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Multifaceted Strategies for Hypertension Control in Low-Income Patients. BACKGROUND: Uncontrolled hypertension disproportionately affects populations that have substantial health disparities. Data regarding the effectiveness and implementation of multifaceted, team-based strategies for hypertension control among low-income patients are lacking. METHODS: We randomly assigned federally qualified health center clinics in Louisiana and Mississippi to use either a multifaceted implementation strategy (intervention group) or enhanced usual care (control group) for hypertension control. The intervention included team-based care, protocol-based intensive blood-pressure management, blood-pressure audit and feedback, health coaching on lifestyle changes and medication adherence, and home blood-pressure monitoring. Enhanced usual care involved educating physicians about clinical guidelines for hypertension. The primary effectiveness outcome was the mean change in systolic blood pressure from baseline to 18 months. The primary implementation outcome was the adherence summary score (on a scale of 0 to 4, with higher scores indicating better adherence to blood-pressure management). RESULTS: A total of 36 clinics underwent randomization. Among these clinics, we enrolled 1272 patients with uncontrolled hypertension who were 40 years of age or older; 642 were in the intervention group and 630 were in the control group. The mean age of the patients was 58.8 years, 56.7% were women, 63.4% were Black, 75.9% were unemployed, and 73.4% had a family income of less than $25,000 per year. At 18 months, the mean change from baseline in the systolic blood pressure was -15.5 mm Hg (95% confidence interval [CI], -17.4 to -13.6) in the intervention group and -9.1 mm Hg (95% CI, -11.0 to -7.2) in the control group (between-group difference, -6.4 mm Hg; 95% CI, -9.0 to -3.8; P<0.001). The mean adherence summary score over the 18-month follow-up period was 2.8 (95% CI, 2.7 to 2.9) in the intervention group and 2.1 (95% CI, 2.0 to 2.2) in the control group (between-group difference, 0.7 points; 95% CI, 0.6 to 0.8; P<0.001). Serious adverse events occurred in 20.9% of the patients in the intervention group and in 21.7% of those in the control group. CONCLUSIONS: Among low-income patients with hypertension, a multifaceted, team-based implementation strategy resulted in a significantly greater reduction in systolic blood pressure than enhanced usual care. (Funded by the National Heart, Lung, and Blood Institute and others; IMPACTS-BP ClinicalTrials.gov number, NCT03483662.).

The Implementation of Multifaceted Patient-Centered Treatment Strategies for Intensive Blood Pressure Control (IMPACTS-BP) study was a cluster-randomized trial conducted in 36 FQHC clinics in Louisiana and Mississippi.14 An effectiveness-implementation hybrid type-2 design was used to test the clinical effectiveness and implementation outcomes of the multifaceted, team-based strategy for blood pressure control simultaneously.15 The study protocol (available online with the full text of this article) was designed by the steering committee and approved by the Tulane University Institutional Review Board. An independent data safety monitoring board (DSMB) monitored trial progress and patient safety (additional information is provided in the Supplementary Appendix online at NEJM.org). Data analyses were performed by the first, seventh, and last authors. All authors vouch for the accuracy and completeness of the data and adherence to the protocol. The last author drafted the manuscript.

progress and patient safety (additional information is provided in the Supplementary Appendix online at NEJM.org). Data analyses were performed by the first, seventh, and last authors. All authors vouch for the accuracy and completeness of the data and adherence to the protocol. The last author drafted the manuscript. Eligibility criteria for clinics and participants were published previously.14 FQHC clinics were eligible if they did not share providers or nurses with other participating clinics. Patients at least 40 years of age who received primary care at participating FQHCs and had untreated systolic blood pressure ≥140 mmHg or a treated systolic blood pressure ≥130 mm Hg were eligible. Pregnant women, patients with end-stage kidney disease, and individuals unwilling or unable to provide informed consent were excluded (Table S1 in the Supplementary Appendix). Electronic health records were used to identify potentially eligible patients with elevated blood pressure. After prescreening, eligible participants were scheduled for two clinic visits to confirm eligibility and collect baseline data. Blood pressure eligibility was based on the average of six measurements taken during these visits. Informed consent was obtained from all participants during screening visits.

blood pressure. After prescreening, eligible participants were scheduled for two clinic visits to confirm eligibility and collect baseline data. Blood pressure eligibility was based on the average of six measurements taken during these visits. Informed consent was obtained from all participants during screening visits. FQHC clinics were randomized in a 1:1 ratio to either a multifaceted team-based implementation strategy or enhanced usual care based on a random allocation sequence generated using SAS software, with stratification by FQHC organization. Due to the nature of the cluster design and intervention program, study participants, healthcare providers, health coaches, and research staff who collected study data were unblinded. A stepped-care protocol, adapted from the SPRINT intensive-treatment algorithm to achieve a systolic blood pressure <120 mmHg and diastolic blood pressure <80 mmHg, was implemented in the intervention clinics (Figure S1). If clinical blood pressure remained above target during a provider visit, antihypertensive medication was titrated up, or a new class was added. Participants were followed monthly for the first three months, then every three months. Those with uncontrolled blood pressure received additional monthly visits until achieving target blood pressure. Antihypertensive drug classes proven to reduce cardiovascular disease risk were recommended as first-line medications, either alone or in combination.8,16

for the first three months, then every three months. Those with uncontrolled blood pressure received additional monthly visits until achieving target blood pressure. Antihypertensive drug classes proven to reduce cardiovascular disease risk were recommended as first-line medications, either alone or in combination.8,16 The multifaceted, team-based implementation strategy included protocol-based treatment, blood pressure audit and feedback, health coaching, and home blood pressure monitoring. In addition, findings from the SPRINT study were disseminated to care teams, patients, and administrators. Initial and annual interactive provider training focused on protocol-based intensive blood pressure management. Nurses and medical assistants were trained to deliver health coaching on lifestyle changes and medication adherence. Providers and clinic staff also received training in standardized blood pressure measurement techniques.17 Each participant in the intervention clinics received a home blood pressure monitor and was instructed to measure blood pressure three days each week. At each visit, health coaches measured clinic blood pressure and averaged home blood pressure values from the past two weeks, recording the information on a standard form for providers. Providers discussed shared treatment goals with individual patients and either adjusted medications or documented reasons for not intensifying treatment. Health coaches met individually with participants in person or by phone to discuss lifestyle changes, medication adherence, and strategies to overcome barriers. When a clinic health coach was unavailable, health coaching was conducted by study staff from the same clinic. Additionally, health coaches and providers met at least quarterly to review lists of patients with uncontrolled blood pressure.

uss lifestyle changes, medication adherence, and strategies to overcome barriers. When a clinic health coach was unavailable, health coaching was conducted by study staff from the same clinic. Additionally, health coaches and providers met at least quarterly to review lists of patients with uncontrolled blood pressure. In enhanced usual care clinics, providers attended a continuing medical education-credited webinar on the 2017 American College of Cardiology and American Heart Association hypertension guideline and SPRINT study findings. In addition, providers and staff were trained in standardized blood pressure measurement techniques.17 Enhanced usual care clinics received no intervention and continued routine hypertension management. Data on demographics, medical history, lifestyle factors, and clinical and implementation outcomes were collected at baseline and at 6, 12, and 18 months of follow-up by trained, certified research staff. Self-reported medication adherence was assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8) and quality of life was measured using the 12-Item Short Form Survey (SF-12).18,19 Three blood pressure measurements were taken at each visit using a standardized protocol with an automated device (HEM-907 XL, Omron Healthcare) and appropriately sized cuffs.17 Measurements were performed with participants seated after 5 minutes of rest, following at least 30 minutes of abstention from alcohol, cigarettes, caffeine, and exercise.

ents were taken at each visit using a standardized protocol with an automated device (HEM-907 XL, Omron Healthcare) and appropriately sized cuffs.17 Measurements were performed with participants seated after 5 minutes of rest, following at least 30 minutes of abstention from alcohol, cigarettes, caffeine, and exercise. The primary effectiveness outcome was the difference in mean systolic blood pressure change from baseline to 18 months between the intervention and control groups, based on six measurements from two visits at each timepoint. Secondary clinical outcomes included the differences in proportions of patients with a systolic blood pressure <120 mmHg, <130 mmHg, and a >30 mmHg reduction in systolic blood pressure between the intervention and control groups at 18 months, as well as mean changes in diastolic blood pressure and 12-item Short Form Health Survey (SF-12) scores from baseline to 18 months. Scores on the SF-12 instrument range from 0 to 100 with higher scores indicating better health. The primary implementation outcome was a summary score of fidelity to key blood pressure management components: high adherence to antihypertensive medications (MMAS-8 score=8), initiation or intensification of antihypertensive treatment, home blood pressure monitoring, and receipt of health education in the past 6 months at the 6-, 12-, and 18-month visits. The score ranged from 0 to 4, with a higher score indicating better fidelity. Secondary implementation outcomes included each component of the fidelity summary score, as well as satisfaction with antihypertensive medications and blood pressure-related care.

tion in the past 6 months at the 6-, 12-, and 18-month visits. The score ranged from 0 to 4, with a higher score indicating better fidelity. Secondary implementation outcomes included each component of the fidelity summary score, as well as satisfaction with antihypertensive medications and blood pressure-related care. Data on the completeness of provider and health coach visits, as well as implementation costs at the intervention clinics, were obtained from the administrative database. Other implementation outcomes were collected through surveys of clinic administrators, providers, and health coaches (see Additional Methods in the Supplementary Appendix). All serious adverse events and selected adverse events resulting in an emergency department evaluation were reported. Participants were queried about these events at each 6-month study visit. The required sample size was 1,260 participants across 36 clinics (35 per clinic), calculated using the formula developed by Donner and Klar.20 This sample size provided 80% statistical power to detect a 5.0 mmHg difference in mean systolic blood pressure change over 18 months at a two-sided significance level of 0.05, with a follow-up rate of 85%. In a previous cluster trial, we observed a standard deviation of 17.0 mm Hg for systolic blood pressure changes and an intra-cluster correlation coefficient of 0.063.21

ct a 5.0 mmHg difference in mean systolic blood pressure change over 18 months at a two-sided significance level of 0.05, with a follow-up rate of 85%. In a previous cluster trial, we observed a standard deviation of 17.0 mm Hg for systolic blood pressure changes and an intra-cluster correlation coefficient of 0.063.21 An intention-to-treat analysis was conducted using multiple imputation for missing outcomes, assuming data were missing at random in the primary analyses (see Additional Methods in the Appendix).22 We tested the difference in mean systolic blood pressure from baseline to 18 months between the intervention and control groups using measurements taken at 0, 6, 12, and 18 months in a linear mixed-effects regression analysis.23 Participants and clinics were modeled as random effects, with intervention group, time, and their interaction as fixed effects. Cluster random intercepts were included to account for within-cluster correlation, and residual within-participant correlation was modeled using an unstructured covariance matrix. If the model did not converge, compound symmetry followed by first-order autoregressive structures were applied. Similarly, we compared the average fidelity summary score over 18 months between the two groups using measurements taken at 6, 12, and 18 months in a linear mixed-effects regression analysis that did not include the time variable. The significance level was set at 0.025 for two-sided tests for the co-primary outcomes.24 We estimated the differences and 95% confidence intervals (CIs) for the secondary binary outcomes between the two groups using a generalized linear mixed-effects model.23 Confidence interval widths were not adjusted for multiplicity and should not be used as a substitute for hypothesis testing.

e co-primary outcomes.24 We estimated the differences and 95% confidence intervals (CIs) for the secondary binary outcomes between the two groups using a generalized linear mixed-effects model.23 Confidence interval widths were not adjusted for multiplicity and should not be used as a substitute for hypothesis testing. In a secondary analysis, models were adjusted for important covariates pre-selected from prior literature.14 We also conducted prespecified subgroup analyses, and the differences in systolic blood pressure and 95% CIs by subgroup were estimated using a linear mixed-effects regression analysis.23 In addition, a tipping point analysis was conducted to examine how assumptions about missing systolic blood pressure values could affect the primary conclusion (see Additional Methods in the Appendix). Statistical analyses were performed using SAS V9.4 (SAS Institute, Cary, NC) and R V4.4.2 (R Foundation) for calculating intraclass correlation coefficients.

Eligibility criteria for clinics and participants were published previously.14 FQHC clinics were eligible if they did not share providers or nurses with other participating clinics. Patients at least 40 years of age who received primary care at participating FQHCs and had untreated systolic blood pressure ≥140 mmHg or a treated systolic blood pressure ≥130 mm Hg were eligible. Pregnant women, patients with end-stage kidney disease, and individuals unwilling or unable to provide informed consent were excluded (Table S1 in the Supplementary Appendix). Electronic health records were used to identify potentially eligible patients with elevated blood pressure. After prescreening, eligible participants were scheduled for two clinic visits to confirm eligibility and collect baseline data. Blood pressure eligibility was based on the average of six measurements taken during these visits. Informed consent was obtained from all participants during screening visits.

FQHC clinics were randomized in a 1:1 ratio to either a multifaceted team-based implementation strategy or enhanced usual care based on a random allocation sequence generated using SAS software, with stratification by FQHC organization. Due to the nature of the cluster design and intervention program, study participants, healthcare providers, health coaches, and research staff who collected study data were unblinded.

A stepped-care protocol, adapted from the SPRINT intensive-treatment algorithm to achieve a systolic blood pressure <120 mmHg and diastolic blood pressure <80 mmHg, was implemented in the intervention clinics (Figure S1). If clinical blood pressure remained above target during a provider visit, antihypertensive medication was titrated up, or a new class was added. Participants were followed monthly for the first three months, then every three months. Those with uncontrolled blood pressure received additional monthly visits until achieving target blood pressure. Antihypertensive drug classes proven to reduce cardiovascular disease risk were recommended as first-line medications, either alone or in combination.8,16

uss lifestyle changes, medication adherence, and strategies to overcome barriers. When a clinic health coach was unavailable, health coaching was conducted by study staff from the same clinic. Additionally, health coaches and providers met at least quarterly to review lists of patients with uncontrolled blood pressure. In enhanced usual care clinics, providers attended a continuing medical education-credited webinar on the 2017 American College of Cardiology and American Heart Association hypertension guideline and SPRINT study findings. In addition, providers and staff were trained in standardized blood pressure measurement techniques.17 Enhanced usual care clinics received no intervention and continued routine hypertension management.

Data on demographics, medical history, lifestyle factors, and clinical and implementation outcomes were collected at baseline and at 6, 12, and 18 months of follow-up by trained, certified research staff. Self-reported medication adherence was assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8) and quality of life was measured using the 12-Item Short Form Survey (SF-12).18,19 Three blood pressure measurements were taken at each visit using a standardized protocol with an automated device (HEM-907 XL, Omron Healthcare) and appropriately sized cuffs.17 Measurements were performed with participants seated after 5 minutes of rest, following at least 30 minutes of abstention from alcohol, cigarettes, caffeine, and exercise.

The primary effectiveness outcome was the difference in mean systolic blood pressure change from baseline to 18 months between the intervention and control groups, based on six measurements from two visits at each timepoint. Secondary clinical outcomes included the differences in proportions of patients with a systolic blood pressure <120 mmHg, <130 mmHg, and a >30 mmHg reduction in systolic blood pressure between the intervention and control groups at 18 months, as well as mean changes in diastolic blood pressure and 12-item Short Form Health Survey (SF-12) scores from baseline to 18 months. Scores on the SF-12 instrument range from 0 to 100 with higher scores indicating better health. The primary implementation outcome was a summary score of fidelity to key blood pressure management components: high adherence to antihypertensive medications (MMAS-8 score=8), initiation or intensification of antihypertensive treatment, home blood pressure monitoring, and receipt of health education in the past 6 months at the 6-, 12-, and 18-month visits. The score ranged from 0 to 4, with a higher score indicating better fidelity. Secondary implementation outcomes included each component of the fidelity summary score, as well as satisfaction with antihypertensive medications and blood pressure-related care.

tion in the past 6 months at the 6-, 12-, and 18-month visits. The score ranged from 0 to 4, with a higher score indicating better fidelity. Secondary implementation outcomes included each component of the fidelity summary score, as well as satisfaction with antihypertensive medications and blood pressure-related care. Data on the completeness of provider and health coach visits, as well as implementation costs at the intervention clinics, were obtained from the administrative database. Other implementation outcomes were collected through surveys of clinic administrators, providers, and health coaches (see Additional Methods in the Supplementary Appendix). All serious adverse events and selected adverse events resulting in an emergency department evaluation were reported. Participants were queried about these events at each 6-month study visit.

The required sample size was 1,260 participants across 36 clinics (35 per clinic), calculated using the formula developed by Donner and Klar.20 This sample size provided 80% statistical power to detect a 5.0 mmHg difference in mean systolic blood pressure change over 18 months at a two-sided significance level of 0.05, with a follow-up rate of 85%. In a previous cluster trial, we observed a standard deviation of 17.0 mm Hg for systolic blood pressure changes and an intra-cluster correlation coefficient of 0.063.21

Thirty-six clinics from eight FQHCs in Louisiana and Mississippi, along with 1,272 patients (642 in the intervention group and 630 in the control group), were recruited between June 27, 2018, and July 31, 2022 (Figure 1). Baseline characteristics appeared comparable between the two groups (Table 1), and additional clinic and participant characteristics are presented in Table S2. The mean age of patients was 58.8 years, 56.7% were women, 63.4% African American, 75.9% unemployed, and 73.4% had a family income <$25,000 per year. The study samples were demographically representative of the target populations (Tables S3 and S4). The mean systolic blood pressure decreased by −15.5 mmHg from baseline to 18 months in the intervention group and by −9.1 mmHg in the control group, with a net difference of −6.4 mmHg (95% CI, 9.0 to 3.8; P< 0.001) (Figure 2). The diastolic blood pressure decreased by −8.7 mmHg in the intervention group and by −5.3 mmHg in the control group, with a net difference of −3.4 mmHg (95% CI, 5.1 to 1.8). At 18 months, 21.8% of patients in the intervention group and 15.1% in the control group achieved a systolic blood pressure <120 mm Hg; 47.7% and 36.4% of patients in the intervention and control groups, respectively, achieved a systolic blood pressure <130 mmHg (Table 2).

difference of −3.4 mmHg (95% CI, 5.1 to 1.8). At 18 months, 21.8% of patients in the intervention group and 15.1% in the control group achieved a systolic blood pressure <120 mm Hg; 47.7% and 36.4% of patients in the intervention and control groups, respectively, achieved a systolic blood pressure <130 mmHg (Table 2). The mean fidelity summary score, averaged over months 6, 12, and 18 months, was 2.8 in the intervention group and 2.1 in the control group, with a between-group difference of 0.7 (95% CI, 0.6 to 0.8; P<0.001). Compared to the control group, patients in the intervention group appeared to have higher proportions of treatment intensification, home blood pressure monitoring, and health education, but not medication adherence during the 18-month intervention (Table 2). At 18 months, satisfaction with medication was reported by 84.5% and 83.1% of patients in the intervention and control groups, respectively, and satisfaction with blood pressure-related care was reported by 89.2% and 89.5% in both groups. Serious adverse events occurred in 20.9% and 21.7% of participants in the intervention and control groups, respectively (Table 2). Other selected adverse events were not significantly different between the two groups.

The mean fidelity summary score, averaged over months 6, 12, and 18 months, was 2.8 in the intervention group and 2.1 in the control group, with a between-group difference of 0.7 (95% CI, 0.6 to 0.8; P<0.001). Compared to the control group, patients in the intervention group appeared to have higher proportions of treatment intensification, home blood pressure monitoring, and health education, but not medication adherence during the 18-month intervention (Table 2). At 18 months, satisfaction with medication was reported by 84.5% and 83.1% of patients in the intervention and control groups, respectively, and satisfaction with blood pressure-related care was reported by 89.2% and 89.5% in both groups. Serious adverse events occurred in 20.9% and 21.7% of participants in the intervention and control groups, respectively (Table 2). Other selected adverse events were not significantly different between the two groups. After adjusting for age, sex, race or ethnicity, education, duration of hypertension, history of antihypertensive treatment, history of major cardiovascular disease, baseline body-mass index, and baseline systolic blood pressure, the net difference in systolic blood pressure change over 18 months was −5.6 mm Hg (95% CI, −8.1 to −3.0) (Table 2). In the complete case analysis, the mean systolic blood pressure decreased by −16.1 in the intervention group and −9.0 in the control group, with a net difference of −7.1 mmHg (95% CI, −9.7 to −4.4; Table S5). Most blood pressure reductions occurred in the first six months (Tables S6, S7, and Figure S2). In predefined subgroup analyses, systolic blood pressure reduction appeared consistent across subgroups defined by age, sex, race, education, family income, health insurance status, history of cardiovascular disease, chronic kidney disease, diabetes, and baseline systolic blood pressure (Figure 3 and Figure S3). Most clinics with large mean systolic blood pressure reductions were in the intervention group (Figure S4). In a tipping point analysis, the change in systolic blood pressure for the intervention group at 18 months had to be inflated by adding 6.5 mmHg to the missing values, while control group data were assumed to be missing at random, before the study results lost significance (Table S8).

he intervention group (Figure S4). In a tipping point analysis, the change in systolic blood pressure for the intervention group at 18 months had to be inflated by adding 6.5 mmHg to the missing values, while control group data were assumed to be missing at random, before the study results lost significance (Table S8). The multivariable-adjusted between-group difference in the mean fidelity summary score, averaged over months 6, 12, and 18, was 0.7 (95% CI, 0.6 to 0.9) for both multiple imputation and complete case analyses (Table 2 and Table S5). Treatment intensification, home blood pressure monitoring, and health education were consistently higher in the intervention group over the 18-month period (Table S9). At the initial visit, 87.1% and 94.1% of participants completed provider and health coach visits, respectively; over 18 months, the averages were 53.4% and 57.9% (Figure S5). The average implementation cost was $762 per participant (95% CI, 741 to 783) (Table S10). Additional implementation outcomes are presented in Table S11. The intraclass correlation was 0.0163 for systolic blood pressure change from baseline to 18 months and <0.0001 for the mean fidelity score averaged over the 18-month intervention (Table S12).

The mean systolic blood pressure decreased by −15.5 mmHg from baseline to 18 months in the intervention group and by −9.1 mmHg in the control group, with a net difference of −6.4 mmHg (95% CI, 9.0 to 3.8; P< 0.001) (Figure 2). The diastolic blood pressure decreased by −8.7 mmHg in the intervention group and by −5.3 mmHg in the control group, with a net difference of −3.4 mmHg (95% CI, 5.1 to 1.8). At 18 months, 21.8% of patients in the intervention group and 15.1% in the control group achieved a systolic blood pressure <120 mm Hg; 47.7% and 36.4% of patients in the intervention and control groups, respectively, achieved a systolic blood pressure <130 mmHg (Table 2).

The mean fidelity summary score, averaged over months 6, 12, and 18 months, was 2.8 in the intervention group and 2.1 in the control group, with a between-group difference of 0.7 (95% CI, 0.6 to 0.8; P<0.001). Compared to the control group, patients in the intervention group appeared to have higher proportions of treatment intensification, home blood pressure monitoring, and health education, but not medication adherence during the 18-month intervention (Table 2). At 18 months, satisfaction with medication was reported by 84.5% and 83.1% of patients in the intervention and control groups, respectively, and satisfaction with blood pressure-related care was reported by 89.2% and 89.5% in both groups.

Serious adverse events occurred in 20.9% and 21.7% of participants in the intervention and control groups, respectively (Table 2). Other selected adverse events were not significantly different between the two groups.

After adjusting for age, sex, race or ethnicity, education, duration of hypertension, history of antihypertensive treatment, history of major cardiovascular disease, baseline body-mass index, and baseline systolic blood pressure, the net difference in systolic blood pressure change over 18 months was −5.6 mm Hg (95% CI, −8.1 to −3.0) (Table 2). In the complete case analysis, the mean systolic blood pressure decreased by −16.1 in the intervention group and −9.0 in the control group, with a net difference of −7.1 mmHg (95% CI, −9.7 to −4.4; Table S5). Most blood pressure reductions occurred in the first six months (Tables S6, S7, and Figure S2). In predefined subgroup analyses, systolic blood pressure reduction appeared consistent across subgroups defined by age, sex, race, education, family income, health insurance status, history of cardiovascular disease, chronic kidney disease, diabetes, and baseline systolic blood pressure (Figure 3 and Figure S3). Most clinics with large mean systolic blood pressure reductions were in the intervention group (Figure S4). In a tipping point analysis, the change in systolic blood pressure for the intervention group at 18 months had to be inflated by adding 6.5 mmHg to the missing values, while control group data were assumed to be missing at random, before the study results lost significance (Table S8).

This effectiveness-implementation trial demonstrated that a multifaceted, team-based strategy effectively reduced blood pressure and improved fidelity to hypertension treatment compared to enhanced usual care among populations experiencing health disparities. This strategy intervened at the clinic level through a team-based care model, at the provider level through protocol-based treatment, and at the patient level through home blood pressure monitoring and health coaching. Intervention effectiveness was consistent across social determinants of health and cardiovascular risk factors. Importantly, the trial was conducted through a partnership among FQHCs, statewide primary care organizations, and academic institutions, enhancing the potential for sustainability and scale-up.

alth coaching. Intervention effectiveness was consistent across social determinants of health and cardiovascular risk factors. Importantly, the trial was conducted through a partnership among FQHCs, statewide primary care organizations, and academic institutions, enhancing the potential for sustainability and scale-up. Our study had several important features. First, it used an effectiveness-implementation hybrid design to assess both blood pressure reduction and intervention fidelity, providing insights for scale-up.15 Second, most participants had long-standing, treated but uncontrolled hypertension, making the observed blood pressure reduction achievable in real-world settings. The team-based model reduced provider burden and improved access through task-sharing. Protocol-based intensive blood pressure management standardized care and improved outcomes, while home blood pressure monitoring and health coaching empowered patients to self-manage and adhere to treatment. This proven, multifaceted strategy is scalable to other primary care settings to improve hypertension control in underserved populations. Given that uncontrolled hypertension is a leading cause of mortality and health disparities in the U.S., the public health implications are substantial.1–4,25

nd adhere to treatment. This proven, multifaceted strategy is scalable to other primary care settings to improve hypertension control in underserved populations. Given that uncontrolled hypertension is a leading cause of mortality and health disparities in the U.S., the public health implications are substantial.1–4,25 Previous trials have tested various implementation strategies for hypertension control.5,21,26 A meta-analysis of 121 trials found that individual interventions modestly reduced systolic blood pressure: health coaching by 3.9 mmHg and home blood pressure monitoring by 2.7 mmHg.5 Multifaceted strategies were more effective: team-based care with medication titration by a nonphysician reduced systolic blood pressure by 7.1 mmHg, by a physician by 6.2 mmHg, and multifaceted strategies without team-based care by 5.0 mmHg.5 Our multifaceted strategies achieved similar systolic blood pressure reductions in an underserved population. Prior hypertension control studies in FQHCs often used non-randomized designs and failed to demonstrate significant blood pressure reduction.27,28 Our trial is the first to show that a multifaceted, team-based strategy effectively lowers blood pressure among low-income patients receiving care at FQHCs.

rved population. Prior hypertension control studies in FQHCs often used non-randomized designs and failed to demonstrate significant blood pressure reduction.27,28 Our trial is the first to show that a multifaceted, team-based strategy effectively lowers blood pressure among low-income patients receiving care at FQHCs. Several lessons were learned from this study. First, the multifaceted, team-based strategy must be integrated into routine clinic operations, with clinics taking ownership of the program. FQHC leadership was engaged throughout, from intervention development to dissemination. Second, provider and clinic staff engagement are crucial for success. A designated clinic champion at each site actively promoted the program and encouraged participation. Additionally, home blood pressure monitoring increased patients’ awareness and facilitated discussions about blood pressure management. However, although mean blood pressure levels were significantly reduced, only a small proportion of patients achieved a systolic blood pressure of <120 mmHg. This may be because providers were reluctant to treat to this level, as current clinical guidelines recommend a systolic blood pressure target of <130 mmHg,16 and FQHCs are evaluated using the <140/90 mmHg benchmark set by the Health Resources and Services Administration.29 Lowering blood pressure targets in clinical guidelines and funding policies is essential to institutionalize intensive blood pressure reduction programs.

d a systolic blood pressure target of <130 mmHg,16 and FQHCs are evaluated using the <140/90 mmHg benchmark set by the Health Resources and Services Administration.29 Lowering blood pressure targets in clinical guidelines and funding policies is essential to institutionalize intensive blood pressure reduction programs. This study has several limitations related to its cluster design. The extended enrollment period prevented recruitment of all participants before randomization. However, we systematically identified eligible patients using electronic health records to minimize selection bias. Masking of patients and study staff was not feasible due to the nature of the intervention, but data collection was conducted by staff external to the FQHCs to reduce observer bias. Furthermore, a random comparison of some implementation outcomes, such as acceptability, adoption, appropriateness, feasibility, and implementation costs was not feasible, as the control group received usual care.30 In conclusion, our study showed that a multifaceted, team-based implementation strategy significantly reduced systolic blood pressure among low-income patients with hypertension compared to enhanced usual care.