Addressing Social Determinants of Health & Diabetes Self-Management in Vulnerable Populations
Phase: NA
Conditions: Diabetes
Sponsor: Kaiser Permanente

 
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Addressing Social Determinants of Health & Diabetes Self-Management  
in Vulnerable Populations 
 
 
STUDY PROTOCOL 
 
NCT# 03802825 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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1. Protocol Title 
Addressing Social Determinants of Health & Diabetes Self-Management in Vulnerable 
Populations (Bridge to Health Study) 
 
2. Objectives 
The purpose of this R34 is to study the feasibility of a large-scale, pragmatic, randomized trial 
designed to compare the effectiveness of navigation only to navigation + diabetes self-
management training on A1C reduction among racial/ethnic minority and low-income patients 
with poorly managed diabetes. In the first phase of this pilot, we will conduct a data only study 
to determine the number and clinic service area of eligible patients from Kaiser Permanente 
Northwest (KPNW) and use this information to inform recruitment strategies and materials for 
the second phase randomized clinical trial.  
For Phase 2 of the study, we will use the electronic health record (EHR) system at KPNW to 
identify and recruit 100 participants that meet eligibility criteria. We will randomize 50 
participants to one of two study arms: 1) patient navigation only; or 2) patient navigation + 
diabetes self-management training.  
 
 
Phase 1 
Aim 1: Determine the number and clinic service area of eligible patients for Phase 2 (RCT) based 
on: A1C ≥ 8; African American, Hispanic, and/or Medicaid recipient (all race/ethnicities); and 
poor follow-up in primary care.  
 
Phase 2 
Aim 1: Determine feasibility of the trial based on: a) recruitment and retention rate; b) 
proportion of participants who actually connect with a Community Health Worker (CHW) and/or 
navigator after referral; c) mean length of time to connect participants to navigators and CHWs; 
and d) proportion of patients whose medical, social, and/or economic needs are met after the 6-
month intervention based on patient self-report questionnaire and intervention process 
measures. 
 
Aim 2: Assess intervention acceptability and determinants of implementation by conducting 
semi-structured qualitative interviews with patients, navigators, CHWs, providers, and health 
care system senior leadership. 
 
Aim 3: Assess preliminary effectiveness by comparing the two study arms on the following 
outcomes at 6-months post-randomization: a) proportion of patients with A1C < 8%; b) 
proportion of patients with an A1C test; c) number of emergency department visits; d) primary 
care visit no-show rate; and e) percent of on-time pharmacy refills for diabetes-related 
medications. 
 
Phase 3 
Aim 1: Extract clinical data on Asian American, Pacific Islander, Native Hawaiian, and Alaska 
Native populations in KPNW from the EHR as preliminary data for a future grant proposal 
including these populations in a large-scale, pragmatic, randomized trial aimed to address 
disparities in diabetes management in relation to socioeconomic needs. 
 
3. Background 
Racial/ethnic minorities and low-income individuals in the U.S. are less likely to achieve diabetes-related 
clinical targets. Only 42% of African Americans and 38% of Hispanics with diabetes have hemoglobin A1C 

 
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levels at target (≤7%), compared to 58% of Whites.1 In addition, individuals with low socioeconomic status 
(of all racial/ethnic backgrounds) are also more likely to have suboptimal diabetes management.1,2 This is 
troubling because poor diabetes management leads to an increased risk for diabetes complications including 
cardiovascular disease events, contributing to the disparities in the rates of these major diseases.3 As such, 
pragmatic, multifactorial interventions to address these disparities in diabetes management are sorely 
needed. 
 
Disparities in diabetes management have been linked to social determinants of health.  Social and 
economic needs, including food insecurity, housing instability, and trouble paying for medical care, are 
common among racial/ethnic minorities and low-income populations.3 These needs interfere with adequate 
diabetes self-management behaviors, including healthy eating, physical activity, self-monitoring of blood 
glucose, and medication adherence,4-9 and are associated with high diabetes-related health care 
utilization.4,10-12 A recent meta-analysis indicated that diabetes self-management interventions are effective 
for reducing A1C by an average of 0.31% among racial/ethnic minorites,13 but access to these interventions is 
limited partly due to social determinants of health such as lack of transportation to attend sessions or access 
to the internet for online programs.14,15 
 
Racial/ethnic disparities in diabetes management and social and economic needs are prevalent among 
insured patient populations. Based on recent population health data, across several Kaiser Permanente 
Northwest (KPNW) primary care clinics, there are disparities in achieving the clinical target of A1C < 8% 
between Hispanic and non-Hispanic White members (3% - 15% gap) as well as African American and non-
Hispanic White members (2% - 9% gap). In January 2017, Kaiser Permanente instituted the Your Current Life 
Situation (YCLS), a 9-item screener for social and economic needs. Over the past year, the YCLS was 
administered to 2,406 KPNW patients (6% African American, 12% Hispanic, and 20% Medicaid) because of 
high emergency department utilization, Medicaid coverage, or referral to a patient navigator. Among these 
patients, 11% had a diabetes diagnosis and 16% had multiple chronic conditions. In a recent study, our team 
administered the YCLS as an online REDCap survey to the ~30,000 adult members on the KPNW Diabetes 
Registry. Among the 3,805 (13%) responders, ~25% endorsed one or more social and/or economic need. 
Most common needs included trouble paying off debts, food insecurity, and trouble paying for medical 
needs; all issues that can interfere with optimal diabetes self-management. Furthermore, a significantly 
higher percent of patients who endorsed one or more social and/or economic need compared to those with 
no needs had a most recent A1C ≥ 8 (28% vs. 16%). This previous work underscores the high prevalence of 
social and/or economic needs among the insured KPNW patient population as well as the interplay with 
diabetes. 
 
The most effective approach for integrating lay health workers in efforts to improve diabetes 
management among vulnerable populations is not clear. There is a growing body of evidence that lay 
health workers, such as patient navigators and community health workers (CHWs), can effectively address 
medical, social and economic needs by connecting patients to medical and community-based services.16-19 
However, it is not clear if solely addressing navigation and access to social and economic resources is 
sufficient for improving long-term diabetes management. For this proposed study, we define patient 
navigators as lay health workers that are embedded in the health system and whose primary role is to 
connect patients with medical services and/or community-based resources. In contrast, CHWs are lay health 
workers embedded in the community and their role is to provide psychosocial support, connect patients to 
community-based resources, and deliver self-management training. 
 
Several studies that have utilized patient navigators16,17 or CHWs,20-22 have generally demonstrated a 
reduction in A1C and in some cases a decrease in the number of emergency department visits,21 and an 
increase in utilization of primary care among racial/ethnic minorities.17 However, the roles of patient 
navigators and CHWs across these previous studies have been mixed including connecting patients to 

 
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medical and social services only, providing diabetes self-management training only, or both. Thus, the 
optimal role of lay health workers is unclear in terms of diabetes management. Also, methodological 
limitations including lack of randomization or a comparison group, limit the conclusions that can be drawn 
from several of these studies. Determining the optimal role of lay health workers is key to translating 
effective diabetes management interventions into clinical practice in a pragmatic, sustainable way. To our 
knowledge, there has been no rigorous trial to compare the effectiveness of a patient navigation only versus 
patient navigation + diabetes self-management training intervention. A trial to address this issue may help 
health systems determine how to best use their resources to improve diabetes outcomes long-term among 
high risk, high cost populations. 
 
Findings from this comparative effectiveness trial will generalize to other health care settings. Because of 
limited staff or access to community-based resources, we expect it would be difficult for a solo-practitioner or 
a rural clinic to implement navigators or connect patients to a community-based organization with a CHW. 
However, if successful, findings from this trial could provide a model of care for community health centers, 
integrated health systems, and specialty clinics that already have access to or would like to embed 
navigators and/or CHWs, but struggle with fully integrating these personnel into clinic workflow, tracking 
community-based referrals, and sustaining reimbursement. Furthermore, several states, including Oregon, 
are currently exploring billing Medicaid to reimburse services provided by lay health workers to low-income 
patients. Thus, our study is also well-positioned to inform payers about implementation cost and contribute 
to the discussion about possible payment models. 
 
Why is a pilot feasibility study needed prior to the full-scale clinical trial? The challenges of engaging, 
enrolling, and retaining racial/ethnic minorities and low-income individuals in randomized clinical trials are 
well established.23 In the future, full-scale trial, in particular, we plan to recruit patients who are also 
disengaged from care (i.e., missed one or more scheduled primary care visits in the past year). Therefore, it 
will be important to test the feasibility of recruiting from this high risk, hard-to-reach population using: the 
electronic health record; recruitment study staff trained in cultural competence, sensitivity, and motivational 
interviewing; and care coordinators within the health system who primarily work with this patient 
population. Furthermore, the proposed study would involve a new partnership between the health system 
and community-based organizations. The feasibility and acceptability of referring patients to community-
based agencies to address social and economic needs and deliver diabetes self-management training while 
maintaining communication with the health system about patient progress also needs to be determined. 
Finally, determinants of implementation and sustainability of this model of care need to be explored with 
various stakeholders to inform the final design of the interventions to be compared in the full-scale clinical 
trial. 
 
4. Study Design 
We will evaluate the feasibility of a large-scale, pragmatic, randomized trial designed to compare the 
effectiveness of navigation only to navigation + diabetes self-management training on A1C reduction among 
racial/ethnic minority and low-income patients with poorly managed diabetes. In this pilot, we will 
randomize 100 African American, Hispanic, and/or Medicaid (all race/ethnicities) patients from KPNW with 
A1C ≥ 8 and poor follow-up in primary care to one of two 6-month interventions: 1) patient navigation only; 
or 2) patient + diabetes self-management training.  
 
Treatment Arms 
 
Patient Navigation 
Participants randomized to the patient navigation only arm will be referred to a KPNW patient navigator 
using a standard EHR-based referral process. Once the participant has completed the YCLS assessment with 
study staff, the navigator will receive the referral and follow-up with the participant to address the social and 

 
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economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 
months by phone or in-person about progress with the referral and help address additional needs that may 
develop during the 6-month intervention. Diabetes educational materials from the American Diabetes 
Association (available in English and Spanish) will be mailed to the participants monthly to keep them 
engaged in the study. 
 
Patient Navigation + Diabetes Self-Management Training 
In addition to receiving patient navigation as described above as well as educational materials from the ADA 
mailed at the beginning of treatment, participants in this arm will also be referred to Project Access NOW by 
study staff via an encrypted email sent via REDCap with a secure link to REDCap. As part of the partnership 
with KPNW, Project Access NOW will be provided with participants’ contact information and other PHI via 
REDCap to facilitate the referral to a certified CHW within a community-based organization. Project Access 
NOW will connect participants to a community-based organization based on their preference, previous 
experience with an agency, geography, and capacity. 
 
Project Access NOW will receive the following private health information only about participants randomized 
to the intervention arm: 
 
- 
Patient contact: name, phone number, address, zip code 
- 
Patient demographics: date of birth, race, ethnicity, gender, primary language 
- 
Patient clinical data: diabetes diagnosis, most recent hemoglobin A1C levels 
- 
Patient health care utilization: assigned Primary Care Provider, clinic service area, KPNW patient 
navigator 
- 
Patient insurance: type of coverage 
- 
Social and economic needs endorsed on the YCLS 
 
Sharing of PHI with Project Access NOW 
CHR runs its own private instance of REDCap, which is housed at CHR. REDCap is hosted on a web server 
which is located in the CHR computing center.  This web server uses a SHA 2 SSL certificate to encrypt the 
data transferred between the server and the end user’s web browser.  The database backend of REDCap is 
located behind the CHR firewall.  Both web and backend servers are protected and are monitored for any 
unusual or malicious activity.  REDCap uses user rights settings that uniquely identify each user and log their 
activities.  These internal security settings determine the access and privileges of the signed in user. The 
study team has also obtained a Data Transfer Agreement with Project Access NOW, which covers the above-
mentioned data points and was executed by CHR and Project Access NOW on Nov. 9, 2018.  KP PHI may be 
stored on Project Access NOW-owned devices, which are encrypted, or will be stored on Clara, a HIPAA-
compliant cloud-based storage. PHI will not be stored on devices that are not behind a firewall or hard copy 
file format. In the rare circumstances that KP PHI needs to be stored in a hard copy file format, it would be 
stored per policies and procedures of Project Access NOW. Transmission of KP PHI will occur via telephone or 
encrypted email communication between Project Access NOW and community-based agencies that house 
the community health workers to facilitate the referral that is currently already happening as clinical practice 
within the Regional Community Health Network, which KPNW is a member.  Project Access NOW policies and 
procedures prohibit the use of removable storage media and PHI will not be transported in a hard copy file 
format. Project Access NOW also has policies and procedures in place to address the minimum necessary rule 
as well as controls in place to limit access. They also have mechanisms for determining if PHI has been 
inappropriately or illegally accessed, used, disclosed, or modified. Project Access NOW staff may remotely 
access KP PHI on their owned devices, which are encrypted. 
 
The CHW will follow-up with the participant to conduct a home visit and follow-up on community-based 
referrals already placed by the KPNW patient navigator and assess for additional needs. The timing of the 

 
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diabetes self-management training will be based on the needs of the participant. The Decision-making 
Education for Choices in Diabetes Everyday (DECIDE) program is a nine-module, literacy adapted diabetes 
and cardiovascular disease education and problem-solving training program. Participants are taught the five 
steps of problem solving with each module going in depth on a single step: 1) identify the problem; 2) 
brainstorm possible strategies for problem resolution; 3) select the most appropriate strategy; 4) apply the 
strategy; 5) evaluate the effectiveness of the strategy. During the six months, CHWs will have weekly or bi-
weekly contract with participants in-person or by phone to deliver the DECIDE modules and address social 
and economic needs. Based on the participant’s availability or preference, the modules may also be 
administered via video (e.g., Skype or other video conferencing program used by the CHWs agency) or over 
the phone. There may be cases when a CHW may not be able to continue meeting with a participant in-
person or via phone. For those instances the participant will be provided hard copies of the intervention 
material and a designated study staff member will conduct monthly check-in calls to review the material and 
address any questions that the participant may have. 
For training and quality assurance purposes, CHWs will be randomly identified by study staff to audio-record 
their sessions with study participants. The selected CHW will be provided with an audio recorder and asked to 
record the entire session. The CHW will also confirm that the study participant agrees to being recorded. 
Once the recording is complete, the CHW will keep the audio recorder in a bag carrier marked ‘confidential’ 
and physically deliver the recorder back to study staff in a secure manner within 48 hours of conducting the 
recording. These audio recordings will not be transcribed and only be reviewed by pertinent study staff. 
Relevant feedback from the recording will be provided to the CHW for training purposes. Any documentation 
drafted related to the recordings will be de-identified. When the study is complete, the recordings will be 
destroyed and removed from the audio recorders. 
 
Qualitative interviews will be conducted with various stakeholders to assess intervention acceptability and 
several implementation domains including intervention burden, professional interactions (referral processes 
and communication across different levels of care), and capacity for organizational change. Preliminary 

 
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effects on A1C, diabetes-related care gaps, health care utilization, and medication adherence will also be 
examined. 
 
The two treatment arms are summarized in the figure below.  
 
 
 
5. Study Population 
For Phase 1, using the electronic health record system at Kaiser Permanente Northwest (KPNW), we 
will identify patients that meet eligibility criteria. 
 
Inclusion criteria: 
- 
Diagnosis of diabetes 
- 
Current Kaiser Permanente Northwest member 
- 
African American, Hispanic/Latino (English, Bilingual, or Spanish speaking only), and/or a 
Medicaid recipient (from any racial or ethnic background) 
- 
Age 18 or older 
- 
Most recent hemoglobin A1C ≥ 8% 
 
Phase 2 Inclusion criteria:  
- Diabetes diagnosis 
- Current Kaiser Permanente Northwest member 
- African American, Hispanic/Latino (English, Spanish-speaking, or bilingual), and/or a Medicaid 
recipient (from any racial or ethnic background) 
- Age 18 or older 
- Most recent hemoglobin A1C test of ≥ 8 
- Endorses 1 or more social and/or economic need on the YCLS 
 
Because patient-level socioeconomic status (SES) is not captured in the EHR, we will identify eligible patients 
based on SES using their health insurance coverage type, Medicaid. 
 
Exclusionary criteria: 

 
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- Patients who are unable to provide verbal informed consent due to cognitive or psychiatric 
impairment 
- Patients with a HIV+ diagnosis 
 
 
      Phase 3 Inclusion criteria: 
- Current Kaiser Permanente Northwest member 
- Age 18 or older 
- Identifies as Asian American, Pacific Islander, Native Hawaiian, and Alaska Native 
- Most recent hemoglobin A1C ≥ 8% 
 
a. Vulnerable Populations 
African Americans, Hispanics, and Medicaid recipients with poorly managed diabetes who will be 
recruited for this study certainly meet the general definition of ‘vulnerable population’ given that 
they represent the disadvantaged sub-segment of the community requiring high quality care and 
special considerations and protections in research. We will follow a strict protocol in terms of 
confidentiality. We will not intentionally target or include data from members of other 
vulnerable populations such as children, pregnant women, prisoners, or employees.  
 
b. Setting 
KPNW is a non-profit, group model integrated health care system that provides comprehensive prepaid 
health care to its more than 550,000 members in southwest Washington and northwest Oregon. It owns 
and operates two hospitals, contracts with six other local hospitals, and maintains 22 medical clinics (17 
with primary care). All patient contacts within the system and all services referred outside are recorded 
in a single, comprehensive electronic health record (EHR, KP HealthConnect, based on Epic®) that has 
been in place since 1996. Health and health care utilization data is stored in the Virtual Data Warehouse 
(VDW), which is maintained by the Kaiser Permanente Center for Health Research. The VDW provides a 
standardized, distributed data warehouse for the EHR and other clinical and administrative informatics 
systems employed by the health system. The VDW includes files for all encounters (outpatient and 
inpatient), vital signs, pharmacy fill data, problem lists and encounter diagnoses, procedures, and 
laboratory results.  
 
c. Informed Consent Waiver and HIPAA Privacy Rule Waiver of Authorization 
Because Phase 1 is a data-only study, we request a waiver of written and signed consent as well as 
HIPAA authorization for the study to extract participant data from the EHR (e.g., demographics, primary 
language spoken, contact information, clinic paneled to, vital signs, labs, diagnoses, encounters). At 
enrollment KPNW members are informed that their medical records may be used for research and that 
they may choose to opt out of such research; CHR maintains a registry of members who have asked not 
to be included in research or to have their records used, or both.  
 
For Phase 2, we also request a waiver of written and signed consent as well as HIPAA authorization. 
Verbal informed consent by the participant will be captured and recorded in REDCap by study staff 
during the initial recruitment call and after study eligibility has been determined. No study activities or 
data collection will be gathered until after verbal informed consent has been obtained.  
 
For Phase 3, we are also requesting a waiver of written consent as well as HIPAA authorization for the 
study to extract participant data from the EHR (e.g., demographics, clinic, primary language spoken, 
medical diagnosis, most recent A1C, most recent blood pressure measurement, BMI, insurance coverage, 
existing YCLS data, and social diagnosis codes). 
 

 
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6. Procedures 
For Phase 1, the study team will conduct a data-only study to determine the number of eligible patients from 
Kaiser Permanente Northwest (KPNW) and the most common clinic service area where these patients receive 
primary care. Results from this data-only study will inform Phase 2, which is a RCT. We plan to extract the 
following variables from the EHR: 
• 
Demographics 
• 
Contact information 
• 
Zip code 
• 
Clinic paneled to 
• 
Primary language spoken 
• 
Any Mental health diagnoses 
• 
Health care utilization 
o Outpatient encounters 
o Inpatient encounters 
o ED visits 
o Navigator visit 
• 
Vital Signs 
• 
Labs 
• 
Medical diagnosis 
• 
Existing YCLS data from the VDW 
• 
Social diagnosis codes 
• 
Insurance coverage 
 
For Phase 2, the study team will utilize the KPNW EPIC system to identify potentially eligible patients 
who meet study criteria. The study team aims to enroll 100 participants and randomize 50 
participants to each study arm. After eligible patients have been identified, using REDCap, we will 
send targeted emails and for those who do not have an email address listed, we will send targeted 
letters via regular mail. The email/letter will provide an overview of the study and provide the study 
number for potential participants to call-in and enroll if eligible. One week after sending the 
emails/letters, bilingual recruitment staff will contact potential participants by phone to follow-up on 
the email/letter and describe the study and enroll those interested. If study staff are made aware 
that an interested participant will be unreachable (i.e., out of town) after randomization, the 
individual will not be randomized until their schedule permits availability to participate in the study, 
applicable for both study arms. After consent has been captured, enrolled participants will be 
randomized to one of the study arms. Enrolled participants will receive a thorough explanation of 
what the randomization process entails, as well as the differences between the two study arms. Data 
collection, which consists of the administration of the Your Current Life Situation (YCLS) will occur at 
the Baseline and 6-month follow-up calls. During the Baseline call, study participants will also be 
provided with contact information to the 211info organization to serve as an additional contact for 
helping individuals navigate and connect with local resources. 
 
The study team is partnering with Kaiser Permanente Northwest to ensure that we are also targeting 
those KPNW members who meet study eligibility criteria and have been identified by the Region as 
being high-risk/ high utilizers in need of intensive case management.  To ensure that we are aligning 
our efforts with similar initiatives simultaneously occurring in the Region, we will share our list of 
identified eligible KPNW members with the Kaiser Permanente Northwest analyst. The analyst will in 
turn provide us with the saber score (indicator of high-risk/ high utilization severity) and probability 
of their diabetes being out of control in the next month (i.e., A1C ≥ 8%) We will use this additional 
information to prioritize these members for recruitment in Bridge to Health as we try to align with 

 
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similar initiatives in the Region. The study team has already submitted a Data Transfer Request form 
and received approval to share the dataset via the CHR Secure File Transfer site. We also want to 
ensure that the KPNW region is aware of which members are participating in the study, so they do 
not receive duplicate services or are contaminated by any clinical interventions being rolled out. At 
the end of recruitment, the study team will send a designated health system staff a list of enrolled 
participants who are either African American or receiving Medicaid coverage via the CHR Secure File 
Transfer site. 
 
The recruitment and randomization process are summarized in the figure below.  
 
           
 
 
  
For Phase 3, the study team will extract data from the EHR on KPNW members who identify as Asian 
American, Pacific Islander, Native Hawaiian, and Alaska Native. Data to be extracted includes demographics, 
clinic, primary language spoken, medical diagnosis, most recent A1C, most recent blood pressure 
measurement, BMI, insurance coverage, existing YCLS data, and social diagnosis codes. Because racial/ethnic 
identity information is often missing in the EHR for individuals with this background, we will also work with 
KP Community Health to get a list of Compact of Free Association (COFA) members who receive premium 
assistance from KPNW.  
 
7. Privacy, Confidentiality, and Data Security 
All KPNW employees receive extensive annual training in privacy protection and HIPAA rules. CHR follows 
strict procedures to assure the security and integrity of all study data. All research databases include only 
study ID and no personal identifiers; the medical record number is not included in either study databases or 
the main CHR research data warehouse; only selected analysts can link back to the medical record. Access to 
project data is restricted to authorized personnel, password-protected, and closely monitored for intrusion. 
All CHR staff, and any outside investigators working with CHR data, are annually required to review CHR’s 

 
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policies on data confidentiality and research ethics and to sign a statement saying that they agree to abide 
by these policies.  
 
In addition, to reduce any risk of disclosure of confidential information, participants’ privacy and 
confidentiality will have been ensured by:  
(1) securely storing all identifiable data in password-protected files and directories on investigator computers 
within firewall-protected networks. 
(2) removing or obscuring participant names and identifying features prior to any presentation, publication, 
or other sharing of data outside the research team, except with the express written consent of the subject(s). 
(3) granting access to unmodified data (containing identifying data or features) only to members of the 
research team or the patient’s care team working under the direction of the investigators for the duration of 
the project. 
 
EHR data for eligible patients will be accessed and utilized for verifying study eligibility and recruitment 
purposes. A crosswalk will be created to link the patient names and MRNs with a unique study identification 
number that will be tracked in REDCap. The crosswalk linking the patient names and MRNs with the study IDs 
will be kept in a secure study file.  
 
For the qualitative component of the study, patient interviews will be recorded on encrypted devices. All 
media files will be downloaded to a secure file service and the recordings will be deleted from the password-
protected audio recorders. 
 
8. Risks and Benefits 
a. Risks to Subjects 
The most serious risks for Phases 1,2 and 3 is a breach of confidentiality. This could happen if, for 
example, confidential information, collected by CHR staff or extracted from the electronic health record 
during the course of the study was inadvertently disclosed to personnel other than the study staff. All 
persons employed by KPNW Center for Health Research (CHR) sign a written pledge every year not to 
reveal information about individual records that is any way traceable to a specific person or group of 
persons participating in research studies. Since its founding 50 years ago, CHR has had an excellent 
record of using these data systems for research without breach of confidentiality. No individual-
identifying data will be published or released, and data will be summarized and presented in public 
forums only in de-identified or aggregate form. CHR actively monitors for signs that the data systems 
have been infiltrated.  
 
Phase 2. Because the purpose of the two intervention arms, patient navigation only and patient 
navigation + diabetes self-management training, is to connect patients to social services and educate 
them about how to better manage their diabetes, we believe that these interventions carry no 
incremental health risks. That is, we believe the study carries no individual level health risks above and 
beyond what might be expected as part of usual care. Indeed, usual care can include referral to similar 
services and programs; the difference is the extent and ongoing nature of navigation and support. 
 
b. Potential Benefits to Subjects 
There are no potential benefits to participants for Phase 1 and Phase 3 of this pilot. 
 
Phase 2. Participants assigned to either intervention arm will benefit from connection to services 
to address medical, social, and/or economic needs as well as the opportunity to improve their 
diabetes management and reduce risks for complications. As previously mentioned, we believe 
that these interventions carry no incremental health risks and the potential benefits of 
participating far outweigh any possible risks. 

 
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9. Costs to Participants 
There are no cost to participants in this study. 
 
 
10. Compensation to Participants 
For Phase 2, participants who complete the YCLS assessment at both Baseline and 6-month follow-up, as well 
as complete an A1C test near the 6-month follow-up, will receive a $50 gift card as an incentive for their 
participation. For participants who do not complete the YCLS at the 6-month follow-up, but complete their 
A1C test or vice versa, we will provide them with a $25 gift card. For those participants who complete a 
qualitative interview, a $25 gift card will be provided for their participation.

 
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PROPOSED STUDY TIMELINE – Anticipated Start Date 09/20/18  
 
Year 1 
Year 2 
 
Q1 
Q2 
Q3 
Q4 
Q1 
Q2 
Q3 
Q4 
SET UP PERIOD 
 
 
 
 
 
 
 
 
IRB approval to begin team meetings and develop study protocol, tracking systems for recruitment, 
and recruitment materials 
 
 
 
 
 
 
 
 
Develop study protocol and tracking systems for recruitment and other process data 
 
 
 
 
 
 
 
 
Develop recruitment materials (e.g., targeted emails, fliers, phone scripts) 
 
 
 
 
 
 
 
 
Full IRB approval 
 
 
 
 
 
 
 
 
RECRUITMENT (Goal = 100 participants) 
 
 
 
 
 
 
 
 
RANDOMIZATION 
 
 
 
 
 
 
 
 
INTERVENTION DELIVERY (6 months) 
 
 
 
 
 
 
 
 
DATA COLLECTION  
 
 
 
 
 
 
 
 
Qualitative interviews  
 
 
 
 
 
 
 
 
Obtain 6-month A1C measure in health system clinic lab; completion of YCLS at 6-month follow-up 
 
 
 
 
 
 
 
 
Data extraction of utilization measures from electronic health record 
 
 
 
 
 
 
 
 
DATA ANALYSIS 
 
 
 
 
 
 
 
 
WRITING/PUBLICATIONS 
 
 
 
 
 
 
 
 
PREPARE R18 SUBMISSION 
 
 
 
 
 
 
 
 
YCLS = Your Current Life Situation 
 
 
 
 
 
 
 
 
 

 
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BIBLIOGRAPHY AND REFERENCES CITED 
 
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effects of medicare coverage. Ann Intern Med. 2009;150(8):505-515. 
2. 
Bae JP, Lage MJ, Mo D, Nelson DR, Hoogwerf BJ. Obesity and glycemic control in patients with 
diabetes mellitus: Analysis of physician electronic health records in the US from 2009-2011. 
Journal of diabetes and its complications. 2016;30(2):212-220. 
3. 
Spanakis EK, Golden SH. Race/ethnic difference in diabetes and diabetic complications. Curr 
Diab Rep. 2013;13(6):814-823. 
4. 
Gucciardi E, Vahabi M, Norris N, Del Monte JP, Farnum C. The Intersection between Food 
Insecurity and Diabetes: A Review. Current nutrition reports. 2014;3(4):324-332. 
5. 
Heerman WJ, Wallston KA, Osborn CY, et al. Food insecurity is associated with diabetes self-
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