Testing the Efficacy of FFC-AC-EIT in Patients With Alzheimer's Disease and Related Dementias
Phase: NA
Conditions: Dementia, Acute Medical Event, Hospitalization
Sponsor: University of Maryland, Baltimore

Testing the Efficacy of FFC-AC-EIT in Patients with Alzheimer’s Disease and 
Related Dementias  
 
NCT04235374 
 
Date:  1/20/2019 
 
 
 

Protocol 
 
Design: To achieve our Aims we will use a cluster randomized clinical trial randomizing 
hospitals to prevent treatment contamination that might occur if we randomized units or patients 
within units.  
 
Sample and Setting: Twelve hospitals (six in Maryland and six in Pennsylvania) will be 
randomized to treatment (FFC-AC-EIT) or Education-Only (EO) using permuted-block 
randomization and 50 patients per hospital will be recruited (total 600 participants).  The 
hypotheses for Aim 1 efficacy testing include: Patient level: Hypothesis 1: At discharge, 
hospitalized patients with ADRD on units in which FFC-AC-EIT is implemented will increase 
time in physical activity; maintain or improve function; perform more function focused care 
activities; have less incidence and severity of delirium; have less evidence of BPSD; have less 
pain; have fewer falls; have fewer tethers; and shorter length of stays compared to those 
exposed to EO; Hypothesis 2:  Patients on units in which FFC-AC-EIT is implemented will 
maintain or increase time spent in physical activity; maintain or improve function; have less 
incidence and severity of delirium; have less evidence of BPSD; have less pain; and have 
fewer falls; fewer emergency room visits; fewer unplanned re-hospitalizations; and fewer new 
admissions to long term care at 1, 6 and 12 months post discharge when compared to those 
exposed to EO. 
Randomization Plan: The level of engagement required for the intervention prevents random 
assignment at the patient level as patients could become aware of differential treatment within 
the same unit in the same hospital and there is the risk of carry-over of treatment by staff.  Thus, 
after hospitals are recruited they will be randomized to cohort (See Study Timeline) and 
randomly assigned to treatment so that the hospital will receive either FFC-AC-EIT or EO. 
Random assignment will be completed by the statistician using SAS proc plan which allows for 
simultaneous randomization on multiple dimensions (time and hospitals). In prior research we 
noted no differences in implementation of function focused care based on facility related 
factors111,137. We recognize, however, that hospital differences may exist and will be controlled 
for in the analysis (e.g.,bed size, ownership).  
 
Sample Size:  Sample size calculation was based on prior research and our primary focus 
which is on physical activity and function12,14,15,33 ,106. For primary patient level outcomes, 
function based on the Barthel Index resulted in a Cohen’s d=.24, for physical activity the 
Cohen’s d=.37, and for participation in function focused care by patients Cohen’s d=.31.  The 
impact on tethering, a secondary outcome, was noted to have a Cohen’s d= .61.  Given a two-
tailed alpha of .05, an estimated intra-class correlation coefficient (ICC) between clusters 
(hospitals) of .02, a correlation coefficient between repeated measures of .60, and assuming 
even dispersion of means, a total sample of 360 patients will provide sufficient power (>.80) to 
detect a small effect size (d=.24)138 in primary patient level outcomes.  Our prior research 
showed an attrition rate of 5-40% over a 12- month period.  Therefore, we anticipate that a total 
of 600 patients from 12 hospitals (50 patients per hospital) will be sufficient to demonstrate 
outcomes.  With regard to hospital level outcomes, our prior work resulted in effect sizes of 0.9 
for environment and policy changes15,33,106,139. With the proposed sample size of 12 hospitals the 
statistical power for these measures will be adequate (.90 for both outcomes based on our 
analysis plan).   
 
Settings: Hospitals will be invited to participate if they: (a) have at least one unit dedicated to 
general medical patients; (b) identify two registered nurses (RN) to be champions (one for day 
and one for evening shifts); (c) enable staff to access email and websites via a phone, tablet or 

computer; and (d) do not have a geriatric program (e.g., Acute Care for Elders, Hospital for 
Elder Life Program/ HELP) on the study units. We will implement FFC-AC-EIT in 6 hospitals (on 
the medical unit) and EO in 6 hospitals (on the medical unit) across Maryland and Pennsylvania. 
(See support letters and Facilities and Resources section).   
 
Patient Participants: Patients will be eligible to participate if they: (a) are admitted into the 
hospital from any setting during the 12 month implementation period; (b) are 65 years of age or 
older; (c) are admitted onto a medical unit for any medical diagnosis; and (d) screen positive for 
dementia based on two well-validated scales: a score of ≤ 25 on the Montreal Cognitive 
Assessment (MoCA) and a score of >2 on the AD8 Dementia Screening Interview140-143; have 
mild to moderate stage dementia based a score of 0.5 to 2.0 on the Clinical Dementia Rating 
Scale (CDR)144; and lastly to differentiate between dementia and mild cognitive impairment 
eligibility is based on evidence of functional impairment with a score of 9 or greater on the 
Functional Activities Questionnaire (FAQ)145.  The AD8, CDR and FAQ are all completed by an 
informant and all screening measures are reliable and valid and accurately differentiate those 
with and without dementia. Patients will be excluded if they: (1) are enrolled in Hospice; (2) have 
been on the unit for greater than 48 hours; (3) do not have a family member/caregiver that we 
can contact; (4) anticipate surgery; or (5) have a major acute psychiatric disorder, or significant 
neurological condition associated with cognition other than dementia. 
The intervention activities continue for a 12 month period and we will recruit patients from 
the units starting at intervention month 3 and following completion of steps 1 and 2 of FFC-AC-
EIT (following evaluation of the environment and policies and staff education) and following 
education in the EO settings. In prior research we have noted changes in staff behavior 
following the first two months of implementation of function focused care approaches39,111,115,130 
therefore we initiate recruitment following this implementation period. We will obtain information 
about eligible patients from a designated staff member and will recruit 50 patients over the 
remaining 10 months of the 12 month intervention. We estimate that approximately 7 to 8 
patients per week will be eligible for the study.  Based on our past recruitment activity12,14 we will 
be able to enroll 1-2 patients per week which will meet our goal of approximately 5 patients per 
month.  This will assure that patient recruitment is spread over the entire intervention period and 
is similar across all settings. Participants will be evaluated to determine their ability to self-
consent using the Evaluation to Sign Consent questionnaire146.   If they do not correctly respond 
to all five questions, verbal or written assent will be obtained and the Legally Authorized 
Representative will complete the consent process (see Human Subjects section).  
 
The Implementation of FFC-AC-EIT:  
 
FFC-AC-EIT is implemented by a Research Nurse Facilitator working with the stakeholder 
team and unit champions for 10 hours weekly during months one and two and then for four 
hours weekly starting in month three for a total of 12 months. Timing of the intervention activities 
will be flexible based on the needs of the unit (e.g., times that work best for champions and 
Research Nurse Facilitator to meet).  The first meeting with the stakeholder team will be 1-2 
hours and the remaining meetings will be approximately 30 minutes monthly to update the 
stakeholders on progress and any challenges associated with implementation of FFC-AC-EIT 
(Table 1). The majority of the time on the unit by the Research Nurse Facilitator will be spent 
with the champions helping and assuring that they are engaging staff in function focused care 
activities via the four steps of FFC-AC-EIT (Table 1).  Once hospitals are randomized we will set 
up a time to meet with the identified contact to determine the stakeholder team members and 
champions and organize the first stakeholder team meeting.  All FFC-AC-EIT related activities 
will be coordinated during scheduled working hours for the stakeholders. The first meeting will 
provide an overview of the implementation of Steps 1 to 4 [(1) Environment and Policy 

Assessments; (2) Education; (3) Establishing Patient Goals; and (4) Mentoring and Motivating of 
Staff, Patients and Families] and will address the unit challenges to implementing function 
focused care using a Brainstorming approach (Table 1). Brainstorming involves having 
stakeholders identify the challenges to engaging patients with ADRD in function focused care 
activities during their hospital stay. We then complete Affinity Diagramming by clustering the 
ideas identified during brainstorming into themes.  Once themes are developed, an 
Interrelationship Diagraph147,148 will be made to determine which of the identified themes is the 
best or strongest driver. Drivers are established by having participants consider how each 
theme is connected to the other themes.  For example, does staff knowledge about BPSD 
influence function.  The theme with the most arrows going away from it is referred to as the 
"driver" or root cause.  If there are multiple themes with the same number of arrows going out of 
them, they can be considered as equally important. The best driver, or the root cause, is the 
theme that is most likely to have an impact on why function focused care approaches are not 
implemented on the unit and will guide the stakeholder group in goal identification.  
Table 1: Content for First FFC-AC-EIT Meeting With the Stakeholder Team  
Introduction and 
Overview of FFC-
AC-EIT 
a. Overview of project; b. Roles and responsibilities of research and stakeholder teams; c. 
Background support for FFC-AC-EIT: 1. Review of current care practices/philosophies of 
care; 2. Task and disease focused versus patient focused care; 3. Optimizing function and 
physical activity in acute care:  identification of and solutions to challenges identified; d. 
Evaluation of the multilevel context that influences implementation of FFC-AC-EIT per unit, 
Brainstorming Activity to identify unit drivers and unit goals. 
Implementation of 
Steps 1 and 2 in 
the four step 
process 
 
a. Training to complete Step 1 Environment and Policy Assessments: Review of the 
Environment and Policy Assessments (Appendix A): Assessments are used to identify need 
for changes in environments and policies to optimize function and safe physical activity of 
patients with ADRD (e.g., open areas for walking). Introduce as policy the use of the Mobility 
Screen and Nursing Progressive Mobility Tool to guide nurses in setting patient goals; b. 
Training to complete Step 2 Education: Review educational materials for staff, patients as 
relevant, and families, which have been developed by the research team12,15 and establish a 
plan for staff education sessions that will assure optimal staff participation (e.g., webinar, 
face to face). Developed education materials include powerpoints and printed materials for 
staff training, patients (as relevant) and families/caregivers about optimizing function and 
physical activity during hospital and post hospital periods.   
Implementation of 
Steps 3 and 4 in 
the 4-step process  
a. Training to complete Step 3 Establishing Patient Physical Activity Goals: 1. 
Demonstration of use of the Mobility Screen and the Nursing Progressive Mobility Tool149,150. 
These tools have established evidence of reliability and validity and have been used 
previously to establish patient goals149,150,151. 2.  Demonstrate goal development for patients 
using the Mobility Screen and the Nursing Progressive Mobility Tool and discuss ways for 
staff to help patients achieve goals (e.g., provide chairs in the rooms; age appropriate 
weights; cueing; use of recreation activities that encourage physical activity); b. Training to 
complete Step 4 Mentoring and Motivating Staff, Patients, and Families: 1. Review self-
efficacy techniques (e.g., verbal encouragement) that are effective for patients with ADRD 
and staff; 2. Demonstrate for champions how to complete the Nurse Checklist for Function 
Focused Care and direct them to complete this with nurses at 0-2, 4-6, and 10-12 months 
post implementation of FFC-AC-EIT and provide feedback to the nurse (e.g., positive 
reinforcement; education); review plans to view and use weekly email Tidbits which are 
innovative ideas emailed about ways to engage staff and patients in function focused care 
activities, ways to prevent and manage delirium and BPSD.  
Summary of 
Training Day  
a. Discussion of ways the stakeholder team will work with the champions and Research 
Nurse Facilitator and establish times for monthly meetings; c. Opportunity for questions; d. 
Review of timeline of project. 
In the first two months the Research Nurse Facilitator completes the environment and policy 
assessments with the champions and implements appropriate changes on the units (e.g., 
clearing hallways and making them pleasant and safe, assuring that there are places to sit in 
the rooms) and plans and provides staff education and makes available information for patients 
and families/ caregivers. The education reviews function focused care, the benefits of physical 
activity for patients with ADRD, ways to evaluate, prevent, and manage delirium and BPSD, 
focuses on elimination of entrenched and inaccurate practices such as unnecessary tethering of 

patients with pulse oximetry97, completion of the Mobility Screen and establishment of patient 
physical activity goals using the Nursing Progressive Mobility Tool, and use of motivational 
techniques to engage patients with ADRD in physical activity during all care interactions without 
exacerbating BPSD. Ongoing work between the champions and the Research Nurse Facilitator 
focuses on motivating staff and patients to work toward achievement of patient goals and 
established unit goals.   
The stakeholder team will continue to meet with the Research Nurse Facilitator monthly 
(approximately 30 minutes) over the 12-month intervention period to review progress and to 
help champions overcome any identified multilevel challenges (Figure 1). We will keep minutes 
of these meetings to describe the implementation process on the unit in each hospital. This 
cyclic feedback pattern of review of progress and challenges will help guide staff intervention 
activities to best respond to contextual changes on the unit and in the hospital over time. In 
addition to monthly visits, weekly emails containing motivational Tidbits will be sent to all 
stakeholder team members within the cohort. The Tidbits include such things as: updates about 
benefits of engaging patients with ADRD in physical activity while hospitalized; information to 
support de-implementation of entrenched and inaccurate practices(e.g., support for removal of 
tethers)97,98,152; symptom management (e.g., management of pain and BPSD); prevention and 
identification of delirium; motivation techniques such as using patients’ prior work life or leisure 
activities to serve as a source of motivation to engage in physical activities153; and motivational 
contests for nurses (e.g., reward for the nurse who provides the most innovative approach to 
engaging a patient in bathing, dressing, or ambulating). To further facilitate implementation we 
will give each treatment site: 1) a 100 dollar gift certificate from Nasco (Nasco.com) to buy 
supplies for the unit to engage patients with ADRD in physical activities (e.g., age-appropriate 
weights; soft horseshoe toss game); 2) 1000 dollars at the end of the study for each champion 
to attend a conference and submit an abstract focused on optimizing function and physical 
activity of hospitalized older adults with ADRD. 
 
Education Only (EO) Control Intervention: Hospitals randomized to EO will be provided with an 
in-service for nursing staff on function focused care in patients with ADRD by an EO Research 
Nurse Facilitator using our developed PowerPoint presentations in 30-minute sessions as is 
currently done in usual practice.  We will provide the education in the preferred format (e.g., 
face-to-face; webinar).  No further interaction with the staff or the units will occur. We recognize 
that there will be differences in time exposure to the Research Nurse Facilitators but we are 
deliberately testing two different approaches to implementation of function focused care on 
hospital units with older adults with ADRD (FFC-AC-EIT versus EO). Time/exposure to the 
Research Nurse Facilitators is part of the approach and we will consider exposure time 
differences between the treatments.  
 
Hospital descriptive data: The following data will be obtained at baseline to describe the 
hospitals and consider confounders: state; bed size; ownership status; urban or rural; MagnetTM 
Status; teaching status.   
Unit descriptive data:  We will obtain staff/patient ratios and mix (registered, licensed practical 
nurses, and nursing assistants) at baseline, 6, 12 and 18 months and bed size.  
Patient descriptive data:  Data will include age, race, sex, cognitive status based on the 
MoCA140,141, marital status, education, admission diagnosis, admission living situation, the 
Cumulative Illness Rating Scale (CIRS)154, medications, length of stay, and discharge location 
and living location at each follow up period.  
 
Measures for Aim 1 (Appendix A): Bolded measures are based on subjective data from 
informants (nurse/family); other measures are completed by evaluators based on observation or 

chart abstracting. Environment and policy assessments are completed by evaluators who are 
blind to randomization. 
 
Efficacy Data (see hypotheses 1-5 above):  
 
For patients:  Barthel Index (BI)155 will be used to evaluate function. The BI is a 10 item 
measure of ability to perform activities of daily living (e.g., bathing, dressing) with evidence of 
internal consistency (alpha coefficients .62-.80), inter-rater reliability (r=.89) and validity based 
on correlations with the Functional Inventory Measure (r=.97)155.  Items are weighted to account 
for the amount of assistance required.  A total score of 100 indicates complete independence. 
The Physical Activity Survey 33,156 is a subjective measure of time spent in physical activities 
over 24 hours based on input from an informant.  Activities include locomotion (e.g., walking, 
wheelchair mobility), personal care (e.g., bathing), structured exercise (e.g., physical and 
occupational therapy), recreational activity (music), and repetitive behavior (moving objects 
repeatedly).  Prior use of the measure provided evidence of criterion-related validity (r=.55 -.60, 
p<.05) and inter-rater reliability (r=.82 -.94, p<.05)33,156. The MotionWatch 8 (only obtained 
during hospitalization) is a compact, lightweight, wrist-worn activity monitoring device used to 
document physical movement. The MotionWatch 8 contains a miniature accelerometer to allow 
measurement and recording of physical movement of the wrist which provides a close 
correlation to whole body movement. Reliability, validity, and cutpoints for different levels of 
activity have been established for older adults157.  We will place the MotionWatch 8 on at 
baseline and leave this on till discharge so that we can capture baseline activities (the first 24 
hours of measurement), mean daily activity while hospitalized and discharge activities (the 24 
hours prior to discharge).  Specifically we will collect counts of activity and time spent in 
sedentary, moderate, and vigorous activity during these time periods.  Patient Checklist for 
Function Focused Care (only completed during hospitalization) is a 19-item measure in which 
nurse-patient interactions are evaluated over a 30 minute period to determine if the patient 
performs function focused care (e.g., participates in bathing at his or her highest level).  Patients 
either do or do not perform the activity (e.g., patient refuses to perform).  If the item/activity is 
not observed it is marked as not observed.  Percentage scores are calculated based on function 
focused care performed/observed activities. Prior testing supported inter-rater reliability (r =.92) 
and validity based on correlations with function (r =.89)158. Delirium occurrence will be based on 
structured interviews consisting of questions from the MoCA140,141 first to establish if there is 
evidence of cognitive impairment and then the Confusion Assessment Method (CAM) to 
establish if there is delirium151. A review of studies testing the psychometric properties of the 
CAM noted that in seven high quality studies there was an overall sensitivity of 94% (95% 
confidence interval, CI, 91–97%), and specificity of 89% (95% CI, 85–94%)159 and evidence of 
inter-rater reliability160. Delirium severity will be determined based on the Delirium Rating Scale 
which is a 10 item scale that is completed by an informant161.  Prior testing supported the validity 
of this measure based on differentiation of delirium among different groups of patients and 
reliability based on inter-rater reliability (r=.97). Scores can range from 0-26 with higher scores 
indicative of more severe delirium. BPSD will be evaluated using the Brief Neuropsychiatric 
Inventory (NPI-Q)162 which is a 12-item, reliable and valid informant-based assessment of 
neuropsychiatric symptoms. Each of the 12 NPI-Q domains contains a survey question that 
reflects symptoms of that domain and if present then severity is rated (symptoms include 
resistance to care, apathy, anxiety, depression, motor disturbance, disinhibition, agitation, sleep 
issues, hallucinations, and delusions).  The informant (nurse/caregiver) providing care to the 
patient on the day of testing will be asked to respond to the items based on the past 24 hours.  
Prior testing has established evidence of validity of the measure with a sensitivity of 74% and 
specificity of 80% and test retest reliability (r=.99)163. Pain will be evaluated using the Pain 
Assessment in Advanced Dementia (PAINAD)164.  The PAINAD includes 5 behaviors that are 

commonly noted among individuals with pain. Observations will be done, as recommended, 
during periods of activity such as transferring or ambulating. Scoring ranges from 0 to 2 for each 
specific pain behavior. A total score of 1-3 is indicative of mild pain, 4-6 is moderate pain and 7-
10 is severe pain.  Prior testing provided evidence of inter-rater-reliability (kappa=.74) and 
concurrent validity (p<.001)165. Tethering: Tethering of patients will be based on chart review of 
orders for:  indwelling urinary catheters, sequential compression devices, continuous 
intravenous, bed/chair alarms, cardiac monitoring and pulse oximetry, physical restraints, 
bedrest orders or negative pressure wound therapy devices.  The total number of tethers will be 
calculated. Patient Falls will be based on chart review and documentation of the falls that occur 
during the acute care stay.  Post hospitalization falls will be based on informant recall of number 
of falls during the course of the follow up period (discharge to 1 month; 2-6 months; and 7-12 
months post discharge). Emergency room visits, unplanned re-hospitalizations, and new 
long term care admissions will be based on informant recall at follow up (discharge to 1 
month; 2-6 months; and 7-12 months post discharge). 
For hospitals: Environment Assessment includes 18 items that have an impact on engaging 
patients in function and physical activity15,166. Examples of items include evidence of having 
clear pathways; pleasant areas to walk; pleasant destinations to walk to; safe footwear; 
appropriate height of chairs and beds to facilitate transfers.  Items are scored as present or not 
present and summed. There was prior evidence of inter-rater reliability (r=.89) and validity 
based on hypothesis testing and prior evidence of change in environments following exposure 
to FFC-AC15,33,166.  Policy Assessment includes 15 items that reflect policies that support 
engaging patients in function and physical activity and support dementia friendly 
environments15,33,166,167. Examples of items include evidence of policies around use of restraints, 
indwelling urinary catheters, and ambulation on the unit.  Items are scored as present or not 
present and summed. There was prior evidence of inter-rater reliability (r=.84) and validity 
based on evidence of improvement in policies to optimize function and physical activity following 
exposure to FFC-AC15,33,166.   
 
Data Analysis:  
 
Efficacy (see hypotheses 1-3 above):   
Descriptive statistics including measures of central tendency, dispersion and appropriate 
visualization approaches (e.g., box plots and spaghetti plots) will be performed on each 
outcome variable for patients and hospitals.  This will be done to ascertain distributional 
characteristics and ensure that the assumptions (e.g., normality) associated with the planned 
statistical procedures are met. When necessary, transformations will be performed. All analyses 
will be done using an intent-to-treat philosophy.  Baseline characteristics (both patient and 
setting levels) will be compared between intervention and control groups and the relevant 
variables (e.g., age) that differ by group will be included as covariates in hypotheses testing. In 
particular, we will control for the variables that correlate with function and physical activity 
including sex, comorbidities and cognitive impairment. Linear mixed models (LMMs)170 for 
longitudinal data (admission, discharge, 1, 6 and 12 months) will be used to assess the 
intervention effect on continuous outcomes (e.g., physical activity, function, and length of stay) 
accounting for clustering of patients that may occur within the same hospital and for correlations 
between repeated measurements of each patient.  Generalized Linear Mixed Model (GLMM) 
analyses will be conducted to assess the effect of the intervention on count outcomes (e.g., 
falls) or binary outcomes (e.g., readmission or not). The fixed effects included in the models will 
be treatment group (FFC-AC-EIT versus EO), time (admission, discharge, 1, 6, and 12 months 
post discharge for patients depending on the time points when the effects are evaluated), group-
by-time interaction term and the aforementioned relevant covariates, such as age, sex, race, 
staffing, hospital size etc., identified from the baseline analyses will be included in the mixed 

model to adjust for their influences. Random effects will include hospitals and patients. The 
hypotheses will be tested by evaluating the interaction term for each outcome variable.  For 
each hypothesis, exploratory analyses will be performed to assess model assumptions.  Post-
analysis diagnostic measures (e.g., residuals) will be explored to assess model fit.  All tests will 
use a 5% significance level.  The use of LMM will provide flexibility with regard to assumptions 
related to the covariance structure of the residuals and the presence of missing data for the 
repeated measures171.  As secondary analyses, we will also consider three-way interactive 
effects among demographic variables of interest (e.g., sex, age), and treatment condition, and 
time to identify moderators of the treatment effects.  All of the Research Nurse Facilitators are 
women so we do not anticipate an effect of sex on outcomes.  Generalized estimating equation 
(GEE) models will be used to compare changes in hospital level measures (i.e., environments, 
policies) (Hypothesis 3) from baseline to 6,12, and 18 months as GEE is more robust than 
LMMs when the sample size is relatively small (n=12)172. 
Missing data. In prior research we had a 5-40% rate of attrition at the patient level and 0% at 
the hospital level12,33.  If there is significant dropout, we will identify baseline characteristics that 
differ between persons or hospitals that drop out. Maximum likelihood methods will be used for 
primary analyses, which address non-informative dropout [missing at random (MAR)]. If 
"informative" dropout is present, we will consider sensitivity analyses that add these relevant 
baseline covariates to make the MAR assumption more plausible173.