The Diabetes Health Plan and Healthcare Utilization Among Beneficiaries with Low Incomes.

BACKGROUND: The socioeconomic status (SES) gradient in hospital and emergency room utilization among adults with type 2 diabetes (T2DM) is partially driven by cost-related non-adherence. OBJECTIVE: To test the impact of the Diabetes Health Plan (DHP), a diabetes-specific health plan incorporating value-based insurance design principles on healthcare utilization among low-income adults with T2DM. DESIGN: To examine the impact of the DHP on healthcare utilization, we employed a difference-in-differences (DID) study design with a propensity-matched comparison group. We modeled count and dichotomous outcomes using Poisson and logit models, respectively. PARTICIPANTS: Cohort of adults (18-64) with T2DM, with an annual household income <$ 30,000, and who were continuously enrolled in an employer-sponsored UnitedHealthcare plan for at least 2 years between 2009 and 2014. INTERVENTIONS: The DHP reduces or eliminates out-of-pocket costs for disease management visits, diabetes-related medicines, and diabetes self-monitoring supplies. The DHP also provides access to diabetes-specific telephone case management as well as other online resources. MAIN MEASURES: Number of disease management visits (N = 1732), any emergency room utilization (N = 1758), and any hospitalization (N = 1733), within the year. KEY RESULTS: DID models predicting disease management visits suggested that DHP-exposed beneficiaries had 1.7 fewer in-person disease management visits per year (- 1.70 [95% CI: - 2.19, - 1.20], p < 0.001), on average, than comparison beneficiaries. Models for emergency room (0.00 [95% CI: - 0.06, 0.06], p = 0.966) and hospital utilization (- 0.03 [95% CI: - 0.08, - 0.01], p = 0.164) did not demonstrate statistically significant changes associated with DHP exposure. CONCLUSIONS: While no relationship between DHP exposure and high-cost utilization was observed in the short term, fewer in-person disease management visits were observed. Future studies are needed to determine the clinical implications of these findings.

A Qualitative Study of Perceptions and Preferences Regarding Social and Behavioral Risk Screening Among Primary Care Patients.

BACKGROUND: Despite its relevance for healthcare settings, social and behavioral risk screening is not systematically performed by clinicians or healthcare systems. OBJECTIVE: To address clinician concerns, such as social and behavioral risk screening disrupting the clinician-patient relationship and lack of resources to respond, we interviewed primary care patients at an academic medical center regarding their perceptions and preferences on social and behavioral risk screening. PARTICIPANTS: Between September and December 2020, we recruited a convenience sample of 14 English-speaking primary care patients 18 years + from three clinics affiliated with an academic medical center. APPROACH: Using a semi-structured interview guide, we asked about the importance of social and behavioral risk screening, whether or not and how to share social and behavioral risk factors, and how social and behavioral risk factors are addressed. We used a multi-step analytic process to identify the range and commonality of participants' responses thematically. KEY RESULTS: Participants recognized that social and behavioral risk factor domains were relevant to primary care and important for treating the patient as a whole person. Participants preferred a conversation regarding social and behavioral risk factor with their primary care providers (PCPs), and suggested that, if surveys are used, they be followed with an open-ended, in-person discussion. Participants also suggested framing the discussion as something that is done routinely with all patients so that patients do not feel judged. Participants felt comfortable sharing social and behavioral risk factors when they trusted their PCPs, and felt that discussing social and behavioral risk factors with their PCPs built trust. Participants recognized that resources exist outside of the clinic, and suggested that PCPs distribute lists of relevant community resources to patients. CONCLUSION: In our study of primary care patients on perceptions and preferences about screening and addressing social and behavioral risk factors, we found that patients were willing to share social and behavioral risk factors with their PCP, preferred an in-person discussions with or without a survey, and wanted a list of community resources to address their needs.

Evaluation of behavioral economic strategies to raise influenza vaccination rates across a health system: Results from a randomized clinical trial.

Influenza vaccination rates are low. Working with a large US health system, we evaluated three health system-wide interventions using the electronic health record's patient portal to improve influenza vaccination rates. We performed a two-arm RCT with a nested factorial design within the treatment arm, randomizing patients to usual-care control (no portal interventions) or to one or more portal interventions. We included all patients within this health system during the 2020-2021 influenza vaccination season, which overlapped with the COVID-19 pandemic. Through the patient portal, we simultaneously tested: pre-commitment messages (sent September 2020, asking patients to commit to a vaccination); monthly portal reminders (October - December 2020), direct appointment scheduling (patients could self-schedule influenza vaccination at multiple sites); and pre-appointment reminder messages (sent before scheduled primary care appointments, reminding patients about influenza vaccination). The main outcome measure was receipt of influenza vaccine (10/01/2020-03/31/2021). We randomized 213,773 patients (196,070 adults ≥18 years, 17,703 children). Influenza vaccination rates overall were low (39.0%). Vaccination rates for study arms did not differ: Control (38.9%), pre-commitment vs no pre-commitment (39.2%/38.9%), direct appointment scheduling yes/no (39.1%/39.1%), pre-appointment reminders yes/no (39.1%/39.1%); p > 0.017 for all comparisons (p value cut-off adjusted for multiple comparisons). After adjusting for age, gender, insurance, race, ethnicity, and prior influenza vaccination, none of the interventions increased vaccination rates. We conclude that patient portal interventions to remind patients to receive influenza vaccine during the COVID-19 pandemic did not raise influenza immunization rates. More intensive or tailored interventions are needed beyond portal innovations to increase influenza vaccination.

"Positive Kidney Health": Implementation and design of a pharmacist-led intervention for patients at risk for development or progression of chronic kidney disease.

BACKGROUND: Patients with early chronic kidney disease (CKD) or underlying risk factors are often unaware of their kidney test results, common causes of CKD, and ways to lower risk of disease onset/progression. OBJECTIVE: To test feasibility of a pharmacist-led intervention targeting patient education and risk factors in patients with early CKD and those at risk for CKD. PRACTICE DESCRIPTION: Ambulatory care pharmacists in community-based primary care clinics delivered kidney health education, ordered labs, and recommended medication adjustments. PRACTICE INNOVATION: We identified patients with a moderate rate of decline (≥2 mL/min/1.73 m2 per year) in estimated glomerular filtration (eGFR) at-risk for CKD or early stage CKD. An interactive workbook was designed to teach patients about kidney test results and self-management of risk factors including hypertension, type 2 diabetes, cigarette smoking, and chronic oral nonsteroidal anti-inflammatory drug use. EVALUATION METHODS: Outcomes included visit uptake, completion of annual albuminuria screening, and initiation of guideline-directed medications for CKD. Patients were surveyed pre- and post-intervention for kidney health knowledge and perceptions regarding pharmacist-provided information. RESULTS: Our sample of 20 participants had a mean eGFR of 59 mL/min/1.73 m2 and the mean eGFR decline was -4.6 mL/min/1.73 m2 per year. There were 47 visits during the pilot period from February 2021 to October 2021. Thirteen patients were missing albuminuria screening within 12 months; 2 of 9 patients with resulting labs had new microalbuminuria and were started on renoprotective medications. Patients had improved understanding of their kidney function test results and most did not consider the information scary or confusing. CONCLUSION: Barriers to enrollment included fewer participants with multiple risk factors for CKD. The pharmacists were able to engage patients in learning the importance of monitoring and self-management of kidney health. A collaborative practice agreement may enhance a similar intervention that includes initiation of renoprotective medications.

Differences in Weight Loss by Race and Ethnicity in the PRIDE Trial: a Qualitative Analysis of Participant Perspectives.

BACKGROUND: Many Diabetes Prevention Program (DPP) translation efforts have been less effective for underresourced populations. In the cluster-randomized Prediabetes Informed Decision and Education (PRIDE) trial, which evaluated a shared decision-making (SDM) intervention for diabetes prevention, Hispanic and non-Hispanic Black participants lost less weight than non-Hispanic White participants at 12-month follow-up. OBJECTIVE: To explore perspectives about weight loss from PRIDE participants of different racial and ethnic groups. PARTICIPANTS: Sample of participants with prediabetes who were randomized to the PRIDE intervention arm (n=24). APPROACH: We conducted semi-structured interviews within three groups stratified by DPP participation and % weight loss at 12 months: (DPP+/WL+, enrolled in DPP and lost >5% weight; DPP+/WL-, enrolled in DPP and lost <3% weight; DPP-/WL-, did not enroll in DPP and lost <3% weight). Each group was further subdivided on race and ethnicity (non-Hispanic Black (NHB), non-Hispanic White (NHW), Hispanic). Interviews were conducted on Zoom and transcripts were coded and analyzed with Dedoose. KEY RESULTS: Compared to NHW participants, Hispanic and NHB participants more often endorsed weight loss barriers of limited time to make lifestyle changes due to long work and commute hours, inconvenient DPP class locations and offerings, and limited disposable income for extra weight loss activities. Conversely, facilitators of weight loss regardless of race and ethnicity included retirement or having flexible work schedules; being able to identify convenient DPP classes; having a strong, positive support system; and purchasing supplementary resources to support lifestyle change (e.g., gym memberships, one-on-one activity classes). CONCLUSIONS: We found that NHB and Hispanic SDM participants report certain barriers to weight loss more commonly than NHW participants, particularly barriers related to limited disposable income and/or time constraints. Our findings suggest that increased lifestyle change support and flexible program delivery options may be needed to ensure equity in DPP reach, participant engagement, and outcomes.

Effect of Personalized Messages Sent by a Health System's Patient Portal on Influenza Vaccination Rates: a Randomized Clinical Trial.

BACKGROUND: Adult influenza vaccination rates are low. Tailored patient reminders might raise rates. OBJECTIVE: Evaluate impact of a health system's patient portal reminders: (1) tailored to patient characteristics and (2) incorporating behavioral science strategies, on influenza vaccination rates among adults. DESIGN: Pragmatic 6-arm randomized trial across a health system during the 2019-2020 influenza vaccination season. The setting was one large health system-53 adult primary care practices. PARTICIPANTS: All adult patients who used the patient portal within 12 months, stratified by the following: young adults (18-64 years, without diabetes), older adults (≥65 years, without diabetes), and those with diabetes (≥18 years). INTERVENTIONS: Patients were randomized within strata to either (1) pre-commitment reminder alone (1 message, mid-October), (2) pre-commitment + loss frame messages, (3) pre-commitment + gain frame messages, (4) loss frame messages alone, (5) gain frame messages alone, or (6) standard of care control. Patients in the pre-commitment group were sent a message in mid-October, asking if they planned on getting an influenza vaccination. Patients in loss or gain frame groups were sent up to 3 portal reminders (late October, November, and December, if no documented influenza vaccination in the EHR) about importance and safety of influenza vaccine. MAIN MEASURES: Receipt of 1 influenza vaccine from 10/01/2019 to 03/31/2020. KEY RESULTS: 196,486 patients (145,166 young adults, 29,795 older adults, 21,525 adults with diabetes) were randomized. Influenza vaccination rates were as follows: for young adults 36.8%, for older adults 55.6%, and for diabetics 60.6%. On unadjusted and adjusted (for age, gender, insurance, race, ethnicity, and prior influenza vaccine history) analyses, influenza vaccination rates were not statistically different for any study group versus control. CONCLUSIONS: Patient reminders sent by a health system's patient portal that were tailored to patient demographics (young adults, older adults, diabetes) and that incorporated two behavioral economic messaging strategies (pre-commitment and loss/gain framing) were not effective in raising influenza vaccination rates. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (NCT04110314).

Evaluating Natural Experiments that Impact the Diabetes Epidemic: an Introduction to the NEXT-D3 Network.

PURPOSE OF REVIEW: Diabetes is an ongoing public health issue in the USA, and, despite progress, recent reports suggest acute and chronic diabetes complications are increasing. RECENT FINDINGS: The Natural Experiments for Translation in Diabetes 3.0 (NEXT-D3) Network is a 5-year research collaboration involving six academic centers (Harvard University, Northwestern University, Oregon Health & Science University, Tulane University, University of California Los Angeles, and University of California San Francisco) and two funding agencies (Centers for Disease Control and Prevention and National Institutes of Health) to address the gaps leading to persisting diabetes burdens. The network builds on previously funded networks, expanding to include type 2 diabetes (T2D) prevention and an emphasis on health equity. NEXT-D3 researchers use rigorous natural experiment study designs to evaluate impacts of naturally occurring programs and policies, with a focus on diabetes-related outcomes. NEXT-D3 projects address whether and to what extent federal or state legislative policies and health plan innovations affect T2D risk and diabetes treatment and outcomes in the USA; real-world effects of increased access to health insurance under the Affordable Care Act; and the effectiveness of interventions that reduce barriers to medication access (e.g., decreased or eliminated cost sharing for cardiometabolic medications and new medications such as SGLT-2 inhibitors for Medicaid patients). Overarching goals include (1) expanding generalizable knowledge about policies and programs to manage or prevent T2D and educate decision-makers and organizations and (2) generating evidence to guide the development of health equity goals to reduce disparities in T2D-related risk factors, treatment, and complications.

Association of Type 2 Diabetes Risk Perception With Interest in Diabetes Prevention Strategies Among Women With a History of Gestational Diabetes.

Objectives: The aims of this study were to identify predictors of perception of type 2 diabetes risk in women with a history of gestational diabetes mellitus (GDM) and to determine factors associated with interest in evidence-based strategies for type 2 diabetes prevention. Research Design and Methods: We surveyed women with a history of GDM who had not progressed to type 2 diabetes from a large academic medical center. We used multivariate logistic regression to assess predictors of high levels of perception of type 2 diabetes risk. We also tested associations between risk perception and interest in a lifestyle change program and/or metformin therapy. Results: In our diverse sample of 264 women, 28% were unaware that GDM is a risk factor for incident type 2 diabetes after pregnancy, and 48% believed their personal risk of type 2 diabetes was low. In multivariate analyses, family history of diabetes (odds ratio [OR] 2.2, 95% CI 1.2-4.4) and knowledge of GDM as a risk factor for incident type 2 diabetes (OR 4.5, 95% CI 2.1-9.8) were significant predictors of greater perception of type 2 diabetes risk. Women with higher risk perception were more likely to express interest in a lifestyle change program compared with women with lower risk perception (OR 2.4, 95% CI 1.3-4.5). Conclusion: Although some women are aware that GDM is a risk factor for incident type 2 diabetes, many still perceive their own risk of developing type 2 diabetes as low. Higher risk perception predicted interest in an evidence-based diabetes prevention program, highlighting the importance of personalized risk assessment and communication about risk for women who have had GDM.

Association between industry payments and prescriptions of long-acting insulin: An observational study with propensity score matching.

BACKGROUND: The rapidly increased spending on insulin is a major public health issue in the United States. Industry marketing might be one of the upstream determinants of physicians' prescription of long-acting insulin-the most commonly used and costly type of insulin, but the evidence is lacking. We therefore aimed to investigate the association between industry payments to physicians and subsequent prescriptions of long-acting insulin. METHODS AND FINDINGS: Using the databases of Open Payments and Medicare Part D, we examined the association between the receipt of industry payments for long-acting insulin in 2016 and (1) the number of claims; (2) the costs paid for all claims; and (3) the costs per claim of long-acting insulin in 2017. We also examined the association between the receipt of payments and the change in these outcomes from 2016 to 2017. We employed propensity score matching to adjust for the physician-level characteristics (sex, years in practice, specialty, and medical school attended). Among 145,587 eligible physicians treating Medicare beneficiaries, 51,851 physicians received industry payments for long-acting insulin worth $22.3 million. In the propensity score-matched analysis including 102,590 physicians, we found that physicians who received the payments prescribed a higher number of claims (adjusted difference, 57.8; 95% CI, 55.8 to 59.7), higher costs for total claims (adjusted difference, +$22,111; 95% CI, $21,387 to $22,836), and higher costs per claim (adjusted difference, +$71.1; 95% CI, $69.0 to $73.2) of long-acting insulin, compared with physicians who did not receive the payments. The association was also found for changes in these outcomes from 2016 to 2017. Limitations to our study include limited generalizability, confounding, and possible reverse causation. CONCLUSIONS: Industry marketing payments to physicians for long-acting insulin were associated with the physicians' prescriptions and costs of long-acting insulin in the subsequent year. Future research is needed to assess whether policy interventions on physician-industry financial relationships will help to ensure appropriate prescriptions and limit overall costs of this essential drug for diabetes care.

A Randomized Encouragement Trial to Increase Mail Order Pharmacy Use and Medication Adherence in Patients with Diabetes.

BACKGROUND: Mail order pharmacy (MOP) use has been linked to improved medication adherence and health outcomes among patients with diabetes. However, no large-scale intervention studies have assessed the effect of encouraging MOP use on medication adherence. OBJECTIVE: To assess an intervention to encourage MOP services to increase its use and medication adherence. DESIGN: Randomized encouragement trial. PATIENTS: 63,012 diabetes patients from three health care systems: Kaiser Permanente Northern California (KPNC), Kaiser Permanente Hawaii (KPHI), and Harvard Pilgrim Health Care (HPHC) who were poorly adherent to at least one class of cardiometabolic medications and had not used MOP in the prior 12 months. INTERVENTION: Patients were randomized to receive either usual care (control arm) or outreach encouraging MOP use consisting of a mailed letter, secure email message, and automated telephone call outlining the potential benefits of MOP use (intervention arm). HPHC intervention patients received the letter only. MEASUREMENTS: We compared the percentages of patients that began using MOP and that became adherent to cardiometabolic medication classes during a 12-month follow-up period. We also conducted a race/ethnicity-stratified analysis. RESULTS: During follow-up, 10.6% of intervention patients began using MOP vs. 9.3% of controls (p < 0.01); the percent of cardiometabolic medication delivered via mail was 42.1% vs. 39.8% (p < 0.01). Metformin adherence improved in the intervention arm relative to control at the two KP sites (52% vs. 49%, p < 0.01). Stratified analyses suggested a significant positive effect of the intervention in White (RR: 1.12, 95% CI: 1.03, 1.22) and Asian (RR: 1.30, 95% CI: 1.17, 1.45) patients. CONCLUSION: This pragmatic trial showed that simple outreach to encourage MOP modestly increased its use and improved adherence measured by refills to a key class of diabetes medications in some settings. Given its minimal cost, clinicians and health systems should consider outreach interventions to actively promote MOP use among diabetes patients. TRIAL REGISTRATION: ClinicalTrials.gov registration number: NCT02621476.

Evaluation of the University of California Diabetes Prevention Program (UC DPP) Initiative.

BACKGROUND: Type 2 diabetes can negatively impact long term health outcomes, healthcare costs and quality of life. However, intensive lifestyle interventions, including the Diabetes Prevention Program (DPP), can significantly lower risk of incident type 2 diabetes among overweight adults with prediabetes. Unfortunately, the majority of adults in the US who are at risk of developing diabetes do not engage in DPP-based lifestyle change programs. Increased adoption of evidence-based obesity and diabetes prevention interventions, such as the DPP, may help large employers reduce health risks and improve health outcomes among employees. In 2018, the University of California Office of thePresident (UCOP) implemented the UC DPP Initiative, a novel, multi-component program to address diabetes and obesity prevention across the UC system. METHODS: The goal of our study is to conduct a multifaceted evaluation of the UC DPP Initiative using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Our evaluation will integrate unique and diverse UC data sources, including electronic health record (EHR) data, administrative claims, campus-based DPP cohort data, qualitative interviews and site visits. Our primary outcome of interest is the mean percent weight change among three groups of overweight/obese UC beneficiaries at risk for diabetes at 12-month follow-up. Secondary outcomes include mean percent weight change at 24-month follow-up, barriers and facilitators associated with implementatio, as well as  the degree of program adoption and maintenance. DISCUSSION: Our study will help inform diabetes and obesity prevention efforts across the UC system. Findings from this evaluation will also be highly applicable to universities and large employers, as well as community organizers, healthcare organizations and insurers implementing the DPP and/or other health promotion interventions.

The impact of Dual Eligible Special Need Plan regulations on healthcare utilization.

BACKGROUND: To determine if requiring Dual Eligible Special Need Plans (D-SNPs) to receive approval from the National Committee of Quality Assurance and contract with state Medicaid agencies impacts healthcare utilization. METHODS: We use a Multiple Interrupted Time Series to examine the association of D-SNP regulations with dichotomized measures of emergency room (ER) and hospital utilization. Our treatment group is elderly D-SNP enrollees. Our comparison group is near-elderly (ages 60-64) beneficiaries enrolled in Medicaid Managed Care plans (N = 360,405). We use segmented regression models to estimate changes in the time-trend and slope of the outcomes associated with D-SNP regulations, during the post-implementation (2012-2015) period, relative to the pre-implementation (2010-2011) period. Models include a treatment-status indicator, a monthly time-trend, indicators and splines for the post-period and the interactions between these variables. We conduct the following sensitivity analyses: (1) Re-estimating models stratified by state (2) Estimating models including interactions of D-SNP implementation variables with comorbidity count to assess for differential D-SNP regulation effects across comorbidity level. (3) Re-estimating the models stratifying by race/ethnicity and (4) Including a transition period (2012-2013) in the model. RESULTS: We do not find any statistically significant changes in ER or hospital utilization associated with D-SNP regulation implementation in the broad D-SNP population or among specific racial/ethnic groups; however, we do find a reduction in hospitalizations associated with D-SNP regulations in New Jersey (DD level = - 3.37%; p = 0.02)/(DD slope = - 0.23%; p = 0.01) and among individuals with higher, relative to lower levels of co-morbidity (DDD slope = - 0.06%; p = 0.01). CONCLUSIONS: These findings suggest that the impact of D-SNP regulations varies by state. Additionally, D-SNP regulations may be particularly effective in reducing hospital utilization among beneficiaries with high levels of co-morbidity.

High-cost high-need patients in Medicaid: segmenting the population eligible for a national complex case management program.

BACKGROUND: High-cost high-need patients are typically defined by risk or cost thresholds which aggregate clinically diverse subgroups into a single 'high-need high-cost' designation. Programs have had limited success in reducing utilization or improving quality of care for high-cost high-need Medicaid patients, which may be due to the underlying clinical heterogeneity of patients meeting high-cost high-need designations. METHODS: Our objective was to segment a population of high-cost high-need Medicaid patients (N = 676,161) eligible for a national complex case management program between January 2012 and May 2015 to disaggregate clinically diverse subgroups. Patients were eligible if they were in the top 5 % of annual spending among UnitedHealthcare Medicaid beneficiaries. We used k-means cluster analysis, identified clusters using an information-theoretic approach, and named clusters using the patients' pattern of acute and chronic conditions. We assessed one-year overall and preventable hospitalizations, overall and preventable emergency department (ED) visits, and cluster stability. RESULTS: Six clusters were identified which varied by utilization and stability. The characteristic condition patterns were: 1) pregnancy complications, 2) behavioral health, 3) relatively few conditions, 4) cardio-metabolic disease, and complex illness with relatively 5) low or 6) high resource use. The patients varied by cluster by average ED visits (2.3-11.3), hospitalizations (0.3-2.0), and cluster stability (32-91%). CONCLUSIONS: We concluded that disaggregating subgroups of high-cost high-need patients in a large multi-state Medicaid sample identified clinically distinct clusters of patients who may have unique clinical needs. Segmenting previously identified high-cost high-need populations thus may be a necessary strategy to improve the effectiveness of complex case management programs in Medicaid.

Sustaining Successful Clinical-community Partnerships in Medically Underserved Urban Areas: A Qualitative Case Study.

Clinical-community partnerships can improve access and receipt of preventive health services in community settings. Understanding how to sustain their potential benefits is warranted. Qualitative case-study of the Faith Community Health Partnership (FCHP), a collaboration between faith-community nurses and community organizations sustained over 25 years. We used content analysis principles to report on partnership sustainability themes identified through semi-structured interviews with FCHP partners (n = 18). Factors supporting partnership sustainability: Maintaining partners' commitment over time; strategic resource-sharing; facilitating engagement; and preserving partnership flexibility. Sustaining clinical-community partnerships is a dynamic and continuous process requiring significant time, effort, and resources on behalf of partners.

Trends in Costs of Care and Utilization for Medicaid Patients With Diabetes in Accountable Care Communities.

BACKGROUND/OBJECTIVES: Medicaid beneficiaries with diabetes have complex care needs. The Accountable Care Communities (ACC) Program is a practice-level intervention implemented by UnitedHealthcare to improve care for Medicaid beneficiaries. We examined changes in costs and utilization for Medicaid beneficiaries with diabetes assigned to ACC versus usual care practices. RESEARCH DESIGN: Interrupted time series with concurrent control group analysis, at the person-month level. The ACC was implemented in 14 states, and we selected comparison non-ACC practices from those states to control for state-level variation in Medicaid program. We adjusted the models for age, sex, race/ethnicity, comorbidities, seasonality, and state-by-year fixed effects. We examined the difference between ACC and non-ACC practices in changes in the time trends of expenditures and hospital and emergency room utilization, for the 4 largest categories of Medicaid eligibility [Temporary Assistance to Needy Families, Supplemental Security Income (without Medicare), Expansion, Dual-Eligible]. SUBJECTS/MEASURES: Eligibility and claims data from Medicaid adults with diabetes from 14 states between 2010 and 2016, before and after ACC implementation. RESULTS: Analyses included 1,200,460 person-months from 66,450 Medicaid patients with diabetes. ACC implementation was not associated with significant changes in outcome time trends, relative to comparators, for all Medicaid categories. CONCLUSIONS: Medicaid patients assigned to ACC practices had no changes in cost or utilization over 3 years of follow-up, compared with patients assigned to non-ACC practices. The ACC program may not reduce costs or utilization for Medicaid patients with diabetes.

Evaluation of a National Care Coordination Program to Reduce Utilization Among High-cost, High-need Medicaid Beneficiaries With Diabetes.

BACKGROUND: Medical, behavioral, and social determinants of health are each associated with high levels of emergency department (ED) visits and hospitalizations. OBJECTIVE: The objective of this study was to evaluate a care coordination program designed to provide combined "whole-person care," integrating medical, behavioral, and social support for high-cost, high-need Medicaid beneficiaries by targeting access barriers and social determinants. RESEARCH DESIGN: Individual-level interrupted time series with a comparator group, using person-month as the unit of analysis. SUBJECTS: A total of 42,214 UnitedHealthcare Medicaid beneficiaries (194,834 person-months) age 21 years or above with diabetes, with Temporary Assistance to Needy Families, Medicaid expansion, Supplemental Security Income without Medicare, or dual Medicaid/Medicare. MEASURES: Our outcome measures were any hospitalizations and any ED visits in a given month. Covariates of interest included an indicator for intervention versus comparator group and indicator and spline variables measuring changes in an outcome's time trend after program enrollment. RESULTS: Overall, 6 of the 8 examined comparisons were not statistically significant. Among Supplemental Security Income beneficiaries, we observed a larger projected decrease in ED visit risk among the intervention sample versus the comparator sample at 12 months postenrollment (difference-in-difference: -6.6%; 95% confidence interval: -11.2%, -2.1%). Among expansion beneficiaries, we observed a greater decrease in hospitalization risk among the intervention sample versus the comparator sample at 12 months postenrollment (difference-in-difference: -5.8%; 95% confidence interval: -11.4%, -0.2%). CONCLUSION: A care coordination program designed to reduce utilization among high-cost, high-need Medicaid beneficiaries was associated with fewer ED visits and hospitalizations for patients with diabetes in selected Medicaid programs but not others.

Psychometric Properties of the Altarum Consumer Engagement (ACE) Measure of Activation in Patients with Prediabetes.

BACKGROUND: Patient activation is associated with better outcomes in chronic conditions. OBJECTIVE: We evaluated the psychometric properties of the 12-item Altarum Consumer Engagement™ Measure (ACE-12) in patients with prediabetes. PARTICIPANTS: ACE-12 was administered to patients in the Prediabetes Informed Decisions and Education Study. MAIN MEASURES: We conducted an exploratory factor analysis followed by confirmatory factor analytic models. We evaluated item response categories using item characteristic curves. Construct validity was assessed by examining correlations of the ACE-12 scales with education, depressive symptoms, self-rated health, hemoglobin A1c, body mass index, and weight loss. KEY RESULTS: Participants (n = 515) had a median age of 58; 56% were female; 17% Hispanic; 54% were non-White. The scree plot and Tucker and Lewis reliability coefficient (0.95) suggested three factors similar to the original scales. One item loaded on the navigation rather than the informed choice scale. Ordinal alpha coefficients for the original scales were commitment (0.75); informed choice (0.71); and navigation (0.54). ICCs indicated that one or more of the response categories for 5 of the 12 items were never most likely to be selected. Patients with lower education were less activated on the commitment (r = - 0.124, p = 0.004), choice (r = - 0.085, p = 0.009), and overall score (r = - 0.042, p = 0.011). Patients with depressive symptoms had lower commitment (r = - 0.313, p ≤ 0.001) and overall scores (r = - 0.172, p = 0.012). Patients with poorer health scored lower on the Commitment (r = - 0.308, p ≤ 0.001), Navigation (r = - 0.137, p ≤ 0.001), and overall score (r = - 0.279, p ≤ 0.001). CONCLUSION: The analyses provide some support for the psychometric properties of the ACE-12 in prediabetic patients. Future research evaluating this tool among patients with other chronic conditions are needed to determine whether Q1 (I spend a lot of time learning about health) should remain in the informed choice or be included in the navigation scale. Additional items may be needed to yield acceptable reliability for the navigation scale.

Effectiveness of Shared Decision-making for Diabetes Prevention: 12-Month Results from the Prediabetes Informed Decision and Education (PRIDE) Trial.

IMPORTANCE: Intensive lifestyle change (e.g., the Diabetes Prevention Program) and metformin reduce type 2 diabetes risk among patients with prediabetes. However, real-world uptake remains low. Shared decision-making (SDM) may increase awareness and help patients select and follow through with informed options for diabetes prevention that are aligned with their preferences. OBJECTIVE: To test the effectiveness of a prediabetes SDM intervention. DESIGN: Cluster randomized controlled trial. SETTING: Twenty primary care clinics within a large regional health system. PARTICIPANTS: Overweight/obese adults with prediabetes (BMI ≥ 24 kg/m2 and HbA1c 5.7-6.4%) were enrolled from 10 SDM intervention clinics. Propensity score matching was used to identify control patients from 10 usual care clinics. INTERVENTION: Intervention clinic patients were invited to participate in a face-to-face SDM visit with a pharmacist who used a decision aid (DA) to describe prediabetes and four possible options for diabetes prevention: DPP, DPP ± metformin, metformin only, or usual care. MAIN OUTCOMES AND MEASURES: Primary endpoint was uptake of DPP (≥ 9 sessions), metformin, or both strategies at 4 months. Secondary endpoint was weight change (lbs.) at 12 months. RESULTS: Uptake of DPP and/or metformin was higher among SDM participants (n = 351) than controls receiving usual care (n = 1028; 38% vs. 2%, p < .001). At 12-month follow-up, adjusted weight loss (lbs.) was greater among SDM participants than controls (- 5.3 vs. - 0.2, p < .001). LIMITATIONS: Absence of DPP supplier participation data for matched patients in usual care clinics. CONCLUSIONS AND RELEVANCE: A prediabetes SDM intervention led by pharmacists increased patient engagement in evidence-based options for diabetes prevention and was associated with significantly greater uptake of DPP and/or metformin at 4 months and weight loss at 12 months. Prediabetes SDM may be a promising approach to enhance prevention efforts among patients at increased risk. TRIAL REGISTRATION: This study was registered at clinicaltrails.gov (NCT02384109)).

Rationale and design of a multicenter Chronic Kidney Disease (CKD) and at-risk for CKD electronic health records-based registry: CURE-CKD.

BACKGROUND: Chronic kidney disease (CKD) is a global public health problem, exhibiting sharp increases in incidence, prevalence, and attributable morbidity and mortality. There is a critical need to better understand the demographics, clinical characteristics, and key risk factors for CKD; and to develop platforms for testing novel interventions to improve modifiable risk factors, particularly for the CKD patients with a rapid decline in kidney function. METHODS: We describe a novel collaboration between two large healthcare systems (Providence St. Joseph Health and University of California, Los Angeles Health) supported by leadership from both institutions, which was created to develop harmonized cohorts of patients with CKD or those at increased risk for CKD (hypertension/HTN, diabetes/DM, pre-diabetes) from electronic health record data. RESULTS: The combined repository of candidate records included more than 3.3 million patients with at least a single qualifying measure for CKD and/or at-risk for CKD. The CURE-CKD registry includes over 2.6 million patients with and/or at-risk for CKD identified by stricter guide-line based criteria using a combination of administrative encounter codes, physical examinations, laboratory values and medication use. Notably, data based on race/ethnicity and geography in part, will enable robust analyses to study traditionally disadvantaged or marginalized patients not typically included in clinical trials. DISCUSSION: CURE-CKD project is a unique multidisciplinary collaboration between nephrologists, endocrinologists, primary care physicians with health services research skills, health economists, and those with expertise in statistics, bio-informatics and machine learning. The CURE-CKD registry uses curated observations from real-world settings across two large healthcare systems and has great potential to provide important contributions for healthcare and for improving clinical outcomes in patients with and at-risk for CKD.