A Telehealth-supported, Integrated care with CHWs, and MEdication-access (TIME) Program for Diabetes Improves HbA1c: a Randomized Clinical Trial.

BACKGROUND: Many individuals with diabetes live in low- or middle-income settings. Glycemic control is challenging, particularly in resource-limited areas that face numerous healthcare barriers. OBJECTIVE: To compare HbA1c outcomes for individuals randomized to TIME, a Telehealth-supported, Integrated care with CHWs (Community Health Workers), and MEdication-access program (intervention) versus usual care (wait-list control). DESIGN: Randomized clinical trial. PARTICIPANTS: Low-income Latino(a) adults with type 2 diabetes. INTERVENTIONS: TIME consisted of (1) CHW-participant telehealth communication via mobile health (mHealth) for 12 months, (2) CHW-led monthly group visits for 6 months, and (3) weekly CHW-physician diabetes training and support via telehealth (video conferencing). MAIN MEASURES: Investigators compared TIME versus control participant baseline to month 6 changes of HbA1c (primary outcome), blood pressure, body mass index (BMI), weight, and adherence to seven American Diabetes Association (ADA) standards of care. CHW assistance in identifying barriers to healthcare in the intervention group were measured at the end of mHealth communication (12 months). KEY RESULTS: A total of 89 individuals participated. TIME individuals compared to control participants had significant HbA1c decreases (9.02 to 7.59% (- 1.43%) vs. 8.71 to 8.26% (- 0.45%), respectively, p = 0.002), blood pressure changes (systolic: - 6.89 mmHg vs. 0.03 mmHg, p = 0.023; diastolic: - 3.36 mmHg vs. 0.2 mmHg, respectively, p = 0.046), and ADA guideline adherence (p < 0.001) from baseline to month 6. At month 6, more TIME than control participants achieved > 0.50% HbA1c reductions (88.57% vs. 43.75%, p < 0.001). BMI and weight changes were not significant between groups. Many (54.6%) TIME participants experienced > 1 barrier to care, of whom 91.7% had medication issues. CHWs identified the majority (87.5%) of barriers. CONCLUSIONS: TIME participants resulted in improved outcomes including HbA1c. CHWs are uniquely positioned to identify barriers to care particularly related to medications that may have gone unrecognized otherwise. Larger trials are needed to determine the scalability and sustainability of the intervention. CLINICAL TRIAL: NCT03394456, accessed at https://clinicaltrials.gov/ct2/show/NCT03394456.

Telemedicine Training and Support for Community Health Workers: Improving Knowledge of Diabetes.

Background: Community health workers (CHWs) are a well-established source to improve patient health care, yet their training and support remain suboptimal. This limits program expansion and potentially compromises patient safety. The objective of the study was to evaluate the feasibility and acceptability of weekly training and support by telemedicine (videoconferencing). Materials and Methods: CHWs (n = 6) who led diabetes group visits for low-income Latinos met weekly with a health care professional for training and support. Feasibility and acceptability outcome measures included telemedicine usability, knowledge of diabetes (baseline to 6 months), and program satisfaction. Results: Telemedicine training and support were found to be feasible and acceptable as measured by usability (Telehealth Usability Questionnaire: average 4.7/5.0, ±0.4), knowledge (Diabetes Knowledge Test: pretest 15.8 ± 1.3, posttest 21.8 ± 1.2, p < 0.001, respectively), and satisfaction (Texas Department of State Health Services survey: average 5.8/6.0, ±0.5). All CHWs preferred telemedicine to in-person training. Conclusions: Telemedicine is a feasible and acceptable modality to train and support CHWs.

A technology-based quality innovation to identify undiagnosed hypertension among active primary care patients.

PURPOSE: The goal of this study was to develop a technology-based strategy to identify patients with undiagnosed hypertension in 23 primary care practices and integrate this innovation into a continuous quality improvement initiative in a large, integrated health system. METHODS: In phase 1, we reviewed electronic health records (EHRs) using algorithms designed to identify patients at risk for undiagnosed hypertension. We then invited each at-risk patient to complete an automated office blood pressure (AOBP) protocol. In phase 2, we instituted a quality improvement process that included regular physician feedback and office-based computer alerts to evaluate at-risk patients not screened in phase 1. Study patients were observed for 24 additional months to determine rates of diagnostic resolution. RESULTS: Of the 1,432 patients targeted for inclusion in the study, 475 completed the AOBP protocol during the 6 months of phase 1. Of the 1,033 at-risk patients who remained active during phase 2, 740 (72%) were classified by the end of the follow-up period: 361 had hypertension diagnosed, 290 had either white-coat hypertension, prehypertension, or elevated blood pressure diagnosed, and 89 had normal blood pressure. By the end of the follow-up period, 293 patients (28%) had not been classified and remained at risk for undiagnosed hypertension. CONCLUSIONS: Our technology-based innovation identified a large number of patients at risk for undiagnosed hypertension and successfully classified the majority, including many with hypertension. This innovation has been implemented as an ongoing quality improvement initiative in our medical group and continues to improve the accuracy of diagnosis of hypertension among primary care patients.

Self-efficacy and barriers to multiple behavior change in low-income African Americans with hypertension.

Behavioral risk factors are among the preventable causes of health disparities, yet long-term change remains elusive. Many interventions are designed to increase self-efficacy, but little is known about the effect on long-term behavior change in older, low-income African Americans, especially when facing more problematic barriers. A cohort of 185 low-income African-Americans with hypertension reported barriers they encountered while undergoing a multiple behavior change trial from 2002 to 2006. The purpose of the present study was to explore the relationships between self-efficacy, barriers, and multiple behavior change over time. Higher self-efficacy seemed to be partially helpful for smoking reduction and increasing physical activity, but not for following a low-sodium diet. Addiction was indirectly associated with less reduction in smoking through lower self-efficacy. Otherwise, different barriers were associated with behavior change than were associated with self-efficacy: being "too busy" directly interfered with physical activity and "traditions" with low-sodium diet; however, they were neither the most frequently reported barriers, nor associated with lower self-efficacy. This suggests that an emphasis on self-efficacy alone may be insufficient for overcoming the most salient barriers encountered by older African Americans. Additionally, the most common perceived barriers may not necessarily be relevant to long-term behavioral outcomes.

Effect of a physician uncertainty reduction intervention on blood pressure in uncontrolled hypertensives--a cluster randomized trial.

BACKGROUND: Clinical inertia, provider failure to appropriately intensify treatment, is a major contributor to uncontrolled blood pressure (BP). Some clinical inertia may result from physician uncertainty over the patient's usual BP, adherence, or value of continuing efforts to control BP through lifestyle changes. OBJECTIVE: To test the hypothesis that providing physicians with uncertainty reduction tools, including 24-h ambulatory BP monitoring, electronic bottle cap monitoring, and lifestyle assessment and counseling, will lead to improved BP control. DESIGN: Cluster randomized trial with five intervention clinics (IC) and five usual care clinics (UCC). SETTING: Six public and 4 private primary care clinics. PARTICIPANTS: A total of 665 patients (63 percent African American) with uncontrolled hypertension (BP ≥140 mmHg/90 mmHg or ≥130/80 mmHg if diabetic). INTERVENTIONS: An order form for uncertainty reduction tools was placed in the IC participants' charts before each visit and results fed back to the provider. OUTCOME MEASURES: Percent with controlled BP at last visit. Secondary outcome was BP changes from baseline. RESULTS: Median follow-up time was 24 months. IC physicians intensified treatment in 81% of IC patients compared to 67% in UCC (p < 0.001); 35.0% of IC patients and 31.9% of UCC patients achieved control at the last recorded visit (p > 0.05). Multi-level mixed effects longitudinal regression modeling of SBP and DBP indicated a significant, non-linear slope difference favoring IC (p (time × group interaction) = 0.048 for SBP and p = 0.001 for DBP). The model-predicted difference attributable to intervention was -2.8 mmHg for both SBP and DBP by month 24, and -6.5 mmHg for both SBP and DBP by month 36. CONCLUSIONS: The uncertainty reduction intervention did not achieve the pre-specified dichotomous outcome, but led to lower measured BP in IC patients.

Medication Adherence and Blood Pressure Control: A Scientific Statement From the American Heart Association.

The widespread treatment of hypertension and resultant improvement in blood pressure have been major contributors to the dramatic age-specific decline in heart disease and stroke. Despite this progress, a persistent gap remains between stated public health targets and achieved blood pressure control rates. Many factors may be important contributors to the gap between population hypertension control goals and currently observed control levels. Among them is the extent to which patients adhere to prescribed treatment. The goal of this scientific statement is to summarize the current state of knowledge of the contribution of medication nonadherence to the national prevalence of poor blood pressure control, methods for measuring medication adherence and their associated challenges, risk factors for antihypertensive medication nonadherence, and strategies for improving adherence to antihypertensive medications at both the individual and health system levels.

Reducing the Burden of Diabetes Treatment: A Review of Low-cost Oral Hypoglycemic Medications.

BACKGROUND: The vast majority of individuals diagnosed with diabetes are low/middle income and may have access to only three of the 11 oral hypoglycemic medications (OHMs) due to cost: metformin intermediate release (IR) or extended release (ER), sulfonylureas (glimepiride, glipizide, glyburide), and pioglitazone. Sulfonylureas and pioglitazone have had significant controversy related to potential adverse events, but it remains unclear whether these negative outcomes are class, drug, or dose-related. OBJECTIVE: We conducted a narrative review of low-cost OHMs. METHODS: We evaluated the maximum recommended (MAX) compared to the most effective (EFF) daily dose, time-to-peak change in HbA1c levels, and adverse events of low-cost oral hypoglycemic medications. RESULTS: We found that the MAX was often greater than the EFF: metformin IR/ER (MAX: 2,550/2,000 mg, EFF: 1,500-2,000/1,500-2,000 mg), glipizide IR/ER (MAX: 40/20 mg, EFF: 20/5 mg), glyburide (MAX: 20 mg, EFF: 2.5-5.0 mg), pioglitazone (MAX: 45 mg, EFF: 45 mg). Time-to-peak change in HbA1c levels occurred at weeks 12-20 (sulfonylureas), 25-39 (metformin), and 25 (pioglitazone). Glimepiride was not associated with weight gain, hypoglycemia, or negative cardiovascular events relative to other sulfonylureas. Cardiovascular event rates did not increase with lower glyburide doses (p<0.05). Glimepiride and pioglitazone have been successfully used in renal impairment. CONCLUSION: Metformin, glimepiride, and pioglitazone are safe and efficacious OHMs. Prescribing at the EFF rather than the MAX may avoid negative dose-related outcomes. OHMs should be evaluated as individual drugs, not generalized as a class, due to different dosing and adverse-event profiles; Glimepiride is the preferred sulfonylurea since it is not associated with the adverse events as others in its class.

Blood pressure control in the elderly: can you have too much of a good thing?

Hypertension (especially systolic hypertension) is very common in older persons. Systolic hypertension occurs because large conduit arteries become stiffer with age. Strong evidence from randomized trials suggests that treating systolic blood pressures initially higher than 160 mm Hg is extremely beneficial, and a recent trial extended this conclusion to healthy persons over 80 years of age. However, the only trial that has directly tested the use of more aggressive treatment goals (< 140 mm Hg) in the elderly did not show benefit in those older than 75. Risks of overtreating hypertension for the elderly include falls and orthostatic hypotension, and the most compromised older persons may be the most likely to experience adverse effects. Our current state of knowledge requires clinical judgment that balances the immediacy of adverse effects versus the potential but unproven benefits of treatment in deciding whether to treat the elderly more aggressively than the goals used in randomized trials.

A Narrative Review of Diabetes Group Visits in Low-Income and Underserved Settings.

BACKGROUND: Prior studies have supported the efficacy of diabetes group visits. However, the benefit of diabetes group visits for low-income and underserved individuals is not clear. The purpose of this study was to conduct a narrative review in order to clarify the efficacy of diabetes group visits in low-income and underserved settings. METHODS: The authors performed a narrative review, categorizing studies into nonrandomized and randomized. RESULTS: A total of 14 studies were identified. Hemoglobin A1c was the most commonly measured outcome, which improved for the majority of group visit participants. Preventive care showed consistent improvement for intervention arms. There were several other study outcomes including metabolic (i.e., blood pressure), behavioral (i.e., exercise), functional (i.e., quality of life), and system-based (i.e., cost). CONCLUSION: Diabetes group visits for low-income and underserved individuals resulted in superior preventive care but the impact on glycemic control remains unclear.

Entertainment education for prostate cancer screening: a randomized trial among primary care patients with low health literacy.

OBJECTIVE: To evaluate an entertainment-based patient decision aid for prostate cancer screening among patients with low or high health literacy. METHODS: Male primary care patients from two clinical sites, one characterized as serving patients with low health literacy (n=149) and the second as serving patients with high health literacy (n=301), were randomized to receive an entertainment-based decision aid for prostate cancer screening or an audiobooklet-control aid with the same learner content but without the entertainment features. Postintervention and 2-week follow-up assessments were conducted. RESULTS: Patients at the low-literacy site were more engaged with the entertainment-based aid than patients at the high-literacy site. Overall, knowledge improved for all patients. Among patients at the low-literacy site, the entertainment-based aid was associated with lower decisional conflict and greater self-advocacy (i.e., mastering and obtaining information about screening) when compared to patients given the audiobooklet. No differences between the aids were observed for patients at the high-literacy site. CONCLUSION: Entertainment education may be an effective strategy for promoting informed decision making about prostate cancer screening among patients with lower health literacy. PRACTICE IMPLICATIONS: As barriers to implementing computer-based patient decision support programs decrease, alternative models for delivering these programs should be explored.

Simultaneous vs sequential counseling for multiple behavior change.

BACKGROUND: Many patients in primary care settings present with multiple behavioral risk factors for cardiovascular disease. Research has provided little information on the most effective ways to approach multiple behavior change counseling in clinical settings. METHODS: We implemented a randomized trial in a publicly funded primary care setting to test whether a sequential presentation of stage of change-based counseling to stop smoking, reduce dietary sodium level to less than 100 mEq/L per day, and increase physical activity by at least 10,000 pedometer steps per week would be more effective than simultaneous counseling. African Americans with hypertension, aged 45 to 64 years, initially nonadherent to the 3 behavioral goals, were randomized to the following conditions: (1) 1 in-clinic counseling session on all 3 behaviors every 6 months, supplemented by motivational interviewing by telephone for 18 months; (2) a similar protocol that addressed a new behavior every 6 months; or (3) 1-time referral to existing group classes ("usual care"). The primary end point was the proportion in each arm that met at least 2 behavioral criteria after 18 months. RESULTS: A total of 289 individuals (67.3% female) were randomized, and 230 (79.6%) completed the study. At 18 months, only 6.5% in the simultaneous arm, 5.2% in the sequential arm, and 6.5% in the usual-care arm met the primary end point. However, results for single behavioral goals consistently favored the simultaneous group. At 6 months, 29.6% in the simultaneous, 16.5% in the sequential, and 13.4% in the usual-care arms had reached the urine sodium goal (P = .01). At 18 months, 20.3% in the simultaneous, 16.9% in the sequential, and 10.1% in the usual-care arms were urine cotinine negative (P = .08). CONCLUSIONS: Long-term multiple behavior change is difficult in primary care. This study provides strong evidence that addressing multiple behaviors sequentially is not superior to, and may be inferior to, a simultaneous approach.

Dual Therapy Appears Superior to Monotherapy for Low-Income Individuals With Newly Diagnosed Type 2 Diabetes.

BACKGROUND: There are variable recommendations regarding initiating monotherapy or dual therapy in patients with newly diagnosed type 2 diabetes (T2D). Clear initial strategies are of particular importance in underserved settings where access to care and financial burdens are significant barriers. OBJECTIVES: To provide descriptive data of metabolic outcomes to therapy regimens for low-income individuals with newly diagnosed T2D placed on oral hypoglycemic agents (OAs). METHODS: We conducted a retrospective chart review of low-income individuals with newly diagnosed T2D initiated on OAs. We provided descriptive data and then evaluated the effects of OA regimens (ie, mono-, dual-, transition [from mono to dual or vice versa] therapy) on hemoglobin A1c (A1c) (baseline to 12 months). RESULTS: A total of 309 patients were included in the study. At 12 months, the mean decrease in A1c for the entire sample was -2.36% (9.37% to 7.01%). Patients prescribed dual therapy had a greater change of A1c compared to those taking monotherapy with metformin (-1.11%, P < .01). Patients who transitioned therapies did not differ in change of A1c compared to monotherapy. CONCLUSION: Initiation of dual therapy was superior to metformin monotherapy or transitioning therapies and may be preferred for low-income individuals with newly diagnosed T2D.

Designing and evaluating health systems level hypertension control interventions for African-Americans: lessons from a pooled analysis of three cluster randomized trials.

OBJECTIVES: African-Americans (AAs) have a high prevalence of hypertension and their blood pressure (BP) control on treatment still lags behind other groups. In 2004, NHLBI funded five projects that aimed to evaluate clinically feasible interventions to effect changes in medical care delivery leading to an increased proportion of AA patients with controlled BP. Three of the groups performed a pooled analysis of trial results to determine: 1) the magnitude of the combined intervention effect; and 2) how the pooled results could inform the methodology for future health-system level BP interventions. METHODS: Using a cluster randomized design, the trials enrolled AAs with uncontrolled hypertension to test interventions targeting a combination of patient and clinician behaviors. The 12-month Systolic BP (SBP) and Diastolic BP (DBP) effects of intervention or control cluster assignment were assessed using mixed effects longitudinal regression modeling. RESULTS: 2,015 patients representing 352 clusters participated across the three trials. Pooled BP slopes followed a quadratic pattern, with an initial decline, followed by a rise toward baseline, and did not differ significantly between intervention and control clusters: SBP linear coefficient = -2.60±0.21 mmHg per month, p<0.001; quadratic coefficient = 0.167± 0.02 mmHg/month, p<0.001; group by time interaction group by time group x linear time coefficient=0.145 ± 0.293, p=0.622; group x quadratic time coefficient= -0.017 ± 0.026, p=0.525). RESULTS were similar for DBP. The individual sites did not have significant intervention effects when analyzed separately. CONCLUSION: Investigators planning behavioral trials to improve BP control in health systems serving AAs should plan for small effect sizes and employ a "run-in" period in which BP can be expected to improve in both experimental and control clusters.

How geriatricians identify elder abuse and neglect.

BACKGROUND: Up to 2 million elderly persons are abused or neglected in the United States each year. Although elderly patients see their physicians an average of five times per year, physicians make only a small percentage of reports to Adult Protective Services (APS) agencies. The purpose of this study was to learn how practicing geriatricians define, diagnose, and address abuse and neglect to provide some guidance to the busy general internist regarding this complex issue. METHODS: Ten local geriatricians were interviewed with a standardized set of open-ended questions. A team analyzed the verbatim transcriptions using both quantitative and qualitative methods. RESULTS: The average number of cases diagnosed per year was 8.7 (range, 2-20). The geriatricians were fairly consistent in their definitions of elder abuse and neglect and how they diagnosed it through the history and physical exam. The most common findings in the history were rapport between the patient and caregiver, medical noncompliance, activities of daily living and instrumental activities of daily living assessments, and loss of social activities. The most common findings on the physical exam were bruising/trauma, general appearance/hygiene, malnutrition, and dehydration. CONCLUSIONS: The geriatricians emphasized keeping the diagnosis of abuse and neglect in mind for every patient. A variety of interventions were employed by physicians and ranged from automatically calling APS on each case to addressing cases through work with an interdisciplinary geriatrics team.

Association of a culturally defined syndrome (nervios) with chest pain and DSM-IV affective disorders in Hispanic patients referred for cardiac stress testing.

BACKGROUND: Hispanics have a high prevalence of cardiovascular risk factors, most notably type 2 diabetes. However, in a large public hospital in Houston, Texas, Hispanic patients referred for cardiac stress testing were significantly more likely to have normal test results than were Whites or non-Hispanic Blacks. We undertook an exploratory study to determine if nervios, a culturally based syndrome that shares similarities with both panic disorder and anginal symptoms, is sufficiently prevalent among Hispanics referred for cardiac testing to be considered as a possible explanation for the high probability of a normal test result. METHODS: Hispanic patients were recruited consecutively when they presented for a cardiac stress test. A bilingual interviewer administered a brief medical history, the Rose Angina Questionnaire (RAQ), a questionnaire to assess a history of nervios and associated symptoms, and the PRIME-MD, a validated brief questionnaire to diagnose DSM-IV defined affective disorders. RESULTS: The average age of the 114 participants (38 men and 76 women) was 57 years, and the average educational attainment was 7 years. Overall, 50% of participants reported a history of chronic nervios, and 14% reported an acute subtype known as ataque de nervios. Only 2% of patients had DSM-IV defined panic disorder, and 59% of patients had a positive RAQ score (ie, Rose questionnaire angina). The acute subtype, ataque de nervios, but not chronic nervios, was related to an increased probability of having Rose questionnaire angina (P=.006). Adjusted for covariates, a positive history of chronic nervios, but not Rose questionnaire angina, was significantly associated with a normal cardiac test result (OR=2.97, P=.04). CONCLUSION: Nervios is common among Hispanics with symptoms of cardiac disease. Additional research is needed to understand how nervios symptoms differ from chest pain in Hispanics and the role of nervios in referral for cardiac workup by primary care providers and emergency room personnel.

Poor hypertension control: let's stop blaming the patients.

Physician behavior--not patient noncompliance--is the major cause of poor hypertension control in the United States, many studies show. Hypertension control is unlikely to improve unless physicians become more aggressive in treating mildly elevated systolic blood pressure.

Characteristics, drug combinations and dosages of primary care patients with uncontrolled ambulatory blood pressure and high medication adherence.

Most studies on the prevalence and determinants of resistant hypertension (RH) do not account for white coat hypertension, medication non-adherence, or use of suboptimal treatment dosages. We studied the characteristics, drug combinations, and dosages of patients on at least three antihypertensives of different classes who had uncontrolled blood pressure on 24-hour ambulatory blood pressure monitoring and high medication adherence measured by electronic monitoring. The data were collected as part of the baseline measures of a hypertension control trial. Of 140 monitored primary care patients, all with uncontrolled office blood pressure, 69 (49%) were on at least three antihypertensives of different classes. Of these 69, 15 (22%) were controlled on ambulatory blood pressure monitoring, 20 (29%) were uncontrolled and non-adherent, leaving only 34 (49%) adherent to their medications and having uncontrolled ambulatory hypertension (uncontrolled RH). Thirty-one (91%) of the 34 uncontrolled RH patients were prescribed a diuretic, of which 24 were on hydrochlorothiazide 25 mg. Less than half of the patients on angiotensin-converting enzyme inhibitor, angiotensin receptor blocker, or calcium channel blocker were prescribed maximal doses of these agents. Half of the RH can be attributed to white coat effect and poor medication adherence, and all of the remaining patients were on apparently suboptimal drug combinations and/or dosages. Primary care physicians need to be educated regarding the optimal treatment of RH.

Patterns of nonadherence to antihypertensive therapy in primary care.

Nonadherence to medications is an important cause of poor blood pressure control. Long-acting antihypertensive agents could theoretically be beneficial in partially adherent patients, who are commonly seen in contemporary practice. Little has been reported about the duration of drug holidays (DHs) in treated hypertensives outside of generally compliant patients in phase 4 clinical trials. The authors described patterns of nonadherence to single and multiple antihypertensives in a random sample of 120 primary care patients with uncontrolled hypertension. Adherence to up to 3 antihypertensives was measured by electronic monitoring. Frequencies of single-day omissions and DHs of 2 consecutive days (DH2), 3 days (DH3), or ≥4 days (DH≥4) for each drug were calculated. Overall, 89 (74%) of patients had at least a 1-day omission. A single day omission was found in 61.4% of the patients taking 1 drug, followed by DH≥4 (28.1%), DH2 (26.3%), and DH3 (8.8%). In patients using multiple drugs, single-day omissions were also most common, followed by DH≥4, DH2, and DH3. Omissions of ≤3 days comprise on average 74% of all omissions. Although encouraging full adherence remains important, it may be prudent to prescribe long-acting antihypertensive agents, which can compensate for the majority of dose omissions.