Faculty Bibliography

BACKGROUND:Type 2 diabetes mellitus (DM) affects 9.4% of US adults and children, while another 33.9% of Americans are at risk of DM. Health care institutions face many barriers to systematically delivering the preventive care needed to decrease DM incidence. Community health workers (CHWs) may, as frontline public health workers bridging clinic and community, help overcome these challenges. This paper presents the protocol for a pragmatic, cluster-randomized trial integrating CHWs into two primary care clinics to support DM prevention for at-risk patients. METHODS:The trial will randomize 15 care teams, stratified by practice site (Bellevue Hospital and Manhattan VA), totaling 56 primary care physicians. The study cohort will consist of ~ 2000 patients who are 18-75 years of age, actively enrolled in a primary care team, able to speak English or Spanish, and have at least one glycosylated hemoglobin (HbA1c) result in the prediabetic range (5.7-6.4%) since 2012. Those with a current DM diagnosis or DM medication prescription (other than metformin) are ineligible. The intervention consists of four core activities - setting health goals, health education, activation for doctor's appointments, and referrals to DM prevention programs - adjustable according to the patient's needs and readiness. The primary outcome is DM incidence. Secondary outcomes include weight loss, HbA1C, and self-reported health behaviors. Clinical variables and health behaviors will be obtained through electronic medical records and surveys, respectively. Implementation outcomes, namely implementation fidelity and physicians' perspectives about CHW integration into the clinic, will be assessed using interviews and CHW activity logs and analyzed for the influence of moderating organizational factors. DISCUSSION/CONCLUSIONS:This is the first rigorous, pragmatic trial to test the effectiveness of integrating CHWs into primary care for DM prevention reaching a population-based sample. Our study's limitations include language-based eligibility and the use of HbA1c as a measure of DM risk. It will measure both clinical and implementation outcomes and potentially broaden the evidence base for CHWs and patient-centered medical home implementation. Further, the intervention's unique features, notably patient-level personalization and referral to existing programs, may offer a scalable model to benefit patients at-risk of DM. TRIAL REGISTRATION/BACKGROUND:Clinicaltrials.gov NCT03006666 (Received 12/27/2016).

BACKGROUND:The Mobile Insulin Titration Intervention (MITI) program helps patients with type 2 diabetes find their correct basal insulin dose without in-person care. Requiring only basic cell phone technology (text messages and phone calls), MITI is highly accessible to patients receiving care in safety-net settings. MITI was shown in a randomized controlled trial (RCT) to be efficacious at a New York City (NYC) safety-net clinic where patients often have challenges coming for in-person care. In 2016, MITI was implemented as usual care at Bellevue Hospital (the site of the original RCT) and at Gouverneur Health (a second NYC safety-net clinic) under 2 different staffing models. OBJECTIVE:This implementation study examined MITI's transition into real-world settings. To understand MITI's flexibility, generalizability, and acceptability among patients and providers, we evaluated whether MITI continued to produce positive outcomes in expanded underserved populations, outside of an RCT setting. METHODS:Patients enrolled in MITI received weekday text messages asking for their fasting blood glucose (FBG) values and a weekly titration call. The goal was for patients to reach their optimal insulin dose (OID), defined either as the dose of once-daily basal insulin required to achieve either an FBG of 80-130 mg/dL (4.4-7.2 mmol/L) or as the reaching of the maximum dose of 50 units. After 12 weeks, if OID was not reached, the patients were asked to return to the clinic for in-person care and titration. MITI program outcomes, clinical outcomes, process outcomes, and patient satisfaction were assessed. RESULTS:levels fell from 11.4% (101 mmol/mol) to 10.0% (86 mmol/mol), P<.001. Process outcomes show that 90.1% of MITI's text message prompts received a response, nurses connected with patients 81.9% of weeks to provide titration instructions, and 85% of attending physicians made at least one referral to the MITI program. Satisfaction surveys showed that most patients felt comfortable sharing information over text and felt the texts reminded them to take their insulin, check their sugar, and make healthy food choices. CONCLUSIONS:This implementation study showed MITI to have continued success after transitioning from an RCT program into real-world settings. MITI showed itself to be flexible and generalizable as it easily fits into a second site staffed by general medical clinic-registered nurses and remained acceptable to patients and staff who had high levels of engagement with the program.

BACKGROUND: In the Spring and Summer of 2016, a text-messaging intervention to titrate basal insulin in patients with type 2 diabetes and poor glycemic control was implemented at two safety net health care systems in New York City. The goal of the current study was to conduct a qualitative evaluation assessing barriers to, and facilitators of, implementation of the mobile insulin titration intervention (called "MITI"). METHODS: We conducted in-depth qualitative interviews with patients (N = 36) and physician, nursing and administrative staff (N = 19) at the two health care systems implementing MITI. Interviews were transcribed and coded by two study investigators using a codebook guided by the Consolidated Framework for Implementation Research and through iterative, consensus driven content analysis. RESULTS: Patients and staff perceived MITI as convenient and timesaving for patients, easy to use, and effective at achieving its clinical goals. Patients were comfortable sharing health information via text, and felt good about communicating with their health team remotely. Interviewees across stakeholder groups felt that MITI was helpful beyond insulin titration by reminding and motivating patients to engage in healthy behaviors and improving medication adherence. Staff felt MITI worked well with existing workflows and expressed a desire to see MITI expanded to other chronic conditions. Nurses responsible for weekly titration reported initial concerns over safety/liability, time required to deliver the program, difficulties reaching patients for titration calls and the need for ongoing support/training in using the online texting platform. Perceived barriers to MITI implementation reported by providers included perceived lack of patient cell phone access or texting capabilities and patient language barriers. There was also a theme that emerged across interviewees of an unmet need for additional diabetes management support among this population, beyond insulin support provided by MITI. The project team made several modifications to MITI operations in response to these findings. CONCLUSIONS: Patients and staff were overwhelmingly supportive of MITI and believed it had many benefits. Initial implementation of MITI should address nurse comfort, workload and training, and sites should provide ongoing support and training for nurses after implementation. Future research should explore options for integrating additional diabetes support for patients enrolled in MITI or after they are discharged from the program

BACKGROUND: Diabetes patients are usually started on a low dose of insulin and their dose is adjusted or "titrated" according to their blood glucose levels. Insulin titration administered through face-to-face visits with a clinician can be time consuming and logistically burdensome for patients, especially those of low socioeconomic status (SES). Given the wide use of mobile phones among this population, there is the potential to use short message service (SMS) text messaging and phone calls to perform insulin titration remotely. OBJECTIVE: The goals of this pilot study were to (1) evaluate if our Mobile Insulin Titration Intervention (MITI) intervention using text messaging and phone calls was effective in helping patients reach their optimal insulin glargine dose within 12 weeks, (2) assess the feasibility of the intervention within our clinic setting and patient population, (3) collect data on the cost savings associated with the intervention, and (4) measure patient satisfaction with the intervention. METHODS: This was a pilot study evaluating an intervention for patients requiring insulin glargine titration in the outpatient medical clinic of Bellevue Hospital Center in New York City. Patients in the intervention arm received weekday SMS text messages from a health management platform requesting their fasting blood glucose values. The clinic's diabetes nurse educator monitored the texted responses on the platform website each weekday for alarm values. Once a week, the nurse reviewed the glucose values, consulted the MITI titration algorithm, and called patients to adjust their insulin dose. Patients in the usual care arm continued to receive their standard clinic care for insulin titration. The primary outcome was whether a patient reached his/her optimal insulin glargine dose within 12 weeks. RESULTS: A total of 61 patients consented and were randomized into the study. A significantly greater proportion of patients in the intervention arm reached their optimal insulin glargine dose than patients in the usual care arm (88%, 29/33 vs 37%, 10/27; P<.001). Patients responded to 84.3% (420/498) of the SMS text messages requesting their blood glucose values. The nurse reached patients within 2 attempts or by voicemail 91% of the time (90/99 assigned calls). When patients traveled to the clinic, they spent a median of 45 minutes (IQR 30-60) on travel and 39 minutes (IQR 30-64) waiting prior to appointments. A total of 61% (37/61) of patients had appointment copays. After participating in the study, patients in the intervention arm reported higher treatment satisfaction than those in the usual care arm. CONCLUSIONS: MITI is an effective way to help low-SES patients reach their optimal insulin glargine dose using basic SMS text messaging and phone calls. The intervention was feasible and patients were highly satisfied with their treatment. The intervention was cost saving in terms of time for patients, who were able to have their insulin titrated without multiple clinic appointments. Similar interventions should be explored to improve care for low-SES patients managing chronic disease. TRIAL REGISTRATION: Clinicaltrials.gov NCT01879579; https://clinicaltrials.gov/ct2/show/NCT01879579 (Archived by WebCite at http://www.webcitation.org/6YZik33L3).

AIMS: To determine whether chronic life stress is differentially associated with quality of life (QoL) for Blacks vs. Hispanics with type 2 diabetes. METHODS: We assessed self-reported chronic stress and QoL in 125 patients with type 2 diabetes who self-identified as either non-Hispanic Black or Hispanic. Separate cross-sectional two-way interaction models (stressxrace/ethnicity) with physical and mental health as outcomes were examined. RESULTS: The two-way interaction predicted mental (b=3.12, P=.04) but not physical health. Simple slopes analyses indicated that under conditions of high stress, Blacks (b=-4.4, P<.001), but not Hispanics, experienced significantly lower levels of mental health. In exploratory analyses, we examined a three-way interaction (stressxrace/ethnicityxsocial support) with physical and mental health as outcomes. Results indicated the three-way interaction predicted mental (b=.62, P=.01) but not physical health. Simple slopes analyses indicated that under conditions of high stress, high levels of social support improved mental health for Hispanics (b=1.2, P<.001), but not for Blacks. CONCLUSIONS: Black patients with type 2 diabetes may be particularly vulnerable to the deleterious effects of high chronic stress. Social support buffers effects of stress on mental health in Hispanics but not Blacks, which suggests differences in the use and/or quality of social support between Hispanics and Blacks. Longitudinal investigations that examine race/ethnicity, stress, social support, and QoL should help clarify the processes that underlie these observed relations.