Handheld Ultrasound at Remote Locations
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Heart failure causes a large patient and financial burden on the health care system. Pocket
      ultrasound imaging devices are utilized to improve time to correct diagnosis. Telemedicine is
      used in a variety of medical professions today. A combination of focused handheld ultrasound
      imaging performed by general practitioners and dedicated nurses in a heart failure
      population, utilizing telemedicine for support, has not yet been studied. The aim of the
      study is to evaluate the feasibility, reliability and clinical influence of implementing
      handheld focused cardiac ultrasound by general practitioners and nurses for diagnostics and
      health-related expenditure in outpatients referred with suspected heart failure.
    

Detailed description: 
      Handheld focused cardiac ultrasound in diagnosis of suspected heart failure

      Diagnostic ultrasound is more frequently used by clinicians in different scenarios.
      Echocardiography (cardiac ultrasound) is the most frequently method used when diagnosing
      heart failure (HF), cardiomyopathies, valvular pathology and cardiac tamponade, as well as
      other diseases affecting the heart, great vessels and pleural cavity. Ideally, the diagnostic
      workflow should conclude with a correct diagnosis as soon as possible, as this is important
      for preserving health and quality of life for the patients, as well as for total health care
      expenditure and the diagnostic workflow logistics.

      For the last 6-7 years smaller and cheaper ultrasound scanners have become available. These
      pocket-sized (or handheld) imaging devices (PSIDs) have allowed for more inexperienced users,
      at locations outside the dedicated ultrasound laboratories, to perform ultrasound
      diagnostics. PSIDs fits in the "white coat" pocket and may be brought to the patient, and
      thus, allowing diagnostic imaging examinations to be performed at the patients'
      point-of-care. PSIDs from different vendors are available on the market. Large efforts are
      made in developing dedicated software helping the inexperienced users to maximize the
      diagnostic gain of including PSIDs in the diagnostic workflow. Experts have launched the
      PSIDs as the next generation stethoscope.

      The cardiac research groups at Levanger Hospital and NTNU (Norway) have recently evaluated
      the PSID Vscan® from GE Ultrasound in several studies where the PSID has been tested on
      cardiac patients by different users. The PSID allow for improved diagnostics by both experts,
      residents, general practitioners (GPs), as well as medical students and dedicated nurses.

      In the inpatients setting the population is selected and the prevalence of disease is high.
      Research has shown that by using the PSIDs the diagnosis was corrected in up to 1 of 5
      medical inpatients. With less experienced users the diagnostic impact may be reduced. Studies
      from outpatient hospital settings have shown that the PSIDs may allow for diagnostic gain
      both in cardiac and non-cardiac care. Studies evaluating the influence of using PSIDs by GPs
      or other health care personnel outside the hospitals are scarce. Thus, there is a need for
      studies evaluating the use of PSIDs or other imaging modalities performed by the GPs in the
      outpatient setting.

      Education

      For all inexperienced users, that are non-experts, dedicated training and education is
      mandatory to optimize gain and minimize misdiagnosis and subsequent imaging procedures. The
      gain of including PSIDs in the diagnostic workflow largely depends on the population
      examined. In the latest recommendation from the European Association of Cardiovascular
      Imaging (EACVI) no specific numbers are given for the training program, neither regarding
      time nor number of examinations. However, it is stated that "since the competency in FoCUS
      (Focused Cardiac UltraSound) should be the minimal net result of the training process, the
      number of required hours/studies might be adjusted for each trainee according to the results
      of the competency evaluation incorporated into the ongoing training process". The training
      program should aim to educate the user in the specific use of the PSIDs relevant for the
      planned scenarios to "ensure that the operators are aware of their own capacity and
      limitations, given the specific equipment and different situations".

      Telemedicine The health care system of today has implemented a variety of technical tools
      that are based on advanced technological innovations. Such advances usually require highly
      technical and medical skills of the users, for optimization of the use and outcome of the
      advances. The advances in information technology, communication bandwidth capacities of both
      wired and non-wired networks have made the basis for performing the diagnostics at one place
      and interpret the diagnostic tests at another location. According to the World Health
      Organization, telemedicine is defined as "the delivery of health care services, where
      distance is a critical factor, by all health care professionals using information and
      communication technologies for the exchange of valid information for diagnosis, treatment and
      prevention of disease and injuries, research and evaluation, and for the continuing education
      of health care providers, all in the interests of advancing the health of individuals and
      their communities".

      Telemedicine has among others been implemented in radiology, where teleradiology is a common
      and accepted form in the diagnostic process. The methodology was first implemented in
      clinical scenarios where the need for a physical meeting between the patient and the
      physician was lower than the need for the specific tests. Traditionally, ultrasound
      examinations have been performed by highly specialized personnel and interpreted by the
      specialist more or less real time and at the same location.

      User support Technological advances with the invention of easy-to-use, cheap and attainable
      ultrasound devices has allowed for a broader spectrum of users to implement ultrasound
      diagnostics. From the health care providers' point of view, this may allow for moving
      diagnostics to the patients' point-of-care, in contrast to moving the patients to the
      diagnostic laboratories. To implement ultrasound diagnostics outside the dedicated
      diagnostics laboratories, education and support of the users is mandatory. Even though
      inexperienced users easily can be trained to perform ultrasound images with indices, the
      interpretation of the images of anatomical structures and cardiac function indices requires
      experience.

      The more inexperienced users can be supported in different ways. Beyond the obligatory
      theoretical support by literature and possibility to discuss findings with experts, there is
      need for qualitative feedback on the ultrasound recordings. Telemedicine may offer secure
      transmission of the ultrasound recordings for interpretation by experts and allowing for
      discussion as well. The outpatient ultrasound recordings may also be included in hospital
      referrals. In addition, our research group has been involved in development of an algorithm
      which can automatically interpret ultrasound recordings of the function of the left
      ventricle. Such software can give quick feedback which may be helpful for training and
      education of the user, as well its possibility to improve the diagnostic ability of the
      ultrasound examination performed by the inexperienced user.

      Heart failure Heart failure (HF) affects 15 million Europeans; incidence in Norway is 11.000
      per year. The prevalence is increasing due to improvements in diagnostics and therapy, not to
      mention the increased age of the population. Health care expenditure related to management of
      heart failure is significant, both with respect to the financial costs and patient burden.
      Thus, early and correct diagnosis is important to improve patient care and reduce the
      financial burden on the health care system. Heart failure patients often have comorbidities,
      and hospitalization is common if not optimally monitored and treated. Today approximately 50%
      of heart failure patients are readmitted within 6 months after hospitalization for
      decompensated heart failure.

      Hyper- and hypovolemia can both lead to decompensated HF and secondary organ failure caused
      by inadequate perfusion. However, pleural effusion is easy assessable by ultrasound and in a
      recent study we found that pleural effusion was present in 42% of the patients.
      Non-cardiologists may have a growing role in diagnostics and follow-up of outpatient HF
      patients, and adding ultrasound diagnostics to the consultations may improve care.

      Telemedicine in follow-up of patients with chronic heart failure The most advanced way of
      monitoring chronic HF patients by telemedicine is the use of implantable devices for
      haemodynamic monitoring, where invasive pressures were automatically uploaded from implanted
      devices through a patient home monitoring system and used to guide treatment. The Remote
      monitoring has become appealing, and is a potentially cost-effective method of home
      management and prevention of readmission.
    

Intervention name(s): Focused ultrasound diagnostics
Intervention type(s): Diagnostic Test
Intervention description(s): Patients first be examined by nurses using a pocket-sized imaging device. Secondly, by a General Practitioner using the pocket-sized imaging device. Thirdly, reference echocardiography will be performed by cardiologist using a high-end echocardiographic scanner. Only tools (ultrasound equipment and dedicated software) approved for clinical practice will be used.
The focused ultrasound examination includes three standard apical views (4-chamber, 2-chamber and long axis) with and without color Doppler, in addition to recordings from both pleural cavities and the inferior vena cava. The reference imaging includes the same recordings, but in addition all other chambers and valves are assessed (grey scale, color Doppler, pulsed wave and continuous wave Doppler and tissue Doppler).
Intervention model: Sequential Assignment
Intervention model description: The focused Pocket ultrasound examination and evaluation will be performed by a general practitioner. A similar focused ultrasound examination will be performed by a nurse without evaluation by the nurse. The complete echocardiographic examination by a cardiologist, using a state of the art ultrasound machine is considered the gold standard method.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pocket sized imaging device; Handheld ultrasound device; General practitioner; Nurse; Focused cardiac ultrasound; FoCUS; Telemedicine; Support