Key Points
- This cluster-randomized trial found that a multifaceted implementation strategy to target an SBP <120 among low-income patients cared for at FQHCs lead to a significant reduction in mean blood pressure and a significant increase in the proportion of patients who achieved an SBP <120 compared to usual care.
- This strategy could be applied widely to other practices caring for low-income patients experiencing health disparities.
Uncontrolled hypertension is a major preventable risk factor for cardiovascular disease (CVD) and all-cause mortality and disproportionately affects low-income, non-White populations. While there is strong evidence that intensive blood pressure lowering reduces the risk of CVD, actually achieving these targets in the real-world is a challenge, especially in low-income populations that suffer from baseline health inequities. On November 13, 2023 the results of “Effect of a Multifaceted Implementation Strategy on Blood Pressure Control in Low-Income Patients A Cluster Randomized Trial” were presented at AHA Scientific Sessions 2023.
This cluster-randomized control trial tested the effectiveness and implementation outcomes of a multifaceted strategy for intensive BP control in low-income patients with uncontrolled hypertension receiving care at Federally Qualified Health Centers (FQHCs) in Louisiana and Mississippi. The participating clinics could not share staff with other participating clinics and had to have a catchment area that primarily consisted of communities facing health disparities. The participants had to be receiving care from the participating clinics, be age 40 or older, and have a systolic BP >140mmHg off hypertensive medications or >=130mmHg despite hypertensive medications; pregnant patients and patients with end stage renal disease were excluded.
Clinics were randomized to intervention or “enhanced usual care” group; providers and participants could not be blinded. Eligible patients were identified by the electronic health record systems of the FQHCs. The intervention consisted of a protocol derived from the SPRINT intensive treatment algorithm with target SBP <120 mmHg. In addition, in intervention clinics, SPRINT study findings were disseminated to care team members and administrators, staff were trained on how to use the algorithm, patients received home BP monitoring, health coaching on lifestyle modification, and medication adherence, and blood pressures were audited and feedback given. The net difference in mean BP changes between the intervention and control groups and the difference in proportions of patients with controlled BP were tested using linear mixed-effects models.
The intention to treat population included 642 patients in the intervention arm and 630 patients in the control arm. Both groups were majority female and majority Black. Baseline mean systolic BP (SBP) was 148.4 +/ 12.9 mmHg in the intervention arm and 146.7+/- 12.1 mmHg in the control arm. The mean change in SBP was significantly greater intervention arm (-16.0 mmHg, 95% CI -17.9, -14.1) than the control arm (-9.1 mmHg, 95% CI -11.0, -7.2) with a net difference of -7.0 mmHg (95% CI -9.7,-4.3; p <0.001). The intervention arm also had a significantly greater proportion of patients with SBP <120 mmHg at 18 months (22.9% vs. 15.7%, net difference 7.2%, 95%CI 1.5 ,12.9; p= 0.013). The treatment effect was consistent across all prespecified subgroups.
In terms of implementation outcomes, the intervention group had a higher fidelity summary score at 18 months. The intervention arm also had a significantly higher proportion of patients who had their treatment intensified, who measured their BP at home, and who received health education than the control arm. Other measures, such as the proportion of patients with high adherence and proportion of patients who were satisfied with BP medications and BP related care, were similar.
Dr. Jiang He of Tulane University concluded: “As compared with enhanced usual care, the multifaceted implementation strategy significantly improved BP control among low-income patients with hypertension who received healthcare at FQHC clinics. This effective and scalable implementation strategy could be widely adopted to improve hypertension control among low-income populations with hypertension in the US and other countries.”
