Clinic to Community Navigation to Improve Diabetes Outcomes

1. Background: Appalachian residents maintain disproportionately high rates of Type 2
Diabetes Mellitus (T2DM) and suffer tremendous burdens from diabetic complications. The
main challenges to stemming adverse outcomes from T2DM involve ensuring optimal clinical
care and self-management. Because the prevalence of diabetes has tripled since 2005, the
already low supply of primary care physicians combined with this tremendous chronic
disease burden places huge demands on providers in rural Appalachia. Enhancing the
quality and efficiency of these practices by linking to community health workers has the
potential of mitigating the adverse effects of these shortages.

Patient navigation, particularly a clinic to community navigation (CCN) model offers an
innovative approach to address these inequities. Patient navigation has been implemented
almost exclusively in the cancer setting, despite being promising for chronic disease
management. The proposed project is, to our knowledge, the first to test a hybrid model
of clinic (health promotion professional) plus community (community health worker)
navigation among rural residents. Clinical patient navigation has been shown to
facilitate appointment setting and return visits, may improve goal setting, and enhances
some adherence (medication taking, blood glucose testing), but does not address some key
psychosocial (self-efficacy, patient activation) and practical concerns (transportation,
childcare, self-management) challenges. Community-based navigation programs have been
shown to enhance self-efficacy, decrease community barriers to care (e.g.,
transportation), and improved self-management, but may be less effective in ensuring
return visits and working collaboratively with the doctor.

2. Objectives: The investigators aim to test a CCN program that may improve the most
salient influences on diabetes outcomes and self-management, the health care context and
the patient's home context. Specifically, the investigators will (1) recruit 1200
participants from community settings with T2DM and HbA1c levels between 9-11% and
randomize them to one of three arms, DSMP; PN, or combined CCN intervention; (2) the
investigators will administer three quantitative assessments. All activities will take
place in Appalachia. Outcomes include physiologic data (HbA1C levels, blood pressure,
lipids, waist circumference and BMI, obtained by research staff); quantitative data
collection of self-management (medication taking, blood glucose, appointment adherence,
diet, physical activity, foot and eye care, obtained by interviewer); and psychosocial
variables (self-efficacy, patient activation, obtained by interviewer).

3. Study Design: Behavioral randomized controlled trial, single blind design.

4. Study Population: Eligibility criteria: Adults 18+; Appalachian residence, and HBA1c
levels between 9-11%. Those who do not meet these inclusion criteria, are cognitively
impaired, or who do not wish to participate will be excluded. All race/ethnicities and
both genders will be included. Participants will be enrolled on a rolling basis from
June 1, 2014-June 2, 2019. Participants will be involved in the study for approximately
one year. The investigators anticipate a total of 1200 participants.

5. Subject Recruitment Methods and Privacy: Participants will be recruited through churches
and other community settings. If eligible (see above), project staff will call potential
participants within five days to verify eligibility and determine their interest in
participating in the study.

6. Informed Consent Process: For those indicating an interest in participating, staff will
visit potential participants at their home or a location of their choosing and
administer the informed consent document. Study personnel for all phases of the project
will provide a clear explanation of the project and invite questions. Our informed
consent forms are written in a basic language. Interested participants will be asked to
provide their signature on the informed consent forms. A copy of the signed consent will
be provided for all participants. All forms will be read to participants to allay
concerns about limited literacy. No non-English speaking or cognitively impaired
participants will be recruited.

7. Research Procedures: The consort diagram (Figure 1) below provides an estimation and
visual description of the recruitment and sampling frame.

Fig 1: Consort diagram of enrollment

1. Once informed consent documents are completed, participants (N=1200) will undergo
the baseline assessment. Baseline, posttest, and exit assessments will consist of
the same measures highlighted in Table 3.

2. There will be three arms. For those randomized to the diabetes self management
program (n=435), within two weeks of initial recruitment and baseline assessment,
project staff will schedule the participant to attend a group Diabetes
Self-management Program, a six week, lay lead and en evidence-based diabetes home
self-management program (See Table 1, DSMP contents). Staff will arrange for the
group sessions of the DSMP. One session will take place every other week. Upon
completion of the DSMP program, approximately three month later, clinic navigation
will be implemented. For those randomized to the Patient Navigation group, within
two weeks of initial recruitment and baseline assessment, project staff will
schedule the participant to meet with the Community Health Worker who will
strategize about insuring that patients make their doctors' appointments as
scheduled. The CHW/Patient Navigator will make at least 4 calls to each participant
randomized to this group. For those randomized to the combined Community to Clinic
Navigation, CCN (n=435), both of the activities for the Diabetes self management
education group and the Patient navigation will be conducted. At month 5-6, the
posttest will take place. To assess sustainability, 3-4 months later, navigation
again will take place. An interviewer will complete the exit interview in month
10-11 using the same assessments. All throughout the intervention, standard medical
visits will take place.

Fig 2: Flow diagram of intervention and control activities by month

Table 1: DSMP contents and conduct:

Class Number Content/Objectives./Activities 1 Diabetes: causes, diagnosis, incidence,
and prevalence Discussion using a pancreas model and the handout "Understanding
Diabetes". How to talk with your doctor and being a proactive patient. Goal setting 2
Blood glucose testing, hyperglycemia, and hypoglycemia Discussion of the blood
glucose-testing procedure, review of the handouts "Hyperglycemia" and "Hypoglycemia.
Goal check in 3 Eating right for diabetes, discussion of the food pyramid and dietary
strategies ; Review of handouts. Goal check in 4 Avoiding complications: Eye care,
dental care, neuropathy, hypertension Discussion of appropriate eye care, dental care,
kidney care. Review of how to talk with your doctor. Goal check in 5 Getting active:
review of physical activity and foot care. Goal check in 6 Empowerment and goal check
in. Class discussion.

Table 2: Timeline

Activity Q1 Q2 Q3 Q4 Staff training Recruitment, informed consent, enrollment,
randomization Baseline medical record review/ interview 0 CCN arm participants receive
DSM sessions (6 sessions total) and navigation to clinic X X Posttest 1 0 CCN arm
Navigation X Exit interview 0 CCN= clinic to community navigation (intervention arm);
DSM= diabetes self-management; X= intervention activity; 0= assessment

8. Resources: The research and intervention activities will be conducted in participants'
homes, community sites, and the health clinics.

9. Potential Risks: The potential risks from participating in the study are very small.
Some risk of pain from a finger prick or psychological upset could result from
responding to interview questions or the emotional distress from questions about
diabetes management. The most significant risk involves any threat to confidentiality.
However, all project staff will be human subjects trained and have extensive experience
maintaining participant confidentiality.

10. Safety Precautions: In each stage of the research, the investigators will make every
effort to provide protection against risks. Study personnel will provide a clear
explanation of the project and invite questions during enrollment. In the rare event
that a participant experiences psychological distress resulting from the interview
questions or from the intervention, our staff will contact Dr. Van Breeding, internal
medicine physician at the MCHC. Dr. Breeding will consult with the participant, debrief
and discuss the participant's concerns, and refer participants to any additional
support. In addition, all project staff will receive training on how to respond to a
participant who needs additional assistance with diabetes management.

11. Benefit vs. Risk Participation in the study involves little risk for subjects in
comparison to the potential benefits of adopting improving diabetes outcomes.
Participants in the intervention group will receive their usual care, plus navigation
from a staff person at MCHC and an evidence-based diabetes self-management program at no
cost. If they are not assigned to the intervention arm, they will receive their usual
diabetes care. Given the disproportionate diabetes burden experienced by Appalachian
populations, implementing and evaluating this novel, theory based intervention has the
potential to save many lives while advancing intervention science.

12. Available Alternative Treatment(s): Participants will be randomized to the intervention
(the standard of care plus navigation with a clinic employee and community-based
navigation) OR will receive the standard treatment, which involves brief
clinically-based consultation with the health care provider.

13. Research Materials, Records, and Privacy: Two sources of data will be collected:
physiologic data collection (HbA1C levels, blood pressure, lipids, and BMI); and
quantitative assessments (surveys). Table 3 highlights the specific data to be
collected.

Table 3: Variables Data sources and collector Main outcomes HbA1C, blood pressure,
lipids, waist circumference, BMI Additional outcomes: Self-management outcomes
Medication taking, blood glucose testing, appointment adherence, diet, physical
activity, foot and eye care.

Assessments by UK project staff Diabetes Empowerment Scale (self-efficacy), patient
activation Assessments by UK project staff Sociodemographic, self-perceived health
status, depression, Clinic attendance, assessments by UK project staff

14. Confidentiality Confidentiality of all data will be maintained by never linking paper or
computer copy of data with the participants' names. A sheet with the participant's name,
address, telephone number, and identification number will be kept by the Project
Director and Principal Investigator separately in a locked file. Only staff members who
are authorized to review files will be permitted access to the data. As part of our
training, each lay health adviser and interviewer will be asked to sign a
confidentiality pledge promising never to reveal, alter, or falsify survey data. This
pledge is especially important in small, tight-knit rural communities. Data are held in
password-protected computers and secure servers at University of Kentucky which have
extensive firewalls and security measures. The investigator will keep all records
(tapes, informed consent documents, and other records like completed questionnaires) for
a minimum of six years after the completion of the study.

16. Costs to Subjects: N/A for program participation. Some costs associated with
transportation may occur.

17. Data and Safety Monitoring: N/A 18. Subject Complaints: Participants will be asked to
contact the investigator, Dr. Nancy Schoenberg at 859-323-8175 should they have any
complaints. If they have any questions about their rights as a volunteer in this research,
they will be asked to contact the staff in the Office of Research Integrity at the University
of Kentucky at 859-257-9428 or toll free at 1-866-400-9428.

19. Research Involving Non-English Speaking Subjects or Subjects from a Foreign Culture: N/A
20. HIV/AIDS Research: N/A 20. PI-Sponsored FDA-Regulated Research: N/A

Inclusion Criteria:

- Adults (age 18+);

- Appalachian residence, no plans to relocate out of the area in the next 18 months,

- Willingness and ability to participate (i.e., no major cognitive impairment)

- HbA1c levels at least 6.5% or Diagnosis of Diabetes.

Exclusion Criteria: