Mandi L. Klamerus

The Role of Clinical Uncertainty in Treatment Decisions for Diabetic Patients with Uncontrolled Blood Pressure

Context Why do clinicians fail to intensify antihypertensive therapy when a patients blood pressure is elevated? Contribution This study involved 1169 diabetic patients seen by 92 primary care providers at 9 Veterans Affairs facilities. All had elevated triage blood pressures, but only half received antihypertensive treatment intensification by providers. Patient reports of home blood pressures or repeated blood pressures by providers within normal limits and discussion of medication issues decreased the likelihood of antihypertensive intensification at clinic visits. Implication Uncertainty about true blood pressure values may underlie many reasons why physicians do not intensify antihypertensive therapy. The Editors Despite some recent improvements in blood pressure control, the number of patients with inadequate control remains high and contributes to excess morbidity and mortality, especially among patients at high risk from complications of hypertension (18). Several studies have suggested that clinical inertiathe failure by providers to initiate or intensify therapy (medication intensification) in the face of apparent need to do sois a main contributor to poor control of hypertension (912). Although the failure to intensify treatment medications for patients with elevated blood pressures at visits has been well documented (5, 6, 1218), factors underlying what seems to be clinical inertia have been studied less systematically. When providers are queried after clinic visits about the lack of medication intensification for elevated blood pressure, they variously report that the patients true blood pressure was lower than the clinic blood pressure reading, that other patient concerns precluded attention on blood pressure management, and that patient adherence should be improved before medication intensification (6, 17). Some studies have examined the role of various clinical and patient factors in intensification decisions (6, 8, 17, 19, 20), but no study has used a detailed conceptual model to comprehensively examine the relative contribution of a broad array of potential patient, provider, organizational, and visit-specific contributors to a medication intensification decision. In addition, although a frequently cited reason for deferring medication changes is that the clinic blood pressure does not reflect the patients true blood pressure (21, 22), this clinical uncertainty and its effects have not been explored. To better understand factors underlying apparent clinical inertia for hypertension, we designed the ABATe (Addressing Barriers to Treatment for Hypertension) study to examine treatment change decisions for diabetic primary care patients with elevated triage blood pressures before a primary care visit. We defined elevated blood pressure for this population to be 140/90 mm Hg, a value well above guideline targets for diabetic patients and one clearly requiring some type of action (4). Our goals were to assess how often patients presenting with an elevated triage blood pressure received medication intensification or were scheduled for close follow-up and the role that clinical uncertainty about blood pressure, competing demands and prioritization, medication-related factors, and care organization play in treatment change decisions. Methods Conceptual Model On the basis of theories of patient, provider, and organization behavior (2336), we developed a conceptual modelthe hypertension clinical action modelto examine decisions that drive treatment change (medication intensification or prompt blood pressure follow-up) for elevated blood pressure (Figure 1). The model, developed by 2 internists and 3 PhD-level methodologists in conjunction with development of ABATe and before data collection, proposes such treatment change decisions at a visit are based on 4 main conceptual domains: clinical uncertainty (Is the patients blood pressure truly elevated? Does the clinic blood pressure reflect the true blood pressure?), competing demands and prioritization (What other problems need to be addressed at this visit? Is blood pressure management a priority for this particular patient? Does the provider place priority on blood pressure management in general?), medication-related factors (Should adherence be addressed first? Is the medication regimen too complex? Will the patient accept another medication?), and care organization (Is there sufficient time to address hypertension? Are staff available for follow-up?). In addition, as part of grant development, we hypothesized that the following factors would lead to a lower probability of treatment change: uncertainty about whether the patients visit blood pressure reflected their true blood pressure (clinical uncertainty), comorbid conditions unrelated to hypertension and diabetes (37), a lower priority placed by the provider on the importance of treating elevated blood pressure, a higher number of baseline medications, perceived medication adherence problems, shorter clinic visit times, and lack of staff to follow up for blood pressure medication adjustment. Figure 1. Hypertension clinical action model. Design Setting We conducted a prospective cohort study of patients with scheduled primary care visits at 9 Veterans Affairs facilities located in 3 midwestern states. These facilities varied in size and structure, with 3 large academic-affiliated medical centers, 1 large nonacademic medical center, and 1 large and 4 small community-based outpatient clinics. From 15 February 2005 to 14 February 2006, approximately 33500 diabetic patients visited primary care providers (including residents) in these facilities (range per facility, 1050 to 9200 diabetic patients). The institutional review boards of all participating facilities approved the study protocol. Both patients and providers gave written informed consent before participating. Providers received a

Improving Blood Pressure Control Through a Clinical Pharmacist Outreach Program in Patients With Diabetes Mellitus in 2 High-Performing Health Systems The Adherence and Intensification of Medications Cluster Randomized, Controlled Pragmatic Trial

50 bookstore gift card, and patients received a

Rates of Deintensification of Blood Pressure and Glycemic Medication Treatment Based on Levels of Control and Life Expectancy in Older Patients With Diabetes Mellitus

10 department store gift card for completing initial surveys. Providers were told that the study was about diabetes and hypertension, with the purpose being to study challenges in treating patients with diabetes and ways to overcome these challenges so that quality of care can be enhanced. Primary Care Providers We invited all nonresident primary care providers with patient care responsibility at least 2 half-days per week to participate in the study. Of the eligible 126 providers approached, 104 consented to participate, for an overall recruitment rate of 83% (median facility-level recruitment rate, 88%). By the time recruitment started, 12 providers had stopped working at their facility or changed their patient care responsibilities, leaving 92 primary care providers still eligible to participate (range per facility, 2 to 28 providers; median, 8). Patients As specified by our institutional review board protocols, potentially eligible patients were referred to study staff by triage personnel. During the enrollment periods at each facility, study staff screened all referred patients who presented for a scheduled visit to participating primary care providers and whose lowest triage systolic blood pressure was 140 mm Hg or greater or whose lowest triage diastolic blood pressure was 90 mm Hg or greater (Figure 2). In each of the facilities, triage staff routinely used an electronic cuff to check the patients blood pressure before the provider visit. Triage policies specified that a second blood pressure measurement should be obtained if the first blood pressure was elevated. In addition to the triage blood pressure, study staff screened patients for the following inclusion criteria: the participant confirmed a diagnosis of diabetes, the participating provider was the primary provider of diabetes care for the participant, and the participant spoke English. Patients with impaired decision-making ability (for example, dementia and traumatic brain injury) or terminal disease and residents of nursing homes were excluded. Of the 1556 patients approached by study staff, 213 were ineligible (Figure 2) and 1169 provided written informed consent to participate in the study (approached and eligible, 87%; median facility-level recruitment rate, 89%). We enrolled a median of 14 patients per provider (range, 1 to 16 patients) from February 2005 to March 2006. Recruitment time per facility varied from 4 to 12 months. Figure 2. Study flow diagram. PCP = primary care provider. *Diabetic patients presenting for a primary care visit to 1 of 92 participating providers were referred for eligibility assessment if their lowest triage blood pressure was140/90 mm Hg. *Number of responses varied by individual item. Our prespecified sample size calculations stipulated that we needed at least 11 patients from 80 physicians across 8 sites (that is, 880 patients) to detect a moderate difference in treatment change (about 12%) when competing demands were or were not present. Data Sources We included data from 5 sources in our analysis (Table 1). First, a baseline survey completed by all providers provided variables assessing provider prioritization to blood pressure management, general provider characteristics, and availability of ancillary support for blood pressure management. Second, providers completed a brief visit survey for each patient after the same clinic session in which they saw the patient (completion rate, 99%). This survey provided information on which issues were discussed during the visit, the providers blood pressure goal for the patient, and whether medications were changed during the visit. Third, a patient survey conducted at enrollment provided sociodemographic characteristics, self-reported adherence and difficulty with medications, and self-management practices (completion rate, 91%). Fourth, review of electronic medical records documented free text blood pressure values and notes on actions taken at the enrollment visit. Finally, patient age, prescribed medications and th

Monitoring Performance for Blood Pressure Management Among Patients With Diabetes Mellitus: Too Much of a Good Thing?

Background— Even in high-performing health systems, some patients with diabetes mellitus have poor blood pressure (BP) control because of poor medication adherence and lack of medication intensification. We examined whether the Adherence and Intensification of Medications intervention, a pharmacist-led intervention combining elements found in efficacy studies to lower BP, improved BP among patients with diabetes mellitus with persistent hypertension and poor refill adherence or insufficient medication intensification in 2 high-performing health systems. Methods and Results— We conducted a prospective, multisite cluster randomized pragmatic trial with randomization of 16 primary care teams at 5 medical centers (3 Veterans Affairs and 2 Kaiser Permanente) to the Adherence and Intensification of Medications intervention or usual care. The primary outcome was relative change in systolic BP (SBP), comparing 1797 intervention with 2303 control team patients, from 6 months preceding to 6 months after the 14-month intervention period. We examined shorter-term changes in SBP as a secondary outcome. The mean SBP decrease from 6 months before to 6 months after the intervention period was ≈9 mm Hg in both arms. Mean SBPs of eligible intervention patients were 2.4 mm Hg lower (95% CI: −3.4 to −1.5; P<0.001) immediately after the intervention than those achieved by control patients. Conclusions— The Adherence and Intensification of Medications program more rapidly lowered SBPs among intervention patients, but usual-care patients achieved equally low SBP levels by 6 months after the intervention period. These findings show the importance of evaluating in different real-life clinical settings programs found in efficacy trials to be effective before urging their widespread adoption in all settings. Clinical Trial Registration— URL: http://clinicaltrials.gov. Unique identifier: NCT00495794.Background— Even in high-performing health systems, some patients with diabetes mellitus have poor blood pressure (BP) control because of poor medication adherence and lack of medication intensification. We examined whether the Adherence and Intensification of Medications intervention, a pharmacist-led intervention combining elements found in efficacy studies to lower BP, improved BP among patients with diabetes mellitus with persistent hypertension and poor refill adherence or insufficient medication intensification in 2 high-performing health systems. Methods and Results— We conducted a prospective, multisite cluster randomized pragmatic trial with randomization of 16 primary care teams at 5 medical centers (3 Veterans Affairs and 2 Kaiser Permanente) to the Adherence and Intensification of Medications intervention or usual care. The primary outcome was relative change in systolic BP (SBP), comparing 1797 intervention with 2303 control team patients, from 6 months preceding to 6 months after the 14-month intervention period. We examined shorter-term changes in SBP as a secondary outcome. The mean SBP decrease from 6 months before to 6 months after the intervention period was ≈9 mm Hg in both arms. Mean SBPs of eligible intervention patients were 2.4 mm Hg lower (95% CI: −3.4 to −1.5; P <0.001) immediately after the intervention than those achieved by control patients. Conclusions— The Adherence and Intensification of Medications program more rapidly lowered SBPs among intervention patients, but usual-care patients achieved equally low SBP levels by 6 months after the intervention period. These findings show the importance of evaluating in different real-life clinical settings programs found in efficacy trials to be effective before urging their widespread adoption in all settings. Clinical Trial Registration— URL: . Unique identifier: [NCT00495794][1]. # Clinical Perspective {#article-title-68} [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00495794&atom=%2Fcirculationaha%2F125%2F23%2F2863.atom

Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study.

IMPORTANCE Older patients with diabetes mellitus receiving medical treatment whose blood pressure (BP) or blood glucose level are potentially dangerously low are rarely deintensified. Given the established risks of low blood pressure and blood glucose, this is a major opportunity to decrease medication harm. OBJECTIVE To examine the rate of BP- and blood glucose-lowering medicine deintensification among older patients with type 1 or 2 diabetes mellitus who potentially receive overtreatment. DESIGN, SETTING, AND PARTICIPANTS Retrospective cohort study conducted using data from the US Veterans Health Administration. Participants included 211 667 patients older than 70 years with diabetes mellitus who were receiving active treatment (defined as BP-lowering medications other than angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, or glucose-lowering medications other than metformin hydrochloride) from January 1 to December 31, 2012. Data analysis was performed December 10, 2013, to July 20, 2015. EXPOSURES Participants were eligible for deintensification of treatment if they had low BP or a low hemoglobin A1c (HbA1c) level in their last measurement in 2012. We defined very low BP as less than 120/65 mm Hg, moderately low as systolic BP of 120 to 129 mm Hg or diastolic BP (DBP) less than 65 mm Hg, very low HbA1c as less than 6.0%, and moderately low HbA1c as 6.0% to 6.4%. All other values were not considered low. MAIN OUTCOMES AND MEASURES Medication deintensification, defined as discontinuation or dosage decrease within 6 months after the index measurement. RESULTS The actively treated BP cohort included 211,667 participants, more than half of whom had moderately or very low BP levels. Of 104,486 patients with BP levels that were not low, treatment in 15.1% was deintensified. Of 25,955 patients with moderately low BP levels, treatment in 16.0% was deintensified. Among 81,226 patients with very low BP levels, 18.8% underwent BP medication deintensification. Of patients with very low BP levels whose treatment was not deintensified, only 0.2% had a follow-up BP measurement that was elevated (BP ≥140/90 mm Hg). The actively treated HbA1c cohort included 179,991 participants. Of 143,305 patients with HbA1c levels that were not low, treatment in 17.5% was deintensified. Of 23,769 patients with moderately low HbA1c levels, treatment in 20.9% was deintensified. Among 12,917 patients with very low HbA1c levels, 27.0% underwent medication deintensification. Of patients with very low HbA1c levels whose treatment was not deintensified, fewer than 0.8% had a follow-up HbA1c measurement that was elevated (≥7.5%). CONCLUSIONS AND RELEVANCE Among older patients whose treatment resulted in very low levels of HbA1c or BP, 27% or fewer underwent deintensification, representing a lost opportunity to reduce overtreatment. Low HbA1c or BP values or low life expectancy had little association with deintensification events. Practice guidelines and performance measures should place more focus on reducing overtreatment through deintensification.

More Than a Pain in the Neck: How Discussing Chronic Pain Affects Hypertension Medication Intensification

BACKGROUND Performance measures that reward achieving blood pressure (BP) thresholds may contribute to overtreatment. We developed a tightly linked clinical action measure designed to encourage appropriate medical management and a marker of potential overtreatment, designed to monitor overly aggressive treatment of hypertension in the face of low diastolic BP. METHODS We conducted a retrospective cohort study in 879 Department of Veterans Affairs (VA) medical centers and smaller community-based outpatient clinics. The clinical action measure for hypertension was met if the patient had a passing index BP at the visit or had an appropriate action. We examined the rate of passing the action measure and of potential overtreatment in the Veterans Health Administration during 2009-2010. RESULTS There were 977,282 established VA patients, 18 years and older, with diabetes mellitus (DM). A total of 713,790 patients were eligible for the action measure; 94% passed the measure (82% because they had a BP <140/90 mm Hg at the visit and an additional 12% with a BP ≥140/90 mm Hg and appropriate clinical actions). Facility pass rates varied from 77% to 99% (P < .001). Among all patients with DM, 197,291 (20%) had a BP lower than 130/65 mm Hg; of these, 80 903 (8% of all patients with DM) had potential overtreatment. Facility rates of potential overtreatment varied from 3% to 20% (P < .001). Facilities with higher rates of meeting the current threshold measure (<140/90 mm Hg) had higher rates of potential overtreatment (P < .001). CONCLUSIONS While 94% of diabetic veterans met the action measure, rates of potential overtreatment are currently approaching the rate of undertreatment, and high rates of achieving current threshold measures are directly associated with overtreatment. Implementing a clinical action measure for hypertension management, as the Veterans Health Administration is planning to do, may result in more appropriate care and less overtreatment.

First Things First: Difficulty with Current Medications Is Associated With Patient Willingness to Add New Ones

BackgroundMany patients with diabetes have poor blood pressure (BP) control. Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications. Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen.MethodsIn this cluster-randomized controlled effectiveness study, primary care teams within sites were randomized to a program led by a clinical pharmacist trained in motivational interviewing-based behavioral counseling approaches and authorized to make BP medication changes or to usual care. This study involved the collection of data during a 14-month intervention period in three Department of Veterans Affairs facilities and two Kaiser Permanente Northern California facilities. The clinical pharmacist was supported by clinical information systems that enabled proactive identification of, and outreach to, eligible patients identified on the basis of poor BP control and either medication refill gaps or lack of recent medication intensification. The primary outcome is the relative change in systolic blood pressure (SBP) measurements over time. Secondary outcomes are changes in Hemoglobin A1c, low-density lipoprotein cholesterol (LDL), medication adherence determined from pharmacy refill data, and medication intensification rates.DiscussionIntegration of the three intervention elements - proactive identification, adherence counseling and medication intensification - is essential to achieve optimal levels of control for high-risk patients. Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care.Trial RegistrationThe ClinicalTrials.gov registration number is NCT00495794.

Assessing Appropriateness of Lipid Management Among Patients With Diabetes Mellitus Moving From Target to Treatment

ABSTRACTBACKGROUNDA difficult to manage comorbid condition, like chronic pain, could adversely affect the delivery of recommended care for other serious health problems, such as hypertension.OBJECTIVEWe examined whether addressing pain at a primary care visit acts as a competing demand in decisions to intensify blood pressure (BP) medications for diabetic patients with an elevated BP.DESIGNProspective cohort study. Participants: 1,169 diabetic patients with a BP ≥140/90 prior to a primary care provider (PCP) visit were enrolled.MEASUREMENTSAfter the visit, PCPs provided information about the top three issues discussed and whether hypertension medications were intensified or reasons for not intensifying. We used multi-level logistic regression to assess whether discussing pain during the visit decreased the likelihood of BP medication intensification. We calculated predicted probabilities of medication intensification by whether pain was discussed.RESULTSPCPs discussed pain during 222 (20%) of the visits. Visit BP did not differ between patients with whom pain was and was not discussed. BP medications were intensified during 44% of the visits. The predicted probability of BP medication intensification when pain was discussed was significantly lower than when pain was not discussed (35% vs. 46%, p = 0.02).CONCLUSIONSDiscussing pain at a primary care visit competed with the intensification of BP medication. This finding is concerning given that controlling blood pressure may be the most important factor in decreasing long-term complications for patients with diabetes. Better care management models for complex patients are needed to ensure that both pain and other chronic conditions are adequately addressed.

Factors associated with persistent poorly controlled diabetes mellitus: Clues to improving management in patients with resistant poor control

AbstractBackground: Inadequate BP control remains prevalent. One proposed explanation is ‘clinical inertia,’ often defined as the failure by providers to initiate or intensify medication therapy when otherwise appropriate. However, patients could contribute to clinical inertia by signaling an unwillingness to consider medication intensification. Objective: To explore co-variates of patient attitudes likely to predict patients’ willingness to intensify (WTI) their medication regimen. Methods: A cross-sectional survey was conducted in nine Midwestern US Veterans’ Administration medical facilities as part of a prospective cohort study of clinical inertia in hypertension treatment. 1062 patients with diabetes mellitus, identified as having BP ≥ 140/90 mmHg, were surveyed. Primary outcome was participants’ indicated WTI BP medications if their provider noted elevated BP levels. Potential co-variates assessed included BP control (actual and perceived), perceived importance of BP control, BP management self-efficacy, competing demands, medication factors (adherence and management issues), trust in provider, and sociodemographic factors. Results: While 64% of participants reported complete WTI BP medications, 36% of participants expressed at least some unwillingness. In ordered logistic regression analysis, WTI was negatively associated with medication concerns, particularly concern about adverse effects (odds ratio [OR] 0.49; 95% CI 0.42, 0.59) and adherence or management problems (OR 0.72; 95% CI 0.57, 0.91), and positively associated with perceived dependence of health on BP medications (OR 1.50; 95% CI 1.26, 1.79) and trust in provider (OR 1.30; 95% CI 1.10, 1.54). Importance of BP control had a weaker, nonsignificant association with WTI (OR 1.17; 95% CI 0.99, 1.40). Competing demands, current BP control, current number of medications prescribed, and self-efficacy were not associated with WTI medications. Conclusions: Patients’ willingness to consider intensification of BP medications appears primarily determined by how well patients are managing their current medications, rather than patients’ perceived importance of BP control, their self-efficacy, or their prioritization of BP control versus other health demands. Greater attention to patients’ pre-existing medication issues may improve providers’ ability to intensify BP medication therapy when medically appropriate while simultaneously improving patient satisfaction with care.

Improving Blood Pressure Control through a Clinical Pharmacist Outreach Program in Diabetes Patients in Two-High Performing Health Systems: The Adherence and Intensification of Medications (AIM) Cluster Randomized Controlled Pragmatic Trial

Background— Performance measures that emphasize only a treat-to-target approach may motivate overtreatment with high-dose statins, potentially leading to adverse events and unnecessary costs. We developed a clinical action performance measure for lipid management in patients with diabetes mellitus that is designed to encourage appropriate treatment with moderate-dose statins while minimizing overtreatment. Methods and Results— We examined data from July 2010 to June 2011 for 964 818 active Veterans Affairs primary care patients ≥18 years of age with diabetes mellitus. We defined 3 conditions as successfully meeting the clinical action measure for patients 50 to 75 years old: (1) having a low-density lipoprotein (LDL) <100 mg/dL, (2) taking a moderate-dose statin regardless of LDL level or measurement, or (3) receiving appropriate clinical action (starting, switching, or intensifying statin therapy) if LDL is ≥100 mg/dL. We examined possible overtreatment for patients ≥18 years of age by examining the proportion of patients without ischemic heart disease who were on a high-dose statin. We then examined variability in measure attainment across 881 facilities using 2-level hierarchical multivariable logistic models. Of 668 209 patients with diabetes mellitus who were 50 to 75 years of age, 84.6% passed the clinical action measure: 67.2% with LDL <100 mg/dL, 13.0% with LDL ≥100 mg/dL and either on a moderate-dose statin (7.5%) or with appropriate clinical action (5.5%), and 4.4% with no index LDL on at least a moderate-dose statin. Of the entire cohort ≥18 years of age, 13.7% were potentially overtreated. Facilities with higher rates of meeting the current threshold measure (LDL <100 mg/dL) had higher rates of potential overtreatment (P<0.001). Conclusions— Use of a performance measure that credits appropriate clinical action indicates that almost 85% of diabetic veterans 50 to 75 years of age are receiving appropriate dyslipidemia management. However, many patients are potentially overtreated with high-dose statins.