Results Summary
What was the research about?
Heart failure is a long-term health problem that can cause shortness of breath, fatigue, and rapid heartbeat. Patients with heart failure often go to their clinicians, such as doctors or nurses, or the emergency room to manage their symptoms.
In this study, the research team planned to compare two approaches to help older patients with heart failure and their caregivers manage their illness:
- Mobile health, or mHealth care. Patients received kits to measure their blood pressure, heart rate, weight, and pulse. The kits included a cloud-based clinician portal connected to a tablet paired with Bluetooth. The portal sent daily readings of these measures to a 24-hour call center staffed by registered nurses. The nurses recommended treatment as needed.
- Enhanced usual care. Patients went to regular doctor visits in person or by phone. Patients could also receive weight scales, blood pressure and pulse monitors, and a paper log for caregivers to record data. Patients and caregivers contacted their clinicians if they had concerns about their results.
What did the research team do?
The research team planned to recruit 400 pairs of older patients with heart failure and their caregivers. But the COVID-19 pandemic delayed the start of the study. When the study started, the team was only able to enroll 13 pairs of patients and caregivers. Due to COVID-19, hospitals no longer allowed caregivers to be in patients’ hospital rooms, which made it harder to recruit caregivers. Also, many patients with heart failure were sicker than in the past due to delays in receiving care. The research team decided to end the study in July 2021.
Patients with heart failure, caregivers, and doctors helped plan the study.
What were the results?
PCORI is committed to making full information on all funded research projects publicly available. This summary doesn’t include results or the limits of the study, because the study was not able to be completed due to the COVID-19 pandemic.
Professional Abstract
Objective
To compare the effectiveness of a mobile health (mHealth) care management model versus a provider-directed care management model in improving self-care for older patients with heart failure
Study Design
| Design Element | Description |
|---|---|
| Design | -Randomized controlled trial |
| Population | Aimed to recruit 400 dyads consisting of patients with heart failure ages 55 and older and their caregivers, but enrolled only 13 dyads before the study closed enrollment in July 2021 due to the COVID-19 pandemic |
| Interventions/ Comparators |
|
| Outcomes |
Primary (planned): self-care of heart failure Secondary (planned): self-efficacy to manage care, symptoms, medications, and treatments; self-care confidence; physical health; heart failure knowledge; satisfaction with care; quality of life; informational support; equipment usability; health distress; mental health, including anxiety, depression, fatigue, and pain; caregiver burden and caregiver health |
| Timeframe | 3-month follow-up for primary outcome |
This randomized controlled trial planned to compare the effectiveness of two approaches in improving self-care for older adults with heart failure:
- The mHealth care management model. This model included real-time biomonitoring kits with a cloud-based clinician portal connected to a Bluetooth-paired tablet. The kits measured patients’ blood pressure, heart rate, weight, and pulse. The tablet transmitted daily readings to a 24-hour call center staffed by registered nurses who triaged care based on existing protocols.
- Usual care. Usual care was a provider-directed management model, which included office visits with communication by telephone or in person. Researchers provided home equipment kits with weight scales, blood pressure and pulse monitors, and a paper log for caregivers to record data. Patients and caregivers used data to self-triage and to contact the patient’s provider if any of the data were concerning or outside the specified parameters for each measure.
The COVID-19 pandemic delayed the start of study recruitment. When recruitment began in November 2020, the original recruitment plan was no longer viable due to the continuing COVID-19 public health emergency. Specifically, caregivers were no longer allowed to be present in patients’ hospital rooms, which made it more difficult to recruit caregivers. In addition, many patients with heart failure were sicker than they had been in the past due to delays in receiving care. As a result, they were unable to enroll in the study. The study enrolled only 13 dyads and lost three of these dyads to follow-up before researchers decided to close enrollment in July 2021.
Patients with heart failure, caregivers, and doctors helped plan the study.
Results and Limitations
PCORI is committed to making full information on all funded research projects publicly available. This summary does not include results and limitations from this study because the study could not be completed as designed due to the COVID-19 pandemic.
COVID-19-Related Study
Comparing In-Person and Telehealth Visits among Older Adults with Heart Failure during the COVID-19 Pandemic
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?
Older patients with heart failure are at higher risk of acquiring or dying from COVID-19. During the COVID-19 pandemic, many health systems moved from in-person care to telehealth. Telehealth is a way to provide care to patients remotely using phone, video, or other devices.
In this study, the research team looked at how well telehealth worked to provide care for patients ages 55 and older with heart failure, compared to in-person visits. The team looked at patient views about the quality of care and interactions with their doctors. They also interviewed patients about using telehealth.
What were the results?
Patients who had telehealth and in-person visits didn’t differ in reports of:
- How well doctors communicated with them
- How helpful and respectful office staff were
Compared with patients who had telehealth visits, patients who had in-person visits were more likely to receive follow-up notes after the visit. But telehealth and in-person visits didn’t differ in other aspects of quality of care, like wait times for visits. Patients with in-person visits said the interaction with their doctors was higher quality than did patients who had telehealth visits.
In interviews, patients who had telehealth visits said they liked:
- The convenience
- Having family members or caregivers attend
- Receiving prompt care
- Having less exposure to COVID-19
Problems with telehealth included:
- Issues using technology
- Lack of equipment or stable internet
- Certain health conditions, such as blindness, that affected the quality of the visit
Patients suggested ways to improve telehealth visits. For instance, doctors could send written instructions on how to connect to the telehealth platform before the visit. They could also send a summary of the care plan after the visit.
What did the research team do?
The research team contacted patients with heart failure who had an in-person or telehealth visit between September 2020 and May 2021. All patients received care at two hospitals in Arkansas and Tennessee. Then, 790 patients completed surveys about the quality of care and interactions with their doctors. Of these patients, 125 had a telehealth visit; 665 had an in-person visit. Among patients, 67 percent were White, 29 percent were Black or African American, and 2 percent were another race. The average age was 72, and 58 percent were women.
The research team interviewed 22 patients about their telehealth use. Of these, 77 percent were White, and 23 percent were Black or African American. The average age was 70, and 55 percent were women.
Patients with heart failure, caregivers, and doctors gave input during the study.
What were the limits of the study?
More patients who had in-person visits completed the survey. To deal with this imbalance, the research team asked patients who had a telehealth visit to complete the survey based on their last telehealth visit, even if they had a more recent in-person visit. This delay may have affected how well patients recalled their telehealth visit.
How can people use the results?
Health systems can use the results when considering telehealth care for older adults with heart failure.
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
During the COVID-19 pandemic, many health systems provided care via telehealth instead of in person. Questions remain about how well telehealth works for older adults with heart failure.
Objective
(1) To compare the effect of in-person versus telehealth visits on quality of care and patient-provider interaction among older patients with heart failure; (2) To explore experiences with telehealth among older patients with heart failure
Study Design
| Design Element | Description |
|---|---|
| Design | Mixed-methods study, with survey and interview data |
| Population |
Survey: 790 adults ages 55 and older living with heart failure, from two health systems in Arkansas and Tennessee Interviews: A subset of 22 adults ages 55 and older living with heart failure who were surveyed |
| Outcomes |
Survey: quality of care outcome that included two composite measures plus individual questions (The two composite measures were how well providers communicated with patients and how helpful, courteous, and respectful the office staff were to patients; the individual questions asked about knowledge of patients’ medical history, appointment wait time, likelihood of receiving follow-up notes after the visit, and whether providers asked questions about patients’ health, used jargon, talked too fast, and discussed prescription medication in a way that could be understood); patient-provider interaction, which included questions about information exchange, patient involvement, and shared decision making Interviews: patient experiences with telehealth visits, including video with audio; e-visits via email, text messages, or patient portal messaging; and audio only |
| Data Collection Timeframe | Survey: November 1, 2020–August 14, 2021 Interviews: August 31, 2021–October 8, 2021 |
This study compared perceptions of care among older patients with heart failure who had in-person or telehealth visits during the COVID-19 pandemic.
Using electronic health records, researchers identified and contacted patients with heart failure who had any in-person or telehealth visit between September 2020 and May 2021. Patients completed surveys about the quality of care received and their interaction with their provider. Of the 790 patients who completed the survey, 125 had a telehealth visit, and 665 had an in-person visit. Among patients, 67% were White, 29% were Black or African American, and 2% identified as another race. The average age was 72, and 58% were female.
Researchers then interviewed 22 patients about their telehealth experiences. Of these, 77% were White, and 23% were Black or African American. The average age was 70, and 55% were female.
Patients with heart failure, caregivers, and doctors provided input throughout the study.
Results
Patients who had telehealth and in-person visits did not differ significantly on the two composite measures of how well providers communicated with them or how helpful, courteous, and respectful office staff were. Compared with patients who had telehealth visits, patients who had in-person visits were more likely to report receiving follow-up notes after the visit (p<0.0001), but responses to other individual questions did not differ significantly.
Compared with patients who had telehealth visits, patients with in-person visits reported a higher quality of patient-provider interaction (p=0.004).
In interviews, patients who had telehealth visits said they liked the convenience, having family members or caregivers attend, having less exposure to COVID-19, and receiving care in a timely manner.
Patients described problems with telehealth, including:
- Lack of experience using technology
- Limited equipment or technology available, such as broadband connectivity
- Certain medical limitations, such as blindness, affecting the quality of the visit
Recommendations to improve telehealth visits included sending written instructions on how to connect to the telehealth platform before the visit and a summary of the care plan after the visit.
Limitations
Fewer patients who had telehealth visits completed the survey than did patients who had in-person visits. To address this imbalance, researchers instructed patients who had at least one telehealth visit to complete the survey based on their last telehealth visit, even if they had a more recent in-person visit. This delay may have affected patient recall.
Conclusions and Relevance
Compared with patients who had a telehealth visit, those who had an in-person visit were more likely to receive follow-up notes and had better patient-provider interaction, but did not differ on how well providers communicated or how helpful, courteous, and respectful office staff were.
Peer Review Summary
The Peer-Review Summary for this COVID-19 study will be posted here soon.
Final Enhancement Report
This COVID-19 study's final enhancement report is expected to be available by June 2024.
Final Research Report
This project's final research report is expected to be available by June 2024.
Peer-Review Summary
The Peer-Review Summary for this project will be posted here soon.