Enhanced Medical Rehabilitation in Older Adults
Phase: NA
Conditions: Disabling Medical Events, Disabled, Depression
Sponsor: Washington University School of Medicine

Version: 8 
IRB approved: 1/18/18 
NCT02114879 
Enhanced Medical Rehabilitation R01 Study Protocol 
Principal Investigator: Eric Lenze, MD 
 
Co investigators: 
Marghuretta Bland, PT, DPT, NCS, MSCI 
Rebecca Birkenmeier, OTD, OTR/L 
Ellen Binder, MD 
Catherine Lang, PhD 
Carolyn Baum, PhD 
Nancy Morrow-Howell, PhD 
Tom Rodebaugh, PhD 
Peggy Barco, OTD, OTR/L, SCDCM 
 
Study team members: 
Emily Lenard, BA 
Julie Schweiger, CCRC 
Selmi Kallmi, BA 
Sarah Pennock  
Henry Mitchell 
Gabriela Gonzalez 
Dave Dixon, PhD 
Michael Yingling, MS 
 
Healthy Mind Lab Staff: 
Michelle Voegtle, BA 
Angela Stevens, BS 
Marissa Rhea, MA 
Brian Abboud 
Andes Perez 
Hayley Hinton, BA 
Jissell Torres 
Kelly Ahern 
 
Supported by: 
The National Institute of Mental Health (NIMH) 
R01 MH099011  

 
 
 
 
 
 
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2 
 
TABLE OF CONTENTS 
ENHANCED MEDICAL REHABILITATION R01 STUDY PROTOCOL .......................................... 1 
A 
INTRODUCTION ............................................................................................................................... 3 
A1 
STUDY ABSTRACT ......................................................................................................................... 3 
A2 
STUDY AIMS AND HYPOTHESES ..................................................................................................... 3 
A3 
PURPOSE OF THE STUDY PROTOCOL .............................................................................................. 4 
B 
BACKGROUND .................................................................................................................................. 4 
B1 
PILOT RCT FINDINGS .................................................................................................................... 4 
B2 
RATIONALE FOR THIS STUDY ......................................................................................................... 5 
C 
STUDY OBJECTIVES........................................................................................................................ 7 
C1 
PRIMARY AIM ................................................................................................................................ 7 
C2 
SECONDARY AIM ........................................................................................................................... 7 
C3 
RATIONALE FOR THE SELECTION OF OUTCOME MEASURES ........................................................... 7 
D 
STUDY INTERVENTION: ENHANCED MEDICAL REHABILITATION ................................ 8 
E 
STUDY DESIGN ................................................................................................................................11 
E1 
DESIGN SUMMARY .......................................................................................................................11 
E2 
SUBJECT SELECTION AND WITHDRAWAL......................................................................................11 
F 
STUDY PROCEDURES ....................................................................................................................15 
F1 
SCREENING FOR ELIGIBILITY.............................................................................................................15 
F2 
SCHEDULE OF MEASUREMENTS ........................................................................................................15 
F3 
SNF ADMIT (BASELINE) VISIT ..........................................................................................................16 
F4 
DAY 30 VISIT ....................................................................................................................................16 
F5 
SNF DISCHARGE ...............................................................................................................................16 
F6 
DAY 60 VISIT ....................................................................................................................................16 
F7 
DAY 90 VISIT ....................................................................................................................................17 
F8 
DATA AND SAFETY MONITORING PLAN ............................................................................................17 
G 
STATISTICAL PLAN ........................................................................................................................19 
G1 
SAMPLE SIZE DETERMINATION AND POWER .................................................................................19 
G2 
INTERIM MONITORING AND EARLY STOPPING ..............................................................................20 
G3 
ANALYSIS PLAN............................................................................................................................20 
G4 
STATISTICAL METHODS ................................................................................................................20 
H 
DATA HANDLING AND RECORD KEEPING .............................................................................21 
H1 
CONFIDENTIALITY AND SECURITY ................................................................................................21 
H2 
TRAINING......................................................................................................................................21 
H3 
RECORDS RETENTION ...................................................................................................................21 
I 
STUDY MONITORING, AUDITING, AND INSPECTING ..........................................................22 
J 
STUDY ADMINISTRATION ...........................................................................................................22 
J1 
ORGANIZATION AND PARTICIPATING CENTERS .................................................................................22 
J2 
FUNDING SOURCE AND CONFLICTS OF INTEREST ..............................................................................22 
J3 
PARTICIPANT PAYMENT ....................................................................................................................22 
K 
PUBLICATION PLAN ......................................................................................................................22 
L 
REFERENCES ...................................................................................................................................23 

 
 
 
 
 
 
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3 
A Introduction 
 
A1 Study Abstract 
For millions of disabled older adults each year, post-acute rehabilitation in skilled nursing 
facilities (SNFs) is a narrow window of opportunity to regain enough function to return 
home and live independently -- but all too often they fail due to problems such as 
depression that undermine rehabilitation’s benefits.    
Therefore, we created Enhanced Medical Rehabilitation (EMR) for older adults.  A real-
world adaptation of the science of behavior change, EMR is an integrated set of skills for 
physical and occupational therapists (PT/OT) that transform standard post-acute 
rehabilitation through: (1) a patient-directed, interactive approach (2) increased 
rehabilitation intensity (3) frequent feedback to patients on effort and progress.  We 
developed training and supervision techniques so that PT/OTs carry out these skills with 
high treatment integrity. 
In NIMH R34 pilot work, we found: (1) EMR is high-intensity and engaging: therapy by 
PT/OTs trained and supervised in EMR is greatly amplified in intensity and patient 
engagement compared to standard-of-care rehabilitation. (2) EMR improves functional 
and affective recovery: patients randomized to EMR had better improvement of function, 
physical performance, and positive and negative affect. (3) EMR overcomes barriers to 
rehabilitation: patients with depressive symptoms, cognitive impairment, and multiple 
medical comorbidities benefitted most from EMR relative to standard therapy.   
We propose a randomized trial that will test EMR’s benefits over standard-of-care 
rehabilitation for affective and functional recovery.  Our aims are (1) examine the 
effectiveness of EMR for improving functional and affective outcomes in 252 older adults 
admitted to SNFs for post-acute rehabilitation, and (2) examine EMR’s ability to 
overcome patient-level barriers (such as depression) to successful rehabilitation. 
The innovation of this project is high: it is a novel application of theories of behavior 
change to improve both affect and function.  It responds to NIMH strategic plan objective 
3, “Develop new and better interventions for mental disorders that incorporate the 
diverse needs and circumstances of people with mental illness.”      
The public health significance is also high: recovery from disablement is a health issue 
of enormous human and economic significance.  Success in this line of research will 
make rehabilitation more effective.  Doing so would benefit all older adults in this sector 
of care but particularly those with depression, cognitive impairment, and other 
complications.  This project addresses NIMH’s goal of interventions to improve mental 
health and related health outcomes in real-world settings. 
A2 Study Aims and Hypotheses 
Aim 1: Examine the effectiveness of EMR for improving functional and affective 
outcomes in older adults admitted to SNFs for post-acute rehabilitation.   
H1: EMR will improve functional and affective recovery to a greater extent than 
standard-of-care rehabilitation. 
Rationale: This test could demonstrate EMR’s effectiveness, a key step toward 
establishing EMR as the gold-standard practice for post-acute rehabilitation, to the 
benefit of millions of older adults. 

 
 
 
 
 
 
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4 
 
Aim 2: Examine EMR’s ability to overcome patient-level barriers to successful 
rehabilitation. 
H2: The effectiveness of EMR for functional recovery will be greatest in: (a) patients with 
clinical depression; (b) patients with high levels of medical comorbidity; (c) patients with 
cognitive impairment. 
Rationale: Demonstrating that EMR is particularly effective in the most vulnerable 
patients could overturn conventional wisdom that such persons should be excluded from 
intensive rehabilitation. 
 
A3 Purpose of the Study Protocol 
This study protocol will serve as the working document for the study team to ensure the 
conduct of the research is consistent with the IRB approval.  
B Background 
 
Disabling medical events frequently occur in elderly persons; one study found that more 
than one-half of community-living elderly persons had a disabling medical event over a 
median four year follow-up (Hardy et al, 2004). In 2001 there were over six million 
hospitalizations in the US for persons aged 65 and older for disabling events such as 
heart disease, stroke, fracture, and osteoarthritis (National Hospital Discharge Survey, 
2001), a number that will dramatically increase in the next 20-30 years as the number of 
persons 65 and older increases from 35 million (in 2000) to more than 86 million by 2050 
(US Bureau of the Census, 2004).  
B1 Pilot RCT Findings 
From 2010-2011 we carried out an NIMH R34 treatment development grant to develop 
and preliminarily test Enhanced Medical Rehabilitation, a novel PT and OT intervention.  
Our goal was to apply the science of behavior change to overcome shortcomings of 
standard of care rehabilitation, namely that it does not provide high-intensity and highly 
engaging therapy. 
We trained and supervised four therapists (2 OT, 2 PT) and we monitored their fidelity to 
the Enhanced Medical Rehabilitation model.  In a case series, we found excellent 
functional recovery and reduction of depressive symptoms with Enhanced Medical 
Rehabilitation. Then, we carried out a pilot RCT, randomizing 26 participants to 
Enhanced Medical Rehabilitation by the trained therapists or standard of care 
rehabilitation by non-trained therapists.   
In this pilot RCT we found the mechanism of Enhanced Medical Rehabilitation is 
increased engagement and increased intensity in therapy sessions; both constructs are 
considered critical in the rehabilitation sector, yet surprisingly little research has 
advanced their measurement.  Enhanced Medical Rehabilitation sessions markedly 
outpaced standard-of-care sessions (by 2-3 fold) in measures of therapy intensity.  
Enhanced Medical Rehabilitation participation scores were higher also in patient 
engagement, indicating more active engagement by patients.  In contrast, scores from 
the Working Alliance Inventory (WAI) are similar (and high) in both Enhanced Medical 
Rehabilitation and SOC.  The WAI examines non-specific therapist variables and may 
therefore be a technique-independent predictor of positive rehabilitation outcomes. Thus, 

 
 
 
 
 
 
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these data indicate that the differences seen are specifically related to higher therapy 
engagement in Enhanced Medical Rehabilitation, not non-specific factors (such as liking 
the therapist).Additionally, among those with high baseline depressive symptoms, 
Enhanced Medical Rehabilitation resulted in greater improvement in negative affect: a 
mean reduction of 5.6 points, vs 2.2 points in SOC rehabilitation (scale’s range was 8-
40). The relative benefits of Enhanced Medical Rehabilitation may be greatest in patients 
with depression, cognitive impairment, and multiple medical comorbidities. We 
developed Enhanced Medical Rehabilitation because these common comorbidities often 
undermine successful rehabilitation, likely via demoralization or lack of insight.  When we 
dichotomized the sample based on present/absent cognitive impairment, high/low 
medical complexity (number of medical conditions), or high/low depressive symptoms at 
baseline, in each case we found trends for greater relative recovery in Enhanced 
Medical Rehabilitation compared to SOC among those with higher impairments.  This 
appeared to be because SOC did not work as well (lower functional recovery in those 
with these comorbidities) while Enhanced Medical Rehabilitation did work as well (similar 
functional recovery with or without these comorbidities.  These results, while very 
preliminary, suggest that Enhanced Medical Rehabilitation does overcome barriers to 
successful rehabilitation, which is consistent with its theoretical focus on overcoming 
barriers to engagement.   
 
B2 Rationale for this Study 
2.a 
The growing role of post-acute rehabilitation  
Americans are aging and having more medical events such as heart attack, stroke, and 
hip fracture.1  More than ever, older adults are surviving these events and leaving the 
hospital, alive but severely disabled.2-4 The solution for these highly disabled older adults 
is rehabilitation in the post-acute care setting, a large and rapidly-growing sector of 
care.5 Post-acute rehabilitation consists of daily physical therapy (PT) and occupational 
therapy (OT) to achieve restoration (e.g., regain walking ability and counteract bone and 
muscle loss by gait and muscle strengthening exercises), and adaptation (e.g., learn to 
perform activities of daily living and safely live at home).   
The most common setting for post-acute rehabilitation is a skilled nursing facility (SNF).  
Length of stay is about 3 weeks, a narrow window in which to recover and return home 
or be institutionalized.  
2.b 
Depression is the most common and deleterious mental 
disorder in post-acute rehabilitation. 
Disabled older adults have high rates of depressive symptoms and disorders which lead 
to and amplify disability.  This bidirectional relationship between late-life depression and 
disability is intensified in post-acute rehabilitation, where affective impairments are 
barriers to successful rehabilitation.6,7  In other words, in this population, depressive 
symptoms are both an outcome of rehabilitation (as disability is depressogenic) and 
moderate (reduce) rehabilitation success.  Additionally, cognitive impairment and high 
levels of medical complexity impede rehabilitation success. 
Existing mental health interventions are a poor fit for these disabled and depressed older 
adults.8-10  Post-acute rehabilitation is a difficult setting in which to integrate evidence-
based mental health treatments, due to short stays, difficulty of case detection, and 

 
 
 
 
 
 
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6 
competing demands (most notably from the rehabilitation itself).  Additionally, frail and 
medically ill older adults have less benefit and greater risks from antidepressants.11  
Finally, the affective state of these older adults appears tightly linked to the disablement 
itself.12-16  Therefore, an optimal intervention would use a common conceptual model to 
address affective impairments together with the disablement.  Trans-NIH initiatives such 
as the NIH Integrated Health Improvement Strategies Workgroup17 have called for more 
research in such treatment models. 
2.c 
Do we need to enhance rehabilitation? 
Post-acute PT/OT itself could be this optimal intervention, ameliorating affective 
impairments and disablement via intensive goal-oriented interactions with highly-trained 
providers.  Yet two factors have been observed to undermine rehabilitation, particularly 
for depressed older adults: (1) The PT and OT is of low intensity, often too low to provide 
adequate restoration of function and improve affect;18,19 (2) The interaction with patients 
is unengaging20 because (a) therapists are directive, telling patients what to do, and (b) 
therapists do not provide adequate feedback on patients’ effort and progress in therapy, 
such that patients will know where they stand in their recovery and why their therapy 
activities are important.   
From a behavior change standpoint, standard rehabilitation fails because it is a 
traditional Action-oriented program, assuming that patients are motivated to carry out 
therapeutic activities and not demoralized or uninsightful.21  Yet our research in post-
acute rehabilitation shows that a substantial proportion are not adequately motivated and 
do not participate well in their therapy22, particularly when they have depressive 
symptoms and/or cognitive impairment.23,24   When participation in therapy is poorer, 
recovery is poorer.6,23-29   
The conventional wisdom in rehabilitation practice guidelines is a distortion of this 
observation; it states that inadequately motivated patients are “poor candidates” for high-
intensity rehabilitation.30,31 This conventional wisdom not only ignores behavior change 
research, it has no evidence basis; indeed, it runs counter to our observation that 
depressed and apathetic older adults do better in high-intensity than lower-intensity 
rehabilitation.27 Yet, no research has clearly refuted this wisdom. The resultant disparity 
is that older adults most at risk for poor outcomes after disablement – such as those with 
depression or cognitive impairment – may be relegated to the least intense 
rehabilitation.32 
To summarize the significance, post-acute rehabilitation is low-intensity, low-
engagement and too often fails to achieve functional recovery, especially in the most 
vulnerable individuals.  This problem should be remediable by applying the science of 
behavior change to this setting.  We therefore developed Enhanced Medical 
Rehabilitation. 

 
 
 
 
 
 
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7 
 
C Study Objectives 
 
C1 Primary Aim 
Aim 1: Examine the effectiveness of EMR for improving functional and affective 
outcomes.   
H1: EMR will improve functional and affective recovery to a greater extent than 
standard-of-care rehabilitation.  
Explanation of H1: The purpose of H1 is to examine the effectiveness of EMR.  If H1 is 
supported, this could establish EMR as the gold-standard practice for post-acute 
rehabilitation.  Our primary analysis is the change from baseline to Day 30.  This single 
primary endpoint allows for an effectiveness test that is not confounded by length of stay 
differences or post-discharge issues beyond the reach of EMR.     
C2 Secondary Aim 
Aim 2: Examine EMR’s ability to overcome patient-level barriers to successful 
rehabilitation. 
H2: The effectiveness of EMR for functional recovery will be greatest in: (a) patients with 
clinical depression; (b) patients with high levels of medical comorbidity; (c) patients with 
cognitive impairment. 
Explanation of H2: EMR was designed to overcome barriers to rehabilitation (for 
example, due to depression); therefore, the difference in functional recovery between 
EMR and SOC should be greater in the most vulnerable older adults.  If H2 is supported, 
we will demonstrate that older adults with these common comorbidities benefit the most 
from high intensity, high engagement rehabilitation.  If so, this would refute conventional 
wisdom in post-acute rehabilitation, codified in admission criteria for rehabilitation 
facilities, regarding the appropriate candidates for rehabilitation (as described in 
Significance).32   
C3 Rationale for the Selection of Outcome Measures 
Consistent with the common conceptual model of EMR improving affective and 
functional recovery, this project has two co-primary outcomes, one of functional 
recovery, and one of affective recovery.  Our primary measure of functional outcome is 
the Barthel Index, a 0-100 scale63 that measures ability (time and physical assistance 
required) to perform 10 basic Activities of Daily Living or mobility items making it optimal 
for this highly debilitated population.62,64-66 The Barthel Index has excellent external 
validity: a higher score predicts greater likelihood of being able to live at home and 
degree of independence following discharge from the hospital.67,68    Secondary 
measures are gait speed (time to walk 6 meters, in meters/second) and 6 minute walk 
(number of feet walked in 6 minutes).  These performance-based measures of physical 
function have found increasing favor as outcome measures in rehabilitation intervention 
studies, because of their strong external validity in predicting clinical outcomes such as 
hospitalization and mortality.3,69-71   
The primary measure of change in depression is the Montgomery Asberg Depression 

 
 
 
 
 
 
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8 
Rating Scale, a commonly-used depression measure in clinical trials.  We have used it in 
many prior studies of older adults.  Our secondary measure is an 18-item positive and 
negative affect scale that measures positive and negative (depressed and anxious) 
affect.  It measures the dominant dimensions of human emotional experience, which 
have important roles in both quality of life and as a predictor of success in geriatric 
rehabilitation.  It is a combination of the full 10-item positive affect scale of the Positive 
and Negative Affect Schedule (PANAS),77 plus five items from the brief PANAS 
measuring negative affect78 and the three non-reverse coded items from a brief State 
Anxiety Scale79 derived from the State Trait Anxiety Inventory to measure negative 
(anxious) affect. This scale uses participants’ responses to questions (e.g., “how anxious 
do you feel at present”) to assess their current feeling or affective states. The PANAS 
has excellent reliability in post-acute rehabilitation, where it is considered valuable in 
capturing the range of mood and motivational issues in this setting.80  Our addition of 
specific anxiety items reflects the high rate of anxiety problems in post-acute 
rehabilitation.29,81-84  Additionally, this dimensional assessment of affect responds to calls 
by NIMH to use as outcomes dimensions that reflect more basic, validated emotional or 
behavioral states, as reflected in the Research Domain Criteria.85  These 
depression/affect measures will only be carried out in participants with a baseline clinical 
diagnosis of current major or minor depressive episode, based on the Structured Clinical 
Interview for DSM-IV (SCID)86 which we will carry out at baseline prior to randomization.  
We have considerable experience with the SCID in this population from prior NIMH-
funded studies.  Based on our pilot RCT experience, about 25% of eligible participants 
will have a current diagnosis; we will enrich the sample by continuing to recruit to ensure 
that 50% of randomized participants have a depression diagnosis, so that this study is 
adequately informative regarding benefits for late-life depression in this setting.  Our 
test-retest Kappa (using different, blinded raters) for major/minor depression in this 
setting is 0.8 (good). 
The measures we have chosen have adequate psychometric characteristics in this 
setting and are minimally burdensome.  We will monitor all of the assessment 
procedures closely during the RCT (inter-rater and test-retest), and if reliability of any 
measure falls below ICC=.8 (or Kappa 0.7) we will re-train research staff. 
D Study Intervention: Enhanced Medical Rehabilitation 
EMR is a set of skills for PT and OT to increase both intensity and the engagement of all 
therapeutic sessions.  It has three foci for therapy sessions: high intensity (“optimizing 
intensity”), feedback to patients on their effort and progress (“linking activities to goals”), 
and a patient-directed approach (“patient as boss”).  EMR is a “how” intervention, not a 
“what” intervention: its skill set integrates into existing OT/PT, rather than adding new 
activities or exercises or adding another specialist to the setting.  In other words, OT or 
PT in the EMR model is still OT or PT (which in this setting is individualized by the 
therapist to the patient’s impairments, abilities, home environment, and other contextual 
factors).  The difference is in the effort to engage the patient and provide high-intensity 
therapy.  For this reason, EMR can integrate well into post-acute OT/PT no matter what 
the patient’s primary impairment, comorbidities (cognitive, medical), or other contextual 
factors.   
EMR’s foci have deep roots in the science of behavior change, including social cognitive 
theory,33 self-regulatory theory,34 the Theory of Planned Behavior,35 and the 
Transtheoretical Model which encompasses these and other theories.21  EMR’s three 

 
 
 
 
 
 
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9 
foci are described with an explanation of their innovation for rehabilitation and 
their link to theories of behavior change here: 
1. Interactive, patient-directed approach 
a. In the first session, OT and PT elicit the patient’s own goals for rehabilitation 
using the Rehabilitation Goals Interview, a brief (15 minute) semi-structured 
interview to generate patient-nominated therapy goals.36  Up to 5 goals are 
nominated by the patient as most important to them.  We found this technique 
to provide more rich and precise information than the standard rehabilitation 
technique of simply asking patients what their goals are.  This interview is 
linked to the Transtheoretical (Stages of Change) Model in that it raises the 
patient’s awareness of themselves presently in contrast to where they want to 
be.  The interview frequently produces an emotional experience by the 
patient, and so therapists are also trained to expect this and work with it.  
Regarding innovation: no rehabilitation therapists, to our knowledge, use a 
structured interview to discern patients’ goals (they typically ask “what are 
your goals?” which is generic and insufficient). 
b. These patient-reported goals become the basis for all interactions:  
i. “You decided that helping care for your grandchildren, getting to 
church, and walking your dog are your goals. Which one of those 
would you like to focus on today?” 
ii. “Okay, so we’ll focus today’s therapy on activities that will get you 
closer to your goal of being able to help take care of your 
grandchildren again. What will you need to be able to do so that you 
can get back to doing that?” 
iii. “Just to make sure we’re on the same page, can you talk me through 
how this activity will get you closer to your goal of helping care for 
your grandchildren?” 
iv. Additionally, study staff (not blinded raters) make a videotape of the 
patient’s home, which the therapists watch alone and again with the 
patient.  This helps to further link (for both patient and therapist) 
rehabilitation activities with goals related to functioning at home 
safely. 
Linking actions to patient goals helps move patients into an action 
phase, in accordance with the Transtheoretical Model; similarly it 
increases intention according to the Theory of Planned Behavior.  This 
explicit linking of therapy activities with the patient’s goals is novel; it is 
not done repeatedly and purposefully by any rehabilitation therapist, in 
our experience. 
c. To choose therapy activities, therapists “ask, don’t tell”: “What activity would 
you like to do next?”  Non-directive interaction is consistent with Social 
Cognitive Therapy (increasing self-control), Self-Determination Theory, and 
the Transtheoretical Model (self-liberation).  In post-pilot study interviews, the 
real-world therapists told us that this skill was one of the more novel (i.e., not 
part of their previous training or practice) and important features of EMR. 
d. Along the same lines, therapists check in with the patient after each activity or 
exercise: “How do you feel you did with those stairs?”…“It seems you weren’t 
happy with how you did; how can you make getting from the bed to the 
wheelchair easier or safer?”   
e. These interaction strategies are also used at a therapist meeting with the 
patient and caregiver(s). 

 
 
 
 
 
 
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10
f. Therapists are trained and supervised to use open-ended questions when 
appropriate, to avoid directive language in general, and to avoid the use of 
jargon. 
Points d-f help EMR therapists to increase their patient’s sense of self-control 
and perceived behavioral control, as well as maintain patient investment, and 
increase rapport.   
2. Increased intensity 
a. Therapist guides patient towards higher-intensity activities:  
i. “Let’s start off with a challenging activity. Which one of those activities 
we just discussed would you like to try first?” 
ii. “How hard are you working?” (patient responds “4” on 1-10 scale, 
indicating that therapeutic exercise requires little effort) “We’d like to 
get you even stronger. What would it take to get you up to a 7 or 8 
while doing this activity?” 
b. Exercises and activities are individualized to maximize effort (“Do you want to 
see how much farther down the hall you can walk?”), not of arbitrary length 
(“now walk 10 feet”).  
c. Therapists are trained and supervised to minimize down-time during therapy 
sessions. 
The focus on maximizing intensity is both novel and an advance over standard 
therapy in which the level of intensity is either arbitrary or at most is encouraged 
non-specifically.  Increased intensity is also closely linked to the other EMR foci 
and their behavioral theory underpinnings.  The 1-10 perceived effort scale, and 
feedback ensuing from it, is an innovation of EMR for rehabilitation settings.  It is 
based on a scale developed for community-dwelling elders relative to exercise 
prescription.37     
3. Frequent feedback on effort and progress 
a. Therapist tells patient the benefits when therapeutic activity/exercise was 
hard: “How hard is this exercise?” (patient responds “9”, indicating that 
therapeutic exercise was very difficult) “I can see you are working hard, and 
your heart is beating fast.  That means right now you are increasing your 
stamina…your endurance and your heart and lung capacity are getting 
better.” 
b. Therapist comments on progress when an activity becomes easier: “You 
rated your effort a 3 on this stair-climbing, and last week you rated it an 8.  
Can you see that you are getting stronger and closer to your goals?” 
c. Therapist links patient’s progress in activities to goal achievement: 
“Remember when you told me that you wanted to be able to walk your dog 
again? Well, today, you were able to walk 15 feet without much assistance. 
You’re closer to your goal.” 
d. Therapists use a progress binder to systematically review progress with 
patients in all activities, each Monday, Wednesday, and Friday after therapy, 
and link it to goal attainment. 
a-d above are consistent with the feedback focus of self-regulatory theory and 
also with social cognitive theory and the Transtheoretical Model in that they are 
intended to increase self-efficacy (or perceived behavioral control) and improve 
outcome expectations. 

 
 
 
 
 
 
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11
e. Therapists are trained to understand and manage displays of affect by the 
patient.  If a patient shows emotional distress, the therapist shows empathy, 
acknowledging the affect prior to continuing therapy.  If a patient appears to 
the therapist as amotivated or disinterested, the therapist conceptualizes this 
as a temporary state (rather than an immutable trait) and tries to find a 
solution with the patient.   
f. Therapists are supervised regarding communication skills such as eye 
contact, speaking at the level of the patient, and avoiding jargon. 
e-f are critical interaction skills to improve rapport-building, and they underlie all other 
aspects of EMR.  They require de novo training (in the case of managing affect) or 
retraining (in the case of basic communication skills because they are not reinforced to 
therapists in real world settings). 
 
E Study Design  
 
E1 Design Summary 
 
 
E2 Subject Selection and Withdrawal  
2.a 
Inclusion Criteria  
Participants must be 65 and older, and be admitted to a skilled nursing facility for 
post-acute care from PT and OT for 2 weeks or more.  
2.a 
Exclusion Criteria  
• 
Language, visual or hearing barriers to participation (e.g. unable to communicate 
with research staff).  
N = 252 participants  
• Age 65+ 
• Admitted to skilled nursing facility (SNF) for 
post-acute care rehabilitation ≥2 weeks 
• 50% with SCID-diagnosed depression 
Enhanced Medical 
Rehabilitation during SNF 
stay (n = 126) 
Standard of Care 
Rehabilitation during SNF 
stay (n = 126) 
Repeat (day 30: primary endpoint) 
Function: Barthel Index (H1a) 
Depression:MADRS (H1b)  
Secondary: Gait speed, 6-minute walk,  
   positive and negative affect  
 
 
90-day follow-up 
Same assessments as above plus 
Rehospitalizations and disposition  
   (e.g., home, institutionalization) 
Baseline (day 0 of rehabilitation) 
Function: Barthel Index (H1a) 
Depression: MADRS (H1b)  
Secondary measures: Gait speed, 
6-minute walk, positive and 
negative affect, Short blessed test 
 

 
 
 
 
 
 
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12
• 
Medical illness preventing study participation or accurate data collection (e.g., 
highly unstable cardiac illness such that early re-hospitalization is expected; 
metastatic or other cancer such that hospice is recommended or survival is 
limited;  
• 
Moderate-severe dementia (demonstrated by chart diagnosis and/or short 
blessed score greater than 13);  
• 
Progressive neurological condition such that recovery of function is not feasible;  
• 
Patient did not have the ability to walk prior to hospitalization (e.g. paraplegic);  
• 
Schizophrenia or other chronic or current psychotic disorder. 
• 
Patient normally resides in a long term care facility. 
2.b 
Ethical Considerations  
This study will be conducted in accordance with modern ethical standards for biomedical 
research, particularly in regards to avoiding conflicts of interest, informed consent, and 
protecting patient privacy. 
2.c 
Subject Recruitment Plans and Consent Process 
The study population consists entirely of patients at skilled nursing facilities and 
recruitment will be facilitated by our ongoing relationship with them. The recruitment and 
consent processes described below were developed with our original partner site, 
Barnes-Jewish Extended Care. Subsequent modifications may be needed to adapt this 
process to the needs of additional sites. 
 
Clinical skilled nursing facility staff will alert the research team of an anticipated 
admission. The research team will review the patient’s records at the skilled nursing 
facility to ensure inclusion/exclusion criteria. 
 
After checking in with facility patient-care staff to confirm the availability of the potential 
participant, patients who appear appropriate per chart will be approached by WU 
research staff and told that they may be eligible for the enhanced rehabilitation study. To 
ensure participants’ comfort, the study team will assess the setting and ensure that the 
individual is positioned such that they can comfortably complete any assessments, 
including writing in a reasonable position, that they have had an opportunity to go to the 
toilet, eat and are dressed (if appropriate).  Just asking the participant may not be the 
best approach for all individuals as some may agree without actually feeling this it is the 
best time or situation.  It is important that participants not put off their own needs 
(whether it be repositioning themselves, using the bathroom or getting dressed) and that 
the research assessments not interfere with this. 
 
If the patient gives their assent, research staff will screen them for cognitive impairment, 
with the Short Blessed Test (SBT). If they do not assent to the screening then we will not 
ask them the questions and will not contact them further. 
 
Patients who score 13 or higher will be assumed unable to provide consent and thus will 
be excluded from the study. Study staff and/or PI will use clinical judgment to determine 
whether to include patients who score between 10 and 12 on the SBT. If they are not 
cognitively impaired (score 0-9 on SBT) at the time of this screening we will go through 
the full informed consent process for the study.  
 

 
 
 
 
 
 
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13
Research staff will review the consent form with the patient in their room at the skilled 
nursing facility, encouraging the patient to ask questions throughout. The assessment of 
understanding tool will be used as needed to ensure each patient understands the 
procedures, risks, and benefits of the study. 
2.d 
Randomization Method and Blinding 
We will randomize 1:1 to EMR (i.e., all OT/PT sessions done by EMR-trained and 
supervised therapists) or SOC (i.e., all sessions done by non-EMR-trained therapists), 
as in our pilot RCT.  We will stratify by SNF site and by baseline depression status.  To 
prevent subversion of randomization,61 the statistician will hold the randomization list, 
releasing an assignment once a participant is consented and eligible.   
EMR group: The EMR group will be the same as in our pilot study; participants who are 
randomized to the EMR group will receive therapy only from therapists who are trained 
and supervised in EMR.  Their therapy sessions will follow the EMR protocol.  Otherwise 
their SNF care will not differ from usual care. 
SOC group: The standard-of-care (SOC) group will receive therapy only from PT/OTs 
(or assistants) who are not trained nor supervised in EMR.  These therapists are 
monitored (videotaped or observed) but not asked to do anything differently with their 
patients.   
 
Blinding: Ratings will be conducted by a research associate who is blind to the study 
intervention, purpose, and randomization status. Patients will not be blinded to their 
randomization status, but will not be made knowledgeable about how exactly Enhanced 
Rehab is different from SOC. Therapists providing SOC treatment will be blinded to the 
principles of Enhanced Rehab to prevent contamination. 
 
Open Label participants: Up to 12 participants at each site will be recruited as "open 
label pilot" participants. These participants will meet the same eligibility criteria as the 
randomized participants but will be automatically assigned to the Enhanced group. This 
will be done prior to beginning to randomize participants to ensure the quality of the 
intervention and data collection procedures. 
2.e 
Risks and Benefits 
Likely risks: There are no likely risks.  
 
Less Likely risks: The enhanced rehabilitation intervention and the measures impose 
some risk of emotional discomfort. The enhanced rehabilitation may cause muscle 
soreness and fatigue. If patients are allowed to take Tylenol or NSAID they may do so 
with approval from their skilled nursing home doctor.  
 
Rare risks: There is a potential breach of confidentiality with research records and with 
videotaping. There is a possibility of falling and fracture during the tests of your walking 
and balance. This will be minimized through the use of a safety belt during all testing 
procedures 
 
Benefits: Research assessments may reveal conditions that had not been identified 
(e.g., depression), leading to management of the patients’ depression or functional 
recovery that would not have occurred otherwise. Research intervention (i.e., Enhanced 

 
 
 
 
 
 
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14
Rehab) may lead to improvements in physical functioning (compared to standard of 
care).  
The results of this research may benefit society in that it will lead to an intervention 
which addresses a major gap in medical/functional rehabilitation in an acute rehab 
setting. 
 
2.f 
Early Withdrawal of Participants  
Participants may be withdrawn prior to study completion for a variety of reasons. 
Reasons for withdrawal will be noted on a termination form. There are no risks 
associated with early withdrawal. Common reasons for early withdrawal include: 
 
-Screen failures: (note which exclusion criteria was met) 
-Participant withdraws from study: (note the participant’s stated reason for withdrawing) 
-Participant no longer able to comply with protocol: (note reason)  
-Death: (note date of death and source of information) 
 
2.g 
Data Collection and Follow-up for Withdrawn Participants 
 
During a situation where a participant is unable to be interviewed due to incapacitation or 
death of participant, research staff will attempt to collect final prognosis information from 
participant’s medical chart or by asking a family member. 
 
Research staff will collect no further data from screen failures. Withdrawn participants 
will not otherwise be followed up with. 

 
 
 
 
 
 
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15
 
F Study Procedures  
F1 Screening for Eligibility 
Upon receiving notification of a newly admitted patient to Barnes-Jewish Extended Care, 
research staff will review patient for information related to eligibility criteria. If the patient 
appears to be eligible, they will be screened using the Short Blessed Test (see 2.c.).   
F2 Schedule of Measurements 
 
Prior to meeting with a participant to perform study assessments, study staff will check-in 
with facility patient-care staff to confirm the availability of the participant. To ensure 
participants’ comfort, the study team will assess the setting and ensure that the 
individual is positioned such that they can comfortably complete any assessments, 
including writing in a reasonable position, that they have had an opportunity to go to the 
toilet, eat and are dressed (if appropriate).  Just asking the participant may not be the 
best approach for all individuals as some may agree without actually feeling this it is the 
best time or situation.  It is important that participants not put off their own needs 
(whether it be repositioning themselves, using the bathroom or getting dressed) and that 
the research assessments not interfere with this. 
 
Schedule of Assessments 
 
SNF 
admit 
(baseline) 
Day 7 
Day 30 
(primary 
endpoint) 
SNF 
discharge 
Day 60 
Day 
90 
Outcomes 
Function 
 
 
Barthel Index (primary outcome) 
X 
 
X 
X 
X 
X 
Gait speed 
X 
 
X 
X 
 
 
6-minute walk 
X 
 
 
X 
 
 
Depression SCID (given if indicated by MADRS) 
X 
 
 
 
 
 
MADRS  
X 
 
X 
 
 
 
17-item positive and negative affect scale 
X 
X 
X 
 
X 
X 
Processes 
Rehabilitation intensity 
 
Patient active time & actigraphy (at 20% of 
sessions at random) 
collected each session throughout stay 
 
 
Treatment engagement 
 
Observer-rated Rehabilitation Participation Scale 
(at 20% of sessions at random) 
collected each session throughout stay 
 
 
Fidelity data (at 20% of session at random) 
collected each session throughout stay 
 
 
Post-Treatment Affect  
 
Self-Assessment Moniker (at 20% of session at 
random) 
collected each session throughout stay 
 
 
Patient Satisfaction and Treatment Fidelity Survey 
Collected after therapy sessions throughout 
stay 
 
 
Other rehabilitation variables 
 
 
Rehospitalization 
 
 
X 
X 
X 
X 

 
 
 
 
 
 
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16
Disposition (home, long-term care) 
X 
 
X 
X 
X 
X 
Social Participation (PROMIS Ability to Participate 
in Social Roles and Activities) 
 
 
 
 
X 
X 
Instrumental Activities of Daily Living (OARS IADL) 
 
 
 
 
X 
X 
 
Executive Functioning (Clock Drawing Test) 
X 
 
 
 
 
 
 
Fear of Falling 
X 
 
 
 
 
 
 
Readiness for Rehab 
X 
X 
 
 
 
 
 
Short Blessed Test 
X 
 
 
 
 
 
 
Medical Comorbidity (CIRS-G) 
X 
 
 
 
 
 
 
Barthel Index: Pre-morbid version 
X 
 
 
 
 
 
 
 
 
F3 SNF Admit (Baseline) Visit 
The baseline visit will take place immediately or soon after the patient consents to the 
study. The rater will conduct the following assessments: Barthel, 6 minute walk, gait 
speed, SCID, MADRS, PANAS, Disposition, Clock Drawing Test, Fear of Falling, 
Readiness for Rehab, CIRS-G, Barthel Index: Pre-morbid version. 
F4 Day 7 Visit 
The day 7 visit will take place 7 days after the patient consents to the study. The rater 
will conduct the following assessments: PANAS, Readiness for Rehab. 
F5 Day 30 Visit 
The day 30 visit will take place 30 days after the patient’s date of admission to the 
facility. If the patient has already been discharged from the skilled nursing facility, the 
rater will call the patient to schedule a home visit to conduct the following assessments: 
Barthel,  gait speed, MADRS, PANAS, Follow-up Disposition. 
F6 SNF Discharge 
The discharge visit will take place as close in time to the patient’s discharge date as 
possible. The rater will conduct the following assessments at the skilled nursing facility: 
Barthel, 6 minute walk, gait speed, Discharge Location..  
F7 Day 60 Visit 
The day 60 visit will take place 60 days after the patient’s date of admission to the facility 
Many participants will be discharged from the skilled nursing facility, but others will still 
be residing there. Unblinded research staff will determine where this assessment is to be 
conducted on a case-by-case basis depending on the patient’s status. These 
assessments may be conducted over the phone depending on the patient’s ability. The 
rater will conduct the following assessments: Barthel, PANAS, Follow-up Disposition, 
PROMIS Ability to Participate in Social Roles and Activities, OARS IADL. 

 
 
 
 
 
 
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17
F8 Day 90 Visit 
The day 90 visit will take place 90 days after the patient’s date of admission to the 
facility. Many participants will be discharged from the skilled nursing facility, but others 
will still be residing there. Unblinded research staff will determine where this assessment 
is to be conducted on a case-by-case basis depending on the patient’s status. The rater 
will conduct the following assessments: Barthel, PANAS, Follow-up Disposition, 
PROMIS Ability to Participate in Social Roles and Activities, OARS IADL. 
F9 Data and Safety Monitoring Plan 
The Data Safety Monitoring Plan (DSMP) outlined below has been approved by the 
NIMH. 
9.a 
General description of monitoring plan: This is a single-site study.  Dr. 
Lenze will be the primary monitoring entity.  He will have primary responsibility 
for the monitoring of subjects during the entire time they participate in the study, 
both with respect to their safety (including confidentiality) and the integrity of their 
research data. 
9.b 
Protection of Subject Privacy  
In addition to research measures, clinical information obtained at initial evaluation and 
clinical treatment notes will become part of subjects’ medical records. The PI and his 
staff will provide adequate safeguards for the protection of confidentiality of these 
records. Procedures designed to maintain confidentially include: (1) training for all 
research staff emphasizing the importance of confidentiality; (2) specific procedures 
developed to protect subjects’ confidentiality, and (3) formal mechanisms limiting access 
to information that can link data to individual subjects. Data forms that include identifying 
information will be kept in locked cabinets. Only the unique ID number, assigned by the 
research coordinator at the time of initial contact will represent subjects during data 
entry, data transfer, data analysis, or other file management procedures. To facilitate 
tracking, a password-protected computer file will be maintained containing the identity of 
subjects, their ID numbers, and information about how they can be reached. This file, 
however, will contain no clinical data. Only members of the investigative group will have 
access to secured files or to master lists for subject code numbers and will be well 
informed regarding the protection of patients’ rights to confidentiality. Identities of 
participants will not be revealed in the publication or presentation of any results from this 
project. 
 
Videotaping permission and confidentiality: subjects will be videotaped for the purposes 
of observing the therapists and providing training material.  Subjects will sign a consent 
which indicates the use of the videotaping, who may have access to the videotaping, 
and the length of time that the videotape will be kept by investigators.  Videotapes will be 
kept with the same confidentiality procedures as other research data. 
9.c 
Database Protection  
All subject research data is stored separate from subject contact information, which is 
stored on our secure servers with network and database level passwords, only 
accessible to research staff who need contact with the subjects.  
 

 
 
 
 
 
 
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18
9.d 
Confidentiality During Adverse Event (AE) Reporting  
AE reports and annual summaries will not include subject- or group-identifiable material. 
Each report will only include the identification code. 
9.e 
Definitions of Adverse Events 
 
An adverse event (AE) is any untoward medical occurrence in a subject temporally 
associated with participation in the clinical study or with use of the experimental 
agent being studied. An adverse finding can include a sign, symptom, abnormal 
assessment (laboratory test value, vital signs, electrocardiogram finding, etc.), or any 
combination of these. 
 
A Serious Adverse Event (SAE) is any adverse event that results in one or more of 
the following outcomes: 
 
• Death 
• A life-threatening event 
• Inpatient hospitalization or prolongation of existing hospitalization  
• A persistent or significant disability/incapacity 
• A congenital anomaly or birth defect 
• Important medical event based upon appropriate medical judgment 
 
9.f 
Classification of AE Severity  
 
AEs will be labeled according to severity, which is based on their impact on the 
patient. An AE will be termed “mild” if it does not have a major impact on the patient, 
“moderate” if it causes the patient some minor inconvenience, and “severe” if it 
causes a substantial disruption to the patient’s well being.  
 
i 
AE Attribution Scale  
 
AEs will be categorized according to the likelihood that they are related to the study 
intervention or other study procedures. Specifically, they will be labeled definitely 
unrelated, definitely related, probably related, or possibly related to the study 
intervention or procedures.   
 
ii 
Severity 
 
AEs will be labeled according to severity, which is based on their impact on the 
patient. An AE will be termed “mild” if it does not have a major impact on the patient, 
“moderate” if it causes the patient some minor inconvenience, and “severe” if it 
causes a substantial disruption to the patient’s well being.  
 
iii 
Expected Risks 
Study assessments: The assessments to be conducted as part of this study are 
non-invasive and carry with them no more than minimal risk. The most significant 
risks to the subjects related to assessments are those that would follow a breach of 
confidentiality and the disclosure of clinical information or video recordings. In 

 
 
 
 
 
 
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19
addition, we recognize that medically ill and debilitated older adults can easily feel 
overwhelmed or fatigued by what would be minimally demanding tasks for others. 
Therefore, we include this discomfort in the potential risks. The instruments to be 
used in this study have been used by the PI in other studies of older medically ill and 
disabled adults. There are very few older adults who are unable to tolerate the length 
of the questionnaires. If this occurs, an assessment battery can be divided into 
several sessions.  
 
Enhanced Medical Rehabilitation: Participants assigned to Enhanced Medical 
Rehabilitation will receive a higher intensity of therapy.  This has the theoretical risk 
of causing cardiac events (as does any rehabilitation).  Only trained physical and 
occupational therapists (and assistants), who are well-trained in the assessment of 
cardiac concerns during rehabilitation, will work with the participants. 
 
Because this study involves participants with depression, there is a risk of suicidal 
behavior. However, these are risks associated with the illness not the study.   
Risks in relation to benefits: No subjects will be denied interventions; participants 
receive either the standard of care rehabilitation, or Enhanced Medical 
Rehabilitation.  No risks other than possible emotional distress exist from the study 
assessments.  Thus, the risks involved in participating in this study are deemed low, 
which justifies the data and safety monitoring plan described here. 
 
9.g 
Data Collection Procedures for Adverse Events 
We will systematically collect AEs and summarize them in a running table throughout the 
study, including date of onset/offset, type of AE, severity, and interventions if any. Per 
Washington University IRB policy, reportable AEs are those that are possibly, probably, 
or definitely related to the study intervention or procedures. 
9.h 
Reporting Procedures 
SAEs that are unanticipated, serious, and possibly related to the study intervention will 
be reported to the IRB, and NIMH in accordance with requirements.   
 
• 
Unexpected fatal or life-threatening AEs related to the intervention will be 
reported to the NIMH Program Officer within 7 days. Other serious and unexpected AEs 
related to the intervention will be reported to the NIMH Program Official within 15 days. 
• 
Anticipated SAEs will be handled in a less urgent manner but will be reported to 
the IRB in accordance with their requirements.   
G Statistical Plan  
 
G1  Sample Size Determination and Power 
Our sample size is based on 80% power to detect a Cohen’s d=0.4 effect size on the 
ANCOVA difference in treatments at day 21, based on a two-tailed p<0.025 (because 
two outcome measures are used).  G*Power 3.1.2 was used for power calculations.  A 
Cohen’s d=0.4 is between “small” (0.2) and “medium” (0.5) effect sizes.  Effect sizes for 
function were in the “large” range, d=0.7-0.9, but we acknowledge that these observed 

 
 
 
 
 
 
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20
effect sizes are qualified by the small sample size, and it makes most sense to be more 
cautious regarding likely effect sizes in a full-scale study, hence our choice to power at 
d=0.4.  Such an effect size is clinically relevant for the functional outcomes.3  We will 
only examine affective recovery as an outcome for those who are “affectively impaired” 
to begin with; i.e., those with clinical depression at baseline; with this reduced N, we are 
powered at 80% for a d=0.54. This same power analysis would apply for any subgroup 
analysis of depressed; i.e., if we wish to demonstrate that EMR is effective both in the 
case of clinical depression and in “non-depressed” older adults.   
G2  Interim Monitoring and Early Stopping 
Not applicable; we do not have any interim data analysis or early stopping plans. 
G3  Analysis Plan 
The continuous demographic and clinical variables at baseline will be compared 
between the EMR group and the SOC group using the Two Independent Sample t Test 
or the Wilcoxon Two Sample Test, whichever is appropriate.  Baseline categorical 
variables (e.g., race) will be compared between the groups using either the Chi Square 
Test or Fisher’s Exact Test, whichever is appropriate.  We will examine data 
descriptively using crosstabulations, histograms, and tests for normality (with corrective 
actions, data transformation or nonparametric alternatives, as needed). An analysis-
appropriate technique will handle missing data.  
G4  Statistical Methods  
Time course analyses will be conducted to investigate the differences between pre and 
post outcome measures.  These analyses will be used to ascertain whether there is a 
statistically significant difference in change over time between the EMR group and the 
SOC group, controlling for baseline values.   Analyses of the outcome measures for 
normality will be carried out.  Time course analysis techniques such as mixed effects 
models, t test of the differences, Wilcoxon test of the differences, or ANCOVA on the 
differences (using baseline value as the covariate) will then be conducted, depending on 
the normality tests.  Our favored method for the primary analysis of baseline to day 30 
(i.e., pre-post treatment) effects is the ANCOVA approach, comparing the EMR and 
standard-of-care groups in change scores, covarying for baseline scores.  This approach 
is recommended as the superior and most well-powered approach for examining pre-
post RCT data.91  Our tests of the pilot data agreed with this: the ANCOVA approach 
had as much or more statistical power than other approaches (t-test, Wilcoxon, mixed-
effect model) for all outcomes. 
Participants will be randomized within each facility (i.e., stratified by facility) and then 
receive a PT/OT therapist pair who either is or is not trained/supervised in EMR based 
on randomization assignment.  Thus participants are nested within therapists and 
therapists are nested within facilities.  This multi-stage nested (hierarchical) design 
structure introduces possible correlation of participant outcomes with therapist.  Such 
classification effects (facility/therapist) will be analyzed using Proc Nested in SAS or with 
the multi-level modeling available in Mplus that deals with stratification, clustering, and 
weighting.   
We will also examine all time points to Day 90, to provide a real-world estimate of EMR 
and improve power to detect important secondary outcomes such as rehospitalization 
and institutionalization. We acknowledge these data may become somewhat naturalistic 

 
 
 
 
 
 
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21
in a rehabilitation population, given differences in length of stay, transfers to different 
facilities, and re-hospitalizations.  Mixed effects models are the preferred method for 
these multiple-time-point analyses, especially as some missing data are to be expected 
post-discharge.92   
 
H Data Handling and Record Keeping  
H1 Confidentiality and Security 
Procedures designed to maintain confidentially include: (1) formal training sessions for 
all research staff emphasizing the importance of confidentiality; (2) specific procedures 
developed to protect subjects’ confidentiality, and (3) formal mechanisms limiting access 
to information that can link data to individual subjects. Data forms that include identifying 
information will be kept in locked cabinets. Only the unique ID number, assigned by the 
research coordinator at the time of initial contact will represent subjects during data 
entry, data transfer, data analysis, or other file management procedures. To facilitate 
tracking, a password-protected computer file will be maintained containing the identity of 
subjects, their ID numbers, and information about how they can be reached. This file, 
however, will contain no clinical data. Only members of the investigative group will have 
access to secured files or to master lists for subject code numbers and will be well 
informed regarding the protection of patients’ rights to confidentiality. Identities of 
participants will not be revealed in the publication or presentation of any results from this 
project.  
 
 
Videotaping permission and confidentiality: subjects will be videotaped for the purposes 
of observing the therapists and providing training material. Subjects will sign a consent 
which indicates the use of the videotaping, who may have access to the videotaping, 
and the length of time that the videotape will be kept by investigators. Videotapes will be 
kept with the same confidentiality procedures as other research data. 
H2 Training  
All research staff will receive standardized training in privacy and confidentiality. All 
research staff will be thoroughly trained on study procedures and assessments. Raters 
will role play assessments with supervisors. New raters will be observed by their 
supervisors before conducting assessments independently. 
 
Therapists at partnering facilities interested in delivering the study intervention will 
receive training in human subjects research in accordance with the Washington 
University policy. They will also participate in initial and ongoing training in the study 
intervention.  
H3 Records Retention 
Records will be kept from all consented participants. De-identified information will be 
kept on excluded participants, limited to age, gender, race, and reason for exclusion. 
 

 
 
 
 
 
 
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22
I Study Monitoring, Auditing, and Inspecting  
 
I1 
Study Monitoring Plan  
As per data and safety monitoring plan above, which has been approved by the NIMH.  
There is no additional monitoring for this study. 
 
I2 
Auditing and Inspecting  
Not applicable. 
J Study Administration 
 
J1 Organization and Participating Centers 
Research staff include Washington University faculty and staff. Recruitment and study 
intervention will take place at Barnes Jewish Extended Care and Alexian Brothers 
Sherbrooke Village. 
Prior to recruiting patients for the study, the research team may work with partnering and 
potential partnering facilities to gather information about institutional practice in order to 
a) facilitate the development of operating procedures b) ensure that the intervention is 
not already being conducted there.  
 
J2 Funding Source and Conflicts of Interest 
This study is funded by The National Institute of Mental Health (NIMH). No members of 
the study team have any conflicts of interest. 
 
J3 Participant Payment  
Participants will be paid $100 in the form of a check. Payment will not be pro-rated for 
early withdrawal. 
 
K Publication Plan  
We plan to publish findings in a peer-reviewed journal in a prompt manner as soon as 
the study is completed. 
 
 
 
 
 
 

 
 
 
 
 
 
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23
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