Nursing Home Prevention of Injury in Dementia (NH PRIDE)
Phase: NA
Conditions: Accidental Falls/Prevention and Control
Sponsor: Hebrew SeniorLife

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 1 of 45 
 
PROTOCOL TITLE: Nursing Home Prevention of Injury in Dementia (NH PRIDE) 
 
PRINCIPAL INVESTIGATORS:  Sarah Berry, MD, MPH; Cathleen Colon-Emeric, MD, MHS 
 
VERSION NUMBER AND DATE: Version 1.11 February 14, 2022 
 
SPONSOR/FUNDING SOURCE: NIA R01 AG062492-01 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 2 of 45 
 
TABLE OF CONTENTS 
Page 
1 
TABLE OF CONTENTS ..................................................................................................... 2 
2 
SUMMARY AND BACKGROUND ........................................................................................ 4 
2.1 
Objective ......................................................................................................................... 4 
2.2       Background and Significance………………………………………………………….. 
4 
2.3 
Design ............................................................................................................................. 6 
2.4 
Outcome Measures.......................................................................................................... 6 
2.5 
ILS Program and Duration .............................................................................................. 7 
2.6 
Sample Size and Population............................................................................................ 8 
3 
STUDY TEAM ROSTER..................................................................................................... 9 
3.1 
Principal Investigator ...................................................................................................... 9 
3.2 
Co-Investigators: ............................................................................................................. 9 
3.3 
Consultants .................................................................................................................... 11 
3.4 
Research Team Members:............................................................................................. 12 
4 
PARTICIPATING STUDY SITES ................................................................................... 15 
4.1 
Objectives ..................................................................................................................... 14 
5 
SELECTION AND ENROLLMENT OF PARTICIPANTS .......................................... 15 
5.1 
Inclusion Criteria .......................................................................................................... 15 
5.2 
Exclusion Criteria ......................................................................................................... 15 
5.3 
Study Enrollment Procedures ....................................................................................... 17 
6 
STUDY ACTIVITIES ........................................................................................................ 18 
6.1 
Study Start-up Activities .................................................................................................. 18 
6.2 
Implementation Phase Activities: ...................................................................................... 19 
6.3 
Data Collection Phase Activities ....................................................................................... 21 
7 
DATA COLLECTION ELEMENTS AND PROTOCOL .............................................. 23 
7.1 
Qualitative Interviews…………………………………………………………………………22 
7.2.        Facility Data ................................................................................................................. 23 
7.3 
Resident Assessments ................................................................................................... 23 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 3 of 45 
 
7.4      Staff Assesments……………………………………………………………………….23 
8 
HUMAN SUBJECT PROTECTIONS .............................................................................. 24 
8.1 
Sources of Data ............................................................................................................. 24 
8.2       Protection against Risk………………………………………………………..……… 
24 
8.3       Potential Benefits of the Proposed Research to Human Subjects and 
Others…………25 
8.4       Program Discontinuation……………………………………………………………..  
25   
 9 
SAFETY MOITORING  ............................................................................................ 26 
10 STATISTICAL CONSIDERATIONS  ............................................................................. 28 
11    DATA 
SECURITIES………………………………………………………………………29 
   11.1      Data Use Agreement………………………………………………………………….  
29 
   11.2      Safety Measures……………………………………………………………………….29 
   11.3      Data Management……………………………………………………………………..29       
12 PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................. 30 
12.1 
Institutional Review Board (IRB) Review .................................................................... 30 
12.2 
Informed Consent ......................................................................................................... 30 
12.3 
Participant Confidentiality ............................................................................................ 30 
13 PUBLICATION OF RESEARCH FINDINGS ................................................................ 31 
14 REFERENCES .................................................................................................................... 32 
 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 4 of 45 
 
2. SUMMARY AND BACKGROUND 
 
2.1. SUMMARY 
We propose to develop and test the implementation of a centralized Injury Liaison Service 
(ILS) to prevent injurious falls in four NH facilities. We will engage stakeholder groups (including 
NH staff, families, and administrators) and implementation scientists to refine and test the ILS. 
The ILS will combine successful elements of a Fracture Liaison Service (FLS) and a virtual case 
based staff education program with the goal of decreasing injurious falls in nursing home 
residents.  This service delivers guideline-recommended fall prevention and osteoporosis 
care consistent with quality improvement initiatives; study activities are limited to data 
collection to evaluate this program.  Our central hypothesis is that the ILS model will reduce 
injurious falls by changing care delivery in 2 areas:  deprescribing psychoactive and 
cardiometabolic drugs to reduce falls, and increasing osteoporosis treatment to prevent injury in 
the setting of a fall.  
 
2.2. Background and Significance 
 
Burden of injurious falls in the NH: The incidence of falls in U.S. NHs is extraordinary: 150 
falls/100 bed years.1 Consequently, falls are the leading cause of hospitalization and ED visits 
among NH residents.2 Five to eleven percent of falls in the NH result in major injury, defined as 
a fracture, joint dislocation, laceration requiring sutures, or serious hemorrhage.1,3 
Approximately one-half of injurious falls are fractures.3  
Injurious falls are costly: the annual direct cost of managing hip fractures alone in U.S. NH 
residents exceeds $665 million.4 For a single, average sized NH, the annual direct cost of 
injurious falls may equal $284,000.5 In addition, injurious falls lead to pain6, functional decline,7,8 
diminished quality of life,8 and frequent litigation.  CMS has determined that the proportion of NH 
residents experiencing an injurious fall is an important quality metric,9 yet no standardized 
approach to prevent injury exists.  
Efficiently target the intervention: A practical approach to preventing injury in the resource-
constrained NH environment requires identification of residents at greatest risk for targeted 
interventions. Previously, our group published a model that estimates the two-year risk of hip 
fracture in NH residents: Fracture Risk Assessment in Long term care (FRAiL).10 This model is 
derived entirely from data collected for the validated11-16 and routinely collected in all nursing 
homes through the Minimum Data Set (MDS). The model identified a unique pattern of risk 
factors for hip fracture not seen in community dwellers: the strongest predictors of fracture were 
related to falls, rather than bone mineral density (e.g., falls history, wandering). In the derivation 
sample, the concordance index (C-index) was 0.71 in women and 0.69 in men. We have 
validated the model to predict the two-year incidence of non-vertebral fracture and hospitalized 
injurious falls, and model performance is similar (C-index for non-vertebral fracture=0.66; for 
hospitalized injurious falls=0.65).   
Medication management prevents injurious falls:  In order to prevent injurious falls it is 
necessary to 1) remove modifiable risk factors for falls, and 2) manage osteoporosis such that a 
fracture is less likely to occur in the setting of a fall. Medications are one of the most common 
and modifiable risk factors for falls and osteoporosis in the NH.  
Deprescribing: Strong evidence from clinical trials supports deprescribing (i.e., discontinuing or 
reducing the dose of) psychoactive17,18 and probably cardiometabolic drugs19,20 as an effective 
strategy to prevent injurious falls in NH residents. In one study, seven pairs of NH facilities were 
randomized to receive individualized assessments from an external, multidisciplinary team.18 
Recommendations included psychoactive deprescribing. The authors achieved 46% adherence 
with deprescribing recommendations, and a 19.1% reduction in recurrent fallers. The 
intervention reduced the rate of injurious falls by 31.2%. Among older community dwellers, 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 5 of 45 
 
reduction of psychoactive drugs resulted in a 39-66% reduction in recurrent falls.17,21 Two 
observational studies have demonstrated a reduction in falls and orthostasis after deprescribing 
cardiometabolic medications in older adults attending falls clinics, and systematic reviews 
provide moderate evidence of benefit in a lower risk community population. 22 This benefit is 
likely greater in a NH population, who are at higher risk for hypotension, hypoglycemia, and 
orthostasis.  
Osteoporosis Treatment: Osteoporosis treatment rates are extremely low in NH residents, 
even among patients at high risk for fracture.23 This is concerning given evidence to suggest 
that treatment is probably cost effective in persons with life expectancies as low as 2 years.24 In 
a large sample of NH residents, we compared the incidence of hip fracture in new 
bisphosphonate users as compared with new calcitonin users, matched 1:1 with propensity 
scores (n=10,418). New users of bisphosphonates had a 17% reduced risk of hip fracture (95% 
CI, 0.71, 0.98) over mean follow-up 2.5 years (under review). These findings are consistent with 
small trials that suggest bisphosphonates may reduce the risk of clinical fracture25 or vertebral 
fracture26 in NH residents. Further, calcium and vitamin D supplementation has been shown to 
decrease the risk of non-vertebral fracture by 32% over 18-months in a large RCT of ambulatory 
NH residents.27    
Overcoming implementation barriers: One of the biggest barriers to implementing clinical 
guidelines in the NH setting is lack of staff knowledge.28 Our team has experience using a case-
based video-consultation program designed to provide geriatric expertise in the care of 
dementia residents to community-based NHs.29 Among the 11 facilities that received the video-
consultation program (ECHO-AGE), staff reported improved knowledge of non-pharmacologic 
strategies to manage behaviors with dementia. Further, facilities receiving ECHO-AGE were 
less likely to use physical restraints (OR= 0.25, 95% CI 0.06, 1.04) and antipsychotic drug 
prescriptions (OR= 0.83, 95% CI 0.68–1.02) as compared with residents in the 22 matched 
facilities with usual care.30 We propose to incorporate a virtual case based staff education 
program to improve education regarding medication management and falls prevention in 
residents with Alzheimer’s Disease and Related Dementias (ADRD).  
Ineffective communication between front-line providers and interdisciplinary staff is another 
major barrier in implementing individualized, multifactorial injury prevention strategies.28 
Successful intervention programs in the NH must change care philosophy,31 which requires 
strong communication among all members of the interdisciplinary NH team. We have previously 
conducted a number of trials to optimize medication prescribing and prevent falls in the NH 
setting.32-34 Our proposed model will use a centralized Injury Prevention (IP) Nurse and the 
virtual case based staff education program to develop an Injury Prevention Plan which reflects 
staff/resident/family and provider input.  The Injury Prevention Plan uses a standard template, 
but it is individualized to each resident. This template will allow the physician or nurse 
practitioner to easily review, modify, accept or reject the proposed recommendations. As part of 
Aim 1, we will interview patients or their proxies, 
nursing 
assistants, 
nurses, 
and 
medical 
providers in order to identify key barriers to 
communication, and a human factors expert will 
help 
work 
with 
our 
team, 
including 
implementation 
scientists, 
to 
enhance 
communication during implementation. 
In the current proposal, we will refine and test the 
implementation of a centralized Injury Liaison 
Service (ILS) to prevent injurious falls in the NH. 
Key features of the ILS are depicted in Figure 1.  
The FRAiL model will be used to automate 
identification of residents at highest risk for 
injurious falls. The ILS will include a nurse who 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 6 of 45 
 
works remotely across multiple facilities with support from a part-time Interdisciplinary Team in 
order to make medication recommendations to prevent injury. Among high risk residents, the IP 
nurse will coordinate deprescribing of fall-related medications, osteoporosis management, staff 
support of behavior management using video case conferencing, and shared decision making 
with residents and/or families.   
 
2.3. Study Design 
This protocol describes refinement and pilot testing activities for the Injury Liaison Service  
outlined above.  The following study designs will be employed: 
 
1. Qualitative interviews will be conducted with approximately 10 NH staff (i.e., nurse, 
certified nurse aide (CNA), physician, and nurse practitioner who have been employed in a 
nursing facility for at least 3 months) to gain a better understanding of effective and non-
effective injury prevention strategies. Information from these interviews will be used to refine 
the program during co-design meetings with key stakeholders 
2. A non-randomized pilot program in four nursing home facilities will provide data on the 
implementation of the ILS Program. This includes cross-sectional measures of acceptability, 
demand, practicality, and feasibility obtained from the electronic medical record (EMR), the 
IP nurse, and a post intervention survey with approximately 60 staff across the four 
facilities. A pre-post study design will be employed in order to measure the safety and 
efficacy of the ILS Program. Safety and efficacy outcomes will be measured at the resident 
level. 
 
2.4. Outcome measures.  The list of measures, data source, and targets are summarized in 
Table 1 and described in detail below.   
 
Table 1. Proposed Measures of Implementation, Efficacy, Safety, and Validity with Data 
Source and Target/Goal 
Type 
Outcomes 
Data Source 
Target/Goal 
Implementation 
 
Acceptability 
Family acceptance of 
recommendations  
IP  Nurse Tracking, 
staff survey 
> 50% 
Provider acceptance of 
recommendations 
>50% 
Provider satisfaction 
≥80% 
Staff participation in virtual 
case based education 
program 
10 staff/NH/mo. 
 
Demand 
Proportion eligible for 
intervention 
IP  Nurse Tracking 
20% 
Proportion of high risk 
residents with 
deprescribing 
recommendations 
50% 
Referral rates to virtual 
cased based education 
program 
15% 
Fidelity 
Proportion of targeted 
staff completing 
intervention checklists 
IP Nurse Tracking 
90% 
 
Cost of IP Nurse per 
resident 
 
$225 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 7 of 45 
 
Acceptability: 
(Primary) 
Number of 
families that 
accepted one 
or more 
medication 
recommendatio
n/ number of 
families offered 
a 
recommendatio
n; Number of 
patients where 
the provider accepted one or more recommendations / number of patients with a medication 
recommendation; % of staff that indicated they were satisfied or very satisfied with the ILS; 
proportion of staff that attended one or more virtual case based education sessions 
(Secondary) number of total medication recommendations accepted/ total number of 
medication recommendations; proportion of staff that attended two or more virtual cased based 
education sessions. 
 
Demand: We will use the FRAiL model to identify residents at greatest risk of injurious falls who 
are eligible for the ILS Program. Residents with an estimated 2-year risk of hip fracture of ≥5%, 
or similar target, will be considered high risk and eligible for the program. The facility staff will 
also be able to refer other at risk patients for participation in the program. Other demand 
outcomes include the proportion of high risk residents with one or more deprescribing 
recommendations or with a recommendation for osteoporosis treatment, AND referral rates to 
virtual case based education sessions, defined as the proportion of high risk residents 
discussed in these sessions. 
 
Fidelity: At each facility, we will identify targeted staff including nurses and medical providers 
(physicians, nurse practitioners, or physician assistants) who will be asked to complete the 
program checklists. Our primary measure of fidelity will be the proportion of staff that complete ≥ 
75% of requested checklists. As a secondary fidelity measure we will examine the proportion of 
resident checklists completed by a provider.  
 
Practicality: We will estimate cost by monitoring the amount of time the IP nurse spends on 
each eligible resident. Other outcomes include the estimated amount of time the staff spend on 
the ILS service by self-reported survey AND the six-month attrition of eligible residents from the 
NH facility due to transfer, discharge to community, or death, as determined by the IP nurse 
from chart review. 
  
Fidelity: Fidelity will be measured as the average number of medications that were 
deprescribed at 1 and 4 months among high risk residents, as well as the proportion of high risk 
residents with a prescription for an osteoporosis medication at 1 and 4-months. The IP nurse 
will review the EMR to determine medications at 1 and 4 months after medication 
recommendations are finalized.  
 
Safety: Detailed resident-level data collection includes the following potential adverse events 
related to medication changes: 1) escalating behaviors, worsening depression, or functional 
decline following psychoactive deprescribing; 2) unplanned medical visits for hypertension, 
Practicality 
NH staff time 
IP  Nurse Tracking, 
staff survey, EMR 
<2 hour/mo. 
High-risk Resident 6-mo 
attrition (death, leave NH) 
<40% 
Fidelity/Safety 
 
Fidelity 
No. of deprescribed 
medications at 3-6 months 
 
EMR 
≥1 
Osteoporosis medication 
initiation 
70% 
 
Safety 
Behaviors 
 
MDS 
<10% increase 
Functional Decline 
 
Unscheduled medical 
visits  
EMR 
<2/facility 
Validation 
Outcome 
Measure 
Injurious falls 
MDS and Chart 
Review 
>90% sensitive, >95% 
specific 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 8 of 45 
 
tachycardia, or hyperglycemia for cardiometabolic deprescribing; 3) new gastroesophageal 
reflux disease or esophagitis following bisphosphonate prescription. 
 
Each facility will provide two Minimum Data Set (MDS) assessments following baseline in order 
to characterize the occurrence of these adverse events.  Behaviors and depression will be 
measured using validated scales from the MDS.35,36 Any worsening of behavior (any category) 
as assessed by nursing will be considered. Worsening depression will be defined as a 1-point 
increase in the PHQ-9 or PHQ-9-OV. This corresponds with meaningful change in depression 
severity.37  Any increase in the frequency of reported verbal, physical, or other behaviors will be 
considered. Functional decline will be defined as a 3-point increase in the MDS Activities of 
Daily Living Scale. A 3-point increase corresponds with complete loss of a single ADL or 
incremental loss of 2 ADLs.38,39 Change in depression, behaviors, and functional status will be 
measured using the MDS assessment closest to and preceding implementation and the 
subsequent MDS assessment.  
Lastly The IP nurse will enter all targeted adverse events into the RedCap database. At the next 
study team meeting, or within 14 days, the IP nurse will review the event with the team for a 
determination of an adverse event using the validated Drug Withdrawal Probability Scale40,41 to 
determine if there is a probable, possible, or doubtful relationship between the medication 
change and the adverse event. Discordance will be adjudicated by a third investigator 
(physician).  
2.5. ILS Program Description  
All four facilities will receive the same ILS Program. Each facility will participate for a total of 18 months, 
including a 6-month start-up/planning period, a 6 month implementation period, and a 6 month 
data collection period. Residents eligible for the ILS Program will be identified during the 6-
month implementation period, and each resident will be followed for up to 6 months. 
The ILS Program has three main components (Section 6 provides additional detail): 
1. Automated identification of NH residents at high risk for injurious falls. Our IT 
personnel will work with the IT Departments at each of the 4 NH facilities in order to 
program the automated calculation of the FRAiL model from the EMR/MDS 
repository. Residents with an estimated FRAiL score ≥5% are eligible for the 
medication review via the IP nurse and videoconferencing. The facility staff may also 
suggest other residents for participation. 
2. The IP nurse will provide recommendations to manage medications. The IP nurse 
will be supported by an interdisciplinary team including geriatricians, bone health 
experts, ADRD behavior management experts, nursing, and pharmacist. The IP 
nurse will develop an Injury Prevention Plan (IPP) with recommendations for 
medication changes including deprescribing medications association with falls and a 
prescription for osteoporosis medications. Recommendations will be left for the 
primary providers to review and co-sign.   
3. Virtual case based education sessions to educate staff. We will hold regularly 
scheduled (up to monthly) virtual case based education with our interdisciplinary 
team and staff (nurses, CNAs, and providers) from the 4 NH facilities. During the 
conferences we may review some of the residents from each facility who are at high 
risk for injurious falls. These sessions could also include educational material on 
non-pharmacologic strategies to manage dementia with behaviors, falls prevention, 
deprescribing, and osteoporosis management. Frequency of meetings and content of 
the meetings will be individualized to each facility needs regarding case review, 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 9 of 45 
 
education, or other implementation support needs.  
2.6. Sample Size and Population  
We anticipate enrolling approximately 10 NH staff and 10 patient/families for an interview on 
injury prevention. 
We anticipate approximately 20% of long-stay residents at the 4 facilities will be eligible for the 
medication management program (n=80). See Section 10, Statistical Considerations for a full 
explanation of sample size. 
We anticipate conducting interviews to assess the acceptability and practicality of the ILS 
Program on 60 staff members across the four facilities. 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 10 of 45 
 
3. STUDY TEAM ROSTER  
 
3.1 Co-Principal Investigators 
Sarah D. Berry, MD, MPH  
Research Scientist, Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, 
Associate Professor of Medicine, Harvard Medical School  
Address:  1200 Centre Street, Boston, MA 02131 
Phone:   617-971-5355, Fax: 617-971-5339   
Email:    sarahberry@hsl.harvard.edu 
 
Role: Together with Dr. Colón-Emeric, Dr. Berry will be responsible for all aspects of the trial. 
Specifically she will take responsibility for overseeing the programming of the FRAiL model in 
the four NH facilities, development of the database used in the trial, and overseeing the virtual 
cased based education session component of the ILS Program. She will be responsible for 
budget management of the HSL site and the subcontract to Brown University. She will be 
responsible for annual project reports to the NIH and IRB approval. Dr. Berry’s involvement as 
both a clinician and investigator is essential to the success of this project. 
Cathleen Colón-Emeric, MD MHS                                                                                                                 
Chief of Gerontology, Department of Medicine                                                                                                        
Professor in Medicine, Duke University School of Medicine                                                                                    
Address: 2509 Hosp South, Durham, NC 27710                                                                                                     
Phone: (919) 620-4070                                                                                                                                
Email:Cathleen.colonemeric@duke.edu 
Role: Together with Dr. Berry, Dr. Colón-Emeric will be responsible for all aspects of the trial. 
Specifically she will take responsibility for overseeing the qualitative interviews conducted at two 
NH facilities, and the recruitment, education and oversight of the ILS nurse. Dr. Colón-Emeric 
will be responsible for the development and refinement of a future embedded pragmatic clinical 
trial to test the efficacy of the ILS Program.   
3.2 Co-Investigators: 
Tom Travison, PhD: 
Research Scientist, Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, 
Assistant Professor of Medicine, Harvard Medical School  
Address:  1200 Centre Street, Boston, MA 02131 
Phone:   617-971-5386, Fax: 617-971-5339   
Email:    tgt@hsl.harvard.edu 
 
Role: Dr. Travison is a senior statistician at the Institute for Aging Research, Hebrew SeniorLife 
and the co-Director of the Interventional Studies in Aging Center (ISAC). Dr. Travison has more 
than a decade of experience with clinical trials in frail, older populations. For the proposed 
project, Dr. Travison will be instrumental in overseeing the data entry process, and in 
developing the analytic approach. He will participate in the development of a study protocol for a 
future pragmatic RCT.  
 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 11 of 45 
 
Susan Mitchell, MD MPH:  
Senior Scientist, Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, 
Professor of Medicine, Harvard Medical School  
Address:  1200 Centre Street, Boston, MA 02131 
Phone:   617-971-5326, Fax: 617-971-5339   
Email:    smitchell@hsl.harvard.edu 
 
Role: Dr. Mitchell is a senior investigator at the Institute for Aging Research, Hebrew SeniorLife 
and the co-Director of the Interventional Studies in Aging Center (ISAC). Dr. Mitchell has 
considerable experience in the design and implementation of pragmatic clinical trials in the 
nursing home setting. She is an expert in the delivery of care to NH residents with ADRD. 
During year one, Dr. Mitchell will help with the recruitment of facilities and advise on the 
qualitative data as part of Aim 1. During the remaining years of the grant, she will advise on the 
implementation and analysis of the ILS Program and she will be instrumental in planning the 
protocol for a future pragmatic RCT.  
 
Lew Lipsitz, MD:  
Director, Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife, 
Professor of Medicine, Harvard Medical School     
Address:  1200 Centre Street, Boston, MA 02131 
Phone:   617-971-5318, Fax: 617-971-5339   
Email:    llipsitz@bidmc.harvard.edu 
 
Role: Dr. Lipsitz is the Chief of Gerontology at Beth Israel Deaconess Medical Center and the 
Director of the Marcus Institute for Aging Research, Hebrew SeniorLife. Dr. Lipsitz has 
previously served as the PI of two successful telemedicine programs. During years 2-3, Dr. 
Lipsitz will be instrumental as an advisor to the virtual case based education session component 
of the intervention. He will be involved in the interpretation of the results, as well as planning for 
a future pragmatic RCT.  
 
Eleanor McConnell, PhD, RN: 
Assistant Research Professor, Duke University School of Nursing                                                                         
Address:  School Of Nursing, 307 Trent Drive, Durham, NC 27710  
Phone: (919) 684-9229 
Email:Eleanor.mcconnell@duke.edu 
 
Role: Dr. McConnell will serve as a human factors expert and facilitator of the stakeholder 
groups and refinement of the intervention during the qualitative study.  She will assist in the 
generation of the resident fall ethnography and flow mapping.  Further, she will assist with ILS 
nurse training and participate in the virtual case based education sessions  as a dementia 
behavioral care expert.  
Andrew Zullo, PharmD, PhD:                                                                                                                                
Assistant Professor at Brown University                                                                                                                  
Clinical Pharmacist at Rhode Island Hospital                                                                                                          
Address: 121 South Main Street, Providence RI  02912                                                                                          
Phone: 401-863-6459                                                                                                                                              
andrew_zullo@brown.edu 
Role: Pharmacy involvement will be key to the success of the proposed project. During Year 1, 
Dr. Zullo will participate as a stakeholder. In Years 2-3, he will be responsible for developing 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 12 of 45 
 
standardized recommendations to deprescribe psychoactive and cardiometabolic drugs. He will 
work closely with Drs. Berry and Colón-Emeric in the development of a future pragmatic trial 
protocol, particularly as it relates to the integration of consultant pharmacists in the NH and he 
will serve as the pharmacist role as part of the interdisciplinary team providing medication 
recommendations. 
3.3. Consultants 
Sarah Sjostrom, R.N.:  
Chief Nursing Officer, Hebrew SeniorLife, 
Address:  1200 Centre Street, Boston, MA 02131 
Phone:   617-363-8604 
Email:   sarahsjostrom@hsl.harvard.edu 
 
Role: Ms. Sjostrom is the Assistant Director of Nursing for Hebrew SeniorLife. During the 
qualitative portion of the study, Ms. Sjostrom will serve as a stakeholder representing nursing at 
the development meetings, and she will work in small groups to strategize an effective 
implementation plan. During subsequent years, she may be asked to review reports and provide 
feedback. She will also facilitate connections with nursing home chains that would be interested 
in participating in a larger pragmatic trial.  
Joseph Ouslander, MD:                                                                                                                                         
Chair, Department of Integrated Medical Science                                                                                                   
Senior Associate Dean of Geriatric Programs  Florida Atlantic University                                                               
Address: 777 Glades Road  Boca Raton, FL 33431                                                                                                
Phone: 561-297-0975                                                                                                                                              
Email: jousland@health.fau.edu 
Role: Dr. Ouslander is a geriatrician and leader in improving the quality of care for older adults 
in skilled nursing facilities. He has recently worked with Dr. Colón-Emeric on a CMS-supported 
Institute for Healthcare Improvement Technical Expert Panel to improve patient safety in NHs. 
In the current proposal, Dr. Ouslander will serve as a consultant. He will participate in the 
qualitative study as a stakeholder. During the implementation study, he will review reports and 
provide feedback. He will also participate as an advisor in the planning of a subsequent 
pragmatic trial. 
 
Heidi White, MD, MHS:  
Professor of Medicine, Duke University School of Medicine 
Address: 2515 Hospital South, Durham NC  27710 
Phone:919-660-7516 
Email: white031@mc.duke.edu 
 
Role: Dr. White is the former President of the American Medical Directors Association, and a 
certified Nursing Home Medical Director with over 25 years of experience in Long-Term Care.  
She will serve on the stakeholder panel representing NH medical professional perspective 
during the qualitative study.  She will provide feedback into the ILS Program refinements and 
pragmatic trial protocol development during the subsequent clinical trial.  
 
 
 
Lisa Gwyther, MSW: 
Associate Professor in Psychiatry and Behavioral Sciences, Duke University School of Medicine 
Address: 3508 Busse Bldg, Durham NC 27710 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 13 of 45 
 
Phone: 919-660-7510 
Email: lisa.gwyther@duke.edu 
 
Role: Ms. Gwyther is a nationally known expert in dementia caregiver support, and the founder 
of the Duke Family Support program with over 30 years of experience in dementia care.  She 
will serve on the stakeholder panel representing family caregiver perspective during the 
qualitative study.  She will provide feedback into the intervention refinements and pragmatic trial 
protocol development in subsequent years. 
 
3.4. RESEARCH TEAM MEMBERS 
 
Jason Rightmyer                                                                                                                                                    
Director of Informatics Core, Hinda and Arthur Marcus Institute for Aging Research                                              
Address: 1200 Centre Street, Roslindale MA  02131                                                                                              
Phone: 617-971-5317                                                                                                                                              
Email: jasonrightmyer@hsl.harvard.edu                                                                                                                  
Role: Mr. Rightmyer will work with Mr. Resuke to oversee programming the calculation of the 
FRAiL risk score in the four facilities. He will meet with Dr. Berry and Mr. Rezuke at least 
monthly to ensure progress.  
Margaret Bryan                                                                                                                                                       
Analyst, Hinda and Arthur Marcus Institute for Aging Research                                                                              
Address: 1200 Centre Street, Roslindale, MA 02131                                                                                              
Phone: 617-971-5342                                                                                                                                              
Email: marg@hsl.harvard.edu                                                                                                                                 
Role: Ms. Bryan will receive the MDS files from the outside facilities. These MDS assessments 
will be used to validate the outcome injurious falls, to calculate the FRAiL score, and to assess 
the safety outcomes. 
Tim Tsai 
Analyst, Hinda and Arthur Marcus Institute for Aging Research                                                                              
Address: 1200 Centre Street, Roslindale, MA 02131                                                                                              
Phone: 617-971-5342                                                                                                                                              
Email: TimothyTsai@hsl.harvard.edu 
Role: Mr. Tsai will assist with the creation of the Minimum Data Set Repository and the 
calculation of the FRAIL score.                                                                                                                                
 
Laurie Herndon, RN NP                                                                                                                                         
Project Manager, Hinda and Arthur Marcus Institute for Aging Research                                                              
Role: Ms. Herndon will be responsible for engaging the four nursing home facilities, identifying a 
site champion and maintaining site engagement in the project. She will additionally be 
responsible for eliciting a full description of the facility processes (flow mapping) necessary to 
implement the intervention. 
 
Ilean Isaza 
Project Director, Program Manager, Hinda and Arthur Marcus Institute for Aging Research 
Address: 1200 Centre Street, Roslindale, MA 02131 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 14 of 45 
 
Phone 617-971-5352 
Email:  IleanIsaza@hsl.harvard.edu 
Role:  Ms. Isaza will develop the REDCap database used to collect study information for Aim 2 
 
Emily Hecker, RN, MSN 
Injury Prevention Nurse, Duke University Medical School 
Role:  Ms. Hecker will be responsible for working with participating sites to identify eligible 
residents for the program.  She will additionally be responsible for providing recommendations 
to manage medications and offer feedback on prescribing practices. 
 
Michelle Tingzhong Xue  
PhD Student, Duke University School of Nursing 
Address: 115 Windermere Dr. Unit 601, Durham, NC, 27712 
Phone: 612-562-5669 
Email: tingzhong.xue@duke.edu 
Role:  Ms. Tingzhong Xue will assist with the qualitative analysis of the key informant 
interviews.  
 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 15 of 45 
 
4. PARTICIPATING STUDY SITES  
The study is being conducted at 4 NH facilities: two in the Durham, NC area and two in the 
Boston area. Eligible homes must have at least 80 long stay beds. Recruitment and study 
enrollment will be done in 2 waves, with each wave starting three months apart. In each wave, 2 
NHs will begin the study.  
For specific Aim 2c, the validation of the outcome measure injurious falls via the MDS v3.0, it 
will take place at  one NC facility and Hebrew SeniorLife. 
4.1. STUDY OBJECTIVES 
Aim 1: Develop an ILS care model designed to prevent injurious falls in NH residents using 1) 
an automated risk calculator to identify high risk residents, 2) centralized care coordination by 
an Injury Prevention Nurse, and 3) videoconferencing with NH staff.   
Aim 2: Test implementation of the ILS in 4 NH facilities. The intervention will target residents at 
high risk for injury as estimated by the risk calculator (~80 residents total). Results will be 
presented among all residents and in ADRD residents separately. 
• 
Aim 2a:  Evaluate implementation of the ILS including measures of acceptability, 
demand, fidelity, and practicality (e.g., provider and family acceptance of 
recommendations, staff participation and time.)    
• 
Aim 2b:   Evaluate effectiveness and safety of the ILS using change in process 
measures related to injurious falls (e.g., number of drugs prescribed, osteoporosis 
medication prescriptions, behaviors, and functional status). Process measures will 
be collected at baseline and 1 and 4 months post-intervention. Additional safety 
measures (e.g., unplanned medical visits due to hypertension or hyperglycemia) will 
be assessed at 1 and 4 months post-intervention by chart review.   
• 
Aim 2c:  Validate the outcome measure for a future pragmatic clinical trial.  
Injurious fall ascertainment from the MDS will be validated against chart review in 
the facilities.  

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 16 of 45 
 
5. SELECTION AND ENROLLMENT OF PARTICIPANTS  
 
The ILS intervention will be rolled out facility-wide. Participation in the study will occur at 4 
levels.  Nursing homes will be recruited and enrolled into the study.  Site administrators who 
agree to participate in the study will serve as gatekeepers within their facility.  Eligible residents 
will be enrolled for ongoing chart reviews and minimum data set assessments in order to assess 
the program effect on injurious falls and safety outcomes. Providers (nurses, CNAs, midlevel 
providers, physicians) will be recruited to participate in the qualitative interviews, the virtual case 
based educational sessions, and to evaluate post-intervention acceptability and practicality. 
Proxies will be approached for qualitative interviews on their experience with preventing 
injurious falls. 
 
5.1. Inclusion Criteria 
5.1.1.Facility inclusion criteria 
1) More than 80 long-stay beds  
2) Within 30 miles of Boston or Durham, NC 
 
5.1.2. Resident inclusion eligibility criteria 
1) Age ≥ 60 years  
2) NH length of stay ≥ 30 days 
3) Estimated 2-year risk of hip fracture ≥ 5% using FRAiL model; OR 
4) Staff referral of someone at high risk for injurious falls 
 
5.1.3. Provider inclusion criteria 
The NH-PRIDE intervention will target the “usual” providers including nurses, CNAs, MDs, NPs 
and PAs routinely caring for NH patients. Nurses should be providing care at a NH facility for a 
minimum of 2 shifts most weeks. MDs, NPs, and PAs should spend, on average a minimum of 
four hours weekly in nursing home care.  We estimate there will be 10 providers for the 
qualitative interviews on injurious falls prevention, 20 providers (4 from each facility) in the 
televideo sessions, and 60 providers (15 per facility) to participate in the post-intervention 
questionnaires. 
Additional eligibility criteria for providers include:  
 
1) Worked in the facility for ≥ 90 days 
2) Can communicate in English (in order to participate in interviews and questionnaires),  
3) Over 21 years of age.  
 
5.1.4. Proxy/resident inclusion criteria 
We will recruit 10 residents/proxies to participate in the qualitative interviews on falls prevention. 
Residents/family must meet the following criteria: 
1) Affiliated resident has lived in the facility for ≥ 30 days 
2) Can communicate in English 
3) Over 21 years of age 
4) Able to provide informed consent to participate in the interviews 
 
5.2. Exclusion Criteria 
5.2.1. Facility exclusion criteria 
1) Population not primarily English speaking 
2) Evidence of institutional instability at time of recruitment 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 17 of 45 
 
5.2.2. Provider exclusion criteria 
1) Does not provide routine care to NH residents (e.g. visiting hospice provider) 
2) Does not speak English 
3) Is less than 21 years old 
5.2.3. Resident exclusion criteria 
1. Life expectancy < 6 months, as indicated by MDS assessment 
2. Living in nursing home for less than 30 days 
3.  Proxy has communicated wish to opt-out of study 
 
Residents will not be excluded from the study based on any specific diagnosis (e.g., 
congestive 
heart failure or schizophrenia); however, the algorithm used to make recommendations for  
medication management will consider individual co-morbidities. 
(see Table 3 for details)   
5.2.4. Proxy/resident exclusion criteria 
1) Affiliated resident has lived in the facility for < 30 days 
2) Cannot communicate in English 
3) Less than 21 years of age 
4) Unable to provide informed consent to participate in the interviews 
 
5.3. Study Enrollment Procedures  
5.3.1. Facility Enrollment 
A total of 2 Boston area and 2 NC NHs will be recruited.  In preparation for this study, 5 facilities 
have already provided assent and a letter of support. The project director and/or PI will contact 
senior administrators of these facilities by email. The email will provide information on the 
intervention and implications of participation, including the need to share limited data from chart 
review and the Minimum Data Set with study investigators.  Following the email, if the sites 
express interest, the project director and/or PI will contact the NHs’ administrators by telephone 
to answer questions and seek their participation. Face to face meetings to further explain the 
study will be held with administrators upon request.  
5.3.2. Provider Recruitment 
We have requested an IRB waiver of written informed consent for provider recruitment. The 
research team works with the intervention NH leadership team and designated site champion to 
facilitate provider recruitment and orientation at the start of the intervention. A list of full-time 
charge nurses and nurse aides working with long-stay residents will be obtained from the facility 
Director of Nursing or designee. Study staff will contact them sequentially to recruit 10 for 
potential participation in the fall prevention ethnography.  Study staff will verbally describe the 
procedure and provide a written brochure and informed consent document for review.  
  
Staff will be provided written and verbal information on the Injury Liaison Service, including the 
available videoconferencing sessions. For staff participating in the Injury Liaison Service 
feedback interviews under a waiver of Informed Consent and HIPAA Authorization, study staff 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 18 of 45 
 
will approach them for assent during previous agreed upon times to minimize interference with 
their work.  
All aspects of provider participation are optional.  Study staff will verbally describe the procedure 
and provide written material for staff to review. They can chose to participate in all, some or no 
aspects of the intervention, and can request exclusion at any time by contacting the research 
project manager, whose contact information is provided in all outreach materials.  Providers who 
participate in the qualitative interviews on falls prevention will receive $50 as an incentive for 
their time. 
5.3.3. Resident Enrollment 
We are requesting an IRB waiver of individual authorization for disclosure of personal health 
information (PHI) to screen and identify eligible residents.  One month before we plan to start 
the ILS Program in a NH facility, residents and/or proxies will be provided or mailed study 
information, including material on deprescribing, osteoporosis medications, and the project 
director’s (PD’s) contact information, if they wish to opt out.  At the start of the study the IP 
nurse will identify eligible residents using the automated calculation of the FRAiL score, and with 
chart review.  In addition, flyers will be posted in ALL participating facilities explaining that the 
study is being conducted and that it includes data collection from the charts of residents. The 
flyers will include contact information for the PD to ask further questions and an opportunity for 
proxies to “opt-out”.    
 
5.3.4. Proxy and Resident Enrollment 
We have requested an IRB waiver of written informed consent for proxy recruitment for the 10 
interviews related to falls prevention. A list of long-stay NH residents with a recent fall will be 
obtained from the local NH champion or Director of Nursing. Study staff will contact them 
sequentially to recruit 10 for potential participation in the fall prevention ethnography. Study staff 
will verbally describe the procedure (in person for residents, over the phone for LARs), and 
provide with written information about the study for review. The procedure for obtaining consent 
is described in detail in Section 12.2. 
 
Proxies or residents who participate in the qualitative interviews on falls prevention will receive 
$50 for their time. If a patient has the ability to consent, the patient will be interviewed directly 
and receive $50. If the patient has moderate to advanced dementia and cannot participate, the 
proxy will be interviewed alone and receive $50. If the patient has mild/moderate dementia, and 
both the patient and proxy participate in the interview, they both will receive $50. 
 
 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 19 of 45 
 
6. STUDY ACTIVITIES  
The qualitative Aim 1 study will be conducted in the 2 facilities in North Carolina. 
All four NH facilities (2 in Boston area, 2 in Durham, NC area) will receive the same ILS Quality 
Improvement Program. Each facility will participate for a total of 18 months, including a 6-month 
start-up/planning period, a 6 month implementation period, and a 6 month data collection 
period. Residents eligible for the ILS Program will be identified during the 6-month 
implementation period, and each  
resident will be followed for up to 6 months.  
The ILS Program is consistent with a quality improvement program because it is delivering 
guideline-
recommend
ed fall 
prevention 
and 
osteoporosis 
care. Study 
interventions 
are therefore 
limited to the 
data 
collection 
procedures 
described 
previously to 
determine 
the 
feasibility 
and 
acceptability 
of the ILS 
program.  
However, 
the 
components of the quality improvement program are summarized in Table 2 and described in 
more details in the following sections.  
6.1. Study Start-up Activities 
The following activities will occur during the 6 month planning period within facilities:   
1. Program the FRAiL model to predict residents at risk for injury.  
2. Identify a NH-PRIDE site champion 
3. Develop implementation plan with NH leadership through on-site planning meetings 
4. Identify targeted providers 
5. Provide orientation packages to targeted providers (we will provide the IRB prior to 
implementation; packets will be developed in early 2020; estimate implementation 
Table 2.  Intervention model components, who is responsible, timing and time involved. 
Activity 
Who, When, Time Required 
High Risk Resident Identification 
FRAiL tool identifies high risk residents from MDS; 
facility champion may also suggest residents for 
participation 
IP Nurse, monthly, 30 minutes 
Resident Data Gathering 
EMR review and relevant data extraction into Redcap 
database 
IP Nurse, 20 minutes/resident 
Medication algorithm identifies those potentially 
eligible for deprescribing and osteoporosis treatment 
Automated, database 
Injury Prevention Plan Development and Documentation 
Documentation of IPP using standard template 
IP Nurse with IDT review during 
weekly meeting, 5 min/resident 
Telephone visit with resident/family for 
modification/acceptance 
IP Nurse 10 min/patient 
Telephone visit with Charge Nurse, scheduling of 
virtual cased based education session if staff has 
concerns about behaviors 
IP Nurse 5 min/patient 
Virtual case based education sessions for selected 
Residents with active behavioral issues 
NH LPN, NA, RNs, ILS Nurse, IDT, 
Family; 15 min/resident; monthly 
IPP Implementation and Follow-Up 
IPP placed in medical record for medical team 
cosignature 
IP Nurse, 5 min/patient 
Issues/problems discussed during next  virtual case 
based education sessions session 
MDS nurse, charge nurse, CNAs,  
Virtual case based education sessions  
IDT 
1 and 4 EMR review and IPP update 
IP Nurse with discussion by IDT as 
needed, 15 min/patient 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 20 of 45 
 
summer 2020)  
6. One month before the ILS Program is planned to start, notify long-stay 
residents/proxies about the program via letter with ability to opt out (HIPAA waiver of 
informed consent; we will provide the IRB prior to implementation, estimate summer 
2020). 
 
Programming the FRAiL model: During the 6 month start-up period, our IT personnel will work 
with the IT Departments at each of the 4 NH facilities in order to assist in the programming of 
the FRAiL model from the EMR/MDS repository. At the beginning of the implementation period, 
the IP nurse will be provided with a report of the FRAiL score for all long-stay residents. 
Residents with an estimated FRAiL score ≥5% will be reviewed for additional eligibility/exclusion 
criteria via chart review (see Section 5).  
Identification of site champion: During the start-up period each NH will designate at least one 
champion. In order to prevent champion loss due to turn-over, we will appoint a secondary 
champion, whenever possible. The champions needs to be persons interested in falls 
prevention who understands the special concerns of managing medications in NH residents. 
The site champion may be the DON or a nurse directing direct patient care. The secondary 
champion may be a unit nursing director or other unit nurse. The site champions will work with 
the research team throughout the planning and implementation period to facilitate successful 
program implementation.  He or she serves as a primary contact for both providers within the 
NH and for the research team.  Site champions are provided with references and support tools 
at the start of the program and they will be encouraged to contact the project director with 
questions or concerns.  During the implementation phase, the champions will be invited to 
participate in the monthly videoconferences with other site champions, in order to discuss the 
program and provide suggestions/support to one another.  The champion is an on-site leader 
and resource, working with both facility and research team to increase likelihood of program 
success.  Site champions should, 1) Help tailor the ILS Program to their facility, 2) Identify and 
motivate providers, 3) Review prescribing feedback reports, 4) Encourage adherence with IP 
nurse recommendations, and 5) Integrate program into quality improvement activities 
Development of implementation plan with NH leadership 
Successful program planning and implementation depends on teamwork between members of 
the facility team and the research team.  This starts with the 6 month planning period wherein 
the research team and NH team meet at least monthly to review and optimize plan for program 
roll-out.  Throughout the program, the research team will work with members of the facility team 
to optimize the program within the facility and to support program activities within the facility.   
See details about enrolling providers and residents in Section 5.3 on enrollment. 
 
6.2. Implementation Phase Activities: 
The following activities will occur during the 6 month implementation period within facilities:   
1. The IP nurse will identify eligible residents for the program. 
2. The IP nurse will provide recommendations to manage medications.  
3. The IP nurse will offer feedback on prescribing practices. 
4. Staff will be invited to participate in regularly scheduled virtual case based education sessions in 
order to education staff on falls, deprescribing, osteoporosis, and non-pharmacological 
management of dementia. Videoconference scheduling and content will be 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 21 of 45 
 
individualized to participating facilities.  
The IP nurse will identify eligible residents for the program. During the startup phase, our study 
team will assist the local IT Departments in creating a report to calculate the FRAiL score for all 
long stay residents. These reports will additionally indicate resident age < 60 years and whether 
a resident has less than a 6 month life expectancy.  The IP nurse will use these reports to 
identify eligible residents and ensure no exclusion criteria. Any resident or proxy who notifies the 
study team and opts out of study participation, will not be included.  The facility champion may 
also suggest other residents for participation. 
The IP nurse will provide recommendations to manage medications. During the qualitative 
portion of the study, an algorithm will be created that includes evidence based decision making 
in deprescribing psychotropic and cardiometabolic drugs, as well as patient/proxy preference. 
We will work with our pharmacist investigator, consultants, and patients/proxies in order to 
identify the classes of medications we will target for deprescribing.  Examples include 
medications associated with falls (e.g., benzodiazepines, beta-blockers) and medications 
associated with bone mineral density loss (e.g., proton pump inhibitors).  We will use 
combinations of existing evidence-based tools to develop the deprescribing  
recommendations including Deprescribing.org (https://deprescribing.org/resources/ 
deprescribing-guidelines-algorithms/) and the EMPOWER tool 
(https://deprescribing.org/news/empower -trial-empowering-older-adults-to-reduce-
benzodiazepine-use/). Appendix 1 shows a medication algorithm: 
For all eligible patients, The IP nurse will utilize the Medication Algorithm and will review the 
EMR and additionally available medical records in order to make informed recommendations 
regarding medication changes. The IP nurse will be supported by an interdisciplinary team (IDT) 
including geriatricians, bone health experts, dementia behavior management experts, nursing, 
and pharmacist. The IP nurse will discuss any recommendations with direct care staff as well as 
residents or proxies. The Injury Prevention Nurse will provide the resident and/or proxy with 
evidenced based literature, existing decision aid tools, and/or short videos so as to facilitate 
shared decision making. Using input from the IDT, direct care staff, residents and proxies, the IP 
nurse will then use the Injury Prevention Plan template to document recommended medication 
changes including deprescribing medications association with falls and a prescription for 
osteoporosis medications. Recommendations will be left for the primary providers to review, 
modify if desired, and co-sign. The IP Nurse will complete an Injury Prevention Service 
Consultation note summarizing communication with resident, family, NH PRIDE team, facility 
staff, and prescribers about recommendations for medication changes.   
The IP nurse will offer feedback on prescribing practices. We will create monthly feedback forms 
for each provider to illustrate adherence with medication recommendations. The IP nurse will 
review these reports with the site champion. We will work with the site champion to employ 
other methods to maintain engagement specific to each site, such as publically displayed 
“thermometers” to document aggregate adherence. The IP nurse will also work with the site 
champion to ensure that staff are communicating any potential adverse events from 
deprescribing or osteoporosis medications as a result of the study recommendations.      
Videoconferencing sessions to educate staff. We will hold regularly scheduled (up to monthly) 
telehealth videoconferences with our interdisciplinary team and staff (nurses, CNAs, and 
providers) from the 4 NH facilities. During the conferences we may review some of the residents 
from each facility who meet eligibility criteria and whom the staff feel are at high risk for injurious 
falls. In addition to the case-based discussions, these sessions may include educational 
material on non-pharmacologic strategies to manage dementia with behaviors, falls prevention, 
deprescribing, and osteoporosis management. These conferences will emphasize non-
pharmacologic and behavioral interventions as alternatives to psychotropic drugs in the nursing 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 22 of 45 
 
home.  In addition they will review potentially adverse drug effects of deprescribing or the 
prescription of osteoporosis medications that concern the staff. 
 
6.3. Data Collection Phase Activities: 
 
The following activities will occur during the Data Collection Phase within facilities:   
 
1. IP nurse will review the EMR at 1 and 4 months of patients with a finalized medication 
recommendation. 
2. IP nurse will administer short survey to staff on feasibility and acceptability 
3. Facilities will provide limited MDS data and a falls log in the 6 months following 
implementation. 
4. Validate MDS injurious falls data with chart review and falls log 
5. Select staff and proxies will be invited to participate in a follow-up semi-structured 
interview to understand any implementation barriers.  
 
Planned data collection activities are described in Section 7. 
 
 
 
 

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7. DATA COLLECTION ELEMENTS AND PROTOCOL  
 
7.1 Qualitative interviews.  Participants (approximately 10 staff and 10 proxies) will be asked 
to tell the story of a recent fall and subsequent attempts to prevent additional falls; a semi-
structured interview guide (See separate Interview Guide) is used to prompt for feelings, 
experiences, and “touch points” where care should be delivered differently.  Staff members will 
be interviewed alone or in small groups. Interviews are audio recorded and transcribed.  These 
interviews will be used to identify touchpoints that the broader research team and consultants 
can use when refining the intervention. Select staff and proxies will be approached for 
willingness to participate in a follow-up semi-structured interview (Guide to be submitted in 
Spring 2020) in order to better understand implementation barriers. 
7.2  Facility Data 
Nursing home data are collected prior to the start of the study for descriptive purposes and to 
inform the development of a list of eligible nursing homes for recruitment (see Section 5 for 
specific facility Eligibility criteria). Prior to recruitment efforts, NH characteristics that may be 
relevant to injurious falls, were abstracted from the Medicare Nursing Home Compare, 
including: the number of beds, hospital-based, special care dementia unit, nursing and nursing 
assistant hours/resident/day, and number of deficiencies on state inspections. Long-term Care: 
Facts on Care in the US (http://www.ltcfocus.org/) is also used to gather information including 
number of beds, number of residents with advanced cognitive impairment, and number of Black 
residents.  Administrators of participating facilities are also asked whether NPs/PAs are on staff 
and whether there is an open or closed medical staff.   
7.3 Resident assessments 
Resident data will be collected by the IP nurse. Charts are abstracted at baseline and again at 1 
and 4 months after the study recommendations are finalized, to determine in medication 
recommendations were followed, and if there was any evidence of adverse events. The IP 
nurse will hold weekly brief telephonic huddles (~10-15 minutes) with direct care staff to 
determine staff perceptions of the program and to collect critical information on data missing 
from chart, such as behaviors. 
Demographic: (baseline; chart and MDS) age, gender, race, ethnicity, length of NH stay and 
proxy contact information (for mailing study information and ability to opt out) and relationship to 
resident.  
Medical co-morbidity: (baseline; chart review) All active medical diagnoses.  
Medications: (baseline, 1 and 4 months; chart review) All prescribed medications and doses. 
Functional status: (baseline, 1-6 months follow-up via MDS) We will categorize functional status 
using the Katz ADLs at baseline and during followup  
Falls, fractures, injurious falls: (baseline, 1 and 4 months: also via MDS and falls log) We will 
ascertain falls and falls with injury from the 2 MDS assessments during followup, the facility falls 
log, and also from chart review. 
Adverse events – other major acute illnesses: (baseline, 1 and 4 months; MDS and chart 
review): We will consider the following adverse events due to medication changes: 1) escalating 
behaviors, worsening depression, or functional decline following psychoactive deprescribing; 2) 
unplanned medical visits for hypertension, tachycardia, or hyperglycemia for cardiometabolic 
deprescribing; 3) new gastroesophageal reflux disease or esophagitis following bisphosphonate 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 24 of 45 
 
prescription. Each facility will provide limited MDS data at baseline and during follow-up in order 
to characterize the occurrence of these adverse events. Change in depression, behaviors, and 
functional status will be measured using the MDS assessment closest to and preceding the 
program implementation and the subsequent MDS assessment. 
Lastly The IPN will enter all targeted adverse events into the RedCap database. At the next 
study team meeting, or within 14 days, the IPN will review the event with the team for a 
determination of  an adverse event using the Drug Withdrawal Probability Scale to determine if 
there is a probably, possible, or doubtful relationship between the medication change and the 
adverse event. Discordance will be adjudicated by a third investigator. 
Health services: (1 and 4 months; chart review) hospitalizations, emergency room visits.  
Death or transfer: (1 and 4 months; chart review) date will be obtained from the chart. 
 
7.4 Staff assessments  
Staff satisfaction and estimated time spent on the ILS Program implementation will be collected 
by a 5 minute survey during followup.  Questions include overall satisfaction with the NH PRIDE 
study, estimates of total amount of time staff spent on study, satisfaction with key components 
of the study, reasons for not accepting pharmacologic and nonpharmacologic 
recommendations, and likelihood that staff would recommend the study to a colleague.  The 
survey will be made available to staff electronically using the Qualtrics Survey Platform and will 
be administered at the beginning of a regularly scheduled Zoom meeting. After staff have 
completed the survey, the research team will ask three open ended questions on what worked 
well and what could have been improved during the study.  The meeting will be recorded on the 
Zoom platform and will be transcribed by study staff.  Staff will be informed at the beginning of 
the meeting that it is being recorded and can choose not to participate.   
Surveys related to deprescribing, osteoporosis treatment, and medical provider workflow will be 
administered to nurse practitioners and physicians via zoom meeting or via the Qualtrix Survey 
Platform. Zoom meetings will be recorded and transcribed by study staff.  Staff will be informed 
at the beginning of the meeting that it is being recorded and can choose not to participate.  
Participants will receive a 50.00 gift card. 
  

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 25 of 45 
 
8. HUMAN SUBJECTS PROTECTION 
Because the ILS is providing guideline recommended clinical care to residents, and all resident-
level data collection is via the EMR (i.e., no direct resident contact) we request waiver of 
informed consent and HIPAA authorization for resident data collection. 
 
Because staff are voluntarily participating in the interviews on injury prevention and the 
videoconferencing component of the program, we request waiver of documentation of informed 
consent to record their interview and obtain feedback about the ILS. 
 
Because proxies/residents who participate in the interviews are voluntarily participating in the 
low-risk activity, we request a waiver of documentation of informed consent. Study staff will 
verbally describe the procedure (in person for residents, over the phone for LARs), and provide 
written material for review before participating in the interview. 
  
 
8.1. Sources of Data 
 
Qualitative interviews. Approximately 15 staff and 15 residents/proxies will participate in an 
audiorecorded interview on falls prevention prior to study implementation. Interviews will be 
transcribed and we will use qualitative software (NVivo) to analyze themes. Approximately 5 
staff and 5 proxies will participate in a follow-up audiorecorded interview to understand 
implementation barriers.   
 
Resident NH records: We will obtain information on medical diagnoses, medications, behaviors 
and adverse events from the EMR (see description of data to be obtained in Section 7). 
 
MDS records: We will request limited information from the MDS for all participants at baseline 
and quarterly. This includes functional status, depression, pain, falls and injurious falls, 
behaviors, or unstable or new medical conditions.    
 
Staff surveys. Approximately 60 staff from the 4 facilities will provide data on acceptability and  
feasibility through a brief survey during follow-up. 
 
 
8.2. Protection against Risk   
 
The NH-PRIDE study poses minimal risks; however, below we list possible risks and our 
proposed strategies to minimize them: 
 
• 
Loss of privacy and confidentiality of research data.  Only PHI necessary to complete study 
aims will be collected.  All data will remain behind either the Duke, NH or the Hebrew Senior 
Life data firewall, all of which meet HIPAA standards for clinical and research data.  Data will 
be transferred between the NH and HSL database via secure data-sharing software 
(Accelion).  No research data containing PHI will be stored on portable devices. PHI/data 
for eligible residents will be stored on secure Duke servers accessible only to study 
staff, and communicated to providers by secure email behind the Duke firewall. 
• 
Loss of confidentiality through videoconferencing sessions. Videoconferencing will include 
discussions of Protected Health Information in an effort to manage medications and 
behaviors in nursing home residents at the greatest risk for injurious falls. These 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 26 of 45 
 
conferences will use secure platforms (e.g., Zoom) and we will only discuss information 
necessary to make informed medical recommendations. 
• 
Loss of confidentiality with audiorecording patient, proxy and provider interviews: After 
audiorecording the interviews, investigators will use NVivo software to extract themes and 
touch points described by participants in an open coding process. Short audio clips 
illustrating each touch point may be re-organized into an ethnography of the fall prevention 
experience, with audioclips preserving the family and staff voices, while removing most 
identifiable information. 
• 
Interference of study procedures with Nursing Home staff duties.  We recognize that NH 
staff have competing clinical demands and study procedures may impact resident care.  
Using successful procedures from prior studies, we will establish preferred communication 
times and venues with each facility’s staff.  We will train study staff to avoid interrupting shift 
change or medication passes. 
• 
Adverse events due to deprescribing medications increasing fall risk.  Although guidelines 
recommend minimizing the dose or discontinuing medications associated with falls in high-
risk patients, they may experience adverse drug withdrawal events related to dose changes.  
These are class specific and include escalating behaviors, worsening depression or 
functional decline following psychoactive deprescribing; hypertension or tachycardia, or 
hyperglycemia for cardiometabolic deprescribing. To minimize this risk, we will: 1) ensure 
that the medical provider has reviewed and concurs with each change by providing a consult 
note and having them sign all medication change orders; 2) use slow tapers and geriatric 
dosing ranges under the guidance of the study geriatricians and geriatric pharmacist; 3) 
develop rapid communication channels between NH staff and the ILS nurse/study team so 
that any symptoms can be reported early.  These include weekly huddles with nursing staff, 
a study contact phone number, and regular virtual case based education sessions  
• 
Adverse events related to prescribing osteoporosis medication.  Adverse drug reactions 
related to osteoporosis medications include gastrointestinal distress, esophagitis, injection 
site reactions (for subcutaneous medications), hypocalcemia/hypercalcemia.  Rare events 
such as osteonecrosis of the jaw or atypical subtrochanteric fractures occur in 1/50,000-
100,000 patient years of exposure and are not expected in this small, short term study.  To 
minimize risks we will: 1) instruct NH staff on proper bisphosphonate administration 
procedures (fasting, sitting upright at least 30 minutes, >8 oz water); 2) ensure study 
protocols do not recommend oral bisphosphonates to residents with dysphagia or known 
esophageal stricture; 3) ensure vitamin D sufficiency or adequate loading dose prior to 
beginning oral bisphosphonates; 4) ensure anabolic agents are not given to patients at risk 
for hyperparathyroidism or with prior hypercalcemia; 4) discontinue antiresorptive agents 
after 5 years of treatment. 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 27 of 45 
 
8.3. Potential Benefits of the Proposed Research to Human Subjects and Others   
• 
Benefits to providers.  The ILS service will reduce the workload of the clinical staff by 
centrally coordinating programs and communicating with patients and families.  NH staff 
may additionally benefit from educational activities offered during virtual case based 
education      
• 
Benefits to NH Residents and Families. If the program is effective, patients and families will 
benefit from improved fall prevention services, with fewer expected to suffer painful and 
debilitating low-trauma fractures and other fall-related injuries.   
 
8.4. Study Discontinuation  
Individual NHs may withdraw from study participation at any time at the discretion of their senior 
management or corporate supervisors. Providers can opt out of any part of ILS Program 
participation at any time, and while not being asked to provide informed consent for this 
research, resident proxies can opt out of reading the fliers at the facility or mailed letter and 
contacting the research team at any time to request exclusion of their resident from ongoing 
data collection efforts.  Participants may choose to terminate data collection via interviews at 
any time. If a participant withdraws consent, no additional data will be used, although data 
previously collected and de-identified may remain in the analyses. There are no anticipated 
circumstances under which subjects will be withdrawn without their consent. 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 28 of 45 
 
9. SAFETY MONITORING 
The study meets criteria for minimal risk. The ILS Program represents best practices in care 
coordination and medication review for NH residents. All the resident data will be obtained from 
their medical record, MDS, and staff interviews, and coded at the time of data entry to protect 
their confidentiality. Given that the program is based on consensus, peer reviewed guidelines, 
the risk from the ILS with regards to medication management is minimal. 
Overall framework for safety monitoring:  The study will employ strategies specific to the 4 types 
of risk expected; 1) loss of privacy and confidentiality of research data; 2) interference of study 
procedures with Nursing Home staff duties; 3) Adverse drug withdrawal events due to 
deprescribing medications increasing fall risk; and 4) Adverse drug reaction related to 
prescribing osteoporosis medication.  In addition, we will monitor for suspected abuse and 
neglect by NH staff. 
All safety events will be reported to the PIs immediately upon recognition by study or NH staff, 
with additional actions as outlined below.  An independent safety monitoring board (will be 
alerted to all Serious Adverse Events (SAEs) potentially related to the study within 24 hours of 
PI notification.  The monitoring board will review all other events during bi-annual safety 
meetings with the PIs. 
The safety monitoring board will be appointed by the NIA and comprised of three individuals not 
otherwise involved in the study. All of the individuals should have expertise in NH care and at 
least one individual should be a physician.  
Information to be monitored: 
• 
Loss of privacy and confidentiality of research data:  The PIs will ask study staff to report 
any potential breaches of data security procedures, such as inadvertent recording or 
transfer of PHI outside of the firewall, during monthly study meetings.  Staff will be reminded 
to report such breaches immediately.  Any identified will be reported to the IRBs, site data 
privacy officer, and awarding IC within 24 hours of discovery.  Staff will be retrained on data 
security procedures at least annually.  
• 
Interference of study procedures with Nursing Home staff duties:  Study staff will enquire 
about such interference during the structured staff interviews during the implementation, 
feasibility, and acceptability testing.  All reported instances will be reviewed during regular 
study team meetings, and remediation plans discussed with the Data Safety Monitoring 
Board as appropriate. 
• 
Withdrawing medications can lead to worsening symptoms. These can include worsening 
anxiety, depression, or behavior, insomnia, elevated blood pressure, or gastrointestinal 
upset, or exacerbation of underlying disease.  NH staff will be provided with written and 
telephonic means of communicating with MD/NP if these symptoms occur.  If one of these 
symptoms is significant enough to warrant an unplanned visit from the MD/NP, it will be 
considered a study-related Adverse Event.  Potentially study-related Adverse Events will be 
recorded in the study database, reviewed with the study PIs to assess relationship to 
medication changes, and reviewed with the Safety Board during bi-annual safety meetings. 
• 
Serious Adverse Events include death, hospitalization, life threatening events, and 
unanticipated problems that pose a risk to subjects or others.  All such events that are 
considered study-related as defined above will be reported to the Safety Board, IRBs, and 
awarding IC within 24 hours.   

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 29 of 45 
 
• 
Adverse events related to prescribing osteoporosis medication will be monitored in the same 
fashion as above.  The following will be considered potentially study-related: gastrointestinal 
distress, esophagitis, injection site reactions (for subcutaneous medications), 
hypocalcemia/hypercalcemia significant enough to warrant an unplanned visit from the 
MD/NP. 
• 
Resident reports of or suspected abuse and neglect by NH staff witnessed by study staff:  
Study staff will be trained to report such events to the PIs immediately.  We will follow the 
process described in Human Subjects to report these to the NH leadership and/or the State 
Ombudsman.  Study staff will follow-up within 1 week and then as needed for resolution of 
the issue.  All such events and their resolution will be reported in writing by the co-PIs and 
within 24 hours to the Safety Board and the IRBs. 
• 
Non-study related Serious Adverse Events (SAEs)  including deaths, hospitalizations, and 
life threatening events and Unanticipated Problems (UPs) will be identified via MDS review 
quarterly, and additional information (clinical notes, hospital discharge summaries) will be 
reviewed in the EMR by study staff.  These non-study related SAEs will be reviewed by the 
Safety Board during bi-annual meetings. 
The frequency of monitoring varies with the type of event and is described above.  Safety 
Monitoring Board meetings will be scheduled bi-annually.  Given the short duration and small 
sample size of this pilot study, there are no plans for interim analysis or stopping rules. 
If a resident discloses acute symptoms, or reports/displays signs of abuse or neglect to study 
staff during any of the planned interviews, we will employ a process that has worked 
successfully in other NH studies. We will work with nursing leadership at each facility at the 
onset of the interviews to establish a plan that will include completion of a standardized report 
form to be given to the NH Director of Nursing and Administrator within 24 hours 
Individual(s) responsible for trial monitoring and advising the appointing entity include the PIs 
and Independent Safety Board as described above. 
 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 30 of 45 
 
10. STATISTICAL CONSIDERATION 
This is a pilot study to test design and test implementation of the ILS Program in four nursing 
home facilities. We will largely use descriptive statistics to present our results, and to inform the 
sample size calculation for a future pragmatic RCT. The following statistical considerations will 
be considered: 
• 
Qualitative Study (Aim 1) - Using NVivo software, investigators will identify themes and 
touch points described by participants in an open coding process.  Short audio clips may be 
created to illustrate each theme and re-organized into ethnography of the fall prevention 
experience, with audio clips preserving the family and staff voices.42 A similar process will 
occur to analyze the post-implementation interviews from staff and proxies, in order to 
identify themes surrounding implementation barriers. 
In addition, the team will use process flow mapping techniques to describe each step, 
however minor, necessary to 1) program the automatic calculation of injury risk using the 
FRAiL model, 2) deprescribe psychoactive and cardiometabolic medications associated with 
falls and injury, 3) prescribe osteoporosis treatment to reduce injury risk in the setting of a 
fall, and 4) introduce other best practices to prevent injurious falls in the NH.   
• 
ILS Implementation (Aim 2) - Quantitative measures of acceptability, demand, fidelity, and 
practicality as defined in Table 1 will be described using descriptive statistics.  As is 
standard in pilot studies, our sample size target is based on the expected proportion of high-
risk residents in the 4 pilot facilities and no statistical testing is planned, thus, formal power 
calculation was not conducted.  However, our goal is to achieve 50% adherence with 
suggested medication changes, and our sample of 80 residents is sufficient to demonstrate 
this with a 95% Confidence Interval of +/- 5% [95% CI assuming SD 10% is 47.8-52.2%; 
assuming SD 20% is 45.6-54.5%]. We will refine the ILS Program until >50% acceptance of 
ILS recommendations is achieved, using the targets set in Table 1. 
Following current recommendations, we will not power the future pragmatic trial on the 
results of this small implementation study with unstable efficacy estimates, but rather we will 
use our clinical knowledge and results of previously published trials of deprescribing in order 
to inform the sample size calculation.43  
• 
Validate Injurious Falls (Aim2c) - We will compare the occurrence of falls with injuries using 
MDS data with the occurrence according to chart review. The MDS defines major injury as 
any fall resulting in a fracture, joint dislocation or intracranial hemorrhage, whereas a minor 
injury includes falls resulting in abrasions, lacerations requiring sutures, hematoma, or pain.  
Participating facilities (Croasdaile Village and Hebrew Rehabilitation Center) will be asked to 
provide limited MDS data for all residents in the facility. A research assistant will conduct a 
chart review (all provider and nursing notes from EMR) of a random sample of 
approximately 300 patients to determine whether any injurious falls were documented. 
Agreement between the MDS and chart review will be compared using Cohen’s Kappa test. 
We will also calculate the sensitivity, specificity, and positive and negative predictive value 
of the MDS to identify injurious falls, as compared with the gold standard of chart review.  

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 31 of 45 
 
11. DATA SECURITIES 
11.1. Data Transfer Agreement 
We will request a Memorandum of Understanding between Hebrew SeniorLife and each of the 
four facilities allowing for the facilities to share limited MDS information and falls log for all long 
stay residents during the study. Other data collected will not require a data agreement: for 
example the facility level data comes from public data sources and resident data will be 
obtained from residents’ medical charts, and a brief nurse interview.  
 11.2. Safety Measures 
Data recorded on paper by NH staff for the support of the program management or data 
collection (e.g., lists of eligible staff/residents, fall logs) as well as audiorecorded interviews, will 
be maintained in the study staff in a locked case at all times when in the facility, and transported 
back to Hebrew SeniorLife and/or Duke University School of Medicine to be stored in a locked 
cabinet.  PHI/data for eligible residents will be stored on secure Duke servers accessible 
only to study staff, and communicated to providers by secure email behind the Duke 
firewall. 
All other data (e.g., EMR reports, chart abstraction) will be entered directly into a research 
database (REDCap) stored behind the Hebrew SeniorLife firewall.  Only IRB-approved study 
staff will have access to these data. The co-PIs and informatics personnel bear primary 
responsibility for overseeing privacy and security of research data.  Risk mitigation strategies 
include: 1) developing a limited dataset with direct identifiers maintained separately in a cross-
walk file as soon as data collection is completed; 2) restricting access to folders containing 
research data to approved personnel only; 3) individual research data will be used only for 
analyses to complete study aims; 4) not transmitting individual data outside the HSL firewall; 5) 
never storing research data on a computer hard drive. 
Should any incident such as theft or loss of data, unauthorized access of sensitive data or non-
compliance with security controls occur it will be immediately reported according to HSL policy. 
All incidents regarding information security/privacy incidents will be reported to the HSL IRB and 
NIH within 24 hours of acknowledgement of issue. Reporting of results, such as in scientific 
papers and presentations, will never identify individual subjects.  Data will be presented in 
aggregate and individual-level data will not be published. 
11.3. Data Management  
Data management and analysis for the study will take place at HSL under the direction of the 
informatics and biostatistics cores at the Marcus Institute for Aging Research (IFAR). Audio 
recorded interviews will be transcribed at Duke University with identifiers removed, whenever 
possible, and stored on Duke University’s secure IT network. GMR Transcription Services, 
Inc. will be provided with the audio files, which are considered protected health 
information.  Duke will establish a services contract with GMR Transcription Services for 
this project.   All access to data is restricted to those on the research team who have been 
authorized by the PI to use this information. The HSL information technology (IT) department 
adheres to all the policies and practices under HIPAA regulations and is responsible for 
securing IFAR's IT infrastructure including physical servers and application software. IFAR has 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 32 of 45 
 
established additional sensitive data policies and procedures in concert with the IRB to ensure 
safe data handling by faculty and staff.  

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 33 of 45 
 
12. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
12.1. Institutional Review Board (IRB) Review 
This protocol and the HIPAA waiver applications will be reviewed and approved by Hebrew 
Senior Life’s IRB.  Duke University School of Medicine and Brown University will cede IRB 
review to Hebrew SeniorLife. Continuation of study is contingent on annual review and approval 
by the IRB.  Any changes to study protocol or materials will be submitted to the IRB for review 
and approval prior to implementation.   
12.2. Informed Consent 
Because the ILS program poses minimal risk to subjects and represents best practices for 
medication optimization, we will request a waiver of individual authorization for disclosure of 
personal health information necessary to screen and follow residents. All long-term stay 
residents/families in the facilities will be mailed a letter describing the study with the option to 
opt out, as described above. Staff will provide verbal assent to provide feedback on study 
feasibility and acceptability, but no PHI will be recorded and a waiver of informed consent will 
also be requested for this minimal risk activity. 
 
We are audiorecording and transcribing stories from a subset of residents, proxies, and staff 
about their fall prevention experiences. While transcripts will remove all names, the stories 
themselves may remain identifiable. Therefore, we will approach potential subjects for informed 
consent (non-written).  
 
For the patient/proxy interviews, residents may lack capacity to consent for research due to 
cognitive impairment. Those with severe dementia indicated in their medical record will be 
unlikely to participate in the interview, and their proxy will be contacted as below. Those with 
moderate dementia indicated on their medical record will be approached in their room for assent 
to contact their proxy and participate in an interview together with their proxy; those who agree 
will have their proxy contacted as below. Those with no or mild dementia indicated on their 
medical record will be approached in their room and the study procedures described. We will 
then administer the Evaluation to Sign Consent (ESC) measure, which is an assessment of 
understanding that has been validated in NH residents (see attached ESC). Those who are able 
to describe a risk of participation and summarize study activities will be asked to proceed with 
the interviews (verbal informed consent). They will have as much time as they choose to 
consider and read the informed consent document. Phone numbers of study staff will be 
provided to answer additional questions. Those who do not pass the ESC will be asked for 
assent, and if provided their proxy contacted as below. Proxies will be contact in-person if 
encountered in the NH, or by phone if not. Study procedures will be described and written 
informed consent obtained as above. Proxies are assumed to have capacity to provide informed 
consent for research for this low risk study by virtue of their designated role as proxy for a 
vulnerable older adult. Phone numbers of study staff will be provided to answer additional 
questions.   
 
12.3 Participant Confidentiality  
This trial will be granted a HIPAA Waiver of Requirement for Authorization for Release of 
Protected Health Information for Research Purposes from the Hebrew Senior Life IRB.   In order 
to preserve confidentiality, subjects will be assigned a study number for tracking and reporting 
purposes.  All physical documentation and IT assets are stored in a locked areas within the 
participating NHs and within HSL, monitored 24-hours a day by security personnel, and 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 34 of 45 
 
accessible only by authorized employees. Access to the HSL cooperate computer network is 
strictly prohibited and all electronic research data will be stored on dedicated IFAR systems 
located on our private network. Access to these data will be limited to study personnel on a 
“need to know” basis. If a NH resident is deemed ineligible for the study, all personal health 
information obtained for screening purposes will be destroyed as soon as possible. 
 
 
13. PUBLICATION OF RESEARCH FINDINGS 
Publication of the results of this trial will be governed by the co-PIs.   

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 35 of 45 
 
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Protocol Number: 1.11  Version Date:  February 14, 2022 Page 38 of 45 
 
Appendix 1 
NH PRIDE Study Medication Algorithms 
Table 1.  Algorithm for Deprescribing Medications Associated with Falls and Injury in NH-PRIDE Study 
Drug Class 
Criteria 
Deprescribing 
Schedule  
Study Team will 
Monitor 
Nursing will notify 
MD/NP for new 
symptoms 
Alternative 
Therapies and 
Approaches 
Benzodiazepines 
• 
Used for 
insomnia, OR 
• 
Used for 
other sleep 
disorder and 
alternative 
therapies not 
tried, OR 
• 
Well-
controlled 
mental 
health 
condition 
AND no acute 
anxiety for 1 
year, OR 
• 
Restless Legs 
Syndrome 
(RLS)/ 
Periodic Limb 
Movement 
Disorder 
(PLMD) 
• 
25% dose 
reduction 
from starting 
dose every 2 
weeks, 
12.5% last 2 
weeks (over 
a total of 8 
weeks) 
• 
If 
withdrawal 
symptoms 
appear (see 
“Monitoring
”), maintain 
the current 
dose for one 
to two 
additional 
weeks and 
then resume 
the taper  
• 
2 MDS 
assessments 
post 
intervention: 
MDS items 
pertaining to 
mood, 
behaviors 
and function 
(ADLs) 
• 
Chart review 
at 1 and 4 
months post 
intervention: 
behaviors, 
worsening 
psychiatric 
symptoms, 
insomnia, 
functional 
decline 
hospitalizatio
ns, ED visits 
• 
Nursing to notify 
MD/NP for 
withdrawal 
symptoms 
during  
medication 
reduction period 
including 
 insomnia, 
anxiety, 
irritability, and 
gastrointestinal 
symptoms 
(End date for 
this order is the 
same end date 
of the taper) 
• 
For insomnia, 
employ non-
pharmacologic 
strategies 
described 
below if 
insomnia 
reoccurs or 
persists during 
tapering 
• 
If used for 
RLS/PLMS, 
may try 
dopamine 
agonist  
• 
If anxiety 
recurs and 
drug therapy is 
required, 
consider a 
selective 
serotonin 
reuptake 
inhibitor (SSRI) 
antidepressant
, particularly 
citalopram or 
sertraline 
Antipsychotics 
• 
Used for 
behavior 
problems in 
or symptoms 
of dementia 
(e.g., 
psychosis, 
agitation, 
aggression) 
OR 
• 
Well-
controlled 
mental 
health 
condition 
AND no 
psychosis 
• 
Dementia 
with 
behaviors: 
25% dose 
reduction 
every 2 
weeks with 
goal of 
discontinuin
g or lowest 
dose 
possible to 
control 
symptoms 
(over a total 
of 8 weeks) 
• 
Other 
• 
2 MDS 
assessments 
post 
intervention: 
MDS items 
pertaining to 
mood, 
behaviors 
and function 
(ADLs) 
• 
Chart review 
at 1 and 4 
months post 
intervention: 
behaviors, 
worsening 
psychiatric 
• 
Nursing to notify 
MD/NP for 
dyskinesias, 
insomnia, 
nausea, 
worsening 
psychosis, 
aggression, or 
hallucinations 
during 
medication 
reduction period 
(End date for 
this order is the 
same end date 
of the taper) 
• 
For insomnia, 
behavioral 
strategies, 
specifically 
consistent 
wake-sleep 
times, opening 
curtains during 
the day to 
maximize 
bright light 
exposure, 
increasing 
daytime 
activity, 
decreasing 
napping, and 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 39 of 45 
 
past year 
AND dose 
higher than 
minimal 
effective 
dose, OR 
• 
Used for 
insomnia   
 
 
mental 
health 
condition: 
25% dose 
reduction 
every 2 
weeks with 
goal of 
minimal 
effective 
dose or 
lowest dose 
to control 
symptoms. 
• 
Insomnia: 
25% dose 
reduction 
every 2 
weeks with 
goal of 
discontinuati
on 
symptoms, 
insomnia, 
functional 
decline 
hospitalizatio
ns, ED visits 
toileting 
before bed 
 
 
 
Antidepressants 
• 
Well-
controlled 
symptoms on 
stable dose 
>1 year   
• 
1st episode of 
depression 
OR dose > 
minimal 
effective 
dose 
• 
No history of 
symptom 
relapse on 
discontinuati
on in the 
prior 2 years 
• 
Recurrent: 
50% dose 
reduction 
every 2 
weeks to 
minimal 
effective 
dose or 
lowest dose 
to control 
symptoms 
(over a total 
of 8 weeks) 
• 
1st episode: 
50% dose 
reduction 
every 2 
weeks to d/c 
or lowest 
dose to 
control 
symptoms 
• 
2 MDS 
assessments 
post 
intervention: 
MDS items 
pertaining to 
mood, 
behaviors 
and function 
(ADLs) 
• 
Chart review 
at 1 and 4 
months post 
intervention: 
behaviors, 
worsening 
psychiatric 
symptoms 
insomnia, 
functional 
decline 
hospitalizatio
ns, ED visits 
• 
Nursing to notify 
MD/MP for 
withdrawal 
symptoms, 
including 
akathisia, 
anxiety, chills, 
gastrointestinal 
distress, 
headache, 
insomnia, 
irritability, 
malaise, 
myalgia, during 
medication 
reduction period 
(End date for 
this order is the 
same end date 
of the taper) 
• 
If drug therapy 
is necessary, 
consider an 
SSRI, 
particularly 
citalopram or 
sertraline 
Hypnotics 
• 
Periodic 
insomnia not 
impacting 
quality of life 
• 
50% dose 
reduction 
every 2 
weeks to d/c 
• 
If 
withdrawal 
symptoms 
appear (see 
“Monitoring
• 
2 MDS 
assessments 
post 
intervention: 
MDS items 
pertaining to 
mood, 
behaviors 
and function 
• 
Nursing to notify 
MD/NP for 
withdrawal 
symptoms, 
including 
insomnia, 
anxiety, 
irritability, and 
gastrointestinal 
• 
Melatonin 
• 
Behavioral 
strategies, 
specifically 
consistent 
wake-sleep 
times, opening 
curtains during 
the day to 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 40 of 45 
 
”), maintain 
the current 
dose for one 
to two 
additional 
weeks and 
then resume 
the taper 
 
(ADLs) 
• 
Chart review 
at 1 and 4 
months post 
intervention: 
behaviors, 
worsening 
psychiatric 
symptoms, 
insomnia, 
functional 
decline 
hospitalizatio
ns, ED visits 
symptoms, 
during 
medication 
reduction 
period. 
(End date for 
this order is the 
same end date 
of the taper) 
maximize 
bright light 
exposure, 
increasing 
daytime 
activity, 
decreasing 
napping, and 
toileting 
before bed 
Anticholinergics 
• 
Used for 
insomnia, OR 
• 
Used for 
muscle 
relaxant, OR 
• 
Short acting 
agent used 
for urinary 
urgency, OR 
• 
Itching 
• 
No taper 
needed 
 
• 
2 MDS 
assessments 
post 
intervention: 
MDS items 
pertaining to 
pain and 
urinary 
incontinence 
• 
Chart review 
at 1 and 4 
months post 
intervention: 
pain, new 
urinary 
incontinence, 
itching, 
insomnia, 
functional 
decline, 
hospitalizatio
ns, ED visits 
• 
Nursing to notify 
MD/NP for 
withdrawal 
symptoms 
specific to the 
agent being 
deprescribed 
during 
medication 
reduction 
period. 
(End date for 
this order is the 
same end date 
of the taper) 
• 
Alternatives 
depend on 
indication 
(e.g., 
melatonin for 
insomnia, 
topicals for 
itching) 
• 
 
Antiepileptics 
• 
Taper only 
attempted if 
used for 
behavioral 
symptoms of 
dementia 
• 
Variable 
based on 
agent 
• 
2 MDS 
assessments 
post 
intervention: 
MDS items 
pertaining to 
mood, 
behaviors 
and function 
(ADLs) 
• 
Chart review 
at 1 and 4 
months post 
intervention: 
behaviors, 
worsening 
psychiatric 
symptoms, 
• 
Nursing to 
monitor for 
increased 
confusion, 
irritability, 
tachycardia, and 
diaphoresis; if 
noted, perform 
dose increases 
no more 
frequently than 
every 14 days 
• 
Some individuals 
may experience 
insomnia, so 
prioritize 
deprescribing of 
doses earlier in 
• 
Consider non-
pharmacologic 
therapies and 
approaches 
like 
implementatio
n of activities, 
music therapy, 
sensory 
interventions 
(e.g., 
massage), 
structured 
routines, and 
light therapy 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 41 of 45 
 
insomnia, 
functional 
decline 
hospitalizatio
ns, ED visits 
the day first  
(End date for 
this order is the 
same end date 
of the taper) 
Alpha Blockers 
• 
Used for BPH, 
OR 
• 
Used for 
hypertension 
with majority 
of SBP < 140 
mmHg OR 
other 
antihypertens
ives have not 
been tried 
• 
No taper 
needed  
• 
2 MDS 
assessments 
post 
intervention: 
MDS items 
pertaining to 
function 
(ADLs) 
• 
Chart review 
at 1 and 4 
months post 
intervention: 
elevated 
blood 
pressure, 
tachycardia, 
functional 
decline 
hospitalizatio
ns, ED visits 
• 
Nursing will 
check blood 
pressure twice 
weekly during 
medication 
reduction 
period; report 2 
or more 
readings of SBP 
> 160 mmHg to 
clinician. 
(End date for 
this order is the 
same end date 
of the taper) 
 
• 
If drug therapy 
is ultimately 
necessary, try 
other 
antihypertensi
ve (e.g., 
amlodipine) 
• 
Alternative 
treatments for 
hypertension 
are unlikely to 
be necessary 
Beta Blockers 
• 
Used for 
hypertension 
OR another 
indication 
aside from 
rate control 
• 
50% dose 
reduction 
every 2 
weeks to 
discontinuati
on (over a 
total of 8 
weeks) 
• 
2 MDS 
assessments 
post 
intervention: 
MDS items 
pertaining to 
behaviors, 
mood, 
function 
(ADLs) 
• 
Chart review 
at 1 and 4 
months post 
intervention: 
elevated 
blood 
pressure, 
tachycardia, 
behaviors, 
anxiety, 
functional 
decline 
hospitalizatio
ns, ED visits 
• 
Nursing will 
check blood 
pressure twice 
weekly during 
medication 
reduction 
period; report 2 
or more 
readings of SBP 
> 160 mmHg  to 
clinician 
(End date for 
this order is the 
same end date 
of the taper) 
• 
Alternative 
treatments are 
unlikely to be 
necessary 
Other 
Antihypertensive 
Drugs (calcium 
channel blocker, 
angiotensin 
• 
SBP 
<140mmHg 
• 
50% dose 
reduction 
every 2 
weeks to d/c 
or SBP 141-
• 
2 MDS 
assessments 
post 
intervention: 
MDS items 
• 
Nursing will  
check blood 
pressure twice 
weekly during 
medication 
• 
Alternative 
treatments are 
unlikely to be 
necessary, but 
behavioral 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 42 of 45 
 
converting 
enzyme 
inhibitor, or 
angiotensin 
receptor 
blocker) 
160mmHg 
pertaining to 
function 
(ADLs) 
• 
Chart review 
at 1 and 4 
months post 
intervention: 
elevated 
blood 
pressure, 
tachycardia, 
functional 
decline 
hospitalizatio
ns, ED visits 
reduction 
period; report 2 
or more 
readings of SBP 
> 160 mmHg to 
MD/NP 
(End date for 
this order is the 
same end date 
of the taper) 
therapies like 
transcendental 
meditation or 
biofeedback 
techniques 
may have a 
role 
Diuretics 
• 
Used for 
venous stasis 
or 
lymphedema, 
OR 
• 
Used for 
hypertension 
with SBP < 
140mmHg 
OR other 
classes not 
tried 
• 
No taper 
needed 
 
• 
2 MDS 
assessments 
post 
intervention: 
MDS items 
pertaining to 
function 
(ADLs) 
• 
Chart review 
at 1 and 4 
months post 
intervention: 
elevated 
blood 
pressure, CHF 
exacerbation, 
functional 
decline, 
hospitalizatio
ns, ED visits 
• 
Nursing will 
check blood 
pressure twice 
weekly during 
medication 
reduction; 
report 2 or 
more readings 
of SBP > 160 
mmHg to 
MD/NP. 
• 
Obtain weekly 
weights x 4 
weeks; nursing 
to notify MD/NP 
of weight gain 
>=5 lbs  
(End date for 
this order is the 
same end date 
of the taper) 
• 
Employ 
compression 
hose 
• 
May try other 
antihypertensi
ve (e.g., 
lisinopril), 
especially if 
SBP increases 
to >180  
mmHg or DBP 
increases to 
>100 mmHg 
 
Proton Pump 
Inhibitors 
• 
Continuous 
PPI use >8 
weeks, AND 
• 
No long-term 
use of non-
steroid anti-
inflammatory 
drugs, history 
of bleeding 
stomach 
ulcer(s), 
severe 
inflammation 
of the 
esophagus, 
or Barrett’s 
esophagus 
• 
Reduce dose 
by half every 
2 weeks 
(over a total 
of 4 weeks), 
OR 
• 
In the case 
of capsules 
that cannot 
be split or 
broken in 
half, take a 
dose every 
other day 
for 2 weeks 
and then 
take a dose 
every 3 days 
• 
2 MDS 
assessments 
post 
intervention: 
MDS items 
pertaining to 
behaviors, 
pain, function 
(ADLs) 
• 
Chart review 
at 1 and 4 
months post 
intervention: 
gastroesopha
geal reflux, 
functional 
decline 
hospitalizatio
• 
Nursing to notify 
MD/NP for 
symptom 
recurrence, 
including 
heartburn, 
dyspepsia, 
regurgitation, or 
anorexia during 
medication 
reduction 
period. 
(End date for 
this order is the 
same end date 
of the taper) 
• 
If heartburn, 
acid reflux, or 
rebound 
symptoms 
occur after 
discontinuatio
n, elevate 
resident’s 
head by using 
extra pillows 

Protocol Number: 1.11  Version Date:  February 14, 2022 Page 43 of 45 
 
for 2 weeks 
(over a total 
of 4 weeks) 
 
ns, ED visits 
Hypoglycemics – 
Sulfonylureas, 
Meglitidines 
• 
Most recent 
hemoglobin 
A1C <8.5, OR 
• 
Insulin dose 
is >40 
units/day, OR 
• 
Patient 
refusing to 
eat or is 
eating 
irregularly 
• 
No taper 
needed 
 
• 
2 MDS 
assessments 
post 
intervention: 
MDS items 
pertaining to 
function 
(ADLs) 
• 
Chart review 
at 1 and 4 
months post 
intervention: 
severe 
hyperglycemi
a (>400), 
polydipsia, 
polyuria, 
functional 
decline 
hospitalizatio
ns, ED visits 
• 
Nursing will 
measure fasting 
blood twice 
weekly for 2 
weeks.  Notify 
MD/NP for any 
BG >300 or >2 
values over 200. 
(End date for 
this order is the 
same end date 
of the taper) 
 
• 
Substitute 
dipeptidyl 
peptidase-4 
inhibitor if A1C 
rises to >9 
(Goal is to 
achieve 
hemoglobin 
A1C 8-9 AND 
no episodes of 
severe 
hypoglycemia 
or severe 
hyperglycemia
) 
Hypoglycemics – 
Sliding Scale 
Insulin (SSI)* 
• 
Type II 
Diabetes, 
AND 
• 
SSI is the only 
insulin 
treatment, 
OR 
• 
SSI in 
addition to 
basal insulin, 
OR 
• 
SSI in 
addition to 
basal insulin 
and mealtime 
insulin 
• 
No taper 
needed 
• 
If  most 
recent 
hemoglobin 
A1C<=8.5, 
discontinue 
SSI without 
adding 
treatment 
 
• 
2 MDS 
assessments 
post 
intervention: 
MDS items 
pertaining to 
function 
(ADLs) 
• 
Chart review 
at 1 and 4 
months post 
intervention: 
severe 
hyperglycemi
a (>400), 
polydipsia, 
polyuria, 
functional 
decline 
hospitalizatio
ns, ED visits 
• 
Nursing will 
measure fasting 
blood sugar 
daily for 2 
weeks.  Notify 
MD/NP for any 
BG >300 or >2 
values over 200 
(End date for 
this order is the 
same end date 
of the taper) 
• 
If most recent 
hemoglobin 
A1C>8.5, 
review 
average daily 
insulin 
requirement 
over prior 5–7 
days, then 
initiate basal 
insulin at 50–
75% of that 
average daily 
insulin 
requirement 
 
*Please see separate table for additional scenarios related to sliding scale insulin which 
deprescribing may be appropriate. 

MPI: Sarah Berry, MD, MPH, Cathleen Colón-Emeric, MD, MHS 
Protocol Number: 1.7    Version Date:  February 22, 2021     
Page 44 of 45 
Table 2. Algorithm for Prescribing Osteoporosis Treatment in NH-PRIDE study 
 
 
Drug Class 
Prescribing Criteria 
Study Team will Monitor 
Nursing will notify 
MD/NP for new 
symptoms 
Treatment Options 
Calcium and 
Vitamin D 
• 
Life expectancy > 6 months 
based on MDS question 
J1400 or  validated tool, and 
not enrolled in hospice, 
AND 
• 
No evidence of 
hypercalcemia 
(>10.5mg/dL) by chart 
review 
• 
2 MDS assessments post 
intervention: MDS items 
pertaining to function 
(ADLs) 
• 
Chart review at 1 and 4 
months post 
intervention: elevated 
serum calcium 
(>10.5mg/dL), worsening 
constipation, functional 
decline hospitalizations, 
ED visits 
• 
Nursing will notify 
MD/NP for 
worsening 
constipation 
• 
Ensure 1200mg 
calcium through 
diet and 
supplements. 
• 
1000-2000IU 
vitamin D daily 
Antiresorptives 
• 
Estimated FRAiL score≥ 10% 
OR Estimated FRAiL score ≥ 
5% + history of fracture 
• 
Life expectancy >6 months 
based on MDS question 
J1400 or validated tool, and 
not enrolled in hospice 
• 
No contraindications 
(allergy, etc.) 
• 
2 MDS assessments post 
intervention: MDS items 
pertaining to function 
(ADLs) 
• 
Chart review at 1 and 4 
months post 
intervention: 
gastroesophageal reflux, 
esophagitis, injection site 
reactions (for 
subcutaneous 
medications),  
hypocalcemia 
(<8.7mg/dL), functional 
decline, hospitalizations, 
ED visits 
• 
Nursing will 
assure proper 
administration of 
oral 
bisphosphonates 
(taken on empty 
stomach, sit 
upright for at least 
30 minutes 
afterwards). 
• 
Nursing will notify 
MD/NP for 
worsening 
indigestion, 
injection site 
reactions (for 
subcutaneous 
medications) 
• 
Oral 
bisphosphonate 
• 
IV 
bisphosphonate 
• 
SQ denosumab 

MPI: Sarah Berry, MD, MPH, Cathleen Colón-Emeric, MD, MHS 
Protocol Number: 1.7    Version Date:  February 22, 2021     
Page 45 of 45 
 
 
 
 
 
 
Table 3. Sliding Scale Insulin (adapt from Munshi et al. Management of Diabetes in Long-term Care and Skilled 
Nursing Facilities: A Position Statement of the American Diabetes Association. Diabetes Care. 2016) 
Criteria 
Schedule and Alternative Therapies  
Scenarios in Which Deprescribing is a Focus 
• 
SSI is the only insulin treatment  
• 
Discontinue (no taper necessary) 
• 
If  most recent hemoglobin A1C<=8.5, discontinue SSI 
without adding treatment 
• 
If most recent hemoglobin A1C>8.5, review average 
daily insulin requirement over prior 5–7 days, then 
initiate basal insulin at 50–75% of that average daily 
insulin requirement  
• 
SSI is used in addition to scheduled basal insulin  
• 
Discontinue SSI 
AND 
• 
Add 50-75% of the average insulin requirement used as 
SSI to the current dose of basal insulin 
-- 
• 
If postprandial hyperglycemia persists, add either fixed-
dose mealtime insulin OR a non-insulin agent (preferably 
a  dipeptidyl peptidase-4 inhibitor or other agent with 
low hypoglycemia risk) 
• 
SSI is used in addition to scheduled basal insulin AND scheduled meal 
time insulin (i.e., correction dose insulin) 
• 
Discontinue correction doses 
AND 
• 
Add the average correction dose before a meal to the 
scheduled mealtime insulin dose at the preceding meal 
-- 
• 
See Munshi et al. Diabetes Care 2016 position statement 
for additional details and examples. 
Other Scenarios in Which Immediate Deintensification May Be Appropriate 
• 
SSI is used in short term due to irregular dietary intake or due to 
acute illness 
• 
Discontinue SSI and return to previous regimen once 
health and glucose levels stabilize 
• 
Monitor acute illness prior to discontinuation and 
promote regular dietary intake 
• 
Short-term use of SSI is appropriate during the episode 
of acute illness while dietary intake is irregular 
• 
Wide fluctuations in glucose levels in patients with cognitive decline 
and/or irregular dietary intake on a chronic basis 
• 
Order scheduled basal and mealtime insulin based on 
individual needs with the goal of avoiding hypoglycemia 
• 
Consider a simple scale such as  “give 4 units of 
mealtime insulin if glucose >300 mg/dL” 
• 
Focus on keeping residents hydrated, especially when 
glucose levels are high (e.g., >300 mg/dL)