Removing Home Hazards for Older Adults
Phase: NA
Conditions: Accidental Falls
Sponsor: Washington University School of Medicine

Protocol Template, Version 1.0 
 
 
Home Hazards Removal Program (HARP) 
Principal Investigator: 
Susan Stark, PhD, OTR/L 
Assistant Professor Occupational Therapy, Neurology and Social Work  
Supported by: 
Department of Housing and Urban Development 
 
Version 1  
October 1, 2014

Protocol Template, Version 1.0 
 
i 
 
TABLE OF CONTENTS 
Page 
TABLE OF CONTENTS .............................................................................................................. i 
1 
STUDY TEAM ROSTER..................................................................................................... 5 
2 
Study objectives ..................................................................................................................... 6 
2.1 
Primary Objective ........................................................................................................... 6 
2.2 
Secondary Objectives...................................................................................................... 6 
3 
BACKGROUND AND RATIONALE ................................................................................ 6 
3.1 
Background on Condition, Disease, or Other Primary Study Focus .............................. 6 
3.2 
Study Rationale ............................................................................................................... 7 
4 
STUDY DESIGN ................................................................................................................... 8 
4.1 
Timeline and Tasks ......................................................................................................... 9 
5 
Selection and enrollment of participants .......................................................................... 10 
5.1 
Inclusion/Exclusion Criteria ......................................................................................... 10 
5.2 
Study Enrollment Procedures ....................................................................................... 10 
6 
STUDY INTERVENTIONS .............................................................................................. 11 
6.1 
Study Interventions ....................................................................................................... 11 
7 
STUDY PROCEDURES .................................................................................................... 12 
7.1 
Schedule of Evaluations ................................................................................................ 12 
7.2 
Overview ....................................................................................................................... 12 
7.3 
Description of Evaluations ............................................................................................ 13 
7.3.1 Screening Evaluations ............................................................................................... 13 
7.3.2 Enrollment, baseline, randomization ........................................................................ 13 
7.3.3 Intervention and follow up sessions .......................................................................... 16 
7.3.4 Completion/Final Evaluation .................................................................................... 17 
7.4 
Process evaluation ......................................................................................................... 17 
7.4.1 Recruitment ............................................................................................................... 17 
7.4.2 Fidelity ...................................................................................................................... 18 

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7.4.3 Dose .......................................................................................................................... 18 
7.4.4 Adherence ................................................................................................................. 18 
7.4.5 Safety ........................................................................................................................ 18 
7.4.6 Cost ........................................................................................................................... 18 
7.5 
Overview of study assessments by time point. ............................................................. 19 
8 
SAFETY ASSESSMENTS ................................................................................................. 20 
8.1 
Safety Parameters.......................................................................................................... 20 
8.2 
Adverse Events and Serious Adverse Events ............................................................... 20 
8.3 
Reporting Procedures .................................................................................................... 20 
8.4 
Follow-up for Adverse Events ...................................................................................... 20 
9 
INTERVENTION DISCONTINUATION........................................................................ 20 
10 STATISTICAL CONSIDERATIONS .............................................................................. 21 
9.1 
Sample Size and Randomization .................................................................................. 21 
10.3 
Data Analyses ............................................................................................................... 21 
11 DATA COLLECTION AND QUALITY ASSURANCE ................................................ 22 
11.1 
Data Collection Forms .................................................................................................. 22 
11.2 
Data Management ......................................................................................................... 22 
11.3 
Quality Assurance ......................................................................................................... 23 
11.4 
Quality-assurance oversight .......................................................................................... 23 
11.4.1 
Protocol Deviations ............................................................................................... 23 
12 PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................. 23 
12.1 
Institutional Review Board (IRB) Review .................................................................... 23 
12.2 
Study Discontinuation ................................................................................................... 24 
13 PUBLICATION OF RESEARCH FINDINGS ................................................................ 24 
14 REFERENCES .................................................................................................................... 24 
15 SUPPLEMENTS/APPENDICES ...................................................................................... 24 
 
 
 

Protocol Template, Version 1.0 
 
iii 
PRÉCIS 
Title: Removing Home Hazards for Older Adults 
 
Investigators:  Susan Stark, PhD, OTR/L &  Yan Yan, MD, PhD  
Washington University School of Medicine, St. Louis, Missouri 
 
Falls remain the leading cause of injury, long-term disability, premature institutionalization, and 
injury-related mortality among older adults and are projected to cost nearly $59.7 billion by 
2020.12-15, 71 Fall-related mortality increases with age.72 Although numerous clinical interventions 
have demonstrated efficacy in reducing the incidence of falls,73 translation to the community has 
failed; fall rates continue to escalate. Indeed, nearly one third of all adults older than 65 years fall 
each year. The majority of falls experienced by older adults, particularly more frail high risk 
older adults, occur in the home, 12, 24, 25 and measurable home hazards are associated with an 
increased risk of older persons falling in the United States.74,26 
 
Setting. This intervention will be implemented and evaluated in the urban core of St. Louis, 
Missouri, an area of high need for an effective fall prevention program. In Missouri, the fall 
death rate for older adults is consistently higher than the national average. The rate nearly 
doubled between 2000 and 2009 from 38 to 72.32 per 100,000.75  Falls are the leading cause of 
unintentional injury-related hospitalizations and ED visits among older Missourians; older adults 
account for 64% of all ED visits and hospitalizations resulting from falls, which is higher than 
national rates. 76, 77 
 
Our long-term goal is to improve older adults’ ability to maintain their independence and safety 
in the community by translating fall prevention research into effective community programs.  We 
plan to establish the effectiveness of a program that demonstrated a reduction in falls among 
community-dwelling older adults at high risk for a fall. It is a practical and scalable intervention 
recommended by the Centers for Disease Control and Prevention(CDC).1 The intervention will 
be delivered by OTs in an Area Agency on Aging (AAA)—part of the Aging Services Network53 
in the US. We will use community-engaged research approaches54 and a hybrid design55 to study 
both the effect of the intervention in a real world setting and the implementation strategy. We 
will prepare for dissemination56 by providing cost estimates, fidelity metrics, and intervention 
manuals.  
 
Design of study:  
To examine the effect of a home modification (home hazard removal) program, we will conduct 
a hybrid effectiveness/implementation trial of 300 older adults at risk for a fall randomized to a 
home hazard removal program or usual care, and follow them for 12 months. We will conduct a 
pragmatic randomized controlled trial/implementation study  
 
Recruitment: We will recruit participants through the SLAAA’s annual assessment of 
participant’s health.  .   
 
Deliver intervention: Interventionists will use a manualized protocol to deliver the intervention.   
 

Protocol Template, Version 1.0 
 
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Follow up: We will follow participants monthly using a highly successful calendar journal 
technique that has demonstrated a 99% response rate in previous studies.   
 
Dissemination: We will disseminate the program, manuals and training programs using our 
advisory network.   
 
Objectives of study: 
1. Determine the acceptability costs and feasibility of delivering the program in an Area 
Agency on Aging. We will conduct a process evaluation78 of the intervention to aid in 
dissemination and interpretability of the trial by evaluating acceptability, feasibility, safety, 
and cost. We will test the hypothesis that home modification interventions will have high 
acceptability (80% retention), high fidelity by therapists (95% of elements; 90% of dose 
delivered), low safety risk (no increased rate of falls compared to usual care group), and high 
adherence (80% of modifications in use) at 12 months. 
 
2. Determine if the program is effective in reducing the rate and risk of falls and improving 
the outcome of other participant-reported outcomes (PROs) that can be effected by the 
intervention. We will test the hypothesis that older adults who receive the program will have 
a lower rate and risk of falls, improved self-efficacy, daily activity performance, and quality 
of life compared with the usual care group. 
      
Expected outcomes: The central hypothesis of this study is that home modifications (home 
hazard removal) will be acceptable to older adults, practical for delivery in an existing social 
service network, and efficacious in reducing falls and maintaining independence for older adults. 
Our research team has a unique skill set to address this problem, including: a long relationship 
with an AAA, experience studying home modifications in the community, experience conducting 
pragmatic trials, and expertise in dissemination and implementation science. If successful, this 
study could have immediate positive impact by leading to dissemination and implementation of a 
program with high adherence, structured to deploy within an existing aging services network that 
could significantly reduce falls among community-dwelling older adults at high risk. 

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1 
STUDY TEAM ROSTER  
 
Researchers 
 
Role 
Phone # 
Email address 
alt 
Susy Stark 
Principal 
Investigator 
314-932-1033 
starks@wusm.wustl
.edu 
 
Fax: 314-
932-1022 
Emily 
Somerville 
OT 
Interventionist 
314-932-1027 
somervillee@wusm.
wustl.edu 
 
 
Marian 
Keglovits 
OT 
Interventionist 
314-932-1032 
keglovitsm@wusm.
wustl.edu
 
 
 
 
Danielle 
Cobbs 
OT 
Interventionist 
314-932-1032 
cobbsd@wusm.wus
tl.edu 
 
 
Jane Conte 
Coordinator 
314-932-1011 
contej@wusm.wustl
.edu 
 
 
Yan Yan 
Statistical  
314-747-1115 
yany@wudoisis.wu
stl.edu 
 
 
 
Community 
Partners 
Role 
Phone# 
Email address 
alt 
SLAAA main 
phone # 
 
 
314-612-5918 
 
Main fax: 
314-612-
5915 
Dave Sykora 
SLAAA 
Executive 
Director 
314-657-1681 
 
sykorad@stlouis-
mo.gov 
 
 
Nora Shields-
Cutler 
SLAAA 
HealthCare 
Coordinator 
314-657-1670 
 
shields-cutlern@stl-
mo.gov 
 
 
Anneliese 
Stoever 
 
Information 
and 
Assistance 
Coordinator 
314-657-1669 
stoevera@stl-
mo.gov 
 
 
 
 
 

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2 
STUDY OBJECTIVES 
2.1 Primary Objective 
Determine the acceptability and feasibility of delivering the program in an AAA. To 
examine the effect of the adapted program, we will conduct a hybrid 
effectiveness/implementation trial of 300 older adults at high risk for a fall who will be 
randomized to the adapted program or usual agency care and then followed for 12 months. 
We will conduct a process evaluation78 of the intervention to aid in dissemination and 
interpretability of the trial by evaluating acceptability, feasibility, safety, and cost. We will 
test the hypothesis that home-modification interventions will have high acceptability (80% 
retention), high fidelity by therapists (95% of elements; 90% of dose delivered), low safety 
risk (no increased rate of falls compared with the usual care group), and high adherence (80% 
of modifications in use) at 12 months. 
 
2.2 Secondary Objectives 
Determine whether the adapted program is effective in reducing the rate and risk of falls 
and improving the outcome of other participant-reported outcomes that can be affected by the 
intervention. We will test the hypothesis that older adults who receive the program will have a 
lower rate and risk of falls and improved self-efficacy, daily-activity performance, and quality 
of life compared with the usual care group. 
  
If successful, this study could have immediate positive impact by leading to dissemination and 
implementation of a program with high adherence that is structured to deploy within an existing 
aging services network and that could significantly reduce falls among community-dwelling 
older adults at high risk. 
3 
BACKGROUND AND RATIONALE  
3.1 Background on Condition, Disease, or Other Primary Study Focus 
Falls remain the leading cause of injury, long-term disability, premature institutionalization, and 
injury-related mortality in the older adult population.12-15 Falls are the most common cause of 
traumatic brain injury and fracture for older adults,16 and they have serious complications such as 
institutionalization,17 functional dependence, and paralyzing fear of falling,18, 19 Every 29 
seconds, an older adult dies from the consequences of a fall.20 Falls are an eminent threat to a 
frail, older adult’s ability to maintain independence in the community. Approximately 1 in 3 
community-dwelling adults aged 65 years and older fall each year,21, 22 and those older than age 
70 have an especially high fall risk.14 Older adults who have experienced a previous fall are at a 
greater risk of falling again.23 Prevalence of the home hazard condition: The majority of falls 
experienced by older adults, particularly more frail, high-risk older adults, occur in the home,12, 
24, 25 and measurable home hazards are associated with an increased risk of older persons falling 

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in the US.26 Economic impact: Falls are costly: $30 billion a year is spent treating older adults 
for the effects of falls.27 As the population ages, costs associated with falls are projected to reach 
$59.6 billion by 2020,22 making fall prevention a public health priority. Gap addressed by this 
proposal: Efficacy studies conducted in Australia and Europe and results from our own efficacy 
trial suggest that home-modification delivered by OTs can significantly reduce falls among 
community-dwelling older adults at high risk.28 Despite these findings and recommendations 
from the American Geriatrics Society that home modifications be routine for community-
dwelling older adults at high risk for a fall,29 home-modification implementation is not standard 
practice in the US. New models of care must be developed to effectively implement this strategy 
nationally. We plan to address this gap by implementing and testing the effectiveness of a home-
hazard removal program in the US Aging Services Network. This study will be based on our 
recently completed home-modification trial in the US.  
 
Home modifications to improve daily-activity performance have been studied in the US,5, 50 and 
there is promising preliminary evidence of the efficacy of home-hazard removal to reduce the 
risk of falls (including our unpublished trial). However, no evidence shows the pragmatic 
effectiveness of home modifications to prevent falls in the US. Important next steps to advance 
the science include better understanding of the effectiveness and implementation of home-hazard 
removal.  
3.2 Study Rationale 
Fall prevention programs, despite success in clinical trials, have not translated to a reduction in 
falls for community-dwelling older adults in the US. The most efficacious fall-prevention 
intervention identified to date is exercise. In randomized controlled trials, multicomponent 
exercise groups and individually prescribed exercises have been shown to reduce the rate and 
risk of falls30. Although effective in controlled studies,31, 32 adherence rates in community 
programs are low (29%–59%),33-35 and older adults report a reluctance to initiate exercise 
programs to reduce their chance of falling.36, 37 This finding is not surprising, given the low rate 
of participation in fitness activities among older adults in general, despite aggressive public 
health campaigns to increase physical activity.38 Additional intervention strategies with high 
acceptance are needed to address the important public health problem of falls. 
 
Home-modification interventions, when delivered by OTs, also demonstrate efficacy in 
reducing falls30 among high-risk populations.28 Home modifications can include installation of 
stairway railings, grab bars, slip-resistant surfacing in the bathroom, and provision of lighting. 
Home-hazard removal is strongly recommended by the American and British Geriatric Societies 
to prevent falls.29 Indeed, home modification interventions, when delivered by OTs, have been 
shown to reduce falls by 39% among high-risk fallers39-41 in studies conducted in Europe and 
Australia.  
 

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Fall-prevention interventions have not been effectively translated into prevention 
programs. This study will be a substantial departure from previous studies. The research 
proposed in this application is innovative, in our opinion, because it represents the first time an 
effective home-modification intervention to prevent falls will be implemented through a US 
social service delivery system. Successful translation into practice requires an understanding of 
the interaction among an intervention, the systems in which it is implemented, and the 
stakeholders.42 We will use community-engaged research approaches43-46 to determine 
adaptations necessary to deploy a home-modification intervention to prevent falls in the US 
within a reliable aging services network. We will reduce barriers to program participation by 
involving key stakeholders as part of the research team47, 48 and clarifying the benefits of the 
research to the community.49  
 
The goal of this study is to implement an evidence-based home-modification intervention for 
older adults that is designed to reduce the incidence of falls through a community program 
delivered through the aging services network with high acceptance. The program will be 
designed to reduce the incidence of falls among community-dwelling older adults so they may 
independently remain in their own homes as long as possible.  
4 
STUDY DESIGN 
To examine the effect of a home-modification 
(home-hazard removal) program, we will conduct 
a hybrid effectiveness/implementation trial of 
300 older adults at risk for a fall who will be 
randomized to a home-hazard removal program 
or usual care and then followed for 12 months. 
Figure 5 outlines the milestones of a pragmatic 
randomized controlled trial and implementation 
study. Study milestones are further detailed in the 
timeline (under Section E.1, Table 2). 
Recruitment: We will recruit participants 
through the SLAAA’s annual assessment of 
participants’ health. We estimate more than 800 
older adults will meet eligibility criteria. 
Deliver intervention: Interventionists will use a 
manualized protocol to deliver the intervention. 
Follow-up: We will follow participants monthly 
using a highly successful calendar journal 
technique that has demonstrated a 99% response rate in previous studies.  Dissemination: We 
will disseminate the program, manuals, and training programs using our advisory network.  
 
 
Pragmatic trial designed for 
implementation and dissemination 
300 community-dwelling older 
adults with high risk of fall 
-Baseline assessment  
-Randomization 
 
Control (150) 
usual care 
Intervention (150) 
Home hazard 
removal   
12 month     
follow-up 
12 month      
follow-up 
 

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4.1 
Timeline and Tasks 
 
Resource  
 
Month 
 
 
Staff 
-3–0 
1-6 
6–12 
13–18 
19–24 
25–30 
31–36 
Personnel 
 
 
 
 
 
 
 
 
Weekly lab meetings 
SS 
xx 
xxx 
xxx 
xxx 
xxx 
xxx 
xxx 
Advisory board meetings 
SS 
x 
▪ ▪ 
▪ ▪ 
▪ ▪ 
▪ ▪ 
▪ ▪ 
▪ ▪ 
Staff training 
SS 
x 
 
 
 
 
 
 
Human Subjects 
 
 
 
 
 
 
 
 
HRPO approval/renewal 
JC 
x 
 
▪ 
 
▪ 
 
▪ 
Quality Assurance Plan 
 
 
 
 
 
 
 
 
development 
SS 
x 
 
 
 
 
 
 
oversight 
WU 
 
▪ 
▪ 
▪ 
▪ 
▪ 
▪ 
Report to advisory committee 
SS 
 
▪ 
▪ 
▪ 
▪ 
▪ 
▪ 
Study Tasks 
 
 
 
 
 
 
 
 
Manuals & training materials  
SS 
 
xxx 
 
 
 
 
 
Recruit , enroll participants 
JC 
 
xxx 
xxx 
xxx 
 
 
 
Baseline assessment 
ES 
 
xxx 
xxx 
xxx 
 
 
 
Deliver intervention  
ES 
 
 
xxx 
xxx 
xxx 
xxx 
 
Follow-up 
JC 
 
 
xxx 
xxx 
xxx 
xxx 
xx 
Data management and analysis  
 
 
 
 
 
 
 
 
Database 
LH 
xxx 
xxx 
xxx 
xxx 
xxx 
xxx 
xxx 
Conduct interim analyses 
YY 
 
 
x 
x 
x 
x 
x 
Conduct final analyses 
YY 
 
 
 
 
 
 
xxx 
Dissemination and Implementation 
 
 
 
 
 
 
 
 
Meeting with participants and 
community 
SS 
 
 
 
 
 
 
▪ 
Dissemination planning meeting 
SS 
▪ 
 
▪ 
 
▪ 
 
▪ 
Peer-reviewed publications 
 
 
 
 
 
 
 
  
Protocol 
SS 
 
▪ 
 
 
 
 
 
Implementation outcomes 
SS 
 
 
 
 
 
 
 ▪ 
Intervention outcomes 
SS 
 
 
 
 
 
 
 ▪ 
Note: x = 2 months; ▪ = single event; SS=S. Stark; JC = J. Conte; WU = oversight; ES = E. Somerville; LH = L. 
Hu; YY = Y. Yan 

Protocol Template, Version 1.0 
 
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5 
SELECTION AND ENROLLMENT OF PARTICIPANTS 
5.1 
Inclusion/Exclusion Criteria  
Inclusion criteria:  1) aged 65 years or older; 2) self-report of one previous fall or more in the 
preceding 12 months or self-report as “worried about falling;” and currently receiving services 
from SLAAA.                                                                                                
Exclusion criteria: 1) residents of nursing homes; 2) individuals with severe cognitive 
impairment who are unable to give consent to participate (as determined by a score of greater 
than 10 on the SBT for memory10) 
5.2 
Study Enrollment Procedures  
Study population, eligibility, and screening. The National Aging Program Information System 
(NAPIS) is a database of information collected annually by the AoA from state units on aging 
describing the general health, nutritional, financial, functional, and environmental status of an 
older adult. Missouri’s assessment (MA4) currently includes an evidence-based fall-risk 
screening as part of an extensive battery of standardized assessments. In the current cohort of 
1,331 older adults screened in CY 2013 by SLAAA, the average age of the cohort is 77 years, 67 
percent are female and 74% are African American. More than 25% reported a fall in the past 12 
months, and 40% are “worried about falling.” The average score on ADL performance was 4 
(range, 1–7); indicating moderate ADL impairment). We will recruit from this cohort of older 
adults who are “at high risk for a fall.”79 We estimate more than 800 older adults will meet 
eligibility criteria in the cohort. 2, 3 The SLAAA staff will identify potential participants and 
assist in recruiting participants at no cost 
 
We will recruit 300 older adults, conduct baseline assessments, and randomize participants to 
receive the adapted program or usual care. Outcomes (falls, fall self-efficacy) will be assessed by 
a blinded evaluator at baseline and 12 months after intervention. Flow through the study is 
illustrated in Figure 5. All assessments and study visits will occur in participants’ homes. 
 
Recruitment. We will randomly select a sample of older adults from the large observational 
cohort of older adults assessed annually by SLAAA via NAPIS as part of service delivery80 and 
invite them to participate by telephone. Refusals will be tracked for attribution of cause.  
 
Consent and enrollment. Consent will be obtained at the baseline home assessment visit. 
Potential participants will be provided with a study brochure and a copy of the large-print 
consent form. Scripted details of the project including the randomization procedure, study 
interventions, and follow-up procedures will be discussed (under Section C.2.c).  
 
Randomization sequence generation, allocation concealment, and implementation. 
Participants will be allocated using a 1:1 ratio via randomization sequences generated a priori 
using a computerized formal probability model. The allocation ratio will be maintained at 
periodic intervals. Groups will be balanced with regard to race (self-reported African American 

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or “other”) and sex. Randomization sequence concealment will be achieved by the Research 
Electronic Data Capture (REDCap) system.81 After baseline assessment, the study coordinator 
will verify that all eligibility requirements are satisfied and then elicit treatment assignment. 
6 
STUDY INTERVENTIONS  
6.1 
Study Interventions  
 
Control group (usual care). During the treatment phase of the study, each participant 
randomized to control will receive usual care from SLAAA, which includes annual NAPIS 
evaluation (in home) and individualized referrals to services based on identified need. Referrals 
are generated by case managers or SLAAA staff based on the annual assessment or if older 
adults (or their family members) call and request a referral for services.  
 
Procedures for intervention (treatment). Participants who are randomized to treatment will 
receive usual care plus the home-modification (home-hazard removal) intervention. The 
intervention, based on a competence/press theoretical framework,96 will be provided by 
registered and licensed OT. The intervention will be delivered via a manualized intervention 
using a visit by visit checklist. Home modifications79 include a 2-hour home assessment 
conducted by an OT in the participant’s home using the WeHSA. A comprehensive clinical 
assessment will be performed on each participant to determine functional limitations that may 
interact with hazards in the home and result in a fall. Environmental hazards and unsafe 
behaviors will be identified. A barrier-removal plan will be provided to the older adult. The OT 
will facilitate home modifications through housing services programs and provided follow-up 2 
weeks after the initial home visit to ensure that the participant adopted the recommended 
modifications.  It is anticipated that 2-3 visits of 90 minutes each will be provided.  At about 6 
months participants will receive a booster session (in home visit by an OT) to reevaluate 
performance in the home and modify the intervention plan as needed.  
 
Interventionist Training 
Each interventionist will receive a 3 hour didactic training and additional 2 hours of guided self-
directed learning.  
   
5.2  Process Evaluation 
We will evaluate a set of implementation outcomes distinct from clinical treatment outcomes99 
that are relevant for decision makers and important for implementation and dissemination of the 
intervention. The components and data sources of the process evaluation are presented in Table 
1. We will conduct a process evaluation to understand the fidelity, safety, cost, and quality of the 
intervention.100 We will monitor recruitment metrics for all eligible participants, including 
demographic characteristics, enrollment status, and reason for decline. We will determine the 
fidelity of the intervention by determining whether the intervention was delivered as planned and 

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calculating the dose of the intervention received by both groups (number of minutes and number 
of sessions delivered). OTs will rate adherence at the final visit as the number of 
recommendations implemented per recommendations suggested.6 Long-term adherence will be 
calculated as the number of recommendations used at 12 months per recommendations 
suggested. We will examine reasons for abandonment of strategies to inform the final program. 
We will explore the safety of the intervention by determining the rate and severity of falls 
(calculated with an algorithm).101 Environmental modifications are provided through a 
patchwork of services in the US; therefore, reliable cost data are not available. We will track the 
cost of service provision (in the treatment group). We will record OT time to provide services 
(direct and indirect)102 and costs of equipment issued to participants. Costs of contracting 
services will include installation (labor and materials) and maintenance or repair during follow-
up. All OT time will be recorded using current procedural terminology codes. The hourly wage of the 
contractor will be estimated using wage rates for the St. Louis area as reported by the U.S. Bureau of 
Labor Statistics.103 The cost of all materials will be captured from invoices. Costs will be estimated from 
the payor perspective (e.g., Medicare allowable costs will be used to estimate covered clinical 
encounters).104  
7 
STUDY PROCEDURES 
7.1 
Schedule of Evaluations 
7.2 
Overview 
Assessments will be conducted at baseline and 6 months after intervention for 
participants in the treatment group and will occur in participants’ homes. For those in the 
control group, no 6 month assessment will occur.  A 12 month phone follow up will 
occur for all participants. 
Treatment 
Time 0 
1 week 
       2 months 
5 months 
6 months 
12 months 
14 months 
Baseline 
assessment; 
monthly fall 
monitoring 
begins
Baseline 
assessment; 
monthly fall 
monitoring 
begins 
Final 
Assessment
; end 
monthly fall 
monitoring
Intervention  
Adherence 
assessment  
Intervention 
booster  
Final 
Assessment
; end 
monthly fall 
monitoring 

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Control 
7.3 
Description of Evaluations  
7.3.1  Screening Evaluations 
7.3.1.1 
Short Blessed Test (SBT). The SBT[61] will be used to screen for severe cognitive impairment. 
The SBT has good validity for older adults[61] and correlates well with the Mini-Mental State 
Exam[62]. This brief, six-item questionnaire assesses cognition, memory, and orientation. 
Incorrect items are scored as the product of the number of errors made and a weighting factor; 
the sum of incorrect item scores comprises the total score. Total scores range from 0-28; scores 
of 10 or more are consistent with dementia and other cognitive difficulties. Individuals who 
receive a SBT score 10 or more will not be allowed to participate in the proposed study. 
7.3.1.2 
Any self-report of fear of falling in past year.  
7.3.1.3 
Falls in past year.  Any report of falls in the previous year will be an automatic inclusion. 
7.3.2 Enrollment, baseline, randomization 
7.3.2.1 
Enrollment  
Informed Consent Process. All elements of consent will be reviewed with older adults prior to 
enrolling in the study, including the purpose of the study, risks, benefits, alternatives to the study, 
how confidentiality will be maintained, the PI’s contact information, no consequences to 
withdrawal, and how study results will be shared. All study staff have undergone IRB training. In 
addition, all staff members have participated in cultural competence training and are trained to 
interview older adults. All staff members are trained to obtain assent, which is particularly 
important for older adults with low vision, low literacy levels, or limited English proficiency. All 
study documents are available in multiple formats, are developed in 16-point Arial font, and are 
written in plain language. All informed consent documents are reviewed by the laboratory 
advisory board of older adults (involved in the design of the study) to ensure clarity for older 
adults.  
Steps to understand the elements of informed consent. Written informed consent to participate in 
the study will be obtained before any test or measurement is performed. Eligibility will be 
confirmed prior to enrollment. All potential participants will be screened using a script by the 
coordinator. Screening will take place in person or over the phone. Potential participants will be 
given a copy of the large-print informed consent document and a study review sheet written at 
the appropriate reading level to review. During screening, all participants (1) will have a 
detailed, plain-language explanation of the study and what is expected of them; (2) will discuss 
potential problems that could interfere with participation; (3) will have their questions answered; 
and (4) will receive a plain-language summary of the study and contact information for the PI 
and study coordinator. Consent will occur during the first home assessment visit. The consent 
form will be signed by a witness and stored in the office of the PI under double locks. 
Participants will be advised in the consent form that there is a possibility that their medical 
research record, including identifying information, may be inspected and photocopied by 

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officials of Federal or state government agencies and the Washington University Human 
Research Protection Office. 
 
Enrollment. Enrollment is defined as the date all of the screening criteria are met and the 
individual agrees to participate.  The enrollment date will be recorded on a case report form. 
 
7.3.2.2 Randomization.  
Participants will be allocated using a 1:1 ratio via randomization sequences generated a priori 
using a computerized formal probability model. The allocation ratio will be maintained at 
periodic intervals. Groups will be balanced with regard to race (self-reported African American 
or “other”) and sex. Randomization sequence concealment will be achieved by the Research 
Electronic Data Capture (REDCap) system.81 The study coordinator will verify that all eligibility 
requirements are satisfied and then elicit treatment assignment prior to baseline assessment. 
7.3.2.3 Baseline Assessment 
Demographics. Demographic and other pertinent information, including assistance received, 
adaptive equipment usage, and falls, will be collected. 
 
OARS ADL scale. The OARS ADL scale[51] will be used to screen for functional performance. 
The OARS ADL has been validated for the older adult ED population[52], is brief and easy to 
administer. Potential participants are asked about their ability to perform each of 14 activities. 
Responses are scored on a 0-2 scale, with higher scores indicating greater independence. 
Individuals who receive a score of 0 on one or more activities or a score of 1 on two or more 
activities will qualify for the study.  
 
Falls Efficacy Scale-International (FES-I). The  Falls Efficacy Scale-International (FES-I)[53] will 
be used to assess participants’ self-efficacy in performing daily activities without falling. The 
FES-I has good test-retest reliability and validity and consists of a list of 16 daily activities (e.g., 
getting in and out of bed) on which respondents rate their confidence doing each activity without 
falling on a scale from 1 (very confident) to 10 (no confidence at all). Total FES-I score is the 
sum of each activity score, with higher scores indicating greater fear of falling. 
 
Patient Reported Outcomes Measurement Information System (PROMIS) Global Scale. Self-
rated health will be measured using the Patient Reported Outcomes Measurement Information 
System (PROMIS) Global Scale[54] which measures general perceptions of health. We will use 
two scales: global physical health (overall physical health, physical function, pain, and fatigue) 
and global mental health (quality of life, mental health, satisfaction with social activities, and 
emotional problems).  Reliability and validity of the scales have been established[54, 55]. 
 

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Westmead Home Safety Assessment (WeHSA). The Westmead Home Safety Assessment 
(WeHSA)[57] will be used to identify the number of environmental hazards in all areas of the 
home (e.g., seating, bedroom, medication management) via 72 categories. Each category is 
specified with explicit descriptors to qualify a given hazard with a score of 0 for absent and 1 for 
present.  Total hazards are summed. 
 
Short Michigan Alcoholism Screening Test – Geriatric Version (S-MAST-G). The S-MAST-
G[58] will be used to screen for the presence of an alcohol problem in potential participants. The 
S-MAST-G has been validated for the older adult population[59]. Potential participants will 
answer 10 yes/no questions about their alcohol consumption in the past year; two or more “yes” 
responses indicate a likely alcohol problem..  
 
Geriatric Depression Scale Short Form (GDS-SF). The GDS-SF[60] will be used to assess 
depression levels in participants. The GDS-SF is a 15-item self-report questionnaire specifically 
designed and validated with the older population, and correlates highly with the original 30-item 
GDS (r=.84)[60]. Participants answer yes-or-no questions about their feelings in the past week. 
Total scores range from 0 to 15, and scores of 5 or more indicate probable depression. 
 
Short Blessed Test (SBT). The SBT[61] will be used to screen for severe cognitive impairment. 
The SBT has good validity for older adults[61] and correlates well with the Mini-Mental State 
Exam[62]. This brief, six-item questionnaire assesses cognition, memory, and orientation. 
Incorrect items are scored as the product of the number of errors made and a weighting factor; 
the sum of incorrect item scores comprises the total score. Total scores range from 0-28; scores 
of 10 or more are consistent with dementia and other cognitive difficulties. Individuals who 
receive a SBT score 10 or more will not be allowed to participate in the proposed study. 
 
Prescription medications. A medication inventory will be collected.  
 
Performance Oriented Mobility Assessment  (POMA). Mobility and balance will be assessed 
using the Performance Oriented Mobility Assessment  (POMA)[63], a task-oriented gait and 
balance assessment that has been validated for the older adult population.  
 
Strength, and range of motion of the upper extremity. Strength and range of motion of the upper 
extremity will be assessed using group muscle tests and goniometry and scored as within normal 
limits, within functional limits, or impaired[64]. Strength of the dominant hand will be assessed 
using a dynamometer.  
 
Pelli-Robson. We will measure visual contrast sensitivity using the Pelli-Robson test[65]. We will 
score participants’ binocular contrast sensitivity letter by letter. 
 

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Falls behavioral Scale for Older People (FaB). Protective behavioral factors to prevent falls will 
be assessed using the FaB. This instrument includes ten behavioral dimensions: cognitive 
adaptations, protective mobility, avoidance, awareness, pace, practical strategies, displacing 
activities, being observant, changes in level, and getting to the phone[66].  
7.3.3 Intervention and follow up sessions 
7.3.3.1 
Intervention 
Participants randomized to the intervention group will receive the intervention over 2 visits and 
one booster session at 6 months according to a manualized intervention.  Briefly, for the 
intervention group, the occupational therapist will begin the intervention during the WeHSA. 
During the WeHSA the occupational therapist will assist the older adult to identify home 
hazards, work through potential solutions to reduce or remove the hazard, if possible, implement 
solutions (such as removing a throw rug), create plan for additional hazard removal, begin self-
management training for behavioral and environmental fall risks, and provide training to 
complete the calendar journal. Between visits, the occupational therapist will assist the older 
adult to obtain equipment or home modifications. At the second visit, the occupational therapist 
will provide any necessary installation of equipment (such as a tub transfer bench), explain the 
purpose of each new equipment, teach techniques to safely use the equipment, and observe the 
older adult safely using the equipment. The occupational therapist will also continue the self-
management training to improve daily activity performance and safety.  
7.3.3.2 
5 month adherence 
A phone call to evaluate adherence will be made at approximately five months (in anticipation of 
the 6 month booster session).  
7.3.3.3 
Six month Booster 
A 6-month booster session will also be provided to assist the older adults with any new fall 
hazards and to reinforce self-management/mindfulness training techniques. To identify 
additional fall hazards, the occupational therapist will complete the WeHSA with the older adult 
and make recommendations for solutions or provide additional training.  
7.3.3.4 
Monthly monitoring falls 
To record falls, an individually customized calendar journal will be designed for each participant 
for daily recording of falls[48]. Our method of tailoring the calendar journal includes life event 
date anchors, incentives  and personalization[49], we will construct the participant-tailored 
calendar journals[50]. There will be space to record the primary outcome of falls (fall or no fall) 
each day. If a participant falls, they will be instructed to complete a fall form. Calendar journal 
pages and fall forms will be collected monthly via U.S. mail. Falls will be verified with a follow-
up telephone interview by a community coordinator. 

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7.3.3.5 
Raters 
Follow up assessments will conducted by trained raters blind to group allocation. The follow-up 
sessions will repeat assessments conducted at the first study home visit and first phone call.  
7.3.4 Completion/Final Evaluation  
List each assessment to be performed at the participant’s final visit.  
 
Falls behavioral Scale for Older People (FaB). Protective behavioral factors to prevent falls will 
be assessed using the FaB. This instrument includes ten behavioral dimensions: cognitive 
adaptations, protective mobility, avoidance, awareness, pace, practical strategies, displacing 
activities, being observant, changes in level, and getting to the phone[66].  
 
OARS ADL scale. The OARS ADL scale[51] will be used to screen for functional performance. 
The OARS ADL has been validated for the older adult ED population[52], is brief and easy to 
administer. Potential participants are asked about their ability to perform each of 14 activities. 
Responses are scored on a 0-2 scale, with higher scores indicating greater independence. 
Individuals who receive a score of 0 on one or more activities or a score of 1 on two or more 
activities will qualify for the study.  
 
Falls Efficacy Scale-International (FES). The  Falls Efficacy Scale-International (FES-I)[53] will 
be used to assess participants’ self-efficacy in performing daily activities without falling. The 
FES-I has good test-retest reliability and validity and consists of a list of 16 daily activities (e.g., 
getting in and out of bed) on which respondents rate their confidence doing each activity without 
falling on a scale from 1 (very confident) to 10 (no confidence at all). Total FES-I score is the 
sum of each activity score, with higher scores indicating greater fear of falling. 
 
Patient Reported Outcomes Measurement Information System (PROMIS) Global Scale. Self-
rated health will be measured using the Patient Reported Outcomes Measurement Information 
System (PROMIS) Global Scale[54] which measures general perceptions of health. We will use 
two scales: global physical health (overall physical health, physical function, pain, and fatigue) 
and global mental health (quality of life, mental health, satisfaction with social activities, and 
emotional problems).  Reliability and validity of the scales have been established[54, 55]. 
7.4 
Process evaluation  
7.4.1 Recruitment 
Enrollment and retention will be tracked by the research coordinator using REDCap, an online 
data entry program. Recruitment information for each participant will include the potential 
participants’ initials, gender, birthdate, race, zip code, stroke date, admission date, and discharge 
date. Reasons for denying participation in the study as well as study attrition will also be tracked 
via REDCap.   

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7.4.2 Fidelity 
In order to guarantee treatment fidelity, or our ability to provide the same treatment as planned to 
each participant, we follow similar methods of Weersing, et al[36] and use a Visit by Visit 
Treatment Grid. This grid specifically outlines the pre, during, and post treatment visit 
requirements for each treatment session. It is designed to be a checklist in which therapists check 
off the action once it is completed.  During weekly interventionist meetings, the lead therapist 
will review the treatment grid for each participant to guarantee the necessary components of the 
intervention are being delivered.  
7.4.3 Dose 
In order to effectively measure the dose of treatment provided for each participant, we will 
measure both the dose that was delivered to each person (minutes of each treatment session and 
number of session) as well as the dose received (recommendations implemented/total 
recommendations). We will use a spreadsheet or Time Log to track minutes spent in each 
treatment session and another spreadsheet or Prescription Log to track the recommendations 
made and implemented for each participant.  
7.4.4 Adherence 
Adherence measures the participant’s continued use of the implemented modifications. We will 
calculate adherence using the standardized approach that Cumming, et al[37] used: adherence = 
recommendations used/total recommendations. Interventionists will rate adherence with 
intervention at the final session by using the Prescription Log to track recommendations made, 
implemented and reasons that any recommendations were not implemented. Initial adherence 
will be a proportion of the number of recommendations implemented /recommendations 
suggested.  Finally, we will determine the number of recommendations used/recommendations 
suggested at 6 months.  Reasons for abandoning strategies will be examined using the Adherence 
Log; in which the participant will report on current level of use for each modification:  very 
useful, somewhat useful, not at all useful, no longer use equipment. Any independence that was 
regained by improved sensorimotor performance will not count against the adherence rating.  
7.4.5 Safety 
 To explore the safety of our study, we will measure the number of falls and the circumstances 
surrounding the falls with a self-report Fall Form used at the 6 month follow up visit. The rate 
and severity of the falls will be calculated using a standardized algorithm established by Tinetti, 
et al, 1988[38]. We will also track both health care utilization for participants in both groups (# of 
emergency room and out patient visits, # of hospitalizations, and number of days in therapy) 
using the Health Care Utilization Form. 
7.4.6 Cost 
The cost of the treatment will be measured by tracking cost of modifications and adaptive 
equipment for each participant. This will be tracked using the Invoice Form which includes both 

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costs from the contractor as well as costs of any equipment ordered from a medical supply 
company or obtained from a community resource (medical equipment lending program).  The 
total amount of money spent on each person will be tracked on this form.  
 
7.5 
Overview of study assessments by time point.  
 
Phone 
Screening 
Consent visit  
Baseline 
assessment 
Treatment 
session 
(tx group only) 
Follow-up 
months 1-12 
5 month phone 
call 
(tx group only) 
6 month 
Booster in 
home 
(tx group only) 
12 month 
phone call 
Consent 
 
x 
 
 
 
 
 
 
Calendar 
Questionnaire 
 
x 
 
 
 
 
 
 
Demographics 
 
x 
 
 
 
 
 
 
WeHSA 
 
 
x 
x 
 
 
x 
 
SMAST-G 
 
 
x 
 
 
 
 
 
GDS 
 
x 
 
 
 
 
 
 
SBT 
x 
 
 
 
 
 
 
 
Medication 
 
x 
 
 
 
 
 
 
ROM 
 
 
x 
 
 
 
 
 
Strength 
 
 
x 
 
 
 
 
 
Grip Strength 
 
 
x 
 
 
 
 
 
Near Visual Acuity 
 
 
x 
 
 
 
 
 
Contrast Sensitivity 
 
 
x 
 
 
 
 
 
POMA 
 
 
x 
 
 
 
 
 
Falls 
 
 
x 
x 
x 
 
 
x 
OARS 
 
 
x 
 
 
 
 
 
x 
FES 
 
x 
 
 
 
 
 
x 
PROMIS 
 
x 
 
 
 
 
 
x 
Falls behavioral 
Scale 
 
x 
 
 
 
 
 
x 
Fidelity to treatment 
(visit by visit grid) 
 
 
x 
x 
 
 
x 
 
Time (Dose), 
Completion of 
Session, Cost 
 
 
 
x 
 
 
x 
 
Adherence  
 
 
 
 
 
x 
x 
x 
 
*randomization before T1 

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*both groups will send in monthly fall journal information 
 
 
8 
SAFETY ASSESSMENTS    
8.1 Safety Parameters 
To explore the safety of our study, we will measure the number of falls and the circumstances 
surrounding the falls and  health care utilization for participants in both groups (# of emergency 
room and outpatient visits, # of hospitalizations, and number of days in therapy) using the Health 
Care Utilization Form. The rate and severity of the falls will be calculated using a standardized 
algorithm established by Tinetti, et al, 1988[38]. We will also track both health care utilization for 
participants in both groups (# of emergency room and outpatient visits, # of hospitalizations, and 
number of days in therapy) using the Health Care Utilization Form. 
8.2 Adverse Events and Serious Adverse Events  
An adverse event (AE) are defined as any unfavorable and unintended diagnosis, symptom, sign 
(including an abnormal laboratory finding), syndrome or disease which either occurs during the 
study, having been absent at baseline, or if present at baseline, appears to worsen. Adverse 
events are to be recording regardless of their relationship to the study intervention. 
 
A serious adverse event (SAE) is generally defined as any untoward medical occurrence that 
results in death, is life threatening, requires inpatient hospitalization or prolongation of existing 
hospitalization, results in persistent or significant disability/incapacity, or is a congenital 
anomaly. 
8.3 Reporting Procedures 
All serious adverse events will be reported to the HRPO in the falling time frames: a) death – 
immediately; b) life-threatening within 7 calendar days; c) all other SAEs within 15 calendar days using 
the Electronic Serious Adverse Event Reporting System. Should there be a serious adverse event that 
occurs that increases the risks to the participants, the study will be stopped, an investigation will be 
conducted, and a findings report will be generated before the study is resumed. 
8.4 Follow-up for Adverse Events 
AEs will be followed until resolved or considered stable for the study period. 
9 
INTERVENTION DISCONTINUATION  
Safety data will be collected on any participant discontinued due to an AE or SAE. In any case, 
every effort must be made to undertake protocol-specified safety follow-up procedures. If 
voluntary withdrawal occurs, the participant will be asked to continue scheduled evaluations, 

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complete an end-of-study evaluation, and be given appropriate therapy until the symptoms of any 
AE resolve or the participant’s condition becomes stable. 
10 
STATISTICAL CONSIDERATIONS  
9.1 
Sample Size and Randomization 
Power computations reflect two general principles. 
The first is that we will be conservative by 
underestimating and overstating power. Second, 
estimates of statistical power will be consistent with 
the method of analyses. Our primary outcome is time 
to event; therefore, we will determine the sample size 
and power within the survival data analyses 
framework. The Cumming et al.79 sample is most 
similar to our target sample and similar regarding the 
method of fall ascertainment using daily calendars. On 
this basis, we assume that approximately 61% of 
control group participants will fall during 1 year of follow-
up. For a meaningful reduction in fall risk, an intervention 
needs to demonstrate at least 30% reduction in falls.105, 106 The Cochrane Review of interventions 
for preventing falls in older, community-dwelling adults reported that randomized trials of home-
safety interventions and personal mobility aids reduced the rate of falls (RaR, 0.59; 95% CI, 
0.42–0.82) among high-risk participants defined as having a history of falling or other risk factor 
for falls.30 Another meta-analysis28 of four randomized trials of environmental interventions, 
which included some of the same studies as the Cochrane Review, reported a 39% reduction in 
the risk of falls in high-risk populations, defined as a history of falling in the past year or 
presence of other risk factors for falling. Because our target sample can be defined as “high risk,” 
and because our intervention can be defined as a high-intensity home modification, we project a 
30% or greater reduction in fall risk at 12 months after treatment. Figure 6 displays the power as 
a function of total sample size given a fall rate of 42% (event-free rate of 0.58) in the 
intervention group and a fall rate of 0.61 (event-free rate of 0.39) in the control group, with a 
20% attrition rate. A two-sided log-rank test with an overall sample size of 300 participants (150 
in each group) achieves 84% power at a 0.05 significance level to detect a difference of 0.19 
between 0.39 and 0.58—the proportions without falls in the control and intervention groups, 
respectively. This corresponds to a hazard ratio of 0.5785 of fall in intervention versus control 
groups. These results are based on the assumption that the hazard rates are proportional. 
10.3 Data Analyses 
We will examine the process data before the efficacy analyses.107 We will use descriptive 
statistics to describe recruitment rates and reasons for not enrolling. To explore the extent and 
Figure. 6. Power calculation. 

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quality of the implementation of the intervention, we will compare the characteristics of patients 
who complete the assigned intervention with those who do not for differences in fall risks. 
Adherence and cost estimates will be conducted for participants in the intervention group. 
Descriptive statistics will be used for adherence. We will test the hypothesis that the intervention 
will have high acceptability (at least 80% retention), high fidelity by therapists (at least 95% of 
elements and at least 90% of dose delivered), and high adherence to the program (at least 80% of 
modifications in use) at 12 months. These hypotheses will be tested using a 1-sample 1-sided 
proportion test. For costs, initial analysis will be conducted to determine what type of approach 
will be necessary to make unbiased and relevant estimates of the cost of the intervention. We 
will compare the effectiveness of the program and usual care with the time to the first fall over 
12 months as the primary outcome of interest. Survival analysis techniques will be used where 
time zero is the date on which the intervention is completed, and the ending time is 12 months 
after the intervention. Participants who do not have a fall will be censored at the end of the study. 
Participants who move to a nursing home will be censored on the date of moving. For those who 
fall during follow-up, the time to the first fall will be the event time. Kaplan-Meier product limit 
estimates will be used to describe the fall experiences for the intervention and control groups, 
with the log-rank statistic testing for significant difference. Prespecified covariates (e.g., age, 
race, sex, number of reported medications, mobility, ADL scores, and visual acuity) will be 
adjusted using the Cox proportional hazards model. We will test the interventions effect using 
the Cox proportional hazards model and adjusting for covariates. The regression coefficient of 
the indicator variable quantifies the difference in the log hazard of time to first fall between 
intervention and control groups. We will determine whether fall-prevention treatment is superior 
to usual care on secondary outcomes (total number of falls, number of injurious falls) and 
participant-reported outcomes (daily-activity performance, fall self-efficacy, and global health). 
We expect that the intervention group will experience fewer total falls, fewer injurious falls, 
greater daily-activity performance, greater self-efficacy, and greater quality of life compared 
with the usual care group. 
11 
DATA COLLECTION AND QUALITY ASSURANCE 
11.1 Data Collection Forms 
Data will be collected at each follow up point by a blinded rater over the phone.  Data will be 
directly entered into an online data management software (see 11.2)  Back up paper forms will 
be available (See MOP).  
11.2 Data Management  
Data-entry and data-management systems have been built to ensure accurate and complete data 
sets. Data will be entered via Web-based screens uploaded to a secure server. REDCap 
provides secure, Web-based applications, including real-time validation rules with automated 
data type and range checks at the time of data entry81. Data will be automatically backed up 

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daily, and copies will be stored offsite. All paper data forms will be reviewed weekly by the 
laboratory manager to ensure complete and accurate entry. Incomplete data will be returned to 
staff to rectify the situation by data edits, chart reviews, participant contact, or search of the 
National Death Index to ascertain status. 
11.3 Quality Assurance  
Training. Examples of quality assurance mechanisms include trained and certified field 
personnel,108; comprehensive documentation of operations and procedures,109 valid and accurate 
instrumentation (see “Outcomes and assessments”), field-tested data collection forms from our 
current HUD-funded study, a data-entry system with validation and checks81 with automated 
systems for scheduling and reminders, and quarterly audits of the database.  
11.4 Quality-assurance oversight   
QA oversight will be provided by the Washington University Human Research Quality 
Assurance (HRQA) program. The program will monitor this study to ensure the protection of 
human subjects and confirm that research is conducted in compliance with Federal regulations 
and university policies. In addition, study staff members (Conte and Somerville) have undergone 
intensive training in quality assurance, quality control, ethics, and operations through the HRQA 
program. The PI and the study team will have access to continuing education, consultation, and 
quality-assurance procedures and forms. Quality assurance will ensure the successful activation 
of the research; the efficient and accurate collection of data to meet protocol objectives; and 
monitoring and auditing trial progress to ensure compliance with regulations, standards of 
operation, and subject safety. 
11.4.1 Protocol Deviations 
Protocol deviations will be captured on a protocol deviation forma and reviewed by the study 
team and advisory board quarterly.  
12 
PARTICIPANT RIGHTS AND CONFIDENTIALITY  
12.1 Institutional Review Board (IRB) Review 
This protocol and the informed consent document (Appendix) and any subsequent modifications 
will be reviewed and approved by the HRPO committee responsible for oversight of the study.  
Informed Consent Forms 
 
A signed consent form will be obtained from each participant.   For participants who cannot 
consent for themselves, such as those with a legal guardian (e.g. person with power of attorney), 
this individual must sign the consent form. The consent form will describe the purpose of the 
study, the procedures to be followed, and the risks and benefits of participation. A copy will be 
given to each participant or legal guardian and this fact will be documented in the participant’s 

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record. we answered ‘no’ in myIRB questions on individuals lacking compacity to consent 
Is this regarding folks who can’t physically sign but understand? 
 
12.2 Participant Confidentiality  
Any data, forms, reports, photographs, and other records that leave the site will be identified only 
by a participant identification number (Participant ID, PID) to maintain confidentiality.  All 
records will be kept in a locked file cabinet.  All computer entry and networking programs will 
be done using PIDs only. Information will not be released without written permission of the 
participant, except as necessary for monitoring by IRB or HUD. 
12.3 Study Discontinuation  
 
The study may be discontinued at any time by the IRB  or government agencies as part of their 
duties to ensure that research participants are protected.  
13 PUBLICATION OF RESEARCH FINDINGS 
Publication of the results of this trial will be governed by the policies and procedures developed 
by the Steering Committee.  Any presentation, abstract, or manuscript will be made available for 
review by the sponsor. 
14 REFERENCES 
Provide the citations for all publications and presentations referenced in the text of the protocol. 
15 SUPPLEMENTS/APPENDICES 
15.1 Redcap data entry screen forms 
15.2 IRB approval