key: cord-1031992-npv02kzz
authors: Mills, Katherine T.; Peacock, Erin; Chen, Jing; Zimmerman, Amanda; Brooks, Kenya; He, Hua; Cyprian, Alecia; Davis, Gerrelda; Fuqua, Sonja R.; Greer, Angelique; Gray-Winfrey, Lea; Williams, Shondra; Wiltz, Gary M.; Winfrey, Keith L.; Whelton, Paul K.; Krousel-Wood, Marie; He, Jiang
title: Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS): Rationale and Design of a Cluster-Randomized Trial()()
date: 2020-08-19
journal: Am Heart J
DOI: 10.1016/j.ahj.2020.08.009
sha: eae1814bfd37b8f0cbbadd0f5297958942fb2bae
doc_id: 1031992
cord_uid: npv02kzz

BACKGROUND: The Systolic Blood Pressure Intervention Trial (SPRINT) reported intensive blood pressure (BP) treatment reduced cardiovascular disease and mortality compared to standard BP treatment in hypertension patients. The next important question is how to implement more intensive BP treatment in real-world clinical practice. We designed an effectiveness-implementation hybrid trial to simultaneously test the effectiveness of a multifaceted intervention for intensive BP treatment and its feasibility, fidelity, and sustainability in underserved hypertension patients. METHODS: Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS) is a cluster randomized trial conducted in 36 Federally Qualified Health Center (FQHC) clinics in Louisiana and Mississippi. FQHC clinics were randomized to either a multifaceted intervention for intensive BP treatment, including protocol-based treatment using the SPRINT intensive BP management algorithm, dissemination of SPRINT findings, BP audit and feedback, home BP monitoring, and health coaching, or enhanced usual care. Difference in mean systolic BP change from baseline to 18 months is the primary clinical effectiveness outcome, and intervention fidelity, measured by treatment intensification and medication adherence, is the primary implementation outcome. The planned sample size of 1,260 participants (36 clinics with 35 participants each) has 90% power to detect a 5.0 mmHg difference in systolic BP at a 0.05 significance level and 80% follow-up rate. CONCLUSIONS: IMPACTS will generate critical data on the effectiveness and implementation of a multifaceted intervention for intensive BP treatment in real-world clinical practice and could directly impact the BP-related disease burden in minority and low-income populations in the US.

and sustainable implementation strategies to improve providers' adherence to clinical guidelines and patients' adherence to antihypertensive treatment. (12) Most recent clinical practice guidelines recommend lower BP treatment targets than in the past, but the specific BP goal varies.(3, 14- Barriers to BP control have been reported at the system, provider, patient, and community levels. (12, (18) (19) (20) (21) (22) Table 1 shows barriers reported in the literature, those identified during focus group discussions we conducted with Federally Qualified Health Center (FQHC) administrators, providers, and patients, and proposed strategies to overcome these barriers. Several strategies are proven to be effective for improving hypertension control. Team-based collaborative care, consisting of either nurses or pharmacists working with primary care providers and patients, improved BP control in hypertensive patients.(23,24) Interactive physician education has also resulted in improvements in professional practice and BP control.(25) Stepped-care protocol-based treatment, including use of treatment protocols and algorithms, has been successfully applied to hypertension control.(26,27) Home BP monitoring has been recognized as an effective tool in hypertension management.(24,28) Several approaches to improve adherence to antihypertensive medications, including motivational health coaching, have been proven effective.(29,30) BP audit and feedback to providers was effective for BP control.(31) Patient and care provider engagement is the key to a successful intervention program.(3,32) Shared decision-making potential partners for the study. Due to staffing logistics, FQHCs outside of the greater New Orleans area were eligible to participate if they had at least four clinics meeting pre-defined clinic eligibility criteria (Table 2) . New Orleans FQHCs were eligible to participate with any eligible clinics. Of the 42 FQHCs in the region, eight are participating in the study, eight were not interested in participating, and 26 did not have enough eligible clinics to participate. A total of 36 clinics from the eight participating FQHCs in Louisiana and Mississippi were eligible and are participating in the IMPACTS trial. Of them, 18 clinics were randomly assigned to the multifaceted intervention and 18 clinics to enhanced usual care, stratified by FQHC (Figure 1) . FQHCs received supplements to cover operational costs for all participating clinics and reimbursement for health coaching and provider visits for intervention clinics only.

To increase the generalizability of our study findings to real-world primary care settings, minimal patient-level eligibility criteria are used ( Table 2) . Briefly, patients aged 40 years or older with elevated BP (systolic ≥ 130 mm Hg if taking antihypertensive medication or ≥ 140 mm Hg if not medicated) are recruited from each participating FQHC clinic. Using electronic health record (EHR) systems at each FQHC, potentially eligible patients with elevated BP seen in clinic during the previous year are identified.

A waiver of HIPAA authorization is approved to obtain patient contact information for recruitment purposes. Patients identified as potentially eligible for the study are contacted via an introductory letter from the research team with both Tulane University and their FQHC logos and a subsequent phone call to assess their willingness to participate and preliminary eligibility. After prescreening, potentially eligible participants are scheduled for a screening visit in the clinic with study staff. Patients are also recruited from provider referrals and in-clinic recruitment.

Conceptual Framework: The Consolidated Framework for Implementation Research (CFIR) was used to guide the development of the intervention and evaluation plans in the IMPACTS study based on its flexibility and comprehensive implementation constructs across socio-ecological levels.(37,38) The framework consists of seven domains that describe the internal and external contexts of implementation that affect the likelihood of a clinical guideline or medical innovation being translated into routine care: intervention characteristics, outer setting, inner setting, characteristics of individuals and teams, process of implementation, implementation outcomes, and clinical outcomes. Features of these seven domains relevant to the IMPACTS study are summarized in Figure 2 .

Core Intervention: The core intervention is a stepped-care protocol adapted from the SPRINT intensivetreatment algorithm (Figure 3) . Primary care providers, nurses/pharmacists, and patients work collaboratively to establish an individualized treatment plan and BP goal for each patient. Findings from the SPRINT trial, other clinical trials, and meta-analyses clearly support a lower BP target for further reductions in CVD and all-cause mortality. (9) (10) (11) 39) The 2017 ACC/AHA hypertension guideline recommended a BP treatment target of <130/80 mm Hg based on clinical BP measurements,(3) which might be, on average, 10 mm Hg higher than BP measurements in research settings. (14) The objective of our study is to implement the SPRINT intensive BP intervention in populations with increased CVD risk and health disparities. Therefore, we recommend a systolic BP target of <120 mmHg for all patients 40 years of age and older with hypertension. Further, a diastolic BP target of <80 mm Hg was used based on the 2017 ACC/AHA guidelines. However, BP treatment targets can be individualized based on each patient's needs in this implementation study.

All antihypertensive regimens should include one or more drug classes proven to reduce CVD risk, i.e., a thiazide or thiazide-like diuretic, calcium channel blocker (CCB), angiotensin converting enzyme inhibitor (ACEI), or angiotensin receptor blocker (ARB).(40-43) ACEI, ARB, and CCB combine effectively with diuretics for lowering BP and CVD risk. Intervention clinic participants visit their FQHC clinic monthly for the first three months after their baseline clinic visit for BP checks and medication adjustments as needed. After the first three months, clinic visits are scheduled every three months for the duration of the trial if BP is below target. If BP is above target at 3 months, monthly visits continue until the target is achieved. Following this, visits are scheduled every 3 months. Milepost visits are conducted every 6 months throughout follow-up. If the target systolic BP is not achieved at a milepost visit, then an antihypertensive drug from a class different from what is being taken should be added, unless there are contraindications.

Implementation Strategies: The IMPACTS study uses a combination of proven-effective strategies to implement the core intervention. In preparation for implementation, we have assessed each FQHC's readiness for implementing the multifaceted intervention using the organizational readiness for implementing change (ORIC) scale. 142 Findings from ORIC and initial conversations with clinic administrators and staff were used to identify barriers to intervention adoption and tailor implementation strategies. All providers were trained to follow ACC/AHA hypertension clinical guideline for BP management. In addition, providers in the intervention clinics received additional interactive training on the SPRINT intensive BP intervention protocol. Any concerns about the intensive BP target were addressed during the training. Implementation strategies include dissemination of the SPRINT study findings, team-based collaborative care, BP audit and feedback, home BP monitoring, and health coaching. We disseminate the SPRINT study findings to provider-teams, patients, and administrators in the intervention clinics using interactive in-person and online workshops and printed training materials. Training (initial and ongoing) includes SPRINT study findings and the intensive BP management strategy using SPRINT treatment protocols including medication selection and algorithms. Providers and staff were also trained in proper BP measurement technique. To encourage stepped care treatment, providers received a laminated pocket card containing the treatment algorithm; in addition, the provider visit form includes recommended treatment information. Further, IMPACTS participants have been flagged in the electronic health record (EHR) systems at each FQHC to remind staff to follow the intervention with those patients. In clinics J o u r n a l P r e -p r o o f Journal Pre-proof with busy schedules, standing spaces are reserved on provider schedules for IMPACTS patients so that they can be seen according to the intervention schedule. All provider and health coaching visits were scheduled by FQHC clinic staff.

We have worked with each FQHC to develop a feasible and sustainable collaborative care team.

Based on availability of in-house nurses and pharmacists, we use a nurse-provider or pharmacist-provider combination. Providers conduct a clinical evaluation of patients, prescribe initial antihypertensive medications based on a treatment protocol, prescribe medication changes based on patients' responses, and supervise nurses/pharmacists. Nurses/pharmacists function as case managers to coordinate patient care and regularly and systematically review patients' clinic and home BP. In circumstances where a nurse or pharmacist is not available, study staff have assumed the back-up role of health coaching. Teams are encouraged to regularly meet and stay in constant communication regarding patient care. Health coaches or in-house quality improvement staff provide audit and feedback to providers by tracking patients' BP readings over time and informing providers of those whose BP is not at target. In addition, study staff provide a list of patients whose BP was not controlled at study visits to each FQHC regularly.

Mean BP of IMPACTS participants for each provider in their FQHC is also provided for comparison. Nurses, pharmacists, or clinic medical assistants provide health coaching to patients including discussion of the SPRINT findings and intensive BP treatment with patients. They emphasize lifestyle modification and medication adherence and suggest strategies for overcoming treatment side effects and poor adherence during patients' clinic visits or by phone. Each intervention clinic patient receives a home BP monitor and instruction on its use from the health coach. Patients are instructed to take at least six BP measurements per week (one in the morning and one in the evening on each of three days). At each health coaching visit, health coaches measure each participant's clinic BP and average home BP values over the previous two weeks. This information is recorded on a form that is given to the provider for the patient's appointment along with the treatment algorithm. The provider records any treatment changes or reasons for not adjusting treatment on the form. The health coach then follows up with the patient as needed after the provider visit.

J o u r n a l P r e -p r o o f Journal Pre-proof Implementation strategies have been adapted based on patient characteristics and clinic personnel and practices for each participating FQHC during the adaptation phase. These include adapting the makeup of teams for intervention delivery and dividing up other responsibilities for care coordination and health coaching depending on what clinic staff is available. Further, in most clinics patients keep track of their home BP monitoring values in a paper log and bring it to their health coaching appointments, but in some clinics with telemonitoring capacity, we have purchased monitors that allow for electronic transmission of BP values. During the COVID-19 state-at-home orders, we have further adapted intervention delivery to allow for telehealth visits with providers, and health coaching by phone and video.

Enhanced Usual Care: In clinics randomized to enhanced usual care, we conduct a brief webinar education session on the 2017 ACC/AHA hypertension guideline and findings from the SPRINT trial. In addition, we train providers and staff on proper BP measurement technique. Otherwise, there is no active intervention, and all enhanced usual care clinics follow their routine clinic practice for the management of hypertensive patients. Contamination between multifaceted intervention and enhanced usual care was avoided or reduced by only including clinics that did not share providers with other clinics within the FQHC and by additional training of providers when providers do move to a new study clinic.Clinical

The primary clinical outcome is the difference in mean change of systolic BP from baseline to 18 months between the intervention and enhanced usual care groups ( Table 3) . Blood pressure at baseline and at 18 months is measured three times at each of two clinic visits by certified research staff at both intervention and usual care clinics. The average of the six measurements is used as the average BP.

The primary implementation outcome is the fidelity of the intervention, i.e., intensification of treatment (titration or addition of new medications) and adherence to medications (Table 3) . Other implementation outcomes include acceptability, adoption, appropriateness, feasibility, and sustainability.

Data collection of clinical and implementation outcomes is conducted at baseline, 6, 12, and 18 months of follow-up by trained, certified research staff based at both intervention and enhanced usual care clinics ( Table 4) . Two data collection visits between 1 and 28 days apart occur at baseline and at 18 months to obtain repeat BP measurements. In addition, a post-trial follow-up visit is conducted 12 months after the end of the NIH-sponsored intervention to examine the sustainability of the intervention program.

At the post-trial visit, we collect data on implementation and clinical outcomes from patients, providerteams, and administrators from each FQHC clinic. In order to ensure participant retention, study visits are coordinated with patients' regular clinic visits to reduce time burden, reminder calls are made prior to participants' clinic visits, modest incentives and small gifts are given to participants, and study staff with excellent interpersonal skills are utilized for the study.

A questionnaire is administered to obtain information on history of hypertension, other CVD risk factors, and health behaviors (e.g., smoking, alcohol drinking, physical activity, and sodium and fruit and vegetable consumption). Self-reported medication adherence is also assessed using the 8-item Morisky The appropriateness and feasibility of our intervention program were assessed among FQHC leadership, providers, and patients using qualitative research methods and were used to improve implementation strategies. Other implementation outcomes, including adoption, acceptability, and fidelity, are obtained using focus group, survey, and administrative data throughout the study (Table   3) proper BP measurements (out of all staff), the treatment algorithm (out of all providers), and health coaching (out of invited staff). Acceptability is defined as satisfaction with the multifaceted strategy among patients, providers, and health coaches and is measured using surveys throughout the study.

Sustainability is evaluated by the maintenance of protocol-based treatment, team-based collaborative care, BP audit and feedback, and health coaching by FQHC clinics and provider-teams, and home BP monitoring, adherence to medication and lifestyle change, and BP control among patients at a post-trial follow-up visit 12 months after external NIH funding ends.

All serious adverse events (SAE) and selected adverse events (AE) are collected and reported to the Tulane University Institutional Review Board (IRB). SAEs are defined as events that are fatal or lifethreatening, result in significant or persistent disability, require or prolong hospitalization, or are J o u r n a l P r e -p r o o f important medical events that investigators judge represent significant hazards or harm to research participants. In addition, the following AEs are reported if they result in an emergency room/department evaluation, regardless of whether or not they require hospitalization: injurious falls, syncope, arrhythmia, new or worsening heart failure, stroke or transient ischemic attack, and electrolyte abnormalities. We also monitor occurrences of acute kidney injury or acute renal failure if they are noted on admission or occurred during a hospitalization and are reported in the hospital discharge summary as a primary or main secondary diagnosis. Participants are queried for SAEs and selected AEs at all clinic visits.

We will test the hypothesis that there is a greater reduction in mean BP in the intervention group than in the enhanced usual care group using a mixed-effects regression analysis with participants and clinics as random effects and intervention group, time, and the group-by-time interaction as fixed effects.

Binary outcome group differences will be tested using adjusted chi-square tests and will be analyzed using generalized estimating equations.(46,47) For primary analyses, data will be assumed to be missing at random, and key baseline variables will be adjusted that are imbalanced between intervention and usual care groups and that are associated with missingness. In sensitivity analyses, multiple imputation for missing data will be conducted using the Markov Chain Monte Carlo method, and effect size estimates with and without multiple imputation will be compared. (48) The cluster randomized IMPACTS trial with a total of 1,260 participants (average of 35 in each clinic) has 90% statistical power to detect a 5.0 mm Hg difference in systolic BP at a two-sided significance level of 0.05. Clustering by clinic was accounted for and an intra-cluster correlation coefficient of 0.063 was used based on prior work.(49) Further, an 80% follow-up rate and a standard deviation of systolic BP of 17.0 mm Hg were assumed.(49) For the secondary outcomes, we have 90% statistical power to detect a 4.88 mmHg difference in diastolic BP and a 15% difference between groups in the proportion of systolic BP <120 mmHg.

The IMPACTS study has been approved by Tulane University IRB, and the study is being conducted following strict guidelines for the protection of rights of human volunteers. An independent data and safety monitoring board (DSMB) monitors safety, study conduct, and scientific validity and integrity of the trial and provides recommendations to the funding agency on trial continuation. Informed consent is signed by all study participants at screening. Two separate consent forms are used based on clinic intervention group assignment, and participants consent to all study activities in their clinic. The proportion of those willing to consent will be reported, and characteristics of those who provide consent will be compared to those who refuse to participate to assess generalizability.

The IMPACTS study is funded by the National Heart, Lung, and Blood Institute (R01HL133790) and partially by the National Institute of General Medical Sciences (P20GM109036). The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the paper and its final contents.

Enrollment began in June 2018 with 854 study participants recruited by March 2020. We anticipate completing recruitment by the end of 2020.

The IMPACTS study is novel in several respects. First, it is the first study to disseminate and implement the SPRINT study findings in real-world clinical practice and to study whether a SPRINT-like BP treatment target can be achieved in predominantly low-income patients with hypertension. Second, the effectiveness-implementation hybrid design blends clinical effectiveness and implementation trials to support more rapid translation into clinical practice. Third, because the study addresses patient-centered issues and is implemented within the resource-limited FQHC setting, the study findings could be readily scaled up to other primary care settings. Fourth, team-based collaborative care includes an increased role for nurses and pharmacists with appropriate supervision from primary care providers. This healthcare J o u r n a l P r e -p r o o f delivery model will increase efficiency and reduce costs, thus improving the likelihood of adoptability and sustainability over time.

The IMPACTS study is very timely and has important public health and clinical implications. It will provide crucial information on developing multifaceted implementation strategies to achieve more intensive BP control in populations with health disparities. If proven effective, the multifaceted intervention strategies can be adopted by other low-resource primary care settings for more intensive BP control, eliminating health disparities and reducing the BP-related disease burden in ethnic minority and low-income populations in the US and around the world.  Predominantly managing underserved populations with health disparities (ethnic minorities, low-income groups, and residents of rural areas and inner cities).

 Having electronic medical record systems.

 Serving >200 hypertension patients (ICD-10-CM I10-I15) during the previous year.

 Not participating in other hypertension control programs.

 Men or women aged ≥40 years who receive primary care from the participating FQHC clinics.

 Systolic BP ≥140 mmHg at two screening visits for those not taking antihypertensive medication or systolic BP ≥130 mmHg at two screening visits for those taking antihypertensive medications.

 Pregnant women, women planning to become pregnant in the next 18 months, or women of childbearing potential and not practicing birth control will be excluded.

 Patients with end-stage renal disease, defined as dialysis or transplantation, will be excluded.

 Able to understand English  No plans to change to a primary healthcare provider outside of the FQHC clinic during the next 18 months.

 Individuals unlikely to complete the study, such as those who plan to move out the study area during the next 18 months, temporary migrant workers, homeless persons, and those whose BP cannot be accurately measured due to an arm circumference ≥ 50 cm, will be excluded.

 The proportion of trained staff continuing health coaching after the study  The proportion of enrolled patients continuing home BP monitoring and BP control after the study BP = blood pressure J o u r n a l P r e -p r o o f 

HCs will receive training prior to the start of the study. The workshop will cover the following areas:

 Review and instruction on all intervention materials  How to use HC session forms  Instruction on home blood pressure monitoring  Instruction and practice how to encourage behavior change using educational counseling In addition, every six months during the study, the HCs will receive additional training and support to help deliver the intervention effectively.

Standardized and accurate measurement of blood pressure is critical to the conduct of the study. A standard automated blood pressure measurement device (the OMRON HEM-907XL Professional Digital Blood Pressure Monitor) and a specific protocol for the measurement of blood pressure and pulse will be utilized.

Blood pressure measurement must be conducted early in the visit and not following potentially stressful exam components.

Participants should be given a full explanation and instructions about the steps involved in BP measurement, as well as an opportunity to ask questions.

The setting in which BP readings are taken must be a separate, quiet room where no other activity is simultaneously taking place and where temperature fluctuations are minimal. It is recommended that the room temperature be 65-75° F. Clinic scheduling procedures should also establish consistent appointment times to minimize, insofar as possible, the impact of daily BP variations. During study visit reminder calls, participants should be told NOT to engage in vigorous exercise, drink alcohol or caffeine, or use tobacco or nicotine products within a half hour prior to BP measurements. If a half hour has not elapsed, the BP measurements must be delayed until a half hour has passed.

This protocol is written for use with the OMRON HEM-907XL Professional Digital Blood Pressure Monitor. Special attention must be placed on assessment and maintenance of the instrument's accuracy as per the manual that accompanies the instrument.

The design and operation of the OMRON HEM-907XL Professional Digital Blood Pressure Monitor are based upon the combined principles of compression of the brachial artery under an elastic, inflatable cuff and estimation of the systolic and diastolic blood pressure levels by oscillometric methods. The observer places the correct size cuff on the participant's arm, pushes the button on the device and waits for the output. All readings should be recorded to the nearest digit. 

Prior to the study visit, the health coach should ensure that the OMRON HEM-907XL Professional Digital Blood Pressure Monitor if programmed to allow a 5 minute rest before the first BP measurement, to take 3 readings at 1 minute intervals, and to display the average. See specific instructions provided in the OMRON User's Manual.

Proper cuff size must be used to avoid under-or over-estimation of blood pressure. Cuff size refers to the cuff's bladder, not the cloth.

 BP measurements should usually be taken in the right arm. The left arm may be used if the presence of an anomaly or other circumstance prohibiting use of the right arm, e.g., mastectomy, dialysis access, open wound, etc. This should be noted on the data collection form.

 Have the participant remove his/her upper garment (bare arm).

 Have the participant stand with his/her right hand placed over the navel, holding right forearm horizontal (parallel) to the floor.

 Measure arm length from the acromion (bony protuberance at the shoulder) to the olecranon (tip of the elbow), using a metric tape. 

The participant should be seated with back supported, legs uncrossed, feet flat on the floor, in a quiet room, with the elbow and forearm of the right arm resting comfortably on the armrest of the blood pressure measurement chair (or the table) with the palm of the hand turned upward. The area to which the cuff is to be applied must be bare.

1) Locate the brachial artery by palpation and mark the skin with a little dot. (The brachial artery is usually found at the crease of the arm, under the muscle and slightly towards the body). 2) Place the appropriate cuff around the upper right arm so that:

a) The midpoint of the length of the bladder lies over the brachial artery, and b) The mid-height of the cuff is at heart level.

3) Place the lower edge of the cuff, with its tubing connections, ½ to 1 inch above the natural crease across the inner aspect of the elbow. 4) Wrap the cuff snugly about the arm, with the palm of the participant's hand turned upward. Make sure that the long edges of the cuff lie on top of each other as you wrap the cuff around.

J o u r n a l P r e -p r o o f 5) Secure the wrapped cuff firmly by applying pressure to the locking fabric fastener over the area where it is applied to the cuff. 6) Do not wrap the cuff too tightly around the arm, but so that you can insert only one finger between the cuff and arm.

1) The participant should sit quietly for a period of 5 minutes before the first blood pressure is taken. He or she should be seated comfortably, feet flat on the floor with back supported. 2) During the 5 minute rest period, participants should be resting and should not be answering questions or speaking with the CRC. The CRC should leave the room during this 5 minute rest period. The following script can be used at this time:

"I would like you to rest for 5 minutes before I begin taking your blood pressure. I will leave the room. Please refrain from talking on your cell phone or moving around. When I return, I will not speak to you but will immediately start the machine. The machine will take three readings, each spaced apart by one minute. Do you have any questions?"

3) Verify that the monitor is on the average setting. Push the button on the machine. 4) Record the systolic and diastolic blood pressure and pulse readings obtained at each of the three readings in the spaces provided on the appropriate form. Record the average of the free readings. 5) Remove the blood pressure cuff from the participant's arm. Use alcohol wipe to remove the marks you placed on the participant's arm.

As a note, the Omron device will "clear" itself of all previous readings after a 5-min interval. Moreover, the Omron does not permit downloading readings to another electronic device. Thus, recording the blood pressure and pulse readings in a timely manner is essential. Note: If average systolic blood pressure is greater than or equal to 180 mm Hg or if average diastolic blood pressure is greater than or equal to 120 mm Hg or if average pulse is less than 45 bpm, notify provider so the participant can be evaluated and treated.

The Omron unit has been validated to remain in calibration for up to 100,000 measurements. The units do not have to be calibrated before their first use. The study coordinators will not have to perform the CHECK MODE function for the first year of the study.

Atrial fibrillation (AF) is not necessarily problematic with oscillometric devices. However, the presence of AF suggests that multiple measurements (three) be taken and averaged to provide a more accurate reading. Functionally, the OMRON IntelliSense unit is designed to take up to three measurements and average them automatically (in AVG Mode). An atrial fibrillation, however, could cause the OMRON IntelliSense unit to error and restart the measurement. If this is the case, the three readings should be taken in the SINGLE Mode and manually averaged. If there is still a problem in obtaining the readings, they should be taken manually with mercury or other properly calibrated manometer.

Refer to the OMRON HEM-907 IntelliSense Digital Blood Pressure Monitor Manual for a list of error codes and how to correct them.

HCs will use the Participant Intervention Materials to conduct the intervention.

HCs will provide participants with basic information on high blood pressure and associated health consequences. The following information will be presented:

1) Blood pressure is the force of blood against the walls of your arteries as it is pumped through the body. Blood pressure is necessary to move the blood through your body so it can get to all the body's organs. 2) Systolic pressure (the top number) is the arterial pressure when the heart pumps blood out. Diastolic pressure (the bottom number) is the pressure when the heart is relaxed and blood is flowing in. 3) High blood pressure occurs when the heart has to work harder to pump the blood through the body, because of the arteries getting stiffer or being blocked. 4) High blood pressure can lead to heart-related problems like stroke, heart attacks, kidney problems, eye problems, and death. 5) Risk factors for high blood pressure include excessive weight (overweight and obesity), alcohol consumption, excessive consumption of sodium, reduced physical activity, inadequate fruit and vegetable intake, older age, and family history of hypertension. 6) There are things that people with high blood pressure can do to lower their blood pressure. These things include taking medication for hypertension that is prescribed by a health care provider, maintaining a healthy weight, being physically active, having a healthy diet, eating less sodium, and limiting alcohol consumption-only in moderation. In addition, HCs will review what blood pressure levels are associated with normal BP (<120/80 mm Hg), elevated BP (SBP 120-129 and DBP <80), Stage 1 hypertension (SBP 130-139 or DBP 80-89), Stage 2 hypertension (SBP ≥140 or DBP ≥90), or hypertensive crisis (SBP ≥180 or DBP ≥120). (Note that those participants taking anti-hypertensive medication can have blood pressure in the normal and elevated range and still have hypertension.)

HCs will also inform participants about intensive blood pressure control; 1) 1) In the past, blood pressure has been controlled to a systolic and diastolic blood pressure target of below 140/90 mm Hg.

2) Recent research has proven that lowering blood pressure more intensively, even as low as <120/80 mm Hg, results in less cardiovascular disease and fewer early deaths than 140/90 mm Hg. 3) In addition, there are fewer side effects than previously anticipated from intensive blood pressure lowering.

J o u r n a l P r e -p r o o f 4) For these reasons, in IMPACTS, health care providers will be intensively lowering participant blood pressure to less than 120/80 mm Hg unless there is a reason for a higher target in some patients. 5) Side effects will be carefully monitored during the study.

HCs will explain the importance of home blood pressure monitoring to the participants providing them with the following information: 1) Regularly monitoring your blood pressure is important for understanding if your efforts to control your blood pressure, such as taking your medications as prescribed, increasing your physical activity and eating healthy, are effective. 2) Knowing your blood pressure numbers can help motivate you to make lifestyle changes to continue to lower your numbers.

3) Monitoring your blood pressure at home provides frequent measurements of blood pressure to your physician, who can adjust your medications or recommend other lifestyle changes based on your blood pressure readings.

HCs will give each participant a digital blood pressure monitor and appropriate cuffs for and train them in how to measure and record their blood pressure at home. HC will emphasize that the BP monitors are important to the study and that participants should keep them in good condition. Participants will be instructed to conduct seated blood pressure monitoring sessions twice daily on three times a week, preferably at the same times each day (30-60 minutes prior to taking BP medications). The provided blood pressure monitor will come with a monitor and cuff (however, some patients may need a different cuff depending on their arm size), batteries and a user's manual. HCs should help participants insert batteries and set the time and date at the initial session. Monitors will not calculate the average blood pressure without the time and date set correctly.

Based on arm circumference measurements made by the clinical research coordinator at baseline data collection visits, the HC will provide each participant with the appropriate sized cuff. The monitor comes with a cuff that fits an arm circumference of 22-42 cm. If participants have an arm circumference in that range, they can use the cuff that comes with the monitor. If a patient has an arm circumference < 22 cm, the HC should give them a small size cuff and instruct them to use it for blood pressure monitoring. If a patient has an arm circumference 42-50 cm, the HC should give them a thigh size cuff and instruct them to use it for blood pressure monitoring. If arm circumference >50 cm, the patient is ineligible for the study. The HC will use the instructions provided in the participant materials to walk through the steps of blood pressure monitoring with each participant. The blood pressure monitoring instructions include the following steps:

3) The participant should be seated with their back supported and feet flat on the floor in a quiet room. The elbow and forearm of the right arm should be resting comfortably on the armrest of the chair or on a table, so that the upper arm is at the level of the heart and the palm of the hand should be turned upward. 4) The area to which the cuff is to be applied must be bare, so long sleeves should be removed. 5) Place the appropriate cuff around the upper right arm so that:

a) The bottom of the cuff should be a ½ inch above the crease of the elbow. b) The arrow and air tube should run along the inside of the arm. 6) Wrap the cuff snugly about the arm, with the palm of the hand turned upward. Make sure that the long edges of the cuff lie on top of each other as you wrap the cuff around. 7) Do not wrap the cuff too tightly around the arm, but so that you can insert only one finger between the cuff and arm. 8) Secure the wrapped cuff firmly. 9) The participant should sit quietly for a period of 5 minutes before the first blood pressure is taken after putting on the cuff. 10) Instruct the participants not to move or speak during the 5 minutes. 11) After 5 minutes, press START/STOP to turn the monitor on and begin the measurement. 12) The cuff will begin to inflate automatically. 13) After the measurement, the systolic blood pressure, diastolic blood pressure, and pulse will be displayed. 14) Record them on the log. 15) Wait one minute and then take another measurement. 16 ) Record values on the log. 17) Wait another minute and take a third measurement. 18) Record values on the log.

button for 3 seconds until the average appears and record it in the log.

HCs will also review with participants the levels of blood pressure that are of concern and at which medical care should be obtained. The patients will be given the following advice if they get a high blood pressure reading when monitoring their blood pressure at home:  A single high reading is not an immediate cause for alarm. If you get a reading that is slightly or moderately higher than normal, take your blood pressure a few more times and consult your healthcare professional to verify if there's a health concern or whether there may be any issues with your monitor.

J o u r n a l P r e -p r o o f  If your blood pressure readings suddenly exceed 180/120 mm Hg, wait five minutes and test again. If your readings are still unusually high, contact your doctor immediately. You could be experiencing a hypertensive crisis.

 If your blood pressure is higher than 180/120 mm Hg and you are experiencing signs of possible organ damage such as chest pain, shortness of breath, back pain, numbness/weakness, change in vision, difficulty speaking, do not wait to see if your pressure comes down on its own. Call 9-1-1. During the first visit, the HC will help the participant enter values in the Blood Pressure Monitoring Log. At subsequent visits, HC will review home BP monitoring with participants and will also get a copy of all of their home BP monitoring values.

Participants will be instructed to take all medications prescribed by their physicians in the doses and at the times instructed. HCs will provide participants with the following information:

1) Taking blood pressure medications the way your doctor tells you is the best way of controlling your blood pressure.

2) Taking blood pressure medications as prescribed is important because it can prevent heart attack, stroke, and heart failure.

3) If medications are not taken the proper way, they may not work, and you may experience side effects such as feeling sick or dizzy. 4) When you start taking blood pressure medication, you will need to work with your healthcare provider to get the right drug and dose level. 5) Most people need to take two or more medications to get their blood pressure under control. 6) All side effects of the medications should be reported to the healthcare provider, so the type or dose of medication can be adjusted. 7) Sometimes it can be hard to remember to take medications, but it is easier if it is part of your daily routine. 8) It is important to remember to get refills for your prescriptions before you run out. It is helpful to mark in your calendar one week prior to running out of pills, so you have time to get the prescription refilled. 9) Do not share medications with friends or family. 10) Don't stop taking your medicine if your blood pressure is okay. Having normal blood pressure means the medicine is working.

HCs will know from the baseline nurse visits whether or not a patient is adherent or non-adherent according to the medication adherence scale. They will also know if non-adherence in a patient is intentional (choosing to not take medications), unintentional (forgetting to take medications), or both. In addition, the HC will talk to participants about their experiences taking antihypertensive medications. The HC will provide them with a pill box to encourage their adherence. If participants report having a prescription but not taking the medication, the HC will ask follow-up questions to determine why they might not be taking their medication. If they report having side effects, the HC will encourage them to speak with their doctor so the doctor can work with them to get treatment in a way that minimizes side effects. If they report feeling like they do not need to take the medication when they do not have symptoms, the HC will explain how important it is to continuously take antihypertensive medication and recommend speaking to their doctor to assess if the participant still needs the medication. If forgetfulness is the reason for lack of J o u r n a l P r e -p r o o f medication adherence, the HC will provide some tips and resources to help participants remember, help them use a medication table, and show them how to fill their pill box. In general, the HC will use educational counseling techniques to encourage medication adherence. The following table contains common patient barriers that may keep them from taking their medications and some talking points and strategies to address them. to support prescription pick-up • Other strategies for alleviating transportation burden, e.g., coordinating prescription pick-up with other errands, switching to comparably-priced pharmacy located near bus line The medications make me feel sick "Some people have side effects when they take their medications. I'm sorry to hear that this is affecting you. The good news is that your provider may be able to help you to avoid some of these side effects by adjusting your medication, but it is important that he/she knows that this is affecting how you take your medications. Let's talk about how you feel when you take your medications and how you can discuss this with your provider." I don't need to "Let's discuss this idea. During these times when you feel good, how do you know J o u r n a l P r e -p r o o f take my medications when I feel good that your blood pressure is under control?" "It sounds like you are in touch with your body, however, high blood pressure is known as a "silent killer" because most people cannot feel when they have it. Regardless, it can still do damage to your body and put you at higher risk for a heart attack or stroke. Taking blood pressure medications will help to protect you from this damage that you cannot feel happening." I don't need to take my medications when I know my blood pressure is under control

That is great that you are keeping track of your blood pressure at home and that you are getting some good readings. However, when you measure your blood pressure, you are getting only one snapshot. Blood pressure can go up and down and it is difficult to know what is happening throughout the day. Taking blood pressure medications will help to keep your blood pressure consistently controlled throughout the day so that you are protected from the damage that high blood pressure can do to your body. I can't take my medications when I am planning to drink alcohol "It is safe to take most blood pressure medications even if you are planning to consume moderate amounts of alcohol. Your provider can help you to understand how alcohol will mix with the medication you are taking. Would you like to talk about how you might discuss this with your provider?" I prefer to use apple cider vinegar or other herbal or home remedies to control my blood pressure "Let's discuss this. What kinds of remedies do you use? Where did you hear about this? How do you know they are working?" "Many of us try alternative remedies that were passed to us by family or friends. Unfortunately, as of now, we don't have any evidence that these remedies are effective at keeping our blood pressure under control consistently throughout the day. The most effective thing for controlling your blood pressure and protecting yourself from the damage that high blood pressure can do to your body is to take your medications regularly. This does not mean that you cannot also use the remedies that you like, but it is important to discuss this with your healthcare provider to make sure that it is okay to mix your remedies with your blood pressure medications. Would you like to talk about how you might discuss this with your provider?" J o u r n a l P r e -p r o o f I would rather use exercise or diet to control my blood pressure "That is really great that you are interested in adopting a healthy lifestyle. That will benefit you in many ways. While it is important to eat a healthy diet and get regular exercise, for some people that change happens more slowly than they would like, and in the meantime we want to make sure you are protected from the damage that high blood pressure can do to your body. The most effective thing for controlling your blood pressure right now is to take your medications regularly. Once you are able to make and maintain your lifestyle changes, you can always revisit the topic of your blood pressure medications with your provider. Until then, the safest thing to do is to protect yourself from the effects of high blood pressure." Taking medications long-term may be bad for me "Let's discuss this idea. What problems do you think might happen if you take your blood pressure medications for a long time? Where did you hear this?" "It sounds like you try to stay very informed about health issuesthat is great! I want to share with you what I know about blood pressure medications. Most blood pressure medications have been around for a long time and have been taken for many years by many patients. For blood pressure medications that are on the market today, there is no evidence that they are harmful to your health long-term. If you have questions about the long-term effects of your specific medications, it is a good idea to ask your provider. Would you like to talk about how you might discuss this with your provider?" For participants that forget to take their medications, HCs will help participants think of strategies for them to remember to take their medications. Some examples of ways to remember that the HC will provide are: 1) Take medications at the same time every day.

2) Keep your medications on the nightstand next to your side of the bed.

3) Take your medications right after you brush your teeth and keep them with your toothbrush as a reminder. 4) Put "sticky" notes in visible places, such as on the refrigerator, the bathroom mirror, or the front door, to remind yourself to take your medications. 5) Set up a buddy system with a friend who also takes medication daily and arrange to message each other every day with a reminder to "take your blood pressure medicine".

J o u r n a l P r e -p r o o f 6) Ask your child or grandchild to message you every day with a quick reminder. It's a great way to stay in touch, and little ones love to help the grown-ups. 7) Remember to refill your prescription. Each time you pick up a refill, make a note on your calendar to order and pick up the next refill one

week before the medication is due to run out. 8) Pill boxes can be an effective tool to help you remember to take your medication. 9) Download an app on your phone that will send you reminders to take your medications.

HCs will give each participant a pill box that has a compartment for each day of the week. The HC and participants will collect all medications that each participant takes regularly for chronic conditions and fill in the medication table with the details of all medications they are prescribed, including name, appearance, dose, what the medicine is for, when to take it, and the doctor that prescribed it. Then they will use the table/schedule to fill the pill box with appropriate medications for each day of the week. Each compartment of the pill box should contain the pills that will be taken at a certain time on a certain day. If the pills for two different medications look the same and are supposed to be taken at the same time of the day, they can be placed in the pill boxes the same as any other medication.

Participants will be encouraged to take an active role in their healthcare and consider themselves a member of their healthcare team, along with their doctor primary care provider, nurses, HCs, and any others. Using the Patient Visit Form, participants will be encouraged to record questions and symptoms they have in between provider's appointments, so they can remember their questions and concerns during their next visit. In addition, the Provider Visit Form contains space for participants to take notes during doctor's appointments so they don't forget important information provided by their doctor. HCs will provide patients with example questions that might be relevant that patients can ask their providers: Using height and weight of the participants from the research coordinator data collection visits and a BMI chart, the HC and the participant will determine the participant's BMI and see what category it falls into. If obese, the HC will advise the participant to lose weight and will brainstorm with the participant about strategies that the participant can use to do so. If overweight, the HC will discuss other heart disease risk factors that the individual might have, and they will determine if weight loss is appropriate. Those in the normal weight category will be encouraged to maintain their healthy weight. The HC give the participant a chance weigh themselves, if they want, and record the weight in the Weight Tracker Log. The HC will give them the chance to weight themselves at each health coaching session, so that weight can be monitored over time and used as a tool to maintain a healthy weight. Subsequent portions of the training will focus on diet and exercise that can be discussed in a weight loss context when appropriate. HCs will provide the following information and tips for losing weight: 1) If you need to lose weight, it's important to do so slowly. Lose no more than ½ pound to 2 pounds per week. Begin with a goal of losing 10 percent of your current weight. This is the healthiest way to lose weight and offers the best chance of long-term success. 2) There's no magic formula for weight loss. You have to eat fewer calories than you use up in daily activities. Just how many calories you burn daily depends on factors such as your body size and how physically active you are. 3) One pound equals 3,500 calories, so, to lose 1 pound a week, you need to eat 500 calories a day less or burn 500 calories a day more than you usually do. It's best to work out some combination of both eating less and being more physically active. 4) We will discuss both adopting healthy eating and increasing physical activity in these training materials.

J o u r n a l P r e -p r o o f

Participants will be instructed to follow the Dietary Approaches to Stop Hypertension (DASH) diet plan. The DASH diet limits intake of saturated fat, total fat, and cholesterol and encourages intake of potassium, calcium, magnesium, protein, and fiber through consumption of fruits, vegetables, and low-fat dairy foods. The DASH eating plan includes whole grains, poultry, fish, and nuts, and has low amounts of fats, red meats, sweets, and sugared beverages. Participants will be provided with guidelines for following the DASH eating plan and sample recipes. The recommendations are based on a 2,000 calorie a day diet. If participants have different caloric needs, the HC can work with the participants to adjust the appropriate number of servings for each food group. Participants will also receive tips for switching to the DASH eating plan. The HC will provide these main dietary recommendations: 1) Participants should limit consumption of red meat, sweets, sugary beverages, and fatty foods.

2) Participants should increase consumption of fruits and vegetables to 4-5 servings of each per day. Some examples include raw and cooked vegetables, fruit or vegetable juice, and dried, fresh or frozen fruits. 3) Participants should eat 7-8 servings of grains per day, including slices of bread, rice, pasta, and cereal. 4) Participants should eat low fat or fat free dairy foods 2-3 times per day. Examples include low fat milk, yogurt, and cheeses. 5) Lean meats, poultry and fish should be eaten two or few times a day. A serving size for meat poultry or fish is approximately three ounces.

Poultry should be prepared without the skin. 6) Nuts, seeds and dry beans should be consumed 4-5 times per week. 7) Participants should eat fats and oils 2-3 times per day. Example serving sizes of fats and oils are 1 teaspoon soft margarine, 2 tablespoon low-fat mayonnaise, 2 tablespoons light salad dressing, or 1 teaspoon vegetable oil. Fat content of oils and dressing vary, so participants should check the nutrition labels when buying these products and try to find low fat or fat free ones. 8) Sweets should be limited to 5 servings per week.

Tips will be provided for switching from the participants' normal diet to the DASH plan. Because the DASH diet is not primarily a weight loss plan, the following additional information will also be provided for those who are trying to lose weight on the DASH plan. The tips encourage participants to substitute fruits and vegetables for high calorie foods:

 Eat a medium apple instead of four shortbread cookies. You'll save 80 calories.

 Eat ¼ cup of dried apricots instead of a 2-ounce bag of pork rinds. You'll save 230 calories.

 Have a hamburger that's 3 ounces instead of 6 ounces. Add a ½ cup serving of carrots and a ½ cup serving of spinach.

You'll save more than 200 calories.

J o u r n a l P r e -p r o o f  When available, buy low-or reduced-sodium or no-salt-added versions of foods.

Participants will be taught to read food labels, so they can tell how much salt is in packaged foods and make smart choices between products. HCs will also show participants how to select foods low in calories, total fat and saturated fat based on food labels. 2I. Limit Alcohol Intake HCs will inform participants that alcohol use can raise blood pressure. Participants who drink will be instructed to drink a maximum of one drink a day for women and two drinks a day for men. In addition, the number of ounces in one drink will be explained, so that participants are not drinking too much alcohol without realizing the proper serving size. 2J. Increase Physical Activity Participants will be instructed to participate in two and a half hours of moderate physical activity each week. Examples of moderate physical activity will be provided, such as walking, bicycling, raking leaves, and gardening. HCs should brainstorm with participants on ways they can fit moderate physical activity into their daily activities. Participants will be provided with a log to write down the amount of time they spend each day being physically active. 

Trends in Prevalence and Control of Hypertension According hypertension in low income residents within Louisiana State University Health Care Services Division Hospital System

Randomized Trial of Intensive versus Standard Blood-Pressure Control

Systolic Blood Pressure Reduction and Risk of Cardiovascular Disease and Mortality: A Systematic Review and Network Metaanalysis

Effects of intensive blood pressure lowering on cardiovascular and renal outcomes: updated systematic review and meta-analysis

Committee on Public Health Priorities to Reduce and Control Hypertension in the U.S. Population I of M. A population-based policy and systems change approach to prevent and control hypertension

Inclusion of special populations in clinical research: important considerations and guidelines

New blood pressure-lowering targets-finding clarity

Guideline for the diagnosis and management of hypertension in adults -2016

The authors would like to acknowledge and thank all IMPACTS study participants, FQHC clinic staff, and study staff for contributing to the study. Donald E. Morisky, ScD, ScM, MSPH claims copyright and trademark rights for the MMAS-8 scale, and that his permission for use of the scale has been obtained. A license agreement is available from him at 294 Lindura Ct., Las Vegas, NV 89138, USA; dmorisky@gmail.com.J o u r n a l P r e -p r o o f Journal Pre-proof

 Instead of 5 ounces of chicken, have a stir fry with 2 ounces of chicken and 1 ½ cups of raw vegetables. Use a small amount of vegetable oil. You'll save 50 calories.3) To increase low-fat or fat free dairy products: Have a ½ cup serving of low-fat frozen yogurt instead of 1 ½-ounce milk chocolate bar. You'll save about 110 calories. 4) And don't forget these calorie-saving tips: Use low-fat or fat free condiments, such as fat free salad dressings. Eat smaller portionscut back gradually. Choose low-fat or fat free dairy products to reduce total fat intake. Use food labels to compare fat content in packaged foods. Items marked low fat or fat free are not always lower in calories than their regular versions. Limit foods with lots of added sugar, such as pies, flavored yogurts, candy bars, ice cream, sherbet, regular soft drinks, and fruit drinks. Eat fruits canned in their own juice. Snack on fruit, vegetable sticks, unbuttered and unsalted popcorn, or bread sticks. Drink water or club soda.

HCs will advise participants to reduce salt consumption to keep blood pressure at a healthy level. Participants will be instructed to consume no more than 2,400 milligrams of sodium each day, which is equivalent to 100 mmol of sodium, 6g/day sodium chloride, or 1 teaspoon of table salt. Participants will be given tips to reduce salt in their diets: Buy fresh, plain frozen, or canned "with no salt added" vegetables  Use fresh poultry, fish, and lean meat, rather than canned or processed types. Use herbs, spices, and salt-free seasoning blends in cooking and at the table. Cook rice, pasta, and hot cereal without salt. Cut back on instant or flavored rice, pasta, and cereal mixes, which usually have added salt. Choose "convenience" foods that are low in sodium. Cut back on frozen dinners, pizza, packaged mixes, soups or broths, and salad dressingsthese often have a lot of sodium.  Rinse canned foods, such as tuna, to remove some sodium.J o u r n a l P r e -p r o o f