Patient-Centered, Interprofessional Approach to Improve Functional Outcomes in a Skilled Nursing Facility
Phase: NA
Conditions: Physical Disability
Sponsor: University of Colorado, Denver

Title: Patient-Centered, Interprofessional Approach to Improve Functional Outcomes in a Skilled Nursing 
Facility
NCT04300413
Version Date: 01.28.2020                                   IRB Approval Date: 03.04.2020

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COMIRB Protocol 
COLORADO MULTIPLE INSTITUTIONAL REVIEW BOARD 
CAMPUS BOX F-490    TELEPHONE:  303-724-1055  Fax:  
303-724-0990 
 
 
 
Protocol #: 19-2490 
Project Title:  Patient-Centered, Interprofessional Approach to Improve Functional 
Outcomes in a Skilled Nursing Facility 
 
 
 
 
 
Principal Investigator:  Jennifer Stevens-Lapsley, MPT, PhD 
 Version Date:  01.28.2020 
 
 
 
 
  
 
I. Hypotheses and Specific Aims:   
 
For many older adults, a skilled nursing facility (SNF) stay is required to address 
functional deficits stemming from hospitalization.  However, during a typical SNF stay, 
patients receive rehabilitation for 1-2 hours of their day and remain sedentary for up to 14 
waking hours, which is not reflective of the mobility levels needed to thrive in the 
community.1-3  While a previous high-intensity strengthening intervention implemented by 
our group (COMIRB Protocol #: 14-2388, Intensive Therapeutic Rehabilitation for Older 
Skilled Nursing Home Residents: i-STRONGER) demonstrated superior outcomes when 
compared to usual care, the benefits of rehabilitation are likely negated by sedentary 
behavior outside of structured rehabilitation time.  We propose that an interprofessional 
movement program combined with i-STRONGER strengthening will be feasible, 
acceptable, and will lead to superior patient outcomes. 
 
AIM 1: Determine the feasibility and acceptability of implementing a structured mobility 
program High-Intensity Rehabilitation plus Mobility (HeRo) for SNF residents and staff 
 
 
H1: HeRo will be acceptable to SNF residents: SNF residents will score ≥70% in 
the patient satisfaction survey and will indicate acceptability in semi-structured interviews.  
HeRo will also be feasible, as evidenced by >90% treatment fidelity scores by providers. 
 
AIM 2: Determine the effectiveness of HeRo for improving patients’ gait speed, short 
physical performance battery (SPPB), and physical activity levels (i.e. upright time, steps 
per day) compared to a) the usual care group and b) the i-STRONGER only group. 
 
 
H2: Patients who participate in HeRo will demonstrate greater gains in gait speed, 
SPPB, and physical activity over the course of a SNF stay when compared to the usual 
care group and the i-STRONGER only group. 
 
II. Background and Significance:  
 
For many older adults, skilled nursing facility (SNF) care may not adequately 
address deficits in function because patient mobility levels are far below what is needed 
for successful community living.4,5 Current rehabilitation paradigms do not sufficiently 
challenge patients to acquire meaningful physiological gains.6-14 This inadequate 
recovery of function directly contributes to poor community discharge rates.  

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Strikingly, only 28% of all patients in SNFs are discharged to a community setting, 
which drastically impacts quality of life and patients’ objectives to stay in their 
home.15 
 
Physical function after hospitalization is a powerful biomarker of health for older 
adults.  Although the risk factors for the development of disability are likely to be complex 
and multifactorial, there is evidence to suggest that physical function alone may be a 
powerful biomarker of overall health following acute hospitalization.16-19 In older 
adults, lower extremity weakness is associated with poor mobility and increased fall risk.20-
23 
Barriers to mobility outside of structured rehabilitation include perceived safety 
concerns (pain, falls), staff shortages, lack of formal training on safety and equipment use, 
time constraints, and interdisciplinary communication barriers.24,25 This gap provides an 
excellent opportunity for the interdisciplinary SNF team to collaborate and use 
supplemental mobility to extend the gains made during formal rehabilitation 
sessions to levels appropriate for discharge into the community and set the stage 
for larger scale dissemination efforts.15,26 One study demonstrated that a twice-daily 
mobility program performed in the acute care setting demonstrated superior outcomes in 
life-space mobility that persisted one month after discharge.27  However, no studies to 
date have evaluated mobility programs implemented in the SNF with behavior-change 
frameworks.   
A critical question from our previous study is whether the positive functional 
results achieved with a progressive rehabilitation program (i-STRONGER) are 
negated by sedentary behavior.This will be the first study 1) develop a collaborative, 
patient-centered model to increase mobility in the SNF setting, 2) apply concepts of 
behavior change to promote functional recovery after hospitalization by reducing 
sedentary time and 3) combine a mobility program with a progressive, intensive 
rehabilitation protocol (i-STRONGER). The results of this study will inform large multi-site 
trials and provide a clinical framework to promote optimal functional recovery and 
discharge to the community for older adults following hospitalization.  
 
III. Preliminary Studies/Progress Report:  
  
Our research group analyzed activity monitoring data from similar patients just days 
before SNF discharge indicated patients took an average of 1,844 steps per day and were 
sedentary for 83% of the day. To put this finding into context: patients in the SNF were 
lower than the ~2,500 steps per day considered basal activity (i.e., baseline activity 
needed for an individual to perform activities of daily living at rest) and ~70% more 
sedentary than community-dwelling older adults.28  This study demonstrates that there 
exists a great opportunity for improvement in mobility in this setting. 
 
Our previous efforts to address functional recovery in the SNF using high-intensity, 
functional resistance training rehabilitation (i-STRONGER), demonstrated superior 
outcomes including improvements in physical function and gait speed, and cost-effective 
reductions in length of stay compared to usual care (COMIRB Protocol #: 14-2388 
manuscript in preparation). However, during a typical SNF stay, patients receive 
rehabilitation for 1-2 hours a day and remain sedentary for up to 14 waking hours, which is 
not reflective of mobility levels needed to thrive in the community.1-3 A critical question 
from the previous study is whether the positive functional results with i-STRONGER 

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are negated by sedentary behavior. The purpose of this study is to determine if an 
interprofessional mobility program (HeRo) has a synergistic effect with i-STRONGER in 
improving patient outcomes. 
 
IV. Research Methods 
 
A.  Outcome Measure(s):   
 
Physical function testing will occur at the SNF by facility Physical Therapists (PTs), 
Physical Therapist Assistants (PTAs), Occupational Therapists (OTs), Certified 
Occupational Therapist Assistants (COTAs), or Speech-Language Pathologists (SLPs).  
The primary functional performance outcome is gait speed (Aim 2). Gait speed was 
chosen because it 1) has been shown to predict risk of disability, higher health care 
utilization, and increased mortality;29,30 2) is a valid and reliable measure;31,32 and 3) is 
easily performed in the clinic and well tolerated by patients varying in condition and 
degree of health.33-35  Gait speed will be measured by the time it takes to walk a 4 meter 
path using a stopwatch to the nearest hundredth of a second. The secondary outcomes 
include Short Physical Performance Battery (SPPB). The SPPB is a well-accepted global 
measure of lower extremity function consisting of walking speed, chair stands, and 
balance. It is a well-studied composite measure and a strong predictor of disability, 
institutionalization, and morbidity in older adults.30 The SPPB is reliable with intra class 
correlation coefficients (ICC) >0.88 and demonstrates good sensitivity to change.36  Both 
gait speed and the SPPB are collected as standard of care in the Community Living 
Center at Fitzsimons.  
 
Numbers and reasons for hospitalizations and emergency room visits during the 
SNF stay will be documented by treating therapists. Falls will also be counted and 
documented by treating therapists or nursing staff. Falls will be defined as an 
unintentional change in position resulting in coming to rest on the ground or other lower 
level. Vital signs, use of assistive device, and pain will also be assessed during treatment 
sessions by therapists.   
 
Patients will complete a 7 question survey at discharge, scoring each question on 
a 1-10 scale (1=not at all and 10=extremely) to determine satisfaction with care (per 
standard of care procedures at SNF).   
 
Physical activity will be measured using the ActivPAL device (PALTechnologies: 
Glasgow, Scotland), which effectively measures sedentary time and steps per day. The 
ActivPAL is a small device which is attached to the participant’s thigh for up to seven days 
at a time. This is a small (35x53x7mm) and lightweight (15 grams) device that uses 
accelerometer-derived information about thigh position to estimate time spent in different 
body positions (i.e., sitting/lying, standing, and stepping). The device is positioned on the 
midline of the thigh, ~1/3 between the hip and knee. The device is placed in a small nitrile 
sleeve and attached using a non-allergenic adhesive pad and thus can be worn during 
bathing and overnight, allowing for continuous measurement.  Participants will be 
instructed to wear the monitor on their leg for up to ten consecutive days at all times 
except when submerged in water (e.g., bath and shower is acceptable). The time-
stamped “event” data file from the ActivPAL software will be used to determine time spent 
sitting/lying, standing and stepping per day. Using a customized R program,38 the event 
data file will be converted to a sec-by-sec file and additional metrics of sedentary behavior 

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(e.g., total time participating in activity, average duration of sedentary bouts) will be 
estimated. The ActivPAL has been validated for use in older and middle aged adults with 
very high levels of accuracy (99-100%)39-41 
 
Feasibility and acceptability (Aim 1) will be assessed by patient surveys,fidelity 
assessments, and semi-structured interviews.  Treatment fidelity will be assessed 
throughout the duration of the study by objective check lists for the mobility coach 
including 1) mobilization of patients.2) application of principals of behavioral economics 
and 3) safe patient handling techniques.  Fidelity assessments will also be performed for i-
STRONGER on PTs, PTAS, COTAs, and OTs to ensure appropriate application of 
principals of i-STRONGER.  Fidelity checks will be performed by Dr. Stutzbach or Dr. 
Stevens-Lapsley one time per week and monthly thereafter as long as fidelity remains 
above 90%.  Patient acceptability will be assessed through semi-structured interviews and 
analyzed using rigorous qualitative methods  Twenty-two participants will participate in 
interviews, and participation in interviews will be voluntary.  Interview participants will be 
recruited using purposive sampling from the total sample of participants. 
 
Falls, rehospitalizations, ER visits, and the life-space mobility assessment will be 
assessed by self-report through two follow-up phone calls: one 7 days following discharge 
and one 60 days following discharge.  These will not be considered as an outcome 
measure as we do not have this information from our historical comparison group but this 
will help us to 1) identify responders and non-responders to the treatment and 2) generate 
preliminary data regarding  the potential role of mobility in determining adverse events 
such as ER visits and rehospitalization.   
 
Covariates, clinical and background characteristics. Information on other patient 
characteristics to describe the patient population and interpret results will be obtained 
from facility medical records.  These characteristics include age; sex; race; history of 
comorbidities; medications; primary diagnosis for hospital admission; medical record 
number; prior level of function; length of skilled nursing facility stay; complications in 
hospital; and hospital length of stay.  SNF staff will administer the Brief Inventory of 
Mental Status (BIMS) to assess baseline cognitive status within 24-48 hours of admission 
to SNF in accordance with current standard of practice.  
 
NIH PROMIS measures will also be completed in order to characterize this population and 
potentially to identify responders and non-responders to HeRo. NIH PROMIS measures 
are well-validated, patient-reported outcome measures of physical, mental and social 
health.  PROMIS uses computer adaptive testing (CAT) to improve precision and 
decrease tester and participant burden.42  The following CAT PROMIS measures will be 
assessed upon admission to and discharge from the SNF: 
• Physical Function for Samples with Mobility Aid Users 
• Sleep Disturbance  
• Self-efficacy (Activities of Daily Living) 
• Fatigue 
• Satisfaction with Participation in Social Roles 
• Social isolation 
 
The Life-Space Mobility Assessment is a self-report measure assessing a patient’s 
movements, extending from within the home to movement beyond a patient’s town or 

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geographic region.43 The life-space mobility assessment is a continuous measure which 
can be scored from 0 (totally bedbound and dependent with all activity) to 120 
(independent with community ambulation without assistance). The scores take into 
account both the performance of movement within and outside the home, the frequency of 
the movement, and the amount of assistance required. Specifically, this measure allows 
evaluation of actual mobility performed in the home and community, and can be evaluated 
for older adults across all levels of function. LSA has concurrent validity with physical 
function measures, as well as self-reported health and ADL disability.44 The Life-Space 
Assessment has good test-rest-reliability (ICC=0.96), and is responsive to change in 
community-dwelling older adults.43 
Specified outcome measures (gait speed, SPPB, life-space mobility assessment, NIH 
PROMIS) are used in a variety of rehabilitation settings under current reporting and 
standard of care practices.  
B. 
Description of Population to be Enrolled:   
 
Patients will be enrolled from one SNF in the Denver metro area: Veterans Community 
Living Center at Fitzsimons.  The Veterans Community Living Center at Fitzsimons has 
been a strong community partner and has served as a research site for two previous 
research studies (COMIRB Protocol #: 14-2388, COMIRB Protocol #: 16-2690).  
Outcomes data will only be collected on patients who fit the inclusion criteria: adults 18 
through 120 years of age who are admitted to a skilled nursing facility,receive at least 
physical therapy and were ambulatory prior to hospitalization Exclusion criteria: Patients 
with neurological disorders, such as a acute stroke or acute traumatic brain injury, will be 
excluded as the best practice for managing these patients is based on motor-control 
theory versus the progressive strengthening and aerobic approach. Patients on hospice 
care will be excluded as hospice care is focused on palliative needs and not rehabilitation. 
Other patients to be excluded will include those with conditions where strength training is 
contraindicated (as indicated by the American College of Sports Medicine Guidelines for 
Exercise Testing and Prescription): recent unstable fractures, advanced congestive heart 
failure (ejection fracture <30%), bone metastasis sites, tumors in strengthening target 
areas, acute illness, recent myocardial infarction (within 3-6 weeks), weight bearing 
restrictions on graft or fracture sites, exposed tendon or muscle, absence of pedal pulses, 
presence of a fistula, and platelet levels <50,000/µL. 
 
C. 
Study Design and Research Methods   
 
This study is a preliminary investigation using a three-stage, pre-post training designs in 
one SNF (Figure 1). Stage 1 (usual care) and Stage 2 (i-STRONGER) have already been 
completed (manuscript in preparation; COMIRB #14-2388).  Given that the average length 
of stay in a SNF is 21 days, the pre/post design will consist of three independent samples 
of patients to include only those that were admitted and discharged within a discrete 
period.  During the 2 year Stage 3 (HeRo) period we will implement the interprofessional 
mobility program. 
 
 

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Figure 1. Study design 
  
 
 
 
Consenting 
Patients will provide written informed consent prior to participating in the study.  Potentially 
eligible patients will be identified upon admission by PTs, OTs, SLPs, PTAs, and COTAs 
at the research site who have a treating relationship with the potential participant.  The 
clinicians will describe the study to potential participants.  If the patient is interested, they 
will sign a HIPAA A form.  Following this, a professional research assistant (PRA) or Dr. 
Stutzbach will screen the patient for eligibility and will approach the patient for consenting 
within the first 4 days of admission to the SNF.   
 
Intervention:  
Mobility program 
Participants in the study will participate in a regular, structured mobility program outside of 
rehabilitation time, guided by a mobility coach (a licensed certified nursing assistant [CNA] 
or physical therapist assistant [PTA]).  In current SNF clinical practice, CNAs and PTAs 
regularly perform walking and other physical activities with patients, so this does not 
provide any additional risk to the participant. The CNA or PTA will be an employee of the 
University and a study team member included on the Personnel Form.  A Professional 
Services Agreement between the University and the Veterans Community Living Center at 
Fitzsimmons will ensure adequate liability coverage, and will outline the services that the 
mobility coach will provide to the facility. In addition, the mobility coach will obtain Workers 
without Compensation (WOC) status through the Veteran’s administration prior to 
providing the intervention. 
 
 During the first three days of the skilled nursing facility stay, the patient will wear an 
activity monitor (the Accusplit) to establish baseline level of mobility (i.e. steps per day) in 
the intervention in order to set and monitor goals, and provide patient feedback.  The 
Accusplit is an inexpensive, non-invasive activity monitor that has been shown to have the 
best accuracy of commercially-availability activity monitors for older adults with slow gait 
speed.45  Concurrently, patients will wear an ActivPAL device to monitor activity levels as 
an outcome for the study.  Participants will not receive feedback directly from the 
ActivPAL, but it will be used for data collection as it is a more reliable and detailed 
measure of physical activity than the Accusplit.   
 
 Following the baseline period, the patient will select two goals: a daily step count 
goal/range for the remainder of the week, between 33-55% increase in step counts as well 
as a functional goal related to mobility and participation in life roles and activities (i.e. 
walking to the activity room or dining room twice per day, walking outdoors) or a goal 
related to time spent out of bed.  Patients will keep a diary of activities performed outside 
of bed, which the mobility coach will review with the patient daily.27  Patients will sign a 
pre-commitment contract in order to enhance accountability for reaching goals.   
 

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Following the baseline assessment period, participants will start out their week with 70 
points.  If the participant does not reach one of their two goals, then they will lose 10 
points for that day.  If they do reach their goal, they will remain at 70 points.  If either of the 
two goals are unable to be assessed, then the patient will keep the 10 points.  This 
method is used to leverage loss aversion, the idea that humans are more prone to change 
behavior if they fear losing as opposed to gaining a desired outcome.46 
 
At the end of each week, the participant will choose a prize with levels depending on how 
many points  he or she have remaining.  Prizes may include mugs, medals, calendars, 
photo frames, jigsaw puzzles, tote bags, crafts, fanny packs, scarfs, and stress balls.  
These prizes will be provided by the University of Colorado and given by a professional 
research assistant.  If the individual is admitted and discharges within one week, they will 
receive a prize if they reach goals for half of their days while admitted. 
 
The intervention will also include training for staff on improving mobility.  PTs, OT, COTAs, 
and/or PTAs will provide verbal presentations and demonstrations for nursing staff on safe 
patient handling techniques as well as a description of the mobility intervention and 
eligibility for the study.   
 
Progressive rehabilitation 
The Veterans Community Living Center at Fitzsimons is already implementing a 
progressive rehabilitation strengthening program (i-STRONGER) as a result of our 
previous work with the facility.  In brief, i-STRONGER is a standardized, progressive, 
multi-component program consisting of strengthening, activities of daily living training, and 
motor control training.  The therapists in this facility adopted i-STRONGER as a new 
standard of care and continue to implement the intervention.  Therapists will continue to 
utilize i-STRONGER as their standard of care throughout the intervention period.   
 
Treatment fidelity 
Treatment fidelity visits will be scheduled using a fidelity checklist.  Fidelity visits will be 
conducted by Dr. Stutzbach or Dr. Stevens-Lapsley with the mobility coach to ensure 1) 
adequate dosage of mobility (to patient tolerance, 2x day) 2) adherence to utilization of 
principals of behavior change and 3) safe patient handling techniques.  Fidelity will be 
assessed 1 x per week with the mobility coach until scores reach 90%, after which fidelity 
assessments will occur monthly  Fidelity will also be assessed by weekly documentation 
audits.   
 
Comparison groups: Previous standard of care and i-STRONGER alone 
Patients in the comparison arm of the study have received usual care as per the previous 
standard of care prior to the i-STRONGER implementation, or the i-STRONGER alone as 
mentioned above.  We will compare the HeRo intervention to historical data we have 
collected on the previous standard of care and the i-STRONGER in Stage 1 and Stage 2 
in COMIRB 14-2388. 
 
Outcome measures 
Outcome measures as listed above will be assessed at admission and discharge.  
ActivPAL monitoring will take place throughout the course of the SNF stay to determine 
the magnitude of change in activity levels from admission to discharge.  A PRA will 
perform phone calls at 7 days and 60 days following discharge from the skilled nursing 
facility.  Information collected at phone calls will include 1) Falls, ER visits, 

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rehospitalizations and 2) Life-space mobility assessment. This cannot be used as an 
outcome measure as it was not collected with our historical data.  However, this will help 
us to determine responders and non-responders to treatment on a longitudinal scale. 
 
D.   Description, Risks and Justification of Procedures and Data Collection 
Tools: 
Veteran data will be managed and stored on CCTSI RedCap and VA server.  
The addition of the physical activity monitor does not pose increase falls risk to the 
patient. There is a possibility of skin irritation from the adhesive used to affix the ActivPAL, 
but we will use a hypo-allergenic adhesive pad, patient education, and frequent monitoring 
to reduce the risk of skin irritation at the site of the ActivPAL.   
There is no expectation that the mobility program will cause serious cardiovascular 
responses or will increase risk of falls.  Gardner et al48 reviewed controlled clinical trials 
with exercise interventions for older adults at-risk for falling. No cardiac events or falls 
were reported in the 12 clinical trials reviewed.  A similar mobility program implemented in 
the acute care setting demonstrated that the group that received the intervention had 
fewer falls than the control group.27 
    
E.   Potential Scientific Problems:   
Missing Data. All patients with outcome measurements will be included in the intent-to-
treat analysis. Although we will encourage patients to be fully compliant to their assigned 
treatment regimen. they will not be dropped from follow-up measurements for lack of 
compliance. Although statistical methods can be used to “adjust” for missing data, these 
methods rely on the untestable assumption that data are “missing at random” so that the 
effect of the missingness can be removed through statistical modeling. We will instead 
focus on preventing missed follow-up visits and evaluate missingness to determine 
whether the data are consistent with the hypothesis of missing at random or missing 
completely at random. 
Patient population:  The SNF population is highly heterogeneous and often 
demonstrates fluctuations in medical status and is at risk for rehospitalizations.  This 
heterogeneity will lead to variability in data, which will try to address by controlling for 
variables such as gender, age, and comorbidities. 
 
F.   Data Analysis Plan:   
 
Aim 1 analysis: The proportion of patients in the HeRo group with a score of ≥70% on 
the satisfaction survey will be compared to the null value of 75% using a one sample 
binomial proportions test. In addition, treatment fidelity checklist scores will be compared 
to the null value of 90% using a one sample binomial proportions test. For the qualitative 
component, verbatim transcripts will be independently coded by two study team members.  
Themes will be developed from those codes as an iterative process until consensus is 
reached among team members.  
Aim 2 primary analysis: The primary analysis will be an intent-to-treat comparison of the 
differences among treatment groups in change in gait speed at time of SNF discharge. 
Statistical inference regarding the difference between treatment groups will be based on 
the estimated coefficient for a treatment group indicator variable in a linear regression 

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model with change in gait speed as the response variable, and explanatory variables that 
include an indicator of treatment group and the baseline value of gait speed. The baseline 
gait speed value is included to improve the precision/power of the inference about 
treatment differences. The conclusion about the statistical significance of differences 
between groups will be determined by this single statistical test to protect against an 
elevated risk of false-positive conclusions. Sensitivity analysis will be done to evaluate 
whether conclusions would differ when other important covariates are added to the model 
(age, gender, comorbidities). We will model gait speed change as a function of treatment 
group (categorical Stages 1, 2 and 3), controlling for the baseline value of function, study 
stage, sex, age, length of stay, total therapy minutes, and potential confounders. 
 
Aim 2 Secondary Analysis: Differences between groups in SPPB, falls, successful 
discharge to the community at time of discharge from SNF will be analyzed as described 
above. Secondary analyses will be evaluated for their consistency with the conclusions of 
the primary endpoints. We anticipate that group differences in secondary measures will be 
correlated with the primary so that significant differences in the primary endpoint will be 
reinforced by similar effects on secondary endpoints. This approach will reduce the risk of 
false-positive conclusions resulting from multiple statistical tests.  
. 
Sample Size Estimates 
 Statistical power was estimated based on measurements of gait speed change from 
admission to discharge on patients in both Stage 1 and Stage 2 (data collection complete, 
N=80). For the primary outcome (change in gait speed), we used the standard deviation of 
0.28. A sample size of 155 patients (75 in Stage 3 [i.e HeRo]) will provide 80% power to 
detect a clinically meaningful difference in change of 0.16 m/sec between Stages 1 & 3 
(primary analysis).  In our previous research, 2/3rds of patients met the inclusion criteria at 
any given time. With an average length of stay of 21-25 days in SNFs, we should have no 
difficulty enrolling 75 patients for this study. 
 
G.  Summarize Knowledge to be Gained:   
 
The proposed research is time-sensitive given increased pressures from the 
healthcare system to promote high-value, cost-effective care by optimizing short and long-
term trajectories of functional recovery for successful community transition after 
hospitalization. This investigation will provide an essential foundation of evidence to 
support the interdisciplinary, multi-component, patient-centered methods for supplemental 
mobility to inform a large cluster-randomized trial.  Our 4 year history of collaborating 
with our clinical partners in a real-world laboratory will increase likelihood of 
success with the proposed research project. 
 
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