Patient and clinician preferences for diabetes management among older adults with co-morbid HIV: A qualitative exploration.

BACKGROUND: Older adults with HIV are at increased risk of developing certain chronic health conditions including type 2 diabetes mellitus (T2DM). As the number and complexity of conditions increases, so do treatment and health care needs. We explored patient and clinician preferences for HIV+T2DM care and perceived solutions to improving care. METHODS: We conducted an exploratory qualitative study comprised of individual in-depth interviews. Participants included English-speaking patients aged 50 and older living with HIV and T2DM and infectious disease (ID) and primary care (PC) clinicians from a large academic health center in Chicago. Thematic analysis drew from the Framework Method. RESULTS: A total of 19 patient and 10 clinician participants were interviewed. Many patients reported seeking HIV and T2DM care from the same clinician; they valued rapport and a 'one-stop-shop'. Others reported having separate clinicians; they valued perceived expertise and specialty care. Nearly all clinicians reported comfort screening for T2DM and initiating first line oral therapy; ID clinicians reported placing referrals for newer, complex therapies. Patients would like educational support for T2DM management; clinicians would like to learn more about newer therapies and easier referral processes. CONCLUSIONS: Patient-centered care includes managing T2DM from a variety of clinical settings for individuals with HIV, yet strategies are needed to better support clinicians. Future research should examine how best to implement these strategies.

Optimizing Telehealth Services: A Mixed-Methods Needs Assessment Conducted Among Community Health Center Patients.

BACKGROUND: The COVID-19 pandemic increased telehealth services in federally funded community health centers (CHCs). Yet little is known about common determinants of use among CHC patients. OBJECTIVE: We examined the use of telehealth among patient participants at 1 large CHC network providing care to underserved populations at urban and suburban sites in the Midwest. METHODS: We conducted a mixed-methods study utilizing a sequential explanatory design. Participants were English and/or Spanish-speaking adults who attended ≥1 visits for themselves or their child over a 12-month period at any practice location. Research staff conducted a structured phone survey of eligible adults. The results subsequently facilitated purposive sampling of telehealth "users" and "nonusers" for qualitative phone interviews. RESULTS: The survey participants included 500 adults. Most had access to the resources needed to utilize telehealth, including a smartphone (90.4%) and home internet (83.0%). About half (50.8%) "rarely or never" had problems with internet speed, reliability, or quality. Most (81.1%) were aware of the patient portal and 59.8% had utilized video visits. Participants who were Spanish-speaking and with limited English proficiency faced some of the greatest barriers. Qualitative interview participants included 12 users and 12 nonusers of telehealth. Users found telehealth convenient and efficient, while nonusers lacked awareness about how telehealth services could be beneficial or needed assistance to sign up, join, or use telehealth. CONCLUSIONS: Most participants had the resources and awareness necessary to use telehealth services. Those who use them appreciate the convenience and efficiency. Nevertheless, additional support may be needed to prevent telehealth from exacerbating health inequities.

Promoting REproductive Planning And REadiness in Diabetes (PREPARED) Study protocol: a clinic-randomised controlled trial testing a technology-based strategy to promote preconception care for women with type 2 diabetes.

INTRODUCTION: Women with type 2 diabetes (T2DM) are more likely to experience adverse reproductive outcomes, yet preconception care can significantly reduce these risks. For women with T2DM, preconception care includes reproductive planning and patient education on: (1) the importance of achieving glycaemic control before pregnancy, (2) using effective contraception until pregnancy is desired, (3) discontinuing teratogenic medications if pregnancy could occur, (4) taking folic acid, and (5) managing cardiovascular and other risks. Despite its importance, few women with T2DM receive recommended preconception care. METHODS AND ANALYSIS: We are conducting a two-arm, clinic-randomised trial at 51 primary care practices in Chicago, Illinois to evaluate a technology-based strategy to 'hardwire' preconception care for women of reproductive age with T2DM (the PREPARED (Promoting REproductive Planning And REadiness in Diabetes) strategy) versus usual care. PREPARED leverages electronic health record (EHR) technology before and during primary care visits to: (1) promote medication safety, (2) prompt preconception counselling and reproductive planning, and (3) deliver patient-friendly educational tools to reinforce counselling. Post-visit, text messaging is used to: (4) encourage healthy lifestyle behaviours. English and Spanish-speaking women, aged 18-44 years, with T2DM will be enrolled (N=840; n=420 per arm) and will receive either PREPARED or usual care based on their clinic's assignment. Data will be collected from patient interviews and the EHR. Outcomes include haemoglobin A1c (primary), reproductive knowledge and self-management behaviours. We will use generalised linear mixed-effects models (GLMMs) to evaluate the impact of PREPARED on these outcomes. GLMMs will include a fixed effect for treatment assignment (PREPARED vs usual care) and random clinic effects. ETHICS AND DISSEMINATION: This study was approved by the Northwestern University Institutional Review Board (STU00214604). Study results will be published in journals with summaries shared online and with participants upon request. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04976881).

A Qualitative Exploration of Perceived Medication Adherence Determinants Conducted Among Older Adults with HIV and Type 2 Diabetes Mellitus.

Background: People living with HIV (PLWH) are at higher risk of developing type 2 diabetes (T2DM). Both chronic conditions require individuals to adhere to medication regimens, yet few studies have sought to explore medication-taking behaviors among individuals with comorbid HIV and T2DM (HIV+T2DM). Objective: This qualitative study sought to: 1) identify and compare perceived determinants of medication adherence for HIV and, separately, for T2DM, and 2) explore how participants prioritize conditions. Methods: Between October 2022 and January 2023, we conducted in-depth interviews with individuals aged 50 or older, living with comorbid HIV+T2DM. Participants were prescribed oral medications to treat their conditions and had recent clinical measures indicating probable challenges with medication adherence. Interviews with consented participants from a large academic health center in the Midwest were conducted remotely. Questions largely drew from the Theoretical Domains Framework (TDF), a widely used implementation science framework. Additional questions explored the prioritization of conditions. Analysis employed the Framework Method and a side-by-side comparison of key determinants of medication adherence by condition. Results: A total of 19 interviews were audio recorded, transcribed, and analyzed. Participants were an average age of 61, mostly male (89.5%), and Non-Hispanic White (47.4%). Although results revealed many commonalities between perceived determinants of medication adherence for HIV and for T2DM, differences relating to two TDF domains were noted: nature of the behavior (taking medications as prescribed), and motivations and goals. Many participants viewed their conditions as equally important, though they suggested T2DM was more difficult to manage, largely due to lifestyle modifications. Conclusion: As individuals with HIV develop chronic conditions, such as T2DM, they may require additional medication adherence support. Attention should be paid to offering support early. Disease perceptions may differ by condition, and as such, one's motivations to take medication as prescribed may also differ by condition.

Long-term impact of the COVID-19 pandemic on self-management of chronic conditions among high-risk adults in the USA: protocol for the C3 observational cohort study.

INTRODUCTION: COVID-19 is an unprecedented public health threat in modern times, especially for older adults or those with chronic illness. Beyond the threat of infection, the pandemic may also have longer-term impacts on mental and physical health. The COVID-19 & Chronic Conditions ('C3') study offers a unique opportunity to assess psychosocial and health/healthcare trajectories over 5 years among a diverse cohort of adults with comorbidities well-characterised from before the pandemic, at its onset, through multiple surges, vaccine rollouts and through the gradual easing of restrictions as society slowly returns to 'normal'. METHODS AND ANALYSIS: The C3 study is an extension of an ongoing longitudinal cohort study of 'high-risk' adults (aged 23-88 at baseline) with one or more chronic medical conditions during the COVID-19 pandemic. Five active studies with uniform data collection prior to COVID-19 were leveraged to establish the C3 cohort; 673 adults in Chicago were interviewed during the first week of the outbreak. The C3 cohort has since expanded to include 1044 participants across eight survey waves (T1-T8). Four additional survey waves (T9-T12) will be conducted via telephone interviews spaced 1 year apart and supplemented by electronic health record and pharmacy fill data, for a total of 5 years of data post pandemic onset. Measurement will include COVID-19-related attitudes/behaviours, mental health, social behaviour, lifestyle/health behaviours, healthcare use, chronic disease self-management and health outcomes. Mental health trajectories and associations with health behaviours/outcomes will be examined in a series of latent group and mixed effects modelling, while also examining mediating and moderating factors. ETHICS AND DISSEMINATION: This study was approved by Northwestern University's Feinberg School of Medicine Institutional Review Board (STU00215360). Results will be published in international peer-reviewed journals and summaries will be provided to the funders of the study.

Barriers and facilitators of self-management behaviors among patients with chronic obstructive pulmonary disease and chronic comorbidities: A mixed-methods investigation.

OBJECTIVES: We investigated how individuals with chronic obstructive pulmonary disease (COPD) and multi-morbidity (MM) navigate barriers and facilitators to their health management. METHODS: We conducted a mixed-methods study using semi-structured interviews and survey assessments of adults with COPD, hypertension, and/or diabetes. We recruited 18 participants with an average age of 65, with 39% being male, 50% Black, and 22% Hispanic/Latino/a. Five investigators used an iterative, hybrid-coding process combining a priori and emergent codes to analyze transcripts and compare quantitative and qualitative data for themes. RESULTS: Participants reported a generalized approach to their health rather than managing MMs separately. Individuals with good or mixed adherence found daily routines facilitated regular medication use, while those with poor adherence experienced complex prescriptions and life stressors as barriers. Walking was viewed as beneficial but challenging due to limited mobility. Most participants viewed diet as important to their MMs, but only two reported high diet quality and many held inaccurate beliefs about healthy diet choices. DISCUSSION: Participants with MM were highly motivated to engage in self-management activities, but some individuals experienced barriers to maintaining them. Emphasizing an individualized clinical approach to assessing and solving patient barriers may improve self-management outcomes in this complex population.

Impact of COVID-19 on the capacity to self-manage health and chronic conditions.

Objective: To investigate well-being, lifestyle behaviors, self-management capacity and healthcare utilization among adults with chronic conditions at the outbreak of the COVID-19 pandemic. Methods: Data was collected from two interviewer-administered telephone surveys conducted between March 27 - May 22, 2020. Participants were patients at Chicago-area clinics. Self-report and validated measures were used for study-related outcomes. Results: A total of 553 participants (age range 23-88) completed data collection at both timepoints. One in five (20.7%) participants experienced stress due to the coronavirus most or all the time and rates of negative well-being were high (WHO-5 Index mean = 58.7%). Almost a quarter (22.3%) engaged in hazardous drinking and 79.7% reported insufficient physical activity. Nearly one in four participants (23.7%) avoided seeking medical care due to worry about COVID-19. In multivariable analyses, greater COVID-19 related stress was associated with less physical activity, lower self-efficacy, greater difficulty managing health and medications, and delays in seeking medical care due to the coronavirus. Conclusions: Mental well-being, lifestyle behaviors, self-management capacity, and healthcare utilization were impacted in the months following the COVID outbreak. Innovation: These findings suggest health systems should implement proactive measures for detecting and treating emotional and behavioral COVID-related concerns.

Trajectories of perceived susceptibility to COVID-19 over a year: The COVID-19 & chronic conditions (C3) cohort study.

ABSTRACT: The U.S. public health response to coronavirus disease 2019 (COVID-19) has been widely criticized as having downplayed the potential implications COVID-19 could have on one's personal health. Despite the unprecedented threat of COVID-19, many individuals still believed that it was not at all likely that they would become infected. We sought to investigate trends in adults' perceived susceptibility to COVID-19 over the first year of the pandemic, whether distinct trajectories emerged, and if these trajectories differed by participant socio-demographic characteristics.This was a longitudinal cohort study with 5 time points of data collection (March 13, 2020-March 3, 2021). Subjects included 627 adults living with ≥1 chronic conditions, who completed a baseline interview and at least one follow-up interview. In addition to collecting relevant socio-demographic characteristics, participants' perceived susceptibility to COVID-19 across time was assessed and classified into distinct trajectories.Nearly two-thirds (62.2%) of participants perceived themselves to be highly susceptible to COVID-19 from the onset of the pandemic ("early responders") and sustained this over a year, a third (29.0%) eventually perceived themselves to be highly susceptible ("late responders"), and 8.8% maintained a low likelihood of susceptibility throughout the pandemic ("non-responders"). In multivariable analyses, compared to White participants, Latinx participants were significantly more likely to be non-responders and report low likelihood of perceived susceptibility (Risk Ratio [RR]: 3.46; 95% confidence interval: 1.19, 10.1), as were Black participants (RR: 5.49; 95% confidence interval: 2.19, 13.8).A year into the COVID-19 pandemic, 1 out of 11 participants persistently did not think they might be susceptible and potentially infected. Future studies are needed to understand reasons why certain individuals, particularly those of racial/ethnic minorities, did not perceive themselves at risk for infection.

Perceived Adequacy of Tangible Support during Stay-at-Home Orders in Chicago and New York.

OBJECTIVES: Physical distancing precautions during the COVID-19 pandemic may challenge the provision of tangible support many middle age and older adults receive in managing their health. We examined the association between unmet tangible support needs and self-management behaviors and mental health status during the stay-at-home orders in Chicago and New York. METHODS: We used data from the COVID-19 & Chronic Conditions study collected between May 1st and May 22nd, 2020. A total of 801 middle age and older adults with ≥1 chronic condition in Chicago and New York City completed the telephone interview. Adequacy of tangible social support was measured using a brief, validated scale that determined whether an individual needed assistance managing his or her health, and if yes, whether this need was met. Participants reported their level of difficulty engaging in self-management behaviors using 2 discrete items; they also self-reported medication adherence using the ASK-12 medication adherence scale. Mental health status was measured using the depression and anxiety PROMIS short-form instruments. RESULTS: Participants' mean age was 63 years; 30% identified as Black, 26% identified as Latino, and 12% identified unmet support needs. Inadequacy of tangible support was associated with greater difficulty managing one's health and accessing medications due to COVID-19, as well as poorer medication adherence, increased anxiety and depressive symptoms, and poorer overall well-being (P's < .05). CONCLUSIONS: Perceived unmet support needs during stay-at-home orders were associated with greater difficulty engaging in self-management behaviors and poorer overall well-being. Two brief items quickly identified individuals with unmet support needs.

Changes in COVID-19 Knowledge, Beliefs, Behaviors, and Preparedness Among High-Risk Adults from the Onset to the Acceleration Phase of the US Outbreak.

BACKGROUND: The US outbreak of coronavirus disease 2019 (COVID-19) accelerated rapidly over a short time to become a public health crisis. OBJECTIVE: To assess how high-risk adults' COVID-19 knowledge, beliefs, behaviors, and sense of preparedness changed from the onset of the US outbreak (March 13-20, 2020) to the acceleration phase (March 27-April 7, 2020). DESIGN: Longitudinal, two-wave telephone survey. PARTICIPANTS: 588 predominately older adults with ≥ 1 chronic condition recruited from 4 active, federally funded studies in Chicago. MAIN MEASURES: Self-reported knowledge of COVID-19 symptoms and prevention, related beliefs, behaviors, and sense of preparedness. KEY RESULTS: From the onset to the acceleration phase, participants increasingly perceived COVID-19 to be a serious public health threat, reported more changes to their daily routine and plans, and reported greater preparedness. The proportion of respondents who believed they were "not at all likely" to get the virus decreased slightly (24.9 to 22.4%; p = 0.04), but there was no significant change in the proportion of those who were unable to accurately identify ways to prevent infection (29.2 to 25.7%; p 0.14). In multivariable analyses, black adults and those with lower health literacy were more likely to report less perceived susceptibility to COVID-19 (black adults: relative risk (RR) 1.62, 95% confidence interval (CI) 1.07-2.44, p = 0.02; marginal health literacy: RR 1.96, 95% CI 1.26-3.07, p < 0.01). Individuals with low health literacy remained more likely to feel unprepared for the outbreak (RR 1.80, 95% CI 1.11-2.92, p = 0.02) and to express confidence in the federal government response (RR 2.11, 95% CI 1.49-3.00, p < 0.001) CONCLUSIONS: Adults at higher risk for COVID-19 continue to lack critical knowledge about prevention. While participants reported greater changes to daily routines and plans, disparities continued to exist in perceived susceptibility to COVID-19 and in preparedness. Public health messaging to date may not be effectively reaching vulnerable communities.

Knowledge and Behaviors of Adults with Underlying Health Conditions During the Onset of the COVID-19 U.S. Outbreak: The Chicago COVID-19 Comorbidities Survey.

Accurate understanding of COVID-19 safety recommendations early in the outbreak was complicated by inconsistencies in public health and media messages. We sought to characterize high-risk adults' knowledge of COVID-19 symptoms, prevention strategies, and prevention behaviors. We used data from the Chicago COVID-19 Comorbidities (C3) survey collected between March 13 thru March 20, 2020. A total of 673 predominately older adults with ≥ 1 chronic condition completed the telephone interview. Knowledge was assessed by asking participants to name three symptoms of COVID-19 and three actions to prevent infection. Participants were then asked if and how they had changed plans due to coronavirus. Most participants could identify three symptoms (71.0%) and three preventive actions (69.2%). Commonly reported symptoms included: fever (78.5%), cough (70.6%), and shortness of breath (45.2%); preventive actions included: washing hands (86.5%) and social distancing (86.2%). More than a third of participants reported social distancing themselves (38.3%), and 28.8% reported obtaining prescription medication to prepare for the outbreak. In multivariable analyses, no participant characteristics were associated with COVID-19 knowledge. Women were more likely than men, and Black adults were less likely than White adults to report practicing social distancing. Individuals with low health literacy were less likely to report obtaining medication supplies. In conclusion, though most higher-risk individuals were aware of social distancing as a prevention strategy early in the outbreak, less than half reported enacting it, and racial disparities were apparent. Consistent messaging and the provision of tangible resources may improve future adherence to safety recommendations.

Awareness, Attitudes, and Actions Related to COVID-19 Among Adults With Chronic Conditions at the Onset of the U.S. Outbreak: A Cross-sectional Survey.

BACKGROUND: The evolving outbreak of coronavirus disease 2019 (COVID-19) is requiring social distancing and other measures to protect public health. However, messaging has been inconsistent and unclear. OBJECTIVE: To determine COVID-19 awareness, knowledge, attitudes, and related behaviors among U.S. adults who are more vulnerable to complications of infection because of age and comorbid conditions. DESIGN: Cross-sectional survey linked to 3 active clinical trials and 1 cohort study. SETTING: 5 academic internal medicine practices and 2 federally qualified health centers. PATIENTS: 630 adults aged 23 to 88 years living with 1 or more chronic conditions. MEASUREMENTS: Self-reported knowledge, attitudes, and behaviors related to COVID-19. RESULTS: A fourth (24.6%) of participants were "very worried" about getting the coronavirus. Nearly a third could not correctly identify symptoms (28.3%) or ways to prevent infection (30.2%). One in 4 adults (24.6%) believed that they were "not at all likely" to get the virus, and 21.9% reported that COVID-19 had little or no effect on their daily routine. One in 10 respondents was very confident that the federal government could prevent a nationwide outbreak. In multivariable analyses, participants who were black, were living below the poverty level, and had low health literacy were more likely to be less worried about COVID-19, to not believe that they would become infected, and to feel less prepared for an outbreak. Those with low health literacy had greater confidence in the federal government response. LIMITATION: Cross-sectional study of adults with underlying health conditions in 1 city during the initial week of the COVID-19 U.S. outbreak. CONCLUSION: Many adults with comorbid conditions lacked critical knowledge about COVID-19 and, despite concern, were not changing routines or plans. Noted disparities suggest that greater public health efforts may be needed to mobilize the most vulnerable communities. PRIMARY FUNDING SOURCE: National Institutes of Health.

Prevalence of Universal Medication Schedule prescribing and links to adherence.

PURPOSE: A Universal Medication Schedule (UMS) that uses explicit language to describe when to take medicine has been proposed as a patient-centered prescribing and dispensing standard. Despite widespread support, evidence of its actual use and efficacy is limited. We investigated the prevalence of UMS instructions and whether their use was associated with higher rates of medication adherence. METHODS: National pharmacy records were analyzed for a cohort of type 2 diabetic adults ≥18 years old (N = 676,739) new to ≥1 oral diabetes medications between January and June 2014. Prescription instructions (N = 796,909) dispensed with medications were classified as UMS or non-UMS. Instructions coded as UMS were further categorized as either providing precise UMS language (tier 1: "take 1 pill at morning, noon, evening, or bedtime") or offering some explicit guidance (tier 2: "take 1 tablet by mouth before breakfast"; tier 3: "take 1 tablet twice daily with a meal"). Adherence over 12 months was measured by proportion of days covered. RESULTS: One-third of instructions (32.4%, n = 258,508) were classified as UMS (tier 1: 12.6%, n = 100,589; tier 2: 6.0%, n = 47,914; tier 3: 13.8%, n = 110,005). In multivariable analyses, UMS instructions (all tiers) exhibited better adherence compared to non-UMS instructions (relative risk [RR], 1.01; 95% confidence interval [CI], 1.00-1.02; P = 0.01). Patients older than 65 years who were less educated and taking medication more than once daily received greater benefit from tier 1 UMS instructions (RR, 1.14; 95% CI, 1.07-1.21; P < 0.001). CONCLUSION: While infrequently used, the UMS could help older, less-educated patients adhere to more complex regimens with minimal investment.

Development of the influence, motivation, and patient activation in diabetes (IMPACT-D™) measure.

AIMS: We sought to create a new research and clinical instrument -the Influence and Motivation for Patient ACTivation in Diabetes care (IMPACT-D™) - to measure the degree to which patients with type 2 diabetes (T2DM) value health and believe they can influence it. METHODS: Candidate items were generated via a literature review, expert opinion, and qualitative interviews and focus groups with T2DM patients in Chicago, IL and Chapel Hill, NC. Psychometric testing guided by item response theory was conducted among an online panel of 500 English-speaking adults with T2DM. Differential item functioning analyses evaluated item performance across key participant characteristics. To determine construct validity, IMPACT-D™ scores were compared to other general measures of personality and patient activation. A second study among 300 patients recruited from two internal medicine clinics further assessed associations between the IMPACT-D™ and health outcomes. Cognitive interviews confirmed patient understanding of IMPACT-D™ items and instructions. RESULTS: Exploratory factor analyses revealed a single-factor solution that included 6 items. The IMPACT-D™ demonstrated adequate reliability (α = 0.72) and moderate construct validity with patient activation (r = 0.51, p < 0.001) and personality-conscientiousness subscales (r = 0.29, p < 0.001). Higher scores on the IMPACT-D™ were associated with better physical health (r = 0.17, p = 0.003) and lower severity of depressive (r = -0.35, p < 0.001) and anxiety (r = -0.28, p < 0.001) symptoms. There were no significant differences by blood pressure (r = -0.0021, p = 0.9) or haemoglobin A1c (r = -0.069p = 0.2). CONCLUSIONS: The IMPACT-D holds potential for use in both clinical care and research applications. Future studies should evaluate how to best operationalize its use for both settings.

Electronic Health Record-Based Strategy to Promote Medication Adherence Among Patients With Diabetes: Longitudinal Observational Study.

BACKGROUND: Poor medication adherence is common; however, few mechanisms exist in clinical practice to monitor how patients take medications in outpatient settings. OBJECTIVE: This study aimed to pilot test the Electronic Medication Complete Communication (EMC2) strategy, a low-cost, sustainable approach that uses functionalities within the electronic health record to promote outpatient medication adherence and safety. METHODS: The EMC2 strategy was implemented in 2 academic practices for 14 higher-risk diabetes medications. The strategy included: (1) clinical decision support alerts to prompt provider counseling on medication risks, (2) low-literacy medication summaries for patients, (3) a portal-based questionnaire to monitor outpatient medication use, and (4) clinical outreach for identified concerns. We recruited adult patients with diabetes who were prescribed a higher-risk diabetes medication. Participants completed baseline and 2-week interviews to assess receipt of, and satisfaction with, intervention components. RESULTS: A total of 100 patients were enrolled; 90 completed the 2-week interview. Patients were racially diverse, 30.0% (30/100) had a high school education or less, and 40.0% (40/100) had limited literacy skills. About a quarter (28/100) did not have a portal account; socioeconomic disparities were noted in account ownership by income and education. Among patients with a portal account, 58% (42/72) completed the questionnaire; 21 of the 42 patients reported concerns warranting clinical follow-up. Of these, 17 were contacted by the clinic or had their issue resolved within 24 hours. Most patients (33/38, 89%) who completed the portal questionnaire and follow-up interview reported high levels of satisfaction (score of 8 or greater on a scale of 1-10). CONCLUSIONS: Findings suggest that the EMC2 strategy can be reliably implemented and delivered to patients, with high levels of satisfaction. Disparities in portal use may restrict intervention reach. Although the EMC2 strategy can be implemented with minimal impact on clinic workflow, future trials are needed to evaluate its effectiveness to promote adherence and safety.

Rationale and design of the regimen education and messaging in diabetes (REMinD) trial.

BACKGROUND: Individuals with type 2 diabetes manage complex multi-drug regimens, but nearly half of all patients do not consistently take the dose prescribed for them, and therefore may not receive the full potential therapeutic benefit. Both patient and health system factors contribute to achieving and maintaining medication adherence. To determine if patients with type 2 diabetes who are concurrently managing other chronic conditions could improve their adherence, we devised and are testing a multifaceted, primary care-based strategy to provide health literacy-appropriate and language concordant regimen information, guidance and reminders. OBJECTIVE: We are testing the effectiveness of an electronic health record (EHR) based strategy and short message service (SMS) text reminders to help patients with type 2 diabetes adhere to their medications. METHODS: We are conducting a 3-arm, multi-site trial to test and compare the effectiveness of the EHR, and EHR + SMS text reminder strategies compared to usual care on medication adherence. Our goal is to enroll a total of 900 English or Spanish-speaking patients with type 2 diabetes and hemoglobin A1C value ≥7.5%. Enrolled participants will complete interviews at baseline and 3 and 6 months following their baseline interview. CONCLUSIONS: Our trial is evaluating practical, clinic-based, scalable, evidence-based solutions for patients with type 2 diabetes managing complex medication regimens. Our findings will evaluate strategies that can be implemented broadly in primary care practices, and programmed as defaults within EHRs to support appropriate medication adherence to allow the widespread implementation of those strategies.

Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults.

BACKGROUND: Patients with chronic conditions are often responsible for self-managing complex, multi-drug regimens with minimal professional clinical support. While numerous interventions to promote and support medication adherence have been tested, most have had limited success or have been too resource-intensive for real-world implementation. OBJECTIVE: To compare the effectiveness of multiple low-cost, technology-enabled strategies, alone and in combination, for promoting medication regimen adherence among older adults. METHODS: Older, English or Spanish-speaking patients on complex drug regimens (N=1505) will be recruited from a community health system in Chicago, IL. Enrolled patients will be randomized to one of four study arms, receiving either: 1) enhanced usual care alone; 2) daily medication reminders via SMS text messages; 3) medication monitoring via a patient portal-based assessment; or 4) both SMS text message reminders and portal-based medication monitoring. The primary outcome of the study is medication adherence, which will be assessed via multiple measures at baseline, 2months, and 6months. The effect of intervention strategies on clinical markers (hemoglobin A1c, blood pressure, cholesterol level), as well as intervention fidelity and the barriers and costs of implementation will also be evaluated. CONCLUSIONS: This randomized controlled trial will evaluate the impact of various low-cost intervention strategies on adherence to complex medication regimens and will explore barriers to implementation. If the studied intervention strategies are shown to be effective, then these approaches could be effectively deployed across a diverse range of clinical settings and patient populations. CLINICAL TRIAL REGISTRATION: This trial is registered on clinicaltrials.govNCT02820753.