PDC is one of the most popular methods to calculate medication adherence and is endorsed and validated by the PQA as a high-quality measure of medication adherence.118,119 * Clinical Recommendations 2017 Hypertension Clinical Practice Guidelines4 In adults with hypertension, dosing of antihypertensive medication once daily rather than multiple times daily is beneficial to improve adherence.115,116,120 (Class 1, Level of Evidence: B-R) Adults initiating a new or adjusted drug regimen for hypertension should have a follow-up evaluation of adherence and response to treatment at monthly intervals until control is achieved.59,60,121 (Class 1, Level of Evidence: B-R) Use of BP-lowering medications is recommended for secondary prevention of recurrent CVD events in patients with clinical CVD and an average SBP of 130 mmHg or higher or an average DBP of 80 mmHg or higher, and for primary prevention in adults with an estimated 10-y atherosclerotic cardiovascular disease (ASCVD) risk of 10% or higher and an average SBP 130 mmHg or higher or an average DBP 80 mmHg or higher.29,37,42,43,46,122 125 (Class 1, Level of Evidence: SBP: A, DBP: C-EO) Use of BP-lowering medication is recommended for primary prevention of CVD in adults with no history of CVD and with an estimated 10-y ASCVD risk <10% and an SBP of 140 mmHg or higher or a DBP of 90 mmHg or higher.39,125 128 (Class 1, Level of Evidence: C-LD) Initiation of antihypertensive drug therapy with 2 first-line agents of different classes, either as separate agents or in a fixed-dose combination, is recommended in adults with stage 2 hypertension and an average BP more than 20/10 mmHg above their BP target. (Class 1, Level of Evidence: C-EO) Use of combination pills rather than free individual components can be useful to improve adherence to antihypertensive therapy.129 132 (Class 2a, Level of Evidence: B-NR) Initiation of antihypertensive drug therapy with a single antihypertensive drug is reasonable in adults with stage 1 hypertension and BP goal <130/80 mmHg with dosage titration and sequential addition of other agents to achieve the BP target. (Class 2a, Level of Evidence: C-EO) *We encourage stratification by clinically relevant subsets, such as stage 1 with ASCVD risk 10, or stage 2, for quality improvement efforts. ACC indicates American College of Cardiology; AHA, American Heart Association; ASCVD, atherosclerotic cardiovascular disease; BP, blood pressure; CVD, cardiovascular disease; DBP, diastolic blood pressure; HBP, high blood pressure; PDC, proportion of days covered; PQA, Pharmacy Quality Alliance; and SBP, systolic blood pressure. 30 Appendix A. Continued Short Title: QM-5: Use of HBPM for Management of ACC/AHA Stage 1 HBP QM-5: Use of HBPM for Management of ACC/AHA Stage 1 HBP Measure Description: Percentage of patients 18 85 y of age who had a diagnosis of ACC/AHA stage 1 HBP for whom HBPM is recommended and HBPM data are documented in the patient record Numerator Documentation of home BP readings in the medical record Denominator All patients 18 85 y of age with ACC/AHA stage 1 HBP who had at least 1 outpatient encounter with a diagnosis of HBP during the first 6 mo of the measurement year or any time before the measurement period Denominator Exclusions End-stage renal disease, kidney transplantation, pregnancy, BP readings taken during an inpatient stay Denominator Exceptions None Measurement Period 12 mo/measurement year Sources of Data Paper medical record/prospective data collection flow sheet, Qualified Electronic Health Record, QCDR, electronic administrative data (claims), expanded (multiple source) administrative data, electronically or telephonically transmitted BP readings Attribution Healthcare provider, physician group practice, accountable care organization, clinically integrated network, health plan, integrated delivery system Care Setting Outpatient (office, clinic, home, or ambulatory) Rationale HBPM or self-monitoring of BP refers to the regular measurement of BP by an individual at home or elsewhere outside the clinic setting. Home-based measurement has been found to be a better predictor of cardiovascular risk than clinic-based measurement. Evidence also suggests that home-based BP measurement in combination interventions with telemedicine with nurse- or pharmacist-led care may be effective for improving hypertension management. Recommended procedures for the collection of HBPM data are as follows4 : Patient training should occur under medical supervision, including: Information about hypertension Selection of equipment Acknowledgment that individual BP readings may vary substantially Interpretation of results Devices: Verify use of automated validated devices. Use of auscultatory devices (mercury, aneroid, or other) is not generally useful for HBPM because patients rarely master the technique required for measurement of BP with auscultatory devices. Monitors with provision for storage of readings in memory are preferred. Verify use of appropriate cuff size to fit the arm. Verify that left/right inter-arm differences are insignificant. If differences are significant, instruct patient to measure BPs in the arm with higher readings. Instructions on HBPM procedures: Remain still: Avoid smoking, caffeinated beverages, or exercise within 30 min before BP measurements. Ensure 5 min of quiet rest before BP measurements. Sit correctly: Sit with back straight and supported (on a straight-backed dining chair, for example, rather than a sofa). Sit with feet flat on the floor and legs uncrossed. Keep arm supported on a flat surface (such as a table), with the upper arm at heart level. Bottom of the cuff should be placed directly above the antecubital fossa (bend of the elbow). Take multiple readings: Take at least 2 readings 1 min apart in morning before taking medications and in evening before supper. Optimally, measure and record BP daily. Ideally, obtain weekly BP readings beginning 2 wk after a change in the treatment regimen and during the week before a clinic visit. Record all readings accurately: Monitors with built-in memory should be brought to all clinic appointments. BP should be based on an average of readings on 2 occasions for clinical decision making. Clinical Recommendation 2017 Hypertension Clinical Practice Guidelines4 Out-of-office BP measurements are recommended to confirm the diagnosis of hypertension and for titration of BP-lowering medication, in conjunction with telehealth counseling or clinical interventions.47 50 (Class 1, Level of Evidence: ASR ) ACC indicates American College of Cardiology; AHA, American Heart Association; BP, blood pressure; HBP, high blood pressure; HBPM, home blood pressure monitoring; and QCDR, Qualified Clinical Data Registry. 31 Appendix A. Continued Short Title: QM-6: Use of HBPM for Management of ACC/AHA Stage 1 or ACC/AHA Stage 2 (Composite Measure Combining PM-5 and QM-5) QM-6: Use of HBPM for Management of ACC/AHA Stage 1 HBP or ACC/AHA Stage 2 HBP (Composite Measure Combining PM-5 and Process QM-5) Measure Description: Percentage of patients 18 85 y of age who had a diagnosis of either ACC/AHA stage 1 HBP or ACC/AHA stage 2 HBP for whom HBPM is recommended and HBPM data are documented in the patient record Numerator Documentation of home BP readings in the medical record Denominator All patients 18 85 y of age who had a diagnosis of either ACC/AHA stage 1 HBP or ACC/AHA stage 2 HBP who had at least 1 outpatient encounter with a diagnosis of HBP during the first 6 mo of the measurement year or any time before the measurement period Denominator Exclusions End-stage renal disease, kidney transplantation, pregnancy, BP readings taken during an inpatient stay Denominator Exceptions None Measurement Period 12 mo/measurement year Sources of Data Paper medical record/prospective data collection flow sheet, Qualified Electronic Health Record, QCDR, electronic administrative data (claims), expanded (multiple source) administrative data, electronically or telephonically transmitted BP readings Attribution Healthcare provider (healthcare provider, physician group practice, accountable care organization, clinically integrated network, health plan, integrated delivery system) Care Setting Outpatient (office, clinic, home, or ambulatory) Rationale HBPM or self-monitoring of BP refers to the regular measurement of BP by an individual at home or elsewhere outside the clinic setting. Home-based measurement has been found to be a better predictor of cardiovascular risk than clinic-based measurement. Evidence also suggests that home-based BP measurement in combination interventions with telemedicine with nurse- or pharmacist-led care may be effective for improving hypertension management. Recommended procedures for the collection of HBPM data are as follows4 : Patient training should occur under medical supervision, including: Information about hypertension Selection of equipment Acknowledgment that individual BP readings may vary substantially Interpretation of results Devices: Verify use of automated validated devices. Use of auscultatory devices (mercury, aneroid, or other) is not generally useful for HBPM because patients rarely master the technique required for measurement of BP with auscultatory devices. Monitors with provision for storage of readings in memory are preferred. Verify use of appropriate cuff size to fit the arm. Verify that left/right inter-arm differences are insignificant. If differences are significant, instruct patient to measure BPs in the arm with higher readings. Instructions on HBPM procedures: Remain still: Avoid smoking, caffeinated beverages, or exercise within 30 min before BP measurements. Ensure 5 min of quiet rest before BP measurements. Sit correctly: Sit with back straight and supported (on a straight-backed dining chair, for example, rather than a sofa). Sit with feet flat on the floor and legs uncrossed. Keep arm supported on a flat surface (such as a table), with the upper arm at heart level. Bottom of the cuff should be placed directly above the antecubital fossa (bend of the elbow). Take multiple readings: Take at least 2 readings 1 min apart in morning before taking medications and in evening before supper. Optimally, measure and record BP daily. Ideally, obtain weekly BP readings beginning 2 wk after a change in the treatment regimen and during the week before a clinic visit. Record all readings accurately: Monitors with built-in memory should be brought to all clinic appointments. BP should be based on an average of readings on 2 occasions for clinical decision making. Clinical Recommendation 2017 Hypertension Clinical Practice Guidelines4 Out-of-office BP measurements are recommended to confirm the diagnosis of hypertension and for titration of BP-lowering medication, in conjunction with telehealth counseling or clinical interventions.47 50 (Class 1, Level of Evidence: ASR ) ACC indicates American College of Cardiology; AHA, American Heart Association; BP, blood pressure; HBP, high blood pressure; HBPM, home blood pressure monitoring; and QCDR, Qualified Clinical Data Registry. 32 Appendix A. Continued Structural Quality Measures The Structural Quality Measure domain should be considered to be at the CDU level (can be a physician group practice, accountable care organization, clinically integrated network, health plan, or integrated delivery system), as opposed to the specific patient or physician/clinician level. The goal will be to guide and motivate CDUs to implement and evaluate these specific guideline recommendations to improve the various and necessary evidence-based components of a guideline-driven system of care and accompanying infrastructure needed for effective identification and management of patients with HBP. Diagnosis, Assessment, and Accurate Measurement SM-1: Use of a Standard Protocol to Consistently and Correctly Measure BP in the Ambulatory Setting Measure Components The CDU uses a standard process/protocol for properly measuring BP consistently and correctly, including: Adoption and implementation of a protocol for accurate measurement and documentation of BP. Availability of staff who are trained in measurement and documentation of BP. Documentation of staff assessment of correct BP measurement skill. Elements Protocol includes preassessment tools, checklists, and metrics to assess gaps in care. Certification of staff in correct BP measurement skills. Recommended Protocol 2017 Hypertension Clinical Practice Guidelines.4 Blood Pressure Assessment in Adults in Clinical Practice and Clinic-Based Research.133 Documentation Documenting the implementing protocols may impose additional burdens on HCOs. Potential options to consider: Attestation, self-reported information External auditor/rater Competency testing Rationale Accurate measurement and recording of BP are essential to categorize level of BP, ascertain BP-related ASCVD risk, and guide management of high BP. Office BP measurement is often unstandardized, despite the well-known consequences of inaccurate measurement. Errors are common and can result in a misleading estimation of an individual s true level of BP if staff are not trained and a protocol is not followed. The use of automated office BP measurements should be considered as part of the protocol for accurate measurement.134 Checklist for Accurate Measurement of BP135,136 Key Steps for Proper BP Measurements Specific Instructions: Step 1: Properly prepare the patient 1. Have the patient relax, sitting in a chair (feet on floor, back supported) for >5 min. 2. The patient should avoid caffeine, exercise, and smoking for at least 30 min before measurement. 3. Ensure patient has emptied his/her bladder. 4. Neither the patient nor the observer should talk during the rest period or during the measurement. 5. Remove all clothing covering the location of cuff placement. 6. Measurements made while the patient is sitting or lying on an examining table do not fulfill these criteria. Step 2: Use proper technique for BP measurements 1. Use a BP measurement device that has been validated, and ensure that the device is calibrated periodically. 2. Support the patient s arm (eg, resting on a desk). 3. Position the middle of the cuff on the patient s upper arm at the level of the right atrium (the midpoint of the sternum). 4. Use the correct cuff size, such that the bladder encircles 80% of the arm, and note if a larger- or smaller-than-normal cuff size is used. 5. Either the stethoscope diaphragm or bell may be used for auscultatory readings.137,138 Step 3: Take the proper measurements needed for diagnosis and treatment of elevated BP/hypertension 1. At the first visit, record BP in both arms. Use the arm that gives the higher reading for subsequent readings. 2. Separate repeated measurements by 1 2 min. For auscultatory determinations, use a palpated estimate of radial pulse obliteration pressure to estimate SBP. Inflate the cuff 20 30 mmHg above this level for an auscultatory determination of the BP level. 4. For auscultatory readings, deflate the cuff pressure 2 mmHg per second, and listen for Korotkoff sounds. (Continued) 33 Step 4: Properly document accurate BP readings Record SBP and DBP. If using the auscultatory technique, record SBP and DBP as onset of the first Korotkoff sound and disappearance of all Korotkoff sounds, respectively, using the nearest even number. 2. Note the time of most recent BP medication taken before measurements. Step 5: Average the readings 1. Use an average of 2 readings obtained on 2 occasions to estimate the individual s level of BP. Step 6: Provide BP readings to patient 1. Provide patients the SBP/DBP readings both verbally and in writing. Clinical Recommendations 2017 Hypertension Clinical Practice Guidelines4 Recommendation for Accurate Measurement of BP in the Office (Guideline Section 4) For diagnosis and management of high BP, proper methods are recommended for accurate measurement and documentation of BP. (Class 1, Level of Evidence: C-EO) ACC indicates American College of Cardiology; AHA, American Heart Association; ASCVD, atherosclerotic cardiovascular disease; BP, blood pressure; CDU, care delivery unit; DBP, diastolic blood pressure; HCO, home care organization; QCDR, Qualified Clinical Data Registry; and SBP, systolic blood pressure. Appendix A. Continued 34 Appendix A. Continued SM-2: Use of a Standard Process for Assessing ASCVD Risk Measure Components The CDU uses a standard process/protocol for properly measuring/assessing ASCVD risk, including: 1. Measurement of ASCVD Risk a. Use of ACC/AHA Risk Estimator139,140 is recommended. Others may be used as alternatives when evaluated in the population seen clinically. b. Healthcare providers identify the health provider responsible for insuring competency and implementation of risk assessment in practice. 2. Incorporation Into Record a. Baseline risk should be part of patient demographics and included in each note when BP is 130 139/80 89 mmHg, with indication of how it is used in defining treatment strategy. b. EMR for systems (eg, Epic, Cerner) should be requested to automatically place cardiovascular risk assessment in the patient record as part of vital signs. 3. Confirmation of Patient Clinician Discussion a. The risk assessment used in the patient clinician discussion should be entered 1) directly by EHR (eg, Epic, Cerner) or 2) by physician or other healthcare provider as part of documentation of the discussion. b. Patients should be knowledgeable about their results and, if interested, may be instructed on how to use the mobile ASCVD risk assessment app.139,140 Rationale Assessment of cardiovascular risk is the fundamental first step toward developing effective evidence-based therapy for treatment strategies for and shared decision discussions with patients. This includes using this assessment to correctly classify a patient s current stage of HBP in accordance with recommendations from the 2017 Hypertension Clinical Practice Guidelines.4 In general, the ACC/AHA race- and sex-specific PCE (ASCVD Risk Estimator139,140 ) should be used for screening and management of hypertension. The 10-y risk is used for patients without ASCVD who have stage 1 hypertension (130/80 139/89 mmHg) to determine those who should be treated with medical therapy (10-y risk >10%) and those who should who should be managed with nonpharmacological therapy (10-y risk <10%). Patients should know their current cardiovascular risk and how it relates to decisions about their therapy. Observational studies have demonstrated that ASCVD risk factors frequently occur in combination, with 3 risk factors present in 17% of patients.141 A meta- analysis from 18 cohort studies involving 257384 patients identified a lifetime risk of ASCVD death, nonfatal MI, and fatal or nonfatal stroke that was substantially higher in adults with 2 ASCVD risk factors than in those with only 1 risk factor.141,142 To facilitate decisions about preventive interventions, it is recommended to screen for traditional ASCVD risk factors and apply the race- and sex-specific PCE (ASCVD Risk Estimator139,140 ) to estimate 10-y ASCVD risk for asymptomatic adults 40 75 y of age.59,139,140 For management of blood cholesterol, adults should be categorized as having low (<5%), borderline (5% to <7.5%), intermediate ( 7.5% to <20%), or high ( 20%) 10-y risk.143 The PCEs are best validated among non-Hispanic whites and non-Hispanic blacks living in the United States.19,144 147 In other racial/ethnic groups148,149 or in some non- the PCE may over- or under-estimate risk. Therefore, clinicians may consider use of another risk prediction tool, as an alternative to the PCE, if validated in a population with similar characteristics to the evaluated patient. Examples include the general Framingham ASCVD risk score,152 Reynolds risk scores,153,154 tools. Other professional societies have incorporated some of these alternative validated risk scores into their lipid management guidelines or have considered different risk thresholds for preventive interventions.155 160 Although slight differences exist across organizational guidelines, they are all very similar in their overarching goal of matching the intensity of preventive therapies to absolute (generally 10-y) risk of the patient.155 160 Clinical Recommendations 2017 Hypertension Clinical Practice Guidelines4 Recommendation for Screening and Management of CVD Risk (Guideline Section 2.4) 1. Screening for and management of other modifiable CVD risk factors are recommended in adults with hypertension.141,142 (Class 1, Level of Evidence: B-NR) 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease14 Recommendation for ASCVD Risk Assessment (Section 2.2, 2019 Prevention Guideline) For adults 40 to 75 y of age, clinicians should routinely assess traditional cardiovascular risk factors and calculate 10-y risk of ASCVD by using the pooled cohort equations (PCE).139,140,146 (Class 1, Level of Evidence: B-NR) ACC indicates American College of Cardiology; AHA, American Heart Association; ASCVD, atherosclerotic cardiovascular disease; BP, blood pressure; CDU, care delivery unit; CVD, cardiovascular disease; DBP, diastolic blood pressure; EHR, electronic health record; HBP, high blood pressure; MI, myocardial infarction; PCE, pooled cohort equations; QCDR, Qualified Clinical Data Registry; and SBP, systolic blood pressure. 35 Appendix A. Continued SM-3: Use of a Standard Process for Properly Screening All Adults 18 Years of Age for HBP (USPSTF) Measure Components The CDU uses a standard process/protocol for properly screening all adults 18 years of age for HBP (based on an average of 2 BP measurements), including: Adults ages 18 39 y with office-measured SBP/DBP <120/80 mmHg who do not have other hypertension risk factors can space out screenings to every 3 5 y (USPSTF).15 Annual BP screening should be done for adults at increased risk for hypertension, defined as those 40 y of age and those <40 y of age who are overweight or obese or black, regardless of age. For adults, the finding of an office BP consistent with hypertension and with SBP/DBP <160/100 mmHg at an initial visit should be confirmed at a follow-up visit within 1 month, based on an average of 2 BP measurements at each visit. 2017 Hypertension Clinical Practice Guidelines Recommendation4 : In adults with an untreated SBP >130 mmHg but <160 mmHg or DBP >80 mmHg but <100 mmHg, it is reasonable to screen for the presence of white-coat hypertension by using either daytime ABPM or HBPM before diagnosis of hypertension.61 68 (Class 2a, Level of Evidence: B-NR) 2017 Hypertension Clinical Practice Guidelines Recommendation4 : In adults with untreated office BPs that are consistently between 120 mmHg and 129 mmHg for SBP or between 75 mmHg and 79 mmHg for DBP, screening for masked hypertension with HBPM (or ABPM) is reasonable.61,62,65,67,161 (Class 2a, Level of Evidence: B-NR) Rationale The evidence for the benefits of screening for HBP is well established. In 2007, the USPSTF reaffirmed its 2003 recommendation to screen for hypertension in adults 18 y of age (Grade A recommendation). Previous evidence reviews commissioned by the USPSTF found good-quality evidence that screening for hypertension has few major harms and provides substantial benefits.162,163 However, these reviews did not address the diagnostic accuracy of different BP measurement protocols or identify a reference standard for measurement confirmation. For the present recommendation, the USPSTF examined the diagnostic accuracy of office BP measurement, ABPM, and HBPM. The USPSTF also assessed the accuracy of these BP measurements and methods in confirming the diagnosis of hypertension. In addition, it reviewed data on optimal screening intervals for diagnosing hypertension in adults. The USPSTF found good evidence that screening for and treatment of HBP has few major harms. The USPSTF concluded with high certainty that the net benefit of screening for HBP in adults is substantial.15 No clinical trials randomly assigned patients to different rescreening intervals and evaluated clinical outcomes. Many observational studies have followed patients over time to determine how many develop hypertension at intervals of 1 to 5 y.15,164 Clinical Recommendations USPSTF Final Recommendation Statement on HBP in Adults15 The USPSTF recommends screening for HBP in adults aged 18 y or older. The USPSTF recommends obtaining measurements outside of the clinical setting for diagnostic confirmation before starting treatment.164 (USPSTF, Grade A) ABPM indicates ambulatory blood pressure monitoring; BP, blood pressure; CDU, care delivery unit; DBP, diastolic blood pressure; HBP, high blood pressure; HBPM, home blood pressure monitoring; SBP, systolic blood pressure; and USPSTF, US Preventive Services Task Force. 36 Appendix A. Continued SM-4: Use of an EHR to Accurately Diagnose and Assess HBP Control Measure Components The CDU uses an EHR system to obtain data that permit assessment of accurate diagnosis and assessment of HBP control and documentation of ASCVD risk, including: The EHR/registry vendor should be able to export SDP and DBP measurements associated with ambulatory clinic visits, including the date of service. The CDU should consider a standardized field in which the clinician can document the BP used in decision making and the date of service. The CDU should consider a standardized field to record home BP determinations and ASCVD risk assessment. The EHR/registry vendors should consider creating structured data elements using established, standardized nomenclature. Rationale A growing number of health systems are developing or using registries and EHRs that permit large-scale queries to support population health management strategies to identify undiagnosed or undertreated hypertension. Such innovations are implemented as ongoing quality improvement initiatives in clinical practice. To reduce undiagnosed hypertension and improve hypertension management, a multipronged approach may include 1) application of hypertension screening algorithms to EHR databases to identify at-risk patients, 2) contacting at-risk patients to schedule BP measurements, 3) monthly written feedback to clinicians about at-risk patients who have yet to complete a BP measurement, and 4) electronic prompts for BP measurements whenever at-risk patients visit the clinic.55,57 Since passage of the Hitech Act, the use of EHRs and registries in clinical practice has become nearly ubiquitous. The purpose of this SM is to provide guidance to the CDU to aid in the identification of patients with elevated BP or stage 1 or stage 2 HBP through the EHR and/or registry. Previous studies have demonstrated that many patients with elevated BP or stage 1 or stage 2 HBP are undiagnosed with conventional administrative data sets (ICD-10). Use of free-text data searches or structured data searches can facilitate the identification of appropriate patients. In particular, we recommend the use of NQF s denominator exceptions for medical, patient, and system exceptions to improve the accuracy of the data. The evaluation of structured data will greatly facilitate the accuracy of this hypertension performance measure. The intention of this measure is to promote the accurate collection and analysis of BP and demographics through the EHR by using standards-based tools. Currently, most EHRs and registries do not have a specific mapping of sufficient elements to allow the accurate recording and attribution of BPs. The intention of this SM is to provide guidance to EHR and registry vendors to support fluid data flow between the EHR and the registry, using existing established structured data elements. Potential additional benefits and characteristics of using properly configured EHRs and registries include: CDS-based algorithms that support evidence-based guideline recommendations for accurate measurement, risk assessment, diagnosis, classification, and appropriate treatment for patients with or at risk of HBP. 2. Properly vetted reminders and alerts for both clinicians and patients to ensure follow-up appointments, patient engagement, and adherence to GDMT. Compliance with current national interoperability standards to facilitate exchange of information, including the timely transmission of digital data from BP measurement and monitoring devices. 4. Easy extraction of data needed for advanced analytic approaches to accurate classification and treatment of populations with or at risk of HBP. Accurate and automated extraction of necessary data elements for construction, benchmarking, auditing, and feedback to providers and external reporting (eg, to CMS, NCQA, commercial payers, quality improvement initiatives, and professional society accrediting bodies) of standardized performance and quality measures. 6. Facilitation of internal and external quality improvement initiatives, such as Target: BP (AHA and AMA) and The Million Hearts campaign (HHS, CDC). 7. Documentation of nonclinical data, such as social determinants of health, health literacy, and shared decision making. Clinical Recommendations 2017 Hypertension Clinical Practice Guidelines4 Recommendations for EHR and Patient Registries (Guideline Section 12.3) Use of the EHR and patient registries is beneficial for identification of patients with undiagnosed or undertreated hypertension.55 57 (Class 1, Level of Evidence: B-NR) Use of the EHR and patient registries is beneficial for guiding quality improvement efforts designed to improve hypertension control.55 57 Level of Evidence: B-NR) ACC indicates American College of Cardiology; AHA, American Heart Association; ASCVD, atherosclerotic cardiovascular disease; BP, blood pressure; CDC, Centers for Disease Control and Prevention; CDS, clinical decision support; CDU, care delivery unit; EHR, electronic health record; GDMT, guideline-directed medical therapy/treatment; HBP, high blood pressure; HHS, Health and Human Services; ICD-10, International Classification of Diseases, 10th edition; NCQA, National Committee for Quality Assurance; PCE, pooled cohort equations; and SM, structural measure. 37 Appendix A. Continued A Patient-Centered Approach for Controlling HBP SM-5: Use of a Standard Process to Engage Patients in Shared Decision-Making, Tailored to Their Personal Benefits, Goals, and Values for Evidence- Based Interventions to Improve Control of HBP Measure Components The CDU uses a standard process/protocol for implementing SDM in clinical settings for patients with HBP, including: One of the following: Structured decision aids A formal SDM tool is available, with evidence that it is being routinely used in clinical encounters. The choice of a decision aid should be informed by a formal quality assessment, as recommended by IPDAS.165 The tool should be published, free of bias, and ideally endorsed by professional organizations. A process exists whereby patients with hypertension are identified and exposed to the SDM tool. A formal SDM encounter occurs between the patient and provider using an evidence-based decision tool before initiation or adjustment of GDMT. Communication skills training for providers A program exists to provide skills in SDM to practitioners, with periodic assessments of providers skills. Built-in triggers in EHRs to remind clinicians to provide a decision aid to patients with hypertension. The use of an SDM tool is documented within the EHR. A process exists for identifying patients with hypertension who have not participated in SDM so that such a process can be offered. Rationale Decisions about primary prevention should be collaborative between a clinician and a patient. SDM occurs when practitioners engage patients in discussions about personalized ASCVD risk estimates and their implications on the perceived benefits of preventive strategies, including lifestyle habits, goals, and medical therapies. Collaborative decisions are more likely to address potential barriers to treatment options.166 169 SDM is defined as an approach where clinician and patients share the best available evidence when faced with the task of making decisions, and where patients are supported to consider options, to achieve informed preferences. 79,170 It draws on the principles of patient-centered care to increase patient commitment to treatment plans, including long-term adherence to drug therapy and lifestyle modification.168,171,172 Adherence to GDMT of hypertension can be enhanced by SDM between clinicians and patients. Patients should be engaged in the selection of antihypertensive drug therapy and lifestyle modification strategies, with consideration of individual values, preferences, and associated conditions and comorbidities (2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease14 ). Measuring SDM in clinical settings One of the following, supplemented with a process for systematic analysis and feedback to practitioners: Patient-reported measures of SDM The 3-item CollaboRATE Scale173 The 9-item Shared Decision-Making Questionnaire (SDM-Q-9 Patient Version)174 The 4-item SURE Scale175 Provider-reported measures of SDM The 9-item Shared Decision-Making Questionnaire (SDM-Q-Doc)176 Clinical Recommendations 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease14 Recommendations for Shared Decision Making (Section 2.1, 2019 Prevention Guideline) Shared decision making should guide discussions regarding the best strategies to reduce ASCVD risk.166 169 (Class 1, Level of Evidence: B-R) ACC indicates American College of Cardiology; AHA, American Heart Association; ASCVD, atherosclerotic cardiovascular disease; BP, blood pressure; CDU, care delivery unit; EHR, electronic health record; GDMT, guideline-directed medical therapy/treatment; HBP, high blood pressure; IPDAS, International Patient Decision Aid Standards; and SDM, shared decision making. 38 Appendix A. Continued SM-6: Demonstration of Infrastructure and Personnel That Assess and Address Social Determinants of Health of Patients With HBP Measure Components The CDU uses a standard process/protocol for addressing SDoH in clinical settings for patients with HBP, including: Utilization of a standardized tool, such as the Accountable Health Communities Screening Tool,177 to screen health-related social needs in clinical settings. Integration of social and behavioral domains (Table A) into EHRs to monitor efforts to address SDoH. Documentation of patient assessments of SDoH and referrals to social services in medical records. Integration of clinical staff members (eg, social workers, case managers, registered dietitians) to link patients with appropriate community resources. Training of volunteers within the CDU to access a database of resources to address SDoH and provide follow-up until a resolution of unmet social needs is achieved. Identification of community health workers to conduct home social assessments to connect socially deprived patients with community resources. Creation of partnerships with community organizations that provide healthy food and assist with enrollment in federal nutrition assistance programs. Creation of partnerships with pharmacies to provide access to home delivery options for obtaining medication to manage HBP. Rationale Socioeconomic inequalities are strong determinants of ASCVD risk internationally.178,179 Therefore, it is important to tailor advice to a patient s socioeconomic and educational status, as well as cultural, work, and home environments.180 The CMS has developed a tool to assess 5 domains of non health-related measures that impact health outcomes: housing instability, food insecurity, transportation difficulties, utility assistance needs, and interpersonal safety.177 ASCVD prevention could benefit from such screening. ASCVD risk begins early in life, with heightened susceptibility tied to low socioeconomic status.181 Examples of upstream SDoH that affect adherence and ASCVD health outcomes include comorbid mental illness, low health literacy, exposure to adversity (eg, home/community violence, trauma exposures, safety concerns), financial strain, inadequate housing conditions, food insecurity (eg, access to affordable and nutritious food), and inadequate social support.182 Systems of care should evaluate SDoH that affect care delivery for the primary prevention of ASCVD (eg, transportation barriers, the availability of health services). Important considerations related to socioeconomic disadvantage are not captured by existing ASCVD risk equations.183 Addressing unmet social needs improves management of BP and lipids,184 highlighting the importance of dietary counseling and encouraging physical activity.185 More time may be required to address ASCVD prevention when working with adults of low health literacy or disadvantaged educational backgrounds. Differential cardiovascular outcomes persist by important sociodemographic characteristics, including but not limited to age, gender, and race/ethnicity.186 189 Failure to address the impact of SDoH impedes efficacy of proven prevention recommendations. Standardized use of EHRs that include social and behavioral domains could improve care for patients with HBP. Table A outlines social and behavioral domains that may be integrated into EHRs to address SDoH.190 Clinical Recommendations 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease14 Recommendations for Addressing Social Determinants of Health (SDoH) (Section 2.1, 2019 Prevention Guideline) Social determinants of health should inform optimal implementation of treatment recommendations for the prevention of ASCVD.178 181,185,189,191 (Class 1, Level of Evidence: B-NR) ACC indicates American College of Cardiology; AHA, American Heart Association; ASCVD, atherosclerotic cardiovascular disease; CDU, care delivery unit; EHR, electronic health record; HBP, high blood pressure; and SDoH, social determinants of health. 39 Appendix A. Continued Table A. Core Domain and Measures Domain Measure Social Race/ethnicity US Census (2 questions) Education Educational attainment (2 questions) Financial resource strain Overall financial resource strain Stress Stress symptoms192 Social connections and social isolation NHANES III (4 questions) Exposure to violence: intimate partner violence HARK (4 questions) Neighborhood and community compositional characteristics Residential address Census tract-median income Behavioral Physical activity Exercise Vital Sign (2 questions) Tobacco use and exposure NHIS (2 questions) Alcohol use AUDIT-C (3 questions) Republished with permission of the Institute of Medicine, from Capturing social and behavioral domains and measures in electronic health records: phase 2. Washington, DC: The National Academies Press, 2014; permission conveyed through Copyright Clearance Center, Inc.190 AUDIT-C indicates Alcohol Use Disorders Identification Test-C; HARK, Humiliation, Afraid, Rape, Kick; NHANES III, National Health and Nutrition Examination Survey III; NHIS, National Health Interview Survey; and PHQ-2, Patient Health Questionnaire-2. 40 Appendix A. Continued Implementation of a System of Care for Patients With HBP SM-7: Use of Team-Based Care to Better Manage HBP Measure Components The CDU relies on various available components of team-based care in clinical settings for patients with HBP, which may include: Pharmacists RNs/APRNs Physician assistants Medical assistants Community health workers Integrated care managers Social workers Behavioral interventionists Trainees Algorithms to support clinicians EHR support (BP recording, actionable prompts for clinicians, population health management) Remote HBPM (EHR integration) Monitoring performance metrics Population health management Telephone-based follow-up Regular team meetings (best practice updates, workflow evaluation) Assigned roles and responsibilities (patient and clinicians, clarity about team member roles) *Optional: SM-4: EHR to diagnose and assess, SM-8: use of telehealth, SM-10: performance measurement Goals of team-based care: Improve clinical workflow Patient education Closer follow-up of BP after initiation Medication titration Laboratory follow-up Improved adherence Lower clinician burn-out193 Checklist Goal: To optimize outpatient hypertension management (to be specifically stated as team s purpose/responsibility). Team Members: Lead clinician (at least 1): APRN or physician Clinical support (at least 1): pharmacist, nurse, physician assistant, medical assistant, community health worker, care manager, or EHR support modules specific to hypertension Administrative support (at least 1): scheduler, receptionist Expert referral (onsite or external): designated referral system for refractory patients: cardiologist, nephrologist, endocrinologist Team meetings: regular meetings on at least a quarterly basis to evaluate delivery of care for patients with hypertension. Performance monitoring: Use of PM 1 5 and QM 1 6 for feedback on performance and quality of care. Program elements (at least 2): 1. Patient educational materials or sessions on hypertension. Availability of BP-specific follow-up in 1 mo (telephone based, with HBPM, telehealth, or clinical support or clinician follow-up). Ability of patients to contact team-based care team in a timely fashion about hypertension concerns (telephone, secure EHR messaging, email, urgent appointments). 4. Algorithm for medication titration led by clinical support team member and lead clinician supervision. 5. Timely follow-up and monitoring of laboratory results, with titration of relevant drug classes. 6. Monitoring adherence by using pharmacy fill data. 7. Provider-specific performance reports with hypertension metrics. (Continued) 41 Rationale RCTs and meta-analyses of RCTs of team-based hypertension care involving nurse or pharmacist intervention demonstrated reductions in SBP and DBP and/or greater achievement of BP goals when compared with usual care.194 197 Similarly, systematic reviews of team-based care for patients with primary hypertension, including a review of studies that included community health workers, showed reductions in SBP and DBP and improvements in BP control, appointment keeping, and hypertension medication adherence as compared with usual care.198,199 Team-based care can be defined by numerous structures that are functional and improve care in various settings and patient populations. Inherently, they try to provide a division of labor and improved workflows so that the delivery of quality care is maximized/optimized. Disease-management-specific programs and protocols help identify areas to improve workflow and patient-centered care. AHRQ summary statement of team-based care: the primary goal of medical teamwork is to optimize the timely and effective use of information, skills, and resources by teams of health care professionals for the purpose of enhancing the quality and safety of patient care. 200 Clinical Recommendations 2017 Hypertension Clinical Practice Guidelines4 Recommendation for Structured, Team-Based Care Interventions for Hypertension Control (Guideline Sections 8.3.2 and 12.2) 1. A team-based care approach is recommended for adults with hypertension.194 197,199,201,202 (Class 1, Level of Evidence: A) For older adults ( 65 y of age) with hypertension and a high burden of comorbidity and limited life expectancy, clinical judgment, patient preference, and a team-based approach to assess risk/benefit are reasonable for decisions regarding intensity of BP lowering and choice of antihypertensive drugs. (Class 2a, Level of Evidence: C-EO) Follow-up and monitoring after initiation of drug therapy for hypertension control should include systematic strategies to help improve BP, including use of HBPM, team-based care, and telehealth strategies.47,203 207 (Class 1, Level of Evidence: A) ACC indicates American College of Cardiology; AHA, American Heart Association; AHRQ, Agency for Healthcare Research and Quality; APRN, advanced practice registered nurse; BP, blood pressure; CDU, care delivery unit; DBP, diastolic blood pressure; EHR, electronic health record; HBP, high blood pressure; HBPM, home blood pressure monitoring; NAM, National Academy of Medicine; PM, performance measure; QM, quality measure; RCTs, randomized controlled trials; RN, registered nurse; SM, structural measure; and SBP, systolic blood pressure. Appendix A. Continued 42 Appendix A. Continued SM-8: Use of Telehealth, m-Health, e-Health, and Other Digital Technologies to Better Diagnose and Manage HBP Measure Components The CDU uses various available components of telehealth, m-health, e-health, and other digital technologies proven by high-quality evidence to better diagnose and manage HBP in clinical settings for patients with HBP, which may include: Deployment of 1 telehealth, m-health, or e-health strategies (eg, Table B) For patients engaged in self-monitoring, a platform is required to communicate home BP measurements to the healthcare provider team. This may require several methods including: Telephonic communication of BP readings Written communication of BP readings Direct integration and delivery of BP readings via the EHR Designating 1 individuals to implement changes in nonpharmacological or pharmacological treatment based on self-monitoring or behavioral/coaching strategies. This may include development of algorithms and involve several members of the care team, including but not limited to: Medical practice coordinators Pharmacists Physician assistants Nurse practitioners Nutritionists Nurses Physicians Developing a framework to iteratively and routinely assess ongoing efficacy of different telehealth strategies for the CDU Maintaining flexibility to modify strategies as new telehealth technologies emerge (eg, novel BP measurement devices, data integration software) Rationale Meta-analyses of RCTs of different telehealth interventions have demonstrated greater SBP and DBP reductions208 210 and a larger proportion of patients achieving BP control210 than those achieved with usual care without telehealth. The effect of various telehealth interventions on BP lowering was significantly greater than that of BP self-monitoring without transmission of BP data, which suggests a possible added value of the teletransmission approach.209,211 Although m-health interventions in general showed promise in reducing SBP in patients with hypertension, results were inconsistent.212 It is unclear which combination of telehealth intervention features is most effective, and telehealth has not been demonstrated to be effective as a standalone strategy for improving hypertension control. Telehealth, m-health, and e-health technologies refer to means of transmission with wired or wireless devices to communicate with a healthcare provider.212 E- health, or digital health, is the use of emerging communication and information technologies to improve health and health care. M-health, a subsegment of e- health, is the use of mobile computing and communication technologies (eg, mobile phones, wearable sensors) for health services and information.212 Table B provides a list of examples of telehealth strategies and telehealth technologies. Importantly, these strategies include interventions beyond reminders for nonpharmacological or pharmacological intervention and increased awareness of BP measurement. They include active self-titration of medication and in- person coaching or e-coaching. M-health technologies are becoming more prevalent, and their use will continue to grow, consistent with recommendations from the Institute of Medicine.213 As new technologies emerge, including new devices for self-monitoring, it is unlikely that clinical trials will be repeated using each new technology. However, if self-monitoring is used, it is important to ensure that the BP measurement device used has been validated with an internationally accepted protocol and the results have been published in a peer-reviewed journal.214 Telehealth strategies that compare different frequencies of HBPM or ABPM have not been rigorously tested. Systems-level support, such as use of EHR (see SM-4), clinical decision support (ie, treatment algorithms), technology-based remote monitoring (see Table B), self-management support tools, and monitoring of performance, are likely to augment and intensify team-based care efforts to reduce HBP (see SM-7). Select telehealth strategies incorporate self-monitoring of BP. Among individuals with hypertension, self-monitoring of BP, without other interventions, has shown limited evidence for treatment-related BP reduction and achievement of BP control.50,211,215 However, with the increased recognition of inconsistencies between office and out-of-office BPs and closer correlation of out-of-office BPs versus office BPs with cardiovascular outcomes,216 and with greater reductions in BP being recommended for hypertension control, increased attention is being paid to out-of-office BP readings. Thus, telehealth, m-health, and e-health strategies will likely increasingly incorporate self-monitoring, as well. As outlined in Table B, there are a wide variety of m-health, e-health, and telehealth strategies that may or may not be available to a specific CDU and therefore to the individual provider/patient. Because development of new mobile technologies is ongoing, we also wished to provide flexibility for each CDU to choose among these and any future strategies that are developed. Although ABPM is generally accepted as the best out-of-office measurement method, HBPM is often a more practical approach in clinical practice. Recommended procedures for the collection of HBPM data are provided in Table C. (Continued) 43 Clinical Recommendations 2017 Hypertension Clinical Practice Guidelines4 Recommendation for Telehealth Interventions to Improve Hypertension Control (Guideline Sections 8.3.2 and 12.3) 1. Telehealth strategies can be useful adjuncts to interventions shown to reduce BP for adults with hypertension.208 212 (Class 2a, Level of Evidence: A) Follow-up and monitoring after initiation of drug therapy for hypertension control should include systematic strategies to help improve BP, including use of HBPM, team-based care, and telehealth strategies.47,203 207 (Class 1, Level of Evidence: A) ABPM indicates ambulatory blood pressure monitoring; ACC, American College of Cardiology; AHA, American Heart Association; BP, blood pressure; CDU, care delivery unit; DBP, diastolic blood pressure; e-health, healthcare services provided electronically via the Internet; EHR, electronic health record; HBP, high blood pressure; HBPM, home blood pressure monitoring; m-health, practice of medicine and public health supported by mobile devices; RCTs, randomized controlled trials; SM, structural measure; and SBP, systolic blood pressure. Appendix A. Continued Table B. Examples of Telehealth Strategies and Technologies to Promote Effective Hypertension Management Telehealth strategies Automated BP data capture and transmission of the patient s self- measured BP Self-management support, including education, reminders, and feedback that is automated or delivered by a healthcare professional Medication titration and follow-up monitoring protocols/algorithm Prescription refill reminders Medication adherence assessments Self-monitoring of lifestyle behaviors Integration of behavior change techniques, including in-person counseling or e-counseling Case/care/population health management Commonly used telehealth technologies Wired landline telephone Wireless smartphone applications Website accessed via computers and handheld devices Text messaging Email messaging Social networking and social media websites/applications Wireless BP measurement devices Electronic pill dispensers/counters Reproduced with permission from Whelton et al.4 Copyright 2018, American Heart Association, Inc., and American College of Cardiology Foundation. BP indicates blood pressure. Appendix A. Continued Table C: Procedures for Use of HBPM Patient training should occur under medical supervision, including: Information about hypertension Selection of equipment Acknowledgment that individual BP readings may vary substantially Interpretation of results Devices: Verify use of automated validated devices. Use of auscultatory devices (mercury, aneroid, or other) is not generally useful for HBPM because patients rarely master the technique required for measurement of BP with auscultatory devices. Monitors with provision for storage of readings in memory are preferred. Verify use of appropriate cuff size to fit the arm. Verify that left/right inter-arm differences are insignificant. If differences are significant, instruct patient to measure BPs in the arm with higher readings. Instructions on HBPM procedures: Remain still: Avoid smoking, caffeinated beverages, or exercise within 30 min before BP measurements. Ensure 5 min of quiet rest before BP measurements. Sit correctly: Sit with back straight and supported (on a straight-backed dining chair, for example, rather than a sofa). Sit with feet flat on the floor and legs uncrossed. Keep arm supported on a flat surface (such as a table), with the upper arm at heart level. Bottom of the cuff should be placed directly above the antecubital fossa (bend of the elbow). Take multiple readings: Take at least 2 readings 1 min apart in morning before taking medications and in evening before supper. Optimally, measure and record BP daily. Ideally, obtain weekly BP readings beginning 2 wk after a change in the treatment regimen and during the week before a clinic visit. Record all readings accurately: Monitors with built-in memory should be brought to all clinic appointments. BP should be based on an average of readings on 2 occasions for clinical decision making. The information above may be reinforced with the following: AHA webpage Monitoring Your Pressure at Home 217 and AHA video At home blood pressure monitoring 218 Reproduced with permission from Whelton et al.4 Copyright 2018, American Heart Association, Inc., and American College of Cardiology Foundation. BP indicates blood pressure; and HBPM, home blood pressure monitoring. Appendix A. Continued 44 SM-9: Use of a Single, Standardized Plan of Care for All Patients With HBP Measure Components The CDU has developed and implemented a single, standardized plan of care for HBP that addresses health behaviors, comorbid conditions, follow-up, and treatment goals through shared decision making, in accordance with Table D. Rationale A specific plan of care for hypertension is essential and should reflect understanding of the modifiable and nonmodifiable determinants of health behaviors, including the social determinants of risk and outcomes. A clinician s sequential flow chart for management of hypertension is presented (Table D). The determinants will vary among demographic subgroups. Studies demonstrate that implementation of a plan of care for hypertension can lead to sustained reduction of BP and attainment of BP targets over several Meta-analysis of RCTs shows reductions in BP of patients with hypertension and achievement of BP goals at 6 months and 1 year when compared with usual care.4 (See Table D.) Clinical Recommendations 2017 Hypertension Clinical Practice Guidelines4 The Plan of Care for Hypertension (Guideline Section 13) Every adult with hypertension should have a clear, detailed, and current evidence-based plan of care that ensures the achievement of treatment and self-management goals, encourages effective management of comorbid conditions, prompts timely follow-up with the healthcare team, and adheres to CVD GDMT. (Class 1, Level of Evidence: C-EO) ACC indicates American College of Cardiology; AHA, American Heart Association; BP, blood pressure; CDU, care delivery unit; CVD, cardiovascular disease; GDMT, guideline-directed medical therapy/treatment; HBP, high blood pressure; and RCTs, randomized controlled trials. Appendix A. Continued Table D. Clinician s Steps for the Management of Hypertension Clinician s Sequential Flowchart for the Management of Hypertension Measure office BP accurately Detect white-coat hypertension or masked hypertension by using ABPM and HBPM Evaluate for secondary hypertension Identify target-organ damage Introduce lifestyle interventions Identify and discuss treatment goals Use ASCVD risk estimation to guide BP threshold for pharmacological therapy Align treatment options with comorbidities Account for age, race, ethnicity, sex, and special circumstances in antihypertensive treatment Initiate antihypertensive pharmacological therapy Insure appropriate follow-up Use team-based care Connect patient to clinician via telehealth Detect and reverse nonadherence Use health information technology for remote monitoring and self- monitoring of BP Reproduced with permission from Whelton et al.4 Copyright 2018, American Heart Association, Inc., and American College of Cardiology Foundation. ABPM indicates ambulatory blood pressure monitoring; ASCVD, atherosclerotic cardiovascular disease; BP, blood pressure; and HBPM, home blood pressure monitoring. Appendix A. Continued 45 Use of Performance Measures to Improve Care for HBP SM-10: Use of Performance and Quality Measures to Improve Quality of Care for Patients With HBP Measure Components The CDU uses performance and quality measures for evaluation and improvement in clinical settings for the diagnosis and management of patients with HBP, which include: Performance measures that are developed according to established ACC/AHA standards. Performance measures that identify key structural components, care processes, and/or outcomes that are highly correlated with important, high-priority patient care goals. Methods to accurately and feasibly collect data in order to assess performance measures. Process to identify appropriate patient groups, healthcare providers, and/or observation periods to be included in the measurement process. Process to include outcomes of performance measurement in quality improvement strategies. Rationale Performance measures are systematic and standardized methods that are aimed at identifying and improving suboptimal medical care and patient outcomes. Performance measures represent one of several potential strategies that can be used, together or alone, to help reduce gaps in the quality of health care. Effective performance measures are those that are associated with meaningful, desirable patient outcomes and include broad sampling from appropriate and related medical domains.2 Performance measure design should follow established standards, as outlined by national organizations,2 and have precise, validated components that are feasible, actionable, and meaningful. Performance measures usually reflect clinical practice guidelines of the highest levels of recommendation and evidence. Given that the identification, treatment, and control of HBP are suboptimal,3,225,226 use of effective performance measures can help improve these gaps in care, as has been shown in 1 observational study from Kaiser Permanente of Northern California.56 No RCTs of HBP performance measures have been published.4 Implementation of Performance Measures 1. Identify performances measures for hypertension that: a. Meet established ACC/AHA standards. b. Include key components that influence the impact and sustainability of hypertension detection, treatment, and control for the target population (medical care, cost of care, patient-reported factors). c. Help address the most pressing gaps in hypertension-related care for the healthcare provider, practice, or system. Coordinate the most feasible and meaningful collection of performance measures data with available data sources (eg, electronic health records, national data registries, administrative databases). Uses of Performance Measures To assess performance of the healthcare provider, practice, or system, identifying and characterizing gaps in quality of hypertension care (based on comparison to a national benchmark standard or based on comparison to previous performance by the same healthcare provider, practice, or system). 2. To be used to design and implement quality improvement plans to help address gaps in quality of hypertension care identified by performance measures. To report the use and outcomes of performance measurement as part of healthcare quality payment programs that are used by organizations to determine reimbursement to healthcare providers, practices, and systems on the basis of achievement and reporting of various performance metrics. Clinical Recommendations 2017 Hypertension Clinical Practice Guidelines4 Recommendation for Performance Measures (Guideline Section 12.4.1) Use of performance measures in combination with other quality improvement strategies at patient-, provider-, and system-based levels is reasonable to facilitate optimal hypertension control.56,227,228 (Class 2a, Level of Evidence: B-NR) ACC indicates American College of Cardiology; AHA, American Heart Association; CDU, care delivery unit; HBP, high blood pressure; and RCT, randomized controlled trial. Appendix A. Continued 46 Appendix B. Author Listing of Relationships With Industry and Other Entities (Relevant) 2019 AHA/ACC Clinical Performance and Quality Measures for Adults With High Blood Pressure Committee Member Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Donald E. Casey Jr, Chair Thomas Jefferson College of Population Health Adjunct Faculty; Rush Medical College Faculty; University of Minnesota, Institute of Health Informatics Affiliate Faculty; President, American College of Medical Quality; IPO 4 Health Principal and Founder None None None None None None Randal J. Thomas, Vice Chair Mayo Clinic Medical Director, Cardiac Rehabilitation Program None None None None None None Vivek Bhalla Stanford University Medical Center Assistant Professor of Medicine, Nephrology; Stanford Hypertension Center Director Relypsa, Inc. None None None PyrAmes Health None Yvonne Commodore- Mensah Johns Hopkins School of Nursing Assistant Professor None None None None None None Paul A. Heidenreich Stanford VA Palo Alto Health Care System Professor of Medicine None None None None None None Dhaval Kolte Massachusetts General Hospital and Harvard Medical School International Cardiology Fellow None None None None None None Paul Muntner University of Alabama at Birmingham Professor, Department of Epidemiology None None None None None None Sidney C. Smith Jr University of North Carolina at Chapel Hill Professor of Medicine; Division of Cardiology, Department of Medicine None None None None None None John A. Spertus Washington University School of Medicine in St. Louis Adjunct Professor of Medicine, Cardiovascular Division; Saint Luke s Mid America Heart Institute Director, Health Outcomes Research; University of Missouri-Kansas City Professor, Daniel J. Lauer Missouri Endowed Chair in Metabolism and Vascular Disease Research AstraZeneca* Bayer Healthcare Pharmaceuticals Boehringer Ingelheim* Janssen* Novartis* None None None AstraZeneca UK Limited Novartis* None John R. Windle University of Nebraska College of Medicine Professor, Internal Medicine, Division of Cardiovascular Medicine None None None None None None Gregory D. Wozniak American Medical Association Director, Outcomes Analytics; Northwestern University, Feinberg School of Medicine Adjunct Assistant Professor None None None None None None Boback Ziaeian UCLA David Geffen School of Medicine Assistant Professor; US Department of Veterans Affairs Assistant Professor None None None None None None This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% of the voting stock or share of the business entity, or ownership of $5000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. According to the ACC/AHA, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document or makes a competing drug or device addressed in the document; or c) the person or a member of the person s household, has a reasonable potential for financial, professional or other personal gain or loss as a result of the issues/content addressed in the document. *Significant relationship. No financial benefit. ACC indicates American College of Cardiology; AHA, American Heart Association; UCLA, University of California, Los Angeles; and VA, Veterans Affairs. 47 Appendix C. Reviewer Listing of Relationships With Industry and Other Entities (Comprehensive) 2019 AHA/ACC Clinical Performance and Quality Measures for Adults With High Blood Pressure Reviewer Representation Employment Consultant Speakers Bureau Ownership/ Partnership/ Principal Personal Research Institutional, Organizational, or Other Financial Benefit Expert Witness Salary Biykem Bozkurt Official TFPM Lead; TFDS Content Reviewer Baylor College of Medicine Mary and Gordon Cain Chair Professor of Medicine and Director, Winters Center for Heart Failure Research; Michael E. DeBakey VA Medical Center, Cardiology Chief, Cardiology Section Bayer Bristol-Myers Squibb Lantheus Medical Imaging, Inc LivaNova USA Respicardia scPharmaceuticals None None LivaNova USA (DSMB) Abbott None None Nicole L. Lohr Official ACC Medical College of Wisconsin Assistant Professor None None None None Amgen None None Andrea L. Price Official ACC Indiana University Health Director, Quality Databases None None None None ACC Accreditation Foundation Board* None None Brent Egan Official AHA Medical University of South Carolina, Charleston (MUSC) Professor of Medicine and Pharmacology Medtronic Emcure Merck KGaA None None UpToDate None None John M. Flack Official AHA Southern Illinois University School of Medicine, Internal Medicine Professor, Chair, and Chief of Hypertension Specialty Services None None None National Institutes of Health (DSMB) Bayer GlaxoSmithKline Valencia None None Sandra J. Taler Official AHA Mayo Clinic Professor of Medicine None None None None None None None Michael Rakotz Official AMA American Medical Association Vice President, Health Outcomes None None None None AMA None None Cheryl Dennison- Himmelfarb Official PCNA Johns Hopkins School of Nursing Associate Dean for Research, Sarah E. Allison Endowed Professor, and Deputy Director, Institute for Clinical Translational Research None None None Helene Fuld Health Trust* NIH* PCNA None Johns Hopkins University* Nathalie De Michelis Content ACC University of California, Irvine Cardiovascular Program Manager None None None None None None None Eugene Yang Content ACC University of Washington School of Medicine Medical Director and Clinical Associate Professor of Medicine, Division of Cardiology, Carl and Ren e Behnke Endowed Professorship for Asian Health Amgen* RubiconMD* None None None Amgen* Third Party, Firefighter who developed an arrhythmia at work, None Marjorie L. King Content ACC/ AHA Helen Hayes Hospital Chief Medical Officer, Internal Medicine (Cardiology) and Director, Cardiopulmonary, Rehabilitation Island Peer Review Organization* None None None None None None (Continued) 48 Raj Padwal Content AMA University of Alberta Professor of Medicine and Director, Hypertension Dyslipidemia Clinic None None mmHG Inc. None None None None Nancy Houston- Miller Content PCNA The Lifecare Company Associate Director Moving Analytics* None None None None None None This table represents all relationships of reviewers with industry and other entities that were reported at the time of peer review, including those not deemed to be relevant to this document, at the time this document was under review. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of 5% of the voting stock or share of the business entity, or ownership of $5000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. Names are listed in alphabetical order within each category of review. Please refer to http://www.acc.org/guidelines/about-guidelines-and-clinical-documents/relationships-with-industry-policy for definitions of disclosure categories or additional information about the ACC/AHA Disclosure Policy for Writing Committees. *Significant relationship. No financial benefit. This disclosure was entered under the Clinical Trial Enroller category in the ACC s disclosure system. To appear in this category, the reviewer acknowledges that there is no direct or institutional relationship with the trial sponsor as defined in the ACCF or ACC/AHA Disclosure Policy for Writing Committees. 