Results Summary
What was the research about?
Uncontrolled blood pressure, or BP, affects tens of millions of Americans. Lowering BP to recommended levels can reduce the risk of heart attack and stroke. Support from a medical team can help patients lower their BP, but questions remain about the best way to provide care.
In this study, the research team compared two ways of providing care:
- Clinic-based care, or CBC. In this group, patients had regular, in-person visits with a doctor or medical assistant.
- Telehealth. In this group, patients received home-based and telephone care from pharmacists or nurse practitioners who had special training to manage patients’ medicines.
What were the results?
After one year, the two groups didn’t differ in how much their BP changed. Both groups had lower BP.
After six months, compared with CBC, patients in the telehealth group:
- Were more satisfied with their care
- Reported that visits by phone were more convenient
The two groups didn’t differ in their confidence in self-care or side effects from BP medicine.
Who was in the study?
The study included 3,071 patients with uncontrolled BP. All received care at one of 21 clinics in Minnesota and Wisconsin. Among patients, 69 percent were White, 19 percent were Black, 7 percent were Asian, 1 percent were American Indian/Alaska Native, and 4 percent were another race; 2 percent were Hispanic. The average age was 60, and 53 percent were women.
What did the research team do?
The research team assigned 21 clinics by chance to one of the two groups. In CBC, patients had a BP checkup with a medical assistant in the clinic within two to four weeks. Patients then had regular, in-person follow-up visits until their BP was controlled.
In the telehealth group, doctors referred patients to have a one-hour, in-person visit within two to four weeks. At the visit, patients learned how to measure their BP. Patients then measured their BP at home six times per week. Pharmacists or nurse practitioners received a report with patients’ BP every two weeks and also got alerts if BP was too high or too low. Patients had regular visits with pharmacists or nurse practitioners by phone about how to make medicine and lifestyle changes.
The research team looked at patient BP at the start of the study and again 12 months later. Patients took surveys about their care at the start of the study and again 6 months later.
Patients, doctors, and health system administrators gave input during the study.
What were the limits of the study?
In both groups, only one in three patients had their follow-up visit within two to four weeks as planned. Also, in the telehealth group, pharmacists and nurse practitioners managed patients’ care. Results may have differed if more timely follow-up visits had occurred or if doctors or nurses had managed telehealth care.
Future research could examine telehealth care managed by other clinicians.
How can people use the results?
Patients and doctors can use the results when considering ways to help manage uncontrolled BP.
Professional Abstract
Objective
To compare the effectiveness of clinic-based care (CBC) versus telehealth in lowering blood pressure (BP) in adults with uncontrolled hypertension
Study Design
| Design Elements | Description |
|---|---|
| Design | Cluster randomized controlled trial |
| Population | 3,071 adults ages 18–85 with moderately severe, uncontrolled hypertension, defined as systolic BP ≥150 or diastolic BP ≥95 at 2 most recent office visits |
| Interventions/ Comparators |
|
| Outcomes |
Primary: change in systolic BP Secondary: patient satisfaction, burden of care, confidence in self-care, medication side effects |
| Timeframe | 1-year follow-up for primary outcome 6-month follow-up for secondary outcomes |
This pragmatic, cluster randomized trial compared the effect of two BP care approaches on improving patients’ systolic BP.
Researchers randomized primary care clinics to one of two groups:
- Clinic-based care. Clinicians referred eligible patients for a follow-up visit with a medical assistant within two to four weeks, including BP measurement. Patients then had regular follow-up visits until their BP was controlled. Clinicians and medical assistants followed best practices for hypertension care in the clinic setting.
- Telehealth care. Clinicians referred eligible patients for a one-hour, in-person visit within two to four weeks to learn from medication therapy management (MTM) pharmacists or nurse practitioners how to measure their BP at home. Patients measured their BP at home six times per week using BP monitors that automatically sent results to their health records. Pharmacists and nurse practitioners received alerts if BP was too high or too low and summary BP data every two weeks. Patients talked with pharmacists or nurse practitioners by phone every two to four weeks about adjusting medication and making lifestyle changes until BP was within recommended levels. Pharmacists and nurse practitioners followed best practices for hypertension care during telehealth visits.
The study included 3,071 adult patients with uncontrolled hypertension who visited one of 21 clinics in Minnesota or Wisconsin. Among patients, 69% were White, 19% were Black, 7% were Asian, 1% were American Indian/Alaska Native, and 4% were another race; 2% were Hispanic. The average age was 60, and 53% were female.
Researchers observed systolic BP at baseline and 12 months later. They surveyed patients about patient-reported secondary outcomes at baseline and 6 months later.
Patients, clinicians, and health system administrators provided input throughout the study.
Results
After 12 months, patients in the two groups did not differ significantly in change in systolic BP. In both groups, patients’ BP decreased by 18 to 19 mmHg on average.
At six-month follow-up, compared with the CBC group, patients in the telehealth group had significantly higher satisfaction with their care (relative risk [RR]=1.25; 95% confidence interval [CI]: 1.02, 1.52) and lower burden in scheduling visits (RR=0.70; 95% CI: 0.55, 0.89).
At six-month follow-up, patients in the two groups did not differ significantly in their confidence in self-care or medication side effects.
Limitations
In both groups, only a third of patients received follow-up visits within two to four weeks of their assignment to care, as planned. Results may have differed if patients had received timely follow-up visits. MTM pharmacists and nurse practitioners managed patients’ care using the telehealth care approach. Results may have differed if primary care physicians or registered nurses had managed the care.
Conclusions and Relevance
In this study, the CBC and telehealth care approach safely reduced systolic BP in patients with uncontrolled hypertension. Patients were more satisfied with telehealth care and its convenience.
Future Research Needs
Future research could examine telehealth BP management by primary care physicians or registered nurses.
Final Research Report
View this project's final research report.
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 questioned how well the interventions in the study could be tested given the low rate of attendance for blood pressure checks at the six-week mark. The reviewers also felt that the high nonadherence to the intervention protocols was an important finding in this study and had large implications for implementing the interventions in real-world settings. The researchers pointed out that the low rate of attendance referred to blood pressure checks with the specific healthcare professional (HCP) listed in the intervention protocol, and this specificity led to the impression of low adherence to the interventions. In fact, a much higher percentage of patients completed the required follow-up if the researchers looked at patients receiving the care from other available HCPs. In response, the researchers added this information in their results and limitations sections, indicating that preferentially directing patients to specific follow-up choices limited adherence to the study protocol.
- The reviewers asked whether the researchers applied multiple imputation techniques to account for the large amount of missing data for the primary outcome, systolic blood pressure, at the six-month follow-up. The researchers explained that the primary outcome was change in systolic blood pressure over 12 months, and almost all of the study participants had at least one more blood pressure reading during that time period. Change in outcomes in the first six months was the secondary outcome, and the researchers applied statistical methods to account for the missing data.
- The reviewers expressed concern about the study conclusions because two graphs relaying the study results seemed to indicate that both systolic and diastolic blood pressure decreased before the start of the interventions. The researchers revised the two graphs to increase the precision of the blood pressure measurements taken, which showed that the sharp drop in blood pressure took place in the 1-15 days after the study start. The researchers attributed this early drop to the alert system incorporated into the electronic health record. This alert meant that clinicians were more likely to identify high blood pressure as a concern at the first study visit and therefore begin treating the condition before the study interventions started. The researchers added this information to their descriptions of clinic referral and follow-up care procedures. The researchers further justified the strength of their results by noting that if the effect was actually due to regression to the mean, the change in blood pressure would be several times smaller.