Optimizing the Safety of Inter-Hospital Transfer
Phase: NA
Conditions: Inpatient Facililty Diagnoses
Sponsor: Brigham and Women's Hospital

PARTNERS HUMAN RESEARCH COMMITTEE 
PROTOCOL SUMMARY 
Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
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Answer all questions accurately and completely in order to provide the PHRC with the relevant 
information to assess the risk-benefit ratio for the study.  Do not leave sections blank. 
 
PRINCIPAL/OVERALL INVESTIGATOR 
Stephanie Mueller, MD MPH 
 
PROTOCOL TITLE 
Optimizing the Safety of Inter-Hospital Transfer 
 
 
FUNDING 
Funded by CRICO/RMF GRANT AWARD 
 
 
VERSION DATE 
November 23, 2020 
 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
 
Inter-hospital transfer (IHT), commonly performed to provide patients with 
more specialized care, involves transfer of patients between providers, 
settings and systems of care, leaving these patients vulnerable to the risks 
of discontinuity of care. Standardized communication tools, which have been 
successful at reducing patient harm among other similar hospital-based care 
transitions (i.e., intra-hospital patient handoffs), have been under-utilized 
during IHT to-date, leaving the process largely non-standardized and 
variable. 
 
The overall goal of this proposal is to optimize patient safety during IHT to 
GMS, cardiology and oncology services, collectively comprising nearly 50% 
of all IHT to Brigham and Women’s Hospital (BWH), by leveraging our pilot 
work to design, implement and rigorously evaluate a standardized 
communication tool to be used during IHT. We propose the following Specific 
Aims to accomplish this goal: 
 
Aim 1. Utilize pilot data and stakeholder input to revise the 
standardized accept note. 
 
Aim 2a. Implement the revised standardized accept note for all 
patients transferred from another acute care hospital to the GMS, 
cardiology, oncology and medical/cardiac ICU inpatient services at 
BWH. 
 

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Aim 2b. Shift the responsibility of documentation of the accept note 
from a diffuse group of individual clinicians to a small group of 
dedicated nurses within the Access Center. 
 
Aim 3. Prospectively evaluate the impact of the intervention on 
patient safety outcomes, including: clinician-reported medical errors 
and adverse events, length of stay after transfer, rapid-response or 
code within 6-hours of transfer, ICU-transfer within 24-hours of 
transfer, and 3-day and in-hospital mortality. 
 
 
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
 
Importance of Patient Safety Issue  
The transfer of patients between acute care hospitals (inter-hospital 
transfer, IHT) occurs regularly: over 100,000 hospitalized Medicare patients 
undergo IHT yearly, with greater frequency among select patients with 
common medical diagnoses. 
 
Though often necessary to provide specialized care, IHT practices are highly 
variable and expose patients to unnecessary risks. Similar to other care 
transitions like patient discharge or intra-hospital patient handoffs, IHT 
exposes patients to known risks of discontinuity of care that may 
result in patient harm, such as errors in communication and gaps in 
information transfer. Moreover, patients undergoing IHT may be even 
more vulnerable to these risks than patients undergoing other care 
transitions, given the severity of illness in this patient population and the 
absence of protective factors to fill in gaps in communication, such as 
common electronic health records.  
 
Existing literature has suggested that poor communication during IHT is 
common and is a significant contributor to adverse outcomes among this 
patient population. This poor communication includes missing clinical 
information, such as test results (leading to diagnostic errors or redundant 
testing), absent or misleading information about how sick a patient is 
(leading to mis-triage), and even the reason for the transfer (leading to 
confusion regarding expected care, therapeutic errors, and patient/family 
dissatisfaction). Clinicians caring for IHT patients after transfer commonly 
describe feeling unprepared to safely care for these patients due to 
incomplete patient information that accompany the patient at the time of 
arrival. Not surprisingly, sub-optimal communication during IHT has been 
associated with poor downstream outcomes such as prolonged length of stay 
and increased mortality.  
 

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Although the association between inadequate communication and patient 
safety outcomes during IHT has been established, solutions to optimize 
communication during IHT have been lacking. Though there has been 
suggestion of improved patient outcomes in IHT with use of a structured 
handover tool and when enhancing information exchange via existent 
electronic health record (EHR) platforms, implementation and evaluation of 
standard communication practices have yet to be rigorously studied among 
the IHT population. In summary, this proposal aims to address the critical 
barrier of lack of evidence-based standardized communication during IHT to 
optimize patient safety during this transition.  
 
Scientific knowledge, technical capability, clinical practice, and malpractice 
risk  
Current IHT practices are largely variable and non-standardized, with limited 
existent guidelines to direct clinical practice during IHT. The Emergency 
Medical Treatment and Active Labor Act (EMTALA) laws dictate that hospitals 
transfer patients requiring a more specialized service unavailable at the 
transferring institution, or when “medical benefits...outweigh the increased 
risks to the individual...”, although these laws provide little practical 
guidance to clinicians during patient transfer. Other existent transfer-related 
guidelines are largely focused on equipment and expertise requirements for 
the physical transfer of the patient and/or are disease- or service-specific, 
rather than addressing inherent risks of discontinuity of care generalizable to 
all IHT patients, such as transfer of essential clinical information between 
transferring and receiving institutions. 
 
Summary of Background and Significance 
This proposal aims to design, implement and rigorously evaluate a 
standardized accept note in a population of patients that have high 
frequency of IHT, including patients transferred to the general medical 
(GMS), cardiology, oncology and ICU services at a large tertiary care 
hospital. This study will improve scientific knowledge by quantifying the 
patient safety impact of an intervention to improve communication of 
essential clinical information during IHT. If shown effective, the results of 
this study can be used to improve clinical practice by establishing evidence-
based communication guidelines for broad dissemination. We will also 
establish technical feasibility by successfully implementing this tool within 
our EHR (Epic, Verona, WI), allowing for feasible adoption and dissemination 
to other institutions with similar EHR capabilities. Lastly, we will address 
malpractice risk by investigating a strategic intervention aimed at reducing 
known contributors to patient harm during IHT, a high-risk transition in care 
that involves transfer of high-acuity patients between providers, settings and 
systems of care. 
 
 

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Version Date:  October 15, 2014 
 
  
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RESEARCH DESIGN AND METHODS 
Briefly describe study design and anticipated enrollment, i.e., number of subjects to be enrolled 
by researchers study-wide and by Partners researchers.  Provide a brief summary of the 
eligibility criteria (for example, age range, gender, medical condition).  Include any local site 
restrictions, for example, “Enrollment at Partners will be limited to adults although the sponsor’s 
protocol is open to both children and adults.”
 
We will conduct a prospective 24-month interrupted time series (ITS) study 
during which we will implement the standardized accept note and evaluate 
impact on all measured outcomes post- versus pre-implementation, 
accounting for baseline temporal trends. 
 
Eligible patient subjects will include any patient age 18 or older transferred 
from another acute care hospital to the GMS, cardiology, oncology or ICU 
(including medical and cardiac ICU) services at BWH during the study period. 
Because the intervention is not directly patient-facing, there will be no direct 
enrollment of eligible patients, and we will be requesting a waiver of written 
informed consent for patients. Thus, all eligible patients transferred during 
the study period will be included in the study. Assuming 1848 total patient 
transfers to GMS, cardiology, oncology and medical/cardiac ICU services at 
BWH per year, we anticipate including approximately 2,772 patients during 
the 18-month data collection period (9 months pre-implementation, 9-
months post implementation). Data collection procedures are described in 
detail below. 
 
Eligible clinician subjects (approached for survey completion to collect 
clinician-reported patient safety outcomes) will include any clinician who 
admitted an included transferred patient during the data collection period, 
using the methodology described below. Clinicians involved in patient 
admissions on GMS, cardiology, oncology and medical/cardiac ICU services 
include medicine resident physicians, attending hospitalist/nocturnist 
physicians, and/or physician assistants on any of the 3 included services. 
Given the described methodology of approach for survey administration and 
repeated offerings to opt-out of participation (see included 
“IntroductoryEmail” and “DirectedEmailSurvey1”) we will be requesting a 
waiver of written informed consent for clinician subjects. 
 
Full description of the research design and methods is as follows: 
 
Overall strategy, work plan, data collection methodology 
Aim 1. Utilize pilot data and stakeholder input to refine the standardized 
accept note. 
 
Two parallel pilot initiatives and key stakeholder input will be used to 
develop the standardized accept note to be implemented during this study. 
The first pilot initiative aimed at improving communication during IHT to 

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GMS services. Stakeholder input was used to successfully design and 
implement a structured accept note template to be completed for all GMS 
patient transfers. The template was made accessible within Epic as a “dot-
phrase” (i.e., a phrase starting with a period that automatically produces 
prespecified text). Components of the structured accept note are shown 
below in Table 1.  
 
Table 1. Components included in structured accept note (pilot)32 
 “Logistical” components  
“Clinical” components  
Name of transferring hospital  
Reason for transfer  
Date of request  
Consulting service expected (Y/N, if Y, who?)  
Requesting physician name  
Code status  
Requesting physician contact information  
Patient summary  
Transferring floor contact information  
Relevant comorbidities  
 
Current inpatient medications  
 
Last vital signs  
 
Pertinent exam findings  
 
Pertinent data (labs, imaging, microbiology)  
 
Expected plan on arrival  
 
The second concurrent pilot initiative aimed at improving communication 
during direct hospital admission from oncology clinic to inpatient oncology 
services and similarly included creation of a structured pre-admission note 
template adapted from the I-PASS structured hand-off tool, shown to 
improve patient outcomes when used during intra-hospital patient hand-offs. 
This note was similarly accessible as a “dot-phrase” within Epic, and 
contained similar (but not identical) components to those used in the above 
pilot, including: (1) Illness severity: Documentation of the patient as 
“stable” or “watcher” (indicating the patient is at risk of becoming unstable); 
(2) Patient summary; (3) Action items: Documentation of the expected care 
plan on arrival; (4) Situational awareness: Documentation of code status 
and any social needs; and (5) Synthesis by receiver: Documentation of 
contact information for the referring outpatient clinician sending the patient 
for direct admission. 
 
These two pilot versions of a structured accept note will be reconciled and 
refined using feedback gathered during these initiatives, along with key 
stakeholder input (below), to develop the standardized accept note that will 
be implemented in this study. 
 
We will engage key stakeholders in the refinement and development of the 
final standardized accept note to be implemented in this study, including: 
Key representatives from the Access Center (Dr. Eric Goralnick, Medical 
Director of the Access Center and Co-I on this proposal; Samantha 
Andreasen, Acting Nursing Director of the Access Center; and Sheila Harris, 
Executive Director of Patient Access and Clinical Services; and to-be-
identified Access Center staff); BWH quality and safety leadership (Dr. 
Mallika Mendu, Medical Director of Quality and Patient Safety) (please note 
that all mentioned stakeholders provided letters of support for this 

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proposal); and select frontline accepting clinicians and admitting clinicians 
from each included service (i.e., those who take transfer request calls and 
those who admit transferred patients at time of arrival) who will be recruited 
at the start of the study. Stakeholders will meet monthly during the 6-month 
period of finalization of the accept note. 
 
Notably, we will ensure that the final version of the standardized accept note 
allows for flexibility within the templated fields to address the unique needs 
of the different included patient populations (e.g., prompts to include 
date/details of any prior cardiac catheterizations for cardiology patient 
transfers). This is similar to how IPASS allows for flexibility in the Patient 
Summary section for different populations while still standardizing 
communication. 
 
Clinical information to populate the note will be collected during a 3-way 
conference call that occurs between the Access Center nurses, transferring 
clinicians, and accepting clinicians prior to all patient transfers (part of 
current workflow, see below Aim 2). The note will be documented and 
accessible within Epic, as it was during the pilot initiatives. 
 
Aim 2a. Implement the revised standardized accept note for all patients 
transferred from another acute care hospital to the GMS, cardiology, 
oncology and ICU (medical, cardiac) inpatient services at BWH. 
Aim 2b. Shift the responsibility of documentation of the accept note from a 
diffuse group of individual clinicians to a small group of dedicated nurses 
within the Access Center. 
 
Currently, documentation of clinical information in advance of patient 
transfer to included services involves a diffuse group of clinicians who are 
responsible for both accepting the patient for transfer and are expected to 
document the patient accept note. For example, for GMS patient transfers, 
this responsibility for accepting patients for transfer and documenting their 
accept note falls to any of the over 50 hospitalist faculty who rotate weekly 
on the clinical service. This diffusion of responsibility is similar for cardiology 
and oncology service patient transfers as well. Collectively, these practices 
result in variable presence, timeliness and quality of accept note 
documentation in advance of patient transfer. 
 
Thus, implementation of the standardized accept note will importantly 
include shifting responsibility for documentation of the note from this diffuse 
group of clinicians to a small group of dedicated nurses within the Access 
Center. Notably, the pilot initiative for GMS patient transfers included this 
shifted responsibility as part of the initiative; thus, the additional 
responsibility for accept note documentation among patients transferred to 
cardiology and oncology services (in addition to GMS services) will involve 
an expansion of the current role of Access Center nurses, rather than 

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introduction of an entirely new role. This expansion of responsibility of 
Access Center nurses is also supported by Access Center leadership (as was 
provided in letters of support for this grant proposal), contributing to the 
feasibility of this aspect of the proposal 
 
Implementation of the standardized accept note will also involve education 
of Access Center nurses on its use (i.e., to familiarize them with the newly 
developed accept note template), and we have included a 3-month “wash-
in” phase following implementation to allow for iterative feedback on its use, 
to improve the quality of documentation during the implementation period. 
 
Of note, the shifting of responsibility of documentation of the new 
standardized accept note will not supplant the current role of the accepting 
clinician to make the clinical decision on acceptance or rejection of the 
transfer request. As is currently done, the Access Center nurse and 
accepting clinician participate in a conference call with the transferring 
clinician such that either can ask questions (and the Access Center nurse can 
hear all the answers and document them in the accept note template). In 
this way, the Access Center nurse can ensure that the minimum necessary 
information is collected and documented, while also including additional 
clinical information requested by the accepting clinician. 
 
Aim 3. Prospectively evaluate the impact of the intervention on patient 
safety outcomes, including: clinician-reported medical errors and adverse 
events, length of stay after transfer, rapid-response or code within 6-hours 
of transfer, ICU-transfer within 24-hours of transfer, and 3-day and in-
hospital mortality. 
 
Study Design: We will conduct a prospective 24-month interrupted time 
series (ITS) study during which we will implement the standardized accept 
note and evaluate impact on all measured outcomes post- versus pre-
implementation, accounting for baseline temporal trends. 
 
Setting, Subjects, Eligibility, Enrollment: Eligible patients will include any 
patient age 18 or older transferred from another acute care hospital to the 
GMS, cardiology, oncology or medical/cardiac ICU services at BWH during 
the study period. Because the intervention is not directly patient-facing, 
there will be no direct enrollment of eligible patients, and we will be 
requesting a waiver of written informed consent for patients (see 
Organizational Internal Review Process, above). Thus, all eligible patients 
transferred during the study period will be in the study. 
 
Instruments, Tests and/or Measurements: A trained research assistant (RA) 
will conduct surveys of admitting clinicians within 48-hours after IHT patient 
admission to obtain clinician- reported medical errors and adverse events, 
including medical errors resulting in patient harm (e.g., preventable and 

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ameliorable adverse events). The RA will use a central patient report derived 
from our EHR system that lists all transferred patients to included services 
on a daily basis Monday through Friday (including weekend transfers on 
Mondays) and will perform targeted EHR review to determine the admitting 
clinician for each patient. The RA will then email that clinician a link and 
instructions to complete a short survey via REDCap, a free, secure, HIPAA 
compliant web-based application hosted by Partners (see included 
“DirectedEmailSurvey1”). Survey questions, based on those from similar 
studies conducted by our group for other types of care transitions, will 
pertain to the clinician’s care of the specific transferred patient and will ask 
about failures in communication (i.e., the presence of inaccurate or missing 
information, including missed or delayed diagnoses) and evaluate for any 
failures or delays in ordering or interpreting diagnostic studies, and delays in 
therapeutic care. The survey also asks about any adverse event (i.e., patient 
harm due to medical care), the severity of the event, and whether it was 
preventable or ameliorable (see “Appendix.ClinicianSurvey”). The RA will 
send 2 follow-up emails over the following 3 days (see 
“DirectedEmailSurvey.FollowUp”). After 3-days, any non-responding clinician 
will be contacted by the RA to conduct an in-person survey using an iPad 
linked to REDCap to improve response rate. All clinicians will be informed 
they have the right to opt out of any data collection activities at the 
beginning of the study and when requested to participate in these activities. 
Each participating clinician will receive a $5 gift card for each completed 
survey (currently submitting to Research Compliance for approval). All other 
outcome measures will be obtained via administrative data with help from a 
database analyst. 
 
Primary and Secondary Outcome Measures:  
1) Clinician-reported medical errors (primary outcome), measured as the 
total number of medical errors per patient  
2) Presence of any adverse event after transfer (secondary outcome)  
3) Preventable adverse event after transfer (secondary outcome)  
4) Ameliorable adverse event after transfer (secondary outcome)  
5) Length of stay of hospitalization after transfer (secondary outcome)  
6) Rapid-response (i.e., “pre-code”) or code within 6 hours of transfer 
(secondary outcome)  
7) ICU-transfer within 24 hours of transfer (secondary outcome, excluding ICU patients)  
8) Mortality, including 3-day mortality (within 3 days of transfer) and in-
hospital mortality (secondary outcome)  
9) Intermediate process outcomes, including presence, timeliness and 
completeness of accept note as measured by frequency of accept note 
availability at time of IHT patient arrival and frequency of inclusion of pre-
specified data elements (secondary outcome)  
 

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Statistical Methods and Analytic Plan: All outcomes will be compared post- 
versus pre-implementation via ITS methodology, allowing us to evaluate for 
statistically significant changes in outcomes while accounting for baseline 
trends. Multivariable analyses will be utilized to adjust for potential 
confounders.  
 
Covariates: Potential confounders will be collected via administrative sources 
and include basic patient demographics (age, gender, race, ethnicity), 
insurance, diagnosis category (using standard ICD-10 grouper algorithms on 
the principal problem on the Hospital Problem List on admission, which we 
have found to be more accurate than the billing diagnosis on admission), 
comorbidity (i.e., Elixhauser score), illness severity (eCART score on 
admission, which uses vital sign and laboratory data to predict cardiac 
arrest, ICU transfer, or death among hospitalized patients),36 clinical service 
at time of admission, and time of year of transfer (by quarter) to adjust for 
training effects on residents and seasonal case mix. To avoid over-testing, 
all patient characteristics will be entered into the analysis model. Non-
significant collinear terms will be removed from the final models. 
 
Subgroup analysis: We will conduct a limited number of a priori subgroup 
analyses to evaluate for differential effect of the intervention in different 
sub-populations of transferred patients by using interaction terms 
(subgroup*intervention) to determine effect modification. Specifically, we 
will stratify analyses by: 1) admitting service (GMS, cardiology, oncology, 
medical/cardiac ICU); 2) diagnosis category; and 3) severity of illness on 
admission (using the eCART score as described above).  
 
Statistical techniques: For all analyses we will use a segmented regression 
analysis on all eligible patients, evaluating outcomes monthly during the pre-
implementation and post-implementation periods (after the 3-month “wash-
in” period). This approach quantifies both a “step” change in the level of 
outcome and a “slope” change in the trend of outcome. For our primary 
outcome (number of clinician-reported medical errors per patient), we will 
use multivariable Poisson regression models (SAS v9.4 statistical package, 
Cary, NC). For adverse events, preventable and ameliorable adverse events, 
and other dichotomous outcomes (rapid response/code, ICU-transfer, 
mortality, presence of accept note) we will use multivariable logistic 
regression models. For LOS, given its skewed nature we will use a 
multivariable generalized linear regression model assuming a gamma 
distribution with a log-link. We will use descriptive statistics to evaluate 
timeliness of accept note availability and inclusion of accept note data 
elements. For all analyses, the transfer episode will serve as the unit-of-
analysis.  
 
Outcomes reporting: Patient and transfer process characteristics will be 
presented descriptively using means with standard deviations, medians with 

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inter-quartile ranges, and proportions with 95% confidence intervals as 
appropriate. Each outcome will be reported as crude as well as adjusted and 
clustered effects with 95% confidence intervals. All analyses will be on an 
intention-to-treat basis. Two-sided p values < 0.05 will be considered 
significant. All analyses will be conducted using SAS (SAS v9.4 statistical 
package, Cary, NC).  
 
Power and sample size: Based on previous data, we estimate a baseline rate 
of 25 reported medical errors per 100 patient transfers. With an alpha of 
0.05, we will require an effective sample size of approximately 594 patient 
transfers during the 9-month pre-implementation period and 594 patients 
transfers during the 9-month post-implementation period to have 80% 
power to detect a 30% relative reduction to 17.5 errors per 100 patient 
transfers, as has been observed in similar studies. Assuming 1,848 total 
patient transfers to GMS, cardiology, oncology and medical/cardiac ICU 
services at BWH per year (1,368 per 9-months, internal data), while allowing 
for missed days of survey administration (i.e., during holidays), and 
accounting for a survey response rate of 90% (based on similar studies), we 
should easily achieve this sample size. 
 
Given the large number of different clinicians likely to admit these patients 
across all services over the 18 months of data collection, the cluster size is 
likely negligible, therefore resulting in an effective sample size close to the 
actual sample size. 
 
 
 
Briefly describe study procedures.  Include any local site restrictions, for example, “Subjects 
enrolled at Partners will not participate in the pharmacokinetic portion of the study.”  Describe 
study endpoints.
 
Please see detailed description of study procedures above. 
 
All study procedures will take place at BWH. There are no local site 
restrictions for the procedures described in this study. 
 
 
For studies involving treatment or diagnosis, provide information about standard of care at 
Partners (e.g., BWH, MGH) and indicate how the study procedures differ from standard care.  
Provide information on available alternative treatments, procedures, or methods of diagnosis.
 
Current practices for inter-hospital transfer of patients to GMS, cardiology, 
oncology and medical/cardiac ICU services at BWH involves an expectation 
of documentation of clinical information in advance of patient transfer. 
However, this documentation is largely non-standardized and involves a 

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diffuse group of clinicians who are responsible for both accepting the patient 
for transfer and are expected to document the patient accept note. For 
example, for GMS patient transfers, this responsibility for accepting patients 
for transfer and documenting their accept note falls to any of the over 50 
hospitalist faculty who rotate weekly on the clinical service. This diffusion of 
responsibility is similar for cardiology, oncology and ICU service patient 
transfers as well. Collectively, these practices result in variable presence, 
timeliness and quality of accept note documentation in advance of patient 
transfer. 
 
We expect (our hypothesis) is that implementation of this standardized 
accept note, as well as centralization of accept note documentation, will be a 
marked improvement over current standard of care – leading to both 
improved frequency of documentation and quality of documentation.  
However, we do not know this for sure – that is why we are conducting the 
study.  In other words, there is equipoise. 
 
 
Describe how risks to subjects are minimized, for example, by using procedures which are 
consistent with sound research design and which do not unnecessarily expose subjects to risk or 
by using procedures already being performed on the subject for diagnostic or treatment purposes.
 
Risks to subjects will be minimized by using procedures which are consistent 
with sound research design. Neither patients nor providers will be 
unnecessarily exposed to excess risk. The designed intervention is a local 
quality improvement initiative, with input from key stakeholders involved in 
the inter-hospital transfer process, and, as stated above, is hypothesized to 
be an improvement to current practices. 
 
Additionally, all collected data is secured within the password-protected 
REDCap ecosystem – REDCap is a secure web application for building and 
managing online surveys and databases. Thus risks to data breach/patient 
confidentiality will be minimized. 
 
 
Describe explicitly the methods for ensuring the safety of subjects.  Provide objective criteria for 
removing a subject from the study, for example, objective criteria for worsening disease/lack of 
improvement and/or unacceptable adverse events.  The inclusion of objective drop criteria is 
especially important in studies designed with placebo control groups.
 
Ensuring safety of patient subjects: The intervention itself will rolled out on 
the specific study units (general medical, cardiology, oncology and 
medical/cardiac ICU services) as part of a quality improvement effort to 
change systems for best practice as described.  We will conduct periodic 
data safety monitoring (see below) to ensure that the intervention is not 

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causing harm (e.g., increased adverse events, prolonged length of stay). 
Additionally, all patient-level data will be kept within Partners firewall, with 
only approved study staff access, thus minimizing risk to patient 
confidentiality/data breaches. 
 
Ensuring safety of provider/clinician subjects: The nature of the study will be 
explained clearly to all providers prior to the start of the study and at all 
points of data collection from providers (i.e., survey administration, as 
described above), with clear instructions that clinician subjects are able to 
opt-out of participation in the study at any time. Although they are hospital 
employees, they will be under no pressure to complete the study surveys or 
participate. They will be told that all data will be presented in aggregate, and 
their supervisors will never see the results of their individual surveys or 
know whether or not they chose to participate in the study. They will be 
given the ability to opt out of the study then, or at any time thereafter.   
 
 
FORESEEABLE RISKS AND DISCOMFORTS 
Provide a brief description of any foreseeable risks and discomforts to subjects.  Include those 
related to drugs/devices/procedures being studied and/or administered/performed solely for 
research purposes.  In addition, include psychosocial risks, and risks related to privacy and 
confidentiality.  When applicable, describe risks to a developing fetus or nursing infant.
 
The foreseeable risks to patients of the study itself is mainly the risk of 
breach of confidentiality, and again, this risk will be minimized given the 
steps to preserve confidentiality noted below. 
 
The risk or discomforts to admitting clinicians are the minor inconvenience of 
completing the surveys, and risks to confidentiality, which we will take every 
effort to minimize as described below.   
 
The data collected from providers will not have any identifiers and will not be 
coded except to track who has completed surveys (e.g., in order to send a 
reminder as needed).  All data will be collected with REDCap, a secure, 
HIPAA compliant web-based application hosted by Partners. Identifiers (i.e., 
on a survey cover sheet) will be removed prior to any analysis, and results 
will only be presented in aggregate. Additional data protection measures 
(see below) will also be taken to ensure protection and restricted access to 
all study related files and data. 
 
 
EXPECTED BENEFITS 
Describe both the expected benefits to individual subjects participating in the research and the 
importance of the knowledge that may reasonably be expected to result from the study.  Provide 
a brief, realistic summary of potential benefits to subjects, for example, “It is hoped that the 
treatment will result in a partial reduction in tumor size in at least 25% of the enrolled subjects.”  

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Indicate how the results of the study will benefit future patients with the disease/condition being 
studied and/or society, e.g., through increased knowledge of human physiology or behavior, 
improved safety, or technological advances. 
 
This project will advance the field by investigating a strategic intervention 
aimed at reducing known contributors to patient harm: sub-optimal 
communication and clinical information exchange within IHT, an 
understudied high-risk care transition. Additionally, if shown effective at 
reducing patient harm, the standardized accept note developed from this 
study can be adapted and used by other CRICO-insured institutions to 
address potential harm and malpractice risk related to IHT. 
 
Given previous data that estimates an approximate baseline rate of 25 
reported medical errors per 100 patient transfers, our anticipated sample 
size will be more than enough to have 80% power to detect a 30% relative 
reduction to 17.5 errors per 100 patient transfers, as has been observed in 
similar studies. 
 
Impact on Department, Institution/Organization, and CRICO-wide 
Membership: If shown effective, our findings will provide convincing 
evidence that this intervention can and should be adapted for use among 
other CRICO-insured institutions to address potential harm and malpractice 
risk related to IHT. Importantly, the standardized accept note developed for 
this study will be generally accessible within the EHR (Epic). This has critical 
implications for future dissemination of this work, as this central accessibility 
will allow for easy modification and expansion to other services at BWH and 
all other Partners hospitals interested in mitigating patient safety risk during 
IHT, either via individual departmental efforts or as part of an organizational 
strategy to address this risk. Moreover, these interventions could be easily 
adapted for other CRICO member hospitals (e.g., note templates are part of 
all EHRs, not just Epic). 
 
Impact on Health Care Providers: The intervention included in this proposal 
directly addresses health care provider-reported patient safety concerns 
regarding incomplete or insufficient availability of clinical information for IHT 
patients, as collected with our prior research on this topic. Thus, we 
anticipate that this proposal will benefit clinicians by improving the presence, 
timeliness, completeness and quality of clinical information available to them 
prior to patient transfer, thereby improving their ability to adequately 
prepare for and care for IHT patients. 
 
Impact on the Field: This project will advance the field by investigating a 
strategic intervention aimed at reducing known contributors to patient harm: 
sub-optimal communication and clinical information exchange within IHT, an 
understudied high-risk care transition. 
 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
14 
 
EQUITABLE SELECTION OF SUBJECTS 
The risks and benefits of the research must be fairly distributed among the populations that stand 
to benefit from it.  No group of persons, for example, men, women, pregnant women, children, 
and minorities, should be categorically excluded from the research without a good scientific or 
ethical reason to do so.  Please provide the basis for concluding that the study population is 
representative of the population that stands to potentially benefit from this research.
 
All patients transferred from another acute care hospital to the GMS, 
cardiology, oncology and medical/cardiac ICU inpatient services at BWH will 
be eligible for the study. No group is categorically excluded from inclusion. 
Additionally, all admitting clinicians in the units targeted in the study 
(general medical, cardiology and oncology services) will be asked to 
participate in the study. 
 
When people who do not speak English are excluded from participation in the research, provide 
the scientific rationale for doing so.  Individuals who do not speak English should not be denied 
participation in research simply because it is inconvenient to translate the consent form in 
different languages and to have an interpreter present.
N/A 
 
 
For guidance, refer to the following Partners policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English
          https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/Non-English-Speaking-Subjects.pdf 
 
 
 
RECRUITMENT PROCEDURES 
Explain in detail the specific methodology that will be used to recruit subjects.  Specifically 
address how, when, where and by whom subjects will be identified and approached about 
participation.  Include any specific recruitment methods used to enhance recruitment of women 
and minorities.
 
Eligible patients will include any patient age 18 or older transferred from 
another acute care hospital to the GMS, cardiology, oncology or 
medical/cardiac ICU services at BWH during the study period. Because the 
intervention is not directly patient-facing there will be no direct enrollment of 
eligible patients. We will request a waiver of written informed consent for 
patients on the grounds that the study is minimal risk and the intervention is 
being provided to all patients transferred to included services during the 
implementation period. Thus, all eligible patients transferred during the 
study period will be in the study. 
 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
15 
A trained research assistant (RA) will conduct surveys of admitting clinicians 
within 48-hours after IHT patient admission to obtain clinician- reported 
medical errors and adverse events, including medical errors resulting in 
patient harm (e.g., preventable and ameliorable adverse events). The RA 
will use a central patient report derived from our EHR system that lists all 
transferred patients to included services on a daily basis Monday through 
Friday (including weekend transfers on Mondays) and will perform targeted 
EHR review to determine the admitting clinician for each patient. The RA will 
then email that clinician a link and instructions to complete a short survey 
via REDCap, a secure, HIPAA compliant web-based application hosted by 
Partners (see”DirectedEmailSurvey1”). As this email will contain patient 
identifiers, all emails will be sent from a Partners institutional email address 
and only to the clinician’s institutional email address (i.e., no 
personal/private email addresses will be used). Survey questions, based on 
those from similar studies conducted by our group for other types of care 
transitions, will pertain to the clinician’s care of the specific transferred 
patient and will ask about failures in communication (i.e., the presence of 
inaccurate or missing information, including missed or delayed diagnoses) 
and evaluate for any failures or delays in ordering or interpreting diagnostic 
studies, and delays in therapeutic care. The survey also asks about any 
adverse event (i.e., patient harm due to medical care), the severity of the 
event, and whether it was preventable or ameliorable (see 
“Appendix.ClinicianSurvey”). The RA will send 2 follow-up emails over the 
following 3 days (See “DirectedEmailSurvey.FollowUp”). After 3-days, any 
non-responding clinician will be contacted by the RA to conduct an in-person 
survey using an iPad linked to REDCap to improve response rate. All 
clinicians will be informed they have the right to opt out of any data 
collection activities at the beginning of the study and when requested to 
participate in these activities. If a clinician chooses to opt out of taking part 
in the study, they will not be approached about study participation again, 
either for the patient they were initially approached about or a future patient 
of theirs. 
 
 
 
Provide details of remuneration, when applicable.  Even when subjects may derive medical 
benefit from participation, it is often the case that extra hospital visits, meals at the hospital, 
parking fees or other inconveniences will result in additional out-of-pocket expenses related to 
study participation.  Investigators may wish to consider providing reimbursement for such 
expenses when funding is available
 
Each participating clinician will receive a $5 gift card for each completed 
survey. This will provide incentive but not enough to be coercive for 
participation. We are currently submitting this to Research Compliance for 
approval, though anticipate approval due to similar approved approaches 
with prior research. 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
16 
 
For guidance, refer to the following Partners policies: 
          Recruitment of Research Subjects 
          https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/Recruitment-Of-Research-Subjects.pdf
 
          Guidelines for Advertisements for Recruiting Subjects
          https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/Guidelines-for-Advertisements.pdf 
 
          Remuneration for Research Subjects
          https://www.partners.org/Assets/Documents/Medical-Research/Clinical-Research/Remuneration-for-
Research-Subjects.pdf 
 
 
CONSENT PROCEDURES 
Explain in detail how, when, where, and by whom consent is obtained, and the timing of consent 
(i.e., how long subjects will be given to consider participation).  For most studies involving more 
than minimal risk and all studies involving investigational drugs/devices, a licensed physician 
investigator must obtain informed consent.  When subjects are to be enrolled from among the 
investigators’ own patients, describe how the potential for coercion will be avoided.
 
Consent procedures for patients - Because the intervention is not directly 
patient-facing, there will be no direct enrollment of eligible patients, and we 
will be requesting a waiver of written informed consent for patients.  
 
Consent procedures for Admitting Clinicians – implied consent is obtained 
from the admitting clinicians as a function of filling out and submitting a 
survey response. All clinicians will be informed they have the right to opt out 
of any data collection activities at the beginning of the study and when 
requested to participate in these activities. 
 
 
 
NOTE: When subjects are unable to give consent due to age (minors) or impaired decision-
making capacity, complete the forms for Research Involving Children as Subjects of Research 
and/or Research Involving Individuals with Impaired Decision-making Capacity, available on 
the New Submissions page on the PHRC website: 
      https://partnershealthcare.sharepoint.com/sites/phrmApply/aieipa/irb 
 
For guidance, refer to the following Partners policy: 
     Informed Consent of Research Subjects:
     https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/Informed-Consent-of-Research-Subjects.pdf
 
 
 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
17 
DATA AND SAFETY MONITORING 
Describe the plan for monitoring the data to ensure the safety of subjects.  The plan should 
include a brief description of (1) the safety and/or efficacy data that will be reviewed; (2) the 
planned frequency of review; and (3) who will be responsible for this review and for determining 
whether the research should be altered or stopped.  Include a brief description of any stopping 
rules for the study, when appropriate.  Depending upon the risk, size and complexity of the 
study, the investigator, an expert group, an independent Data and Safety Monitoring Board 
(DSMB) or others might be assigned primary responsibility for this monitoring activity.        
 
NOTE: Regardless of data and safety monitoring plans by the sponsor or others, the principal 
investigator is ultimately responsible for protecting the rights, safety, and welfare of subjects 
under his/her care. 
 
The principal investigator and data analyst will review all complaints and 
adverse events reported from patient and provider subjects each quarter.  
These will be reported to the study sponsor and Partners IRB annually or 
immediately if the complaint or adverse event is serious.  In addition, the 
principal investigator and data analyst will review on a monthly basis 
adverse event rates, hospital length of stay, and 7-day readmission rates to 
ensure that the intervention itself is not causing harm compared with the 
pre-intervention period.  If an increase in harm is suspected, we will report it 
to the IRB and take action as needed.  Given the minimal risk of this study, 
we are not planning any automatic stopping rules or using a DSMB. 
 
 
Describe the plan to be followed by the Principal Investigator/study staff for review of adverse 
events experienced by subjects under his/her care, and when applicable, for review of sponsor 
safety reports and DSMB reports.  Describe the plan for reporting adverse events to the sponsor 
and the Partners’ IRB and, when applicable, for submitting sponsor safety reports and DSMB 
reports to the Partners’ IRBs.  When the investigator is also the sponsor of the IND/IDE, include 
the plan for reporting of adverse events to the FDA and, when applicable, to investigators at 
other sites.   
 
NOTE: In addition to the adverse event reporting requirements of the sponsor, the principal 
investigator must follow the Partners Human Research Committee guidelines for Adverse Event 
Reporting
See Above 
 
 
MONITORING AND QUALITY ASSURANCE 
Describe the plan to be followed by the principal investigator/study staff to monitor and assure 
the validity and integrity of the data and adherence to the IRB-approved protocol.  Specify who 
will be responsible for monitoring, and the planned frequency of monitoring.  For example, 
specify who will review the accuracy and completeness of case report form entries, source 
documents, and informed consent.   
 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
18 
NOTE: Regardless of monitoring plans by the sponsor or others, the principal investigator is 
ultimately responsible for ensuring that the study is conducted at his/her investigative site in 
accordance with the IRB-approved protocol, and applicable regulations and requirements of the 
IRB.
 
The principal investigator and study analyst will review the study database 
monthly during the data collection period to ensure data integrity. 
Additionally, survey collection directly into REDCap will ensure data integrity 
with limited opportunity for errors in data transfer. Protocols will also be 
monitored quarterly to ensure adherence to the study protocol as approved 
by the IRB. 
 
 
For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance
         https://www.partners.org/Assets/Documents/Medical-Research/Clinical-Research/DSMP-in-
Human-Subjects-Research.pdf 
 
          Reporting Unanticipated Problems (including Adverse Events)
          https://www.partners.org/Assets/Documents/Medical-Research/Clinical-
Research/Reporting-Unanticipated-Problems-including-Adverse-Events.pdf
 
 
 
PRIVACY AND CONFIDENTIALITY 
Describe methods used to protect the privacy of subjects and maintain confidentiality of data 
collected.  This typically includes such practices as substituting codes for names and/or medical 
record numbers; removing face sheets or other identifiers from completed 
surveys/questionnaires; proper disposal of printed computer data; limited access to study data; 
use of password-protected computer databases; training for research staff on the importance of 
confidentiality of data, and storing research records in a secure location.   
 
NOTE: Additional measures, such as obtaining a Certificate of Confidentiality, should be 
considered and are strongly encouraged when the research involves the collection of sensitive 
data, such as sexual, criminal or illegal behaviors.
 
The data collected from providers will not have any identifiers and will not be 
coded except to track who has completed surveys (e.g., in order to send a 
reminder as needed).  Patient identifiers (i.e., to connect survey data 
collected from providers with data abstracted from administrative data 
sources) will be kept in a separate, password-protected file. Any patient 
identifiers will be removed prior to any analysis, and results will only be 
presented in aggregate. 
 
All data will be collected through REDCap, a secure, HIPAA compliant web-
based application hosted by Partners, and only accessible to IRB-approved 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  October 15, 2014 
 
  
19 
study staff. Additionally the iPad being used for this study will be linked to 
REDCap and will likewise be password protected. 
 
All other files and electronic data will be stored on within databases in a 
shared file area within the Partners firewall on a Partners password-
protected computer with anti-virus software.  A database with the link from 
PHI (e.g., MRN) to subject ID number will be kept separate from the rest of 
the data.  Only IRB-approved study staff trained in the protection of human 
subjects will have access to study data. 
 
 
SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
Specimens or data collected by Partners investigators will be sent to research collaborators 
outside Partners, indicate to whom specimens/data will be sent, what information will be sent, 
and whether the specimens/data will contain identifiers that could be used by the outside 
collaborators to link the specimens/data to individual subjects.
N/A 
 
 
Specifically address whether specimens/data will be stored at collaborating sites outside 
Partners for future use not described in the protocol.  Include whether subjects can withdraw 
their specimens/data, and how they would do so.  When appropriate, submit documentation of 
IRB approval from the recipient institution.
N/A 
 
 
RECEIVING SPECIMENS/DATA FROM RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
When specimens or data collected by research collaborators outside Partners will be sent to 
Partners investigators, indicate from where the specimens/data will be obtained and whether the 
specimens/data will contain identifiers that could be used by Partners investigators to link the 
specimens/data to individual subjects.  When appropriate, submit documentation of IRB 
approval and a copy of the IRB-approved consent form from the institution where the 
specimens/data were collected.
N/A