Heart FailureNCT02115620
Telemedicine Technology Demonstration Project for Heart Failure
A study testing Telemedicine in people with Heart Failure, run by Providence Health & Services at 1 site in United States.
Trial summary
The purpose of this study is to see if telemedicine can help improve the health of patients with heart failure who have recently been hospitalized with heart problems, and are being discharged to a Skilled Nursing Facility. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Telemedicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2014to 26 Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Primary or secondary diagnosis of heart failure
- Being discharged to a skilled nursing facility
Who cannot join
- Life expectancy of < 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence St. Vincent Medical Center
Portland, Oregon, 97225
About this study
Official title: Demonstration Project Using Technology to Improve Health Outcomes for Hospitalized Patients With Heart Failure Discharged to Skilled Nursing Homes
The purpose of this study is to see if telemedicine can help improve the health of patients with heart failure who have recently been hospitalized with heart problems, and are being discharged to a Skilled Nursing Facility. Telemedicine uses electronic communications to make patient/doctor visits possible from a distance.
This study will use remote video to allow heart failure specialists at Providence St. Vincent Medical Center to provide clinical health care to patients at Marquis Hills. Electronic monitors (including an electronic scale and blood pressure machine), and phone calls with the Marquis Hill nursing staff will be used to track patients' health status. The nursing staff will provide the heart failure specialists with daily updates on patients' symptoms, weight, vital signs (heart rate, blood pressure, pulse), and results of blood tests.
Read more
Additionally, some patients will be provided with monitoring devices that include an iPhone blood pressure monitor, and Smart Body Analyzer to use for 14 days. The Smart Body Analyzer measures weight, body fat percentage, and heart rate. It also measures indoor air quality. Special software on the iPhone will save this information and the information will be transmitted by secure email to the study doctors.
Hypothesis: The patients followed by telemedicine will have fewer visits to the Emergency Department, fewer deaths, and fewer hospital re-admissions than last year's site-specific average for this patient population.
Read the detailed description
The clinical course of heart failure (HF) is highly variable, but most patients eventually require hospitalization to manage symptomatic exacerbations. As HF progresses, hospitalizations become increasingly frequent as overall function and health decline. After an acute hospitalization, many older patients are discharged to skilled nursing facilities (SNF). Patients discharged to SNF after a HF hospitalization experience rates of death and re-hospitalization that are substantially higher than similar patients who are discharged home, even after adjusting for patient factors. The risk of worsening HF is highest in the first week after hospital discharge. Close monitoring of a patient during this vulnerable period could allow early detection and treatment that would avert clinical deterioration and the need for re-hospitalization; however, patients do not routinely receive cardiac specialty care while in SNF for many reasons, including patient immobility, limited transportation options, under-trained staff, competing medical conditions, and lack of timely access to cardiologists.
This research will address the issues associated with heart failure using a multi-faceted intervention consisting of provider, patient, and caregiver education and training, peer-to-peer telephone support for SNF staff, improved access to specialty care to include telemedicine evaluation by HF specialists, and early follow-up following SNF discharge. Specifically: Study the effect of a telemedicine disease management intervention in older patients with HF (either as a primary OR secondary diagnosis) discharged to a SNF from Providence St. Vincent Medical Center (PSVMC) after a cardiac-related admission.
Multiple benefits are anticipated from these interventions. First, a close partnership between the staff at the SNF (Marquis Hills) and the Providence Heart Clinic will be fostered. A major focus early in this partnership will be teaching SNF personnel how to assess signs and symptoms of HF, how to promote patient education and self-management ("teaching the teachers"), and how to use an existing HF disease management tool ("HF Zone tool"). Second, heightened monitoring of patients during the period of greatest risk for HF decompensation is expected to improve care, efficiency, and patient outcomes and reduce costs. Earlier detection and intervention can mitigate worsening HF, as well common complications of HF therapies, such as kidney dysfunction and electrolyte abnormalities. Third, this novel use of telemedicine could radically alter the approach to chronic disease management in care facilities, where specialty care is not readily available even for a high-risk population. Fourth, the use of telemedicine enables the intervention to be scaled easily to other SNFs and clinics and other chronic conditions.
Patients being discharged to Marquis Hills SNF will be identified by case management prior to discharge and consented for enrollment in the study. A Heart Failure clinician, will assess the patient's baseline capacity for self-care for HF (Self Care of Heart Failure Index, SCHFI), and quality of life (Kansas City Cardiomyopathy Questionnaire, KCCQ).
Intake and data collection at SNF will involve baseline assessment of HF symptoms and basic physiologic parameters (weight, blood pressure, heart rate) using the HF Zone tool. Certified nursing assistants will provide basic education on management of heart failure to patient and their families. The first business day following SNF admission, cardiology nurses will contact the SNF staff to review the daily HF Zone tool findings and follow-up any laboratory testing.
Daily updates on symptoms, weight, vital signs, and relevant labs will be communicated by phone with cardiology nurses at Providence Heart Clinic. Concerning changes in symptoms or signs will trigger a telemedicine clinic visit with a HF specialist using remote video/audio, virtual stethoscope technology, and VZ Cloud managed hosting. Any significant changes in symptoms (as reflected by Zone tool) or vital signs will be communicated by cardiology nursing staff to a HF clinician.Within 24 hours of this notification, a telemedicine evaluation will be performed, allowing for a virtual face-face interview and physical examination between patient and HF clinician using Cisco Yabber Video, Littman e-stethoscope, and Verizon managed hosting. Medication changes, laboratory testing, additional virtual visits, or in-person clinic visits can be arranged as appropriate. The visit findings will become part of the patient's electronic medical record and communicated to the facility physician and the patient's outpatient primary care provider.
Upon discharge from the SNF, the patient will have an in-person cardiology follow-up clinic visit within two weeks of discharge and as needed, with re-measurement of the SCHFI at the first follow-up visit.
Subjects' participation in the study will last about 60 days after they are discharged from the skilled nursing facility. They will not be told the results of the study.
- Conditions
- Heart Failure
- Being tested
- Telemedicine
- Keywords
- Heart failure, Cardiac failure, Congestive Heart Failure, Cardiomyopathy, Myocardial Failure, Telemedicine, Telehealth, Remote Consultation
- Medical subject headings
- Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelemedicineOther
Daily updates on symptoms, weight, vital signs, and relevant labs will be communicated by phone with cardiology nurses at Providence Heart Clinic. Concerning changes in symptoms or signs will trigger a telemedicine clinic visit with a HF specialist using remote video/audio, virtual stethoscope technology, and VZ Cloud managed hosting. The consult will include a virtual face-face interview and physical examination between patient and HF clinician using Cisco Yabber Video, Littman e-stethoscope, and Verizon managed hosting. Medication changes, laboratory testing, additional virtual visits, or in-person clinic visits can be arranged as appropriate.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Experimental | Patients will be followed using frequent communication of symptom status and physiologic data and remote consultations with Heart Failure specialists. Receives: Other: Telemedicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint (re-admission/ Emergency Department visit/ death)
The primary composite outcome of all-cause re-admission to the hospital/ Emergency Department visits/ death at 30 and 60 days will be compared to facility-specific historical event rates from the prior year.
Measured: up to 60 days after patient is discharged from skilled nursing facility
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study start23 Mar 2014
- Primary completion26 Aug 2015
- Study completion26 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Collaborators
- Verizon Wireless
- Responsible party
- Sponsor
- Investigators
- Jacob Abraham, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115620
- Sponsor's protocol ID
- 13-165A
- Status last verified
- Aug 2018
- First submitted
- 14 Apr 2014
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demonstration Project Using Technology to Improve Health Outcomes for Hospitalized Patients With Heart Failure Discharged to Skilled Nursing Homes
- ClinicalTrials.gov ID
- NCT02115620
- Acronym / sponsor ID
- 13-165A
- Conditions
- Heart Failure
- Keywords
- Heart failure, Cardiac failure, Congestive Heart Failure, Cardiomyopathy, Myocardial Failure, Telemedicine, Telehealth, Remote Consultation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Collaborators
- Verizon Wireless
- Study start
- 23 Mar 2014 (actual)
- Primary completion
- 26 Aug 2015 (actual)
- Study completion
- 26 Aug 2015 (actual)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if telemedicine can help improve the health of patients with heart failure who have recently been hospitalized with heart problems, and are being discharged to a Skilled Nursing Facility. Telemedicine uses electronic communications to make patient/doctor visits possible from a distance.
This study will use remote video to allow heart failure specialists at Providence St. Vincent Medical Center to provide clinical health care to patients at Marquis Hills. Electronic monitors (including an electronic scale and blood pressure machine), and phone calls with the Marquis Hill nursing staff will be used to track patients' health status. The nursing staff will provide the heart failure specialists with daily updates on patients' symptoms, weight, vital signs (heart rate, blood pressure, pulse), and results of blood tests.
Additionally, some patients will be provided with monitoring devices that include an iPhone blood pressure monitor, and Smart Body Analyzer to use for 14 days. The Smart Body Analyzer measures weight, body fat percentage, and heart rate. It also measures indoor air quality. Special software on the iPhone will save this information and the information will be transmitted by secure email to the study doctors.
Hypothesis: The patients followed by telemedicine will have fewer visits to the Emergency Department, fewer deaths, and fewer hospital re-admissions than last year's site-specific average for this patient population.
Detailed description
The clinical course of heart failure (HF) is highly variable, but most patients eventually require hospitalization to manage symptomatic exacerbations. As HF progresses, hospitalizations become increasingly frequent as overall function and health decline. After an acute hospitalization, many older patients are discharged to skilled nursing facilities (SNF). Patients discharged to SNF after a HF hospitalization experience rates of death and re-hospitalization that are substantially higher than similar patients who are discharged home, even after adjusting for patient factors. The risk of worsening HF is highest in the first week after hospital discharge. Close monitoring of a patient during this vulnerable period could allow early detection and treatment that would avert clinical deterioration and the need for re-hospitalization; however, patients do not routinely receive cardiac specialty care while in SNF for many reasons, including patient immobility, limited transportation options, under-trained staff, competing medical conditions, and lack of timely access to cardiologists.
This research will address the issues associated with heart failure using a multi-faceted intervention consisting of provider, patient, and caregiver education and training, peer-to-peer telephone support for SNF staff, improved access to specialty care to include telemedicine evaluation by HF specialists, and early follow-up following SNF discharge. Specifically: Study the effect of a telemedicine disease management intervention in older patients with HF (either as a primary OR secondary diagnosis) discharged to a SNF from Providence St. Vincent Medical Center (PSVMC) after a cardiac-related admission.
Multiple benefits are anticipated from these interventions. First, a close partnership between the staff at the SNF (Marquis Hills) and the Providence Heart Clinic will be fostered. A major focus early in this partnership will be teaching SNF personnel how to assess signs and symptoms of HF, how to promote patient education and self-management ("teaching the teachers"), and how to use an existing HF disease management tool ("HF Zone tool"). Second, heightened monitoring of patients during the period of greatest risk for HF decompensation is expected to improve care, efficiency, and patient outcomes and reduce costs. Earlier detection and intervention can mitigate worsening HF, as well common complications of HF therapies, such as kidney dysfunction and electrolyte abnormalities. Third, this novel use of telemedicine could radically alter the approach to chronic disease management in care facilities, where specialty care is not readily available even for a high-risk population. Fourth, the use of telemedicine enables the intervention to be scaled easily to other SNFs and clinics and other chronic conditions.
Patients being discharged to Marquis Hills SNF will be identified by case management prior to discharge and consented for enrollment in the study. A Heart Failure clinician, will assess the patient's baseline capacity for self-care for HF (Self Care of Heart Failure Index, SCHFI), and quality of life (Kansas City Cardiomyopathy Questionnaire, KCCQ).
Intake and data collection at SNF will involve baseline assessment of HF symptoms and basic physiologic parameters (weight, blood pressure, heart rate) using the HF Zone tool. Certified nursing assistants will provide basic education on management of heart failure to patient and their families. The first business day following SNF admission, cardiology nurses will contact the SNF staff to review the daily HF Zone tool findings and follow-up any laboratory testing.
Daily updates on symptoms, weight, vital signs, and relevant labs will be communicated by phone with cardiology nurses at Providence Heart Clinic. Concerning changes in symptoms or signs will trigger a telemedicine clinic visit with a HF specialist using remote video/audio, virtual stethoscope technology, and VZ Cloud managed hosting. Any significant changes in symptoms (as reflected by Zone tool) or vital signs will be communicated by cardiology nursing staff to a HF clinician.Within 24 hours of this notification, a telemedicine evaluation will be performed, allowing for a virtual face-face interview and physical examination between patient and HF clinician using Cisco Yabber Video, Littman e-stethoscope, and Verizon managed hosting. Medication changes, laboratory testing, additional virtual visits, or in-person clinic visits can be arranged as appropriate. The visit findings will become part of the patient's electronic medical record and communicated to the facility physician and the patient's outpatient primary care provider.
Upon discharge from the SNF, the patient will have an in-person cardiology follow-up clinic visit within two weeks of discharge and as needed, with re-measurement of the SCHFI at the first follow-up visit.
Subjects' participation in the study will last about 60 days after they are discharged from the skilled nursing facility. They will not be told the results of the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Experimental | Other: TelemedicinePatients will be followed using frequent communication of symptom status and physiologic data and remote consultations with Heart Failure specialists. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Primary or secondary diagnosis of heart failure
- Being discharged to a skilled nursing facility
Key exclusion criteria (1 listed)
- Life expectancy of < 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelemedicineDaily updates on symptoms, weight, vital signs, and relevant labs will be communicated by phone with cardiology nurses at Providence Heart Clinic. Concerning changes in symptoms or signs will trigger a telemedicine clinic visit with a HF specialist using remote video/audio, virtual stethoscope technology, and VZ Cloud managed hosting. The consult will include a virtual face-face interview and physical examination between patient and HF clinician using Cisco Yabber Video, Littman e-stethoscope, and Verizon managed hosting. Medication changes, laboratory testing, additional virtual visits, or in-person clinic visits can be arranged as appropriate. | Other | Telemedicine |
Primary outcome
Composite endpoint (re-admission/ Emergency Department visit/ death)
Time frame: up to 60 days after patient is discharged from skilled nursing facility
The primary composite outcome of all-cause re-admission to the hospital/ Emergency Department visits/ death at 30 and 60 days will be compared to facility-specific historical event rates from the prior year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
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HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Abraham, MD principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine in people with Heart Failure, run by Providence Health & Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint (re-admission/ Emergency Department visit/ death) (time frame: up to 60 days after patient is discharged from skilled nursing facility). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.