lengths ranging from 20 to 
50m did not significantly change patient walking distance results. Every effort will be made 
to control for variation, including the amount of encouragement provided by project staff 
member and stopping conditions. We will follow the ATS guideline providing encouragement 
at one minute intervals. 
 
Patients may stop by leaning against the wall before resuming. At the end of six minutes, we 

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will record patient-perceived exertion using the Borg scale. We will also ask the patient for a 
reason for stopping. Recording the perceived exertion and reason for stopping will allow us to 
interpret outlier values and other potential variation among patients who otherwise have 
similar predicted walk distance. Although a research staff member will record the walk 
distance, we will require that a RN or another more senior clinician be present during the 
examination to monitor for patient fatigue or angina. Reasons for immediately stopping a 
6MWD include the following:(1) chest pain, (2) intolerable dyspnea, (3) leg cramps, (4) 
staggering, (5) diaphoresis, and (6) pale or ashen appearance.  If space is not available, we will 
conduct the test on a treadmill with guard rails which should provide adequate safety. An RN 
or another more senior clinician will be present during the examination to monitor for patient 
fatigue or angina for subjects completing the assessment on a treadmill as well.  
 
Aim 1a: Balance, strength and gait speed: We will follow the short performance physical 
battery (SPPB) protocol by Guralnik.11  A research staff member will measure the patient’s 
ability to balance in three separate positions: side-by-side stand, semi-tandem stand, and 
tandem stand. Scores range from 0 for someone unable to balance in any of the positions to 4 
for someone able to stand in each position for 10 seconds. Given we have already measured 
gait speed during the screening process we will move on to patient’s ability to perform five 
chair sit-to-stand maneuvers with scoring based on the time required.  
 
Aim 1a: Self-reported function: We will administer the 12 items of the Veteran Rand (VR-
12) in order to measure self-reported function.16 We will then calculate the summary 
physical component score (PCS) using a published algorithm.16 The algorithm norms PCS to 
range between 0 and 100, with 50 as a mean, and 10 as the standard deviation for the US 
population. 
 
Aim 1b: Adherence with exercise: We will measure the percentage of days in which the 
participant meets his/her step count target for intervention patients and activity journals for 
both groups of patients 
 
Aim 1b: Patient satisfaction: We will design a custom instrument to assess patient 
satisfaction with our intervention. 
 
Aim 2: Time and cost to recruit 400 frail older adults: We will calculate the time and cost to 
recruit 400 patients. We will assess time in multiple ways: number of calendar days and 
number of working clinic days. For cost, we will assign an hourly wage for research staff 
member and RN efforts and then multiply by the number of hours required to perform 
recruitment, follow-up telephone calls, and follow-up assessments. 
 
Aim 3: Postoperative outcomes:  we may also measure several postoperative outcomes, 
including:  
Change in six-minute walk distance from baseline 
The number of steps per day in the hospital  
Time to 100 steps at the day of discharge. 
Discharge to skilled nursing facility 

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Length of stay 
Postoperative Recovery (measured via quality of recovery scale, abdominal surgery 
impact scale) 
Thirty-day outcomes including serious complication, readmission, and death  
 
Aim 4: Thirty-day outcomes including serious complication, readmission, and death  
 
 
 
Descriptive variables / covariates. We will collect basic demographic information (age, 
race, and gender), comorbidity, body mass index information, and surgical information 
including principal CPT code for surgical procedure and anesthesia type. We will also 
assess exercise self-efficacy using a modified version of the exercise self-efficacy scale.1  
Exercise self-efficacy is the belief that a patient can exercise targeted amounts without 
additional assistance from others.   Assessing for this will allow us to control for baseline 
difference in the intervention and control patients that might impact on our interpretation 
of the efficacy of the intervention.  The instrument is a simple inventory of items 
questioning if a patient can accomplish exercise target under various circumstances.  A 
copy of the instrument has been included with the protocol submission. 
 
11. PROCEDURES INVOLVED* 
Recruitment and screening phase:   
Using HIPAA waiver, we will review the charts of potential patients prior to scheduled visit in 
the colorectal surgery office. Typically, we will review charts the day before scheduled visits 
but up to four weeks prior.  In terms of the variables we will collect, we are specifically 
interested in information about age, sex, race, ethnicity, functional status, height, weight, type 
of surgery, surgeon, and date and time of appointment in colorectal surgery office These 
variables will allow us to compare patients who agree to participate with those that decline for 
the purpose of reporting generalizability in future scholarship originating from this work. The 
appointment time and provider involved will help with cueing clinic staff members to broach 
the subject of participation in the research as described further in the next paragraph.  We are 
also reviewing charts for evidence of guardianship or significant cognitive impairment. 
Specifically, we will look evidence of guardianship established or prior consent documents 
signed by somebody other than the patient.  
 
Using the information gathered above, we will request clinic staff members (surgeon, surgical 
resident, nurse practitioner, nurse, or medical assistant) working in the colorectal surgery office 
to ask if any patient undergoing intestinal surgery would be willing to speak to a research staff 
member about our research study.  For those agreeing, the research staff member will discuss 
participation in the frailty screening phase of the study through an informed consent process as 
described further in section 30. The research staff member will also obtain hipaa authorization 
to collect postoperative outcomes (aim 3) to all adults aged 50 and above scheduled for 
colectomy or other intestinal surgery not including hemorrhoid surgery. Investigators have 
previously demonstrated that the Edmonton frailty scale can predict outcomes of surgery 
including postsurgical complications and length of stay.2   For patients scoring 4 or above (out 

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of 17) which has been linked with frailty, we will invite to participate in this study to assess 
preoperative walking as described further below.  For those with score of 4 or below, we will 
not require any further participation apart from the six-month interview. For patients for whom 
consent can be obtained at the same visit as patient surgical consultation, we will proceed with 
the baseline assessment as described below. For patients for whom consent cannot be obtained 
right away or who prefer to come back at another time, we will schedule a follow-up visit 
within two weeks of initial visit. 
 
 
Baseline assessment: The RA will record baseline physical status assessments to establish 
baseline values. We anticipate this will take approximately 30 minutes in addition to the 
regular office visit. Included in the baseline assessments will be the 6MWD, the SPPB (See 
attachment), and the Veteran Rand (VR-12) (see attachment). 
 
We will follow the guidelines set in place by the American Thoracic Society (ATS) for 
administration of the 6MWD. We will utilize safety precautions such as keeping a chair with 
wheels at the ready nearby at all times for any patient who becomes dizzy or needs to sit for any 
reason. The baseline 6MWD will be completed in the hallway of the colorectal surgery office at 
67 Belmont Street. This is a very low traffic area but we will also do as much as we can to 
prevent anyone from walking on the course during use. For later assessments administered in 
the hospital we will set up temporary cones to ensure that no one walks on the course as the 
patient is walking.  Also per the ATS guidelines, the RA will walk the course prior to the 
patient, so they can ensure that there are no obstructions on the course that may hinder the 
patient.  
 
We will also follow the ATS guidelines in regards to instructing and encouraging the patient 
during the walking test. These instructions are stated as follows: 
“After the first minute, tell the patient the following (in even tones): “You are doing well. You 
have 5 minutes to go.” When the timer shows 4 minutes remaining, tell the patient the 
following: “Keep up the good work. You have 4 minutes to go.” When the timer shows 3 
minutes remaining, tell the patient the following: “You are doing well. You are halfway done.” 
When the timer shows 2 minutes remaining, tell the patient the following: “Keep up the good 
work. You have only 2 minutes left.” When the timer shows only 1 minute remaining, tell the 
patient: “You are doing well. You have only 1 minute to go.” Do not use other words of 
encouragement (or body language to speed up). If the patient stops walking during the test and 
needs a rest, say this: “You can lean against the wall if you would like; then continue walking 
whenever you feel able.” Do not stop the timer. If the patient stops before the 6 minutes are up 
and refuses to continue (or you decide that they should not continue), wheel the chair over for 
the patient to sit on, discontinue the walk, and note on the worksheet the distance, the time 
stopped, and the reason for stopping prematurely. When the timer is 15 seconds from 
completion, say this: “In a moment I’m going to tell you to stop. When I do, just stop right 
where you are and I will come to you.” When the timer rings (or buzzes), say this: “Stop!” Walk 
over to the patient. Consider taking the chair if they look exhausted. Mark the spot where they 
stopped.” 
 

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Randomization: we will randomize patients in a 1:1 fashion into intervention and control groups 
using a prespecified table generated by our study statistician.  More specifically we will use 
REDCap software to assign a study arm assignment using randomly permutated blocks of 
sizes 4 and 6. 
 
Intervention patients: intervention patients will receive a walking prescription weekly 
calls from a study staff member as described below 
 
Walking prescription: A study staff member in consultation with study physician (PI or 
co-I) will then provide the initial walking prescription based on the participants’ baseline 
performance on the 6MWD following a published example 12,13 and will focus the 
participant on walking at a moderate intensity (level of approximately 3 on the modified 
Borg Perceived Exertional Scale;14 laminated Borg scales will be distributed to 
participants). 
 
Participants may walk steps over the course of a day or in one session. The initial 
walking prescription will also provide instructions to the participant to increase his/her 
number of steps each week by 10 to 20%. 
 
A research staff member will then orient the participant to the pedometer 
 
Weekly calls: During the interim between the day of consultation until the day of 
surgery, a study staff member will make weekly calls to each patient. The calls will 
provide participants an opportunity to report any symptoms which could warrant 
stopping the walking regimen and/or seeking urgent medical attention. In addition, we 
will train the study staff member to troubleshoot any problems setting step count targets 
or other problems with the pedometer. In cases in which the pedometer fails, we will 
budget to have additional pedometers available to mail to the patient. 
 
Activity log: we will ask participants to log all of their physical activities-date, activity type, 
number of minutes.  We will submit a copy of the activity log to the irb for approval prior to 
recruiting randomized participants to complete it. 
 
Control subjects: a study staff member will provide general walking advice with typical 
warnings about when to stop (e.g., chest pain, breathing difficulty, or fall).  Control subjects 
will receive no other intervention. We will also ask control subjects to log their physical 
activities. 
 
Preoperative assessment: On the day of preoperative testing, which will usually occur three 
to five weeks after the baseline measurement, a research staff member or other project staff 
member will collect the pedometer and record the repeat physical status assessments 
(6MWD and SPPB). On the day of surgery, we may also place a research grade monitor on 
patients so as to track their steps while in the hospital. 
 
Hospital period assessment:. By the day of discharge, we will collect the research grade 
monitors and repeat our physical status measurements. 

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In order to test the above procedures in the randomized individuals, we will enroll up to 15 
patients as test patients. All these patients will undergo screening, baseline assessment/interview, 
follow-up assessment on day of preoperative testing, in-hospital step tracking and Hospital 
period assessment.   
 
30 day assessment: Approximately 30 days from day of surgery, at office of surgery clinic, we 
will repeat our physical status measurements 
 
During the 6MWD measurement issued during the baseline assessment, day of surgery, hospital 
period, and 30-day assessment, a nurse or more senior clinician will be available during the 
examination to monitor for patient fatigue or angina.  
 
6 month assessment: We will attempt to make contact by phone, mail, or email with enrolled 
patients no more than five times total (regardless of the method of contact).  For patients not 
picking up the phone, we will leave a voicemail message up to three times  following a script 
that we will forward to the IRB prior to implementation of this procedure. We will make these 
attempts over 2 months (i.e. months 7 and 8) and not contact patients after 8 months have 
elapsed from the day of surgery).  During our conversation with patients, we will request 
information about the occurrence of any serious complication since surgery and also will re-
administer VR-12. Our prior experience with contacting patients (Pfizer - Anticoagulation 
Medical Home study) demonstrated the growing difficulties in reaching patients, particularly 
older vulnerable adults, often who are shifting location between children and rehabilitation 
facilities making follow-up more challenging. We will use a mailer or post card (depending on 
availability/prevailing pricing) for the purpose of this correspondence. (See attached)  
 
NSQIP data download 
In order to capture information about patient comorbidities and outcomes, study staff will 
download information already collected on surgical patients at UMass for the purposes of quality 
control as organized by the National Surgical Quality Improvement Program. Specifically, the 
study staff member will search for all records relating to the operation. These records will be 
stored in a password-protected server, same as for the information collected directly from the 
patient. A programmer assigned to the project will then link data we collected directly with 
NSQIP using the medical record number and date of surgery.  The project programmer/analysts 
will assemble a limited dataset with no direct personal identifiers to support merger and creation 
of a common analytic file.   
 
The analytic dataset will be a limited dataset, containing at a minimum dates and a unique 
artificial Study ID number that is linked through separate coding to the patient’s health record 
number. This linkage coding will be stored separately from the analysis coding. Analyses will be 
performed using only limited datasets and only aggregate data will be reported.   
 
We will create the interview scripts and data collection forms as one of our first tasks of the 
study and will upload for approval. We will not commence with any data collection until the 
tools have been reviewed and approved by the IRB. 

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12. DATA AND SPECIMEN BANKING* 
No specimens are being collected as part of the research. Data will not be banked for use in 
future research outside of the scope of this study.  
 
13. Data Analysis and Management  
 
Analysis As a first step, we will examine the distributions of all variables using histograms and 
summary statistics for continuous variables, and frequencies for categorical variables. We will 
consider transformations to enhance normality where continuous variables demonstrate 
substantial skew or outliers.  
 
 Aim 1: We will calculate the distribution of within-participant change for each of the five 
physical status measures and assess the average and median change against the minimal 
clinically important difference (MCID) for each assessment, as well as the percentage of patients 
with a minimal clinically important difference. In cases where a MCID is not available we will 
decide among our expert advisory team members the threshold values that indicate some 
important improvement. In our analysis we will also examine the role of baseline assessment on 
the amount of improvement by using a generalized linear model for the outcome of change in 
physical status controlling for baseline assessment. 
Aim 1a: In this aim, we will examine the association of duration of time available for the 
intervention with within-participant change in physical status outcomes, using 
nonparametric locally-weighted scatterplot smoothing (LOESS) regression.17 We will rerun 
our generalized linear model controlling for duration of time available for the intervention, 
transforming the duration variable if indicated by the LOESS plots, e.g., piecewise linear if 
a threshold effect is seen. 
 
Aim 1b: Similar to Aim 1a analyses, we will examine the association of percentage of days 
(of the 30 days available in pedometer memory), the step count target was met with within-
participant change in physical status outcomes, again using LOESS plots. We will rerun our 
generalized linear model controlling for the percentage of days in which the patient met their 
step count target, transforming the percentage of days if indicated by the LOESS plots. 
 
Aim 1c: We will calculate the distribution of patient satisfaction with the intervention, using 
descriptive statistics, e.g., mean, percentiles, as well as a histogram. Using generalized linear 
modeling, we will measure patient satisfaction adjusted for changes in physical status. Given 
the possibility of co-linearity of physical status assessments, we will construct five separate 
models, one for each of the five physical status assessments. 
 
Aim 2: We will calculate the average time and cost required to recruit each patient by taking 
the total time and cost divided by the number of patients we eventually enroll (i.e. 200 
patients). 
 

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Aim 3: In patients for whom we have recorded postoperative six minute walk distance and step 
counts, we will calculate change in six minute walk distance from baseline to day of discharge. 
We will also calculate steps per day and time to first 100 steps. We will calculate the average 
steps per day using postoperative days 1 and 2 given variation in the start time of surgery for 
the surgical day and time of transportation availability on the discharge date.  For the rare 
patient leaving the hospital on postoperative day 2, we will only use postoperative day 1.  For 
patients with serious complications requiring ICU stay, we anticipate no steps will be taken 
and will adjust for this in our analysis. We will measure time to walking at least 100 steps in a 
single bout, defined as continuous minutes walking at least 1 step/minute following example in 
the literature.  Being able to walk 100 steps in a single bout approximates criteria used to 
predict successful discharge home from acute hospitalization.  We recognize that some 
patients will not walk 100 steps and so we will adjust for this in our analysis (i.e. we will 
censor their data in survival analysis). 
 
In terms of the other outcomes, we will compute length of stay in hours from the time of 
surgery until time of discharge. We will also perform chart review between 30 and 120 days 
after surgery to tabulate number of patients discharged to nursing home, readmitted at 30 days, 
dead at 30 days, or having a serious complication of 30 days. 
 
 
Interim Analyses: Given the possibility that our walking intervention does not improve our 
physical status measures, we will perform the Aim 1 analysis after recruitment of each batch 
of 10 patients.  More specifically, we will assess the average and median change against the 
MCID for each of the five measures.  If we have not achieved the MCID for any of the 
measures after any one batch, we will work with our advisors, particularly Roger Fielding, to 
revise our intervention (e.g. intensifying the walking regimen) with the goal of improving 
physical status more than the MCID of one or more measures by the time of the next interim 
analysis. 
 
14. PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF SUBJECTS* 
The proposed study involves no more than minimal risk to participants.  Therefore, we believe 
that an intensive data and safety monitoring plan is not needed.  However, we will take steps to 
ensure the integrity of the data and to detect any adverse effects of the study on participants. 
 
See also #27 Provisions to Protect the Privacy Interests of Subjects. 
 
 
15. WITHDRAWAL OF SUBJECTS WITHOUT THEIR CONSENT* 
We do not anticipate the need to withdraw patients unless it is at their request.  However, we will 
remove patients who appear unduly distressed during the research interview. 
 
16. RISKS TO SUBJECTS* 
Potential Risks 

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Page 13 of 22 
 
 
 
The proposed study poses minimal risks to the participants. There is a slight risk that research 
records (interview forms, interview notes, audio-recordings, transcripts, and electronic data) 
might be obtained by persons not authorized to do so.  There is a slight risk that research data 
files might be compromised, and obtained or viewed by unauthorized persons.  There is also a 
risk that the patient may feel uncomfortable answering some of the questions in the interviews. 
We will inform all patients during the informed consent process that they do not have to answer 
any questions that they do not want to. There is also a risk that the patient may fall. We screen 
patients initially based on prior falls to minimize this risk. In addition, there is screening for 
cognitive impairment for patients who may not fully appreciate risks of walking. The same 
screening process protects patients against development of chest pain or shortness of breath. We 
exclude patients with existing angina is such that small amount of walking or being at rest (i.e. 
class III or IV angina).  We also have a physician or nurse on the premises at all times 
responsible for the patient if he or she were to develop shortness of breath, chest pain, or fall.  
 
See also #14 Provisions to Monitor the Data to Ensure the Safety of Subjects, and #27 
Provisions to Protect the Privacy Interests of Subjects.   
 
17. POTENTIAL DIRECT BENEFITS TO SUBJECTS* 
The walking intervention has the potential to decrease adverse post-surgical outcomes for 
patients involved in our study, but cannot be guaranteed.  
 
 
18. VULNERABLE POPULATIONS* 
Adults unable to consent (adults lacking capacity) 
Given the topic of study and the inclusion/exclusion criteria, it is possible that potential 
participants with impaired decisional competency will be identified for this study.  However, this 
study has anticipated direct benefits to subjects, and we will therefore enroll cognitively impaired 
patients. We will implement consent procedures consistent with those recommended for patients 
with cognitive impairment. This includes reviewing consent with a legally authorized 
representative and close monitoring of patients. If patients appear unduly distressed, they will be 
withdrawn from the study.  Please see section # 30. Consent Process for additional details.    
 
Individuals who are not yet adults (infants, children, teenagers)  
This study excludes anyone who is less than 65 years old; no children will be included in this 
study. 
 
Pregnant women  
Pregnant women will not be included. 
 
Prisoners  
Prisoners will not be included in the study.   
 
Non-English speaking subjects 
Patients speaking a language for which the UMass IRB does not have a short form consents 
available will not be included. For non-English speaking patients, we will utilize an interpretive 

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Page 14 of 22 
 
 
 
service referred to us by UMass Memorial Interpretive Services. The interpretive service will not 
be given any information about the patients we enroll. They are only notified of the department 
from which we are calling from.  
 
We will use the telephone interpretive services or a family member who is conversant in English 
and the language understood by the subject to conduct the interview. We will use the short forms 
provided by the UMass IRB.  We will have the interpreter or family member act as the witness. 
If the interpreter is the only witness, we will send the consent form for his/her signature and keep 
a copy of the version signed by the interpreter. Because the involvement of each patient does not 
extend beyond one interview study session, we will not reassess consent with the research 
participant. 
 
 
19. MULTI-SITE RESEARCH* 
N/A; this is not a multi-site study.  
 
 
20. COMMUNITY-BASED PARTICIPATORY RESEARCH* 
N/A 
 
 
21. SHARING OF RESEARCH RESULTS WITH SUBJECTS* 
There are no specific plans to share results with study subjects; study procedures do not include 
any type of diagnostic testing.   
 
All results shared in published research will be in aggregate or summary format and will not 
include identifiable information about participants.  Published results are available to the greater 
community at large, including study subjects.   
 
22. SETTING 
We will recruit patients from the surgery clinics of UMass Memorial Medical Center - strewn 
between University and Memorial campuses. 
 
 
23. RESOURCES AVAILABLE 
All research personnel listed on this study will read the protocol and receive the appropriate 
supervision and possess the appropriate experience (both higher education and related work 
experience) needed to fulfill their roles and complete their responsibilities for this study. All 
investigators and project staff are required to receive and complete IRB and HIPAA training.  
 
The Principal Investigators will oversee all personnel and all research activities conducted within 
this study. 
 
The Principal Investigator will have responsibility for the overall conduct of the project at this 
study site. They will have primary oversight of all study personnel.  They will participate in the 

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Page 15 of 22 
 
 
 
design and the execution of the respective study analyses and will be responsible for the 
reporting of study results.  The Principal Investigators have extensive experience and expertise in 
surgical outcomes research and perioperative medicine.  
 
The Programmer will perform a range of programming and data management activities essential 
to conduct of the project.  S/he will develop study data bases, and perform analyses under the 
direction of the PI.  Programmers at the Meyers Primary Care Institute all hold graduate level 
degrees and have vast experience working with administrative claims data for research purposes.   
 
The Project Manager will assist the Principal Investigator and the Co-Investigators in 
implementing all aspects of the project.  Under the direction of Principal Investigator, the Project 
Manager will be responsible for day-to-day coordination and oversight of the project, including:  
developing timelines, work allocation, workflow plans, monitoring project progress and task 
completion, monitoring spending and effort allocation, and managing correspondence and 
administrative tasks.  S/he will monitor/manage ethics and regulatory approvals (IRB, 
HIPAA/DUA).  The Project Manager will attend and plan for all project-related meetings as 
needed.  S/he will work under the direction of the Principal Investigator to assist with all study 
activities, preparing IRB submissions and reports, and developing study materials such as 
development of data collection instruments and intervention-related tools.  S/he will be 
responsible for maintaining communications with all parties participating in the project. She will 
maintain project documentation and will assist in developing and filing required project reports.  
Project Managers at the Meyers Primary Care Institute all hold graduate level degrees and have 
vast experience working on healthcare services research projects.   
 
A research staff member will work under the direction of Principal Investigator, Project Manager 
and Research Manager to assist with all study activities.  S/he will assist the PI and other project 
staff in managing the administrative activities of the project.  S/he will prepare materials for team 
meetings, and will facilitate communication between all project staff through written 
correspondence, telephone, fax, and email.  A research staff member will be trained to formulate 
walking prescriptions (with oversight from the PI) as well as conduct the 6MWD measurement. 
A nurse or senior clinician will be available during the time when a research staff member is 
conducting the 6MWD measurement.  
 
The REDCap Administrator will be the contact with UMass for all REDCap administrative 
needs throughout the study.  As the appointed REDCap administrator for the Meyers Primary 
Care Institute site, s/he will have access to all study data collected within REDCap.  
 
All study personnel are required to undergo Human Subjects Training and hold a current CITI 
Human Subjects Training Certificate and will familiarize themselves with the study protocol and 
IRB documents.  
 
Individuals have not yet been identified to fill the roles of programmer and research staff 
member. Once the staff has been identified they will be added into the eIRB system. No study 
staff will begin any study activities until they have been added into the eIRB.   
 

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24. LOCAL RECRUITMENT METHODS 
 
We will attempt to recruit 200 subjects from the surgery clinics affiliated with UMass Memorial 
Medical Center. We believe 200 subjects is the requisite number we need to successfully answer 
our research question. We believe the annual pool of eligible patients is more than 400. This 
accounts for a reasonable amount of refusal, surgery cancellation, and also loss to follow-up.    
 
Typically, consultation with colorectal surgeon occurs after colonoscopy has detected a 
significant lesion. Once the surgeon and participant have agreed to a surgical plan, the surgeon 
will invite the participant to speak to our project staff member about the study.   
 
For those participants agreeing, the research staff member (already on site based on having 
reviewed the appointment lists the day before) will obtain informed consent and conduct 
initial interview.  
The research staff member will then ask the patient about falls, visual impairment, and chest 
pain to elicit any exclusion to eligibility.  
 
 
We do not intend to provide stipends. 
 
25. LOCAL NUMBER OF SUBJECTS 
 
We will attempt to recruit 400 subjects who contribute to the ultimate analysis of this work.  
 
 
26. CONFIDENTIALITY  
 
All persons accessing patient records must adhere to the following guidelines: 
• The information in a patient’s record cannot be disclosed without the patient’s knowledge 
and consent; however, there are occasions when there is a legal obligation or duty to 
disclose information. Requests for patient information from external sources must be 
directed to the Medical Records Department. 
• Paper medical records must be signed out by an authorized person whenever they are 
removed from the department. 
• All paper records must be returned to the Medical Records Department. 
• Medical records must not be left unattended where unauthorized persons might read them 
Access to business information, including billing information, is also granted on a need- 
to-know basis. 
• No patient records will be left open on a computer unless actively in use. 
• Patient records will be closed as soon as the necessary information has been retrieved. 
• Computers with access to patient medical records will be locked unless actively attended. 
All computerized data will be kept on secured computers or network servers.  These data will be 
accessible only by approved research staff, using confidential usernames and passwords. Direct 

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Page 17 of 22 
 
 
 
patient identifiers will be removed from study data files as soon as possible in the data 
processing steps. Statistical analyses will be performed using a limited dataset.  All information 
linking identifiable data to analysis files will be kept separate from analysis files.  All data will 
be used only for research purposes only; published data will not contain any individual 
identifiers, only aggregate-level data will be reported. 
 
Only study personnel included in IRB applications have access to project-specific data.  All 
persons collecting or handling data are trained in human subjects’ procedures, confidentiality and 
privacy protection.  All investigators and project staff are required to receive and complete IRB 
and HIPAA training. 
 
In addition, risks to confidentiality of the data collected throughout the proposed study will be 
addressed as follows:  Assurance and confidentiality of information will be made to all 
participants. Data will be handled with the same confidentiality accorded to patient’s medical 
records. Specific procedures protecting participant confidentiality will be as follows: 
• ID number, as well as full name, medical record number, and dates of service will be 
placed on electronic study forms or records on which data are collected and/or stored 
(specifically medical record abstraction forms in RedCap). 
• Access to data files will be secured with a password-filing system (that logs entry) and is 
restricted to authorized staff only 
• Necessary hard-copy records containing study data of any type will be kept in locked 
files. Master lists linking participant information with ID number will be numbered 
consecutively and prepared before data collection to ensure accurate accounting. These 
lists will be kept locked, in duplicate, with access only by the PI and other investigators. 
• All project staff will sign an oath of confidentiality to ensure their understanding of the 
terms of confidentiality required. They will be trained in specific procedures to ensure 
confidentiality. 
• Sign-out procedures for all access to data files will be strictly enforced. 
• All reports and publications will preserve the subjects’ anonymity. 
 
Any breach of confidentiality will be subject to a root cause analysis and preventive measures 
taken as appropriate. We will report any breach of confidentiality as required. 
 
 
27. PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF SUBJECTS 
 
Protection for Risks Associated with Potential Loss of Confidentiality 
The organizations proposing this study have systems, oversight, experienced personnel, and an 
organizational culture that supports the appropriate use, access and storage of confidential 
information. All persons collecting or handling data will be trained in human subjects’ 
procedures, confidentiality and privacy protection. All investigators and project staff are required 
to receive and complete IRB and HIPAA training. 
 

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Page 18 of 22 
 
 
 
Data for all participants will be kept strictly confidential. All research files will be kept in locked 
file cabinets or a locked file room. Participants will be assigned a numerical code (Study ID) for 
identification in the files. Names and other identifiers will be kept in separate locked files.  
 
Individual identifier information will be removed from study data files as soon as possible in the 
data processing steps. All computerized data will be kept on secured computers or networks at 
each site. These data will be accessible only to research staff, using confidential usernames and 
passwords. Analysis files of de-identified data will be created at each site and will be transferred 
between sites using password-protected files and secure encrypted web transfer procedures.  
Statistical analyses will be performed using only de-identified datasets and only de-identified 
data will be reported. All data will be used only for research purposes only; published data will 
not contain any individual identifiers. 
 
We are requesting a HIPAA waiver for the purposes of recruitment, for which we need to access 
patient medical record and contact information. 
 
We will ask study participants to sign a HIPPA authorization form. 
 
 
28. COMPENSATION FOR RESEARCH-RELATED INJURY 
None; there are no resources available. We do not anticipate any research-related injuries. We 
believe the research poses no more than minimal risk to subjects. 
 
29. ECONOMIC BURDEN TO SUBJECTS 
We anticipate no economic burden to subjects in this study.  
 
30. CONSENT PROCESS 
 
During the patient’s scheduled surgery clinic appointment, a surgery clinic staff member will 
then introduce the study and ask if the patient is willing to discuss the study with a study staff 
member after his/her surgery clinic appointment. If a patient expresses interest, the surgery 
clinic staff member will notify study staff member. 
 
For patients who agree to speak, the study staff member will find a private room and discuss 
enrollment and informed consent. Prior to documenting written consent, the study staff member 
will determine if a patient needs to undergo cognitive testing. Criteria for this determination include 
presence in the electronic medical record of prior consent document such as for undergoing medical 
procedures signed by a person other than the patient, patient report of having somebody else sign for 
him or herself, mention of legal guardian in electronic medical record, or study staff members belief 
that the patient may be cognitively impaired. If legal guardian documentation in the electronic 
medical record indicates that medical decision-making requires guardian to sign consent, we will 
omit cognitive testing and proceed to obtain consent from the guardian and assent from the patient.  
Otherwise, to execute cognitive testing, the study staff member will  administer the MiniCog 
test. We are waiving written documentation of consent, as the MiniCog presents no more than 
minimal risk of harm to subjects and involves no procedures for which written consent is 

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Page 19 of 22 
 
 
 
normally required outside of the research context. If the patient passes the MiniCog assessment, 
the patient will sign a consent form to participate in the study. If the patient does not pass, we 
will obtain informed consent from a caregiver or surrogate and will ask the patient to indicate 
their assent. At the time of consent, the recruiter will also ask the participant and/or caregiver 
to sign a HIPAA authorization form for the purposes of chart review. 
 
In order to facilitate organization/storage of informed consent and HIPAA authorization 
documentation and to permit participation in the research in the case of legal guardian who is 
not available in person to sign hardcopy of consent document, we will permit written or 
electronic signature. For electronic signature when guardian is not available in person we will 
send a link through redcap to sign the informed consent. We will then print a hard copy of 
signed consent form to subject and send a secure email with signed consent and HIPAA 
authorization to any legal guardian signing remotely.  For those patients and/or guardians who 
are consenting in person, we will allow for electronic or written signature, and will print a hard 
copy for them to keep. We will then maintain all documents in REDCap system including 
uploading of written consent and HIPAA forms for ease of storage and IRB audit. 
Note: For those who sign consents electronically, the printed hard copy will not contain the 
IRB stamp.  
 
For non-English speaking patients, we will utilize an interpretive service referred to us by UMass 
Memorial /University Of Massachusetts Medical School interpretive services. The interpreting 
service is not given any information about the patients we enroll. They are only notified of the 
department from which we are calling from.  
 
We will use the telephone interpretive services or a family member who is conversant in English 
and the language understood by the subject to conduct the interview. We will use the short forms 
provided by the UMass IRB.  We will have the interpreter or family member act as the witness. 
If the interpreter is the only witness, we will send the consent form for his/her signature and 
keep a copy of the version signed by the interpreter. Because the involvement of each patient 
does not extend beyond one interview study session, we will not reassess consent with the 
research participant. 
 
For test patients who will not be randomized, we will administer a separate consent that 
explicitly mentions that they will not be randomized but that their data will still be useful and 
that the intervention will still be useful to them in terms of improving their physical condition 
prior to undergoing surgery. 
 
For the consent process, we will follow SOP: Informed Consent Process for Research 
(HRP-802) in obtaining and documenting consent.   
 
 
31. PROCESS TO DOCUMENT CONSENT IN WRITING 
 
Please see #30 above.  
 

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32. DRUGS OR DEVICES 
N/A 
 
 
 

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Page 21 of 22 
 
 
 
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