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: