search
Back to results

Telemedicine for Ultrasound Support in Nurse-based Outpatient Heart Failure Clinic

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Diagnostic ultrasound
Sponsored by
Helse Nord-Trøndelag HF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring Echocardiography, Telemedicine, Nurses, Decision support, eHealth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Heart failure patients at the outpatient heart failure clinic at Levanger Hospital, which have consented to participate in the study.

Exclusion Criteria:

  • As for inclusion, when the patient is not able to consent.

Sites / Locations

  • Levanger Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Intervention

Arm Description

Experimental: Addition of diagnostic ultrasound performed by nurses at the outpatient heart failure clinic. Interpretation by specialist per telemedicine. No Control arm

Outcomes

Primary Outcome Measures

Reliability of diagnostic ultrasound examinations using support by telemedicine
Reliability (accuracy) will be tested with C-statistics of ultrasound performed by nurses at an outpatient heart failure clinic, with interpretation by telemedicine support of cardiologist compared to Reference imaging by specialists in cardiology

Secondary Outcome Measures

Feasibility of echocardiography performed by nurses with support by telemedicine
Feasibility, as the proportion of recordings, of echocardiographic images with telemedicine interpretation of the echocardiographic recordings. Specified will we evaluate the proportion of exams that is successfully recorded by the nurses, then transmitted by and, at last, interpretated by telemedicine approach.
Time use of echocardiography performed by nurses with support by telemedicine
Time used for the sum of recording of echocardiographic images by the nurses, uploading for transferral and, at last, interpretation by telemedicine approach.
Quality of echocardiography performed by nurses with support by telemedicine
Evaluation of the quality of recordings of echocardiographic images obtained by the nurses as a semiquantitative score reflecting the whole examination compared to the reference images by the cardiologist.
Classification of type of heart failure by echocardiography by nurses with near real-time support by telemedicine
Comparison of classification of type of heart failure (reduced ejection fraction, mildly reduced ejection fraction or preserved ejection fraction) by the telemedicine approach compared to reference imaging. reference echocardiography by cardiologist
Evaluation of volume status with echocardiography by nurses with near real-time support by telemedicine
Comparison of volume status (classified individually by a score based on dimension and respiratory variation of the inferior vena cava, visual and Doppler echocardiography and quantification of pleural effusion) by the telemedicine approach compared to reference imaging by cardiologist

Full Information

First Posted
September 26, 2016
Last Updated
November 5, 2021
Sponsor
Helse Nord-Trøndelag HF
Collaborators
Norwegian University of Science and Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT02936050
Brief Title
Telemedicine for Ultrasound Support in Nurse-based Outpatient Heart Failure Clinic
Official Title
The Use of Ultrasound Diagnostics for Clinical Decision Making at Remote Locations - Data From an Outpatient Heart Failure Clinic
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helse Nord-Trøndelag HF
Collaborators
Norwegian University of Science and Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The cost related to management of heart failure is significant, both with respect to the financial costs and the suffer of patients. Still as much as 50% of heart failure patients are readmitted within 6 months after hospitalization for decompensated heart failure. Specialized nurses have a growing role in diagnostics and follow-up of outpatient HF patients, and adding ultrasound diagnostics to the nurses consultations may improve care. In heart failure patients the use of ultrasound as a tool for assessing volume status and guidance of diuretic therapy are promising. Aim of the study is to evaluate the feasibility and reliability of echocardiographic acquisitions by heart failure nurses to assess cardiac function indices and assess volume status in outpatient heart failure clinics combined with a telemedicine approach for near real-time interpretation of the recordings by a cardiologist specialized in echocardiography and heart failure at a remote location.
Detailed Description
The worsening heart failure epidemic is a significant driver of health care expenditure with increasing costs, lost productivity and increased suffer of patients. Thus, there important to develop strategies to improve heart failure care and reduce hospital readmissions. Some progress in heart failure management has been made with new drug therapies and remote monitoring of patients with heart failure. This project aims to provide data which may add to the existing literature regarding the use of telemedicine for safe transfer of ultrasound data of relatively inexperienced users for qualitative and quantitative interpretation by experts at a different location. The authors will study whether diffusion of focused cardiac ultrasound to outpatient heart failure clinics with support of cardiologist provided by telemedicine is feasible and provides reliable data. Firstly, the investigators will study the use of high-end ultrasound machines connected to a wired broadband network with a CE-classified software providing safety and anonymization of all transferred data. This project could be of significant importance for further support for widening the use of ultrasound diagnostics, even when the expert is not at the same location as the health-care provider performing the ultrasound acquisition. For the patients this may allow for better and faster diagnostics, and thus treatment. For the health-care system this may both improve quality of diagnostics and therapy, and be cost-saving as well. Lastly, this could make the way for further innovations which again can improve diagnostics and thus therapy. Aims To study the feasibility of implementing focused echocardiography and ultrasound examinations to assess volume status in a heart failure clinic where the caregiving nurses acquire the ultrasound images but have access to the near real-time interpretation by the cardiologist only by telemedicine. To study the reliability of the measurements of cardiac size and function indices in ultrasound recordings acquired by heart failure nurses, provided to another location for interpretation by cardiologists by telemedicine, in comparison to reference imaging. To study the clinical influence of implementing ultrasound examinations performed by nurses to assess volume status and cardiac function at outpatient heart failure clinics when the support and collaboration with the specialist is available by telemedicine only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Echocardiography, Telemedicine, Nurses, Decision support, eHealth

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm Description
Experimental: Addition of diagnostic ultrasound performed by nurses at the outpatient heart failure clinic. Interpretation by specialist per telemedicine. No Control arm
Intervention Type
Procedure
Intervention Name(s)
Diagnostic ultrasound
Other Intervention Name(s)
Echocardiography
Intervention Description
All participants will be examined by diagnostic ultrasound by nurses for the assessment of the Cardiac size and function, and for volumic state. Transmission of the ultrasound recordings by telemedicine and interpretation by specialist in echocardiography and heart failure. All participants will then be examined by reference imaging in specific ultrasound laboratories.
Primary Outcome Measure Information:
Title
Reliability of diagnostic ultrasound examinations using support by telemedicine
Description
Reliability (accuracy) will be tested with C-statistics of ultrasound performed by nurses at an outpatient heart failure clinic, with interpretation by telemedicine support of cardiologist compared to Reference imaging by specialists in cardiology
Time Frame
Reliability will be tested on day 0 (time of study inclusion)
Secondary Outcome Measure Information:
Title
Feasibility of echocardiography performed by nurses with support by telemedicine
Description
Feasibility, as the proportion of recordings, of echocardiographic images with telemedicine interpretation of the echocardiographic recordings. Specified will we evaluate the proportion of exams that is successfully recorded by the nurses, then transmitted by and, at last, interpretated by telemedicine approach.
Time Frame
Feasibility will be tested on day 0 (time of study inclusion)
Title
Time use of echocardiography performed by nurses with support by telemedicine
Description
Time used for the sum of recording of echocardiographic images by the nurses, uploading for transferral and, at last, interpretation by telemedicine approach.
Time Frame
Feasibility will be tested on day 0 (time of study inclusion)
Title
Quality of echocardiography performed by nurses with support by telemedicine
Description
Evaluation of the quality of recordings of echocardiographic images obtained by the nurses as a semiquantitative score reflecting the whole examination compared to the reference images by the cardiologist.
Time Frame
Quality will be tested on day 0 (time of study inclusion)
Title
Classification of type of heart failure by echocardiography by nurses with near real-time support by telemedicine
Description
Comparison of classification of type of heart failure (reduced ejection fraction, mildly reduced ejection fraction or preserved ejection fraction) by the telemedicine approach compared to reference imaging. reference echocardiography by cardiologist
Time Frame
Classification of type of heart failure by will be tested on day 0 (time of study inclusion)
Title
Evaluation of volume status with echocardiography by nurses with near real-time support by telemedicine
Description
Comparison of volume status (classified individually by a score based on dimension and respiratory variation of the inferior vena cava, visual and Doppler echocardiography and quantification of pleural effusion) by the telemedicine approach compared to reference imaging by cardiologist
Time Frame
Evaluation of volume status will be tested on day 0 (time of study inclusion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Heart failure patients at the outpatient heart failure clinic at Levanger Hospital, which have consented to participate in the study. Exclusion Criteria: As for inclusion, when the patient is not able to consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Havard Dalen, MD, PhD
Organizational Affiliation
Helse Nord-Trøndelag HF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Levanger Hospital
City
Levanger
ZIP/Postal Code
7600
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

Telemedicine for Ultrasound Support in Nurse-based Outpatient Heart Failure Clinic

We'll reach out to this number within 24 hrs