Results Summary
What was the research about?
High blood pressure can cause health problems such as stroke and heart disease. It is more common among people who are Black and Hispanic than people who are White. It can be hard for people to control high blood pressure because of stress at home or work, inability to pay for food or medicine they need, or lack of access to health care.
In this study, the research team compared two programs to improve blood pressure control among patients from different racial and ethnic groups:
- Standard of Care Plus, or SCP. Clinics received information on care for high blood pressure, and reports about how well they were doing on blood pressure control for patients from different racial and ethnic groups. Staff also learned ways to better measure and control blood pressure and attended 16 sessions on health equity.
- Collaborative Care/Stepped Care, or CC/SC. Clinics received SCP and formed care teams to help patients reduce high blood pressure. Care teams included care managers, nurses, community health workers, social workers, and doctors. These teams helped each patient develop and complete a blood pressure control care plan. Staff on care teams received blood pressure education, training, and coaching calls. The teams provided stepped care, which had more services for patients with continuing challenges in controlling blood pressure.
What were the results?
After one year, in both programs, the percentage of patients at clinics with controlled blood pressure increased. The two programs didn’t differ in:
- The percentage of patients with controlled blood pressure.
- How much patients’ blood pressure changed.
- How confident patients felt about managing their blood pressure.
The research team looked at different racial and ethnic groups and found that:
- Among Black and White patients, the two programs didn’t differ in blood pressure control.
- Among Hispanic patients, blood pressure control improved more in SCP than in CC/SC. But this difference was based on a small number of patients who received care at one health system.
Who was in the study?
The study included 1,820 patients with high blood pressure. Of patients, 57 percent were non-Hispanic Black, 33 percent were non-Hispanic White, and 9 percent were Hispanic. The average age was 60, and 59 percent were women. All received care at one of 30 clinics in five health systems in Maryland and Pennsylvania.
What did the research team do?
The research team assigned clinics by chance to SCP or CC/SC. The team used health records to identify patients with high blood pressure. At the start of the study and one year later, the team reviewed health records for patients’ blood pressure. Patients completed surveys about their confidence.
Patients with high blood pressure, clinicians, health system staff, and community groups provided input on the study.
What were the limits of the study?
This study only enrolled people who had regular visits with their primary care clinic.
Future research could look at ways to control blood pressure for people who don’t receive regular care.
How can people use the results?
Clinics can use the results when considering ways to help patients control high blood pressure.
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PCORI identified high blood pressure as an important research topic. Patients, clinicians, and others wanted to learn: What are effective ways to improve blood pressure control, especially for people who are at high risk for heart disease and other problems related to high blood pressure? To help answer this question, PCORI launched an initiative in 2014 on Testing Multi-Level Interventions to Improve Blood Pressure Control in Minority Racial/Ethnic, Low Socioeconomic Status, and/or Rural Populations. The initiative funded this research project and one other. |
Professional Abstract
Objective
To compare the effectiveness of two blood pressure control programs on reducing elevated blood pressure in patients from different racial and ethnic groups who have hypertension
Study Design
| Design Element | Description |
|---|---|
| Design | Cluster randomized controlled trial |
| Population | 1,820 patients ages 21 and older with an uncontrolled hypertension diagnosis and at least one cardiovascular disease risk factor, who identified as non-Hispanic White, non-Hispanic Black, or Hispanic |
| Interventions/ Comparators |
|
| Outcomes |
Primary: percentage of patients with blood pressure <140/90 mm Hg, patient activation Secondary: change in systolic blood pressure |
| Timeframe | 1-year follow-up for primary outcomes |
This cluster randomized trial compared the effectiveness of two blood pressure control programs in reducing elevated blood pressure in patients from different racial and ethnic groups with hypertension.
Researchers randomly assigned 30 community-based practices to one of two blood pressure control programs:
- Standard of Care Plus (SCP). Practices received information on evidence-based best practices for blood pressure measurement and hypertension care and audit and feedback reports about their performance in hypertension control by race and ethnicity. Staff at all practices participated in a leadership engagement program that included 16 quarterly, one-hour equity training sessions and discussions with health system staff and community organizations.
- Collaborative Care/Stepped Care (CC/SC). Practices received the SCP program and established collaborative care teams. These teams included care managers, nurses, community health workers (CHWs), physicians, and social workers. CHWs and specialists provided stepped care, which included expanded services for patients facing continuing challenges in controlling blood pressure. CHWs supported patient self-management, and specialists provided consultations for patients with complex conditions. Practices received quarterly education and training in using a hypertension dashboard, plus two quarterly coaching calls with health system staff.
The study included 1,820 patients with hypertension. Of these, 57% were non-Hispanic Black, 33% were non-Hispanic White, and 9% were Hispanic. The average age was 60, and 59% were female. All received care from one of 30 community-based practices across five health systems in Maryland and Pennsylvania.
Using electronic health records, researchers identified patients with a hypertension diagnosis. At baseline and one year later, researchers collected clinical data on blood pressure from health records and conducted telephone surveys with patients about patient activation. Researchers compared the two programs overall as well as clinic-level blood pressure control by racial and ethnic group.
Patients with hypertension, clinicians, health system staff, and representatives from community-based organizations provided input during the study.
Results
At one year, in both programs, patients’ blood pressure control improved (61.0% of patients in SCP, 59.1% of patients in CC/SC). The two programs did not differ significantly in change in blood pressure control, patient activation, or systolic blood pressure.
For non-Hispanic Black and White patients, the two programs did not differ significantly in blood pressure control. For Hispanic patients, the SCP program was more effective than the CC/SC program in improving blood pressure control (66.2% versus 43.4%; p=0.04). This difference was based on a small number of patients predominantly from one health system.
Limitations
This study enrolled patients who regularly received primary care. Results may differ for patients who do not receive routine care.
Conclusions and Relevance
In this study, both programs improved blood pressure control, but neither program was more effective in controlling blood pressure or in improving systolic blood pressure or patient activation.
Future Research Needs
Future research could examine ways for controlling blood pressure with populations who do not receive regular care.
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PCORI identified high blood pressure as an important research topic. Patients, clinicians, and others wanted to learn: What are effective ways to improve blood pressure control, especially for people who are at high risk for heart disease and other problems related to high blood pressure? To help answer this question, PCORI launched an initiative in 2014 on Testing Multi-Level Interventions to Improve Blood Pressure Control in Minority Racial/Ethnic, Low Socioeconomic Status, and/or Rural Populations. The initiative funded this research project and one other. |
Final Research Report
This project's final research report is expected to be available by January 2024.
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Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers noted that the report emphasized the secondary outcomes results over the primary outcome, blood pressure control. They asked the researchers to revise the report to make sure that the primary outcome results were more prominent even though the results did not show a difference between the two interventions. The researchers acknowledged that there were no between-group differences in blood pressure control based on treatment arm but pointed out that a major goal of the study was to see if the interventions could attenuate the health disparities for known at-risk groups. For this reason, they felt it was particularly important to show the effects of the collaborative care intervention on particular subgroups of patients.
- The reviewers were unclear on whether the researchers assessed blood pressure control disparities between Black and White patients in the participating clinics at baseline, given the focus on disparities in treatment outcomes. The researchers explained that they could not assess the level of disparity in blood pressure control at baseline overall because they only collected data on study participants, who all had uncontrolled blood pressure. However, the researchers did identify differences in systolic and diastolic blood pressure at baseline by racial and ethnic group and reported those differences in the text. They also noted some treatment differences at 12 months by racial and ethnic group.
- The reviewers asked for more information about plans to analyze the results after imputing missing data. The researchers added information about the imputation analyses they had completed to account for missing data under the assumption that the data were missing at random. The researchers explained that they would complete additional analyses later after investigating potential reasons for some of the missing data.