Results Summary
What was the research about?
Uncontrolled high blood pressure, or BP, causes more than 500,000 deaths each year in the United States. Medicine can help patients control their BP. But patients and doctors need better ways of managing BP to make sure that medicines work well for patients.
The research team did two studies comparing new clinic programs and technologies for patients to help control high BP:
- Study 1 tested a program to improve the quality of BP care at clinics. The research team compared clinics using the program with staff coaching versus without staff coaching. They also compared clinics that did and didn’t use the program.
- Study 2 compared patients who used a home BP monitor with and without a smartphone app.
What were the results?
Study 1. At six months, the percentage of patients whose BP was within the normal range didn’t differ between:
- Clinics that used the program with and without coaching
- Clinics that did and didn’t use the program
At clinics that used the program, the percentage of patient visits where staff documented rechecking a high BP measurement increased by up to 20 percent. Documentation didn’t change at clinics that didn’t use the program.
Study 2. At six months, BP decreased in patients who used the home BP monitor with and without the app; the two groups didn’t differ in how much their BP decreased. Across both groups, 70 percent of patients were very likely to recommend the BP monitor to a friend.
What did the research team do?
For both studies, the research team used electronic health record data from PCORnet®.
Study 1. The research team assigned 24 clinics in four states by chance to the program with or without coaching. All clinics had access to a website with training and reports about how the clinic was doing. For clinics with coaching, staff at the clinic led the program after receiving training from a coach. The coach had expertise in helping clinics improve care for people with high BP. Clinics without coaching followed a self-guided process for the program. The team also looked at data for 18 clinics that didn’t use the program.
Study 2. The research team assigned 2,101 patients with high BP by chance to use a home BP monitor with or without the app. The app reminded patients to check their BP, explained the results, and supported emailing results to others. Among patients, 64 percent were White, 22 percent were Black, 9 percent were Hispanic or Latinx, 1 percent were Asian, and 4 percent were more than one race. The average age was 58, and 57 percent were women.
Patients, doctors, and a nurse gave input during the study.
What were the limits of the study?
The research team didn’t track how well clinics followed the program. The studies didn’t use a standard way to measure BP, which may have affected results.
Future research could look at whether clinics follow the program.
How can people use the results?
Clinics can use the results when considering ways to manage high BP.
| How this project fits under PCORI’s Research Priorities The PCORnet® Study reported in this results summary was conducted using PCORnet®, the National Patient-Centered Clinical Research Network. PCORnet® is intended to improve the nation’s capacity to conduct health research, particularly comparative effectiveness research (CER), efficiently by creating a large, highly representative network for conducting clinical outcomes research. PCORnet® has been developed with funding from the Patient-Centered Outcomes Research Institute® (PCORI®). |
Professional Abstract
Objective
(1) To compare the effectiveness of a primary care clinic quality improvement (QI) program with and without a QI coach in improving clinic-level blood pressure (BP) control; (2) To compare the effectiveness of home BP monitoring with and without a smartphone app on reducing BP among patients with hypertension
Study Design
| Design Element | Description |
|---|---|
| Design | Two pragmatic studies:
|
| Population | Electronic health record data from PCORnet®:
|
| Interventions/ Comparators |
Cluster randomized trial: QI program to implement BP management strategies with a QI coach versus without a QI coach |
| Outcomes |
Cluster randomized trial: clinic-level BP control of less than 140/90, documentation of confirmatory repeat BP measurement |
| Timeframe |
Cluster randomized trial: 6-month follow-up for study outcomes Randomized controlled trial: 6-month follow-up for study outcomes |
Researchers conducted two pragmatic studies using electronic health record data from PCORnet® and patient surveys to examine BP control among patients with hypertension.
In the cluster randomized trial, researchers randomized 24 safety net clinics in four states to an American Medical Association QI program with or without QI coaching. All clinics had access to a website with training modules on communicating with patients, measuring BP, and hypertension treatment guidelines. All clinics also had access to a dashboard with real-time performance metrics and received monthly performance reports. In clinics with coaching, a clinic champion led the QI program with support from an external QI coach, who provided training and met periodically with clinic staff. Clinics without coaching followed a self-guided implementation process. Researchers also compared randomized clinics to a non-randomized usual care cohort of 18 health systems not participating in the QI program.
In the second trial, researchers randomized 2,101 patients treated for uncontrolled hypertension to use a home BP monitor with or without a smartphone app. The app provided reminders, explained results, and supported emailing results to others. Patients completed surveys at baseline and again at six months. Among patients, 64% were White, 22% were Black, 9% were Hispanic or Latinx, 1% were Asian, and 4% were more than one race. The average age was 58, and 57% were female.
Patients and clinicians provided input throughout the study.
Results
Cluster randomized trial. At six months, clinic-level BP control did not differ significantly between clinics with and without coaching; across clinics, BP control improved slightly, but this result was not significant. In usual care health systems, BP control declined slightly but did not differ significantly from randomized clinics with and without coaching.
Documentation of confirmatory BP measurement increased among randomized clinics (with coaching, 45.2% to 64.8%; without coaching, 49.5% to 64.0%), which differed significantly from usual care health systems, which had no change (21.1% to 21.6%).
Randomized controlled trial. At six months, patients in both groups had reductions in systolic BP of around 11 mmHg; reductions did not differ significantly between the groups. Across groups, about 70% of patients were very likely to recommend the home monitoring device to a friend.
Limitations
The cluster randomized trial did not assess QI program adoption. Also, the studies did not dictate a standard approach for BP measurement, increasing the potential for measurement bias.
Conclusions and Relevance
In this study, providing coaching for a clinic-level QI program did not improve BP control more than the program without coaching. Among patients with hypertension, reductions in BP did not differ between home BP monitoring with and without a smartphone app.
Future Research Needs
Future research could include measures to track QI program adoption.
| How this project fits under PCORI’s Research Priorities The PCORnet® Study reported in this results summary was conducted using PCORnet®, the National Patient-Centered Clinical Research Network. PCORnet® is intended to improve the nation’s capacity to conduct health research, particularly comparative effectiveness research (CER), efficiently by creating a large, highly representative network for conducting clinical outcomes research. PCORnet® has been developed with funding from the Patient-Centered Outcomes Research Institute® (PCORI®). |
COVID-19-Related Study
Do Blood Pressure Medicines Affect the Risk of a Hospital Stay or Death for Patients with COVID-19? -- A PCORnet® Study
Results Summary
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
What was this COVID-19 study about?
Early in the pandemic, questions arose about how medicines used to treat high blood pressure affect people with COVID-19. Two such medicines are:
- Angiotensin-converting enzyme, or ACE, inhibitors
- Angiotensin receptor blockers, or ARBs
In this study, the research team wanted to learn if having prescriptions for ACE inhibitors or ARBs affected patients with high blood pressure and COVID-19. The team looked at the risk of a hospital stay and the risk of death among patients with high blood pressure who had COVID-19.
What were the results?
Among patients who were diagnosed with COVID-19 outside of the hospital, for example at a clinic:
- Patients with and without prescriptions for ACE inhibitors or ARBs had a similar risk of a hospital stay or death from any cause.
- These risks were also similar between patients with ACE inhibitor versus ARB prescriptions.
Among patients who were first diagnosed with COVID-19 while in the hospital:
- Patients with prescriptions for ACE inhibitors or ARBs had a lower risk of death from any cause than patients without them.
- The risk of death from any cause was similar between patients with ACE inhibitor versus ARB prescriptions.
What did the research team do?
The research team looked at health records for two groups of adults with high blood pressure. All received care at one of 17 health systems participating in PCORnet® across the United States. PCORnet is a national network of health systems created to conduct research funded by PCORI.
The two groups of patients were:
- 11,246 patients diagnosed with COVID-19 outside of the hospital. Of these, 55 percent were White, 27 percent were Black, 3 percent were Asian, 1 percent were American Indian or Alaska Native, and 1 percent were more than race; 15 percent were Hispanic. The average age was 61, and 56 percent were women. Also, 68 percent had or filled at least one ACE inhibitor or ARB prescription within the last year.
- 2,200 patients diagnosed with COVID-19 while in the hospital. Of these, 55 percent were White, 31 percent were Black, 2 percent were Asian, 1 percent were American Indian or Alaska Native, 1 percent were Native Hawaiian or Other Pacific Islander, and 1 percent were more than one race; 12 percent were Hispanic. The average age was 67, and 50 percent were women. Also, 67 percent had or filled at least one ACE inhibitor or ARB prescription within the last year.
The research team compared patients with and without prescriptions for ACE inhibitors or ARBs. They also compared patients with ACE inhibitor versus ARB prescriptions.
An advisory board gave input during the study.
What were the limits of the study?
The research team didn’t have data on if or for how long patients took the medicines, which may affect the study results.
How can people use the results?
Patients and their doctors can use the results when considering treatment for high blood pressure during the COVID-19 pandemic.
| How this project fits under PCORI’s Research Priorities The PCORnet® Study reported in this results summary was conducted using PCORnet®, the National Patient-Centered Clinical Research Network. PCORnet® is intended to improve the nation’s capacity to conduct health research, particularly comparative effectiveness research (CER), efficiently by creating a large, highly representative network for conducting clinical outcomes research. PCORnet® has been developed with funding from the Patient-Centered Outcomes Research Institute® (PCORI®). |
Professional Abstract
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
Background
The coronavirus infects humans via an enzyme that is also affected by angiotensin-converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBs), common types of hypertension medicines. Researchers wanted to learn how these medicines may affect COVID-19 severity among patients with hypertension who contract this illness.
Objective
To explore the association between exposure to ACE inhibitors or ARBs and the risk of hospitalization or death among patients with hypertension and COVID-19
Study Design
| Design Element | Description |
|---|---|
| Design | Observational: cohort study |
| Population |
EHRs for adults who were prescribed an antihypertensive medicine at 1 of 17 PCORnet® health systems Outpatient cohort: 11,246 adults who received a COVID-19 diagnosis in an outpatient setting Inpatient cohort: 2,200 adults who received a COVID-19 diagnosis in an inpatient setting |
| Outcomes |
Outpatient cohort: first occurrence of all-cause hospitalization or all-cause death (primary); all-cause hospitalization alone, all-cause death alone (secondary) Inpatient cohort: All-cause death (primary) |
| Data Collection Timeframe | February–December 2020 |
This observational cohort study analyzed the association between ACE inhibitor and ARB exposure and risk of all-cause hospitalization or death among adults with hypertension who received a COVID-19 diagnosis. Researchers reviewed electronic health records (EHRs) from 17 health systems participating in PCORnet®, developing separate cohorts for patients who were diagnosed with COVID-19 in outpatient and inpatient settings.
The outpatient cohort included 11,246 adults with hypertension and COVID-19. Of these, 55% were White, 27% were Black, 3% were Asian, 1% were American Indian or Alaska Native, and 1% were multiple races; 15% were Hispanic. The average age was 61, 56% were female, and 68% had or filled at least one ACE inhibitor or ARB prescription within the last year.
The inpatient cohort included 2,200 adults with hypertension and COVID-19. Of these, 55% were White, 31% were Black, 2% were Asian, 1% were American Indian or Alaska Native, 1% were Native Hawaiian or Other Pacific Islander, and 1% were multiple races; 12% were Hispanic. The average age was 67, 50% were female, and 67% had or filled at least one ACE inhibitor or ARB prescription within the last year.
The study’s advisory board reviewed and provided input on the analytic plan.
Results
Outpatient cohort. This cohort had 1,015 all-cause hospitalizations or deaths. The risk of all-cause hospitalization or death did not differ significantly between:
- Patients with ACE inhibitor and ARB prescriptions versus those without
- Patients with ACE inhibitor versus ARB prescriptions
When analyzing all-cause hospitalizations alone, patients with ACE inhibitor prescriptions had a higher risk of hospitalization than patients with ARB prescriptions (adjusted hazard ratio [HR]=1.35; 95% confidence interval [CI]: 1.14, 1.61). When analyzing all-cause deaths alone, the risk did not differ significantly between patients with ACE inhibitor versus ARB prescriptions.
Inpatient cohort. This cohort had 218 all-cause deaths. Patients with ACE inhibitor or ARB prescriptions had a lower risk of all-cause death than patients who did not have such prescriptions (adjusted HR=0.76; 95% CI: 0.57, 0.99). Risk of all-cause death did not differ significantly between patients who took ACE inhibitors versus ARBs.
Limitations
Researchers did not randomize patients to treatments and could not control for length of medication exposure or prescription adherence, which may have affected findings.
Conclusions and Relevance
In this study, among patients with hypertension who were diagnosed with COVID-19 in an outpatient setting, the risk of all-cause hospitalization or death was similar for patients with and without prescriptions for ACE inhibitors or ARBs. Patients who were diagnosed with COVID-19 in inpatient settings who had prescriptions for these medicines had a lower risk of all-cause death.
| How this project fits under PCORI’s Research Priorities The PCORnet® Study reported in this results summary was conducted using PCORnet®, the National Patient-Centered Clinical Research Network. PCORnet® is intended to improve the nation’s capacity to conduct health research, particularly comparative effectiveness research (CER), efficiently by creating a large, highly representative network for conducting clinical outcomes research. PCORnet® has been developed with funding from the Patient-Centered Outcomes Research Institute® (PCORI®). |
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 asked for more information about the cohort of COVID-19 patients included in this study, especially how the researchers handled patients who were already hospitalized before the observation period started, how multiple hospital stays for the same patient were counted, and how the researchers adjusted their analyses to take into account patients who were hospitalized just before the observation end date in December 2020. The researchers responded that they excluded patients with COVID-19 who entered the hospital before the study started, even if they were still hospitalized at the start of the study, and that they counted each patient only once, even if the patient had multiple hospitalizations. The researchers also explained that their chosen analytic technique took into account that some of the patients would not have been hospitalized long enough for measurement of study outcomes, so they did not need to conduct additional analyses to control for those later patients with missing outcome data.
- The reviewers expressed concern over the amount of missing data in the medical records and asked whether some study sites had more missing data than others. The researchers acknowledged that the amount and type of missing data varied by site and included their observations of this phenomena in their report appendix. The researchers also added to the limitations section that they could not be sure about the extent of confounding present because of the relationship between site and missing data.
Final Enhancement Report
View this COVID-19 study's final enhancement report.
DOI - Digital Object Identifier: 10.25302/05.2022.PaCR.2017C28153-C19
Final Research Report
This project's final research report is expected to be available by December 2023.
Journal Citations
Results of This Project
Related Journal Citations
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 requested additional information about how the researchers managed missing data, especially in the first two parts of the project. The researchers explained that the first two parts of the project focused on aggregate metrics that could account for patients who might not be fully involved in their health system and might be receiving their care elsewhere. Because the aggregate metrics themselves could not be missing, the researchers did not feel it was necessary to complete sensitivity analyses or otherwise account for missing data. The researchers did expand their discussion in the limitations section on the effect of missing data on the third part of the project, where they felt such discussion to be very relevant.
- The reviewers asked the researchers to emphasize their findings regarding the continued disparity in hypertension control between White and Black patients, even after the intervention improved hypertension outcomes. The researchers added to the discussion of this finding in their results section.
- The reviewers noted that treatment intensification was defined only as adding additional anti-hypertensive medications to a treatment regimen because the data available for tracking patients did not include sufficient information about medication dose to measure whether there were also dose effects on hypertension. The researchers acknowledged that the lack of information on medication dose in this case demonstrated a limitation of the common data model used by PCORnet.
- The reviewers suggested that the researchers consider issues that might have affected their results in the study comparing two blood pressure home monitoring interventions. The researchers enumerated the issues that could affect interpretation of the study in their discussion, noting that the large drop in blood pressure could be due to regression to the mean, many patients with high blood pressure were taking no medications and there were low response rates from patients.