Results Summary and Professional Abstract

Results Summary

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Results Summary

What was the research about?

Heart failure occurs when the heart doesn’t pump blood as well as it should. When heart failure occurs or gets worse suddenly, it’s called acute heart failure, or AHF. Patients with low incomes or who are racial or ethnic minorities are more likely to have AHF events than patients from other backgrounds.

Many patients with AHF go to the emergency room, or ER, for treatment. In this study, the research team tested how well a self-care program supported patients with AHF after they left the ER. The team looked at whether this program improved patients’ health outcomes and need for health care after leaving the ER compared with usual care.

What were the results?

After one month, compared with patients who weren’t in the program, patients in the program had

• Fewer deaths from AHF
• Fewer visits to the ER, hospital, or clinic due to AHF
• Higher ratings of their health

After three months, patients didn’t differ in these outcomes.

At one and three months, patients in the program knew more about AHF than patients who weren’t in the program. Patients didn’t differ in satisfaction with care or in symptoms of anxiety and depression.

Who was in the study?

The study included 491 patients leaving the ER with AHF. Of these, 63 percent were African American, 33 percent were non-Hispanic White, 2 percent were White Hispanic, and 2 percent were another race. The average age was 63, and 64 percent were men.

What did the research team do?

The research team recruited patients from 1 of 15 medical centers. The team assigned patients by chance to receive the program or not.

In the program, a self-care coach visited patients within seven days after they left the ER and called patients twice a month. The coach created a custom care plan for patients that included help to find the right medicine and make follow-up appointments. The plan could also include advice on diet, weight, AHF warning signs, and quitting smoking.

Patients who weren’t in the program received usual care. In usual care, ER staff reviewed patients’ current medicines and helped patients schedule a follow-up visit seven days later.

The research team called patients and reviewed health records for information about patient deaths and hospital, ER, or clinic visits.

Patients with AHF, caregivers, and advocates provided input during the study.

What were the limits of the study?

Patients who weren’t in the program had fewer health events from AHF than the research team expected, making it hard to detect differences between those who were and weren’t in the program.

Future research could look at how to maintain benefits of the self-care program after one month.

How can people use the results?

Hospitals can use the results when considering ways to support patients with AHF after they leave the ER.

Professional Abstract

Professional Abstract

Objective

To compare the effectiveness of a self-care intervention versus usual care for patients discharged from the emergency department (ED) with acute heart failure (AHF) in reducing AHF events and improving health status.

Design Element	Description
Design	Randomized controlled trial
Population	491 patients discharged from the ED with AHF
Interventions/ Comparators	Self-care intervention Usual care
Outcomes	Primary: cardiovascular-related deaths, AHF events (ED, hospital, or clinic visits due to AHF), patient self-perception of health status Secondary: primary outcomes at 30 days, patient satisfaction with care, heart failure knowledge, symptoms of anxiety and depression at 90 days
Timeframe	90-day follow-up for primary outcomes

This randomized controlled trial compared the effectiveness of a self-care intervention versus usual care for patients with AHF in reducing cardiovascular-related deaths and AHF events and improving health status. Patients with low incomes and patients from racial and ethnic minority backgrounds are at greater risk for disparities in AHF events than patients from other backgrounds.

Researchers recruited patients with AHF who were discharged after ED-based management from 1 of 15 medical centers and randomized patients to receive either a self-care intervention or usual care. In the self-care intervention, a self-care coach provided patients with a personalized discharge plan addressing clinical practice guidelines and barriers to outpatient management. The plan could include information about AHF medications and smoking cessation, advice on diet and weight, and information on AHF warning signs and the importance of HF provider follow-up. Patients could also receive support in making follow-up appointments. The self-care coach visited patients within seven days of ED discharge and called twice monthly. In usual care, patients received medication reconciliation and assistance with obtaining a seven-day follow-up appointment with a heart failure provider.

The study included 491 patients with AHF. Of these patients, 63% were African American, 33% were non-Hispanic White, 2% were White Hispanic, and 2% were another race. The median age was 63, and 64% were male.

At 30 and 90 days after randomization, researchers called patients and reviewed medical records to assess study outcomes

Patients with AHF, caregivers, and advocates provided input throughout the study.

Results

At 30 days, compared with patients who received usual care, patients who received the self-care intervention had fewer cardiovascular-related deaths and fewer ED, hospital, or clinic visits for AHF. They also had improved health status (all p<0.05). These outcomes did not differ significantly at 90 days.

At 30 and 90 days, patients who received the self-care intervention had significantly more knowledge about AHF than patients who received usual care (both p<0.01). Patient satisfaction and symptoms of anxiety and depression did not differ significantly between the intervention and usual care groups.

Limitations

Fewer cardiovascular-related events than expected occurred among patients who received usual care, limiting researchers’ ability to detect differences between the intervention and usual care.

Conclusions and Relevance

In this study, the self-care intervention resulted in fewer cardiovascular-related deaths and fewer ED, hospital, or clinic visits, and improved health status at 30 days but not at 90 days. Patients who received the self-care intervention also reported more knowledge of AHF, but no differences were seen in patient satisfaction or anxiety and depression symptoms.

Future Research Needs

Future research could look at how to sustain the benefits of the self-care intervention after 30 days.

More on this Project  

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 raised concerns about the study design. In particular, they expressed concern that assigning individual patients within the same sites to different interventions could have caused cross-contamination in how the interventions were administered. The reviewers noted that the team of nurses, study coordinators, paramedics, and others who administered the interventions may have adopted elements of the intervention in their treatment of patients in the control arm because of their knowledge of the intervention and desire to provide the best care possible. The researchers acknowledged this was a limitation of the study. They said they randomized patients but stratified by site to ensure balanced randomization at each site because it would be difficult to use clinic randomization in this study design. The researchers added that they monitored the care that patients in the control arm, those receiving usual care,  received to try to detect the possibility of cross-contamination and could confirm that they did not have home visits or coaching calls. However, the researchers acknowledged that being on a site with patients in the treatment arm could have affected usual care patients’ emergency department encounters.
• The reviewers said the researchers should address the lack of blinding as a potential limitation in the study design. In other words, patients and the coaches who administered the interventions were aware of who received the interventions, and the reviewers suggested that the awareness of being treated may have been sufficient to yield the statistically significant differences in patient-reported, subjective outcomes. The reviewers agreed this was an important limitation of their study design and said they tried to mitigate against it by ensuring that those who assessed outcomes had been blinded to the treatment that patients had received, and that the coaches would not know about patients’ follow-up cardiac events.
• The reviewers expressed concern that the researchers overstated the importance of the study results, given the lack of statistically significant or clinically significant findings. The researchers toned down the significance of their results, but also stated that the size of the difference that was identified (i.e., 4 percent absolute risk or 11 percent relative risk) was important and could be an impactful finding.

Conflict of Interest Disclosures

View the COI disclosure form.

Project Details

Principal Investigator

Sean P. Collins, MD, MSc

Project Status

Completed; PCORI Public and Professional Abstracts Posted

Project Title

GWTG Interventions to Reduce Disparities in AHF Patients Discharged from the ED -- The GUIDED HF Study

Board Approval Date

April 2015

Project End Date

December 2020

Organization

Vanderbilt University Medical Center

Year Awarded

2015

State

Tennessee

Year Completed

2020

Project Type

Research Project

Health Conditions  

Cardiovascular Diseases

Congestive Heart Failure

Intervention Strategies

Behavioral Interventions
Drug Interventions
Care Coordination
Other Health Services Interventions
Training and Education Interventions

Populations

Low Health Literacy/Numeracy
Low Income
Racial/Ethnic Minorities

Funding Announcement

Addressing Disparities

Project Budget

$1,817,538

Study Registration Information

HSRP20153364

NCT02519283