Shifting Rehabilitation Paradigms in Skilled Nursing Facilities
Phase: NA
Conditions: Physical Deconditioning
Sponsor: VA Office of Research and Development

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Shifting Rehabilitation Paradigms in Skilled Nursing Facilities 
  
NCT:  02927171  
 
 
Version Date:  12.06.2018  
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Each year Medicare spends approximately $31.3 billion on 2.4 million skilled nursing 
facility (SNF) episodes of care.1 SNFs rely on interdisciplinary approaches to patient care 
to maximize rehabilitation potential for return to prior level of function and reduce the risk 
of adverse events in older adults. However despite a substantial increase in spending on 
SNF services and minimal change in complexity of the caseload, 68% of patients are 
below their pre-hospitalization level of function at discharge, 25% return to the community, 
and 18% are hospitalized.2 This may be partially explained by current SNF approaches to 
patient care which foster inactivity3, 4, 5 and participation in low intensity rehabilitation 
interventions (preliminary data). Both inactivity and low-intensity interventions may 
perpetuate further functional decline or impede maximal recovery. The serious implication 
of risk with functional decline is exemplified by studies which have shown declines in 
physical function can increase the risk of being re-hospitalized six-fold6 and may infer 
other long term effects such as increased risk for mortality, morbidity, and 
institutionalization.7 Muscle weakness, reduced cardiorespiratory reserve, and 
neuromuscular deficits have been attributed to this acute decline in function. However 
current rehabilitation strategies in SNFs do not promote adequate dose and mode of 
interventions to induce beneficial systemic adaptations, perhaps due to the lack of 
evidence on effective rehabilitation protocols for this medically-complex population. In 
addition, the lack of standardization across rehabilitation practices makes it difficult to 
discern which treatment approaches are the most effective. We propose to implement a 
standardized, progressive, multi-component program (PMC) to address this gap in 
research and clinical practice. The study will be completed concurrently in two SNFs and 
consist of three periods: 5 month pre-PMC training period, 2 month PMC training period, 
and 5 month post-PMC training period (Figure 1). We increased the data collection period 
from 3 to 5 months due to the variability in month to month census at the SNFs. The data 
from each facility will be pooled into the respective time period to dilute the effects of 
facility variability. Given the high turnover of patients in SNFs (average length of stay ~21 
days), the analysis will consist of independent 2-sample t-tests. During pre and post PMC 
training periods, measures of physical function will be assessed on all patients weekly and 
at discharge from SNF.  Any hospitalizations or emergency room visits and falls will be 
obtained from the medical record and documented. The discharge location of all patients 
will be documented. The length of stay will be recorded, but given the current 
reimbursement model, the average length of stay is not expected to change with 
implementation of PMC. 

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I. Hypotheses and Specific Aims:   
 
Specific Aim 1: To determine if the group in the post-PMC training period demonstrates 
better physical function, as measured by gait speed (primary outcome), timed-up-and go 
test (TUG), and the Short Physical Performance Battery (SPPB) compared to pre-PMC 
training period. 
 
Hypothesis 1: Patients in the post-PMC training period will demonstrate greater 
improvements in gait speed, TUG, and SPPB at time of discharge from SNF (primary 
endpoint) compared to the group in the pre-PMC training period. 
 
Specific Aim 2: To determine if the group in the post-PMC training period demonstrates 
improved rates of discharge to the community from SNF facilities and lower hospital re-
admission rates compared to pre-PMC training period. 
 
Hypothesis 2: Following the post-training PMC period, patients will demonstrate higher 
rates of discharge to the community and have a lower frequency of hospital re-admissions 
during SNF stay compared to the pre-PMC training period. 
 
II. Background and Significance:  
 
Increased Costs and Resource Allocation in SNFs 
Following hospitalization, older adults experience rapid declines in functional mobility.8,9 
Patients who are discharged to skilled nursing facilities (SNFs) participate in rehabilitation 
programs while being monitored by trained physicians and nurses to prepare for return to 
home or prior level of function. However, 24% of patients in a SNF will be readmitted to 
the hospital and 68% will be discharged at a lower level of function compared to pre-
hospitalization levels, which calls for a change in current clinical practices across multiple 
health care providers in SNFs.1 Physical mobility has been suggested to be a strong 
predictor for hospitalization readmission; 10-13 in fact those with lower levels of physical 
5 Months 
7 Months 
12 Months 

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activity are six times more likely to be re-hospitalized.6 Rehabilitation services provided by 
physical therapists (PTs), occupational therapists (OTs) and speech language 
pathologists (SLPs) have the potential to impact physical function outcomes, discharge to 
community, and rates of rehospitalization. Though these effects have not been 
consistently observed in combination under usual care or specifically attributed to therapy 
services. 6,13,14,15,3,16 Observational data suggests patients are inactive more than 80% of 
the day and participate in conservative rehabilitation interventions over the course of their 
SNF stay, which may contribute to the persistently high rates of re-hospitalization, 
institutionalization, and poorer functional outcomes. The perpetuation of inactivity and use 
of conservative interventions presents an opportunity to develop and implement 
progressive, multi-component rehabilitation protocols that have the potential to impact 
practice patterns and outcomes in SNFs.  
 
Lack of standardized care 
Currently, there is little standardization of overall care across facilities and regions, which 
likely contributes to varying outcomes and increased costs. SNF care consists of a multi-
faceted approach from a variety of health care disciplines. Thus, attention to the quality of 
care from individual disciplines and interaction between disciplines could contribute to 
improvements in the overall care quality and subsequent outcomes. Rehabilitative therapy 
constitutes a pivotal role in facilitating a patient’s return to previous level of activity and 
participation. However therapy sessions only comprise ~2-3 hours or 6-13% of a patient’s 
day and are generally dosed at a poorly defined intensity.17-20 Therefore, greater 
concentration needs to be given to the quality and effectiveness of therapy interventions 
to induce greater gains within a shorter time. The reduced amount of time with a skilled 
therapist also diminishes the total activity or mobilization completed per day, which raises 
concern for further detrimental sequela stemming from immobility.  
 
Limitations with Conservative Rehabilitation Approaches 
In the literature, the definition of treatment intensity is variable and ranges from a 
monitoring of total therapy time per session, time per activity, total therapy time per LOS, 
magnitude of activity counts with accelerometers or effort (% maximum).15,17-27 This 
evidence does give insight into the quality of the intervention and the amount of 
physiologic effort needed to complete activities. A preponderance of evidence exists 
which demonstrates the beneficial and safe effects of strength and aerobic training in 
older adults with and without chronic diseases. 28,29,30,31 These benefits also extend to 
adults over 80 years old and frail individuals.32,33,34,29 In addition, the benefits of strength 
and aerobic training have been demonstrated in older adults with chronic conditions such 
as CHF, COPD, cancer, PVD, obesity, HTN, osteoporosis, CVA, dementia, osteoarthritis, 
hip fracture, joint arthroplasty, DM II, sarcopenia.35,36,37 Patients with the aforementioned 
conditions are commonly seen in SNF, though our observational data revealed limited use 
of strength and aerobic training principles during the course of usual care, which may 
impede maximal recovery of function. Furthermore, whether the beneficial effects of 
strength on function can be observed within the average 21 day stay in a SNF has yet to 
be evaluated. The focus on progressive, multi-component rehabilitation programs extends 
previous work being done by our lab which indicates increasing the complexity or effort 
during rehabilitation interventions-- including strengthening, balance and functional 
mobility training-- is safe, feasible, and improves outcomes in home and outpatient 
physical therapy settings.38,39  In our proposed study we will incorporate progressive 
strengthening, mobility, and aerobic interventions into a multi-faceted approach that 
provides carryover into performance of challenging functional tasks in multiple 

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environments. This approach is novel in 1) the application of progressive exercise 
programs designed using the American College of Sports Medicine Guidelines to 
older adults in SNF settings and 2) the intervention occurs within current Medicare 
reimbursement guidelines for SNFs. 
 
Culture of Inactivity 
In addition to progressive therapeutic interventions, education and training on graded 
mobility guidelines for allied health disciplines (nursing, aides) will promote a culture of 
mobility to prepare patients for return home or decrease burden of care. A major goal of 
rehabilitation in the SNF setting is to prepare individuals for return to the community and 
presumably tolerate community levels of activity and participation. Low levels of physical 
activity have been connected to mortality rates and further health complications in acute 
care settings. That being said, evidence suggests patients in SNFs are ~80% less active 
compared to community-dwelling, older adults and, when active, do not engage in activity 
at a moderate intensity adequate for systemic adaptations.4,40,3 Barriers to mobilization by 
nursing staff may include perceived safety risk (falls, adverse acute events with exercise), 
staff shortages, lack of formal training on safety and equipment use, time constraints, etc. 
Nursing care directed at promoting independent self-cares and completion of exercise or 
walking programs may foster increased motor learning through high repetition practice, 
improved self-efficacy, and increased habitual activity.17,41 Enhanced motor learning, 
increased self-efficacy and improved mobility which can contribute to functional gains and 
increased preparedness in completion of instrumental and basic daily activities after 
discharge.17,41 The implementation of a practical framework from which multiple 
disciplines can become involved in promoting activity outside of therapy sessions 
is a novel approach to reducing the detrimental sequelae stemming from the 
perpetuation of inactivity in SNFs.  
 
III. Preliminary Studies/Progress Report:  
Preliminary Data in Home Health Settings 
Our research group has conducted a preliminary investigation on the feasibility and safety 
of implementing a similar PMC program during home physical therapy sessions 
(manuscript in review). Patients who receive home physical therapy are often medically-
complex and at high risk for re-hospitalization, which makes this population comparable to 
the proposed SNF population.   
 
For the preliminary work, patients were recruited from the University of Colorado hospital 
(n=22) and randomized into the PMC intervention group or usual care (UC). Treatment of 
both groups occurred over the course of ~30 days with a total of 8-10 treatment sessions, 
which is consistent with current reimbursement guidelines and home health practice. 
Measurements of gait speed and short physical performance battery (SPPB) were 
assessed at baseline, 30 days (end of treatment), and 60-day follow-up (primary 
endpoint). Preliminary data from this investigation provides compelling evidence that 
implementation of the PMC intervention results in 1) substantially improved physical 
function over a short duration, 2) sustainability of improvements at 30 and 60-days post 
discharge, and 3) no increased risk for injury.  
 
Results: PMC resulted in a 60% improvement in function at 60 days compared to only 
9.7% improvement with UC. For walking speed, a 0.1m/s difference in walking speed 
represents substantial meaningful change, and we saw differences almost twice this 
large in our preliminary data. In fact, 30% of patients in the PMC group achieved >1.0m/s 

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walking speed (threshold for independent community ambulation) at 60 days; no UC 
group patients achieved this walking speed threshold. A one-point difference in the SPPB 
represents substantial meaningful change, and we saw differences twice this large in our 
preliminary data. In fact, PMC resulted in a 60% improvement in function at 60 days 
compared to only 9.7% improvement with UC. Importantly, both groups received a 
comparable number of visits. In the usual care group there were 4 total episodes in (3 re-
hospitalizations, 1 emergency room visit), while the PMC group had only 1 emergency 
room visit. Furthermore, these results provide evidence for the investigative team’s 
experience managing medically complex patients using the proposed intervention strategy 
to promote favorable outcomes.   
  
IV. Research Methods 
 
  A.  Outcome Measure(s):   
During both the pre-PMC and post-PMC training periods, a trained Certified Nursing 
Assistant (CNA) (blinded) will assess gait speed, TUG, and SPPB within 24-48 hours of 
admission to SNF. If the CNA is unable to assess within 24-48 hours of admission, then 
the physical therapist performs the assessments. The occupational therapist will 
administer the Mini Mental Status Scale to assess baseline cognitive status within 24-
48 hours of admission to SNF. A trained CNA (blinded) will continue to perform 
functional assessments (gait speed, TUG, SPPB) weekly and at discharge from SNF 
(Figure 2). Physical therapists (PTs) and physical therapist assistants (PTAs) will 
perform weekly and discharge assessments as necessary.  
Interventions: During the 5-month pre-PMC training period (baseline), all current 
patients at the SNF will receive usual care treatment as facility therapists will practice 
per current standard of care. We will collect pre-PMC training data for 3 months or until 
collection of data on 602 patients (half the number of patients approved to be 
consented) (Figure 1).  Therapists will then be trained on the PMC intervention for 2 
months. After training, the facilities and individual therapists will decide how to 
implement such care at their discretion.  Following the training period, we will collect 
post-PMC training data for 5 months or until collection of data on 602 patients (half the 
number of patients approved to be consented) (Figure 1).  The data collected in all 
facilities during the pre-PMC training period will be pooled into one group to dilute the 
effect of facility variability. The data collected during post-PMC training period will be 
pooled in the same way.  
 
Figure 2. Outcome Measure Assessments Time points 

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Outcomes: All testing will occur at the SNF by facility PTs, PTAs, OTs or a trained CNA 
(blinded).  Primary Outcome: Gait speed will be measured by the time it takes to walk 
a 4-meter path. Time will be measured with a stopwatch to the nearest hundredth of a 
second. This measure was selected as the primary outcome because: 1) it has been 
shown to predict risk of mobility and physical disability, higher health care utilization 
and increased mortality; 42,43 2) it has been established as a meaningful outcome 
measure in older persons with a wide range of conditions;  3) it is a valid and reliable 
measure; 44,45 4) it is easily understood by patients, their families, providers and health 
care policy makers (good face validity); and 5) it is easily performed in the home and 
well tolerated by patients varying in condition and degree of health. Secondary 
Outcomes: The Timed Up And-Go (TUG) test will be performed on each patient as a 
measure of basic mobility skill and evaluation of fall risk. 46 The TUG test well 
established cut-off scores to indicate falls in both frail and community dwelling older 
adults. The TUG has excellent inter-rater reliability, and is responsive to changes in 
mobility status.47,48The Short Physical Performance Battery (SPPB) is a well-
accepted global measure of lower extremity function, which consists 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.49 The test takes 
~10-15 minutes to administer and was designed to be administered in a setting with 
limited space. The battery has an excellent safety record as it has been administered to 
well over 10,000 persons in various studies. The SPPB components and total score are 
derived from normative values obtained from a population-based study. The reliability 
of the individual components, as well as the summary score of the SPPB, are good with 
intra class correlation coefficients (ICC) >0.88 and good sensitivity to change.50 The 
continuous scoring system minimizes ceiling effects and scores range from 0-12 with 
higher scores indicative of better performance.  
 
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 

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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.  
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; all data will be de-identified. These characteristics include 
age; gender; race; history of comorbidities, medications, primary diagnosis for hospital 
admission; length of skilled nursing facility stay; complications in hospital and length of 
stay.  
 
Qualitative data will be collected through voluntary focus group discussions consisting of 
therapists in the SNFs with current IRB approval (Brookdale Mountain View, Veterans 
Community Living Center at Fitzsimons, PowerBack Rehabilitation, Gardens on Quail, 
Good Sam-Ambassador, Villa St. Louis Park). The data collected will inform future 
refinement of the PMC program for large-scale dissemination.  
 
B. Description of Population to be Enrolled:   
Patients will be enrolled from four SNFs in the Denver metro area: Gardens on Quail, 
Brookdale Mountain View, Veterans Community Living Community at Fitzsimons, 
and Powerback Rehabilitation; and two in Minnesota: Good Sam-Ambassador and 
Villa St. Louis Park. All patients temporarily residing in the designated SNFs will receive 
the current standard of care during the 5-month pre-PMC training period. Outcomes data 
will be collected for all patients who are admitted and discharged during the 5-month pre-
PMC training period. Once SNF staff have been trained on the PMC protocol (2-month 
period), all patients will receive the PMC intervention (post-PMC training period) as the 
new standard of care per therapist discretion, unless contraindicated. Outcomes data will 
be collected for all patients who are admitted and discharged during the 5month post-
PMC training period. All patients will receive the respective intervention (current standard 
of care or PMC) until discharge from the SNF. Outcomes data will only be collected on 
patients who fit the inclusion criteria: adults older than 18 years of age who are admitted 
to a skilled nursing facility and receive at least physical or occupational therapy. Exclusion 
criteria: Patients with neurological disorders, such as a stroke or traumatic brain injury, will 
be excluded as the best practice for managing these patients is based on motor-control 
theory versus the proposed 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. 
 
Up to 30 therapists will be recruited from the Gardens on Quail, Brookdale Mountain View, 
Veterans Community Living Center at Fitzsimons, Powerback Rehabilitation, Good Sam-
Ambassador, and Villa St. Louis Park staff who have been trained in the PMC 
intervention.   
Inclusion criteria:  Trained in PMC intervention, provided PMC intervention to patients at 
Gardens on Quail, Brookdale Mountain View, Veterans Community Living Center at 
Fitzsimons, Powerback Rehabilitation, Good Sam-Ambassador, and Villa St. Louis Park.    
Exclusion criterion:  Decline to participate. 

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C. Study Design and Research Methods   
 
This study is a preliminary investigation using a pre-post training design in six SNFs 
(Figure 1). We will pool the data across the six SNFs into the pre and post-PMC training 
periods to dilute the effect of facility variability. Given that the average length of stay in a 
SNF is 21 days, the pre/post PMC training design will consist of two independent samples 
of patients to include only those that were admitted and discharged within a given period. 
As we get interest from additional facilities, we may submit an addendum to include them. 
Additional sites would help inform sample size estimates for a potential future, cluster-
randomization study design. During the 5-month pre-PMC training period, the 
rehabilitation therapists will treat patients per the current standard of care and a trained 
CNA (blinded) or PT/PTA (as necessary) will collect outcomes data at admission, weekly, 
and at discharge. Then, training on the PMC intervention will occur over a 2-month period. 
Any patients admitted or discharged in the SNF during the PMC training period will not be 
used. During the 5-month post-PMC training period, therapists will implement the PMC 
protocol and collect outcomes data as indicated previously (Figure 1).  
 
The medical records will provide information on prior level of function, age, other medical 
conditions, re-hospitalization and emergency room visits, medications, sex, admitting 
diagnosis, falls, SNF length of stay, discharge location, evaluation and treatment 
documentation.  
 
Five focus group discussions of 4-6 therapists each will follow an interview guide and last 
a duration of approximately 1 hour. Therapist participation is voluntary, and all participants 
will be asked for informed consent. Discussions will be recorded and transcribed for 
content analysis. 
 
D.   Description, Risks and Justification of Procedures and Data Collection 
Tools: 
 
 
Veteran data will be managed and stored on VINCI RedCap and VA server. Non-Veteran 
data will be collected and managed using REDCap (Research Electronic Data Capture). 
Study data will be collected and managed using REDCap (Research Electronic Data 
Capture). REDCap is a secure web application designed to support data capture for 
research studies, providing user-friendly web-based case report forms, real-time data 
entry validation (e.g. for data types and range checks), audit trails and a de-identified data 
export mechanism to common statistical packages (SPSS, SAS, Stata, R/S-Plus). The 
system was developed by a multi-institutional consortium which includes University of 
Colorado–Denver and was initiated at Vanderbilt University. The database is hosted at the 
University of Colorado–Denver Development and Informatics Service Center (DISC), 
which will be used as a central location for data processing and management. REDCap 
data collection projects rely on a thorough study-specific data dictionary defined in an 
iterative self-documenting process by all members of the research team with planning 
assistance from the DISC. This iterative development and testing process results in a 
well-planned data collection strategy for individual studies. REDCap also includes a 
powerful tool for building and managing online surveys. The research team can create 
and design surveys in a web browser and engage potential respondents using a variety of 
notification methods. REDCap is flexible enough to be used for a variety of types of 
research and provides an intuitive user interface for database and survey design and data 
entry.51 

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Patients in either training period may experience muscle soreness after the first few 
sessions.  The soreness typically does not last more than 2-3 days and does not damage 
the muscle. The physical therapist will instruct the patient on the proper use of superficial 
heat or ice if muscle soreness occurs. A minimal risk for falls exists for patients receiving 
either intervention strategy (pre-PMC or post-PMC). This minimal risk is no different than 
the risk that is normally present during rehabilitation interventions or walking/moving 
around with assistance in the SNF.  
The outcome measures specified are used in a variety of rehabilitation settings under 
current reporting and standard of care practices. Furthermore, some physical therapists 
already use the treatment principles included in the PMC intervention. Therefore, these 
treatment options are already implemented safely in some settings. Yet without concrete 
evidence to support the effectiveness of the PMC approach, it is not possible to change 
the standard of practice on a larger scale to improve the quality of care in this patient 
population.     
    
E.   Potential Scientific Problems:   
 
There are some limitations that will need to be addressed in future studies. There are a 
large number of therapists treating patients, but we have methods in place for training to 
ensure ongoing procedural reliability across sites as a larger number of therapists/sites 
increases the generalizability of the results. We also acknowledge the heterogeneity in the 
patient population. While this could dilute the effect of the intervention, we will be then 
able to determine if the intervention is effective in a wide variety of patients or perhaps 
more effective in an identified sub-group. This will help guide therapists in future treatment 
plans. 
 
F.   Data Analysis Plan:   
 
Analysis 
Primary and Secondary Outcomes: The primary outcome (Aim 1) for this study is the 
change in gait speed between admission and discharge from a SNF. The change in 
gait speed will be pooled across the six facilities for the two respective time periods 
(pre and post PMC training). The mean change in gait speed for the independent 
group of patients tested during the pre-PMC training period will be assessed and 
compared to the mean change in gait speed for the independent group of patients during 
the post-PMC training period.  
 
Secondary outcomes include physical function measures (SPPB, TUG) and health care 
utilization outcomes (emergency room visits, falls, skilled nursing home length of stay, and 
re-hospitalizations), which will be recorded weekly and at discharge from SNF. Preliminary 
descriptive and graphical analyses (including boxplots, scatterplots, profile plots to 
examine change over time) will be used for data cleaning and visualization of primary and 
secondary outcomes.  
 
Primary Analysis: The primary analysis will be an intent-to-treat comparison of change in 
gait speed from SNF admission to discharge between 2 independent groups of patients 
(pre and post-PMC training groups).  Statistical inference regarding the difference 
between pre and post-PMC training groups will be based on independent sample t-tests. 
Comparisons will be made on changes in outcome measures (admission to discharge) 

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within pre/post PMC training groups. Groups of patients will be pooled from all facilities to 
form 2 independent samples for comparison of time periods (pre and post PMC training) 
(See Figure 3). The conclusion about the statistical significance of differences between 
pre/post groups will be determined by this single statistical test to protect against an 
elevated risk of false positive conclusions.  
 
Figure 3. Data analysis plan 
 
 
Secondary Analyses (Aim 2): We will estimate health care utilization outcomes rates 
(falls, emergency department visits, skilled nursing home length of stay or re-
hospitalizations) for each pre/post PMC training period and compare rates between arms 
using a likelihood ratio test.  
 
The characteristics of the time trajectory (weekly and at discharge from SNF) for treatment 
effects will also be analyzed in secondary analyses to inform the development of methods 
to improve long-term outcomes. The analytic methods will include maximum likelihood 
estimates from a repeated measures model of the mean effect of gait speed at each of the 
measurement times. The trend in means will be evaluated using a linear contrast as the 
summary measure of greatest interest. This approach will evaluate whether there are 
differences in the first-order trends (slope) between the pre/post PMC training groups. The 
evaluation of the time trajectory will be conditioned on the stratification variables and the 
baseline value of gait speed.  
 
The qualitative study will be conducted after quantitative data collection for the parent 
study has been completed to better understand the process of implementation for future 
refinement of the program.  The audio from the focus group discussions will be 
transcribed either by two study team members or by Transcription Outsourcing. Two 
coders will review the transcription and develop a code book in an iterative process until 
both coders reach agreement. Coded transcripts will be analyzed to identify barriers and 
facilitators to implementation of PMC. 
 
Sample Size Estimates 
Statistical power was estimated based on the results of a home-health pilot study of 22 
participants: 10 were randomized to PMC, 12 to the usual care interventions. The home 
health population is similar to the SNF population given both experienced a recent acute 
hospitalization and subsequent decline in function. However, we anticipate patients in 
SNF will have less gain in gait speed compared to home health participants because the 
significant decline in function demonstrated in the patients in SNFs has rendered them 
unable to manage in the home. Therefore, we used the following results for the power 
analysis: means ± standard deviations (SD) of 0.31 ± 0.29 feet for PMC and 0.13 ± 0.12 
for usual care. For the power analysis we used a SD of 0.29 and mean difference of 0.14, 
which is the midpoint between 0.1 (clinically significant difference) and 0.18 (the difference 

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of the means of from the home health study). Thus, a sample size of 184 patients 
completing the study (92/group) will provide 90% power (assuming the same SD in both 
groups to be conservative) to detect differences at least that great. This estimate is 
conditional upon using a 1-sided, alpha = 0.05 level 2-group t-test.  
 
. Of the sites currently listed under COMIRB 14-2388, we have not begun collecting data 
at Powerback Rehabilitation. Powerback is a growing facility that, on average, provides 
rehabilitation services to 120 patients a day. Approximately 2/3 of patients will likely be 
appropriate for the intervention; thus, across a 10-month data collection phase, we will 
require an increase in enrollment numbers to 800. Our current number approved is 434, 
so a total of 1,234 is being requested for approval to accommodate the large numbers of 
patients being seen for rehabilitation at Powerback.  While this exceeds our initial sample 
size estimates, each facility has more variability than we anticipated (e.g., patient 
population, ratio of PTs to PTAs, rehab coverage on weekend, in house vs contracted 
rehab services). Therefore, additional facilities are necessary to better determine the 
variability of patient outcomes across different types of facilities for a future, multi-site 
pragmatic clinical trial. Furthermore, anticipated funding through the VA requires us to 
include facilities with Veterans (e.g., Veterans Community Living Center at Fitzsimons).  
 
G.  Summarize Knowledge to be Gained:   
 
Rehabilitation therapy is known to help improve function in older adults after an acute 
functional decline. However, we do not know if there is an additional benefit to 
implementing a progressive program with an emphasis on activity throughout the day in 
the SNF setting. Effective rehabilitation interventions in SNFs can improve function in 
adults, which allows patients to return to prior level of care and location. This study has 
the potential to not only improve individual functional outcomes but also increase 
community discharge rates and reduce hospital readmissions. The alternative treatment is 
to choose a different skilled nursing facility (non-research site) which employs a different 
standard of care. 
 
 H. References: 
 
1. 
Health Care Spending and the Medicare Program. In: Commission MPA, ed. Washington 
DC2013. 
2. 
Skilled Nursing Facility Services. In: Commission MPA, ed2013. 
3. 
Peiris CL, Taylor NF, Shields N. Patients receiving inpatient rehabilitation for lower limb 
orthopaedic conditions do much less physical activity than recommended in guidelines for 
healthy older adults: an observational study. Journal of physiotherapy. 2013;59(1):39-44. 
4. 
Grant PM, Granat MH, Thow MK, Maclaren WM. Analyzing free-living physical activity of 
older adults in different environments using body-worn activity monitors. Journal of aging 
and physical activity. 2010;18(2):171-184. 
5. 
Smith P, Galea M, Woodward M, Said C, Dorevitch M. Physical activity by elderly patients 
undergoing inpatient rehabilitation is low: an observational study. The Australian journal of 
physiotherapy. 2008;54(3):209-213. 
6. 
Fisher SR, Kuo YF, Sharma G, et al. Mobility after hospital discharge as a marker for 30-
day readmission. The journals of gerontology. Series A, Biological sciences and medical 
sciences. 2013;68(7):805-810. 
7. 
Miller EA, Weissert WG. Predicting elderly people's risk for nursing home placement, 
hospitalization, functional impairment, and mortality: a synthesis. Medical care research 
and review : MCRR. 2000;57(3):259-297. 

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8. 
Creditor MC. Hazards of hospitalization of the elderly. Annals of internal medicine. 
1993;118(3):219-223. 
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