Results Summary
What was the research about?
Heart failure occurs when the heart is unable to pump enough blood to the rest of the body. It can often cause admission to the hospital, especially for people 65 or older. Heart failure can lead to frequent hospital visits, poor quality of life, and death.
In this study, the research team wanted to improve care for black and Hispanic adults with heart failure after they leave the hospital. The team compared two groups for three months.
- Telehealth self-monitoring with a computer system. The team asked patients to use a device to submit their vital signs, including blood pressure and heart rate, every day. A research nurse reviewed this information within three days. Patients also had weekly video calls with the nurse. During these calls, the nurse discussed the vital signs, asked about symptoms, and listened to the patient’s heart and lungs with a digital stethoscope.
- Clinic outpatient management. Patients received usual care from the hospital or their main heart doctor.
The team looked at how many times patients in each group visited the emergency room and had hospital stays. The team also compared quality of life, anxiety, and depression in the two groups.
What were the results?
During the study, the percentage of patients who went back to the hospital at least once was about the same for the two groups. The average number of times each patient stayed in the hospital for any reason was higher among patients using self-monitoring. However, the number of times patients stayed in the hospital for heart failure or heart disease was about the same for the two groups.
The groups didn’t differ in emergency room visits, quality of life, or depression. Patients who received clinic outpatient management showed greater reduction in anxiety than patients in the telehealth self-monitoring group.
Who was in the study?
The study included 104 adults with heart failure who received care at a hospital in New York that serves people with low incomes. Of these adults, 69 percent were black, and 31 percent were Hispanic. The average age was 60, and 59 percent were men.
What did the research team do?
The research team assigned each patient by chance to one of the two groups. Care for patients in both groups began within one week of patients leaving the hospital and continued for three months. For the next two months, patients using telehealth self-monitoring had a video call with a nurse, while the clinic group received care as usual.
To ask about emergency room visits and hospital stays, a nurse called all patients weekly. The team also looked at medical records for information about these visits and stays. All patients completed a survey about their quality of life at the start and end of the study.
The team worked with a community advisory group during the study. This group included black and Hispanic patients with heart failure, caregivers, patient advocates, and healthcare providers.
What were the limits of the study?
Half of the patients in the telehealth self-monitoring group didn’t submit their vital signs regularly. The self-monitoring program may not have worked well for them for this reason. The study was small and included patients who received care at only one specialized heart failure clinic. Results may differ for people receiving care at other clinics or hospitals.
Future studies could look at ways to encourage patients to submit their vital signs daily.
How can people use the results?
Heart failure clinics could use these study results as they are thinking about how to provide care for black and Hispanic patients with heart failure.
Professional Abstract
Objective
To compare the effect of telehealth self-monitoring and clinic outpatient management among black and Hispanic patients recently hospitalized with heart failure on inpatient and emergency department utilization and quality of life
Study Design
Design Elements | Description |
---|---|
Design | Randomized controlled trial |
Population | 104 black and Hispanic adults recently hospitalized with heart failure |
Interventions/ Comparators |
|
Outcomes |
Primary: inpatient utilization Secondary: emergency department utilization, quality of life, anxiety, depression |
Timeframe | 90-day follow-up for primary outcome |
This randomized controlled trial compared two methods of postdischarge care for heart failure: telehealth self-monitoring and outpatient clinic management. The study included 104 adults who received treatment for heart failure at a safety net hospital in New York that serves mainly patients with Medicaid or no health insurance. Of these patients, 69% were black, and 31% were Hispanic. The average age was 60, and 59% were male.
All patients received a phone call from the hospital’s heart failure clinic within three days and attended one clinic visit within one week of discharge. All patients also received four weekly phone calls from a research nurse who asked about adherence to medication, diet, and activity recommendations and about changes in weight or symptoms.
Researchers randomly assigned participants to one of two groups:
- Telehealth self-monitoring. This program included two components: daily vital signs self-monitoring and a weekly telehealth visit via a video call. Patients uploaded vital signs data daily using a computerized device. A nurse reviewed the uploaded data, and during the weekly video calls, used a digital stethoscope to assess heart and lung sounds. The video calls also included discussion of telemonitoring results, heart failure symptoms, and behaviors contributing to symptoms.
- Clinic outpatient management. After the first four weeks, patients received usual clinical care through the heart failure clinic or their primary cardiologists. The research nurse continued to make weekly phone calls for two more months to inquire about emergency department visits and hospitalizations.
Researchers recorded demographic and medical information and quality of life assessments at baseline and 90-day follow-up. To assess healthcare utilization, they reviewed medical records and interviewed patients during the weekly video or phone calls.
A community advisory board of patients with heart failure, caregivers, patient advocates, healthcare practitioners, and representatives from community-based organizations worked with the researchers throughout the study.
Results
A similar percentage of patients in each group was hospitalized at least once during the study. The number of hospitalizations for any cause was higher for the telehealth self-monitoring group (p=0.03), but the number of hospitalizations for heart failure or cardiovascular disease was similar for both groups.
Compared with the telehealth self-monitoring group, patients in the clinic outpatient management group showed greater improvement in anxiety symptoms (p=0.05). The two groups did not differ in emergency department utilization, quality of life, or depression.
Limitations
Half of patients in the telehealth group uploaded data fewer than 10 times during the study. As a result, these patients may not have received the full effects of self-monitoring. The study took place at a single center; results may be different for patients in other regions or practice settings. The relatively small sample size may have reduced researchers’ abilities to detect statistically significant differences between groups.
Conclusions and Relevance
Among black and Hispanic patients with heart failure recently discharged from a safety net hospital, the study did not find differences between telehealth self-monitoring and clinic outpatient management in heart failure–related healthcare utilization, quality of life, or depression. Patients in the clinic outpatient management group reported fewer hospitalizations for any cause and greater decreases in anxiety than patients in the telehealth self-monitoring group.
Future Research Needs
Future studies could explore ways to increase patients’ use of self-monitoring systems.
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:
- Reviewers expressed concern that the report overstated findings related to the superiority of telehealth self-management over comprehensive outpatient management. The report highlighted nonsignificant results trending towards the superiority of telehealth self-management over comprehensive outpatient management, but not the nonsignificant results trending towards comprehensive outpatient management over telehealth self-management. The researchers made extensive revisions in the report to more accurately portray the preponderance of similar outcomes in the two study arms.
- Reviewers asked why the study used an adherence cutoff of 10 uploads over 90 days, rather than a cutoff that had been used in earlier, similar studies. The researchers explained that they established this cutoff because adherence numbers were low in the study. Stratifying results based on previously established adherence cutoffs would have led to too few outcome events to draw any conclusions about the comparative effectiveness of the two interventions.