PROVEN: Pragmatic Trial of Video Education in Nursing Homes
Phase: NA
Conditions: Alzheimer Disease, Dementia, Heart Failure, Pulmonary Disease, Chronic Obstructive
Sponsor: Brown University

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Protocol  
Supported by: 
The National Institute on Aging 
UH3AG49619 

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PROVEN: PRagmatic trial Of Video Education in Nursing homes
Principal Investigators: 
Susan L. Mitchell, MD, MPH 
Senior Scientist, Institute for Aging Research, Hebrew Senior Life,  
Professor of Medicine, Harvard Medical School 
Vincent Mor, PhD 
Professor of Health Services, Policy & Practice and the Florence Pirce Grant University 
Health Professor in the Brown University School of Public Health 
Angelo Volandes, MD, MPH 
Assistant Professor of Medicine, Harvard Medical School, Division of General Internal 
Medicine, Massachusetts General Hospital 
Supported by: 
The National Institute on Aging 
UH3AG49619 

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TABLE OF CONTENTS 
Page 
TABLE OF CONTENTS ............................................................................................................ iii 
PRÉCIS ......................................................................................................................................... vi 
STUDY TEAM ROSTER ............................................................................................................ 1 
Co-Principal Investigators: ......................................................................................................... 1 
Co-Investigators: ......................................................................................................................... 2 
Health Care System Partner Representatives: ............................................................................. 2 
Research Team Members: ........................................................................................................... 3 
PARTICIPATING STUDY SITES ............................................................................................. 4 
1.   STUDY OBJECTIVES ........................................................................................................... 5 
2.
BACKGROUND AND RATIONALE ............................................................................ 7 
3.    STUDY DESIGN .................................................................................................................. 11 
4.
SELECTION AND ENROLLMENT OF PARTICIPANTS ...................................... 12 
4.1. 
Facility Inclusion Criteria  Facility eligibility criteria include: .................................... 12 
4.2. 
Patient Inclusion Criteria: ............................................................................................. 12 
4.3. 
Exclusion Criteria ......................................................................................................... 13 
4.4. 
Study Enrollment Procedures ....................................................................................... 13 
5.
STUDY INTERVENTIONS .......................................................................................... 15 
5.1. 
Interventions, Administration, and Duration ................................................................ 15 
5.2. 
Intervention Training, Implementation, and Adherence Monitoring ............................ 16 
5.3. 
Concomitant Interventions ............................................................................................ 18 
5.4. 
Control .......................................................................................................................... 18 
5.5. 
Adherence Assessment ................................................................................................. 18 
6.
DATA SOURCES AND ELEMENTS .......................................................................... 19 
6.1 
Data Sources ................................................................................................................. 19 
6.2 
Data Linkage and Management .................................................................................... 19 

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6.3 
Data Elements ............................................................................................................... 20 
7.
SAFETY ASSESSMENTS ............................................................................................. 22 
7.1. 
Minimal Risk Determination ........................................................................................ 22 
7.2. 
Serious Negative Reactions and Serious Adverse Events ............................................ 22 
7.3. 
Reporting Procedures .................................................................................................... 23 
7.4. 
Follow-up for Serious Negative Reactions ................................................................... 23 
7.5. 
Safety Monitoring ......................................................................................................... 23 
8.
INTERVENTION DISCONTINUATION.................................................................... 24 
9.
STATISTICAL CONSIDERATIONS .......................................................................... 24 
9.1. 
General Design Issues ................................................................................................... 24 
9.2. 
Sample Size and Randomization .................................................................................. 25 
9.3. 
Interim Analyses and Stopping Rules ........................................................................... 26 
9.4. 
Outcomes ...................................................................................................................... 26 
9.5. 
Data Analyses ............................................................................................................... 26 
9.6. 
Undertaking Supplemental “As Treated” Analyses ...................................................... 29 
10.
DATA COLLECTION AND QUALITY ASSURANCE ............................................ 31 
10.1. Data Collection ................................................................................................................ 31 
10.2. Data Confidentiality ......................................................................................................... 31 
10.3. Data Management ............................................................................................................ 32 
10.4. Data Use Agreements ...................................................................................................... 32 
10.5. Quality Assurance Metrics ............................................................................................... 32 
11.
PARTICIPANT RIGHTS AND CONFIDENTIALITY ............................................. 32 
11.1. Institutional Review Board (IRB) Review ....................................................................... 32 
11.2. Informed Consent ............................................................................................................. 32 
11.3. Participant Confidentiality ............................................................................................... 33 
11.4. Study Discontinuation ...................................................................................................... 33 
12.
ETHICAL CONSIDERATIONS ................................................................................... 34 
13.
COMMITTEES .............................................................................................................. 35 
14.
PUBLICATION OF RESEARCH FINDINGS ............................................................ 35 

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15. 
REFERENCES ................................................................................................................ 36 
16 
APPENDICES ................................................................................................................. 44 
 
 
 

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PRÉCIS 
 
Study Title: PROVEN: PRagmatic trial Of Video Education in Nursing homes 
 
Objective: To conduct a pragmatic cluster randomized control trial (RCT) of an Advance Care 
Planning (ACP) video support intervention for nursing home (NH) patients ≥ 65 cared for in 360 
NHs (intervention, n=119; control, n=241) within two NH health care systems; Genesis 
HealthCare and PruittHealth. 
 
Design and Outcomes: Aim 1 of this study is to implement all aspects of a pragmatic cluster 
RCT trial of an ACP video support intervention in two NH health care systems, including: 1. 
Recruitment of a sufficient number of NHs to achieve the sample size of patients needed to 
demonstrate a clinically meaningful difference in the primary outcome; 2. Facility staff 
training and implementation of the intervention; and 3. Outcome assessment using EMR 
records, the Minimum Data Set (MDS), and Medicare Claims.  
In this stratified cluster RCT, the unit of random assignment is the facility but the unit of 
analysis is the patient, clustered within the facility. The intervention will be implemented facility-
wide, thus all patients cared for in the NHs during the 24-monthimplementation period are subjects 
in this study (N ~ 152,160). However, outcomes will be analyzed in targeted sub-populations with 
advanced comorbid conditions for whom the opportunity and need to improve ACP and goal-
directed care are greatest. These subgroups include very disabled older patients with advanced 
dementia and advanced congestive heart failure (CHF) or chronic obstructive pulmonary disease 
(COPD) (i.e., cardiopulmonary disease).  
Outcomes to be compared between patients in the intervention and control NHs include: 
advance directives orders (Do Not Resuscitate (DNR), Do Not Hospitalize (DNH), Do Not 
Intubate (DNI), and no tube-feeding), hospital transfers, use of other burdensome interventions 
(new feeding tube insertions, parenteral therapy, intubation, ICU care), hospice use, and Medicare 
ACP billing codes. The effectiveness of the intervention to improve these outcomes among those 
targeted sub-populations with advanced illness will be assessed among long-stay (≥ 90 days) NH 
residents > 65 (Aim 2) and new admissions to post-acute care (short-stay < 90 days) (Aim 3). 
Finally, we will evaluate the effects of the intervention by examining the aforementioned outcomes 
among long-stay NH patients and new admissions who do NOT have either of the pre-specified 
advanced illnesses (Aim 4). 
The primary outcome for this pragmatic trial is hospital transfers (quantified as number of 
hospital transfers/person-days alive based on Medicare claims data), which include admissions, 
emergency department visits, and observation stays over a 12-month follow-up period among 
long-stay residents with advanced dementia and/or advanced CHF/COPD. For all analyses 
involving this hospital transfer outcome, including the primary trial outcome, the main analyses 
will be restricted to Medicare Fee-for-Service patients because ascertainment of hospital transfers 
is most accurate from Medicare Claims data. Exploratory analyses will also be done on all patients, 
not just FFS, using the MDS as well as Medicare claims as the data sources.  Secondary outcomes 
include advance directive orders, other burdensome treatments, and hospice use.  An exploratory 
aim will be, among decedents, to compare the proportion of patients in the intervention and control 
facilities who had any of the following interventions in the last month of life: hospital transfer or 
other burdensome interventions (feeding tube insertion, parenteral therapy, intubation, ICU care).  

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Separate analyses will be done among decedents from the short and long-stay cohorts with 
advanced dementia, CHF or COPD, as well as those without advanced disease. 
 
Interventions and Duration: The intervention consists of a suite of five videos designed to 
address common ACP decisions confronting NH patients and their families:  
 
1. Goals of Care for Any Patient 
2. Goals of Care for Patients with Advanced Dementia 
3. Decisions about Hospitalization 
4. Decisions about Hospice 
5. General Information about Advance Care Planning for Healthy Adults 
 
NHs randomized to the control arm of the study will use the usual ACP procedures already 
practiced in their facilities. The ACP Video Program will be implemented for 24 months in the 
intervention facilities. Individual patients in both arms who are in the NHs during the 24-month 
implementation period are eligible, and their outcomes will be assessed for up to 12 months in 
the long-stay cohort and 100 days in the short-stay cohort. 
 
Sample Size and Population: The ACP video intervention will be implemented facility-wide in 
the NHs randomized to the intervention arm. Thus, ALL patients who are cared for during the 
24-month implementation phase are potential participants in the trial and comprise the study 
population (N ~ 152,160). However, the analyses described in Aims 2 and 3 will focus on target 
populations with advanced comorbid conditions that are cared for in the NHs during the 24-
month implementation period. For Aim 2, the target sample is long-stay patients with advanced 
dementia or CHF/COPD (N~ 14,760). As the primary study trial outcome is hospital transfers in 
the long-stay patients, sample size estimates and power calculations are based on this target 
group. For Aim 3, the target sample is short-stay patients with advanced dementia or 
CHF/COPD. For Aim 4, the target sample is long-stay and short-stay NH patients who do NOT 
have either of the pre-specified advanced illnesses. 
In this stratified cluster RCT, the unit of random assignment is the facility. Facilities will be 
randomized in the following strata in the following order: 1. Health care system (Genesis 
HealthCare and PruittHealth), and 2. Hospitalization rates in the 12 months prior to recruitment in 
target sub-populations (grouped as terciles). Outcomes analyses will not differ by strata.

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STUDY TEAM ROSTER 
Co-Principal Investigators: 
 
 
Susan Mitchell, MD, MPH  
Senior Scientist, Institute for Aging Research, Hebrew SeniorLife,  
Professor of Medicine, Harvard Medical School  
http://www.instituteforagingresearch.org/    
Address:  1200 Centre Street, Boston, MA 02131 
Phone:   617-971-5326, Fax: 617-971-5339   
Email:    smitchell@hsl.harvard.edu 
Main Roles: Member of Steering and Executive Committees; leader of Human Subjects and Data 
Safety and also Stakeholder Engagement working groups; management of team that coordinates 
all intervention implementation and training activities. 
 
Vincent Mor, PhD 
Professor of Health Services, Policy & Practice and the Florence Pirce Grant University 
Professor in the Brown University School of Public Health  
Address:  Center for Gerontology and Healthcare Research, School of Public Health 
Box G-121-6, Providence, RI 02912 
Phone:   (401) 863-3211, FAX: 401-863-3489 
Email:    vincent_mor@brown.edu 
Main Roles: Member of Steering and Executive Committees; leader of the Facility Selection and 
Recruitment and also Measurement working groups. Oversight of all issues related to data 
acquisition, merging, and management. Member of the Statistical Methods, Data Management, 
and Stakeholder Engagement working groups. Study representative to NIH; responsible for 
establishing and monitoring contracts with health care system partners. 
 
Angelo Volandes, MD, MPH  
Assistant Professor of Medicine, Harvard Medical School 
Division of General Internal Medicine, Massachusetts General Hospital 
Address:  50 Staniford Street, 9th Floor, Boston, MA 02114-2621 
Phone:   917-612-9762 
Email:    avolandes@partners.org 
Main Roles: Member of Steering and Executive Committees and the Stakeholder Engagement 
working group; leader of the Intervention Refinement and also Intervention Training and 
Implementation working groups. Primary developer of ACP videos. 
 
 

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Co-Investigators: 
 
 
Constantine Gatsonis, PhD 
Professor of Biostatistics, Brown University 
121 South Main Street, Providence RI 02912-9107 
Phone: 401-863-9183, FAX: 401-863-9182 
Email: Constantine_Gatsonis@brown.edu 
Roles: Senior/lead biostatistician; Steering Committee member; leader of Statistical Methods 
working group; member of Measurement working group. 
 
Pedro L. Gozalo, PhD 
Associate Professor of Health Services, Brown University 
Address: 121 South Main Street, Providence, RI 02912-9107 
Phone: 401-863-7795, FAX: 401-863-3489 
Email: Pedro_Gozalo@brown.edu 
Roles: Leader of Data Management working group; member of Steering Committee and the 
Measurement and also Human Subjects and Data Safety working group. 
 
Roee Gutman, PhD 
Assistant Professor of Biostatistics, Brown University 
Address: 121 South Main Street, Providence, RI 02912-9107 
Phone: 401-863-2682, FAX: 401-863-9182 
Email: Roee_Gutman@brown.edu 
Roles: Biostatistician; member of Measurement and also Statistical Methods working groups. 
 
Joan M. Teno, MD, MSc 
Professor of Medicine, Gerontology and Geriatrics  
Cambia Palliative Care Center of Excellence, University of Washington 
Phone: 206-744-9875 
Email: jteno@medicine.washington.edu 
Roles: Provides content and analytic expertise; member of Intervention Refinement and also 
Measurement working groups. 
 
Health Care System Partner Representatives: 
 
Crystal Bowens 
Senior Vice President of Professional Services 
PruittHealth Consulting Services 
Address:  1626 Jeurgens Court, Norcross, GA. 30093-2219 
Phone:  770-279-6240 
Email: crharris@pruitthealth.com 
Roles: Member of the Steering Committee and leads project at PruittHealth. 
 
 
 
 

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Julie Britton, DNP, CNS, RN 
Vice President of Clinical Operations 
Genesis HealthCare 
Address: 101 E. State Street, Kennett Square, PA 19348 
Phone:   610-444-6350 
Email: Julie.Britton@genesishcc.com 
Roles: Member of the Steering Committee and leads project at Genesis HealthCare. 
 
Research Team Members: 
Elaine Bergman, MGS 
Project Director, Institute for Aging Research, Hebrew Senior Life 
Address:  1200 Centre Street, Boston, MA 02131 
Phone: 617-971-5335 
Email:  elainebergman@hsl.harvard.edu 
Roles: Manages meeting materials for Human Subjects and Data Safety and also Stakeholder 
Engagement working groups and DSMB; responsible for IRB interactions at Hebrew Senior 
Life; MOP development and management. 
Faye V. Dvorchak 
Project Coordinator, Brown University 
Address: 121 South Main Street, Providence RI. 02912-9107 
Phone: 401-863-2486  
Email: Faye_Dvorchak@brown.edu 
Roles: Manages Steering Committee and working groups including: Facility Selection and 
Recruitment, Measurement, Statistical Methods, and Data Management; manages study data 
flow, integrates and updates data from participating NH systems and government data, monitors 
facility and patient accrual, assists with regular reporting to DSMB, manages tracking system 
and meeting calendars, as well as efforts to document the implementation of the intervention. 
Jeffery Hiris  
Systems Manager/Senior Programmer, Brown University 
Address: 121 South Main Street, Providence RI. 02912-9107 
Phone: 401-863-3317 
Email: Jeffrey_hiris@brown.edu 
Roles: Coordinates all data transfer and data file storage and linkages at Brown. 
Julie Lima, PhD 
Manager of Data Acquisition and Senior Programmer Analyst 
Health Services Policy & Practice, Brown University 
Address: 121 South Main Street, Providence RI. 02912-9107 
Phone: 972-355-7814 
Email: julie_lima@brown.edu 
Roles:  Member of Data Management and also Human Subjects and Data Safety working groups; 
responsible for DUAs and IRB activities within Brown. 
 

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Jessica Ogarek, MS 
Biostatistician 
Brown University 
Address: 121 South Main Street, Providence RI. 02912-9107 
Phone: 401-863-9356 
Email: jessica_ogarek@brown.edu 
Roles:  Member of the Data Management working group; performs analyses, generates reports. 
 
PARTICIPATING STUDY SITES  
 
The study is being conducted at 360 NHs owned by Genesis HealthCare and PruittHealth 
corporations. Julie Britton (Genesis HealthCare) and Crystal Bowens (PruittHealth) lead the 
project at these health care system partners. Their contact information is listed above.  
 
 
 
 

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1.   STUDY OBJECTIVES 
 
Aim 1: To implement all aspects of a pragmatic cluster RCT trial of an ACP video support 
intervention in two NH health care systems, including: 1. Recruitment of a sufficient number of 
NHs to achieve the sample size of patients needed to demonstrate a clinically meaningful 
difference in the primary outcome; 2. Facility staff training and implementation of the 
intervention; and 3. Outcome assessment using EMR records, the Minimum Data Set (MDS), 
and Medicare Claims.  
 
Aim 2: To evaluate the effectiveness of the ACP intervention by comparing the following 
outcomes over 12 months among long-stay NH residents > 65 with advanced comorbid conditions 
(advanced dementia and/or advanced congestive heart failure (CHF) or chronic obstructive lung 
disease (COPD)) in the intervention vs. control NHs: 1. Advance directives to withhold specific 
treatments (DNH, DNR, DNI, and no tube-feeding), 2. Hospital transfers (# hospital 
transfers/person-days alive), 3. Other burdensome treatments (new feeding tube insertions, 
parenteral therapy, intubation, ICU care), 4. Hospice use, and 5. Medicare ACP billing codes. 
H2a: A higher proportion of long-stay residents in the intervention (vs. control) NHs will have 
advance directive orders to withhold specific treatments over 12 months. 
H2b: Over 12 months, hospital transfers (primary study outcome) and other burdensome 
interventions will be lower among long-stay residents in the intervention (vs. control) NHs. 
H2c: A higher proportion of long-stay residents in the intervention (vs. control) NHs will be 
enrolled in hospice. 
 
Aim 3: To evaluate the effectiveness of the ACP intervention by comparing the following 
outcomes in the intervention vs. control NHs among new admissions to post-acute care  > 65 with 
advanced comorbid conditions (as defined in Aim 2): 1. Advance directives to withhold specific 
treatments (DNH, DNR, DNI, no tube-feeding), 2. Hospital transfers within 100 days of the post-
acute care admission (# hospital transfers/per-days alive), 3. Hospice enrollment within 100 days 
of the post-acute care admission, and 4. Medicare ACP billing codes within 100 days of the post-
acute care admission.  
H3a: A higher proportion of post-acute care patients in the intervention (vs. control) NHs will 
have advance directive orders to withhold specific treatments during their admission. 
H3b: Hospital transfer rates will be lower among post-acute care patients in the intervention (vs. 
control) NHs. 
H3c: A higher proportion of post-acute care in the intervention (vs. control) NHs will be enrolled 
in hospice. 
 
Aim 4: To evaluate the effects of the ACP intervention by comparing outcomes (advance directive 
orders, hospital transfers, hospice use, and Medicare ACP billing codes) in the intervention vs. 
control NHs among long-stay residents and newly admitted post-acute care patients who do NOT 
have designated advanced illness (i.e., dementia, CHF, or COPD).  
H4a: A higher proportion of NH patients without advanced dementia, COPD, or CHF in the 
intervention (vs. control) NHs will acquire advance directives to withhold specific treatments. 
H4b: Hospital transfers will be lower among NH patients without advanced dementia, COPD, or 
CHF in the intervention (vs. control) arms.  
H4c: A higher proportion of NH patients without advanced dementia, COPD, or CHF in the 
intervention (vs. control) NHs will be enrolled in hospice. 

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Exploratory Aim: Among decedents, to compare the proportion of patients in the intervention 
and control facilities who had any of the following interventions in the last month of life: hospital 
transfer or other burdensome interventions (feeding tube insertion, parenteral therapy, intubation, 
ICU care).  Separate analyses will be done among decedents from the short and long-stay cohorts 
with advanced dementia, CHF or COPD, as well as those without advanced disease.  
 
Cohort and outcomes specifications: 
 
A. Hospital transfer outcome 
1. For all analyses involving this outcome, including the primary trial outcome, the main 
analyses will be restricted to Medicare Fee-for-Service patients because ascertainment of 
hospital transfers is most accurate from Medicare Claims data. Exploratory analyses will 
also be done on all patients, not just FFS, using the MDS as well as Medicare claims as the 
data sources. 
2. For the primary outcome and all relevant secondary outcomes, ‘hospitalizations’ was 
modified to ‘hospital transfers’ based on Medicare claims data, which include admissions, 
emergency department visits, and observation stays. This change was made so as to capture 
the main “decision” to send a patient from the nursing home to the hospital. 
 
B. Advance directive outcome 
1. For all aims, advance directives analyses will be limited to Genesis facilities in which 
>75% of patients have any advance directive because the remaining Genesis and Pruitt 
facilities do not have reliable sources for these data.  
2. The proportion of residents in a facility whose last observed advance directive status during 
their observation period was DNR, DNH, DNI or feeding restrictions 
i. The proportion of short-stay residents in a facility whose last observed 
advance directive status during their 100-day observation period was DNR, 
DNH, DNI or feeding restrictions 
ii. The proportion of long-stay target residents in a facility whose last observed 
advance directive status during their 12-month observation period was 
DNR, DNH, DNI or feeding restrictions 
iii. The proportion of long-stay non-target residents in a facility whose last 
observed advance directive status during their 12-month observation period 
was DNR, DNH, DNI or feeding restrictions 
3. Among participants who are full code when they become part of the study (on admission 
to a NH), the average time to switching from full code to DNR, DNH, DNI or feeding 
restrictions during a 12-month observation period. 
 
C. Burdensome interventions 
1. For Aim 2.3, burdensome interventions will include: new feeding tube insertions (i.e., did 
not have a feeding tube at start of observation period), parenteral therapy (for hydration or 
medication delivery), intubation, or ICU care). The outcome will be analyzed as the 
proportion of long-stay target cohort residents that had any burdensome intervention during 
the 12-month observation period.  
 

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D. Hospice:  
1. In the long-stay target cohort, the proportion of residents with any Medicare hospice claim 
in the 12-month observation period. 
2. In the non-target long-stay cohort, the proportion of residents with any Medicare hospice 
claim in the 12-month observation period. 
3. In the short-stay cohort without advanced comorbid conditions, the proportion of residents 
with any Medicare hospice claim in the 100-day observation period. 
4. In the short-stay cohort with advanced comorbid conditions, the proportion of residents 
with any Medicare hospice claim in the 100-day observation period. For both long-stay 
and short-stay cohorts, residents on hospice at the start of the observation period will be 
excluded.  
 
E. Medicare Advance Care Planning Billing  
1. In long-stay target cohort, the proportion of residents with any Medicare ACP billing code 
in the 12-month observation period. 
2. In non-target long-stay cohort, the proportion of residents with any Medicare ACP billing 
code in the 12-month observation period. 
3. In short-stay cohort (with and without advanced comorbid conditions), the proportion of 
patients with any Medicare ACP billing code in the 100-day observation period. 
 
 
2.  BACKGROUND AND RATIONALE  
 
2.1. Epidemiology: Nursing homes (NHs) care for approximately 3 million individuals annually, 
including 1.5 million frail older persons with advanced chronic disease requiring long-term care, 
and a growing proportion of seriously ill patients admitted for post-acute care. 1, 2 Approximately 
11% of Americans over 85 years reside in NHs. In the past 3 decades, NHs have evolved into 
complex health care systems serving an increasingly sick and heterogeneous population. While 
NHs serve a growing number of patients recuperating from acute illnesses, they also are a common 
site of care for patients nearing the end-of-life. In 2009, 45% of U.S. Medicare beneficiaries who 
died were in a NH during the last 90 days of life, and 28% died in that setting. 3 Taken together, 
NHs are often charged with guiding patients with complex medical problems and advanced illness 
through challenging decisions about the direction of their treatment. 
 
2.2. Need to improve advance care planning (ACP) in NHs: Advance care planning (ACP) is a 
process of communication between providers and patients/families to identify anticipated medical 
decisions and clarify goal-directed treatment preferences. Ideally, ACP leads to completion of 
advance directives that come into effect if/when a patient becomes incapacitated. Advance 
directives include living wills, appointment of a health care proxy, and formal medical orders to 
withhold specific treatments, such as resuscitation. In observational studies, ACP is the strongest 
and most consistent modifiable factor associated with better palliative care outcomes in the NH 
setting.4-9 The lack of advance directives has been associated with greater use of feeding tubes, 7, 
10, 11 more terminal hospitalizations, 5, 12-14 higher health care costs,9  worse family satisfaction and 
mental health outcomes, 6, 10, 15, 16 and lower hospice use. 10, 17    
The Patient Self-Determination Act (PSDA) of 1991 mandated that NHs ascertain and 
document patients’ advance directives.18 Unfortunately, advance directive completion remains 
inadequate and does not always reflect the patient’s goals of care. 4, 6, 8, 18-24 The proportion of NH 

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patients with DNR orders increased from 31% in 1990 to 52%,19 but has remained relatively 
unchanged thereafter.25 Other, perhaps more consequential directives for NH patients, were not 
influenced by the PSDA and continue to be low. In 2007, only 4% of U.S. NH patients had DNH 
orders and 11% had orders to withhold tube-feeding. 25 Not surprisingly, markers of the quality of 
end-of-life care, such as terminal hospitalizations, have also not improved.25 Other serious 
concerns related to advance directives in the NH persist, most notably marked racial and regional 
disparities,8, 26-29 and very low completion rates in post-acute care, where only 32% and 2% of 
patients have DNR and DNH orders, respectively. 29 
There have been some, albeit limited, efforts to design and evaluate approaches other than 
legislation to improve advance directives in NHs.30 An RCT from the late 1990s of an advance 
directive program in 6 Ontario facilities resulted in more advance directive documentation, fewer 
hospitalizations, and lower expenditures, with no change in survival. 31 A more recent initiative is 
the Physician Order for Life-Sustaining Treatment (POLST) program, which translates treatment 
preferences into medical orders that are documented on a form designed to be portable across care 
settings. POLST does not intervene on the process of counseling patients about how to make 
preference-based decisions. While many states have adopted POLST programs in NHs, 32 its 
efficacy and effectiveness are under-studied. A retrospective cohort study from 90 NHs found that 
POLST resulted in care consistent directives and greater advance directive documentation.33, 34  
There is growing recognition that improving goal-directed care in NHs will require greater 
focus on improving the process of ACP (i.e., helping to prepare patients for medical decision-
making), rather than just static advance directive completion. 18, 35-37 In one of the few rigorous 
RCTs designed to improve this process, social workers were trained how to have structured ACP 
discussions with all newly admitted NH patients.38 This approach reduced unwanted care and 
increased advance directive documentation, but was never adopted into practice perhaps because 
such complex interventions are resource intensive, require on-going staff training, and are difficult 
to replicate across facilities.  
The proposed pragmatic RCT of the video decision support tools addresses many of the 
lessons learned, research gaps, and on-going concerns about ACP in NHs by rigorously evaluating 
the implementation of a standardized, practical intervention that targets the ACP process in two 
large NH systems.  
 
2.3. Hospitalizations of NH patients are common, burdensome, costly, and often avoidable: An 
estimated 15% of NH patients are hospitalized in the last week of life. 25 Between one-third and 
one-fifth of patients in sub-acute skilled nursing facilities (SNFs) are re-hospitalized within 30 
days.39 Prior work reports that 23-60% of hospitalizations of NH patients are avoidable, either 
because hospital-level care is unnecessary or unwanted, and, if averted, could potentially save the 
U.S. health care system billions of dollars annually. 40-44  
This opportunity and need to reduce avoidable hospitalizations are greatest among patients 
with advanced chronic illnesses, for whom the burdens of hospitalization often outweigh the 
benefits. The decision to hospitalize patients should be guided by the primary goal of care (i.e., 
prolongation of life vs. comfort). The goal of care for many NH patients with advanced disease is 
comfort. With rare exceptions (e.g., hip fracture), hospitalization seldom promotes a goal of 
comfort. Hospitalization can be traumatic, 45, 46 and often involves burdensome and costly 
treatments that may be of limited clinical benefit. 45-48 For example, 68% of feeding tubes are 
placed in NH residents with advanced dementia during a hospitalization. 47 Care transitions also 
place NH residents at risk of medical errors and adverse drug events. 49, 50 For those NH patients 

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whose goal of care remains life prolongation, many of the most common illnesses precipitating 
hospitalization (i.e., infections), can be usually treated with the same efficacy in the NH. 51-54  
  
Better ACP is a key strategy to reduce avoidable hospitalizations. 44 A DNH order is the 
strongest factor associated with lower hospitalization rates. 5, 12, 55, 56 NHs with higher rates of DNR 
orders, a marker of facility culture with better ACP, have lower hospitalization rates among dying 
patients.25 A before and after study of an ACP-focused intervention in SNFs that targeted patients 
with > 3 hospitalizations in the prior 6 months reduced re-hospitalization rates by 20%.57 The 
Interventions to Reduce Acute Care Transfers (INTERACT) program, of which ACP is a key 
component, has also been shown to reduce NH hospitalizations. 58 
 
2.4. Video decision support tools improve ACP for multiple conditions: The traditional approach 
to ACP primarily relies on ad hoc verbal descriptions of hypothetical clinical states and 
interventions. This approach is limited because complex scenarios are difficult to envision, 
provider information is inconsistent, and verbal explanations are hampered by literacy and 
language barriers. Decision support tools have been used to overcome some of these barriers59-65 
and are meant to supplement, not replace, provider counseling by providing standardized 
information about options and a framework for weighing options with preferences.  
 
More than 700 decision support tools exist, including 50 that utilize videos. 63-65 Video 
addresses some of the limitations of traditional verbal ACP by providing realistic visual images of 
complex medical scenarios. A growing body of work, including several RCTs, supports the 
effectiveness and feasibility of video decision support tools for ACP for various advanced illnesses 
(e.g., dementia, cancer, heart failure) and among patients in different settings (out-patient, hospital, 
short-term rehabilitation) (see Section 3.C.i.c. Preliminary Studies). 66-75 These studies consistently 
find that subjects who view the video, when compared to those who listen to verbal information, 
have greater knowledge about their condition and treatment choices and are more likely to choose 
less aggressive interventions as their preferred care. Findings also show that the videos reduce the 
racial and health literacy disparities that typically characterize traditional verbal counseling. 69, 76   
 
The promise of video for ACP is reflected by the widespread attention this work has received 
by the scientific community, 77-79 media, 80, 81 the U.S. Congress, and early adoption by major 
health care systems. Kaiser Permanente, Group Health Cooperative, and the Palo Alto Foundation 
are currently using the ACP videos in their out-patient and hospital practices. The state of Hawaii 
is using these tools across health care settings, including NHs (see Section 3.C.i.d. Preliminary 
Studies). However, none of these efforts involve formal research designs or evaluation. Thus, the 
proposed pragmatic trial is a logical next step towards understanding the real world application of 
a video ACP support tool for NH patients.  
 
2.5. Electronic health records and secondary data sources are powerful tools for NH heath 
systems research: Since 1998, when The Centers for Medicare & Medicaid Services required full 
electronic submission of Minimum Data Set (MDS) data, all licensed U.S. NHs have had 
rudimentary EMRs.82, 83 The MDS is a comprehensive, standardized resident assessment 
instrument federally mandated for use in all licensed U.S. NHs. The latest iteration, the MDS 
Version 3.0, was introduced in 2010. MDS assessments are completed on all NH patients upon 
admission, quarterly, annually, and whenever they have a significant status change. The uniformly 
collected MDS data have been used for care planning, fiscal, policy, and research purposes. Prior 
work has shown that MDS data are valid and reliable for these purposes as collected in the real 
world, not merely during field testing.84-90 

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Over the past 17 years, analyses of the MDS on its own and linked with other secondary 
data sources, most notably the Medicare and Medicaid claims, have made key contributions to our 
understanding of clinical outcomes and health care utilization in the NH setting. These merged 
datasets have been used extensively to address research questions in the areas of ACP and end-of-
life care, including: tube-feeding in advanced dementia, 7, 11, 91, 92 hospitalization, 5, 8, 39, 93 hospice 
use, 94-96 health care expenditures, 56 regional disparities, 11, 92 and prognostication.11, 97 Much of 
this work has emanated from Brown University in efforts led by Dr. Mor and in collaboration with 
Dr. Mitchell (See Section 3.C.i.a.2. Preliminary Studies).  
 
The introduction of the MDS stimulated the development of integrated EMR systems in NHs 
capable of filing MDS assessments, billing payers, and ultimately pharmacy management and 
physician ordering. One of our partner NH health care systems, Genesis HealthCare, uses 
PointClickCare™, one of the most sophisticated among these EMR systems. 98 PointClickCare™ 
integrates data from MDS assessments, physician order entry, health care utilizations (hospital 
transfer, hospice referral), and pharmacy prescriptions into patient care plans. Our second partner 
NH system, PruittHealth, uses American Health Tech, 99 which has capabilities and components 
that are very similar to PointClickCare™. 
 
2.6. A pragmatic trial with a cluster randomized design is a well-suited approach to evaluate the 
effect of the ACP video intervention in NH health care systems: Over the past 15 years, cluster 
randomized controlled trial (RCT) designs have been increasingly used in health services research, 
including trials of NH interventions. 52, 100-108 This work has contributed to more refined and 
standardized approaches to the unique biostatistical, implementation, and ethical considerations 
associated with clustered trial designs. 103, 109-113 Several advantages of cluster RCTs for testing 
interventions in NHs are notable. Given that the facility is the unit of randomization, the 
contamination that can occur when randomizing individuals within NHs is avoided. Moreover, the 
types of interventions being tested will likely be implemented at the NH level. Finally, individual 
patient consent procedures are often unnecessary provided the study is of low risk.  
While the increasing number of cluster RCTs conducted in NHs has established the 
feasibility of this approach, most were in a relatively small number of facilities and evaluated the 
effects of interventions under ideal circumstances (i.e., explanatory trials). Pragmatic trials, which 
intend to determine the effects of interventions under usual conditions, are a next critical 
translational step in NH research. 114 A small but growing number of pragmatic trials of NH 
interventions have been conducted, all of which were outside the U.S. 115-117 Based on the 10 
domains outlined in the Pragmatic–Explanatory Continuum Indicator Summary Tool (PRECIS),118 
the rationale for pragmatic trials in the NH setting is very compelling, particularly for an ACP 
intervention. NHs must engage all patients in ACP to maintain an expected standard of care and 
as a matter of federal legislation. However, NH providers include a variety of practitioners caring 
for a heterogeneous population. Thus, a pragmatic trial that involves facility-wide implementation 
of a standardized, feasible, but flexible, ACP intervention makes sense. Moreover, large networks 
of NHs across the U.S. are owned and operated by single corporations, such as Genesis HealthCare 
and PruittHealth. These NH systems are uniquely suited for pragmatic trials as they have efficient 
and established infrastructures for staff training and new program implementation. Moreover, they 
have integrated computerized clinical information systems (e.g., PointClickCare™) providing an 
easily accessible data source for patient characterization, intervention implementation, and 
outcomes measurement. 
 

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2.7. Summary of background and rationale based on the literature: The significance of the 
proposed pragmatic cluster RCT of an ACP video intervention in two NH health care systems is 
summarized in the following points: 1. NHs have evolved into complex health care systems serving 
an increasingly sick patient population with advanced comorbid conditions; 2. These NH patients 
often get aggressive and costly interventions that may be of little clinical benefit and inconsistent 
with their preferences; 3. There is an opportunity to promote more preference-based, higher 
quality, and cost-effective care among NH patients with advanced disease through better ACP; 4. 
An intervention comprised of a suite of ACP video decision support tools presents a promising, 
scalable, and efficacious approach to address that opportunity that can be implemented on a 
system-wide level in a flexible manner; and, 5. NH systems offer an ideal setting for a pragmatic 
cluster RCT. This design is enabled by system-wide infrastructures for staff training, program 
implementation, and existing electronic data capture. Taken together, this work has the potential 
to improve the quality of care provided to millions of older Americans in NHs and to enable future 
pragmatic trials in this increasingly important care setting. 
 
3.    STUDY DESIGN 
This is pragmatic stratified cluster RCT that will evaluate an ACP video support intervention 
for patients > 65  cared for in 360 NHs (intervention, n=119; control, n=241) within two NH health 
care systems, Genesis HealthCare and PruittHealth. Aim 1 of this study is to conduct all aspects 
of this pragmatic trial. 
The intervention consists of a suite of five videos designed to assist NH patients with ACP 
decisions (see Section 5). The ACP video intervention will be implemented in NHs assigned to the 
intervention arm for 24 months. Data needed to assess outcomes will be derived from the NH EMR 
systems merged with MDS and Medicare files. NHs randomized to the control arm will use the 
usual ACP procedures practiced in their facilities.  
 
In this stratified cluster RCT, the unit of random assignment is the facility but the unit of 
analysis is the patient, clustered within the facility (See Section 4.4.2). The intervention will be 
implemented facility-wide, thus all patients cared for in the NHs during the 24-month 
implementation period are subjects in this study (N ~ 152,160). However, our primary outcomes 
will be measured in targeted sub-populations with advanced comorbid conditions for whom the 
opportunity and need to improve ACP and goal-directed care are greatest. These subgroups 
(n~14,760) include very disabled older, long-stay patients with advanced dementia and those with 
advanced congestive heart failure (CHF) or chronic obstructive pulmonary disease (COPD) (i.e. 
cardiopulmonary disease). 
Outcomes to be compared between patients in the intervention and control NHs include: 
advance directives orders (DNR, DNH, DNI, and no tube-feeding), hospital transfers, use of other 
burdensome interventions (new feeding tube insertions, parenteral therapy, intubation, ICU care), 
hospice use, and Medicare ACP billing codes. The effectiveness of the intervention to improve 
these outcomes among those targeted sub-populations with advanced illness will be assessed 
among long-stay (≥90 days) NH residents (Aim 2) and new admissions to post-acute care (short-
stay < 90 days) (Aim 3). Finally, we will evaluate the effects of the intervention by examining the 
aforementioned outcomes among long-stay NH patients and new admissions who do NOT have 
either of the pre-specified advanced illnesses (Aim 4).The primary outcome for this pragmatic trial 
is hospital transfers (quantified as number of hospital transfers/person-day alive based on Medicare 
claims data), which include admissions, emergency department visits, and observation stays over 
a 12-month follow-up period among long-stay residents with advanced dementia and/or advanced 

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CHF/COPD. Secondary outcomes for these patient groups include advance directive orders, other 
burdensome treatments, hospice use, and Medicare ACP billing codes. 
 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
 
4.1.  Facility Inclusion Criteria 
 
Facility eligibility criteria include:  
Matched facility ID on Brown University’s list of all Medicare/Medicaid-certified nursing 
facilities in the U.S. 
Serve both short and long-stay patients 
Have >50 beds 
Have an EMR system 
Have at least 20 admissions and 20 annual Minimum Data Set (MDS) assessments (regardless of 
whether patients were discharged alive) 
We anticipated that a total of approximately 360 (297 Genesis HealthCare / 63 PruittHealth) 
facilities would be eligible for random assignment. 
 
4.2.  Patient Inclusion Criteria: 
As the ACP video intervention will be implemented facility-wide, all patients in eligible NHs 
during the 24-month implementation period are eligible. There are no exclusions based on age, 
gender, race, ethnicity, or clinical features. 
Although the ACP intervention will be implemented facility-wide, its effectiveness will be 
examined among targeted NH sub-populations for Aims 2, 3, and 4. Target populations for these 
Aims include patients > 65 in the NHs during the 24-month implementation period who meet the 
following eligibility definitions based on MDS assessments. For all three aims, residents will be 
eligible for the target sub-populations if they meet these criteria either at the start (prevalent cases) 
or during (incident cases) the 24-month implementation phase. Incident cases include new 
admissions and long-stay residents who “convert” over the implementation phase by meeting 
eligibility criteria based upon changes in their repeated MDS assessments.   
 
Aim 2: Patients > 65 who are in nursing home ≥90 days (long-stay) who have EITHER of the 
following two conditions: 
1. 
Advanced Dementia: must have all three criteria: a, b, and c 
a. 
Alzheimer’s disease or other dementia 
b. 
Advanced cognitive impairment*  
c. 
Extensive or total assistance needed for eating and transferring 
*Advanced cognitive impairment is defined as a score of 3 or 4 on the Cognitive Function Scale 
based on variables from the MDS Version 3.0 119, 120  
 
2. 
Advanced COPD/CHF: must have all three criteria: a, b, and c 
a. 
CHF/COPD 
b. 
Shortness of breath sitting or lying flat 
c. 
Extensive or total assistance walking in room, transferring, walking in corridor,   
locomotion on/off unit, or dressing. 

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Aim 3:  Patients > 65 who are in nursing home < 90 days (short-stay) who have advanced dementia 
OR advanced CHF/COPD as defined above. 
 
Aim 4: Long and short-stay patients > 65 who do NOT have either advanced dementia OR 
advanced CHF/COPD as defined above. 
 
4.3. Exclusion Criteria 
Facilities with unstable organizational or regulatory issues (in transition or leadership 
problems or recent poor performance in regulatory surveys) such as those listed below will be 
excluded prior to randomization based on input from corporate leadership: 
 
Recent turnover in NH Administrator or Director of Nursing 
Recent bad state or federal quality assurance survey (e.g., restriction on admissions, levied large 
civil monetary penalty, etc.) 
Current new initiatives/competing demands 
 
There are no patient exclusion criteria other than those implied by eligibility criteria.  
4.4. Study Enrollment Procedures  
4.4.1. 
Facility Recruitment Procedures:  
Facility recruitment will be conducted during months 1 and 2 of year 1. As a first step, eligible 
facilities among the Genesis HealthCare and PruittHealth NHs will be identified by the research 
team at Brown University using the most recent patient and organizational data available (at least 
2014). Bed size will be determined using CMS’s Provider of Service files. Case-mix (number of 
short and long stay patients) will be determined using the most recent aggregated nursing home 
resident assessment Minimum Data Set data available. Once candidate facilities are identified 
based on size and case-mix, final facility eligibility will be determined by corporate representatives 
based on the presence of EMR systems that include physician order sets and the absence of facility 
organizational instability or regulatory challenges since these will consume executive time and 
attention, possibly complicating participation in the implementation of the intervention. 
Once eligible facilities are identified, they will be randomly assigned to either the control or 
intervention arm (see Section 4.4.2. for randomization procedures) by statisticians at Brown 
University. An information letter endorsed by senior corporate leaders will be mailed to the senior 
administrators of all NHs randomized to the intervention arm. The letter will explain what 
involvement the facility has been selected for the ACP Video Program. Facility leadership will be 
given the opportunity to opt out. While senior corporate leaders will strongly endorse the project, 
the final decision to participate in the intervention arm will be at the discretion of the individual 
facility’s administrator. NHs randomized to the intervention whose administrators refuse to 
participate will not receive the intervention, but will be considered as intervention NHs in the 
intention-to-treat analyses (see Section 9). NHs randomized to the control arm will not be formally 
contacted and will not be aware that they are serving as control facilities. 
The decision to randomly assign facilities prior to recruitment was based on the following 
reasons: 1. With strong corporate endorsement, we believe a very high recruitment rate in the 
intervention arm can be achieved (i.e., > 90%), and 2. We feel it would be unfair to conditionally 
offer the ACP Video Program to all eligible NHs, and then rescind that possibility to the NHs 

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randomized to the control arm, and 3. Our partner health care systems strongly preferred post-
randomization recruitment.  
Once the intervention NHs are recruited, intervention training and implementation will be 
rolled out in a staggered fashion over the next 6 months (see Section 5.2), such that by month 8 of 
year 1, all intervention NHs will be up and running.   
 
4.4.2.  
Facility Recruitment Estimates:  
Based upon our sample size calculations, we require 103 facilities per arm (See section 9.2). 
To account for the fact that some (we estimated up to 10%) facilities randomized to the intervention 
arm would fail to participate fully in the intervention implementation (but will be included in our 
intention to treat analysis) we increased our facility recruitment targets by at least 10%, for a total 
of 119 facilities in the intervention study arm.  
From the pool of eligible facilities, 119 will be randomly assigned to the intervention arm, 
and all the remaining eligible facilities (n=241) will be assigned to the control arm (approximate 
2:1 control:intervention match). We will leave all non-intervention facilities in the control arm 
since there is no additional cost to do so and having the increased number of control facilities 
increased precision. 
 
4.4.3. Facility Randomization and Stratification Procedures:  
Facilities will be randomized using a stratified approach with two levels of stratification.  The 
first stratum is the NH health care system (Genesis HealthCare and PruittHealth). Within each 
health system, the second stratum will be on the hospitalization rate as measured by # 
hospitalization/person-days alive for patients with advanced dementia or COPD/CHF in all NHs 
in each health care system in the prior 12 months based on MDS files available at Brown 
University. The rationale for this stratum is that hospitalization rates, the primary trial outcome, 
are known to vary considerably at the facility-level due to regional practice, market influences and 
underlying quality. Since inter-facility hospitalization rates vary quite broadly, facilities will be 
grouped into terciles to minimize the chance of misdistribution. After the second stratification level 
is applied, facilities will be randomly assigned to either the control or intervention arm by a 
statistician at Brown University. Immediately following random assignment, we will test the 
balance between the arms using all available facility and resident-level data.  
 
 
 
Total eligible facilities 
N=360 
Healthcare system 1 
eligible facilities 
n=297 
Healthcare system 2 
eligible facilities 
n=63 
Intervention 
n=98 
Control 
n=199 
Intervention 
n=21 
Control 
n=42 

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4.4.4. Patient Participation and Consent 
There are special informed consent considerations for individual patients in this pragmatic, 
cluster RCT (see Sections 6.2 and 11.2). The NH is the unit of randomization, the intervention is 
of relatively low risk, and it will be implemented facility-wide as part of the intervention facilities’ 
standard operating procedures for ACP. In the control arm, usual care for ACP will be in place. In 
both study arms, all data will be ascertained from existing sources. NH administrators, who either 
agree or disagree to facility participation in the intervention arm, are serving as gatekeepers for the 
study. Thus, we will seek a waiver of individual informed consent as set forth by criteria found in 
HHS 45 CFR 46:116: (1) the research involves no more than minimal risk; (2) the waiver will not 
adversely affect the rights and welfare of the subjects; (3) the research could not practicably be 
carried out without the waiver; and (4) if appropriate, the subjects will be provided with additional 
pertinent information after participation. 
5. STUDY INTERVENTIONS  
5.1. Interventions, Administration, and Duration  
The ACP Video Program will be implemented for 24 months in each intervention facility. 
The intervention consisted of five previously created videos that addressed common ACP 
decisions in NHs: 1. Goals of Care for Any Patient; 2. Goals of Care for Patients with Advanced 
Dementia, 3. Decisions about Hospice, 4. Decisions about Hospitalization, and 5. General 
Information about Advance Care Planning for Healthy Adults. The videos are in English and 
Spanish, 6-10 minutes in duration, and offered to patients, family members, or both as deemed 
appropriate by the providers.  
The Goals of Care for Any Patient video outlines three broad levels of care: intensive medical 
care, basic medical care, and comfort care. A physician-moderator introduces the broad concept 
of ACP and the levels-of-care framework.  The video continues with narrative explanations and 
visual images of typical treatments that align with each level. For example, for intensive medical 
care, a resuscitation being conducted on a simulated patient and an actual ventilated patient in an 
intensive care unit are shown. For basic medical care, a patient in a hospital bed getting 
intravenous treatment is shown. For comfort care, a patient lying comfortably getting oxygen via 
a face mask and an attendant assisting with self-care are shown. A similar rubric is used for the 
Goals of Care for Patients with Advanced Dementia video, but it is tailored to this specific 
condition and aimed at family members. The Decisions about Hospitalization and Decisions 
about Hospice videos focus on decision-making for these specific interventions. The General 
Information about Advance Care Planning for Healthy Adults video is designed for the relatively 
healthy patients admitted to a NH for post-acute care for a focused, time-limited medical issue, 
such for rehabilitation following an elective knee replacement. This is primarily an educational 
video that presents the basic concepts of ACP and advance directives in a manner that would be 
appropriate for any relatively healthy person to understand. Inclusion of this video was informed 
by our experience in the pilot study, during which NH staff felt they did not have the “right” 
video to show these relatively healthy post-acute care patients.  
The videos are intended to supplement, not replace, existing ACP counseling practices. Thus, 
provider training included guidance on initiating ACP conversations, integrating videos into 
discussions, and debriefing with patients and families after the video.  
 

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5.2. Intervention Training, Implementation, and Adherence Monitoring 
At each intervention facility, two senior staff members were designated as ACP Champions 
and were responsible for implementing all aspects of the ACP Video Program. Implementation 
involved two major components: 1. Use of the videos with individual patients and families, and 2. 
Integration of the ACP Video Program into the workflow of the NH. Our research team provided 
a standardized approach for both these components through our training program. However, in the 
spirit of a pragmatic trial, NH staff had the flexibility to tailor aspects of the implementation as 
dictated by local NH practices, workflow, and culture. Providers also individualized the timing, 
format, and intensity of ACP Video Program based on each patient’s clinical needs.  
Intervention training and implementation began in January 2015; approximately 30 
intervention NHs were trained in each of 4 sequential waves. The implementation strategy was 
collaboratively designed by the research team and corporate leaders but executed almost 
exclusively by the healthcare systems. Each NH designated two ACP program champions, one of 
whom was a social worker, charged with leading implementation at their facility. Only corporate 
leaders were aware the intervention NHs were part of an RCT. ACP champions and NH 
providers were simply told the program was a new, corporate-led initiative. 
In keeping with a pragmatic trial, healthcare systems and NHs had flexibility to tailor the 
implementation protocol to their specific environments. The protocol instructed NH staff to offer 
videos to patients or families at the following trigger events: 1. Within 7 days of admission or 
readmission, 2. Every 6 months for long-stay patients, 3. When decisions were being discussed 
for which there was a specific video (e.g., hospice), and 4. Special circumstances (e.g., out-of-
town family visit, change in health status). Clinicians could choose which video(s) to show, with 
the goal-of-care video being the most widely applicable. Videos were pre-loaded onto tablet 
devices (two devices per facility) and available for out-of-town family members through a 
password-protected web link.  
Training materials included two printed toolkits, webinar companions to the toolkits, and 
pocket-sized reference guides. One toolkit focused on protocols for providers showing the videos 
to patients and families; another focused on implementing the videos into the NH workflow. 
Training occurred during the month prior to the implementation for each wave and periodically 
thereafter. Monthly conference calls are held among ACP champions, corporate leaders, and 
researchers to review the progress of implementation and resolve difficulties. 
To monitor adherence, a Video Status Report (VSR) was integrated into the electronic 
medical records of intervention NHs. Providers were instructed to complete the VSR each time a 
video was offered, even if it was not shown (e.g., patient refused). The VSR documented which 
video(s) was shown, who watched it (e.g., family, patient), and who showed it. The research 
team linked VSR with real-time MDS data to generate adherence reports which were sent to 
corporate leaders each month. The reports presented adherence measures for two primary 
indications for offering videos which were readily quantifiable; within 7 days of 
admission/readmission and every 6 months for long-stay patients. MDS data provided the 
denominator (e.g., number of admissions), and the VSR provided the numerator (e.g., VSRs 
completed for the new admissions). Both healthcare systems constructed similar internal reports, 
albeit primarily for admissions, every two weeks using their own data for more frequent 
monitoring. 
 
All NHs are required by federal law to engage patients in ACP, which currently occurs in an 
ad hoc fashion. The intervention is intended to provide a standard framework for ACP to 
complement direct counseling by providers. Thus, the ACP Video Program will be integrated into 

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the workflow of each facility as part its standard operating procedures. The ACP Video Program 
will be rolled out at the facility-level in much the same way as other new system-wide clinical 
programs are introduced through existing NH corporate infrastructures and procedures with the 
exception that this roll-out will only occur in intervention facilities. Typically, these roll-outs are 
done on a regional basis under the direction of a senior corporate administrator responsible for 
NHs within specific regions. Our research team will work directly with these regional directors to 
facilitate the ACP Video Program roll-out and facility-level implementation. 
 
The standardized approach for using the ACP videos with individual patients and families 
includes the following considerations: 1. When to offer the videos, 2. Who should offer the videos, 
3. Which video to show which patients, 4. How to show the videos, and 5. How to integrate the 
videos into broader ACP discussions, and 6. Completion of a Video Status Report User Defined 
Assessment. 
 
As per our protocol, NH staff will be instructed to offer videos to patients at the following 
clinical triggers:  
 Within 7 days of a new admission or readmission 
 Every 6 months for long-stay patients coinciding with regularly scheduled care planning 
meetings 
 Whenever there is a significant change in clinical status 
 When a treatment decision arises for which there is a specific video (e.g., hospice) 
 Special circumstances when goals of care are being considered (e.g., family visiting from out-
of-town) 
 
The discipline of the NH staff member showing the videos can vary and should align with the 
person who is typically responsible for ACP in the facility (e.g., physician, social worker, nurse). 
The staff will have flexibility with respect to choosing which video (s) to show individual patients, 
with the general goals-of-care video being the most generic and widely applicable. The videos will 
be pre-loaded onto tablet devices provided to each NH (2 devices/facility). The videos are typically 
shown at the bedside. In addition, the videos will be available through password protected internet 
links for family members to access remotely.  
 
5.2.2. Intervention training: The training materials and procedures described below have been 
developed and successfully tested in the 4 pilot facilities in the UH2 year. In the full trial, training 
procedures will be scaled up and conducted on a regional basis within each corporate chain using 
the existing infrastructures.  
Training materials that have been developed specifically for this project include:  i. an ACP 
Video Program toolkit, ii. a webinar companion to the toolkit, and iii. a laminated pocket sized 
quick reference guide. The toolkit presents detailed guidance and suggested protocols for: 1. using 
the videos with individual patients and families, and 2. integrating ACP Video Program into the 
workflow of the NH.  The 30-minute webinar presents essentially the same material as the toolkit 
but in PowerPoint format narrated by Dr. Volandes. The pocket sized reference guide is intended 
for staff using the videos and serves as a reminder of key points (i.e., when to show a video, which 
video to show which patient, documentation to complete). 
Training procedures involve several formats. As in the pilot study, members of our research 
team will travel to central locations to conduct regional trainings for staff representing multiple 
NHs within a corporate chain (i.e., regional directors, facility ACP Champions). We use a train-
the-trainer approach such that these representatives will return to their facilities to train their own 
staff on-site. In addition, Webinars will be held on a regular basis via WebEx during the 

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implementation start up. The printed toolkit and pocket reference guide will be distributed to all 
NH staff involved in the ACP Video Program. SharePoint sites will be set up through both the 
Genesis HealthCare and PruittHealth intranets exclusively for the intervention NHs. The 
SharePoint sites will include all study related information including the training materials (toolkit, 
Webinar), dates of Webinars and other meetings, internet links to videos, and how to get help with 
the ACP Video Program. Webinars and regional trainings will continue periodically during the 24-
month implementation period for new staff. Finally, we will hold at least bi-monthly check-in 
conference calls for each corporate chain during which NH staff will have the opportunity to 
problem solve any issues with the research team and share their experiences. As of June 2017, 
these group check-in conference calls have been cancelled and replaced with calls attended by 
members of the research team, healthcare system coordinators and ACP champions at each 
intervention site individually. These calls are dedicated to reviewing a list of long-term care 
patients at the facility and providing strategies for improving the show rates for these patients. A 
list of long-term care patients with names, numerical identifiers, and video offered/shown status is 
provided to the ACP Champions. Members of the research team are provided with the same list 
with numerical identifiers only. The following call is spent reviewing an update on the video shown 
status of each patient previously discussed and reviewing an updated list of long-term care patients. 
These calls occur every 2-3 months.  
 
5.3. Concomitant Interventions 
ACP is required by federal law in all NHs. Thus, intervention facilities will already have 
existing procedures or programs for ACP prior to this study.  As this is a pragmatic trial, our 
research team will not interfere with ongoing ACP initiatives or dictate whether they should be 
replaced with the ACP Video Program. Rather, it will be left to the discretion of individual 
facilities to integrate the program into their existing ACP procedures.   
 
5.4. Control 
Participant NHs randomized to the control arm will use the usual ACP procedures practiced 
in their facilities. Control facilities will not be offered an alternative intervention for this 
pragmatic trial as this is not what happens in the “real world.” We recognize that control and 
intervention facilities may be using other programs intended to improve ACP and/or reduce 
hospitalizations that are continuously being introduced into health care setting (e.g., 
INTERACT,58 POLST 32). This is what “usual” care reflects in a large pragmatic trial and 
experience suggests that these practices vary widely within and between NH systems.  
 
5.5. Adherence Assessment 
A user defined assessment record entitled a “Video Status Report” created and tested in the 
pilot study will be uploaded into the EMR of all the intervention facilities. Staff will complete 
this record each time they offer a video, which will capture: the date a video was offered, who 
offered it, the clinical trigger prompting the video, whether or not the video was shown, which 
video was shown, who viewed it (patient and/or family), if any serious negative reaction 
occurred, and if any clarifications were requested about the subject matter. Real-time MDS data, 
which will be obtained monthly from our partner health care systems for all intervention and 
control facilities, will provide the estimated number of patients who could have been shown a 
video within a specific time frame, (e.g., all new admissions) allowing us to calculate an estimate 
of the proportion of patients for whom a Video Status Report User Defined Assessment was 
completed and therefore the proportion of patients by type who watched a video. Adherence data 

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will allow the research team to measure intervention fidelity and to distribute reports to regional 
directors and ACP Champions that assess adherence to the video program so that they can make 
improvements as needed.  
 
6. DATA SOURCES AND ELEMENTS 
 
With the exception of the Video Status Report User Defined Assessment, all data are derived 
from existing data sources. 
6.1 
Data Sources 
6.1.1. 
Electronic Medical Record (EMR). Both NH systems have sophisticated EMR systems 
in their facilities. Genesis HealthCare uses PointClickCare™,98 and  PruittHealth uses American 
Health Tech. 99 Both EMRs integrate individual patient-level data such as MDS assessments and 
physician order entry. The EMR will be a source for MDS data, advance directives, and the Video 
Status Report User Defined Assessment (in intervention facilities only). The EMR will be used to 
ascertain health care utilization data (i.e., hospital transfers) for patients in Medicare Advantage 
programs, as Medicare claims will not have these data as they would for patients with traditional 
fee-for-service Medicare insurance.  
 
6.1.2. 
Minimum Data Set Standardized (MDS) Resident Assessment: The MDS resident 
assessment instrument has nearly 400 data elements. The assessments are done for all patients 
admitted to Medicare- and Medicaid-certified NHs, including enrollees in both traditional 
Medicare and Medicare Advantage. Assessments are done upon admission and at least quarterly 
thereafter. NHs are required to submit their MDS data to CMS on a regular basis. 82, 85, 121, 122 
Repeated evaluations of the reliability of the MDS yielded adequate to good values on most data 
items and scales. Brown University investigators found that the “missingness” of elements is 
low.82, 85, 121, 122  
 
6.1.3. 
Medicare Enrollment, Vital Status, and Claims data: Medicare enrollment and vital status 
data will be used to obtain death dates and to identify patients enrolled in traditional fee-for-service 
Medicare or Medicare Advantage insurance programs.  Medicare claims ascertain health care 
utilization data for fee-for-service Medicare beneficiaries, including hospital transfers (hospital 
admissions, emergency room visits, observation stays, etc.) and hospice enrollment.  
 
6.1.4. 
Online Survey Certification Automated Record (OSCAR): The OSCAR is a publicly 
available system of records based upon the Medicare/Medicaid certification and inspection process 
all NHs being reimbursed undergo. OSCAR data will be used to screen facilities for eligibility 
(i.e., size) and to describe characteristics of participant NHs (e.g., ownership, size, staffing, 
services, patient acuity and quality inspection results).123, 124  
6.2 Data Linkage and Management 
Brown University investigators and database management staff already receive national 
MDS, Medicare, and OSCAR data semi-annually or quarterly under several CMS data use 
agreements (DUAs). There is a well-established data base management structure for linking 
these files. The only new activity for PROVEN is integration of the EMR data from experimental 
and control facilities with CMS Medicare enrollment records and Medicare claims. Both partner 

PROVEN Protocol - Version 3.0 - Date: 4/17/2018 
Page 20 
NH systems have experience generating files for export for data warehousing. Using algorithms 
based on standard patient identifiers including Heath Insurance Claim (HIC) numbers, date of 
birth, gender, and Social Security Numbers (SSNs), matching rates generally exceed 98%. In the 
UH2 pilot study, secure data transfer and linkage of EMR data from four facilities (two 
NHs/chain) to Brown University were successfully accomplished, and frequency distributions of 
the resulting data have been generated. During the full trial, EMR data for all eligible facilities 
will be transferred from participating health care system corporations’ IT staff to Brown 
University on a monthly basis. These data will be transferred to a secure server at Brown 
University using an encrypted SFTP connection. Once the data are examined for completion, the 
health care system corporation IT staff will be notified that transfer was successful. The HIC and 
SSN identifiers will then be replaced by Brown University’s system manager with an 
alphanumeric ID that will allow analysts to link these EMR records to Medicare datasets. 
6.3 Data Elements 
Data elements and sources are described below and in Table 2. 
 
6.3.1. Facility-level data: Facility-level data are needed for facility recruitment, randomization, 
and descriptive purposes. Organizational data from OSCAR include: number of beds, for-profit 
status, and NH chain. Aggregated MDS data at Brown University provide information case-mix 
(% long-stay and post-acute care patients). MDS data are also use to calculate the hospitalization 
rate of each facility by estimating the number of patient days at risk of hospitalization from the 
nursing home and counting the number of actual hospital transfers to hospital per unit time. It is 
these hospital specific rates from the prior year which will be used to undertake the stratified 
randomization scheme (see Section 4.4.2).Medicare claims available at Brown University will be 
used to determine the facilities’ hospitalization rates for the subset of patients with Medicare fee 
for service. 
 

PROVEN Protocol - Version 3.0 - Date: 4/17/2018 
Page 21 
 
 
6.3.2. Patient-level data: 
6.3.2.a. Cohort description, identification of target sub-groups, and other independent variables 
Demographic data: From MDS: Age, gender, race, ethnicity, religion, primary language, marital 
status, and length of NH stay.  
Long-stay or new admission to post-acute care: From MDS. 
Functional status: From MDS: Ability to perform specific activities of daily living ADLs (as 
required for cohort identification (i.e., feeding, transferring, ambulation) and validated ADL 
summary scale (range, 7-28).  
Cognitive status: From MDS: Ability for daily decision-making and Brief Interview for Mental 
Status (BIMS).87 
Medical conditions: From MDS: Dementia, CHF, COPD and all other active medical diagnoses.  
Insurance status: Medicare Enrollment file: Traditional Medicare Fee-for-Service or Medicare 
Advantage, Medicaid. 
 
6.3.2.b. Outcomes 
Advance directives: From EMR: DNR, do-not intubate (DNI), DNH, no feeding tubes, no artificial 
hydration. 
Health services utilization: From Medicare claims and EMR/MDS (for patients not in traditional 
Medicare fee-for-service): i. hospital transfers, and ii. hospice. 
Table 2: Data Element and Sources 
Data Element 
Purpose 
SOURCE 
EMR 
MDS 
Medicare OSCAR 
Facility-Level 
 
 
 
 
 
Organization 
recruitment 
 
 
 
X 
Case-mix 
recruitment 
 
X 
 
 
Prior Hospitalization 
rate 
randomization 
 
X 
 
 
 
 
 
 
 
 
Patient-Level 
 
 
 
 
 
Demographic 
covariate 
X 
X 
 
 
Long vs. short-stay 
Cohort definition 
 
X 
 
 
Functional status 
target sub-population 
identification, covariate 
 
X 
 
 
Cognitive status 
target sub-population 
identification, covariate 
 
X 
 
 
Medical condition 
target sub-population 
identification, covariate 
X 
X 
 
 
Insurance 
covariate 
 
 
X 
 
Advance directives 
2o outcome 
X 
 
 
 
Health services use 
1o and 2o outcome 
X 
X 
X 
 
Burdensome 
interventions 
2o outcome 
X 
X 
X 
 
Death 
description, competing risk 
 
X 
X 
 
Intervention 
implementation 
monitoring fidelity 
X 
 
 
 

PROVEN Protocol - Version 3.0 - Date: 4/17/2018 
Page 22 
Burdensome interventions:  From Medicare claims and EMR/MDS: Feeding tube insertion, 
intubation, intravenous therapy. 
Death: From Medicare Vital Status files: Date of death 
Intervention implementation: EMR: Video Status Report User Defined Assessment.  
 
                                                                                                                                                                                                     
7. SAFETY ASSESSMENTS  
 
7.1. Minimal Risk Determination 
We will seek a minimal risk determination for the PROVEN trial as per HHS 45 CFR 
46.102: “Minimal risk means that the probability and magnitude of harm or discomfort 
anticipated in the research are not greater in and of themselves than those ordinarily 
encountered in daily life or during the performance of routine physical or psychological 
examinations or tests.”  
Justification for a minimal risk determination is based on several considerations. First, all 
NHs must engage patients and families in ACP as part of routine clinical practice. There is 
currently no standardized method by which NHs conduct ACP. PROVEN will compare a 
practice intervention (rolled out in intervention sites as standard operating procedures as directed 
by corporate leadership) that uses videos to enrich ongoing ACP practices. Prior studies 
evaluating the ACP videos by our group included several hundred subjects, including healthy 
older adults, NH patients, family members of patients with life-limiting illnesses and patients 
with advanced cancer and congestive heart failure. 66, 67, 70-72, 125 The videos were also tested in 
our UH2 pilot study. Finally, the videos have been seen by thousands of patients in Hawaii as 
part of an on-going state-wide implementation program. In prior research, our pilot testing, and 
Hawaii initiative, there were no instances of untoward viewer distress and the videos never had 
to be stopped because of adverse viewer reactions. Thus, we believe the intervention does not 
incur any greater distress than usual ACP practices.  
 
Second, data collection also conforms with the definition of minimal risk. No direct input 
from the resident or family member is needed to obtain any data for this study. All the data are 
already being collected as part of routine medical care (EMR, MDS, Medicare data). The only 
additional data being collected in the intervention NHs is the Video Status Report User Defined 
Assessment, which is being embedded into the EMR. The Video Status Report User Defined 
Assessment is needed to monitor intervention fidelity and will be incorporated into the intervention 
facility’s ACP protocol.   
 
7.2. Serious Negative Reactions and Serious Adverse Events 
The potential serious negative reaction (SNR) that could occur during this trial is serious 
distress by patients or family members in the intervention NHs while viewing an ACP video. As 
described in Section 7.1., we anticipate that such SNRs will be exceedingly rare. Nonetheless, 
serious distress by may be manifested as a very negative emotional reaction while watching or 
after watching a video, asking for the video to be stopped, or leaving the room while a video is 
being shown. Due to the sensitive nature of the material, tearing up by the proxy can be expected 
and is not deemed to be a reflection of distress. 
We do not believe that there are any potential consequences of this trial that meet the definition 
of serious adverse events (SAEs). 
(We do not believe death should be considered a SAE for the PROVEN trial for the following 
reasons. First, the study is being conducted in a frail NH population with advanced illnesses. Thus, 

PROVEN Protocol - Version 3.0 - Date: 4/17/2018 
Page 23 
death is often not an unexpected event in their clinical course. Second, all NHs must engage 
patients and families in ACP as part of routine clinical practice. The videos are meant as an adjunct 
to facilitate ACP counseling. The underlying intent of all ACP, regardless of how it is done, is to 
help patients make informed treatment decisions so they receive care that is concordant with their 
preferences. For patients who prefer comfort or palliation as a main goal of care (vs. life 
prolongation), death is not an adverse outcome. Finally, it is not known whether more aggressive 
care (i.e., hospitalization) would result in greater mortality compared to less aggressive care (i.e., 
conservative or palliative treatment on-site in the NH). Therefore, while we hypothesize that there 
will be fewer hospitalizations among NH patients with advanced disease randomized to the 
intervention arm (vs. control), it is impossible to predict how this may impact mortality rates.) 
 
7.3. Reporting Procedures 
As part of NH staff training, instructions will be given to the facility ACP Champions and 
providers who will be showing the video (i.e., physician, nurse, social worker) about what 
constitutes an SNR, i.e., serious distress by a patient or family member during or immediately 
after a video. As described in Section 7.1., we anticipate that such SNRs will be exceedingly 
rare. Nonetheless, staff will be instructed that if such an event occurs, then the video should be 
stopped. The provider should report the event to his/her immediate supervisor and ACP 
Champions as soon as possible, but not exceeding 4 hours after the event. Together, these health 
professionals will determine the severity of the event. If deemed to be a true SNR, the ACP 
Champion will complete an SNR Form created by our research team, which will be submitted to 
the research project directors via email or fax within 24 hours of the event. The ACP Champion 
will also inform the PROVEN project director within 24 hours of the event by telephone. The 
project director will report the SNR to all 3 co-PIs via email or telephone immediately upon 
becoming aware of the event and will also notify the Data Safety and Monitoring (DSMB) Chair 
in writing (email and hard copy) within 48 hours. It will ultimately be the co-PIs responsibility to 
ensure that the DSMB chair is informed in a timely manner.   The Brown University IRB has 
indicated that SNRs do not need to be reported to them.  This is because the video intervention 
itself is considered standard operating procedures in the nursing homes, and so it is not part of 
the human subjects research that the IRB is monitoring. 
 
7.4. Follow-up for Serious Negative Reactions 
The NH provider and ACP Champion will be instructed to check on the patient or family 
who experienced the distress at 6 and 24 hours after a SNR to see how he/she is managing. If 
deemed necessary, a patient should be referred for counseling with a NH social worker or other 
mental health professional. In the case of a family member, if deemed necessary, the NH 
provider may suggest to the proxy that he/she contact his/her own primary care provider. The 
research project director will contact the facility ACP Champion within 48 hours of the SNR to 
determine the status of the patient/family and whether further counseling was deemed necessary. 
The project director will in turn report the follow-up information to the co-PIs (by telephone) and 
to the DSMB (in writing) within 72 hours using an SNR Follow-up form. 
 
7.5. Safety Monitoring 
A DSMB for PROVEN will act in an advisory capacity to the National Institute on Aging 
(NIA) Director to monitor participant safety, data quality, and progress of the study. External 
DSMB members include: Christine S Ritchie, MD, MSPH (University of California San 
Francisco) (Chair), Cynthia J. Brown, MD, MSPH (University of Alabama at Birmingham), and 

PROVEN Protocol - Version 3.0 - Date: 4/17/2018 
Page 24 
Michael E. Miller, PhD (Wake Forest University School of Medicine).  Dr. Miller’s membership 
was approved by Dr. Richard Hodes (NIA Director) on 6/9/2016 to replace Arthur V. Peterson, 
Jr., Ph.D. (Department of Biostatistics, University of Washington).  Dr. Peterson served on the 
DSMB from 1/9/2015 to April 2016. Members of the PROVEN team who will participate in the 
open sessions of the DSMB include the 3 co-PIs (Mitchell, Mor, Volandes), the lead biostatistician 
(Gatsonis), and project director (Elaine Bergman). The NIA project officer for PROVEN, Dr. 
Marcel Salive, will attend DSMB meetings and serve as the liaison between the DSMB and NIA. 
A PROVEN DSMB Charter outlines its roles and responsibilities (see Appendix 16.1).  
 
8. INTERVENTION DISCONTINUATION 
The study may be discontinued at any time by the IRB, the NIA, the OHRP, the FDA, or 
other government agencies as part of their duties to ensure that research participants are 
protected. Individual NHs in the intervention arm may withdraw from study participation at any 
time at the discretion of their senior management or corporate supervisors. Individual patients 
and families, while not being asked to provide informed consent for this research, can refuse to 
watch a video offered to them as part of this new ACP video program being adopted into the 
clinical practice of participating intervention NHs. Such refusals are expected as part of this 
pragmatic trial.  
9. STATISTICAL CONSIDERATIONS  
9.1.General Design Issues 
PROVEN is pragmatic cluster RCT of an ACP Video Program intervention for NH patients 
cared for in two NH health care systems: Genesis HealthCare and PruittHealth. Rationale for this 
choice of study design is provided in Section 2.6. The intervention will be implemented facility-
wide; thus, all patients in the NHs during the 24-month implementation period comprise the 
study population. However, the analytic plan focuses on the effect of the ACP Video Program vs. 
control in the following targeted patient sub-groups: 
 
• 
Long-stay residents (≥90 days) with advanced dementia or advanced CHF/COPD (Aim 2) 
• 
Short-stay patients (<90 days) with advanced dementia or advanced CHF/COPD (Aim 3) 
• 
Long and short-stay patients without these advanced illnesses (Aim 4). 
 
The primary trial outcome is hospital transfers (number of hospital transfers/person-days 
alive based on Medicare claims data), which include admissions, emergency department visits, 
and observation stays over a 12-month follow-up period among Medicare fee-for-service long-
stay residents with advanced dementia or advanced CHF/COPD. The primary hypothesis is that 
the rate of hospital transfers will be lower in the intervention group.  
Secondary outcomes include hospital transfer rates in the sub-groups examined in Aims 3 
and 4, and the following outcomes for all sub-groups in Aims 2, 3 and 4: advance directives, 
burdensome treatments, hospice use, and Medicare ACP billing codes. 
Each long-stay resident will be followed for up to 12 months starting from the date they are 
first identified as meeting our target cohort definition during the 24-month intervention period 
and short-stay patients will be followed for 100 days from their NH admission date. The analytic 
approach to Aims 2, 3, and 4 are similar. Analyses begin with descriptions of all major variables 
using frequencies and means/medians with SDs/interquartile ranges, as appropriate. Outcomes 
will be compared between the control and intervention arms using a zero-inflated Poisson model 

PROVEN Protocol - Version 3.0 - Date: 4/17/2018 
Page 25 
with random effects to account for clustering at the NH level. While we do not anticipate an 
effect on mortality, analyses will also examine the effects on mortality. Primary analyses will 
follow the intention to treat principle and will adjust for minor imbalances in patient 
characteristics, as needed. 
 
9.2. Sample Size and Randomization 
Sample size estimates are based on the primary trial outcome: # hospital transfers/person-
days alive based on Medicare claims data), which include admissions, emergency department 
visits, and observation stays over a 12-month follow-up period among Medicare fee-for-service 
long-stay residents with advanced dementia or advanced COPD/CHF. Based on data from our 
partners’ NHs in 2012 and 2013, we estimate that hospital transfers per person-year alive in the 
control arm will be between 1.06 and 2.12. Based on prior research; we estimate the absolute 
reduction in hospital transfer rates in the intervention vs. control NHs will range from .200 to 
.275 points, representing approximately a 16% relative reduction.  
Computations for sample size 
estimates were performed using 
the approach for the comparison of 
incidence rates discussed in 
Chapter 5 of Donner & Klar and in 
Hayes & Bennett (1999). The 
sample size computation is based 
on a simplifying assumption of a 
Poisson distribution for the 
numbers of hospital transfers, and 
it assumes equal number of 
facilities in each arm. To achieve 
power of at least 90% in testing for 
a .25 point absolute reduction in the observed average hospital transfer rate of 1.51, we will 
require 103 facilities per study arm. This represents approximately a 16% relative reduction in 
the hospital transfer rate.  
Although our sample size calculations indicate that we require 103 NHs/arm, to 
accommodate the anticipated 10% non-participation rate among NHs randomized to the 
intervention arm, we will recruit an additional 16 facilities in the intervention arm for a total of 
119 intervention NHs. Moreover, because there is an available total pool of 360 eligible facilities 
in our partner health systems, we will choose to assign the remaining 241 facilities to the control 
arm (approximate 2:1 control:intervention match) since there is no additional cost to do so.  
While more control facilities only marginally increases power it allows for a more precise 
estimate of the outcome of interest in the control group.  
Data for 2012-13 from our partners reveal that there are, on average, 42 people meeting 
advanced dementia and/or CHF/COPD target criteria per facility. Thus, we estimate that there 
will be approximately 4,326 target patients in the 103 control NHs in (103*42=4,326) required 
by our aforementioned power calculation. In the actual assigned facilities, we estimate there will 
be 4998 patients meeting these criteria in 119 intervention NHs and 10,122 patients in the 241 
control NHs. 
 
Table 3. Number of Clusters Required 
Initial 
Hospital Transfer 
Rates/Year 
Effect Size 
0.20 
0.225 
0.25 
0.275 
1.06 
81 
63 
50 
41 
1.51 
165 
129 
103 
84 
2.12 
351 
275 
220 
180 

PROVEN Protocol - Version 3.0 - Date: 4/17/2018 
Page 26 
9.2.2. Treatment Assignment Procedures: Please refer to section 4 for a detailed description of 
the treatment assignment procedures.  
 
9.2.3. Blinding: Our partner health care systems will know which facilities are designated 
intervention facilities, but will not be aware of those in the control group. Only Brown 
University statistician and data management staff will know the identity of the control facilities.  
They will present aggregated post-random assignment comparisons of intervention and control 
facilities’ baseline characteristics, but these preliminary analyses will be not generated at the 
individual facility level. As Dr. Volandes will be leading intervention training, he will be aware 
of the identity of the intervention NHs but will not be involved in data analyses activities. Drs. 
Mitchell and Mor will be blinded to the identity of both the control and intervention facilities. 
Facility assignment will be unblinded to the DSMB members at their request.  
 
9.3.Interim Analyses and Stopping Rules 
We are not including stopping rules in the PROVEN trial protocol for several related reasons.  
First, it is our contention that this is a minimal risk study for which serious negative reactions 
will be extremely rare (see Section 7.1). Second, a stopping rule would not be very feasible. The 
implementation period is only 24 months in each facility and the outcome observation period is 
12 months for each target patient followed during that 24-month period.  Final hospital transfer 
data may not be available for up to six months after the admission. Thus, differences in hospital 
transfer rates between the two study arms will not be known until the end of the 24-month study 
facility intervention period.   
 
9.4.Outcomes 
 
9.4.1. Primary outcome: The primary trial outcome is the hospital transfer rate (number of 
hospital transfers/person-day alive based on Medicare claims data), which include admissions, 
emergency department visits, and observation stays) over a 12-month follow-up period among 
Medicare fee-for-service among long-stay residents with advanced dementia or advanced 
CHF/COPD over 12 months (Aim 2). 
 
9.4.2. Secondary outcomes: Secondary outcomes include: i. hospital transfer rates in the sub-
groups examined in Aims 3 (short-stay patients with advanced dementia or advanced CHF/COPD) 
and Aim 4 (short-and long stay patients who do NOT have advanced dementia or CHF/COPD), 
and ii. The following outcomes for target sub-groups defined in Aims 2, 3, and 4: advance 
directives, burdensome treatments (e.g., tube-feeding), receipt of hospice services, and Medicare 
ACP billing codes.  
All outcomes in the long-stay patient populations are calculated over a 12-month follow-up 
period. For short-stay patients, advance directive completion rates will be calculated over the 
admission period, and hospital transfer rates, use of burdensome treatments, and hospice 
enrollment will be examined within 100-days after the NH admission date. 
9.5. Data Analyses 
Aim 1: To implement all aspects of a pragmatic cluster RCT: Assessment of Aim 1 will largely 
be experiential and based on meeting planned recruitment milestones. We will assess the 
implementation of the ACP Video Program by examining data from the new Video Status Report 

PROVEN Protocol - Version 3.0 - Date: 4/17/2018 
Page 27 
User Defined Assessment record created in the EMR that documents the videos offered. 
Descriptive statistics will be generated describing the proportion of the general NH population and 
targeted sub-populations exposed to the video, which videos they saw, who saw them (patient 
and/or family members), who showed the videos (nurse, physician, social worker), and the timing 
of exposure (i.e., relative to admission, discharge care planning meetings). 
 
Aim 2 To evaluate the effectiveness of the ACP intervention among long-stay NH residents with 
advanced comorbid conditions: The sample includes long-stay residents with advanced dementia 
and advanced CHF/COPD. The primary trial outcome is the hospital transfer rate (number 
transfers/person-days alive based on Medicare claims data), which include admissions, emergency 
department visits, and observation stays) over a 12-month follow-up period among Medicare fee-
for-service) in this cohort. Secondary outcomes include: advance directives (DNR, DNH, DNI, no 
tube-feeding), burdensome treatments (new feeding tube insertion, intubation, parenteral therapy, 
ICU care), hospice admission, and Medicare ACP billing codes. All outcomes will be 12-month 
incidence measures starting from the date residents are first identified as meeting the criteria for 
definitions of having advanced dementia or CHF/COPD during the 24-month intervention period. 
While we do not anticipate the ACP intervention to affect mortality,31 our analyses will account 
for censoring during the 12-month observation period. We will formally test for a mortality 
differential between intervention and controls arms using a logistic regression random effects 
model, where clustering is performed by facility.   
Using current MDS data from CMS, we observe that the distribution of the primary outcome, 
hospital transfers, is over-dispersed with many of the patients having no hospital transfer over the 
12-month follow up period. In addition, we also observed that hospital transfer rates vary across 
facilities, even after adjusting for underlying patient risk. To account for these phenomena, we will 
utilize a zero-inflated Poisson distribution with facility random effects to test and estimate the 
effects of the ACP intervention. Zero-inflated Poisson models have been used in other public 
health settings. 128, 129 Formally, let Yij be the number of hospital transfers for person i in facility j, 
Nij is the number of person days alive for person i in facility j, and Tj is a treatment indicator that 
is equal to one if facility j is in the intervention group. Then where β1 is the conditional increase 
in the log hospital transfer rate in facilities that receive treatment vs. those that do not, and α1 is 
the conditional log odds ratio for being hospitalized vs. never being hospitalized in the intervention 
vs. the control arm. When both α1 and β1 are smaller than 0, the ACP video is effective in reducing 
the proportion of patients hospitalized and the number of times hospitalized. Using this model we 
will estimate the marginal average hospital transfer rate in each arm and calculate the difference 
between the two arms. We will use a two sided test to examine if the marginal average difference 
is significantly different than zero, and we will calculate the corresponding interval estimate. As a 
secondary analysis, we will use the likelihood ratio test to compare the null hypothesis, 
, to the alternative hypothesis 
. 130 Confidence intervals 
for α1 and β1 can be obtained by inverting the likelihood ratio test.132 This analysis will enable us 
to provide additional details as to whether the effectiveness of the intervention is to reduce the 
likelihood of one hospital transfer or the number of hospital transfers if transferred at least once. 
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PROVEN Protocol - Version 3.0 - Date: 4/17/2018 
Page 28 
The secondary outcomes are binary. 
Commonly used methods applied to the 
analysis of clustered RCT with binary 
outcomes 
are 
GEE 
and 
multilevel 
models.131 The former method provides a 
population “average” effect, while the 
latter results in a conditional cluster 
effect.  For continuous Gaussian data, 
interpretation of the treatment coefficient 
is the same in conditional and marginal models; however, with binary data, the treatment 
coefficient from a marginal model is smaller than that from a conditional model and has a different 
interpretation.132 For binary outcomes, Bellamy et al133 have shown that with few clusters GEE 
results were more likely to reject the null hypothesis, while conditional models resulted in more 
conservative estimates. Austin concluded that the power of GEE and multilevel models are very 
similar for studies, like ours, that include more than 30 clusters (facilities) with either variable or 
equal cluster size.134 To estimate the effect of ACP on secondary outcomes we will use random 
effects logistic model. Formally, let Sij one of the secondary outcomes for person i in facility j, and 
Tj is a treatment indicator that is equal to one if facility j is in the treated arm.  
  
where γ1 is the conditional log odds ratio for observing the secondary outcome in the treatment 
arm vs. the control arm. When γ1 is smaller than 0, ACP is effective. As for the primary outcome 
we will use the likelihood ratio test the null hypothesis 
 , and by inverting this test we 
will obtain the corresponding confidence interval. 
 
Aim 3. To evaluate the effectiveness of the ACP intervention among new admissions to post-
acute care with the advanced comorbid conditions: Newly admitted NH patients to post-acute 
care with advanced dementia or advanced CHF/COPD disease will accrue throughout the 24-
month intervention. Measured outcomes for this group will include: advance directives to withhold 
specific treatments (DNH, DNR, DNI, no tube-feeding) at any time during their post-acute care 
admission, hospital transfers, and hospice enrollment within 100 days following NH admission. 
Preliminary data found that 100-day hospital transfer rates among post-acute patients with 
advanced dementia and/or CHF/COPD was 37%, and that nearly 50% of advanced dementia and 
30% of advanced CHF/COPD patients died within 6 months of NH admission. In light of the high 
mortality rate, we will adopt the hospital transfers per person-day alive approach described for 
Aim 2 to evaluate the effectiveness of the intervention.  
 
Aim 4. To evaluate the effects of the ACP intervention among long-stay and new admissions to 
post-acute care WITHOUT advanced dementia 
or COPD/CHF: The intervention is being 
implemented facility-wide, thus all long-stay 
residents and post-acute care admissions will be 
exposed to it. Aim 4 tests the impact of the 
intervention 
on 
NH 
patients 
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PROVEN Protocol - Version 3.0 - Date: 4/17/2018 
Page 29 
advanced dementia or advanced CHF/COPD. Outcomes include:  advance directives during their 
NH stay, the number of hospital transfers over 12-months for long-stay or over 100 days for short-
stay; and hospice admission over 12 months for long-stay or over 100 days for short-stay. As 
hospital transfers and hospice enrollment among post-acute care patients are likely to occur after 
NH discharge, these outcomes can only be assessed among the fee-for-service Medicare 
beneficiaries using Medicare claims. The outcome, Yij,is a total count of hospital transfers. Many 
relatively healthy patients will have Yij=0 while others’ hospital use depends on the number of 
days that they are alive. We will use a zero-inflated Poisson model 135, 136of the following form 
shown in the equation, where 
, Xi are the covariates, η is the treatment 
effect, and εij ~ N(0, σπ) is a random between facility effect. When η is larger than 0 and λ is smaller 
than 0, ACP video is effective.  The same analytic approach described for Aim 2 will be used to 
evaluate the effectiveness of the intervention. 
 
Sub-Group Analyses of Racial and Ethnic Group Differences in Intervention Effects: It is well-
recognized that African-American NH patients with advanced illness are more likely than white 
patients to have outcomes reflecting more aggressive care, including higher hospitalization rates 
and lower advance directive documentation rates, even after controlling for patient and facility 
factors. Nonetheless, there is no evidence suggesting that African American patients respond 
differently to our ACP intervention than white residents. In fact, the videos have been specifically 
designed to be appropriate to viewers from all backgrounds 
Based on existing data, we anticipate only 11% of the patients included in our analyses will be 
African-American, and even lower proportions will be of other non-white racial and ethnic groups. 
Thus, there will not be sufficient power to detect small differences in outcomes among non-white 
groups. Consequently, these sub-group analyses are necessarily exploratory. Nonetheless, we will 
conduct sub-group analyses for Aim #2 separately among African-American residents and other 
racial/ethnic groups (e.g., Hispanic) if numbers allow. Additionally, we will examine differences 
in video viewing rates among racial and ethnic groups.  
 
9.6. Undertaking Supplemental “As Treated” Analyses  
The primary analysis for the PROVEN trial is an “intention to treat” analysis in which the 
outcomes of target group long-stay nursing home residents of intervention facilities are 
compared to those of identically defined residents of control facilities.  This approach assumes 
that most eligible subjects in the intervention facilities will be directly exposed to the 
intervention by watching one of the videos. While there may be an indirect effect on the facility 
culture related to the availability of the videos and increased discussions of “comfort care”, 
direct exposure by watching the video is assumed to be the more powerful and complete 
approach to delivering the intervention. 
As part of the PROVEN trial, intervention staff are to record when patients are offered and 
subsequently shown a video at each facility. The total number of long-stay target residents who 
“should have been shown” the video and the total number of such patients who actually viewed 
the video at the facility are routinely calculated. Although some families and patients may have 
watched videos online, we are unable to identify this number precisely. Thus, the proportion of 
patients whom staff report as having watched the video is a reasonable proxy for the level of 
implementation of the intervention across intervention facilities. As of the end of February 2018, 
only 12.5% of the long stay residents in System 1 facilities and 31.4% in System 2 facilities were 
logit(
)
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ij
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PROVEN Protocol - Version 3.0 - Date: 4/17/2018 
Page 30 
reported as having been shown a video.  However, there is substantial variation in the rates of 
target residents reported as having been shown the video, ranging from 0% to over 80%. This 
raises the question of whether it would be possible to compare the outcomes of patients exposed 
to the video who reside in nursing centers that embraced the video-assisted advance care 
planning intervention to similar control patients from similar facilities. 
The principal stratification framework138 has been proposed as a possible solution to address 
non-compliance in randomized trials and is appropriate in this instance because facilities can be 
classified on the basis of the extent to which they implemented the intervention. The basic 
principal stratification framework initially posits that patient i has two possible potential 
compliances: compliance under the intervention arm, Di(1), and compliance under the control 
arm Di(0). Using these potential states (outcomes), we can classify patients into different strata 
and calculate the average effect within each stratum. When patients can either comply with the 
intervention or not, there are four principal strata: compliers (Di(1) = 1, Di(0)=0); never takers 
(Di(1) = 0, Di(0)=0); always-takers (Di(1) = 1, Di(0)=1); and defiers (Di(1) = 0, Di(0)=1).  For 
each patient, only one of these compliance outcomes is observed.  
Studies, such as ours, in which patients in the control group cannot obtain the intervention 
are commonly referred to as one-sided non-compliance. There are three possible strata: (1) 
assigned to the intervention and did not take it – never-takers; (2) assigned to the intervention 
and receive it – compliers; (3) assigned to the control and received control – can be either never-
takers or compliers. Thus, a statistical methodology that is aimed at identifying the effect among 
compliers needs to identify among the control group those that would have not refused the 
treatment were it to have been offered.  Numerous studies have fruitfully employed the principal 
stratification framework to estimate the effects of an intervention on compliers.139, 140, 141, 142 
We will estimate the effect of the intervention on the compliers who reside in facilities that 
have adopted the video-assisted intervention by creating a hierarchy including compliance at the 
facility level and, within facility, adjusting for compliance status at the individual level.  As 
noted, we find high variability between intervention facilities related to the likelihood that a 
patient would receive the intervention. Because the intervention is delivered almost entirely 
through the mechanism of facility staff, we assume that individual compliance is affected by the 
facility’s and patient’s characteristics.  We can classify the treated facilities into compliance 
groups based on the reported show rates and/or based upon more qualitative assessment of 
research staff working to implement the intervention with participating facilities. Compliance 
groups can be constructed and facility-level characteristics that are predictive of the compliance 
status can be identified using the large amount of facility and aggregated resident data we have 
available. Preliminary analyses reveal that several facility-level characteristics are correlated 
with the video offer and show rates.  We propose developing a Bayesian model to multiply 
impute the compliance groups of control facilities based upon these types of facility-level 
characteristics for which we have considerable data elements. The net result is a pool of high 
intervention implementers and a corresponding set of control facilities with similar predicted 
compliance. 
Preliminary data suggest that facility-level characteristics are more correlated with facility 
offer rates than to facility show rates. This suggests that, although facility characteristics 
influence the offer rate, patient-level characteristics are also important determinants of actually 
watching the video. Thus, we will develop a modeling framework that identifies the compliance 
status for each patient within the hierarchy of the cluster randomized trial. This approach will 
first impute compliance status group for control facilities and then will impute patient-level 

PROVEN Protocol - Version 3.0 - Date: 4/17/2018 
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compliance status within each facility compliance group. This two-part imputation is performed 
using Bayesian models to predict compliance status for each facility, followed by a Bayesian 
model of patient-level compliance within facilities with similar predicted compliance status. 
Formally, let Yi(W) represent the potential outcomes for patient i under the intervention, W=1, or 
the control, W=0. In addition, let Lj(1) be the average compliance of facility j if it would have 
been assigned to the intervention arm, and Mi(1) be the compliance of patient i if s/he would 
have resided in a facility exposed to the intervention. We would estimate the following models: 
 
1. ݂ሺܻ௜ሺ1ሻ, ܻ௜ሺ0ሻ|ܮ௝ሺ1ሻ, ܯ௜ሺ1ሻ, ܺ௜, ܹ௜, ܼ௝ሻ - The potential outcomes conditional on patient's 
and facility's compliance status, and patient- and facility-level covariates. These models 
would be hierarchical zero inflated Poisson models. 
2. ݂ሺܯ௜ሺ1ሻ|ܮ௝ሺ1ሻ, ܺ௜, ܹ௜, ܼ௝ሻ - The compliances status of patients conditional on the 
compliance status of the associated facility and on patient- and facility-level covariates. 
This model would be a hierarchical logistic regression model. 
3. ݂ሺܮ௝ሺ1ሻ|ܼ௝, ܹ௝ሻ - Models the compliances status of facilities conditional on facility 
characteristics. This model would be a linear regression model (with possible 
transformation) where X are patient level characteristics and Z are facility level 
characteristics.  
 
10. DATA COLLECTION AND QUALITY ASSURANCE  
10.1. Data Collection 
All data are derived from existing data sources with exception of the Video Status Report 
User Defined Assessment. Please see Section 6 which details these sources.  
 
10.2. Data Confidentiality 
Brown University’s Center for Gerontology and Health Care Research will receive EMR 
patient-level data from PruittHealth and Genesis HealthCare. Both NH systems have integrated 
sophisticated EMR systems in their facilities. Genesis HealthCare uses PointClickCare™,98 and 
PruittHealth uses American Health Tech.99 The NH networks already have experience extracting 
MDS from their EMR systems for purposes of submitting mandatory, regular MDS reports to 
CMS. To protect patient confidentiality, the two corporations will place their data in a SSH 
secure server and will provide login information to Brown University. Data transfer to Brown 
University secure servers will be via SFTP protocol with password protection. Once the files 
have been uploaded to Brown University's servers they will be stored, unmodified, in a secure 
file location specific to these uploads. They will then be read into SAS datasets, one per file type. 
Brown University will then notify the facilities that the data was successfully downloaded and 
extracted, at which point the facilities will remove the data from their servers. All data files will 
be accompanied by a manifest detailing the number of distinct persons and records expected in 
them. Brown University will connect to the corporation servers on a monthly basis. Identifiers 
such as HICs and SSNs, will be included in order to be able to merge these person-level data to 
the data received from CMS. Brown University’s information systems manager will be in charge 
of the data transfer, and he will replace the HICs and SSNs fields with a Brown University-
generated identification number (throughout our different data sources) to allow linkage of data 
for analytic purposes. 
 

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10.3. Data Management 
Brown University’s Center for Gerontology and Health Care Research will serve as the Data 
Management/Statistical Center for the PROVEN trial. The Center will be responsible for: 1. 
Receiving all data from CMS (Medicare, MDS), ii. Receiving all EMR data from PruittHealth 
and Genesis HealthCare Study facilities, iii. Linking all data sources, and iv. Creating an analytic 
file and conducting analyses. Brown University investigators and database management staff 
already receive national MDS, Medicare, and OSCAR data semi-annually or quarterly under 
several CMS DUAs. There is a well-established data base management structure to linking these 
files. The only new activity for PROVEN is integration of the EMR data from facilities with 
CMS Medicare claims and the MDS. The integration will be easily achieved thanks to the 
availability of HIC and SSN personal identifiers in both the EMR data from facilities and in the 
CMS Medicare claims and MDS data. 
 
10.4. Data Use Agreements 
The Brown University Center for Gerontology has an extensive history of working with 
ResDac to obtain DUAs to use CMS MDS and Medicare data for NIH funded projects, which 
will be obtained for this project. DUAs for the data sharing arrangement between Brown 
University and the two partner health care systems, Genesis HealthCare and PruittHealth have 
already been obtained.  Our team will ensure all DUAs are compliant with NIH requirements.  
 
10.5. Quality Assurance Metrics 
For the primary outcome, hospital transfers, we will have a quality control metric which 
compares hospital transfers as derived from MDS assessments with hospital transfers obtained 
from Medicare Part A claims for patients who are in the traditional fee-for-service Medicare 
program. 
 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
 
11.1. Institutional Review Board (IRB) Review 
The PROVEN protocol will be reviewed and approved by the Brown University IRB.  
 
11.2. Informed Consent 
There are special informed consent considerations for individual patients in this pragmatic, 
cluster RCT. The NH is the unit of randomization, the intervention is of relatively low risk, and it 
will be implemented facility-wide as part of the intervention facilities’ standard operating 
procedures for ACP. In the control arm, usual care for ACP will be in place. In both study arms, 
all data will be ascertained from existing sources. NH administrators, who either agree or 
disagree to facility participation in the intervention arm are serving as gatekeepers for the study. 
Thus, we will seek a waiver of individual informed consent so as set forth by the four criteria 
found in HHS 45 CFR 46:116. 137  
 
(1) The research involves no more than minimal risk: See Section 7.1 for rationale for 
Minimal Risk Determination 
 
(2) The waiver will not adversely affect the rights and welfare of the subjects: All NHs 
must engage patients and families in ACP as part of routine clinical practice. There is currently 
no standardized method by which NHs conduct ACP. The ACP Video Program is intended to 

PROVEN Protocol - Version 3.0 - Date: 4/17/2018 
Page 33 
enrich ongoing ACP practices in the intervention NHs. Study randomization is at the level of 
the NH, not the patient. While the patients in the intervention arm are not informed of the 
study itself they are asked whether or not they want to be shown the video.  They are free to 
decline as they are free to decline any type of ACP discussion.  Patients in control NHs will 
be exposed to usual care. For NH residents in both study arms, we will be using data 
previously collected for non-research purposes (EMR and CMS data. These data will be 
obtained and managed in a confidential manner for study purposes (see Sections 10.2). 
 
(3) The research could not practicably be carried out without the waiver: It would 
impossible to conduct this pragmatic trial if it required ascertainment of individual informed 
consent for several reasons. Doing so would undermine the very intent of the pragmatic trial 
design trial: to test whether the videos are effective in a “real-world” application under usual 
conditions. ACP is part of usual NH care and is simply being augmented in the intervention 
facilities with the videos. Getting written informed consent is not ‘usual’ for everyday NH 
care. In that vein, members of the NH staff are offering the videos to the patients in the 
intervention facilities, not the research team. The ACP videos are being integrated into the 
NHs’ standard operating procedures and offered to ALL NHs residents as part of the facility’s 
daily work-flow. It would not be feasible for the NH staff to obtain informed consent from all 
residents being offered the videos, especially since the videos are being integrated into the 
standard of care in that NH. With regards to data acquisition, all the data used in the study, 
with the exception of the Video Status Report User Defined Assessment, are already being 
collected for non-research purposes in both the intervention and control NHs. If permission to 
use these data were required by way of informed consent, this would have to be done for ALL 
residents in all facilities by staff in BOTH the control and intervention NHs. It would be 
impossible and put undue burden on the NH staff and the residents themselves to collect 
individual consent for the use of their records. Such an approach would once again undermine 
the pragmatic intent of the study and also dramatically reduce both NH and patient 
participation to the extent the study would not be possible. 
 
(4) If appropriate, the subjects will be provided with additional pertinent information 
after participation: We will provide the NH corporations, PruittHealth and Genesis 
HealthCare, with copies of the reports and manuscripts that result from this project.  They are 
free to share the information with their NHs, and the NHs will be free to share the information 
with interested families and patients. 
 
11.3. Participant Confidentiality 
We request a HIPAA Waiver of Requirement for Authorization for Release of Protected 
Health Information for Research Purposes from the Brown University IRB to conduct this study.  
Please see Section 10.2 for procedures for data confidentiality.  
 
11.4. Study Discontinuation 
The study may be discontinued at any time by the IRB, the NIA, the OHRP, the FDA, or 
other government agencies as part of their duties to ensure that research participants are 
protected.  
 

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12. ETHICAL CONSIDERATIONS 
 
Ethical consideration for the PROVEN trial will be in  accordance with the Federal Policy for 
the Protection of Human Subjects (HHS Human Subjects Research 45 Code of Federal Regulations 
(CFR) 46).137 
 

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13. COMMITTEES 
 
Figure 2 displays the 
organizational structure of the 
PROVEN team.   The Executive 
Committee consisting of the 3 co-
PIs will have ultimate responsibility 
for all aspects of the proven trial. 
As Brown University is the prime 
grant recipient, Dr. Mor will serve 
as the primary liaison for the trial to 
the NIH. 
 
The 
project's 
Steering 
Committee 
has 
the 
following 
responsibilities: i. oversee overall 
project direction, ii. ensure close 
collaboration with HCS Research 
Collaboratory and NIH with timely 
submission of all requested project 
materials to these entities, iii. serve 
as the primary liaison between the 
project and the NH health care 
systems, iv. coordinate tasks among individual working groups, v. ensure project milestones are 
met, and vi. review and approve all publications forthcoming from the PROVEN trial. The Steering 
Committee will ALSO serve as the primary vehicle for decision-making and help resolve conflicts 
or divergent approaches amongst investigators.  
The functions of the individual working groups are to establish and coordinate all processes 
implicit in their titles. 
 
14. 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 and the NIA prior to submission. 
 
 
Executive
Committee
Co-PIs
Steering Committee
Co-PIs, NH  partners, NIH/Duke CCC representative (s),  
Working group leaders
Stakeholder
Engagement
Mitchell
Human 
Subjects and
Data Safety
Mitchell
Data 
Management
Gozalo
Statistical 
Methods
Gatsonis
Facility 
Selection & 
Recruitment
Mor
Intervention 
Refinement
Volandes
Measurement
Mor
Intervention 
Training
Volandes
FIGURE 2.
W
O
R
K
I
N
G
G
R
O
U
P
S

PROVEN Protocol - Version 3.0 - Date: 4/17/2018 
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52. Loeb M, Carusone SC, Goeree R, et al. Effect of a clinical pathway to reduce 
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16 APPENDICES 
16.1. Data Safety and Monitoring Board Charter 
 

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16.1 Data Safety and Monitoring Board Charter 
 
 
DSMB Charter  
 
Title: PROVEN: Pragmatic Trial of Video Education in Nursing Homes, 
Grant #:  UH2AG049619 
 
Principal Investigators: Vincent Mor, Susan Mitchell, and Angelo Volandes 
 
Institution: Brown University  
 
The Data and Safety Monitoring Board (DSMB) will act in an advisory capacity to the National 
Institute on Aging (NIA) Director to monitor participant safety, data quality and progress of the 
study by the Principal Investigators Vincent Mor, PhD, Susan Mitchell, MD, and Angelo 
Volandes, MD for "PROVEN: Pragmatic Trial of Video Education in Nursing Homes" (grant 
UH2AG049619) and any successor grants funded by the National Institute on Aging.   
DSMB Responsibilities 
The DSMB responsibilities are to:  
 
review the research protocol, informed consent documents, and plans for data safety 
and monitoring;  
 
advise the NIA on the readiness of the study staff to initiate recruitment; 
 
 
evaluate the progress of the trial, including periodic assessments of data quality and 
timeliness, recruitment, accrual and retention, participant risk versus benefit, 
performance of the trial sites, and other factors that can affect study outcome; 
 
 
consider factors external to the study when relevant information becomes available, 
such as scientific or therapeutic developments that may have an impact on the safety of 
the participants or the ethics of the trial; 
 
 
review study performance, make recommendations, and assist in the resolution of 
problems reported by the Principal Investigator; 
  
 
protect the safety of the study participants; 
 
 
report to NIA on the safety and progress of the trial;  
 
 
make recommendations to the NIA, the Principal Investigator, and, if required, to 
regulatory authorities concerning continuation, termination, or other modifications of the 
trial based on the observed beneficial or adverse effects of the treatment under study; 

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 
ensure the confidentiality of the study data and the results of monitoring; and,  
 
 
assist the NIA by commenting on any problems with study conduct, enrollment, sample 
size, and/or data collection. 
 
The DSMB will discharge itself from its duties when the study is complete. 
Membership 
Membership consists of persons completely independent of the investigators who have no 
financial, scientific, or other conflict of interest with the trial. Collaborators or associates of the PI 
are not eligible to serve on the DSMB. Written documentation attesting to absence of conflict of 
interest is required. This DSMB will consist of 3 members having been approved by the Director 
of NIA.  
The DSMB includes experts in or representatives of the fields of: 
 
relevant clinical expertise,  
 
clinical trial methodology, and  
 
biostatistics.  
Dr. Christine Ritchie, MD has been selected by NIA to serve as the Chairperson and is 
responsible for overseeing the meetings, reviewing the first draft of the meeting notes with the 
NIA Program Official, and any decision making in the case of a tie vote. The Chair and the NIA 
Program Officer are the contact people for the DSMB. Brown University shall provide logistical 
management and support for the DSMB.  
 
The Chair will also serve as the safety officer. Any serious adverse events that might be related 
to the intervention will be reported to the Chair of the DSMB and the NIA Program Official by the 
PI within 24 hours of his learning of the event. 
Board Process  
The Principal Investigators will prepare the agenda to address the review of study materials, 
modifications to the study protocol and informed consent document, initiation of the trial, 
reporting of serious negative reactions, and statistical analysis plan for the first meeting. This 
will be in consultation with the DSMB Chairperson and NIA Program Official. 
 
Meetings of the DSMB will be held at least two times a year or at the call of the Chairperson. 
The NIA Program Official or designee will be present at every meeting. An emergency meeting 
of the DSMB may be called at any time by the Chair or the NIA, should participant safety 
questions or other unanticipated problems arise. 
 
Meetings shall be closed to the public because discussions may address confidential participant 
data. Meetings are attended by the Principal Investigators and members of their staff. These 
meetings are expected to be conducted via conference call, however an in-person meeting 
could be requested.   
 
Meeting Format 
 

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DSMB meetings will consist of open and closed sessions. Discussion held in all sessions is 
confidential. The Principal Investigators and key members of the study team attend the open 
sessions. Open session discussion will focus on the conduct and progress of the study, 
including participant accrual, protocol compliance, and problems encountered. Unblinded data 
are not presented in the open session.  
 
The closed session will be attended by the DSMB members and the NIA representative(s). 
The study statistician should be present to present the report. Any data by blinded study group 
and, as necessary, unblinded data, are presented during the closed session. 
 
If necessary, an executive session will be attended by voting DSMB members and the NIA 
staff and their representatives. The executive session will be held to identify and discuss the 
DSMB’s recommendations to the NIA. The study staff may be present, at the request of the 
DSMB, during the executive session.  
 
Each meeting must include a recommendation to continue or to terminate the study made by a 
DSMB majority or unanimous vote. Should the DSMB decide to issue a termination 
recommendation, the full vote of the DSMB is required. In the event of a split vote, majority vote 
will rule and a minority report should be appended. The DSMB Chair provides the tiebreaking 
vote in the event of a 50-50 split vote. 
 
A recommendation to terminate the study may be made by the DSMB at any time by majority 
vote. The Chair should provide such a recommendation to the NIA immediately by telephone 
and email. After the NIA Director makes a decision about whether to accept or decline the 
DSMB recommendation to terminate the study, the PI is immediately informed about the 
decision. 
 
Meeting Materials  
 
DSMB interim report templates will be prepared by the study staff, typically the statistician, to be 
reviewed by the DSMB members at the first meeting.  Interim data reports generally consist of 
two parts:  
 
 
Part 1 - Open Session Report and  
 
Part 2 - Closed Session Report  
 
Format and content of the reports for both the open and closed sessions and plans for interim 
analyses should be finalized and approved at the initial DSMB meeting, although changes 
throughout the trial may be requested by the Board. 
 
The reports will list and summarize safety data and describe the status of the study. All meeting 
materials should be sent to the DSMB and the NIA at least 7 days prior to the meeting. The 
reports are numbered and provided in sealed envelopes within an express mailing package or 
by secure email as the DSMB prefers. 
 
1. Part 1 - Open Session Reports: Open session reports will include administrative reports 
that describe participants screened, enrolled, completed, and discontinued, as well as 
baseline characteristics of the study population. Other general information on study status 
may also be presented. Listings of serious negative reactions and serious adverse events, 
as well as any other information requested by the DSMB, may also be in the open session 

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report, but none of the data will be presented in an unblinded manner. The DSMB may 
direct additions and other modifications to the reports on a one-time or continuing basis.  
 
2. Part 2 – Closed Session Report:  Closed session reports will present the same information 
as presented in the open session but by blinded treatment group (e.g. A/B, etc.). The reports 
will contain data on safety measures. The closed session reports should be destroyed at the 
conclusion of the meeting. If meetings are held by telephone, printed copies of the closed 
reports should be destroyed immediately following the meeting.  
Additional Reports 
1.  Mailings to the DSMB: On a scheduled basis (as agreed upon by the DSMB) blinded safety 
data will be communicated to all DSMB members or to the designated Safety Officer. Secure 
email can be used for distribution. 
 
2.  Access to Interim Data: Access to the accumulating endpoint data should be limited to as 
small a group as possible, such as the statistician. Limiting access to interim data to the DSMB 
members relieves the investigator of the burden of deciding whether it is ethical to continue to 
randomize individuals and helps protect the study from bias in recruitment and/or evaluation.  
 
Reports from the DSMB 
 
A report containing the recommendations for continuation or modifications of the study will be 
prepared by the NIA Project Officer. The draft report will be sent to the DSMB members not later 
than three weeks after the meeting. Once approved by the DSMB members, the Program 
Official will forward the DSMB recommendations to the Principal Investigator. It is the 
responsibility of the Principal Investigator to distribute the DSMB recommendation to all co-
investigators and to ensure that copies are submitted to all the IRBs associated with the study. 
 
As previously stated, the DSMB report must include a recommendation to continue or to 
terminate the study. This recommendation should be made by formal majority vote. A 
termination recommendation may be made by the DSMB at any time by majority vote. The NIA 
is responsible for notifying the Principal Investigator of a decision to terminate the study. In the 
event of a split vote in favor of continuation, a minority report should be contained within the 
regular DSMB report. The report will not include unblinded data or discussion of the unblinded 
data.  
 
Confidentiality  
 
All materials, discussions and proceedings of the DSMB are completely confidential. Members 
and other participants in DSMB meetings are expected to maintain confidentiality.