Diabetes to Go Inpatient: A Study of the Implementation of a Technology-enabled Diabetes Survival Skills Education Program Within Medical-Surgical Nursing Unit Workflow
Conditions: Diabetes Mellitus
Sponsor: Medstar Health Research Institute

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Protocol Title:  
Diabetes To Go Inpatient 
 
Funding Mechanism:  
NIH PAR-15-158  Planning Grants for Pragmatic Research in Healthcare Settings to 
Improve Diabetes and Obesity Prevention and Care (R34) 
 
Principal Investigator: 
Michelle Magee, MD 
 
Co-Investigators: 
Joan Bardsley, MBA, BSN, RN, CDE, FAADE 
David Brennan, MBE 
Patricia McCartney, RN, PhD 
Mihriye Mete, PhD 
Kelly Smith, PhD 
 
 
Institution(s): 
MedStar Health Diabetes, Research & Innovation Institutes 
MedStar Washington Hospital Center  
1-18-2016 

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 TABLE OF CONTENTS 
Page 
 
Cover page……………………………………………………………………….....Error! 
Bookmark not defined. 
Table of contents……………………………………………………………………2 
 
      Signature page………………………………………………………………..........3 
List of abbreviations……………………………………………………………….. 4 
 
 
Back ground / Scientific Ratioanale ………………………………………………5  
Objectives…………………………………………………………………………....9 
Expected risks/ benefits…………………………………………………………...10 
Eligibilty……………………………………………………………………………..10  
Subject Enrollment…………………………………………………………………11 
Study Design and Procedures……………………………………………………12 
Data Collection and Management Procedures…………………………………24 
Statistical Consierationa and Data Analysis…………………………………….25 
Quality Control and Quality Assurance………………………………………….27 
Regulatory Requirements…………………………………………………………27 
 
 .....Informed consent…………………………………………………………….27 
 
 .... Subject confidnentiality ……………………………………………………..28 
 
Unanticapted Problems……………………………………………………..28 
 
    References ………………………………………………………………………….29 
 
 
 
 
 

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SIGNATURE PAGE 
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this study will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable US federal 
regulations and ICH guidelines. 
Site Investigator:* 
 
Signed: 
 
Date: 
 
 
Michelle Magee, MD 
Director MedStar Diabetes Institute  
 
 
 
* The protocol should be signed by the clinical site investigator who is responsible for 
the day to day study implementation at his/her specific clinical site.

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LIST OF ABBREVIATIONS 
A1C   
Hemoglobin A1C 
ADA  
American Diabetes Association 
 
 
BG  
 
Blood glucose   
CDE  
Certified Diabetes Educator    
D/C 
 
Discharge  
 
 
 
 
DM 
 
Diabetes mellitus 
DM2go 
Diabetes 2 Go    
DRNC  
Diabetes Resource Nurse Champion     
 
 
DSME  
Diabetes self-management education  
ED 
 
Emergency Department  
EMR  
Electronic Medical Record 
FSBG  
FingerStick Blood Glucose 
GLP-1  
Glucagon-like peptide   
GOCADAN 
A Genetic and Epidemiological Study of Cardiovascular Disease in Alaska Natives  
HF 
 
Human Factors 
IE 
 
Implementation Effectiveness 
IT 
 
Information Technology   
LOS  
Length of Stay 
MDI 
 
MedStar Diabetes Institute 
MHRI   
MedStar Health Research Institute   
MI2 
 
MedStar Institute for Innovation 
MMAS-8 
Modified Morisky Rx Adherence Score 8-item 
MWHC 
MedStar Washington Hospital Center 
NIH 
 
National Institute of Health  
PCT  
Patient Care Technicians 
PCP  
Primary Care Provider 
PRISM 
Practical, Robust Implementation and Sustainability Model 
REAIM          Reach, Efficacy, Adoption, Implementation, and Maintenance Framework. 
Red CAP 
Research Electronic Data Capture 
Rx 
 
Medication    
SANDS   
Stop Atherosclerosis in Native Diabetics Study  
 
 
 
 

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1 
BACKGROUND/SCIENTIFIC RATIONALE 
     The Research Problem – Hospitalizations and emergency department (ED) visits among patients 
with diabetes mellitus (DM) are key contributors to rising U.S. DM-related health care costs.1
 
 DM self-
management education (DSME) has been shown to reduce utilization of acute care services. 
Traditionally considered a suboptimal environment in which to provide education, the hospital may 
actually provide a unique opportunity to educate patients with DM. Recent studies suggest that 
inpatient DSME, improving communication of discharge instructions and involving patients in 
medication (Rx) reconciliation may reduce risk for early readmissions2, and improves outcomes.3,4,5 
The American Diabetes Association (ADA)6 and The Joint Commission7 delineate educational content 
to communicate to all DM patients before hospital discharge. 
Inpatient delivery of DSME per national guidelines presents a challenge to hospitals.6,8,9 
Hospital-based DM specialists -endocrinologists and DM educators- cannot reach all patients who 
need DSME. Methodology for delivery of learner-centered DSME to inpatients with DM at the 
bedside within existing workflow on nursing units is needed. This study will deploy pre-
implementation assessment methods and designs coupled with established implementation 
effectiveness (IE) evaluation frameworks to integrate delivery of DSME sustainably into ongoing 
hospital nursing unit processes for patient education and discharge planning. Evidence 
generated by this study will be used to support a future application for NIH R18 funding.  
 
     Importance of the Problem – Studies of patients hospitalized with poorly controlled DM report 
that readmissions occurred in <30 days in 14%, <180 in 32%,4 and that 17% were readmitted to the 
ED in <30 days.10 Readmissions can be partially attributed to deficits in DM knowledge and self-
management skills, including poor adherence to DM medications (Rxs). Hospitals face challenges in 
delivering education to all DM patients as recommended in national guidelines.6,8.9 Hospital-based 
DM specialists –endocrinologists and DM educators- cannot reach all patients who need DSME. 
Survival skills education, teaching topics essential for safe patient discharge, is recommended for 
inpatient DSME4. Despite some success, patient factors including Rxs non-adherence remain a 
critical barrier to improved outcomes even when education is provided. This suggests that a more 
holistic approach is required including personalized feedback to effectively integrate the patient into 
the chronic care continuum.11 Innovative providers are responding by implementing efforts to deliver 
DSME and discharge transition support to patients. Evidence-based sustainable tactics for 
offering learner-centered, knowledge-based DM education in hospitals to all patients with DM 
are needed.   
 
     Literature important to the study – The data summarized in the following section directly 
support the need for interventions such as Diabetes To Go. 
 
   The need for DM education. DSME, part of the chronic care and health promotion models, 
improves knowledge, self-care behaviors including Rx adherence,12 clinical indicators and health 
status and reduces healthcare utilization.4,7,13  Patients who receive inpatient DSME have a lower 
frequency of 30-day readmits than those who do not (11 vs 16%; p=0.0001).7 DSME is usually 
delivered outpatient 1:1 or via classes, allowing the patient to make informed decisions regarding 
daily self-care, yet many patients do not return to complete the full curriculum, and readmitted 
patients have been shown to have dramatically low knowledge.2  
                                            
 

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   The need for strategies to support improvement in Rx adherence. Patients are primarily 
responsible for safely and appropriately self-administering Rx regimens. 6 In a study of patients 
surveyed at discharge, only 28% were able to list all their Rxs, with only 37% being able to recount 
their purposes, and just 14% able to state their common side effects.14 To gain the benefits of drug 
therapy while minimizing adverse drug events, patients must: have a functional knowledge of Rxs 
and their proper dosaging; consolidate the regimen to an efficient daily schedule; problem-solve 
around regimen use as changes occur (e.g., sick days); and continue the behaviors over time. 
Studies have shown that patients have problems performing these tasks. This need is particularly 
important for those with DM, a complex chronic condition requiring long-term understanding of the 
timing, purpose, and side effects of multiple Rxs.15-19 Initiatives targeting improved knowledge of 
and adherence to Rxs prescribed at hospital discharge are needed.  
 
   The need for discharge care transition support. Illuri, Wallia, et al conducted a DM-specific 
Failure Modes Effects and Analysis, a risk assessment method used in high reliability industries. The 
analysis revealed that patient variability in both DM Rxs and education comprehension is a high risk 
barrier to improved care in the transition from inpatient to outpatient care. Of the 3 highest risks 
identified in this analysis, two are directly relevant to the present proposal: 1) variability in patient 
comprehension of DSME and DM Rxs (including use, effects and reconciliation); and 2) Rx discharge 
recommendation variability between providers9.  
 
   The need for methodology for hospital DSME delivery. Few, if any, clinical trials in the DM field 
have utilized robust pre-implementation assessment methods and designs coupled with established 
implementation effectiveness (IE) evaluation frameworks to help inform and assess implementation 
practices. This project will help overcome these deficiencies by 1) applying the principles of 
implementation science (IS) and human factors (HF) engineering9,20-25 and 2) utilizing mixed methods 
to design the intervention, workflow processes and plan the intervention to be sustainable within 
existing care delivery models. Information technology (IT) tools are increasingly being leveraged as a 
method to deliver content at the bedside and provide support for care transitions from hospital to 
home.26 An IT platform for delivery of messaging content is used in the hospital in this study.   
 
Prior experience and/or history relevant to the research -  
 
   This proposal seeks to build on our transdisciplinary investigators’ prior work and examine 
ways to optimize DSME, skills training and discharge transition support integration within 
nursing unit workflow. This planning grant, will address concerns of the NIDDK Special Emphasis 
Panel on Pragmatic Research and Natural Experiments Reviewers provided in response to a PAR 
13-366 R18 proposal submitted by our group (eRA Commons IR18DK108109-01; Grant11851018; 
reviewed 05-06-2015). Here, we will examine the feasibility of integrating a diabetes survival skills 
self-management education program ( Diabetes To Go) within nursing unit workflow, assess 
potential ‘burden’ on staff, align nursing and patient time for intervention delivery, and assess nursing 
unit staff, hospital leadership and patient acceptance of the intervention.  
 
The study team, led by Dr. Michelle Magee, PI, reported pilot study results for Diabetes To Go in 
which a learner-centered survival skills DSME program was offered to 125 hospitalized patients with 
uncontrolled type 2 DM (mean age 58+13 yrs; 66% female; 89% Black). While 70% had had prior DM 
education, only about half reported education within 2-5 years. Deficits identified on a pre-test 
(KNOW Diabetes) auto-directed the patient to video education content (view content examples at- 
http://vimeopro.com/sitelvideo/diabetes - password diabetes). Study team research assistants spent 
30-60 min in 5-10 min time blocks per patient for intervention delivery. DM knowledge improved, with 

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61% answering >5 questions correctly at baseline and 89% at post-test (P<0.0001). Odds of being 
recognized as highly adherent (Modified Morisky Rx Adherence 4-item Score©) were 1.28 times 
higher at 2 wks (p<0.0001) and 1.36 times higher at 3 month  post-discharge (p=0.0002) compared to 
baseline. Hospital and ED readmissions, although not powered sufficiently for statistical testing, 
showed encouraging results, with a decrease from 14% to 5% (P=0.0588).4 The Diabetes To Go pilot 
showed the feasibility and preliminary efficacy of delivering DSME at the bedside. This content and 
delivery model will be optimized and further developed for provision of education in this proposed pilot 
intervention.  
 
The MedStar team has extensive experience in focused DSME delivery in additional settings, 
including the ED and the community which have also generated support for such an approach and 
which was used to inform Diabetes To Go education content. The Synergy To Enable Control 
Program for Adults with type 2 DM study generated evidence that ED visits made by adults with 
DM and hyperglycemia can be used to initiate a 4-wk intervention with titration of DM Rxs and 
survival skills DSME. Among 101 participants (96% Black; 54% female; and 62.3% 
Medicaid/Medicare insurance) learner-centered survival skills DSME initiated in the ED significantly 
increased knowledge and few patients required meter and insulin shot instruction at follow-up, 
indicating skills retention. Modified Morisky Rx adherence score© improved from low to medium 
(p<0.001), a clinically meaningful improvement.27.28 The ABCs of Diabetes placed a DSME program 
in a public library. Two small-group interactive DSME classes improved DM knowledge. Significant 
clinical outcomes included reduction in self-reported ED visits and in mean A1C.5 These data support 
the contention that concise, focused DSME, as will be provided in this study, can improve DM 
outcomes among high-risk adults with type 2 DM.  
 
MWHC has an established DM resource nurse champion (DRNC) program. Nurses interested in 
developing DM expertise are provided 1 hour a month to attend continuing education meetings at 
which a DM topic is presented and DM-related issues arising on units discussed. This group 
participated as a Diabetes To Go Advisory Board for the purpose of this grant submission. The 
proposed program was overviewed and the DRNCs were given the opportunity to ask questions and 
to provide input and preliminary suggestions on program design, perceived strengths and 
weaknesses and identification of processes to enable program success. Two areas for consideration 
in program development were identified. The first was in-/exclusion- criteria: Will Spanish speaking, 
low literacy patients, Psychiatry inpatients and/or ED patients be included? The second area was 
program design: It was suggested that the technology platform generate a report of survey results for 
each patient so the staff nurse can see in which areas education should be focused; Concern was 
expressed that iPads would be taken if not tethered and that attaching the iPad to a rolling pole would 
prevent theft; It was noted that it will be important to determine which patients are also seen by the 
hospital diabetes educators as a confounding variable of study outcomes. These 
observations/findings were considered in the present study design. This DRNC group will participate 
in the Advisory group for the R34 study. 
 
In addition to the DM related research, the study team has significant experience in conducting 
pragmatic health services research in telehealth, patient safety, 29-31 and quality health improvement 
for patients with cardiovascular disease32-38.  Dr Kelly Smith has experience in mixed methods and 
ethnographic approaches to examining how to integrate programs and processes into existing 
hospital workflow. Specific experiences include integrating and optimizing cardiovascular surgical 
approaches to off-pump surgery34, examining effectiveness of oxygenators39, and optimizing surgical 
care for elderly patients .33,40 In her current AHRQ funded study called We Want to Know, Dr. Smith 
is partnering with hospital leadership and nursing staff to actively engage hospitalized patients to 

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report potential patient safety events. Detailed interviews, field observations, and focus groups with 
patients, providers, and leaders in 9 units have been conducted to establish a sustainable process for 
program integration into standard hospital processes prior to launching the program system-wide. We 
Want to Know is included in the MedStar Health system FY16 annual operating plan. Another 
example of pragmatic work is Dr. Smith’s AHRQ funded contract to implement, evaluate, and spread 
a medical liability and communication resolution toolkit called CANDOR. This work is ongoing and 
has also been approved as part of the FY16 operating plan. Program education and training of 
system leadership and local hospital leaders has been completed. Processes have been established 
and are currently in field testing. System-wide launch began in July 2015 and will be implemented 
throughout all hospitals within MedStar Health by January 2016. These experiences will support 
successful completion of the Diabetes To Go R34 planning study. 
 
Our transdisciplinary team of investigators has a full range of complementary expertise which will 
enable successful conduct of this study. Michelle Magee, MD, PI, is an endocrinologist and 
dedicated DM health services researcher. NIH funding for this study would represent the next step 
in moving her work forward as an independent investigator.  She has experience in the conduct of 
major NIH clinical and Pharma trials with MHRI and her own research has focused on strategies to 
improve delivery of DSME and evidence-based diabetes care, including Diabetes To Go.  
 
Kelly Smith, PhD, Co-I, is a cardiovascular physiologist and health services researcher. As 
Scientific Director for Healthcare Quality and Patient Safety Research at MHRI, she is committed to 
advancing care through applying mixed methods and IS frameworks to engage stakeholders in the 
development of innovations to improve health. She has experience in ethnography, field testing and 
leading practice improvements for quality and safety. Dr. Smith currently leads three AHRQ-funded 
studies that employ similar methodologies as proposed in this study to advance patient 
engagement in patient safety efforts (We Want to Know) and transform practice response to patient 
harm events (CANDOR). She is also leading a contract for AHRQ to develop, evaluation and 
disseminate a guide to improving patient safety in primary care settings through patient and family 
engagement. In addition to her roles as a PI, Dr. Smith is a Co-Investigator within the biostatistics, 
epidemiology, research and development (BERD) core of the CTSA. In her role with the CTSA, she 
serves as the lead health services researcher guiding new and existing investigators in 
development activities for implementation and systems delivery sciences.  
 
Pat McCartney, RN, MSN, PhD is Director of Nursing Research with the MWHC Department of 
Nursing, Quality, Safety and Education. She will bring her academic and practice background to the 
study to enable bridging of research and practice perspectives and collaboration between the study 
team, nursing leadership and unit staff.  
 
Joan Bardsley, MBA, BSN, RN, CDE RN, FAADE is a distinguished diabetes educator whose 
experience includes direct DSME, professional education for multidisciplinary teams, advocacy for  
access to and reimbursement for DSME, clinical trial management and executive administration with 
MHRI. She is a member of the Chief Nurse Officer Council of MedStar Health and is also a past-
President of the American Association of Diabetes Educators.  
 
Mihriye Mete, PhD is a senior statistician and Biostatistics Manager for MHRI. She has extensive 
experience with research design and data analysis. She is an experienced researcher who has 
contributed to 3 major NIH funded longitudinal studies (Strong Heart, SANDS and GOCADAN). Drs 
Mete and Magee have previously collaborated on the ADA Core Research Award STEP-DM study27. 

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Dr Mete worked with Drs Magee and Smith in the design of the present proposal and developed the 
statistical analysis plan which she will conduct when the study is completed.  
 
David Brennan, MBE is MI2 Director of Telehealth. With an extensive background in technology 
development, project management, applied health services research, and clinical program 
development, he will lead user-centered design tasks related to updating and refining the Diabetes To 
Go content and managing usability testing.  
2. OBJECTIVES 
We seek to determine the feasibility of integrating the Diabetes To Go program sustainably 
into ongoing hospital nursing unit processes for patient education and discharge planning. If 
successful, preliminary data generated will be used to develop a randomized controlled trial 
which will further assess program outcomes, including clinical and economic measures and 
potential for widespread dissemination. 
 
The objectives of the present R34 Diabetes To Go Inpatient proposal are to refine the Diabetes To 
Go program content based on user feedback and experience, as well as to design and develop 
processes to enhance the feasibility of integrated implementation within usual nursing unit workflow 
within a large health system. A mixed-methods approach is used to leverage implementation science 
frameworks and human factors principles to make DM survival skills education and discharge support 
more accessible, interactive and engaging for patients. The long-term goal of this research is to 
optimize scalable and sustainable solutions for DSME and for DM-related discharge support. This 
personalized approach leverages e-health technologies to pursue the following Specific Aims: 
 
 Aim 1: To refine and optimize the Diabetes To Go program content and implementation 
processes. 
  
This will be achieved by applying user-centered interface design principles, content development in 
partnership with patients and providers, detailed process mapping for program integration into 
existing processes and workflow, and integrating mobile and e-health technology to support care 
transitions. The Practical, Robust, Implementation and Sustainability Model will guide implementation 
planning and evaluation.  
    
   Hypothesis 1.  Diabetes To Go: will be optimized for patient and provider usability and integration 
into nursing unit workflow; will enhance patient self-care knowledge and skills; and will support the 
discharge transition process.  
 
Aim 2:  To conduct iterative rapid-cycle usability testing of the enhanced Diabetes To Go 
program content and processes and establish a Diabetes To Go program toolkit for 
widespread implementation. 
   
This will be achieved by a series of intervention-evaluation cycles of field testing, refinement, retesting 
of the Diabetes To Go program and evaluation through: direct observation; patient, provider and 
system leadership stakeholder interviews and focus groups; and evaluation of changes in early 
patient outcomes.  
    
   Hypothesis 2.  The Diabetes To Go program will be perceived favorably by stakeholders yielding a 
high-quality toolkit for implementation and delivery of the program for further evaluation and testing.   

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Preliminary data gathered during this study will be used to design an R18 pragmatic trial in response 
to PAR 15-157 which will examine outcomes of implementation of the Diabetes To Go program when 
delivered on hospital nursing units to adult patients with diabetes across hospitals and health 
systems. The model has the potential to cause a paradigm shift in sustainable and generalizable 
approaches for delivery of patient-centered education and medication adherence and discharge 
transition support in the hospital 
 
3 
EXPECTED RISKS/BENEFITS 
If successful, Diabetes to Go has the potential to benefit patients and the health care delivery 
systems within which they receive care by causing a paradigm shift in sustainable and generalizable 
approaches for delivery of patient-centered education and discharge transition support. We expect 
that enhanced delivery of education, targeted to the patient’s individual learning needs, will lead to 
enhanced understanding of the need for and adherence to medications to control their diabetes and 
other comorbid conditions. Preliminary data gathered during this study will be used to design an R18 
pragmatic trial in response to PAR 15-157 which will examine outcomes of implementation of the 
Diabetes To Go program when delivered on hospital nursing units to adult patients with diabetes 
across hospitals and health systems. In the future the learnings from this study may benefit nursing 
staff, hospitals and patients. Nursing unit staff and hospitals may benefit from the system developed if 
it is effectively integrated into workflow processes and discharge care to support delivery of DSME at 
the bedside with minimal disruption of unit workflow. Benefits to patients in terms of knowledge 
conveyed and potential clinical impact of the Diabetes To Go Inpatient intervention will be determined 
in future studies. 
 
We believe that this study will expose nursing unit staff and patients to “Minimal risk”.  The probability 
and magnitude of harm or discomfort anticipated in this research are not greater in and of themselves 
than those ordinarily encountered in daily nursing unit life or during the performance of routine 
physical or psychological examinations or tests.  No blood is being drawn.  All staff and patient level 
data, including focus group, 1:1 interview and satisfaction data, as well as technology usage and 
usability data will be de-identified. For staff and patient interviews, we will be seeking a waiver of 
documentation of informed consent as the only document linking the individual to the study outcomes 
would be the consent document itself. All data will be coded and de-identified. Data will also be 
presented only in aggregate form, further limiting the risks of loss of confidentiality and breach of 
privacy.  
   
4.  ELIGIBILITY 
Study population & sources - 
The participants will vary based upon the phase of the study.  
 
Phase 1. Workflow Assessment and Processes Intervention Design  
• A purposive sample of 10-14 nurses and patient care technicians (PCTs) on 4 non-critical care 
adult medicine nursing units, including 1 psychiatry unit 

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• 
A group of 4 patient end-users will be engaged in usability testing. In addition to the inclusion and 
exclusion criteria outlined below under Phase 2 that represent the target audience for the Diabetes To 
Go platform, the following additional criteria for inclusion will also be used: 
o Speak, read, write English 
o Inpatient admission to a MedStar hospital within the prior 12-18 months 
o Experience with the Diabetes To Go program and/or DSME 
 
Phase 2.  Pilot intervention.  
• All unit staff will participate in the education delivery program which will be introduced as a unit 
Quality Improvement initiative.   
• Staff may opt-out of participation in the interview activities without consequences. 
• ALL patients on the 4 units who have a diagnosis of DM will be offered the program to 
minimize workflow disruption and enhance operational sustainability.  
 
Inclusion and exclusion criteria – These criteria have intentionally been kept broad to minimize 
disruption to unit workflow and to increase generalizability of findings.  Where appropriate, the 
justification for each criteria is also presented, eg exclusion of minors. 
 
   Inclusion Criteria--Age > 18 yrs (lower limit of age for admission to MWHC adult units; all of the 
Diabetes To Go content is designed for adult learners); English speaking (Diabetes To Go content is 
currently only available in English); a diagnosis of diabetes mellitus (ICD9 250.xx/ICD-10-CM E08-
E11) documented in the EMR; admitted to one of the inpatient units (non-critical care adult medicine 
nursing units, including 1 psychiatry unit) where the study is being conducted; willing and able to 
participate in the program.  
 
   Exclusion criteria: Age < 18 years (MWHC does not admit minors to its Medicine units and 
Diabetes To Go content has been prepared for adult learners); Pregnancy or anticipated conception 
within 3 mos (Diabetes To Go content does not address gestational diabetes or diabetes in 
pregnancy where management and glycemic targets differ considerably from those for non-pregnant 
adults ); admission to an intensive-care unit, diabetic ketoacidosis, hyperglycemic hyperosmolar state 
– conditions in which the acuity level would likely preclude participation in DSME; patient declines 
participation in the education program for any reason; and any medical condition or cognitive 
dysfunction that, in the opinion of unit staff, would preclude participation in the education program. 
5 
SUBJECT ENROLLMENT 
Phase 1. Workflow Assessment and Processes Intervention Design.  
 
Drs. Magee, McCartney and Smith will present the Diabetes To Go research project at a nursing 
leadership meeting. Dr. McCartney and Dr. Smith will work with unit nursing leaders to identify 
individuals who may serve as key informants. They will request permission to present the Phase 1 
study objectives to the frontline nurses during standing team meetings and/or during team huddles on 
the unit. A recruitment flyer with information about the study and about how to participate in the 
platform usability testing will be made available to each nurse and nurse manager. Individuals who 
agree to participate as key informants will go through the informed consent process at the time of the 
usability testing and be given an information sheet for their records. A waiver of documentation of 
informed consent will be applied for as it will be the only document linking the staff member to the 
project outcomes. 
 

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Dr. McCartney and Dr. Smith will work with the nursing leaders to identify optimal dates/times to 
observe current rounding practices for diabetes education in order to map processes for the pilot 
intervention. Individuals (nurses, patient care technicians, and diabetes educators) will be shadowed 
by one of the project coordinators/human factors specialists. Identification of the individual shadowed 
will be withheld from documentation and the output of the process mapping and field observations will 
be presented in aggregate as flow diagrams and thematic representations of current and optimal 
workflow.  
 
Phase 2.  Pilot Intervention 
 
A Diabetes To Go Inpatient Program informed consent will be provided to each patient admitted to 
the participating units who has a DM diagnosis.   
 
The study team will inform the DRNC (or alternate designated staff member) via an ongoing 
electronic screening list of unit patients who have DM.  All DM patients admitted to the unit will be 
considered for program participation by unit staff.  Staff will assess ability to participate in the program 
(see Patient Screening Checklist) and if appropriate will offer each patient the program. At the time 
the program is offered to each patient, nursing unit staff will answer any questions that the patient 
may have about Diabetes To Go. Patients who agree to participate will then be asked to provide 
informed consent and when they have done so, will be enrolled in the program. 
 
Reasons for exclusion from the offering (screen failures) will be recorded in the study database by the 
study team from the screening checklists. Patients who decline participation in the program will be 
also be considered as screen failures.  The reason(s) for declining participation will be captured.  
6 
STUDY DESIGN AND PROCEDURES 
An overview of the research design is shown (Figure 1). The 
work will be conducted over 2 years in 3 phases. The study 
timeline and major activities by phase are shown in Table 1. 
Phase 1 will be dedicated to Workflow Assessment and 
Intervention Design (1 yr) and geared to accomplish activities to 
support Specific Aim 1. Phase 2 of the study will focus on 
achieving Specific Aim 2 by conducting a series of iterative 
pilots and revisions of the Diabetes To Go program and 
processes (9mos) designed in Phase 1. Phase 3 will be 
dedicated to analysis and reporting of results and setting up a 
large pragmatic trial (3mos). Work plans for each phase are 
detailed below in Table 1.     
 
 
 
 
Table 1. Timeline & Major Activities 
Year 1 
Year 2 
Quarter 
Phase 1: Workflow Assessment and Diabetes To Go Program and Processes Intervention 
Design 
a. 
IRB approvals 
b. 
Workflow and initial PRISM elements assessment  
Figure 3. 
Overview of Research Design 
 
Phase 1
•Baseline Workflow 
Assessment
•Implementation Design
Phase 2
•Prospective pilot 
implementation trial
• Implementation effectiveness
• Assessment of sustainability     
potential
Phase 3 •Analysis & Reporting of results
Figure 1. 

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c. 
IT platform usability assessment & refinement 
d. 
Implementation design 
e. 
Groundwork for pilot 
Phase 2: Prospective Pilot Implementation Trial 
a. 
Pilot intervention  
b. 
Implementation Effectiveness Evaluation 
Phase 3: Analysis and Reporting of Findings 
a. 
Finalize data set 
b. 
Analysis 
c. 
Reporting of findings1 
1 Findings will be reported following completion of phase 1 and following conclusion of the study.  
 
The Diabetes To Go conceptual model is shown in Figure 2. Individualized learner-centered 
education addresses patient’s DM self-care 
management knowledge and skills deficits 
and discharge transition support. Knowledge 
of DM medications (Rxs) prescribed at 
hospital discharge, access to those 
medications and communication with the 
Primary Care Provider (PCP) to assure 
continuity of care will be emphasized. If 
successful, preliminary evidence generated 
by this R34 will serve to inform the design, 
methods and measures to support a full 
scale pragmatic trial (PAR- 15-157). This 
prospective pilot study will examine 
strategies to optimize an inpatient DSME, 
skill building and technology-assisted 
discharge care transition program 
delivered at the bedside by existing staff 
on nursing units. Intervention design will be informed by mixed methods using human factors 
principles and implementation science approaches to optimize unit integration.   
 
Phase 1 Project – Design Diabetes To Go Program & Processes 
 
Aim 1: To refine and optimize the Diabetes To Go program content and implementation 
processes. This will be achieved by applying user-centered interface design principles, content 
development in partnership with patients and providers, detailed process mapping for program 
integration into existing processes and workflow, and integrating mobile and e-health technology to 
support care transitions. The PRISM will guide stakeholder engagement, implementation planning 
and evaluation. Hypothesis 1- The Diabetes To Go program: will be optimized for patient and 
provider usability and integration into nursing unit workflow; will enhance patient self-care knowledge 
and skills; and will support the discharge transition process.  
 
E1a. Baseline Workflow and Initial PRISM Elements Assessment. The MHRI Implementation 
Science team will collaborate with the MedStar Diabetes Institute (MDI) clinical research team and 
MWHC Nursing to perform an ethnographic study examining workflow of identified staff engaged in 
DSME and discharge planning to develop a process map for integrating Diabetes To Go into day-to-
day practice. A purposive sample of nurses and patient care technicians (PCTs) (n=10-14) will be 
observed for 6- or 10-hr blocks on 4 non-critical care adult medicine nursing units, including 1 
Diabetes To Go Conceptual Model
Diabetes to Go
Intervention
DM PATIENT 
Survival skills self-
management 
education;
Pre-discharge 
medication 
reconciliation & 
ascertain access 
to DM Rxs;
Talk to Your 
Doctor
PROVIDER
Hospital:  
DM Rxs
Medical Home: 
Ongoing
DM care
Innovative, Evidence-based
BEST PRACTICES
Generalizable; Sustainable
Optimal 
HEALTH OUTCOMES: 
ED & Hospital Readmissions;
Glycemic control;
Self-care behaviors, including 
medication adherence;
Resources Utilization.
Adapted from the 
Chronic Care Model 
(Wagner).
Figure 2.

 ____________________________________________________________________________________________ 
14 
psychiatry unit, resulting in a total of 280 hrs of observational data. The sample size is consistent with 
other observational studies of nursing care.41, 42 The time blocks were chosen to avoid shift turnovers, 
when no education will be taking place and will be varied so that all days of the week and  
shifts will be covered. Semi-structured interviews with 
 nurses and PCTs will be conducted to solicit perceptions 
of how intervention integration could be optimized. 
Participatory action methods will be employed to 
iteratively identify common themes and validate the 
themes and process maps that are developed with 
relevant nursing staff and leaders and hospital 
leadership.43-49  
   Participatory action research is an iterative 
process that seeks to understand and improve the 
problem and reduce deficiencies through involving 
the recipients (stakeholders) of the intervention in 
the process of development who, in turn, take 
actions to improve the system. Figure 3 depicts the 
iterative cycle of data collection, information synthesis 
and analysis, feedback and refining of assumptions, 
synthesis and prioritization, and output validation, prioritization and group consensus. The process 
continues until researchers and stakeholders comes to consensus. This is a rapid process, quickly 
moving from base knowledge to group consensus. It can also be used iteratively. Field observations 
will be recorded and time-stamped to document and code each staff task performed and time spent 
on the task in the patient room. Data on key characteristics of each task will be collected, such as 
whether the task is an interaction with the patient that is cognitive or physical or both, is required or 
optional, and whether the task is interrupted. Descriptive statistics will be calculated to determine the 
total staff time spent in the room, and the nature and duration of the tasks performed there. Initial key 
informant interviews will be conducted 1:1 with patients, with physician providers (inpatient and 
primary care providers) and with nursing and hospital leadership. Initial PRISM elements will be 
assessed.Dr. Smith and her team have experience in applying these methods in support of hospital 
practice transformation. 
   User-Centered Development and Usability Testing of the Tablet-Based Learning Platform. 
The MedStar Institute for Innovation (MI2) team, under the direction of Dave Brennan, MBE, will plan 
and carry out the user-centered design of two additional Diabetes To Go modules.  How to Talk to 
Your Doctor (adapted from the AHRQ, NIH Office of Research in Minority Health endorsed Baylor 
College of Medicine “How to Talk to Your Doctor” (and get your doctor to talk to you!) program 
content 50.) will focus on strategies for enhancing patient-provider-communication and generate take-
home printed handouts patients can use during post-discharge PCP visits to generate discussions 
around DM targets and the importance of appropriate medication choices. The DM-related skills 
management module will guide patients through insulin (vial and syringe or pen) and GLP-1 analog 
shot self-administration instructions and through the technique of performing fingerstick self-blood 
glucose monitoring.  Each module will consist of a mix of content format and type (images, videos, 
animation –eg for role modeling for patient-provider communication- and text) developed in-house or 
from external industry partners. MedStar’s e-Visit platform will also be integrated into the post-
discharge support process for patient and provider use and its’ uptake/adoption assessed. 
     A user-centered design approach will be employed during development of both the new modules 
as well as revisions to the entire tablet-based learning platform, which will be built using MedStar 
Health’s existing patient engagement and data collection engine, Tonic Health 
(https://tonicforhealth.com/).  MI2 Human Factors and Medical Usability specialists 
Process 
Stakeholders Inform 
& Investigators 
Collect Data 
Researchers 
Compile & 
Synthesize 
Stakeholders & 
Researchers Reflect 
on Output 
Researchers 
Synthesize feedback 
& prioritize output 
Validate Output, 
Gain Group 
Consensus, 
Prioritize Problems 
Figure 3                
Participatory Action 

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15 
(http://medicalhumanfactors.net/) will provide heuristic review of initial designs and conduct 3 
sequences of rapid-cycle usability testing, each with 4 patient end-users (a sample size which has 
been cited as being adequate to identify 80% of usability problems with a system51). Results from 
each cycle will be used to drive iterative improvements in design and to study the program processes. 
During usability testing, participants will be asked to complete an entire education session from 
registration through follow-up survey. To support the Research Data Collection needs of the study, 
the MI2 Team will code the required data collection instruments in the REDCap (Research 
Electronic Data Capture) web-based research data system.51 MedStar is a partner in the REDCap 
Consortium and this study will leverage an existing operational best practices for secure data 
access/storage and system-wide training. 
    
Implementation Design/Planning 
 
Implementation design and the pilot protocol will be informed by the workflow assessment and 
initial PRISM elements evaluation; Analysis of observational and key informant interview data, 
and resource nurse focus group data will provide insight into implementation barriers and 
strategies to overcome them to assure integration of the intervention with minimal workflow 
impact. PRISM will enhance the translation of research into practice52 by guiding Phase 1 
implementation planning and Phase 2 evaluation in support of Specific Aim 1 – Optimization of 
intervention design. The PRISM elements addressed during planning and throughout the trial are 
shown on Table 2. 
   Phase I activities aim to identify barriers and facilitators of intervention success across 
organizational, patient, and environmental (internal and external) stakeholders. Representatives from 
each group will be interviewed (semi-structured interviews/focus group). Data on barriers and 
facilitators will be validated with the 
stakeholders using a participatory action methods approach. Phase 2 approaches are detailed in the 
Implementation Effectiveness Evaluation section below. 
  Early identification and evaluation of barriers and facilitators of implementation will allow for creative 
solutions to be embedded into the study protocol prior to clinical implementation, thus, creating an 
innovative, sustainable program for patients and clinical stakeholders. 
 
 
Table 2.    PRISM Framework for planning and evaluation 
PRISM element 
Characteristics 
Operationalization 
Intervention/Program 
Organizational 
Perspective 
Organizational readiness; evidence 
strength; frontline staff barriers; 
coordination across depts; burden 
(complexity & costs); Usability & 
adaptability; trialability & reversibility; ability 
to observe results 
Engagement of clinical leadership (Nursing; 
Nursing Research; MD leadership & providers) 
and unit staff (nurses, PCTs) in all processes of 
protocol and intervention development and 
refinement; satisfaction 
Patient  
Perspective 
Patient-centeredness; addresses patient 
barriers; seamlessness of transitions 
between program elements; service and 
access; burden (complexity and costs); 
feedback of results 
Patient (from prior hospitalizations) and family 
advisory group engaged in all processes of 
protocol & intervention development & 
refinement; identify barriers & facilitators; study 
patient interviews with IE team. 
External  
Environment 
Payer satisfaction; competition; regulatory 
environment; reimbursement; community 
resources 
Engagement of regulatory compliance, payer, & 
other key environmental stakeholders to support 
IE.  
Implementation & 
Sustainability 
Infrastructure 
Performance data; dedicated team; 
adopter training & support; relationship & 
communication with adopters; adaptable 
Enhance adaptability via early & ongoing 
stakeholder engagement, design & 
development, including human factors/systems 

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16 
protocol & procedures; facilitate sharing 
best practices; plan for sustainability 
engineering integration implementation 
assessment; iterative evaluation of 
barriers/facilitators  
Recipients 
Organizational 
Characteristics 
Organizational health and culture; 
management support and communication; 
shared goals and cooperation; clinical 
leadership; systems and training; data and 
decision support; staffing and incentives; 
expectation of sustainability 
Patient & nursing staff advisory groups  and 
clinical leadership engaged throughout 
processes of pilot protocol & intervention 
development & refinement; clear expectation 
setting; leverage existing resources to foster 
sustainability within nursing units 
Patient 
Characteristics 
Demographics; disease burden; competing 
demands; knowledge and beliefs 
Early patient engagement in process; sensitive 
to local & individual cultures; readiness to 
change; satisfaction; pilot focus groups to 
identify barriers/facilitators of IE.  
 
The MWHC Chief Nursing and Medical Officers and the MedStar Health Executive Medical Officer 
have expressed support for the study (See Letters of Support).  These leadership stakeholders will be 
engaged for the provision of Administration input throughout the study as Key Informants. 
 
  Phase 2 Project – Iterative Pilot Testing 
 
Aim 2:  To conduct iterative rapid-cycle usability testing of the enhanced Diabetes To Go 
program content and processes and establish a Diabetes To Go program toolkit for 
widespread implementation. 
  This will be achieved by a series of intervention-evaluation cycles of field testing, refinement, 
retesting of the Diabetes To Go program and evaluation through direct observation, stakeholder 
(patient, provider, system leadership) interviews and focus groups, and evaluation of changes in early 
patient outcomes. This will enable demonstration of uptake and adoption of the program by unit staff 
and by patients. Hypothesis 2- Diabetes To Go will be perceived favorably by patients, providers, 
and health system leaders yielding a high-quality toolkit for implementation and delivery of the 
program for further evaluation and testing.   
  
Pilot Implementation (9 months). Phase 2 activities will enable accomplishment of Specific Aim 2.  
Diabetes To Go will be piloted in 4 units as a Quality Improvement initiative. All methods described 
in this section are subject to revision per baseline workflow and PRISM assessments and the 
optimized study design developed by the team based on those findings. The program will be offered 
by staff to ALL patients on the unit with DM to minimize workflow disruption and enhance operational 
sustainability. A series of iterative implement-observe-refine cycles will be conducted during the 
Phase 2 to assess process, workflow and patient receptivity to the program.  This will provide 
opportunities to make rapid-cycle improvements.  Details of the pilot study work plan are provided 
below.   
   
Study Participants.  Table 3 outlines characteristics of the proposed study participants. 
 
Table 3.   Study Participant Characteristics. 
Participant 
Description/Characteristics 
Unit Staff 
All unit staff will participate in the program.   Staff will be invited to participate in focus groups and 1:1 
interviews.  Staff may opt-out of participation in the interview activities without consequences.  
Patients 
All adults admitted to the target units with a diagnosis of DM will be identified daily via the hospital’s 
electronic data repositories. All DM patients will be offered the program by unit staff.  Inclusion and 
exclusion criteria have been intentionally kept broad to minimize disruption to unit workflow and to 
increase generalizability.  Inclusion Criteria--Age > 18 yrs (lower limit of age for admission to MWHC 
adult units); English speaking; and diabetes mellitus (ICD9 250.xx/ICD-10-CM E08-E11); Exclusion 

 ____________________________________________________________________________________________ 
17 
criteria: Pregnancy or anticipated conception within 3 mos, admission to an intensive-care unit, diabetic 
ketoacidosis, hyperglycemic hyperosmolar state, patient declines participation, and any medical 
condition or cognitive dysfunction that, in the opinion of unit staff, would preclude participation. 
 
 
  Pilot Study Timeline & Events.  The proposed schedule of visits and events are shown on Table 4. 
 
 
  Outcomes – Proposed Outcomes for the pilot trial are provided on Table 5. 
 
Table 5-PIlot 
Outcomes  
Outcomes 
Measures 
Data Source(s) 
PATIENT 
Knowledge  & Skills 
Acquisition 
DM knowledge and 
skills 
DM knowledge test score 
KNOW Diabetes Survey 
Behavioral  
Rx adherence 
Morisky score; DM Rxs names, 
doses, timing, side effects, 
access, barriers 
MMAS-8© Survey; self-
report 
Table 4. Study 
Schedule 
Intervention Visits 
Follow-up visits 
 
Baseline 
Interim 
Pre-d/c 
2-5 d10 
30 d 
Baseline Data-- by study team 
Demographics 
x 
 
 
 
 
Clinical history & baseline 
data1 with admit DM Rxs2;  
x 
 
 
 
 
Admit & last pre-d/c glucose 
x 
 
x 
 
 
Discharge DM Rxs2 
 
 
x 
 
 
Diabetes To go Intervention - by existing nursing unit staff 
Surveys – KNOW Diabetes; 
Modified Morisky 8-item 
KDM; 
MMAS-8 
 
KDM 
 
MMAS-8 
item 
DM2Go content completed(%) 
x 
 
 
 
 
FSBG/shot competency3 
x 
Prn3 
Prn3 
 
 
D/C DM Rxs1 & access4 
x 
 
x 
x 
 
Report to PCP5 
 
 
x 
 
 
Talk to your Doctor 
questions6 
 
 
x 
x 
x 
Post-program – by study staff 
Patient satisfaction 
 
 
 
 
x 
Nurse/PCT satisfaction 
 
 
 
x  
Implementation costs7 
x 
Post-discharge patient telephone follow-up  
DM meds access & barriers8 
 
 
 
x10 
x 
Survey – Morisky 8-item 
 
 
 
 
x 
ED/hospital readmissions9 
 
 
 
 
x 
Missed days work/usual 
activities 
 
 
 
 
x 
Legend:  1 Clinical information to include DM type, co-morbid medical conditions; height, weight, BMI, education history, 
including prior DSME and skills instruction (timing and extent), access to Rxs, including co-pays; current laboratory results (Crs, 
AST, ALT, A1C if available in EMR. 3 FSBG/shot competency = fingerstick blood glucose monitoring technique/self-injection 
technique if applicable, repeated prn until competent; 4access=confirm DM Rxs on formulary &/or if pre-authorization 
required/obtained, can afford co-pay; 5Report to PCP=d/c DM Rxs, follow-up (f/u) DSME recommendation; 6 Talk to Your 
Doctor questions provided at time of d/c; 7implementation costs (staff time, supplies, hardware, software licenses); 8 f/u phone 
call=confirm Rxs filled, other barriers to taking meds;9emergency department ( ED) or hospital readmisions=self-reported 
ED/hospital readmissions since index admit –plus- augmented by local EMR/hospital data repository data as needed to 
minimize missing data to provide preliminary data for pragmatic study. 10TBD – who will do the 2-5 d rapid post-discharge f/u 
call (unit staff, hospital post-d/c call team or the study team). 

 ____________________________________________________________________________________________ 
18 
Healthcare 
resources utilization 
LOS**; Hospital 
based acute care 
visits 
LOS; ED/hospital readmissions 
Self-report augmented by 
EMR 
DM2go platform 
adoption 
Platform user 
uptake 
#, % modules viewed; time used; 
content skipped and/or replayed 
Tonic platform 
Satisfaction with 
Diabetes To Go 
program 
Expressed 
satisfaction 
Satisfaction with program & IT 
platform 
Survey; interviews; Tonic 
IT platform 
STAFF 
Satisfaction with 
DM2go program 
Expressed 
satisfaction 
Satisfaction with program & IT 
platform 
Survey; interviews 
Program adoption 
DM2go program 
uptake 
#, % DM patients offered program;   
#, % patients completing program 
Patients; Tonic IT platform 
COST ANALYSIS 
 
Implementation 
costs 
Staff time/effort; capital costs; IT 
effort 
Observation; interviews; 
costs for IT and education 
tools 
Legend:  DM2Go = Diabetes to Go intervention ** LOS will be collected to allow preliminary determination of the LOS 
correlation with time required for meaningful content delivery. 
 
 
General Methods.  
  Baseline Assessment: All participants on intervention units will undergo baseline assessment as 
shown in Table 4. After unit staff have provided the patient with program information about the 
program, the study team will obtain baseline data as shown on Table 4. Because this pilot study, by 
design, is not assessing lab clinical outcomes the study will not be conducting any study-provided 
laboratory tests.  
  Patient outcomes surveys. The KNOW Diabetes knowledge survey and the Modified Morisky53 Rx 
Adherence Survey 8-item (MMAS-8© with permission from D. Morisky) are delivered via the Tonic 
platform. Delivery oversight will be provided by the unit staff. The KNOW Diabetes survey was 
developed by MedStar for use with the STEP-DM and Diabetes To Go programs. Each knowledge 
question is linked to video content so that education addresses knowledge deficits directly via the 
platform when an incorrect response is entered.  
  Evaluation of Implementation Costs. Preliminary costs for program implementation will be 
collected by the study team and will include unit clinical staff effort/time accrued in program delivery 
and costs for technology, for licenses and for printed nurse and patient education tools.  
  Staff training. The DRNC will train staff via change of shift in-services. Each staff member will also 
take the knowledge pre-test, view the program education content and take the post-test. A web-based 
training module will be available so that staff may also complete the training online. A pocket version 
(print & tablet/smartphone app) of the education content will be provided. A CDE member of the study 
team will serve as the unit program liaison/champion. Unit in-services will address 1) Evidence-
including research, clinical & patient experience, local data/information; 2) Context-setting in which 
proposed change will be implemented; culture-how things are done at the site, values, beliefs, 
assumptions; leadership; evaluation,  effectiveness 3) Facilitation- including purpose, role and 
description of skills and attributes.  
 
 
 
 

 ____________________________________________________________________________________________ 
19 
                                                            
Pilot Intervention. An overview 
of intervention flow and key 
activities is provided in Figure 4. 
 
Education implementation. A 
CDE member of the study team 
will serve as the unit program 
liaison/champion. Unit in-services 
will address 1) Evidence-including 
research, clinical & patient 
experience, local data 2) Context-
setting in which proposed change 
will be implemented; culture-how 
things are done at the site, 
values, beliefs, assumptions; 
leadership; evaluation,  
effectiveness 3) Facilitation- 
including purpose, role and 
description of skills and attributes.  
   The study team will inform the DRNC (or alternate designated staff member) via an ongoing 
electronic list of unit patients who have DM.  Staff will assess ability to participate and if appropriate 
will offer them the program. Training in use of the technology until the patient feels comfortable with it 
will be provided. It is likely that most patients will use the tablet to complete surveys and access 
education content. The option to take the surveys on paper and to read the education content in the 
Diabetes To Go book will be available should a patient prefer the print modality. Using the methods 
agreed upon during the design phase, staff will encourage patients to progress through the program 
and provide an opportunity to ask questions when in the room.   
   Individualized education assignments are driven by the pre-test knowledge assessments. The 
patient takes the knowledge and MMAS-8 pre-tests via the Tonic platform. After the patient responds 
to each question, the program lets him/her know if the response was correct or not and gives the 
correct response as a first teaching point. At pre-test completion, the platform auto-directs the patient 
to each module corresponding to the areas in which a knowledge deficit existed. The unit staff 
member will be provided with a report card detailing the survey questions where deficits were 
identified so they can focus on these areas for subsequent education with the patient. Mandatory 
modules include those on each DM Rx which will be prescribed at discharge (including insulin or 
GLP-1 analog injection technique), when to call the doctor or go to the ED, and Talk To Your Doctor. 
DSME includes 7 core areas; 5 of these will be tailored for each patient based on knowledge deficits 
identified by the KNOW Diabetes survey: 1) know your DM numbers (sugar and A1C), 2) know when 
your blood sugar is low, 3) know when your blood sugar is high, 4) basic diet education, 5) self-
monitoring of BG. Rx adherence issues identified on the MMAS-8 will also be addressed. DSME will 
be delivered via brief video clips (3-5 minutes in length) via the tablet. When assigned content has 
been completed, the patient will take the post-test surveys. Each patient will be given a Diabetes To 
Go book with the same content delivered on the videos to use as a reference following discharge.     
   Discharge DM Rxs management and Arrangement for follow-up ‘virtual’ visits. Prior to 
discharge, unit staff will review the DM Rxs prescribed with the patient and flag the matching content 
in the Diabetes To Go book. Access to the Rxs will be assessed via the tablet/internet (http://drg-
fingertipformulary.com/) and/or the hospital EMR formulary database. If Rx access is an issue, staff 
will consult the provider writing the discharge Rxs to reconcile. When possible, a 30d supply of any 

 ____________________________________________________________________________________________ 
20 
 
•Implement 
•Observe 
•Refine 
Pilot 1 
•Implement 
•Observe 
•Refine 
Pilot 2 
•Implement 
•Observe 
•Refine 
Pilot 3 
Rxs newly prescribed or in need of resupply will be delivered to the bedside prior to discharge by the 
MWHC Pharmacy “Meds to Beds” program to facilitate access.  Staff will let patients know that they 
will be called 2-5 days post-discharge and will ask for preferred contact information and the best time 
to call/text/videochat.  We anticipate aligning these processes with current unit discharge medication 
management processes in order to minimize disruption to workflow. 
 
   Rapid cycle redesign and redeployment.  During the 
pilot, 2-3 implement-observation-revision cycles for the 
program and process will be conducted (Figure 5). The  
approach to observations and refinement are detailed in 
section 1a-c. Each iteration will take approximately 2-3 
mos to complete. The final Diabetes To Go Toolkit 
deliverable will be refined and revised based on user 
feedback at the end of the 3rd pilot. Stakeholders will be 
interviewed for user experience feedback. Process will 
be directly observed for > 3 days on each unit/iteration to collect implementation process information 
and feedback. Recruitment and retention approaches are detailed in table 5 below. 
 
Table 5. Recruitment and Retention Strategies 
Subject 
Description 
Unit Staff 
The main key to unit staff retention will be design optimization so it does not negatively affect workflow. 
Engaging unit staff and Nursing Leadership in study design will enhance program engagement. Staff will 
be invited to provide feedback to the study team during the intervention phase so that issues may be 
addressed. DRNCs will be enabled to have a specialized expertise in DM that will support nursing ladder 
advancement. Light food and beverages will be offered during staff advisory group meetings, during in-
services and during training to help minimize time spent off the units/ non-productive time.  
Patients 
A stipend in the form of gift cards will be offered to each patient completing the program after the the 30 
day follow-up visit to promote retention as described in the budget justification section. Follow-up virtual 
visits will be arranged at the patient’s convenience, including early AM, late PM and weekends to minimize 
disruption to usual daily activities, including work schedules. 
 
 
   Strategies for sustainability outside the study setting. Unit nurses previously provided input into 
the existing program education content and delivery format. The intervention will be further developed 
by a multi-disciplinary team with strong representation from nursing unit staff and leadership, 
research and education stakeholders. It will be delivered by existing staff. Our intent is to show that 
the program model could be implemented on non-critical care hospital units by existing staff. The 
MedStar Institute for Quality and Safety has strong experience in quality, efficiency, reliability, and 
safety improvement, including workflow process implementation (see Investigators and Facilities 
sections), and will conduct this study’s workflow process analysis to assure efficient, effective 
program implementation. MedStar implementation scientists will employ the PRISM framework to 
optimize likelihood of implementation success and enhance generalizability. The resulting program 
could potentially be incorporated into the education delivery paradigm for all hospitals. Developing 
systems to understand individualized operability, and then using existing personnel and current 
scopes of practice for education delivery will be efficient in terms of resources utilization and broad 
applicability. Additionally, offering DRNCs the opportunity to develop expertise in diabetes is aligned 
with professional development and supervisor and peer recognition of the expertise gained. 
    Potential for generalizability. Our study’s inpatient medical and surgical environment reflects the general 
U.S. hospital population, in that up to 30% of inpatients have DM and standardized strategies and tools to 
educate patients are lacking. If successful in a subsequent RCT, the Diabetes To Go learner-centered, 
technology assisted model could potentially be applied in other clinical settings (e.g., the Medical Home and/or 
Figure 5 

 ____________________________________________________________________________________________ 
21 
on other inpatient services) to bring DM subspecialty education directly to high volumes of patients who often 
do not access formal outpatient DM education programs. This model could also be applied to other chronic 
complex medical conditions in in- and outpatient settings to deliver education and thus improve outcomes.  
 
 
    Implementation Cost Analysis.  Professional labor and other personnel time will be determined 
using time-motion analysis supplemented by provider/staff interview. Unit labor costs will be 
determined from hourly wage or annual salary data as determined by the U.S. Department of Labor. 
Capital costs for technology (hardware, software) and education tools (printed books and pocket 
guides) will also be determined.  
 
F.  Environment. The MWHC hospital environment and the spectrum of support for conduct of 
clinical research offered by MHRI will aid in the success of this study. The transdisciplinary clinical 
and scientific environment detailed in the Investigators and Facilities sections will contribute to 
successful conduct of the study. Institutional support from Hospital Leadership, MHRI, and MedStar 
Health’s Chief Medical Officer (see letters of support) will assure successful implementation and 
sustainability of the proposed delivery model. 
 
G.  Limitations/Pitfalls 
 
Our study has potential limitations. Most notably, as described by the NIH Reviewers of our R18 
proposal is that it may not be possible to fit the proposed intervention into unit workflow. Every effort 
is being made in our study design to avoid this pitfall; however, the following situations may arise 
which could impact outcomes:   
   Nursing unit staff have many competing demands on their time. The intervention will not work if the 
staff do not support it. Incorporating HF/IE principles and early nursing leadership and staff 
engagement in the process design will provide an opportunity to avoid this challenge via thorough 
baseline assessment and ongoing IE. In the event that the intervention does not succeed, a fallback 
plan will be examination of the potential for deployment of staff dedicated to patient education 
program delivery that is deployed across units. 
   Many factors contribute to poorly controlled DM and to readmissions. We will examine a few key 
variables—DSME and skills education, their delivery at the bedside and strategies to enhance 
medication management during the discharge process.  Our intention is to address these high risk 
factors in our study in a focused concise way in order to assure delivery of key DSME and skills 
content and to support Rxs management and to engage the patient in healthy self-care behaviors 
which will promote outcomes improvement. We will identify additional variables affecting outcomes 
and address them as appropriate in this or future interventions. 
   Our post-discharge assessment period is 30 days, due to the short (2 yr) duration of this study. This 
time period will allow us to generate sufficient preliminary data for assessment we propose for this 
intervention. It will not however, permit determination of intermediate or long-term outcomes. These 
would be the focus of a future RCT if our preliminary data shows promise.   Evaluation to determine 
long-term impact is beyond the scope of the present study and could be addressed in a future study.   
 
Additional Information. 
 
The Behavioral Intervention  
 
“Diabetes To Go” is a learner-centered behavioral self-mangement education and medication 
adherence intervention that has been developed by a multidisciplinary team led by the present 

 ____________________________________________________________________________________________ 
22 
proposal’s PI (Magee). It has also been pilot tested. The Diabetes To Go intervention and findings of 
the pilot study which assessed its preliminary impact on diabetes knowledge and medication 
adherence are described in the Section above on “Prior experience and/or history relevant to the 
research”.  
 
During Phase 1 of this study, we will refine and optimize/adapt the Diabetes To Go program 
content and implementation processes to enhance the likelihood of optimal uptake and impact of 
the behavioral intervention.  This will be achieved by applying user-centered interface design 
principles with our human factors partners, development of additional content in partnership with 
patients, providers and MDI and MI2 content development experts, detailed process mapping for 
program integration into existing processes and workflow, and integrating mobile and e-health 
technology to support care transitions. The Practical, Robust, Implementation and Sustainability 
Model, deployed by our implementation science experts will guide implementation planning and 
evaluation. Audio recordings obtained during focus groups will be immediately transcribed following 
the interview. Transcripts will be reviewed and validated for accuracy. Once accuracy of the 
transcripts has been validated, the original audio recordings will be destroyed.   
 
The Diabetes To Go program (surveys and video content) will then be deployed in Phase 2 of the 
present study as an integrated teaching tool at the bedside to enable assessment of the effectiveness 
and short-term sustainability of the workflow processes developed in Phase 1 of the study.  We will 
be gathering pilot behavioral intervention patient outcomes related to knowledge and skills 
acquisition, Rx adherence, healthcare resources utilization, platform adoption, and satisfaction with 
the program.  
 
Fidelity and competence of the behavioral intervention will be maintained and demonstrated 
throughout the study as described below. 
 
Fidelity of the intervention process will be assured by reviewing to ensure that each education 
content area is consistently offered to each patient. Nursing Unit staff will encourage each patient to 
complete the program content during the time that they are on the unit prior to discharge. Reasons for 
failure to complete the full program will be captured from the patient and the unit staff’s perspective in 
the program platform prior to or at the time of discharge from the unit.  The study coordinator will 
conduct audits to assess the degree of compliance with the program. Data for survey completion, 
survey results and video content usage will be auto-extracted from the Tonic for Health platform for 
provision to the data management team and will also be used in the assessment of fidelity. 
 
Competence or compliance with fidelity will be demonstrated via analysis of the number of content 
areas accessed by each patient, time spent viewing video content which corresponds to knowledge 
deficits on the surveys and time spent viewing mandatory video content. 
 
Focus Group Specifications. 
 
  Dr. Smith and her team have extensive experience in conducting interviews and focus groups for the 
purpose of developing and designing sustainable solutions for implementation within hospital in-
patient settings. These experiences include focus groups for patients with chronic disease (diabetes, 
cardiovascular disease, obesity), frontline staff (nurses, patient care technicians, transporters, 
administration), physicians, and senior hospital and healthcare leaders (board members, chief 
executives, middle management). In her current work on the We Want to Know project, Dr. Smith 
employs multiple interview methods include participatory action, cognitive interviewing, motivational 

 ____________________________________________________________________________________________ 
23 
interviewing and focus groups to interview patients and family members about perceived breakdowns 
in care as well as healthcare staff and leaders about their experience with the We Want to Know 
program implementation and sustainability of the program after grant funding.    
  A comprehensive interview guide will be created during the development phase of the Diabetes To 
Go project and submitted to the IRB prior to initiating any interviews or focus groups.  Focus groups 
will be conducted using a semi-structured interview approach, with questions on usability of the 
technological platform, content of the Diabetes To Go program, and identification of any perceived 
challenges or barriers to implementation. 
  Focus groups will be limited to English speaking patients and participants. For patient focus groups, 
we will work to ensure that all patient focus group guides are written in plain language at no higher 
than a 6th grade level.   
  Information will be captured during the interviews/focus groups in two ways. First, the members of 
the focus groups will be asked to provide verbal consent to be audio recorded for the purpose of the 
project. Second, in addition to the Focus Group Facilitator, a note take for  the project will be in 
attendance to take notes and assist the facilitator with ensuring attention to all the key components of 
the interview. Information from the focus groups will be reviewed, synthesized, and aggregated using 
standard approaches for thematic review using grounded theory. Transcripts of the focus groups will 
be reviewed independently by two investigators for common themes. Adjudication of differences will 
be presented to a third investigator for validation and resolution. Once the common themes have 
been identified, this information will be presented back to the participants for validation and revision. 
Once validated, a final report on the outcomes of the focus groups will be generated and the 
information gained from the participants will be used to revise the Diabetes To Go platform, 
educational content, and expected processes as appropriate. Digital audio recordings of the focus 
groups will be destroyed upon completion of validation of the written transcripts.  
  Permission to audio record participants will be included in the informed consent process and 
assented to verbally. Recording of the verbal assent will be conducted after initial agreement to be 
recorded. Information of the need to audio record the focus groups will also be a part of all 
recruitment materials so that any volunteer is aware of the need to record responses prior to their 
attendance at the focus group. 
 
Methodology Specific to Study Surveys  
 
Phase 1. 
 
All information for Phase 1 will be collected using semi-structured interviews and/or focus groups. 
Approaches to these activities are presented above. 
 
Phase 2.  Pilot Intervention 
 
Survey methodology – all surveys (baseline data, knowledge survey and medication adherence, 
satisfaction) will be self-administered via the Tonic for Health platform.  Patients will be provided 
instruction in use of the platform until they feel comfortable using it and in an ongoing fashion if 
needed during the participation period.  Patients who prefer not to use the technology platform will be 
provided with print copies of the surveys and if needed, eg the patient cannot read, then the surveys 
will be administered by the study team (baseline data and satisfaction) and the nursing unit staff 
(knowledge and medication adherence).  Staff will be trained in methods for administration of surveys 
so that bias in patient responses will not be introduced as a variable. 

 ____________________________________________________________________________________________ 
24 
  As described in the approach sections above, two surveys are embedded in the Diabetes To Go 
program.  The first is the KNOW Diabetes survey. This tool was developed by the MedStar Diabetes 
Institute in recognition of the fact that there is no existing validated diabetes knowledge survey which 
specifically addresses diabetes “survival skills” self-management education content areas. This 
survey is used as the pre- post-knowledge survey in this study.  Importantly, responses to the survey 
determine which video content area patients will be directed to for viewing.  When a patient answers 
a question incorrectly, the platform provides a link to the video content which provides information on 
the topic for which a knowledge deficit was identified; thus, the content is tailored to the patient’s 
learning needs. In an ongoing study, the MDI is currently in the process of validating the KNOW 
Diabetes survey.   
 
  The second survey is the Modified Morisky Medication Adherence Survey, 8-item. This is a 
validated survey which is used with permission from David Morisky. 
 
  In addition to these surveys, a baseline survey will be administered to each patient participating in 
the program to gather data which will be used to augment data extracted from the hospital EMR (See 
Baseline patient data survey).  A patient satisfaction survey will also be administered at the time the 
patient completes the education program. This survey will address patient perceptions of the inpatient 
education experience and with the technology platform. These surveys will be developed during 
Phase 1 and submitted to the IRB for approval prior to use in Phase 2.   
 
Other  Consideration Relative to Study Specifications: 
 
• Specimen Collection – No biological specimens will be collected in this study. 
•    Studies involving use of product (licensed, labeled of small size, simple) – No product  
will be used in this study. 
 
7 
DATA COLLECTION AND MANAGEMENT PROCEDURES 
The source document will contain the original signed informed consent document, completed 
baseline data collection forms, and copies of all survey responses and will be kept in a locked cabinet 
on the MDI study team unit.  
 
Consented, participants will undergo baseline assessment as shown in Table 4. The study team will 
obtain all study-specified baseline data from the patient and/or from the EMR, with the exception of 
the knowledge and medication adherence survey responses. 
 
The education program-specific KNOW Diabetes knowledge survey and the Modified Morisky53 Rx 
Adherence Survey 8-item (MMAS-8© with permission from D. Morisky) are delivered by the nursing 
unit team via the Tonic platform. As part of the education program, nursing unit staff delivering the 
program to an individual patient will have access to his/her survey responses in order to enable 
tailoring education at the bedside to identified knowledge deficits and medication adherence issues.  
 
Data entered into the platform by the patient will be transferred to REDCap in a file format and de-
identified prior to presentation to the data management and statistics team for analysis.  
 

 ____________________________________________________________________________________________ 
25 
The Tonic for Health platform is cloud based. The platform is currently in use MedStar system-wide 
clinical settings, including in MedStar Medical Group practices and for the MedStar patient portal. The 
platform interfaces with MedStar systems have been structured by MedStar to meet all system-
required security and privacy requirements.   
 
Because this pilot study, by design, is not assessing lab clinical outcomes the study will not be 
conducting any study-provided laboratory tests. 
 
8 
STATISTICAL CONSIDERATIONS & DATA ANALYSIS 
Analysis Plan. A convenience sample of 4 nursing units and approximately 60 patients/unit, for a 
total of 240 patients for whom data will be collected and analyzed, will be utilized in this pilot study 
designed to generate preliminary data to inform a future pragmatic trial. 
   
Baseline Characteristics: Summary statistics, including means, medians, standard deviations for 
continuous variables and, frequencies and percentages for categorical variables on all baseline data 
will be obtained for the overall sample and by nursing unit. The factors that may influence patients’ 
non-participation decision will be examined by testing associations with baseline variables such as 
gender, race, age or severity of patients’ conditions. Two-sample t-tests, Analysis of Variance 
(ANOVA), chi-square analyses and other nonparametric tests will be conducted as appropriate for the 
proposed bivariate analyses. DM2-related measurements A1C and blood glucose will also be 
described using summary statistics for the baseline and before the patient gets discharged and the 
differences will be tested using paired t-tests (or non-parametric tests when needed). The data 
collected at this stage will allow us to better evaluate the effectiveness of the education by controlling 
for patients’ DM2 measures at discharge.   
 
Pilot Outcomes: The effect of the intervention on Knowledge and Skills Acquisition outcomes will 
be examined by computing the differences in the total score of KNOW Diabetes survey between 
baseline and discharge. The differences will be tested using paired t-test for the continuous scores 
and McNemar’s or symmetry test for the categories of specific items of interest The data collected on 
the number of times the education module replayed until competency demonstrated, the time used, 
the amount of content skipped (skills acquisition) will be summarized using descriptive statistics and 
correlated with patients’ characteristics to better understand the difficulties experienced by the 
patients. Medication Adherence, a patient-centered behavioral outcome, will be measured at 
baseline and 30-day follow-up. To test if medication adherence has increased as a result of the 
intervention, the changes in continuous scores at baseline and at 30 days will be computed and the 
percentage of patients who show “improvement in Rx adherence” will be obtained.  ED/Hospital 
readmissions and missed work/activity days within the 30 days after discharge will also be 
summarized using descriptive statistics and their associations with baseline and discharge 
characteristics will be explored using bivariate analyses. Multivariate analyses using linear (change in 
continuous scores of KNOW Diabetes and MA8), logistic (increase in medication adherence) and 
Poisson (count outcomes such as the number of replays, readmissions, days of missed work/activity) 
regression models will be conducted by adjusting for potential confounders at baseline or discharge 
(age, race, BMI, gender, comorbidities, A1C – when available- and blood glucose) within the 
constraints of the final sample size of approximately 240 patients). IT Platform Adoption Metrics- # 
and % of modules viewed; time used; content skipped; content replayed. 
Implementation Effectiveness Evaluation Approach 

 ____________________________________________________________________________________________ 
26 
  Implementation effectiveness evaluation will be guided by the RE-AIM32,33,54,55 framework. Our 
approach will consider differences in hospital and nursing workflow, patient characteristics and be 
sensitive to differences in patient culture, knowledge and beliefs. Our mixed methods approach to 
operationalizing the RE-AIM framework will select qualitative and quantitative outcomes at the setting, 
staff, and patient levels. Table 6 provides an overview of the RE-AIM domains, definition, and 
proposed strategy for evaluation data.  
 
Table 6. RE-AIM Characteristic Definitions and Project Operationalization 
RE-AIM Domain Definition 
Operationalization 
Reach 
The number, proportion, and 
representativeness of participants. 
Setting: Descriptive characteristics of intervention settings (geographic location, size of 
hospital and units, staffing levels, acuity level); Staff: Provider characteristics 
(male/female; profession (leader, management, clinician, administrative); other 
relevant characteristics); Patient: Characteristics of those exposed to intervention 
(age, gender, race/ethnicity, discharge site/status, co-morbidities; others) 
Effectiveness 
Key outcomes impact, including: potential 
negative effects; economic outcomes. 
Primary outcome: Emergency Dept/Hospital Readmissions 
Additional outcomes: Patient satisfaction; provider satisfaction, others as defined by 
project (See Tables 4 & 5 – Timeline & Study Outcomes). 
Adoption  
Number, proportion, and 
representativeness of settings and 
intervention agents (“Recipients”) 
Setting: Medicine  implementation environments; representativeness will be assessed 
using descriptive data; Staff: Number and proportion of staff participating in 
development, training, implementation, and evaluation stages/phases of prototype 
intervention; Patient: Number and proportion of patients exposed to intervention; 
engaged in solution design and development 
Implementation  
Fidelity to intervention protocol, including 
delivery consistency as intended, 
time/cost of intervention.  
Setting: Ethnographic analysis of prototype intervention implementation fidelity via 
direct observation, policy review, leadership informant interviews; Staff: Key informant 
interviews, focus groups to identify barriers/facilitators of prototype implementations; 
Patient: Informant interviews, nursing discharge calls, other project specific outcomes  
Maintenance  
Extent to which program becomes 
institutionalized. 
Clinicians’ and leaderships’ intent to continue the intervention beyond the initial period; 
perceived alignment with organizational mission; sustainability; intent to 
institutionalize/ spread to other units/hospitals/clinics. Patient: Sustainability of 
outcomes at 30 days. 
 
The team, led by Dr. Smith, will identify and validate barriers and facilitators of reach, effectiveness, 
adoption, implementation, and maintenance in each study phase. The PRISM and RE-AIM will utilize 
a combination of interviews, surveys, direct observations, and existing data systems to inform 
intervention fidelity and effectiveness (Table 7).  
 
 
Table 7. Methods for Patient, Organizational & Environmental Data Collection for PRISM and RE-AIM 
Method 
Description 
Stakeholders/Audience 
Semi-structured interviews & 
focus groups 
Processes to solicit information to better 
understand barriers/facilitators to behavior 
change adoption within each stakeholder group 
as well as the perceived relevant factors 
impacting it. 
Clinicians, frontline staff, 
organizational and clinical 
leadership, patients. 
Ethnographic observations 
Immersion in the environment; direct 
observations of process and workflow on units 
for purposes of intervention and implementation 
planning and evaluation. Identify environmental 
factors acting as barriers/facilitators to 
implementation success. 
Clinical teams within their 
environment of care 
 
 
    Outcomes Identification and Analyses: A mix of quantitative and qualitative data is expected to 
be available to evaluate intervention effectiveness. Quantitative data may be sourced from case 
record forms, clinical databases, patient and provider surveys and other data captured during 
implementation (Tables 4 & 5). Qualitative data from ethnographic observations, key informant 
interviews and focus groups will be analyzed using standard techniques.56,57 Content codes will be 

 ____________________________________________________________________________________________ 
27 
generated using an iterative process involving transcript review, generation of preliminary codes, 
team review, revision, application or codes to transcripts, elaboration, and continued application and 
elaboration as needed. When the full team concurs that the code list captures all themes identified in 
the transcripts, a research assistant will be trained to code all transcripts. Another team member will 
also code a subset of at least 10% of the transcripts to check coding consistency. Dr. Smith (IE lead) 
will meet with the coders to resolve any discrepancies and to discuss any text that is not readily 
coded with the existing list. Review will continue until coding is reliable..  
9 
QUALITY CONTROL AND QUALITY ASSURANCE 
As described in the data collection and management process there will be review of by the study 
team of the data to ensure consistency of coding. A sub set will be by another member of the team to 
check consistency of data entry.  
10 
REGULATORY REQUIREMENTS 
10.1 Informed Consent  
• This study is considered minimal risk and therefore is submitted for expedited IRB 
review.   An IRB-approved informed consent document will be used to consent all 
potential participants into the study.  Trained study coordinators will be responsible for 
conducting the informed consent process with oversight from the PI.  The informed 
consent process will be documented in the participant’s study chart.  An 
inclusion/exclusion checklist will be used to ensure recruitment and enrollment of 
eligible participants only. 
• The research will not require the participation of minors and therefore an assent 
document will not be required. 
• The proposed informed consent document is attached as an appendix.  The informed 
consent document is written in layman’s language understandable to the potential 
participants.  The document includes the following information:   
o A statement that the study involves research. 
o An explanation of the purposes of the research. 
o The expected duration of the subject’s participation. 
o A description of the procedures to be followed. 
o Identification of any procedures which are experimental. 
o A description of any reasonably foreseeable risks or discomforts.   
o A description of any benefits to the subject or to others that may reasonably be 
expected from the research.   
o A statement describing the extent, if any, to which confidentiality of records 
identifying the subject will be maintained. 
o An explanation of whom to contact for answers to pertinent questions about the 
research and the research subjects’ rights, and whom to contact in the event of 
research-related injury to the subject. 
o A statement that participation is voluntary, refusal to participate will involve no 
penalty or loss of benefits to which the subject is otherwise entitled, and the 
subject may discontinue participation at any time without penalty or loss of 
benefits to which the subject is otherwise entitled. 

 ____________________________________________________________________________________________ 
28 
 
10.2 Subject Confidentiality  
• The participants’ personal health information (PHI) will be kept private to the extent allowed 
by law.  Study records identifying participants will be kept confidential and will not be made 
publicly available.  Participants will not be identified by name in any publications resulting 
from this study.  Participants will be asked to authorize the investigator, representatives from 
government agencies, including the Food and Drug Administration (FDA), institutional 
review boards, the sponsor and/or the sponsor’s representative(s), and certain other people, 
agencies or entities, to look at and review the records related to this study including any 
personal health information and the information discovered during this study.   
• For the purposes of data analysis, only the study investigators and research staff will 
have access to the data which identifies participants by name.  
• Minimal Personal Health Information (PHI) will be used for this study.  All participants 
will receive a study ID number that will be used to identify their surveys.  Surveys will be 
administered through the use of special software currently used by MedStar Health for 
all clinical data collection activity. The data from these surveys will be maintained on a 
secure, password-protected server within the MedStar Health firewall.   
• A Certificate of Confidentiality will not be requested for this project.   
10.3 Unanticipated Problems 
• The PI will report all unanticipated problems to the IRB per MHRI IRB policy.  This 
policy requires serious, unexpected and related (or possible related) events to be 
reported to the IRB within 24 hours.  Adverse events that do not meet the criteria for a 
serious adverse event will be reported to the IRB at the time of continuing review of the 
project. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 ____________________________________________________________________________________________ 
29 
11 
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34 
APPENDICES 
•