Reducing Disability Via a Family-centered Intervention for Acutely-ill Persons With Alzheimer's Disease and Related Dementias
Phase: NA
Conditions: Alzheimer Disease
Sponsor: Penn State University

Page 1 of 48 (V.06/27/2016) 
 
 
 
 
 HRP-592 - Protocol for Human Subject 
 
Research with Use of Test Article(s) 
 
Protocol Title: 
Provide the full title of the study as listed in item 1 on the “Basic Information” page in CATS IRB (http://irb.psu.edu).  
Reducing Disability via a Family-centered Intervention for Acutely Ill Persons with Alzheimer’s disease  
  
 
 
 
and Related Dementias  
 
Principal Investigator: 
Name: [Marie Boltz] 
Department: [College of Nursing] 
Telephone: [215-962-9712] 
E-mail Address: [mpb40@psu.edu] 
 
Version Date: 
Provide the date of this submission. This date must be updated each time the submission is provided to the IRB office 
with  
June 8, 2021 
 
Clinicaltrials.gov Registration #:  
Provide the registration number for this study, if applicable. 
 NCT03046121  
 
Important Instructions for Using This Protocol Template: 
1. 
Add this completed protocol template to your study in CATS IRB (http://irb.psu.edu) on the “Basic Information” 
page, item 7.  
2. 
This template is provided to help investigators prepare a protocol that includes the necessary information needed 
by the IRB to determine whether a study meets all applicable criteria for approval.  
3. 
Type your protocol responses below the gray instructional boxes of guidance language.  If the section or item is 
not applicable, indicate not applicable. 
4. 
For research being conducted at Penn State Hershey or by Penn State Hershey researchers only, delete the 
instructional boxes from the final version of the protocol prior to upload to CATS IRB (http://irb.psu.edu).  For all 
other research, do not delete the instructional boxes from the final version of the protocol. 
5. 
When making revisions to this protocol as requested by the IRB, please follow the instructions outlined in the Study 
Submission Guide available in the Help Center in CATS IRB (http://irb.psu.edu) for using track changes.  
 
If you need help… 
University Park and other campuses: 
Office for Research Protections Human Research Protection Program 
The 330 Building, Suite 205 
University Park, PA 16802-7014 
Phone: 814-865-1775 
Fax: 814-863-8699 
Email: irb-orp@psu.edu 
College of Medicine and Hershey Medical Center: 
Human Subjects Protection Office 
90 Hope Drive, Mail Code A115, P.O. Box 855 
Hershey, PA 17033 
(Physical Office Location: Academic Support Building Room 1140) 
Phone: 717-531-5687 
Fax number: 717-531-3937 
Email: irb-hspo@psu.edu 

Page 2 of 48 (V.06/27/2016) 
 
Table of Contents 
1.0 
Objectives 
2.0 
Background 
3.0 
Inclusion and Exclusion Criteria 
4.0 
Recruitment Methods 
5.0 
Consent Process and Documentation 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
7.0 
Study Design and Procedures 
8.0 
Subject Numbers and Statistical Plan 
9.0 
Confidentiality, Privacy and Data Management 
10.0 
Data and Safety Monitoring Plan 
11.0 
Risks 
12.0 
Potential Benefits to Subjects and Others 
13.0 
Sharing Results with Subjects 
14.0 
Subject Stipend (Compensation) and/or Travel Reimbursements 
15.0 
Economic Burden to Subjects 
16.0 
Resources Available 
17.0 
Other Approvals 
18.0 
Multi-Site Research 
19.0 
Adverse Event Reporting 
20.0 
Study Monitoring, Auditing and Inspecting 
21.0 
Future Undetermined Research: Data and Specimen Banking 
22.0 
References 
 
 

Page 3 of 48 (V.06/27/2016) 
1.0 
Objectives 
 
1.1 
Study Objectives 
Describe the purpose, specific aims or objectives.  State the hypotheses to be tested. Describe the 
treatment that is considered standard of care (i.e., indicate how patients would be treated in a non-
investigational setting). Indicate if the study test article(s) is available to patients without taking part in 
the study. 
 
The overall aim of this study is to conduct a formal, real world test of the efficacy of Family-centered function-
focused care ( Fam-FFC) on patient and caregiver-centered outcomes in community- dwelling, hospitalized older 
adults with very mild to moderate dementia. 
              Aim 1: Validate the efficacy of Fam-FFC on physical function (ADLs/ performance and physical activity),  
              delirium occurrence and severity, behavior, and mood.  
H1: Patients exposed to Fam-FFC will demonstrate more return to baseline ADL function as compared to those in 
the control condition.  
H2:  Patients exposed to Fam-FFC will demonstrate increased physical activity, improved chair rise and less 
delirium occurrence and severity, less NPS, and less depression, as compared to those in the control condition. 
 
       Aim 2: Evaluate the impact of Fam-FFC on CG –centered outcomes.  
H3: CGs exposed to Fam-FFC will demonstrate improved preparedness for caregiving, and less strain, burden, 
and desire to institutionalize as compared to those in the control condition. 
               Aim 3: Evaluate the relative costs for Fam-FFC v. control condition, and calculate health care (post-  
               acute health care utilization) costs and total cost savings for Fam-FFC.  
               H4: Patients exposed to Fam-FFC will demonstrate higher intervention costs but lower post-discharge  
               cost for health care services (emergency room admissions, hospital admissions, and long-term  
               nursing home admissions) as compared to those in the control condition. 
               H5: Patients exposed to Fam-FFC will demonstrate total cost savings overtime as compared to those in the 
 
        control condition.   
 
        Exploratory Aim: Assess the cultural appropriateness of Fam-FCC for diverse families.  
 
1.2 
Primary Study Endpoints 
State the primary endpoints to be measured in the study.  Clinical trials typically have a primary 
objective or endpoint. Additional objectives and endpoints are secondary.  The endpoints (or outcomes), 
determined for each study subject, are the quantitative measurements required by the objectives.  
Measuring the selected endpoints is the goal of a trial (examples: response rate and survival). 
 
Patient outcomes: physical function (return to baseline ADLs/ performance, physical activity), delirium 
occurrence and severity, neuro-psychiatric symptoms, and mood. 
Family CG-centered outcomes: preparedness for caregiving, strain, burden, and desire to institutionalize. 
 
Relative costs for Fam-FFC v. control condition,health care cost (post-acute health care utilization) and  
 
total cost savings for Fam-FFC. 
 
1.3 
Secondary Study Endpoints 
State the secondary endpoints to be measured in the study. 
 
Cultural appropriateness of Fam-FCC. 
 
2.0 
Background 
 
2.1 
Scientific Background and Gaps 
Describe the scientific background and gaps in current knowledge. 

Page 4 of 48 (V.06/27/2016) 
 
 
Persons with Alzheimer’s disease and related dementias (ADRD) account for 3.2 million hospital admissions 
per year and are about two times more likely to be hospitalized than their peers who are cognitively healthy.1-4 
Once hospitalized, individuals with ADRD are more likely to experience potentially preventable complications such 
as delirium,  neuropsychiatric symptoms (NPS), pressure ulcers, falls, and nutritional deficiencies.5-8 The 
unfortunate consequences of this combination of factors is that persons with ADRD often have clinically 
significant functional decline resulting in increased risk for hospital readmission, emergency department use, 
morbidity, earlier mortality,9-14 and long-term care placement.
  15,16 
 
Prior to hospitalization, approximately 75% of hospitalized patients with ADRD are living at home and 
receiving care from family members or friends,2, 17,18   Upon hospitalization, the goal of most families is to have 
their relative return home.19,20  However, family caregivers (CGs) are limited in the amount of physical care they 
can provide in terms of lifting, moving and providing incontinence care.21  The additive stress of the hospitalization, 
and the patient’s increased functional dependency, often co-existing with persistent delirium, compounds the 
strain of the family CG,58 prompting the decision to seek long-term nursing home care.22,23  It is particularly 
important, therefore, that patients with ADRD receive the type of care, beginning at admission and continuing 
through the post-acute transitional period, that optimizes function and physical activity and helps prevent or 
decrease functional decline. 
In hospital settings, acute illness, superimposed upon baseline cognitive and functional vulnerabilities,24-31 
account for only some of the functional decline associated with hospitalization of the person with ADRD. Our 
team’s extensive preliminary work identified factors associated with negative outcomes, including: 1) non-dementia 
friendly care processes (i.e., inadequate assessment of patient/CG needs and preferences),32,33 2) activity-restrictive 
policies and environments,34-39 3) staff under-prepared to care for persons with cognitive impairment,40,41 and 4) 
patient, staff, and CG attitudes regarding physical activity in the acute setting. 42,43 Another salient finding was that 
patients were more likely to be involved in function–promoting activities (e.g., walking, using the toilet) when family 
CGs encouraged them and advocated for them to do so.43-44   
Specialized hospital programs have effectively improved some patient outcomes, such as reduced delirium.45-48 
These programs do not, however, include the needed approaches to promote return of the person with ADRD to pre-
hospital function, and the ability to return to home and remain at home.  Researchers have identified that a social-
ecological approach (function-focused care; FFC) improves functional outcomes in long-term care residents with 
ADRD.49-53 FFC components include: 1) policy and environmental assessment; 2) staff education; and (3) mentoring 
and motivating nursing staff and patients. Our team has conducted a series of preliminary studies demonstrating the 
benefits of adapting this model for the hospital setting.42-44, 54-58 In an intervention entitled, Family-centered 
function-focused care (Fam-FFC), we modified FFC components to the unique needs of hospitalized patients with 
ADRD and their family CGs.59   
Fam-FFC provides expert dementia care by formal caregivers (nursing staff) through adaptations to the physical 
and care environment but, importantly, incorporates the additional component of the patient’s family CG. In our 
unique family-centered care approach, nurses purposefully engage CGs in the assessment, decision-making, care 
delivery, and evaluation beginning at admission, continuing through the hospital stay and the 60-day post-acute 
period. Fam-FFC emphasizes the critical role of CGs as often the expert, voice, and advocate of the patient’s needs 
and desires. In non-randomized, feasibility pilots, Fam-FFC demonstrated moderate effect sizes in improving ADL 
function and reducing delirium as well as increasing family CG preparedness for caregiving, without increasing CG 
strain.59,60 These pilot findings warrant an efficacy trial.   
 
2.2 
Previous Data 
Describe any relevant preliminary data. 
 
• 
Understanding and documentation of functional decline in hospitalized older adults. From our longitudinal, 
descriptive studies, 36, 55 we concluded: (a) most patients (70-80%) did not return to baseline function; (b) 
hospitalization is often preceded by a decline in functional status (worse in situations of high family caregiver 
strain115); and (c) factors associated with failure to return to baseline by discharge included lower baseline and 
admission ADL function, delirium, and cognitive impairment. We also found that controlling for baseline/admission 
ADL function and cognition, the degree to which nurses encouraged self-care and physical activity in routine 
interactions with patients (FFC) was associated less functional (ADL) loss from admission to discharge, and baseline 

Page 5 of 48 (V.06/27/2016) 
to discharge.55  
• 
Barriers and facilitators to the engagement of older adults in functional and physical activities. Qualitative and 
mixed method approaches identified barriers: 42-44, 54, 56  (a) intrinsic patient factors including cognitive impairment, 
delirium, depression, fear of falling, and symptoms (emphasizing the need for individualized treatment plans); (b) 
inadequate staff knowledge regarding care of the patients with dementia including behavioral manifestations of 
distress, techniques to motivate, and communication and collaboration with families; (c) family beliefs and attitudes 
toward physical activity; (d) environmental impediments (e.g., inadequate bed/toilet height, seating, walking paths, 
lighting, access to assistive and sensory devices); (e) policy barriers such as inadequate assessment of physical and 
cognitive function; inadequate information of the patient’s social profile and family roles; lack of a care planning 
process to address symptom management, delirium prevention, and function; and the need to incorporate plans for 
functional recovery into discharge planning and post-acute follow-up. The family CG can provide motivation, 
support, and encouragement to promote physical activity but was rarely engaged to do so. 42-44, 54, 56 This work 
informed the development of Family-centered Function-focused Care (Fam-FFC).  
• 
Development and Feasibility Testing of Fam-FFC.  
       The first pilot study (24% of eligible recruited; attrition less than 5%, 28% of sample with ADRD) demonstrated 
feasibility of the staff training, nurse champion role, environmental and policy assessments, systematic method of 
partnering with families in function-focused care, and post-acute follow-up.60 Treatment fidelity observations of care 
delivery by nursing staff showed ≥ 90% agreement between the care plan and enactment of the plan. Qualitative 
data showed that families of persons with ADRD reported the need for education, support, and engagement unique 
to managing their relative with ADRD.60 This pilot study identified the need for more robust recruitment/ enrollment 
strategies and customization of Fam-FFC for persons with ADRD (including adapted communication, motivation 
techniques, behavioral support). The subsequent pilot study addressed these issues.  
        The second pilot study conducted with hospitalized medical patients with ADRD 60  incorporated recruitment 
approaches to include: a) twice a day phone contact with unit secretaries to capture potential participants,(b) 
incentives for unit managers to assist recruiting (free continuing education programs for staff unrelated to the study 
focus), and (c) the coordination of recruitment activity so as not to conflict with routine patient and staff activity 
(e.g., rounds, meals, peak personal care times). Enrollment of eligible patients increased from 24% in the first pilot 60 
to 41% of potential and 97% of eligible participants enrolled in the second study.59 Patients were able to participate 
in data collection and tasks. Attrition and missing data was less than 5% in both pilot studies.59,60 Similar to the first 
pilot, patients exposed to Fam-FFC demonstrated closer return to baseline ADL performance (Χ2 p = .003) at two 
months post-discharge, less 30-day hospital readmissions (Χ2 = 5.8, p = .02), and less delirium (Χ2 = 3.8, p = .05).  CGs 
who participated in Fam-FFC reported better preparedness for caregiving (F (2.6) = 3.0, p =.04, partial η2= .06), from 
admission to two months post-discharge, with no significant increases in strain or decreased mutuality (relationship 
with the patient). 59, 60 These pilot studies however, were limited by a lack of randomization, single site selection, and 
lack of cost-effectiveness measurement.   
 
2.3 
Study Rationale 
Provide the scientific rationale for the research. 
 
         In summary, we have demonstrated that Fam-FFC is feasible to implement for hospitalized persons with 
Alzheimer’s disease and related dementias. We found that hospital nursing staff can integrate FFC into their practice 
and that CGs can adapt this approach in their various role functions.  
The next step is to conduct a randomized, controlled trial to further our understanding of mechanisms of functional 
decline.  This design will allow us to examine functional decline over a longer period of time, validate both the short 
and long term consequences of functional decline as well as cost, and determine how a multi-component 
intervention can alter this course.  We are particularly interested in building caregiver science to understand 
whether and how caregivers become an essential part of the hospital care team, and whether this is associated with 
better overall CG outcomes as well.  
 

Page 6 of 48 (V.06/27/2016) 
3.0 
Inclusion and Exclusion Criteria 
Create a numbered list below in sections 3.1 and 3.2 of criteria subjects must meet to be eligible for study 
enrollment (e.g., age, gender, diagnosis, etc.). Indicate specifically whether you will include any of the 
following vulnerable populations: (You may not include members of these populations as subjects in your 
research unless you indicate this in your inclusion criteria.) Review the corresponding checklists to ensure that 
you have provided the necessary information. 
• 
Adults unable to consent 
o Review “CHECKLIST: Cognitively Impaired Adults (HRP-417)” to ensure that you have 
provided sufficient information. HRP-417 can be accessed by clicking the Library link in 
CATS IRB (http://irb.psu.edu). 
• 
Individuals who are not yet adults (infants, children, teenagers) 
o If the research involves persons who have not attained the legal age for consent to 
treatments or procedures involved in the research (“children”), review the “CHECKLIST: 
Children (HRP-416)” to ensure that you have provided sufficient information. HRP-416 
can be accessed by clicking the Library link in CATS IRB (http://irb.psu.edu). 
• 
Pregnant women 
o Review “CHECKLIST: Pregnant Women (HRP-412)” to ensure that you have provided 
sufficient information. HRP-412 can be accessed by clicking the Library link in CATS IRB 
(http://irb.psu.edu). 
• 
Prisoners 
o Review “CHECKLIST: Prisoners (HRP-415)” to ensure that you have provided sufficient 
information.  HRP-415 can be accessed by clicking the Library link in CATS IRB 
(http://irb.psu.edu). 
• 
Neonates of uncertain viability or non-viable neonates 
o Review “CHECKLIST: Neonates (HRP-413)” or “CHECKLIST: Neonates of Uncertain Viability 
(HRP-414)” to ensure that you have provide sufficient information.  HRP-413 and HRP-414 
can be accessed by clicking the Library link in CATS IRB (http://irb.psu.edu). 
 
3.1 
Inclusion Criteria 
List the criteria that define who will be included in your study. 
 
FOR THE PRIMARY STUDY AIMS  
Patient  
1.  age ≥ 65 
2.  speak English or Spanish 
3.  live in the community prior to admission to the hospital  
4.  screen positive for dementia on well-validated scales (Montreal Cognitive Assessment {MoCA} ≤ 25123   
     -127 and AD8 >2 with symptoms evident for several years128,129 
5.  have a diagnosis of very mild to moderate stage dementia as confirmed by a score of 0.5 to 2.0 on  
      the  Clinical Dementia Rating Scale130   
6.  have a family caregiver as the designated study partner for the duration of the study.   
 
 
Family caregiver 
1. age 18 and above 
2. are related to the patient by blood, marriage, adoption, or affinity as a significant other (defined by 
the legally authorized person as the primary person providing oversight and support on an ongoing 
basis) 
3. speak English or Spanish 
4. able to recall at least two words on the Three Word Recall 
5. participate, at a minimum, in the initial assessment and development of FamPath 
Nurses (at the conclusion of the intervention at each site) 
1. identify the intervention unit as the primary unit worked  
2. speak English or Spanish 

Page 7 of 48 (V.06/27/2016) 
 
FOR THE EXPLORATORY AIM of assessing the cultural appropriateness of the intervention, we will 
recruit family CGs who self-identify as black, Latino, Asian and white, randomly selected from the Fam-
FFC sample. Approximately 10 percent of families from each ethnic group represented in the study will 
be approached for consent for participation in interviews. (If theoretical saturation is not reached, 
interviews will continue until saturation is reached).  Additionally, the six nurse champions will be 
consented and interviewed after the study ends in his/her particular unit/setting to provide their 
perspective on the cultural appropriateness of Fam-FFC.   
 
3.2 
Exclusion Criteria 
List the criteria that define who will be excluded in your study. 
 
Patient 
1. enrolled in hospice and/or have a life expectancy of six months or less 
2. admitted from a nursing home 
3. no family caregiver to participate 
4. mild cognitive impairment (CDR 0.5 without functional or ADL impairments) 
5. severe dementia (CDR 3)  
6. any significant neurological condition associated with cognitive impairment other than dementia 
(e.g. brain tumor) 
7. a major acute psychiatric disorder 
 
Family caregiver 
1. unable to recall at least two out of 3 words on the Three Word Recall  
 
3.3 
Early Withdrawal of Subjects 
 
3.3.1 
Criteria for removal from study 
Insert subject withdrawal criteria (e.g., safety reasons, failure of subject to adhere to protocol 
requirements, subject consent withdrawal, disease progression, etc.). 
 
For both patient and family caregiver:    
1. Subject consent withdrawal  
2. Death  
3. Failure of subject to adhere to protocol 
                               The Intent-To-Treat Principle will be followed to analyze data from the current proposed trial.  
                                           
                             For the nurse/nurse champions:  
1. Subject consent withdrawal  
 
3.3.2 
Follow-up for withdrawn subjects 
Describe when and how to withdraw subjects from the investigational product or study; the 
type and timing of the data to be collected for withdrawal of subjects; whether and how 
subjects are to be replaced; the follow-up for subjects withdrawn from investigational 
treatment. 
 
If the participant withdraws from this study, already collected data will not be removed from the study 
database. The participant will be asked whether the investigator can collect data from his /her clinical 
records in the facility. If the individual agrees, this data will be handled the same as all other research 
data. Subjects will not be replaced.  
 

Page 8 of 48 (V.06/27/2016) 
4.0 
Recruitment Methods 
 
4.1 
Identification of subjects 
Describe the methods that will be used to identify potential subjects or the source of the subjects.  If not 
recruiting subjects directly (e.g., database query for eligible records or samples) state what will be 
queried, how and by whom. 
 
The Project Manager, research evaluators and PI will work with identified setting staff to provide us with 
a list of potentially eligible patients and recruit 146 patient/family caregiver dyads per participating 
setting (total sample 438 dyads). We are requesting a partial waiver to allow identification and, as 
appropriate, contact of potential participants to determine their interest in study participation.  A flyer 
posted in the nursing station will alert/remind nursing staff of the study and ask them to refer potential 
study participants. It is the study staff’s responsibility to ask permission of the patient to explain the 
study to the patient. 
 
4.2 
Recruitment process 
Describe how, where and when potential subjects will be recruited (e.g., approaching or providing 
information to potential subjects for participation in this research study). 
 
The research evaluators will provide IRB-approved information about the study/invitation to participate 
will to all potentially eligible patients/legally authorized representative (LAR) admitted to the study units 
(six medical or medical/surgical units of three hospitals in Pennsylvania). The patient and LAR will be 
approached to visit and discuss the study, and if granted, will receive: 1) brief oral information about the 
study; and 2) a copy of the consent form. The requirement to have a family CG (defined as the primary 
person providing oversight and support on an ongoing basis) involved and consented is explained to the 
patient/LAR. The patient and LAR may decide that another person, a CG other than the LAR, is the best 
person to participate in the study. In that case, that CG is provided information and if agreeable, 
engaged in the consent process.  
 
Additionally, for the exploratory aim of assessing the cultural appropriateness of the intervention, we 
will recruit family CGs who self-identify as black, Latino, Asian and white, randomly selected from the 
Fam-FFC sample. Approximately 10 percent of families from each ethnic group represented in the study 
will be provided verbal information and approached for consent for participation in these interviews.   
Additionally, the six nurse champions will be consented and interviewed after the study ends in his/her 
particular unit/setting to provide their perspective on the cultural appropriateness of Fam-FFC.  At the 
conclusion of the intervention at each site, approximately 6-8 nurses representing both shifts will be 
recruited to participate voluntarily in focus groups evaluating nurse-reported perceptions of: influence 
of nurse managers, organizational culture, likelihood of continuing to implement the intervention, and 
satisfaction.   The purpose, voluntary nature, confidentiality, setting, time, and duration of the focus 
group will be shared with staff nurses at a staff meeting.  If more than 8 nurses volunteer, we will 
accommodate their involvement by holding a second focus group.  
 
4.3 
Recruitment materials 
List the materials that will be used to recruit subjects. Add recruitment documents to your study in CATS 
IRB (http://irb.psu.edu) on the “Consent Forms and Recruitment Materials” page. For advertisements, 
upload the final copy of printed advertisements. When advertisements are taped for broadcast, attach 
the final audio/video tape. You may submit the wording of the advertisement prior to taping to preclude 
re-taping because of inappropriate wording, provided the IRB reviews the final audio/video tape. 
 
 
The data evaluator, responsible for recruitment, will provide information to all potential participants,  
 
 
using a flyer and verbal script.  This information will be provided in person, and in some cases over the  
 
 
phone to family members who are not present.   
 

Page 9 of 48 (V.06/27/2016) 
4.4 
Eligibility/screening of subjects 
If potential subjects will be asked eligibility questions before obtaining informed consent, describe the 
process. Add the script documents and a list of the eligibility questions that will be used to your study in 
CATS IRB (http://irb.psu.edu) on the “Consent Forms and Recruitment Materials” page. 
 
Both patient and CG (who may or may not be the LAR) consent are required for the study process to 
proceed to screening. The research evaluator will check CG eligibility (able to recall at least two words 
on the Three Word Recall) in person or over the phone, and then screen the patient in person for 
dementia using the Montreal Cognitive Assessment (MoCA) 123 and AD8.128 Patients who screen positive 
for dementia will then be assessed for severity of dementia using the Clinical Dementia Rating (CDR). A 
diagnosis of very mild to moderate stage dementia as confirmed by a score of 0.5 to 2.0 on the Clinical 
Dementia Rating Scale will be required. Functional ability will be assessed with the Pfeffer Functional 
Activities Questionnaire (FAQ) to discriminate MCI from dementia. 
 
5.0 
Consent Process and Documentation 
Refer to “SOP: Informed Consent Process for Research (HRP-090)”, for information about the process of 
obtaining informed consent from subjects.  HRP-090 can be accessed by clicking the Library link in CATS IRB 
(http://irb.psu.edu). 
 
5.1 
Consent Process  
  
5.1.1 
Obtaining Informed Consent 
 
5.1.1.1 
Timing and Location of Consent 
Describe where and when the consent process will take place. 
 
The consent process of patient/family caregiver dyads will occur within 48 hours of admission to the 
unit.  Patients will be consented in person. The family caregivers will also be consented in person unless 
they are unable to be present with the research staff within the 48- hour timeframe, in which case they 
will be consented over the telephone.   Nurse champions will be consented at the beginning of the 
study, prior to patient/family caregiver enrollment.  Hospital staff nurses will be consented for post-
intervention focus groups at the conclusion of the intervention.  All consenting will occur within a 
private setting.  
 
5.1.1.2 
Coercion or Undue Influence during Consent 
Describe the steps that will be taken to minimize the possibility of coercion or 
undue influence in the consent process. 
 
Patient/family caregivers will be informed about the study.  Research staff are trained to give sufficient 
time for answers and questions and to offer to come back/give extra time for consideration.  Because 
the focus of this study is partnership with the family caregiver to improve the care /outcomes of persons 
with dementia, we will inform patients/families that in order to be eligible to participate, both members 
of the dyad need to assent or consent.  If one member of the chooses not to participate, we don’t enroll 
the dyad, and assure them that there are no negative sequelae associated with this decision.   
 
Both patient/family caregivers will need to pass the Evaluation to Sign Consent to fully consent. This will 
assure that they understand what they are volunteering to participate in the study.  Both patient and 
family caregivers will be informed that the decision to participate or not will have no bearing on the care 
and services provided by the hospital to both patient and family caregivers.   
 
We will provide a $20 gift certificate at three time points during the study, at discharge from the 
hospital, at the second post-discharge data collection,  and upon conclusion of the study. The two 

Page 10 of 48 (V.06/27/2016) 
different time-periods and modest nature of this honorarium offset the potential for undue 
influence. 
 
The inclusion of nurse champions and staff nurses in the study is purely voluntary.  Those who volunteer 
will be consented.  All staff will be informed that their decision to participate or not will not in any way 
influence their working conditions or standing.  
 
5.1.2 
Waiver or alteration of the informed consent requirement 
If you are requesting a waiver or alteration of consent (consent will not be obtained, required 
information will not be disclosed, or the research involves deception), describe the rationale 
for the request in this section.  If the alteration is because of deception or incomplete 
disclosure, explain whether and how subjects will be debriefed. Add any debriefing materials or 
document(s) to your study in CATS IRB (http://irb.psu.edu) on the “Supporting Documents” 
page.  NOTE: Review the “CHECKLIST: Waiver or Alteration of Consent Process (HRP-410)” to 
ensure you have provided sufficient information for the IRB to make these determinations. 
HRP-410 can be accessed by clicking the Library link in CATS IRB (http://irb.psu.edu).  
 
n/a  
 
5.2 
Consent Documentation 
 
5.2.1 
Written Documentation of Consent 
Refer to “SOP: Written Documentation of Consent (HRP-091)” for information about the process 
to document the informed consent process in writing.  HRP-091 can be accessed by clicking the 
Library link in CATS IRB (http://irb.psu.edu). 
 
If you will document consent in writing, describe how consent of the subject will be documented 
in writing. Add the consent document(s) to your study in CATS IRB (http://irb.psu.edu) on the 
“Consent Forms and Recruitment Materials” page. Links to Penn State’s consent templates are 
available in the same location where they are uploaded and their use is required. 
 
 
 
The following participants will be consented: 1) patient and CG, 2) nurse champions, and 3) nurses.  
 
Both patient and CG consent are required. After information is provided, and the patient and CG agree 
to participate, an evaluation of capacity to provide consent will be conducted, using the Evaluation to 
Sign Consent (ESC).131 If capacity is determined the patient may provide his or her own consent. If 
decisional capacity is impaired, and the patient provides assent , the LAR will complete the consent 
process. The legally authorized representative will be encouraged to try and determine what the patient 
would do if competent and base his/her decision upon what he/she thinks is in the patient’s best 
interest. The CG’s ability to sign consent will also be evaluated using the ESC. Only CGs answering all ESC 
questions correctly will be enrolled. Both patient and CG (who may or may not be the LAR) consent are 
required for the study process to proceed to screening.  The consenting party is requested to sign the 
consent form.  If it is not possible to obtain written signature from the LAR, verbal consent may be 
documented. The research evaluator will check CG eligibility (including the ability to recall at least two 
words on the Three Word Recall) and then screen the patient for dementia using the Montreal Cognitive 
Assessment (MoCA) 123 and AD8.128 Patients who screen positive for dementia will then be assessed for 
severity of dementia using the Clinical Dementia Rating (CDR). A diagnosis of very mild to moderate 
stage dementia as confirmed by a score of 0.5 to 2.0 on the Clinical Dementia Rating Scale will be 
required. Functional ability will be assessed with the Pfeffer Functional Activities Questionnaire (FAQ) to 
discriminate MCI from dementia.132 
 
Prior to the study the PI will ask the unit manager of the three intervention units to identify two nurse 
champions (to cover both nursing shifts). The PI will emphasize that the nurse champions must be 

Page 11 of 48 (V.06/27/2016) 
volunteers, in order to support their right to refuse without losing any job standing, as well as to support 
the success of the study.  The PI will meet with the prospective nurse champions in private, explain the 
purpose of the study, procedures, possible risks and benefits, time commitment, compensation, privacy/ 
confidentiality, payment, PI contact information, and voluntary nature of the research, including the 
interview that will be conducted at the end of the study. If the nurse declines to participate as  
champion,  another potential participant will be recruited and asked to provide an informed consent. A 
total of six nurse champions will be recruited. 
 
At the end of the study at each of the three hospital cites, the PI will attend a staff meeting on the three 
intervention units.  The PI will explain the plan for focus groups to obtain nurses’ feedback on the 
effectiveness and sustainability of the intervention. Staff nurses will receive information on the focus 
groups and asked to participate. The nurses will receive information about the purpose, procedures, 
possible risks and benefits, time commitment, compensation, privacy/confidentiality, payment, PI 
contact information, and voluntary nature of the research 
 
 
 
All participants will receive a copy of the consent to keep for future reference. 
 
 
5.2.2 
Waiver of Documentation of Consent (Implied consent, Verbal consent, etc.) 
If you will obtain consent (verbal or implied), but not document consent in writing, describe how 
consent will be obtained. Add the consent script(s) and/or information sheet(s) to your study in 
CATS IRB (http://irb.psu.edu) on the “Consent Forms and Recruitment Materials” page. Links to 
Penn State’s consent templates are available in the same location where they are uploaded and 
their use is required. Review “CHECKLIST: Waiver of Written Documentation of Consent (HRP-
411)” to ensure that you have provided sufficient information. HRP-411 can be accessed by 
clicking the Library link in CATS IRB (http://irb.psu.edu). 
 
If your research presents no more than minimal risk of harm to subjects and involves no 
procedures for which written documentation of consent is normally required outside of the 
research context, the IRB will generally waive the requirement to obtain written documentation 
of consent. 
 
The research presents no more than minimal risk of harm to subjects and involves no 
procedures for which written documentation of consent is normally required in acute care 
settings.  There are patients who are unable to write or unable to consent due to cognitive 
impairment (unable to pass the Evaluation to Sign Consent) but would like to participate in the 
study or are willing to have us speak with their LAR. There are also situations in which the LAR 
would really like to have the patient participate but can't meet face-to-face to sign the consent 
or HIPPA form; in this case the research staff will document verbal consent on the consent form.  
 
5.3 
Consent – Other Considerations  
 
5.3.1 
Non-English Speaking Subjects 
Indicate what language(s) other than English are understood by prospective subjects or 
representatives. 
 
If subjects who do not speak English will be enrolled, describe the process to ensure that the 
oral and written information provided to those subjects will be in that language. Indicate the 
language that will be used by those obtaining consent. 
 
Indicate whether the consent process will be documented in writing with the long form of the 
consent documentation or with the short form of the consent documentation.  Review the 
“SOP: Written Documentation of Consent (HRP-091)” and the “Investigator Manual (HRP-103)” 

Page 12 of 48 (V.06/27/2016) 
to ensure that you have provided sufficient information. HRP-091 and HRP-103 can be accessed 
by clicking the Library link in CATS IRB (http://irb.psu.edu). 
 
Study participants will speak English or Spanish.  The research evaluators will speak both English 
and Spanish. Study information, consents, and interventional material will be available in both 
English and Spanish. The long form of the consent documentation will be used.  
  
5.3.2 
Cognitively Impaired Adults 
Refer to “CHECKLIST: Cognitively Impaired Adults (HRP-417)” for information about research 
involving cognitively impaired adults as subjects. HRP-417 can be accessed by clicking the Library 
link in CATS IRB (http://irb.psu.edu). 
 
5.3.2.1 Capability of Providing Consent 
Describe the process to determine whether an individual is capable of consent. 
 
All potentially eligible patients and family caregivers (CGs), defined as or by the patient/legally 
authorized person (LAR) as the primary person providing oversight and support on an ongoing 
basis, will be approached to complete the Evaluation to Sign Consent (ESC). The Evaluation to 
Sign Consent is a four item measure with an opening question that is not scored. The opening 
question is used to indicate if the individual is alert and able to communicate. The five items 
reflect the participants’ ability to name at least two potential risks incurred as a result of 
participating in the study; name two things that will be expected of him/her related to 
participation; explain what he/she would do if no longer interested in participating in the study; 
or if distress or discomfort was experienced associated with study participation. Evidence of 
ability to sign consent is based on correct responses to all five items on the ESC.  
 
Both patient and CG (who may or may not be the LAR) consent are required for the study 
process to proceed to screening. 
 
5.3.2.2 
Adults Unable To Consent 
Describe whether and how informed consent will be obtained from the legally 
authorized representative.  Describe who will be allowed to provide informed 
consent. Describe the process used to determine these individual’s authority to 
consent to research. 
 
For research conducted in the state, review “SOP: Legally Authorized 
Representatives, Children and Guardians (HRP-013)” to be aware of which 
individuals in the state meet the definition of “legally authorized 
representative”. HRP-013 can be accessed by clicking the Library link in CATS IRB 
(http://irb.psu.edu). 
 
For research conducted outside of the state, provide information that describes 
which individuals are authorized under applicable law to consent on behalf of a 
prospective subject to their participation in the procedure(s) involved in this 
research.  One method of obtaining this information is to have a legal counsel or 
authority review your protocol along with the definition of “children” in “SOP: 
Legally Authorized Representatives, Children, and Guardians (HRP-013).” HRP-
013 can be accessed by clicking the Library link in CATS IRB (http://irb.psu.edu). 
 
If capacity is determined, based upon the ESC, the patient may provide his or her 
own consent. If decisional capacity is impaired, then assent, either verbal or 
written, will be obtained from the patient and the legally authorized representative 

Page 13 of 48 (V.06/27/2016) 
will be approached to complete the consent process. Therefore, we are requesting 
that Assent and Consent be either written or verbal. If the patient does not pass 
the Evaluation to Sign Consent and assents to participate the LAR will be 
approached. Many of the LARs live out of town and/or are unable to get to the 
facility to sign a face-to-face consent. We are therefore asking to be able to obtain 
verbal consent via phone communications if needed.  
 
5.3.2.3 Assent of Adults Unable to Consent 
Describe the process for assent of the subjects.  Indicate whether assent will be 
required of all, some or none of the subjects.  If some, indicate which subjects will 
be required to assent and which will not.  
 
If assent will not be obtained from some or all subjects, provide an explanation of 
why not. 
 
Describe whether assent of the subjects will be documented and the process to 
document assent.  The IRB allows the person obtaining assent to document assent 
on the consent document and does not routinely require assent documents and 
does not routinely require subjects to sign assent documents. 
 
After information is provided, and the patient and CG agree to participate, an 
evaluation of capacity to provide consent will be conducted, using the Evaluation 
to Sign Consent (ESC).131 If capacity is determined the patient may provide his or 
her own consent. If decisional capacity is impaired, and the patient agrees to 
participate (provides assent), the legally authorized representative (LAR) will 
complete the consent process.  The LAR will be encouraged to try and determine 
what the patient would do if competent and base his/her decision upon what 
he/she thinks is in the patient’s best interest.  The assent will be documented on 
the consent form by the research staff who are securing consent.  
 
5.3.3 
Subjects who are not yet adults (infants, children, teenagers)  
 
5.3.3.1 Parental Permission 
Describe whether and how parental permission will be obtained. If permission  
will be obtained from individuals other than parents, describe who will be 
allowed to provide permission.  Describe the process used to determine these 
individual’s authority to consent to each child’s general medical care. 
 
For research conducted in the state, review “SOP: Legally Authorized 
Representatives, Children and Guardians (HRP-013)” to be aware of which 
individuals in the state meet the definition of “children”. HRP-013 can be 
accessed by clicking the Library link in CATS IRB (http://irb.psu.edu). 
 
For research conducted outside of the state, provide information that describes 
which persons have not attained the legal age for consent to treatments or 
procedures involved in the research, under the applicable law of the jurisdiction 
in which research will be conducted.  One method of obtaining this information 
is to have a legal counsel or authority review your protocol along with the 
definition of “children” in “SOP: Legally Authorized Representatives, Children, 
and Guardians (HRP-013).” HRP-013 can be accessed by clicking the Library link 
in CATS IRB (http://irb.psu.edu). 
 
n/a 

Page 14 of 48 (V.06/27/2016) 
 
5.3.3.2 Assent of subjects who are not yet adults 
Indicate whether assent will be obtained from all, some, or none of the children. If 
assent will be obtained from some children, indicate which children will be 
required to assent. When assent of children is obtained describe whether and how 
it will be documented. 
n/a 
 
6.0 
HIPAA Research Authorization and/or Waiver or Alteration of Authorization 
This section is about the access, use or disclosure of Protected Health Information (PHI). PHI is individually 
identifiable health information (i.e., health information containing one or more 18 identifiers) that is transmitted 
or maintained in any form or medium by a Covered Entity or its Business Associate. A Covered Entity is a health 
plan, a health care clearinghouse or health care provider who transmits health information in electronic form.  
See the “Investigator Manual (HRP-103)” for a list of the 18 identifiers.  HRP-103 can be accessed by clicking the 
Library link in CATS IRB (http://irb.psu.edu). 
 
If requesting a waiver/alteration of HIPAA authorization, complete sections 6.2 and 6.3 in addition to section 
6.1. The Privacy Rule permits waivers (or alterations) of authorization if the research meets certain conditions. 
Include only information that will be accessed with the waiver/alteration.  
 
6.1 
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
Check all that apply: 
  
Not applicable, no identifiable protected health information (PHI) is accessed, used or 
disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable] 
 
X
 
Authorization will be obtained and documented as part of the consent process. [If this is the 
only box checked, mark sections 6.2 and 6.3 as not applicable] 
 
X 
 
Partial waiver is requested for recruitment purposes only (Check this box if patients’ medical 
records will be accessed to determine eligibility before consent/authorization has been 
obtained). [Complete all parts of sections 6.2 and 6.3] 
 
 
Full waiver is requested for entire research study (e.g., medical record review studies). 
[Complete all parts of sections 6.2 and 6.3] 
 
 
Alteration is requested to waive requirement for written documentation of authorization 
(verbal authorization will be obtained). [Complete all parts of sections 6.2 and 6.3] 
 
6.2 
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI 
 
6.2.1 
Access, use or disclosure of PHI representing no more than a minimal risk to the privacy of the 
individual 
 
6.2.1.1 Plan to protect PHI from improper use or disclosure 
Include the following statement as written – DO NOT ALTER OR DELETE unless this 
section is not applicable because the research does not involve a waiver of 
authorization. If the section is not applicable, remove the statement and indicate 
as not applicable.  
  

Page 15 of 48 (V.06/27/2016) 
Information is included in the “Confidentiality, Privacy and Data Management” 
section of this protocol. 
 
6.2.1.2 Plan to destroy identifiers or a justification for retaining identifiers  
Describe the plan to destroy the identifiers at the earliest opportunity consistent 
with the conduct of the research. Include when and how identifiers will be 
destroyed. If identifiers will be retained, provide the legal, health or research 
justification for retaining the identifiers. 
Because, we plan to follow up with post-acute visits after discharge, we will collect 
information on the discharge date, discharge location/address, and family 
caregiver telephone number, and email.  We will maintain a separate file of this 
information, which will include names and ID number, maintained on RedCap and a 
separate hard copy file in a locked cabinet in the research office. This file will be 
deleted at the conclusion of the study.   
 
6.2.2 
Explanation for why the research could not practicably be conducted without access to and 
use of PHI 
Provide an explanation for why the research could not practicably be conducted without access 
to and use of PHI. 
 
 
 
 
In order to evaluate the effectiveness of the intervention, we need to collect data co-variate  
 
 
 
demographic, health and treatment data, as well as outcome measures such as physical function  
 
 
 
and delirium.  
 
6.2.3 
Explanation for why the research could not practicably be conducted without the waiver or 
alteration of authorization 
Provide an explanation for why the research could not practicably be conducted without the 
waiver or alteration of authorization. 
 
We are only seeking HIPAA documents for recruitment purposes. We are trying to avoid 
unnecessary use of patient/caregiver and research staff time and resources.  This, we are asking 
hospital staff (unit secretary or nurse) to identify potentially eligible patient/caregiver dyads 
who meet inclusion/exclusion (e.g., age, not admitted from a nursing home, dementia diagnosis 
not hospice) criteria.  If necessary we will access the hospital record to get inclusion/exclusion 
criteria and a family caregiver telephone number for recruiting purposes. We will not be 
accessing records for protected information such as treatments and medications until after 
consent is secured.  
 
6.3 
Waiver or alteration of authorization statements of agreement 
By submitting this study for review with a waiver of authorization, you agree to the following statement 
– DO NOT ALTER OR DELETE unless this section is not applicable because the research does not involve a 
waiver or alteration of authorization. If the section is not applicable, remove the statement and indicate 
as not applicable. 
 
Protected health information obtained as part of this research will not be reused or disclosed to any 
other person or entity, except as required by law, for authorized oversight of the research study, or for 
other permitted uses and disclosures according to federal regulations.  
 
The research team will collect only information essential to the study and in accord with the ‘Minimum 
Necessary’ standard (information reasonably necessary to accomplish the objectives of the research) 
per federal regulations.  
 

Page 16 of 48 (V.06/27/2016) 
Access to the information will be limited, to the greatest extent possible, within the research team. All 
disclosures or releases of identifiable information granted under this waiver will be accounted for and 
documented. 
 
7.0 
Study Design and Procedures 
 
7.1 
Study Design 
Describe the type/design of trial to be conducted (e.g., double-blind, placebo controlled, parallel design, 
etc.). Provide a schematic diagram of study design, procedures and stages, if appropriate. 
 
The experimental design for this study is a repeated measures analysis with study units randomized by 
clustering to either treatment (Fam-FFC) or the control condition. This allows a within- and between-
groups analysis to ascertain the effects of Fam-FFC. 
 
7.2 
Study Procedures 
Provide a description of all research procedures being performed and when they are being performed 
(broken out by visit, if applicable), including procedures being performed to monitor subjects for safety 
or minimize risks.  Include any long-term follow-up procedures and data collection, if applicable.  
 
Describe where or how you will be obtaining information about subjects (e.g., medical records, school 
records, surveys, interview questions, focus group topics, audio or video recordings, data collection 
forms, and collection of specimens through invasive or non-invasive procedures to include the amount 
to be collected and how often). Add any data collection instruments that will be seen by subjects to your 
study in CATS IRB (http://irb.psu.edu) in the “Supporting Documents” page.  
 
7.2.1 
EXAMPLE: Visit 1 or Day 1 or Pre-test, etc. (format accordingly) 
Provide a description as defined above and format accordingly. 
 
 
7.2.2 
EXAMPLE: Visit 2 or Day 2 or Post-test, etc. (format accordingly) 
Provide a description as defined above and format accordingly. 
 
Pre-intervention Procedures, all three hospital sites: The three hospital units will be randomized into treatment cohorts 
(time 1, time 2, time 3).  The statistician will assist with randomization.  There will be a meeting with all three hospitals 
to establish plans for implementation and randomization.  
 
SITE Procedures (These procedures are repeated for Sites 1, 2 and 3.)  
Pre-intervention: Baseline setting (census, ownership, etc.) as well as an environmental and policy information will be 
collected by the research evaluator on the two study units.  The units will be randomized into treatment or control 
arm.  Nurse champions (two per the intervention unit) will be recruited and consented.   
 
Month 1-2 
INTERVENTION UNITS: 1) Component I: Nursing (nurses and nursing assistants) staff education and 2) Component II: 
environmental and policy assessment conducted by the research nurse (TBN). 
1) The staff education will be provided though instructor-led power-point presentations.  Education in webinar 
format and one on one review will be provided for those unable to attend the training.  Staff are requested to 
take a post-test after the training.  The educational material and post -test have been uploaded in the supporting 
document section. 
2) The environmental and policy assessment will be conducted by the research nurse who will include the nurse 
champions. The research nurse and champions will meet with the unit manager and discuss recommendations 
for change. Possible modifications include development of policies for: 1) labeling glasses/hearing aids, and 2) 
uninterrupted quiet times, and access to: 3) bedside white boards to promote family CG/patient communication 

Page 17 of 48 (V.06/27/2016) 
with the interdisciplinary team; and access to inexpensive hearing amplifiers, activity cart/supplies; mobility 
devices; and noise trackers. The site will be provided with up to $2000 to order supplies/equipment. The 
environmental and policy assessment has been uploaded in the supporting document section. 
CONTROL UNITS: 1) Staff education (same content as in the intervention) conducted by a nurse member of the research 
team, who is not familiar with other components of the intervention.  
Data Collected:  Time spent in activity, recorded by the research nurse for cost study. Post-tests (Knowledge of Fam-FFC) 
collected by the research nurse and co-investigator.  
 
 
Month: 3-14 Twelve months of recruitment/enrollment and intervention (Component III and IV). 
I. 
Recruitment/enrollment 
The research evaluators will work with unit staff to identify potentially eligible patients/family caregivers.  A list of those 
who meet Information about the study/invitation to participate will be provided to all patients/legally authorized 
representative (LAR) admitted to the study units. The patient and LAR will be approached to visit and discuss the study, 
and if granted, will receive: 1) brief oral information about the study; and 2) a copy of the consent form. The 
requirement to have a family CG (defined as the primary person providing oversight and support on an ongoing basis) 
involved and consented is explained to the patient/LAR. The patient and LAR may decide that another person, a CG 
other than the LAR, is the best person to participate in the study. In that case, that CG is provided information and if 
agreeable, engaged in the consent process. Both patient and CG consent are required. After information is provided, and 
the patient and CG agree to participate, an evaluation of capacity to provide consent will be conducted, using the 
Evaluation to Sign Consent (ESC).131 If capacity is determined the patient may provide his or her own consent. If 
decisional capacity is impaired, and the patient provides assent, the LAR will complete the consent process. The legally 
authorized representative will be encouraged to try and determine what the patient would do if competent and base 
his/her decision upon what he/she thinks is in the patient’s best interest. The CG’s ability to sign consent will also be 
evaluated using the ESC. Only CGs answering all ESC questions correctly will be enrolled. Both patient and CG (who may 
or may not be the LAR) consent are required for the study process to proceed to screening.  
 
Upon consent, the research evaluator will check CG eligibility and then screen the patient for dementia using the 
Montreal Cognitive Assessment (MoCA) 123 and AD8.128 Patients who screen positive for dementia will then be assessed 
for severity of dementia using the Clinical Dementia Rating (CDR). A diagnosis of very mild to moderate stage dementia 
as confirmed by a score of 0.5 to 2.0 on the Clinical Dementia Rating Scale will be required. Functional ability will be 
assessed with the Pfeffer Functional Activities Questionnaire (FAQ) to discriminate MCI from dementia.132                
THE RECRUITMENT/ENROLLMENT PROCEDURES ARE THE SAME ON THE INTERVENTION AND CONTROL UNITS. 
 
II. 
Intervention 
FOR CONSENTED PATIENTS ON THE INTERVENTION UNITS:   
The research nurse will provide Component III, the FamPath Care Pathway:  1) Information to the patient and family 
caregiver on the admitting condition, diagnostics, and treatment; 2) Family/patient education: provided in lay terms 
(cueing and motivating techniques, support of physical activity, meals, cognitive stimulation, behavioral support, and 
safety, provided in written and CD format) linked to joint family CG/nurse assessment (baseline cognition, physical 
function and social profile); 3) Jointly developed bedside goals and treatment plans (updated daily); discharge checklist; 
and 4) Coaching of  primary nurse to communicate and provide a copy of the FamPath plan to post-acute providers.  
The FamPath Care Pathway is initiated and continues throughout the hospitalization; it will vary based upon 
the patient’s length of stay.  In addition, 5) post-acute follow-up will provide ongoing education and modification 
of the function-focused care plan (phone contact within 72 hours of discharge, weekly telephone calls for a total of 7 
additional weeks, then monthly for 4 months), coaching of CGs to communicate FFC goals and expectations to the post-
acute providers as indicated.   
The research nurse will also provide Component IV (mentoring ) Assistance to champions and nurses on above 
consented patients to: a) complete the Physical Capability Assessments*,118  b) establish and update FFC goals with input 
from CGs/patients (Goal Attainment Scale*)119 and c) develop a care plan with family CG/ patient addressing factors that 
impede FFC (e.g., acute illness, sedation, pain, fear/anxiety, pain, apathy, NPS, depression)  2) Support to the unit 
champions to mentor and motivate nursing staff (RN, LPN, nursing assistants) by: (a) role modeling; (b) highlighting staff 
role models and positive opinion leaders; (c) garnering support by sharing success stories with nursing council and 

Page 18 of 48 (V.06/27/2016) 
administration; (d) maintaining Fam-FFC bulletin board with updates /educational reinforcement; and (e) observing 
nursing staff during care interactions using the Function Focused Care Behavior Checklist*,120 providing feedback to staff 
(See Tools).  
 
FOR CONSENTED PATIENTS ON THE CONTROL UNITS: The CGs will receive information about hospital orientation and 
reinforcement of discharge teaching (medications/treatments, medical follow-up). This will be provided by a nurse 
member of the research team who is not familiar with Component II, III, and IV of the intervention.  
 
III. 
Data Collection  
Patient data will be collected based on chart review, observations, actigraphy, and staff proxy informant 
interviews. Family CG data will be collected via electronic surveys on a tablet or by paper if a participant chooses. At all 
measurement time points, research evaluators will end data collection with the patient if he/she observes signs of 
dissent from the patient which includes: verbal refusal to answer a question, closing eyes and refusing to respond, 
asking the evaluator to leave, and moving away from the evaluator.  The training of evaluators will include interrater 
reliability (minimum of 90%).  Evaluators will not be informed of randomization results or provided with the details of 
the intervention. The research evaluators are fluent in Spanish and will use translated consents and study materials, in 
the event that Spanish is the primary language. The RedCap system will be used for screening of participants and data 
collection. The same data is collected on the intervention and control units.  Descriptive (one-time) and outcome 
(multiple time-points) data are collected.  
Upon enrollment, within 48 hours of admission to the unit, patient and family CG descriptive measures will be 
collected. Patient characteristics will include age, race/ethnicity, gender, marital status, education, medical diagnoses, 
medications, the use of sensory and mobility devices, and disease burden. Comorbid conditions will be classified with 
the Charlson Comorbidity Index.133 Pre-admission function (ADL performance 2 weeks prior to admission) using the 
Barthel Index 134 (also an outcome measure) will be evaluated based on report from the family CG. Evaluation of hearing 
loss will be assessed using The Whisper Test. Pain will be measured using the Pain Assessment in Advanced Dementia 
and The Verbal Descriptor Scale.  Upon discharge, length of stay, use of tethers (IV lines, pulse oximetry, urinary 
catheters, etc.), physical restraint use, and discharge disposition will be acquired. Cognitive domains affected by both 
dementia and delirium will be evaluated: executive function, orientation, memory, abstract thinking, and attention, 
evaluated by the subdomains of the MoCA. 123  The types of interventions provided on the FamPath assessment and care 
plan will be collected for descriptive purposes, extracted at the completion of the intervention.  
We would like to test the efficiency of a new app to detect delirium and validate its use. The content includes 2 new 
questions (Ultra-brief CAM); the other questions are ones that we currently ask in the MoCA and CAM-Severity scale. 
We will test the app upon enrollment and each day until discharge. Thus, we will be extending our data collection time 
to less than one minute.   
Here is the following description of the App: The READI delirium assessment app uses the REDCap application 
programming interface (API) for use on the iPad Air® tablet. The app executes the adaptive testing of the 2-step 
protocols using the Ultra-brief CAM and the 3D-CAM and together they take less than one minute to administer. The 
app allows the user to record accuracy of patient responses and automatically times each question.  A pause button is 
available for interruptions. On subsequent days, the app retrieves information from the previous day’s assessment to 
automatically assess for acute change. At the end of the assessment, the app reports the presence or absence of 
delirium, and uploads data into RedCAP, a HIPAA-compliant secure research database.   
        Family CG descriptive measures will include age, race, gender, marital status, education, relation to patient, 
employment status, other caregiving responsibilities, number of additional caregivers, and health literacy. General 
health and change in health compared to one year ago will be assessed using two widely used items from the SF-36.135  
Health Literacy (reading) will be measured with the REALM-short form). The REALM-short form is highly correlated with 
three other tests with a reported test-retest of 0.99.136 Anxiety will be evaluated with the seven-item Hospital Anxiety 
and Depression Scale (HADS) subscale for Anxiety (HADS-A) and depression with the seven-item Hospital Anxiety and 
Depression Scale (HADS) subscale for Depression (HADS-D).138 Suicidal ideation will be assessed using the Ask Suicide-
Screening Questions (https://www.nimh.nih.gov/news/science-news/ask-suicide-screening-questions-asq.shtml) The 
type and level of caregivers’ participation in hospital care will be measured by the researcher-developed tool that 
provides a self-report of the type of care and the number of hours per week spent providing care both in the hospital 
and post-discharge setting.59,60   

Page 19 of 48 (V.06/27/2016) 
The use of rehabilitation therapies and psychotropic medication prescribed during the hospitalization (drug, dose, 
frequency of antipsychotics, antidepressants, anxiolytics, sedatives/ hypnotics, mood stabilizers), length of stay, 
discharge disposition, setting and contact information, will be obtained through chart abstraction at discharge. 
The following outcome measure data collection/ will be initiated within 48 hours of admission to the unit (T0), 
within 72 hours of discharge (T1), and 2 month (T2) and 6 month post-discharge (T3), by research evaluators via 
observation, input from staff, chart abstracting or interview of the patient/family CG. Post-discharge data collection 
allows a one-week window post 72 hours of discharge. Also, a two-week window pre and post 2 month and 6 month 
time points to promote feasible and complete data collection. 
The change in study procedure is due to COVID-19. The following outcome measure data collection/ will be 
initiated within 48 hours of admission to the unit (T0), within 72 hours of discharge (T1), and 2 month (T2) and 6 
month post-discharge (T3), by research evaluators via observation, input from staff, chart abstracting or interview of 
the patient/family CG.  Outcome measures (and additional COVID-19 questions) collected at 72 hours of discharge, 2 
month and 6 month post-discharge will be completed with family CG via telephone or zoom as able. Functional 
performance and physical activity (objective measure) will not be collected in post-acute setting. Post-discharge data 
collection allows a one-week window post 72 hours of discharge. Also, a two-week window pre and post 2 month and 6 
month time points to promote feasible and complete data collection. 
Patient outcome measures- collected for both control and intervention group. 
Aim 1: Validate the efficacy of Fam-FFC on physical function (ADLs/ performance and physical activity), delirium occurrence and 
severity, behavior, mood, and adverse events. 
Measure  
Tool   
Description  
                                                                                     Physical Function 
ADLs (activities of 
daily living)  
 
Barthel Index: verbal report of function 
will be obtained from the nurse who is 
assigned to the patient’s care on the 
day of data collection..Return to 
baseline function (ADL function 2 
weeks prior to admission) will be 
calculated   
A 14-item measure of physical function that assesses ability for self-
care.134There is sufficient evidence for the reliability and validity of the 
Barthel Index when used with older adults,134, 140 individuals with 
progressive neurological conditions,141 and when proxy respondents were 
utilized to report the functional abilities of dementia patients.142 
Functional 
performance  
Timed Chair Rise (observation) 
An item on the Balance subscale of the Tinetti Gait and Balance Scale.143  
Previous work has identified this measure as a reliable and valid indication 
of function and strength.140 
Physical activity  
 
Objectively measured (actigraphy) for 
24 hours using the Motionwatch. 
The MotionWatch offers wrist-worn actigraphy that records activity in set 
epochs of time.145  with established reliability and validity;145-148 well-
tolerated by cognitively impaired older adults.148 The MotionWatch is applied 
within 24 hours of consent, and then upon subsequent data collection 
points.  
                                                                                            Delirium   
Delirium 
occurrence  
Structured interview consisting of 
questions from the MoCA observation 
123 and the Confusion Assessment 
Method (CAM).149 
The CAM has high sensitivity and specificity;149, 150  validated in persons with 
dementia.151 Delirium occurrence will be evaluated as the presence of full or 
subsyndromal delirium, a binary outcome (present or absent).151,152 
Delirium severity  
 
 
 
Confusion Assessment Method (CAM) 
149 
An additive score for six items of the CAM (inattention, disorganized thinking, 
disorientation, memory impairment, perceptual disturbances, and 
psychomotor agitation/ retardation), scored as “absent” (0 points), present in 
mild form (1 point), or present in severe form (2 points). The seventh item, 
altered level of consciousness, will be scored as alert (0 points), vigilant or 
lethargic (1 point), and stupor or coma (2 points). Scores range 0 - 14, with a 
higher score indicating greater severity of delirium.153 
Mood and Behavior 
Depression 
Cornell Scale for Depression in 
Dementia (CSDD)154,155 
A 19-item survey designed to assess depressive symptoms in individuals 
with dementia.154, 155 There is sufficient evidence of reliability and validity.155 
NPS 
Brief Neuropsychiatric Inventory   
(NPI-Q)156 
A 12-item, reliable, validated informant-based assessment of 
neuropsychiatric symptoms and associated caregiver distress. 156 

Page 20 of 48 (V.06/27/2016) 
 
The following outcome measure  data collection will be initiated  within 72 hours of discharge (T1), and 2 month (T2) 
and 6 month post-discharge (T3), by research evaluators via interview of the patient/family CG 
Family Caregiver Outcome Measures- collected for both control and intervention group. 
Aim 2: Evaluate the impact of Fam-FFC on Family CG-centered outcomes.  
All measures are self-rated and will be initiated within: 72 hours of discharge (T1), 2 (T2) and 6 months post-discharge (T3). This data 
is collected via pen/paper tools completed by family CG.  
Measure  
Tool   
Description  
Preparedness for 
caregiving  
Preparedness for Caregiving 
Scale 157 
An 8-item instrument that asks caregivers how well prepared they believe 
they are for multiple domains of caregiving: physical care and emotional 
support, setting up support services, dealing with the stress of caregiving. 
Items are rated 0 (not at all prepared) to 4 (very well prepared); shows very 
good reliability and internal consistency,157 including in family CGs of 
hospitalized persons with dementia.59   
Caregiver Strain 
Modified Caregiver Strain Index 
(CSI)158 
A 13-question tool that measures strain (financial, physical, social, 
psychological, and personal) related to care provision, with excellent 
internal consistency and reliability.158,159 
Caregiver Burden  
Zarit Burden Interview (ZBI-12)160 
short version  
12-item tool that measures caregiver perception of burden has shown high 
internal consistency and discriminative ability in caregivers of persons with 
dementia.160,161 
Desire to Institutionalize  
Desire to Institutionalize Scale162 
6-item scale with moderate reliability; Cronbach alpha = 0.694.162 
 
Nurse Champion Interviews: For the exploratory aim of assessing the cultural appropriateness of the intervention, 
the six nurse champions (intervention units) will be consented and interviewed, using a semi-structured interview guide, 
after the study ends in his/her particular unit/setting to provide their perspective. Qualitative content analysis of 
audiotaped, transcribed interviews will be conducted.  The research evaluators will be trained to conduct these 
interviews. 
 
Staff Nurse Interviews: Staff nurses will also be recruited at the end of the intervention at each study site, to participate 
in a focus group to determine their views on the effectiveness and sustainability of the intervention. We anticipate 
having 6-8 nurses per site (representing all three intervention units). This number is based upon our past experience 
recruiting for focus groups in this type setting, and the expected number to reach data saturation. However, if more 
than nurses volunteer/ want to participate, and/or the responses indicate the need to elicit more participation, we will 
add focus groups at the site.   The PI and a member of the research team will conduct these interviews.  
 
Family CG interviews: For the exploratory aim of assessing the cultural appropriateness of the intervention, we will 
recruit family CGs who self-identify as black, Latino, Asian and white, randomly selected from the Fam-FFC 
(intervention) sample. Approximately 10 percent of families from each ethnic group represented in the study will be 
approached for consent for participation in these interviews.  Qualitative content analysis of audiotaped, transcribed 
interviews will be conducted at the six-month post-hospital discharge visit.  A draft semi-structured interview guide will 
be refined with the input of a hospital patient /family council. Additional COVID-19 questions be asked during interview 
of the family CG. The research evaluators will be trained to conduct these interviews. 
 
Cost Outcomes Aim3: Evaluate the relative costs for Fam-FFC v. control condition; calculate health care cost (post- 
acute health care utilization) and total cost savings for Fam-FFC.  We have developed cost-related data collection 
forms, specifically Activity Diaries, to help facilitate data collection for the champions, research nurse facilitators, and 
staff.  These include staff and research nurse time and hours worked, training time (including replacement), supplies, 
and incentives.  Post –acute utilization will be evaluated with a cumulative count of emergency room visits, 
number/days of hospitalizations, and long-term nursing home admissions six months after discharge, obtained from 
questioning of the family at each point of data collection.  Health care unit charges and reimbursement rates will be 
obtained from yearly publications from the American Hospital Associations and other health data organizations. 
Treatment Fidelity. Treatment fidelity will be evaluated with regard to delivery of the intervention, receipt, and 
Adverse Events 
Report of falls, hospitalizations, 
transfers to the emergency 
department  
A monthly check of the patient hospital record to evaluate for 
hospitalizations/ED visits (in addition to the family caregiver 
report at month 2 and month 6).  

Page 21 of 48 (V.06/27/2016) 
enactment163,164  as shown in Table 5. Assessment of Environment and Policy will be conducted by the Fam-FFC Research 
Nurse with champions as part of the intervention (See Component 1).59 Knowledge of  Fam-FFC is a valid and reliable 15- 
item paper and pencil multiple choice exam that tests staff knowledge about Fam-FFC.59 The Goal Attainment Scale 119  
evaluates attainment of up to four patient goals and will be completed by the Fam-FFC Research Nurse with input from 
CGs, champions, nursing staff, and other health care professionals who work with the patient.  This will be reviewed at 
discharge and post-discharge data collection points. The FamPath Audit tracks delivery of FamPath and Family CG 
Activity Logs monitor CG involvement and agreement with the care plan. The Function Focused Care Behavior Checklist 
(FFC-BC)120 is a valid and reliable objective measure including a 19-item checklist reflecting nursing staff performance of 
Fam- FFC. Oversight of treatment fidelity will be provided by the co-investigator (BR) who will collaborate with the 
research team to ensure adherence to the study manual of operations and standardization across sites. See below for a 
comparison of treatment fidelity for treatment and control sites. 
 
 
 
 
7.3 
Duration of Participation 
Describe the duration of an individual subject’s participation in the study. 
 
Six months (with a potential two week extra to complete data collection.) 
 
7.4 
Test Article(s) (Study Drug(s) and/or Study Device(s)) 
 
7.4.1 Description 
Provide a brief description of all test articles (drugs (including any foods and dietary 
supplements), devices and/or biologics used in the research including the purpose of their use 
and their approval status with the Food and Drug Administration (FDA). Include information 
about the form of the drug product (e.g., tablets, capsules, liquid). 
The experimental condition, Fam-FFC, will be coordinated and implemented by a Family-
centered Function Focused Care Nurse (Fam-FFC Nurse), who will work in the treatment units 20 
hours a week for 14 months to implement the four components of the intervention. In addition, 
the sites will identify two members of the nursing staff from each unit (one for day and one for 
evening shift) to be Family-centered Function Focused Function Focused Care Champions (Fam-
FFC Champions). The four components of Fam-FFC include: Component I- Environmental and 
Policy Assessments; Component II- Education and Training of Nursing Staff; Component III-
Ongoing Training and Motivation of Nursing Staff. The Fam-FFC Nurse will work with the 
champions to mentor and motivate nursing staff (RN, LPN, nursing assistants) to provide Fam-
FFC by: (a) role modeling Fam-FFC, reinforcing performance of and benefits of Fam-FFC, and 
brainstorming about ways to overcome challenges; (b) highlighting staff role models and 
 Treatment Fidelity (Bolded items: both treatment and control sites; items not bolded: treatment site only) 
Focus  
Data  (Appendix B) 
Evidence of Treatment Fidelity 
Delivery  
Environment/Policy Assessments 59, 60 
(Component I) 
Completion of assessments by Fam-FFC Research Nurse 
Education: Percentage of nurses 
exposed  (Component II) 
80% of all nursing staff working on participating nursing units (# 
exposed/total # nursing staff) 
Goal Attainment Forms 119 (Comp. III) 
Forms completed on all recruited patients in treatment units 
Fam-Path Audit  (Component IV) 59, 60 
Completion of: bedside goals and treatment plans, discharge checklist, post-acute 
follow-up and plan update, communication with post-acute provider    
Receipt 
Knowledge of Fam-FFC Test 59, 60 
Mean score of > 80% among nursing staff after Education 
Environment/Policy Assessments 59, 60 
Evidence of change(s) made over the course of the study 
Goal Attainment Scale 119 
Positive goal attainment scores incorporated into care plans 
Enactment 
FFC Behavior Checklist 59, 60, 120 
Performance of Fam-FFC by nurses based on observations of care interactions in 
the hospital  
Family CG Activity Logs 59, 60 
Family CG involvement in care and follow-through on plan. 

Page 22 of 48 (V.06/27/2016) 
positive opinion leaders; and (c) eliminating the influence of negative opinion leaders; 
Component IV Implementation of the FamPath Care Pathway which includes: (a) information on 
the admitting condition, diagnostics, and treatment, (b) family/patient education, (c) transitional 
hand-off to post-acute providers, and (d) post-acute follow-up to provide ongoing education and 
modification of the function-focused care plan.   
       The Attention Control condition (Fam- FFC Ed-only) consists of Component II, education of 
the nursing staff in participating hospital units (exactly as offered in treatment sites), and 
education of CGs about hospital orientation and reinforcement of discharge teaching 
(medications/treatments, medical follow-up). Research staff not familiar with Components I, III 
and IV will deliver the staff and CG education per manualized protocol. 
 
 
7.4.2 Treatment Regimen 
Describe dose, route of administration and treatment duration. Include information about dose 
adjustments. 
 
The intervention begins during hospitalization. Post -acute follow-up will provide ongoing 
education and modification of the function-focused care plan (contact within 72 hours of 
discharge, weekly telephone calls for a total of 7 additional weeks, then monthly for 4 months).  
 
7.4.3 Method for Assigning Subject to Treatment Groups 
Describe the randomization process and how the associated treatment assignment will be 
made. 
 
After the hospitals are randomized to the time cohort, within each six hospitals the two 
inpatient units will be randomly assigned so that one unit will receive Fam-FCC and the other 
unit will receive Staff-Ed (control) intervention. Random assignment will be completed by the 
statistician using SAS proc plan which specifically allows simultaneous randomization on 
multiple dimensions (time and units) as well as counterbalancing across units. 
 
7.4.4 Subject Compliance Monitoring 
Insert the procedures for monitoring subject compliance. 
 
 
Treatment Fidelity. Treatment fidelity will be evaluated with regard to delivery of the intervention, 
receipt, and enactment. 163,164 Assessment of Environment and Policy will be conducted by the Fam-FFC 
Research Nurse with champions as part of the intervention (See Component 1).59 Knowledge of  Fam-
FFC is a valid and reliable 15- item paper and pencil multiple choice exam that tests staff knowledge 
about Fam-FFC.59 The Goal Attainment Scale 119  evaluates attainment of up to four patient goals and 
will be completed by the Fam-FFC Research Nurse with input from CGs, champions, nursing staff, and 
other health care professionals who work with the patient.  This will be reviewed at discharge and post-
discharge data collection points. The FamPath Audit tracks delivery of FamPath and Family CG Activity 
Logs monitor CG involvement and agreement with the care plan. The Function Focused Care Behavior 
Checklist (FFC-BC) 120 is a valid and reliable objective measure including a 19-item checklist reflecting 
nursing staff performance of Fam- FFC. Oversight of treatment fidelity will be provided by the co-
investigator (BR) who will collaborate with the research team to ensure adherence to the study manual 
of operations and standardization across sites. 
 
7.4.5 Blinding of the Test Article 
Describe how the test article is blinded. 
 

Page 23 of 48 (V.06/27/2016) 
To ensure comparable samples in both the treatment and control condition participants will be blinded 
to treatment arm prior to consent, since the Fam-FFC treatment requires more effort that the control 
condition. 
 
7.4.6 
Receiving, Storage, Dispensing and Return  
 
7.4.6.1 
Receipt of Test Article  
Describe how the test article will be obtained and from what source. Describe 
how the study test article will be packaged along with amounts (e.g., number of 
tablets/capsules or volume of liquid) and labeling. If drug kits are used, describe 
all the contents of the kit and associated labeling. 
 
n/a 
 
7.4.6.2 
Storage 
Describe the plans to store, handle the test article so they will be used only on 
subjects and only by authorized investigators. Describe storage temperature 
requirements and how temperature will be monitored and recorded. 
 
n/a 
 
7.4.6.3 
Preparation and Dispensing 
Describe how the test article will be assigned to each subject and dispensed. 
Describe the steps necessary to prepare the test article. Include where the test 
article preparation will be done and by whom. Fully describe how the study 
treatment is to be administered and by whom. 
 
n/a 
 
7.4.6.4 
Return or Destruction of the Test Article 
Describe the procedures for final reconciliation of the test article supply at the 
end of the study and whether the test article is to be shipped back to a source 
or destroyed on site. 
 
n/a 
 
7.4.6.5 
 Prior and Concomitant Therapy 
Describe what prior and/or concomitant medical therapy will be collected. 
Describe which concomitant medicines/therapies are permitted during the 
study. Describe which concomitant medicines are not permitted during the 
study. 
 
n/a 
 
8.0 
Subject Numbers and Statistical Plan 
 

Page 24 of 48 (V.06/27/2016) 
8.1 
Number of Subjects 
Indicate the total number of subjects to be accrued.  
 
If applicable, distinguish between the number of subjects who are expected to be enrolled and 
screened, and the number of subjects needed to complete the research procedures (i.e., numbers of 
subjects excluding screen failures.) 
 
We expect to screen 1000 dyads (patients/caregivers) and enroll  458-468.  
We plan to enroll ten nurse champions (2 per intervention unit, a high estimate with a plan for 
replacement if needed).  
We plan to enroll approximately 6-8 nurses for focus groups from each intervention unit at the 
conclusion of the intervention, with a high estimate of a total of 35 nurses.  This number is based upon 
our past experience recruiting for focus groups in this type setting, and the expected number to reach 
data saturation. However, if more than nurses volunteer/ want to participate, and/or the responses 
indicate the need to elicit more participation, we will add focus groups at the site.   
 
We will oversample by 20- 30 patients in order to continue promoting diversity.   
 
8.2 
Sample size determination 
If applicable, provide a justification of the sample size outlined in section 8.1 – to include reflections on, 
or calculations of, the power of the study. 
 
We target a total sample size of 438 with 73 per inpatient unit is sufficient to detect an intervention 
effect comparable to the observed effect size in our pilot study, with 80% statistical power assuming a 
20% attrition rate.  
 
Our last site afforded us the opportunity to increase diversity; we will oversample by 20-30 patients in 
order to continue promoting diversity.   
 
8.3 
Statistical methods 
Describe the statistical methods (or non-statistical methods of analysis) that will be employed. 
       Aim 1: Validate the efficacy of Fam-FFC on physical function (ADLs/ performance and physical activity), 
delirium occurrence and severity, behavior, and mood. For each outcome, an appropriate mixed effects model 
(either a LME or a GLMM) will be identified for model fitting. For delirium occurrence (a binary variable) we will 
use generalized linear mixed models with a logistic link function. The primary independent variables will be 
GROUP (Fam FCC v. control), TIME (day of admission, day of discharge, 2-month post discharge and 6-month 
post discharge) and SITE (for the three hospitals). The TIME x GROUP interaction will be tested for differential 
rate of change in the outcome.  The GROUP x SITE interaction will be tested for heterogeneous center effects. 
Three-level models using an unstructured correlation will be fitted for the repeated measures within individuals 
who are nested within the same inpatient unit.181-184 Time will be modeled continuously using day since 
admission so that trajectories can vary across individuals depending on time spent in the inpatient unit. This also 
allows us to examine non-linear time functions (e.g., quadratic) that allow the rate of change to vary over the 
different intervals. Covariates identified from the baseline analyses will be included in the mixed model to adjust 
for their influences. We will also consider interactive effects among demographic variables of interest (e.g., age, 
gender of patient and caregiver, ethnicity) and treatment condition to identify moderators of the treatment 
effects. Bootstrap methods will be applied to the mixed effects models in addition to the Wald test and the 
likelihood  ratio test within the mixed effects models.185-187 Subject level propensity score matching will be 
applied to improve the statistical power of the planned hypothesis tests.175 To address the multiple endpoints 
issue in this trial,  P<0.05 for the primary hypothesis and then multiple testing procedures such as closed testing 
implemented in PROC MULTTEST will be applied to adjust p values.188-190  
       Aim 2: Evaluate the impact of Fam-FFC on family CG-centered outcomes (family CG preparedness for 
caregiving, strain, burden, and desire to institutionalize). LME similar to Aim 1, will be used. 

Page 25 of 48 (V.06/27/2016) 
      Aim 3: Evaluate the relative costs for Fam-FFC v. control condition, and calculate health care and total cost 
savings for Fam-FFC. Standard micro-costing methods will be used to estimate costs. Using the guidelines 
offered by Chatterji and colleagues,191 total intervention costs will be based on expenditures/outlays for each of 
the following: (1) intervention; (2) consultant fees; (3) personnel costs, (4) incentives, meals, travel for study 
participants; (5) utilities, maintenance, security and other operating costs; and (6) administrative costs. We will 
identify all of the “inputs” that go into the implementation and then assign unit costs to these inputs 
(wages/salaries acquired from the unit managers, cost of materials, etc.). Then, we will multiply the units of 
inputs by their unit costs and sum this across all of inputs to determine the total cost of implementation per 
setting. An average across all settings will then be calculated.  To estimate the cost of healthcare for each group, 
we will collect unit costs from existing literature including data published yearly by the American Medical 
Association, the American Hospital Association, the National Hospital Discharge Survey, and the American 
Managed Behavioral Healthcare Association.  Similarly, these unit cost estimates for each type of health care 
utilization (emergency room, hospital and long-term nursing home admissions) will then be multiplied by the 
number of units used by each individual in the sample.  A variable will be created for total health care cost by 
summing across conditions while exercising care to avoid any double counting of services.  Health care and total 
cost savings will be calculated for each treatment condition. Mean costs and savings will be computed and 
subsequently tested for statistical significances across conditions using a t-test. In calculating cost we will also 
take into account fixed versus variable costs adjusting for variation over time in wages, benefits, and supplies 
using a standard micro-costing approach. We will then use multivariable regressions to determine whether Fam-
FCC is significantly related to lower costs of healthcare and total cost savings controlling for covariates.  
Moreover, we will compare health care costs in terms of changes over time with paired t-test (within group 
differences) and with parametric Analysis of Variance (between group differences). 
 
Assessment of the cultural appropriateness of Fam-FCC for diverse families in our sample: We employ the 
Ecological Model (EM) originally developed by Bernal and colleagues as a framework to assess the cultural 
appropriateness of the Fam-CC intervention192,193 and to refine Fam-FCC for future studies. See below for 
analysis plan.  
EM Model Component  
Sample/Data Source  
Analysis 
I. Family-CG experiences of EM model 
constructs (categories 1,3,4,5,6,8) 
 
Caregivers who self-identify as black, Latino, Asian and white 
will be randomly selected (Approximately 10% of families 
from each ethnic group; if theoretical saturation is not 
reached, interviews will continue until saturation is reached.)  
A draft semi-structured interview guide will be refined with 
the input of a hospital patient /family council. 
Qualitative content analysis of audiotaped, 
transcribed interviews conducted at the six-month 
post-hospital discharge contact. Trustworthiness194 is 
enhanced by the team’s methodological expertise, 
random sampling, rigorous analytic approaches, 
member checking, and a detailed audit trail. 
II. Nurse champion experiences of EM 
model constructs (categories 
1,3,4,5,6,8) 
The six champions (2 per setting) will be interviewed using a 
semi-structured interview guide.  
Qualitative content analysis of audiotaped, 
transcribed interviews at conclusion of intervention at 
each site.  
III. Evaluation of measures for reliability 
and validity for the ethnic groups  
represented in the study (category 7) 
1)The internal consistency of the caregiver outcome 
measures as well as relationships with known correlates 
(e.g., educational level) will be evaluated in the first 20 
Spanish-speaking respondents and 2) Both content and face 
validity of each measure will be discussed in participant 
interviews outlined in Component I above.  
Cronbach’s alphas for caregiver outcomes will be 
assessed. 
The participants will be asked to assess their 
perceptions of measures and identify potential 
cultural gaps in measurement content in Component I 
above. 
IV. Assessment of whether ethnic 
concordance moderates the 
relationship between treatment group 
and patient/ family outcomes (category 
2). 
The ethnicities of nurse champions and each family will be 
documented as concordant or not.  
 
Concordance will potentially be used as a covariate 
in analyses for specific aims 1, 2. 
 
 
9.0 
Confidentiality, Privacy and Data Management  
For research being conducted at Penn State Hershey or by Penn State Hershey researchers only, the research 
data security and integrity plan is submitted using “HRP-598 – Research Data Plan Review Form Application 
Supplement”, which is available in the Library in CATS IRB (http://irb.psu.edu).  Refer to Penn State College of 
Medicine IRB’s “Standard Operating Procedure Addendum: Security and Integrity of Human Research Data”, 
which is available on the IRB’s website. In order to avoid redundancy, for this section state “See the Research 

Page 26 of 48 (V.06/27/2016) 
Data Plan Review Form” in section 9.0 if you are conducting Penn State Hershey research and move on to 
section 10.  
 
For all other research, in the sections below, describe the steps that will be taken to secure the data during 
storage, use and transmission. 
 
9.1 
Confidentiality 
// 
9.1.1 
Identifiers associated with data and/or specimens 
List the identifiers that will be included or associated with the data and/or specimens in any way 
(e.g., names, addresses, telephone/fax numbers, email addresses, dates (date of birth, 
admission/discharge dates, etc.), medical record numbers, social security numbers, health plan 
beneficiary numbers, etc.).   
 
If no identifiers will be included or associated with the data in any way, whether directly or 
indirectly, please indicate this instead.   
 
All data will be coded with an arbitrary subject number to allow for linking of data over time. 
The linkage to individual names will be kept in a locked file in the project office. Additionally, we 
plan to follow up with post-acute visits after discharge. Thus we will collect information on the 
discharge date, discharge location/address, and family caregiver telephone number, and email.  
We will maintain a separate file of this information, which will include names and ID number, 
maintained in a separate file on RedCap or HIPAA-secure BOX so research evaluators can access,  
and a separate hard copy file in a locked cabinet in the research office.  
 
9.1.1.1 Use of Codes, Master List 
If identifiers will be associated with the data and/or specimens (as indicated in 
section 9.1.1 above), describe whether a master record or list containing a code 
(i.e., code number, pseudonyms) will be used to separate the data collected 
from identifiable information, where that master code list will be stored, who 
will have access to the master code list, and when it will be destroyed.  
 
If identifiers are included or associated with the data as described in section 
9.1.1 above, but no master record or list containing a code will be used, it will be 
assumed by the IRB that the investigator plans to directly link the identifiers 
with the data.    
 
 
 
 
 
Identifying information (name, address, telephone number, email, discharge date)  
 
 
 
along with the study ID number will be maintained in a separate master file (on secure   
 
 
 
server and locked file), not linked to the data.  Only the project manager and research   
 
 
 
evaluators will have access to this information.  Master files/codes will be deleted/ destroyed  
 
 
 
three years after the conclusion of the study.    
 
9.1.2 
Storage of Data and/or Specimens 
Describe where, how and for how long the data (hardcopy (paper) and/or electronic data) 
and/or specimens will be stored. NOTE: Data can include paper files, data on the internet or 
websites, computer files, audio/video files, photographs, etc. and should be considered in the  
responses.  Refer to the “Investigator Manual (HRP-103)” for information about how long 
research records must be stored following the completion of the research prior to completing 
this section. HRP-103 can be accessed by clicking the Library link in CATS IRB 
(http://irb.psu.edu).  
 

Page 27 of 48 (V.06/27/2016) 
Please review Penn State’s Data Categorization Project for detailed information regarding the 
appropriate and allowable storage of research data collected according to Penn State Policy 
AD71. Although the IRB can impose greater confidentiality/security requirements (particularly 
for sensitive data), the IRB cannot approve storage of research data in any way or using any 
service that is not permissible by Penn State Policy AD71.   
 
The RedCap system, an electronic system used by universities worldwide, will be used for both 
data entry and data storage. The RedCap system will be accessed via the Penn State Clinical and 
Translational Science Institute (CTSI). RedCap is HIPAA compliant, with all data stored on a 
secure server, and encrypted. Data entry modules and stored data access is password protected 
and based on the individual’s role on project. RedCap provides logging and audit trails on all 
data interactions.  Consents and enrollment tracking, and contact information will be stored on 
a secure server (HIPAA compliant Box or RedCap) Hard copies of data will be stored in a locked 
cabinet in a locked office.  We will store data for six years.  
 
Consistent with NIH’s Certificate of Confidentiality, the researchers  will not disclose or use 
information, documents, or biospecimens that may identify subjects in any federal, state, or 
local civil, criminal, administrative, legislative, or other action, suit, or proceeding, or be used as 
evidence, for example, if there is a court subpoena, unless study subjects have consented for 
this as participants about the protections afforded by the Certificate and any exceptions to that 
protection. Information, documents, or biospecimens will not be disclosed to anyone else who is 
not connected with the research except, if there is a federal, state, or local law that requires 
disclosure (such as to report child abuse and neglect, elder mistreatment, harm to self or others, 
or communicable diseases but not for federal, state, or local civil, criminal, administrative, 
legislative, or other proceedings),  if subjects have consented to the disclosure, including for 
medical treatment; or if it is used for other scientific research, as allowed by federal regulations 
protecting research subjects.   
 
The researchers will comply with requests for information from personnel of the National 
Institute of Health which is funding this project. 
 
The audio recording is uploaded into PSU BOX (approved for PHI) immediately and then 
transferred to the transcription service. Within 72 hours, the transcription is reviewed for 
accuracy and the recording is deleted from the device. The transcriptions will be destroyed 6 
years after the completion of this evaluation. 
 
9.1.3 
Access to Data and/or Specimens 
Identify who will have access to the data and/or specimens. This information should not conflict 
with information provided in section 9.1.1.1 regarding who has access to identifiable 
information, if applicable.    
 
Only the Project Manager and data collectors/evaluators will have access to participant 
names/identifying information.  The investigators and other members of the research team will 
have access only to de-identified data.  
 
9.1.4 
Transferring Data and/or Specimens 
If the data and/or specimens will be transferred to and/or from outside collaborators, identify 
the collaborator to whom the data and/or specimens will be transferred and how the data 
and/or specimens will be transferred. This information should not conflict with information 
provided in section 9.1.1.1 regarding who has access to identifiable information, if applicable. 
 
Data will not be transferred.  Only the investigators and members of the research team will 
access data via a secure server.  

Page 28 of 48 (V.06/27/2016) 
 
9.2 
Subject Privacy 
This section must address subject privacy and NOT data confidentiality. 
 
Indicate how the research team is permitted to access any sources of information about the subjects.  
 
Describe the steps that will be taken to protect subjects’ privacy interests. “Privacy interest” refers to a 
person’s desire to place limits on whom they interact with or to whom they provide personal information. 
 
Describe what steps you will take to make the subjects feel at ease with the research situation in terms 
of the questions being asked and the procedures being performed. “At ease” does not refer to physical 
discomfort, but the sense of intrusiveness a subject might experience in response to questions, 
examinations, and procedures. 
 
Data will be obtained in a private area within the setting and all data will entered into RedCap data 
collection system. The only way to access the RedCap database is to have permission from Penn State 
Hershey. Only the study team will have access to this data on the RedCap server.  
 
Participants in the focus groups and interviews will not provide any identifiable data. Members of the 
research team will have access to the data. 
 
10.0 Data and Safety Monitoring Plan 
This section is required when research involves more than Minimal Risk to subjects. As defined in “SOP: 
Definitions (HRP-001)”, available in the Library in CATS IRB (http://irb.psu.edu), Minimal Risk is defined as the 
probability and magnitude of harm or discomfort anticipated in the research that are not greater in and of 
themselves than those ordinarily encountered in daily life or during the performance of routine physical or 
psychological examinations or tests.  For research involving prisoners, Minimal Risk is the probability and 
magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine 
medical, dental, or psychological examination of healthy persons. Please complete the sections below if the 
research involves more than minimal risk to subjects OR indicate as not applicable.   
 
We will have a DSMB and this information is located in the supporting documents. 
 
10.1 
Periodic evaluation of data 
Describe the plan to periodically evaluate the data collected regarding both harms and benefits to 
determine whether subjects remain safe. 
 
n/a 
 
10.2 
Data that are reviewed 
Describe the data that are reviewed, including safety data, untoward events, and efficacy data. 
 
n/a 
 
10.3 
Method of collection of safety information 
Describe the method by which the safety information will be collected (e.g., with case report forms, at 
study visits, by telephone calls and with subjects). 
 
n/a 
 
10.4 
Frequency of data collection 
Describe the frequency of data collection, including when safety data collection starts. 

Page 29 of 48 (V.06/27/2016) 
 
n/a  
 
10.5 
Individuals reviewing the data 
Identify the individuals who will review the data. The plan might include establishing a data and safety 
monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the 
sponsor. 
 
n/a 
 
10.6 
Frequency of review of cumulative data 
Describe the frequency or periodicity of review of cumulative data. 
 
n/a 
 
10.7 
Statistical tests 
Describe the statistical tests for analyzing the safety data to determine whether harms are occurring. 
 
n/a] 
 
10.8 
Suspension of research 
Describe any conditions that trigger an immediate suspension of research. 
 
n/a] 
 
 
11.0 Risks 
List the reasonably foreseeable risks, discomforts, hazards, or inconveniences to the subjects related the 
subjects’ participation in the research.  For each potential risk, describe the probability, magnitude, duration, 
and reversibility. Consider all types of risk including physical, psychological, social, legal, and economic risks. If 
applicable, indicate which procedures may have risks to the subjects that are currently unforeseeable. If 
applicable, indicate which procedures may have risks to an embryo or fetus should the subject be or become 
pregnant. If applicable, describe risks to others who are not subjects. 
 
Please keep in mind that loss of confidentiality is a potential risk when conducting human subject research and 
should be addressed as such.  
 
Risks associated with survey and observational data collection for patients in this study includes some concerns 
about privacy and embarrassment. The collection of actigraphy data from the MotionWatch may be mildly 
uncomfortable for participants, similar to the sensation of wearing a watch. Lastly, the patient may experience 
some stress completing study-related activities while trying to participate optimally in treatments and 
assessments that occur as part of hospital care.  Research evaluators will be members of the research team, 
with health-related and/or research-related experience.  We will train the research evaluators on safety 
precautions, including fall prevention and signs of patient stress. We also will train them on communicating with 
persons with dementia and their family caregivers.  
 
Family CGs may also experience embarrassment, emotional discomfort, and increased stress. We will train 
research evaluators on observing for signs of distress and preventive strategies (e.g., pacing, active listening, and 
flexibility in scheduling study activity).  The evaluators will be trained for to observe for, detect, and report signs 
of depression and suicidal ideation in both patients and family CGs.   
 

Page 30 of 48 (V.06/27/2016) 
There is also a potential risk of a loss in confidentiality since patients/family CGs are sharing personal 
information with the study staff. Several measures will be taken to safeguard personal information: 1) All study 
documents will be coded with a special identifier number; 2) study data will be stored on a secured electronic 
system (RedCap) which can be accessed only by the study team; and 3) study related interviews will take place 
in a private setting, away from others; and 4) information provided by participating in this study will not be 
shared with the facility staff or administration. 
 
During interviews and focus groups, nurse champions and staff nurses respectively, may experience stress, 
embarrassment, or the feeling that they need to offer only positive comments about the intervention. We will 
train evaluators on techniques to support the participants’ comfort and emphasize the need to identify any 
needed improvements in the intervention. We will schedule interviews and focus groups at a time convenient.  
Releases for using audio recordings will be secured since such recordings cannot be entirely de-identified.  
Participants will be informed that the purpose of the interviews and focus groups will be to evaluate the 
intervention, not the hospital or unit, and results will not be shared with the facility. Nurses who participate in 
focus groups and interviews that confidentiality cannot be assured.  
 
We will protect the rights of the patients, family CGs and champions to refuse to participate in, or withdraw 
from, the research without penalty and to have an opportunity to communicate directly with the researchers 
about their participation should they have any concerns.  The informed consent preamble will provide 
participants with a way to reach the researchers directly.  Participant data will not be shared with administrators 
except in the aggregate.  
 
12.0 Potential Benefits to Subjects and Others 
 
12.1 
Potential Benefits to Subjects 
Describe the potential benefits that individual subjects may experience from taking part in the research. 
If there is no direct benefit to subjects, indicate as such. Compensation is not considered a benefit. 
Compensation should be addressed in section 14.0. 
 
Potential benefits to patients include improved functional performance, less delirium, less inappropriate 
psychotropic medication use, improved behavioral symptoms, and less hospital readmissions and 
admissions to a nursing home for long-term stay. Family CGs may experience decreased burden/strain 
and improved skills in sharing information, making decisions, advocating, coordinating, and providing 
direct care related to function-promoting care, during and after hospitalization. Nursing staff will learn 
skills in communicating and motivating patients with dementia and gain knowledge around alternatives 
to restrictive interventions when managing fall prevention and behavioral manifestations of distress. 
They will also learn how to promote function and physical activity and how to support family CG 
effectiveness through sound communication, information-sharing, and partnership, including shared 
decision-making. In addition, the nurses will learn that providing Fam-FFC does not place patients at risk 
for adverse events (e.g., falls) and may save nurses time by decreasing time spent doing tasks that 
patients can perform themselves or with less assistance. Our intervention also views the acute illness of 
the person with dementia across settings, offering approaches that may have long-term positive effects 
on the person with dementia. 
 
12.2 
Potential Benefits to Others 
Include benefits to society or others.  
 
Fam-FFC has the potential to reduce poor health outcomes that are major sources of today’s spiraling 
health care costs. This study will have direct implications for clinical practice and informing policy 
related to effective care delivery for persons with dementia in acute care, a neglected area of research 
and program development. The societal implications of helping older individuals with dementia avoid 
functional decline, adverse events, long-term nursing home admissions, and hospitalizations are 

Page 31 of 48 (V.06/27/2016) 
enormous in terms of aging in place, quality of life, cost, and caregiver burden. Further this study will 
provide information about the theoretical utility of using Social Ecological Models, Social Cognitive 
Theory to facilitate behavior change related to optimizing function and physical activity in real world 
clinical settings. These findings will be relevant for other areas of behavior change research in acute 
care. 
 
13.0 Sharing Results with Subjects 
Describe whether results (study results or individual subject results, such as results of investigational diagnostic 
tests, genetic tests, or incidental findings) will be shared with subjects or others (e.g., the subject’s primary care 
physicians) and if so, describe how it will be shared. 
 
Results will not be shared with individuals. We will share full study results with facility leadership and they can 
determine if they would like to disseminate findings to staff. 
 
14.0 Subject Stipend (Compensation) and/or Travel Reimbursements 
Describe the amount and timing of any subject stipend/payment or travel reimbursement here. If there is no 
subject stipend/payment or travel reimbursement, indicate as not applicable.  
 
If course credit or extra credit is offered to subjects, describe the amount of credit and the available alternatives. 
Alternatives should be equal in time and effort to the amount of course or extra credit offered. 
 
If an existing, approved student subject pool will be used to enroll subjects, please indicate as such and indicate 
that course credit will be given and alternatives will be offered as per the approved subject pool procedures.  
 
We will offer a modest honorarium ($20 gift card) to family caregivers at discharge from the hospital, month 2 
and month 6.  
 
15.0 Economic Burden to Subjects 
 
15.1 
Costs  
Describe any costs that subjects may be responsible for because of participation in the research. 
 
Participants will not incur any additional costs for the intervention above what their hospital costs are. 
15.2 
Compensation for research-related injury 
If the research involves more than Minimal Risk to subjects, describe the available compensation in 
the event of research related injury. 
 
If there is no sponsor agreement that addresses compensation for medical care for research subjects 
with a research-related injury, include the following text as written - DO NOT ALTER OR DELETE: 
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Costs for the treatment of research-related injuries 
will be charged to subjects or their insurance carriers.  
 
For sponsored research studies with a research agreement with the sponsor that addresses 
compensation for medical care for research-related injuries, include the following text as written - DO 
NOT ALTER OR DELETE: 
It is the policy of the institution to provide neither financial compensation nor free medical treatment 
for research-related injury. In the event of injury resulting from this research, medical treatment is 
available but will be provided at the usual charge. Such charges may be paid by the study sponsor as 
outlined in the research agreement and explained in the consent form. 

Page 32 of 48 (V.06/27/2016) 
 
n/a. The research involves minimal risk  
16.0 Resources Available 
 
16.1 
Facilities and locations 
Identify and describe the facilities, sites and locations where recruitment and study procedures will be 
performed.  
 
If research will be conducted outside the United States, describe site-specific regulations or customs 
affecting the research, and describe the process for obtaining local ethical review. Also, describe the 
principal investigator’s experience conducting research at these locations and familiarity with local 
culture. 
 
We will recruit from six medical or medical/surgical units of three hospitals in Philadelphia, 
Pennsylvania.   
 
16.2 
Feasibility of recruiting the required number of subjects 
Indicate the number of potential subjects to which the study team has access.  Indicate the percentage 
of those potential subjects needed for recruitment. 
 
We estimate that approximately 7.5 patients per week on average will be eligible for the study 
in the study units.  Based on our past recruitment/ enrollment activity 59,60 (24%-97% from the 
eligible pool), we will be able to enroll more than the 1.5/week necessary to meet the required 
sample 
 
16.3 
PI Time devoted to conducting the research 
Describe how the PI will ensure that a sufficient amount of time will be devoted to conducting and 
completing the research. Please consider outside responsibilities as well as other on-going research for 
which the PI is responsible. 
 
The PI has allocated 30% of her time to this study.  
 
16.4 
Availability of medical or psychological resources 
Describe the availability of medical or psychological resources that subject might need as a result of 
their participation in the study, if applicable. 
 
Those family caregivers who screen positive for suicide or demonstrate a high level of depression (score 
15–21) on the Hospital Anxiety and Depression Scale (HADS) subscale will be referred to psychiatry 
services at the participating hospital. This is in the consent form. 
 
16.5 
Process for informing Study Team 
Describe the training plans to ensure members of the research team are informed about the protocol 
and their duties, if applicable. 
 
With regard to testing of patients in the proposed study, we will use a training manual that details how 
to safely complete each measure with cognitively impaired patients. The evaluators are trained to be particularly 
sensitive to any changes in mood/behavior, evidence of fatigue, shortness of breath, acute pain or evidence of a 
desire to stop the assessment in which case the evaluators will stop testing. In the event that the research 
evaluator feels a participant has had an acute change in condition or behavior, all testing will be stopped and the 
evaluator will inform the patient’s nurse. 

Page 33 of 48 (V.06/27/2016) 
Training of evaluators for this study will be conducted by Dr. Boltz and the project manager. Throughout 
the study, Dr. Boltz will be available to provide additional support with training and "on call" availability to 
answer questions for evaluators should they arise. All of the measures utilized have been developed for and/or 
used with cognitively impaired and physically frail older adults and allow for a broad range of function and 
activity. There are response options that include inability to perform an activity or performance of an activity 
with assistance. Thus, patients will not be required to perform an activity beyond his or her capability to safely 
do so. Cardiovascular events associated with performance of activities of daily living and physical activity, 
including moderate intensity physical activity are extremely rare. To prevent and decrease any risk of injury or 
harm during physical activity the Fam-FFC research nurse will work closely with other members of the health 
care team (e. g., physicians, physical therapists) and investigative team members (Drs. Boltz and Resnick) to 
assure that patient goals involve only those activities that can be safely performed. Dr. Boltz will train the Fam-
FFC research nurse in her ability to continually reinforce safety measures throughout the study period. We have 
integrated safety materials into Component II (staff training). Additionally, we have incorporated safety training 
into the family CG education, including fall prevention and general safety considerations. 
The PI and an expert in family health disparities will train the study nurse evaluator to conduct the 
qualitative interviews that assess cultural appropriateness and perceptions/satisfaction. The interview guide will 
be reviewed by a representative group of a patient/family council for content as well as clarity. 
 
17.0 Other Approvals 
 
17.1 
Other Approvals from External Entities 
Describe any approvals that will be obtained prior to commencing the research (e.g., from cooperating 
institutions, community leaders, schools, external sites, funding agencies). 
 
After PSU approval, we will seek approval from the University of Pennsylvania Health System for the 
three participating hospitals 
 
17.2 
Internal PSU Committee Approvals 
 
Check all that apply: 
  Anatomic Pathology – Hershey only – Research involves the collection of tissues or use of pathologic 
specimens. Upload a copy of HRP-902 - Human Tissue For Research Form on the “Supporting 
Documents” page in CATS IRB. This form is available in the CATS IRB Library. 
 
  Animal Care and Use – All campuses – Human research involves animals and humans or the use of 
human tissues in animals 
 
  Biosafety – All campuses – Research involves biohazardous materials (human biological specimens 
in a PSU research lab, biological toxins, carcinogens, infectious agents, recombinant viruses or DNA or 
gene therapy).  
 
  Clinical Laboratories – Hershey only – Collection, processing and/or storage of extra tubes of body 
fluid specimens for research purposes by the Clinical Laboratories; and/or use of body fluids that had 
been collected for clinical purposes, but are no longer needed for clinical use. Upload a copy of HRP-901 
- Human Body Fluids for Research Form on the “Supporting Documents” page in CATS IRB. This form is 
available in the CATS IRB Library. 
 
  Clinical Research Center (CRC) Advisory Committee– All campuses – Research involves the use of 
CRC services in any way.   
 
  Conflict of Interest Review – All campuses – Research has one or more of study team members 
indicated as having a financial interest. 
 

Page 34 of 48 (V.06/27/2016) 
  Radiation Safety – Hershey only – Research involves research-related radiation procedures. All 
research involving radiation procedures (standard of care and/or research-related) must upload a copy 
of HRP-903 - Radiation Review Form on the “Supporting Documents” page in CATS IRB. This form is 
available in the CATS IRB Library. 
 
  IND/IDE Audit – All campuses – Research in which the PSU researcher holds the IND or IDE or 
intends to hold the IND or IDE. 
 
  Scientific Review – Hershey only – All investigator-written research studies requiring review by the 
convened IRB must provide documentation of scientific review with the IRB submission. The scientific 
review requirement may be fulfilled by one of the following: (1) external peer-review process; (2) 
department/institute scientific review committee; or (3) scientific review by the Clinical Research Center 
Advisory committee.  NOTE: Review by the Penn State Hershey Cancer Institute Scientific Review 
Committee is required if the study involves cancer prevention studies or cancer patients, records and/or 
tissues. For more information about this requirement see the IRB website at: 
http://www.pennstatehershey.org/web/irb/home/resources/investigator  
 
18.0 Multi-Site Research 
If this is a multi-site study (i.e., the study will be conducted at other institutions each with its own principal 
investigator) and you are the lead investigator, describe the processes to ensure communication among sites in 
the sections below. 
n/a  
18.1 
Communication Plans 
Describe the plan for regular communication between the overall study director and the other sites to 
ensure that all sites have the most current version of the protocol, consent document, etc.  Describe the 
process to ensure all modifications have been communicated to sites. Describe the process to ensure 
that all required approvals have been obtained at each site (including approval by the site’s IRB of 
record).   Describe the process for communication of problems with the research, interim results and 
closure of the study. 
 
n/a 
 
18.2 
Data Submission and Security Plan 
Describe the process and schedule for data submission and provide the data security plan for data 
collected from other sites.  Describe the process to ensure all engaged participating sites will safeguard 
data as required by local information security policies. 
 
n/a 
 
18.3 
Subject Enrollment 
Describe the procedures for coordination of subject enrollment and randomization for the overall 
project. 
 
 n/a 
 
18.4 
Reporting of Adverse Events and New Information 
Describe how adverse events and other information will be reported from the clinical sites to the overall 
study director. Provide the timeframe for this reporting. 
 
n/a 
 

Page 35 of 48 (V.06/27/2016) 
18.5 
Audit and Monitoring Plans 
Describe the process to ensure all local site investigators conduct the study appropriately. Describe any 
on-site auditing and monitoring plans for the study. 
 
n/a 
 
19.0 Adverse Event Reporting 
 
19.1 
Adverse Event Definitions 
 
For drug studies, incorporate the following definitions into the below responses, as written: 
Adverse event 
Any untoward medical occurrence associated with the use of the drug in 
humans, whether or not considered drug related 
Adverse reaction 
Any adverse event caused by a drug 
Suspected adverse 
reaction 
Any adverse event for which there is a reasonable possibility that the drug 
caused the adverse event.  Suspected adverse reaction implies a lesser degree 
of certainty about causality than “adverse reaction”. 
• 
Reasonable possibility.  For the purpose of IND safety reporting, 
“reasonable possibility” means there is evidence to suggest a causal 
relationship between the drug and the adverse event. 
Serious adverse 
event or Serious 
suspected adverse 
reaction 
Serious adverse event or Serious suspected adverse reaction: An adverse event 
or suspected adverse reaction that in the view of either the investigator or 
sponsor, it results in any of the following outcomes: Death, a life-threatening 
adverse event, inpatient hospitalization or prolongation of existing 
hospitalization, a persistent or significant incapacity or substantial disruption 
of the ability to conduct normal life functions, or a congenital anomaly/birth 
defect. Important medical events that may not result in death, be life-
threatening, or require hospitalization may be considered serious when, based 
upon appropriate medical judgment, they may jeopardize the patient or 
subject and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition.  
Life-threatening 
adverse event or 
life-threatening 
suspected adverse 
reaction 
An adverse event or suspected adverse reaction is considered “life-
threatening” if, in the view of either the Investigator (i.e., the study site 
principal investigator) or Sponsor, its occurrence places the patient or research 
subject at immediate risk of death.  It does not include an adverse event or 
suspected adverse reaction that had it occurred in a more severe form, might 
have caused death. 
Unexpected 
adverse event or 
Unexpected 
suspected adverse 
reaction.   
An adverse event or suspected adverse reaction is considered “unexpected” if 
it is not listed in the investigator brochure, general investigational plan, clinical 
protocol, or elsewhere in the current IND application; or is not listed at the 
specificity or severity that has been previously observed and/or specified. 
 
 
 
For device studies, incorporate the following definitions into the below responses, as written: 
Unanticipated 
adverse device 
effect 
Any serious adverse effect on health or safety or any life-threatening problem 
or death caused by, or associated with, a device, if that effect, problem, or 
death was not previously identified in nature, severity, or degree of incidence 
in the investigational plan or IDE application (including a supplementary plan 
or application), or any other unanticipated serious problem associated with a 
device that relates to the rights, safety, or welfare of subjects. 
 

Page 36 of 48 (V.06/27/2016) 
19.2 
Recording of Adverse Events 
Address the frequency and process for eliciting adverse event information from research subject, e.g., 
“Research subjects will be routinely questioned about adverse events at study visits.” 
 
In the response, incorporate the following as written: 
All adverse events (serious or non-serious) and abnormal test findings observed or reported to study 
team believed to be associated with the study drug(s) or device(s) will be followed until the event (or 
its sequelae) or the abnormal test finding resolves or stabilizes at a level acceptable to the 
investigator. 
 
An abnormal test finding will be classified as an adverse event if one or more of the following criteria 
are met: 
• 
The test finding is accompanied by clinical symptoms 
• 
The test finding necessitates additional diagnostic evaluation(s) or medical/surgical 
intervention; including significant additional concomitant drug treatment or other therapy 
NOTE: Simply repeating a test finding, in the absence of any of the other listed criteria, does 
not constitute an adverse event. 
• 
The test finding leads to a change in study drug dosing or discontinuation of subject 
participation in the clinical research study 
• 
The test finding is considered an adverse event by the investigator. 
 
Based upon our past pilot research as well as other related studies, we don’t expect serious adverse 
events, such as fall-related injury.   
Risks associated with survey and observational data collection for patients in this study includes 
some concerns about privacy and embarrassment. The collection of actigraphy data from the 
MotionWatch may be mildly uncomfortable for participants, similar to the sensation of wearing a watch. 
Lastly, the patient may experience some stress completing study-related activities while trying to 
participate optimally in treatments and assessments that occur as part of hospital care. We will train 
evaluators on safety precautions, including fall prevention and signs of patient stress.  
Family CGs may also experience embarrassment, emotional discomfort, and increased stress. 
We will train research evaluators on observing for signs of distress and preventive strategies (e.g., 
pacing, active listening, and flexibility in scheduling study activity).  The evaluators will be trained for to 
observe for, detect, and report signs of depression and suicidal ideation in both patients and family CGs.   
During interviews, champions and nurses may experience stress, embarrassment, or the feeling 
that they need to offer only positive comments about the intervention. We will train evaluators on 
techniques to support the participants’ comfort, and emphasize the need to identify any needed 
improvements in the intervention. We will schedule interviews at a time convenient for the participants.  
HIPAA releases for using audio recordings will be secured since such recordings cannot be entirely de-
identified.  Participants will be informed that the purpose of the recordings will be to evaluate cultural 
competency and effectiveness of the intervention, not the hospital or unit. 
 
19.3 
Causality and Severity Assessments 
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE:  
 
The investigator will promptly review documented adverse events and abnormal test findings to 
determine 1) if the abnormal test finding should be classified as an adverse event; 2) if there is a 
reasonable possibility that the adverse event was caused by the study drug(s) or device(s); and 3) if the 
adverse event meets the criteria for a serious adverse event. 
 
If the investigator’s final determination of causality is “unknown and of questionable relationship to the 
study drug(s) or device(s)”, the adverse event will be classified as associated with the use of the study 
drug(s) or device(s) for reporting purposes.  If the investigator’s final determination of causality is 

Page 37 of 48 (V.06/27/2016) 
“unknown but not related to the study drug(s) or device(s)”, this determination and the rationale for the 
determination will be documented in the respective subject’s case history. 
 
19.4 
Reporting of Adverse Reactions and Unanticipated Problems to the FDA   
 
19.4.1 Written IND/IDE Safety Reports 
For a drug study under an IND, incorporate the following from 21 CFR 312.32 as written – DO 
NOT ALTER OR DELETE:  
The Sponsor-Investigator will submit a written IND Safety Report (i.e., completed FDA Form 
3500A) to the responsible new drug review division of the FDA for any observed or volunteered 
adverse event that is determined to be a serious and unexpected, suspected adverse reaction.  
Each IND Safety Report will be prominently labeled, “IND Safety Report”, and a copy will be 
provided to all participating investigators (if applicable) and sub-investigators. 
 
Written IND Safety Reports will be submitted to the FDA as soon as possible and, in no event, 
later than 15 calendar days following the Sponsor-Investigator’s receipt of the respective 
adverse event information and determination that it meets the respective criteria for reporting. 
 
For each written IND Safety Report, the Sponsor-Investigator will identify all previously 
submitted IND Safety Reports that addressed a similar suspected adverse reaction experience 
and will provide an analysis of the significance of newly reported, suspected adverse reaction in 
light of the previous, similar report(s) or any other relevant information. 
 
Relevant follow-up information to an IND Safety Report will be submitted to the applicable 
review division of the FDA as soon as the information is available and will be identified as such 
(i.e., “Follow-up IND Safety Report”). 
 
If the results of the Sponsor-Investigator’s follow-up investigation show that an adverse event 
that was initially determined to not require a written IND Safety Report does, in fact, meet the 
requirements for reporting; the Sponsor-Investigator will submit a written IND Safety Report as 
soon as possible, but in no event later than 15 calendar days, after the determination was made. 
 
For a device study under an IDE, incorporate the following from 21 CFR 812.150 as written – 
DO NOT ALTER OR DELETE:  
The Sponsor-Investigator will submit a completed FDA Form 3500Ato the FDA’s Center for 
Devices and Radiological Health for any observed or volunteered adverse effect that is 
determined to be an unanticipated adverse device effect.  A copy of this completed form will be 
provided to all participating sub-investigators. 
 
The completed FDA Form 3500Awill be submitted to the FDA as soon as possible and, in no 
event, later than 10 working days after the Sponsor-Investigator first receives notice of the 
adverse effect. 
 
If the results of the Sponsor-Investigator’s follow-up evaluation show that an adverse effect that 
was initially determined to not constitute an unanticipated adverse device effect does, in fact, 
meet the requirements for reporting; the Sponsor-Investigator will submit a completed FDA 
Form 3500Aas soon as possible, but in no event later than 10 working days, after the 
determination was made. 
 
For each submitted FDA Form 3500A, the Sponsor-Investigator will identify all previously 
submitted reports that that addressed a similar adverse effect experience and will provide an 
analysis of the significance of newly reported adverse effect in light of the previous, similar 
report(s).  

Page 38 of 48 (V.06/27/2016) 
 
Subsequent to the initial submission of a completed FDA Form 3500A, the Sponsor-Investigator 
will submit additional information concerning the reported adverse effect as requested by the 
FDA. 
 
n/a. There are no drugs or devices evaluated.  
 
19.4.2 Telephoned IND Safety Reports – Fatal or Life-threatening Suspected Adverse Reactions 
For a drug study under an IND, incorporate the following from 21 CFR 312.32 into the 
response, as written: 
In addition to the subsequent submission of a written IND Safety Report (i.e., completed FDA 
Form 3500A), the Sponsor-Investigator will notify the responsible review division of the FDA by 
telephone or facsimile transmission of any unexpected, fatal or life-threatening suspected 
adverse reaction.  
 
The telephone or facsimile transmission of applicable IND Safety Reports will be made as soon 
as possible but in no event later than 7 calendar days after the Sponsor-Investigator’s receipt of 
the respective adverse event information and determination that it meets the respective criteria 
for reporting. 
 
n/a 
 
19.5 
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB 
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE:  
 
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) 
experienced by a subject or other individual, which in the opinion of the investigator is determined to be 
(1) unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures. 
 
19.6 
Unblinding Procedures 
Describe the procedures for unblinding study therapy on a subject, including documentation of this in 
the subject’s source document. Include example(s) here why someone might unblind a study. In most 
cases, the unblinding will be part of managing a serious adverse reaction and will be reported with the 
serious adverse event. However, in cases where unblinding was not associated with a serious adverse 
event, such actions should be reported in a timely manner. 
 
n/a  
 
19.7 
Stopping Rules 
In studies with a primary safety endpoint or studies with high risk to study subjects, provide the rules 
that define the circumstances and procedures for interrupting or stopping the study. If an independent 
Data and Safety Monitoring (DSMB) or Committee (DSMC) is set up for the study, the same stopping 
rules should be incorporated into the safety analysis plan as well. 
 
n/a 

Page 39 of 48 (V.06/27/2016) 
20.0 Study Monitoring, Auditing and Inspecting 
 
20.1 
Study Monitoring Plan  
 
 
20.1.1 Quality Assurance and Quality Control 
Include this section if FDA regulations apply to this study (see “WORKSHEET: Drugs (HRP-306)” 
and “WORKSHEET: Devices (HRP-307)”. HRP-306 and HRP-307 can be accessed by clicking the 
Library link in CATS IRB (http://irb.psu.edu).  
 
Describe how you will ensure that this study is conducted and that the data are generated, 
documented (recorded) and reported in compliance with this protocol, with institutional and 
IRB policies, with Good Clinical Practice guidelines and any other applicable regulatory 
requirements. 
 
Indicate who is responsible for monitoring the conduct of the study and specify how often the 
study will be monitored.  
 
For single-site studies with low risk, it may be appropriate for the principal investigator to 
monitor the study. 
 
For multi-center studies or single site studies involving significant risk, an independent monitor 
may be required (e.g., monitoring by the staff of the PSU quality assurance program office(s) or 
by a clinical research organization). 
 
We plan the use a Data Safety Monitoring Board (DSMB) for this study. Upon review and  
approval by the National Institute on Aging Program Official (PO), we plan the DSMB to be chaired by a 
researcher who has extensive expertise in data safety and monitoring, clinical trials, and dementia 
caregiving research including bioethical considerations. The additional members of the DMSB will 
include two biostatisticians who have experience on a DSMB and a nurse with extensive experience in 
behavior change research and care of older adults with dementia. Potential members who fulfill these 
qualifications include a dementia caregiving researcher (Meredeth Rowe, PhD), a statistician (Shijun Zhu, 
PhD), and a dementia expert clinician and nurse researcher (Elizabeth Galik, PhD, CRNP). 
The group will meet at least annually via web conferencing. Telephone conferencing and email 
may be used for additional interactions as needed. The first meeting of the DSMB will be prior to 
recruitment of participants and will focus on review of the study protocol and recruitment plan, 
consideration of participant burden, a review of our plan for participant safety and comfort, and 
approval of monitoring and reporting forms and a plan for PI blinding to closed forms.  The subsequent 
meetings will focus on the progress of the study with regard to data quality and timeliness, participant 
consent, accrual and retention of participants, participant risk versus benefit, performance of 
intervention units, and any adverse events that occur during the course of the study to date. One or 
more major adverse events will also trigger a DSMB meeting.  At the end of each meeting the 
committee will make recommendations to NIH, institutional review board(s) and the PI and investigative 
team concerning continuation or conclusion of the trial.  
 
20.1.2 Safety Monitoring 
Include this section if FDA regulations apply to this study (see “WORKSHEET: Drugs (HRP-306)” 
and “WORKSHEET: Devices (HRP-307)”. HRP-306 and HRP-307 can be accessed by clicking the 
Library link in CATS IRB (http://irb.psu.edu).  
 
Indicate the process for identifying, recording and reporting adverse events. 
 

Page 40 of 48 (V.06/27/2016) 
Specify roles for adverse event recording and monitoring. Indicate each staff member’s role in 
the adverse event reporting process. Include the following if applicable: 
 
The Principal Investigator will confirm that all adverse events (AE) are correctly entered into the 
AE case report forms by the coordinator; be available to answer any questions that the 
coordinators may have concerning AEs; and will notify the IRB, FDA, sponsor and/or DSMB of all 
applicable AEs as appropriate. All assessments of AEs will be made by a licensed medical 
professional who is an investigator on the research. 
 
The Research Coordinator will complete the appropriate report form and logs; assist the PI to 
prepare reports and notify the IRB, FDA and/or DSMB of all Unanticipated Problems/SAE’s. 
 
The Monitor will confirm that the AEs are correctly entered into the case report forms. The 
Monitor will also confirm that the adverse events are consistent with the source documents and 
are reported to the appropriate regulatory bodies as required. 
 
21.0 Future Undetermined Research: Data and Specimen Banking 
If this study is collecting identifiable data and/or specimens that will be banked for future undetermined 
research, please describe this process in the sections below. This information should not conflict with 
information provided in section 9.1.1 regarding whether or not data and/or specimens will be associated with 
identifiers (directly or indirectly). 
 
21.1 
Data and/or specimens being stored 
Identify what data and/or specimens will be stored and the data associated with each specimen. 
 
The data collected may be used for future secondary analyses.  
 
21.2 
Location of storage 
Identify the location where the data and/or specimens will be stored. 
 
The data will be stored on RedCap.  
21.3 
Duration of storage 
Identify how long the data and/or specimens will be stored. 
 
The data will stored for at least six years after the data collection is completed.  
 
21.4 
Access to data and/or specimens 
Identify who will have access to the data and/or specimens. 
 
 
 
 
 
Only members of the research team will have access to the data.  
 
21.5 
Procedures to release data or specimens 
Describe the procedures to release the data and/or specimens, including: the process to request a 
release, approvals required for release, who can obtain data and/or specimens, and the data to be 
provided with the specimens. 
 
Data will be released only upon request to the Office of Human Research Protections in the U.S. Dept. of 
Health and Human Services; The Pennsylvania State University Institutional Review Board; The 
Pennsylvania State University Office for Research Protections, and the University of Pennsylvania Health 
System Institutional Review Board. 

Page 41 of 48 (V.06/27/2016) 
 
21.6 
Process for returning results 
Describe the process for returning results about the use of the data and/or specimens. 
 
n/a 
 
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