Telestroke in Nordland Hospital. A Study of a Telemedicine Network in Rural Hospitals (Telestroke)

March 24, 2020 updated by: University Hospital of North Norway

Telestroke in Nordland Hospital: Improved Treatment of Cerebral Stroke in Small Hospitals

The purpose is to study the clinical, technological and organizational impacts of a telestroke service between Nordlandssykehuset, Bodø, and two small rural hospitals in Lofoten and Vesterålen. The stroke specialist in Bodø will examine the patient in cooperation with the doctor at the local hospital through video- and sound communication. Radiology images are transmitted using the RIS/PACS system.

Telestroke consultations may be useful to assess whether the patient needs thrombolysis medication, and also whether there is a need for more advanced specialist neurological or neurosurgical treatment, supporting quick triaging and transfer to the appropriate unit.

The study design is a multi-method approach using before-and-after hospital information data as well as registration forms monitoring patient outcome and pathways. The research questions will be approached from medical, organisational and technological perspectives.

A telestroke service in North Norway is expected to face other challenges than those reported internationally: In Nordlandssykehuset, as in Helse Nord in general, the number of cases is low, clinicians have high turnover, technical support is not available 24/7 and severe weather conditions and long distances might add to the transport time.

Primary hypothesis: The use of telestroke leads to faster and more accurate diagnosis and proper treatment

Secondary hypothesis: Telestroke leads to improved overall patient treatment

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

There is good evidence that the prognosis for patients with ischemic stroke is improved by thrombolysis in the acute phase. The challenge is the narrow time window: Thrombolysis should be given as soon as possible and not later than 4.5 hours after the first symptoms. In Norway, only approximately 2% of all stroke patients receive thrombolysis whereas 20 % are expected to benefit from such treatment (The Norwegian Directorate of Health, 2010). The low rate could be due to geographical conditions with long travel distances, lack of awareness in the population, but also little experience with the treatment in local hospitals may play a role.

The overall aim of this project is to improve health outcome for stroke patients by telemedicine. This study will investigate the potential outcome for stroke patients in small rural hospitals using a telestroke service.

The project will study the "patient flow" by analysing hospital information system (HIS) data as well as monitoring the teleconsultations and logging the main purpose for and results of the consultation. This will be conducted throughout the project, and analysed for a period of 18 months. Hospital data on diagnosis, thrombolysis frequencies, stroke complications like haemorrhage or stroke recidive, will be used in the analysis process.

Around 60 cases may potentially be included in the study during the 18 month observation period, which can be compared with register data from patients before the study. Control-groups have been considered, but found not ethical since the telestroke equipment is already installed in the two hospitals.

Log information from the Norwegian Health Net on the use of videoconferencing will be used as a basis for field observations and interviews and to verify the actual use of the system.

Corresponding with the logged data, semi-structured interviews will be conducted by making follow-up phone calls to hospital staff after the telestroke incidents. Using a qualitative approach, the number of follow-up calls will be decided in the process, adding up to app 20 cases. This method will be used to capture what happened in the concrete telestroke incident from the first call to the hospital and throughout the process, while the details of the session are still fresh. There will also be periods of fieldwork at all three hospitals. This will include observations at the hospital wards and during concrete telestroke consultations. Semi-structured focus groups interviews will be conducted with health personnel involved with stroke-patients, including ambulance personnel, doctors and nurses, as well as technical support. Fieldwork will take place early in the project phase, and then at intervals during the project period. Fieldwork and follow-up phone interviews at different times in the research period will capture potential changes in the stroke treatment over time.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Stokmarknes, Norway
        • Nordlandssykehuset HF Vesterålen
    • Nordland
      • Gravdal, Nordland, Norway, 8372
        • Nordlandssykehuset HF Lofoten

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients admitted to the two local hospitals diagnosed with acute cerebral stroke

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in the proportion of stroke patients receiving thrombolysis treatment after the introduction of a telestroke service
Time Frame: Approx. 30 months
Approx. 30 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Door-to-(thrombolysis)needle-time
Time Frame: 18 months
18 months
Scores for functional outcomes at admission and discharge
Time Frame: 18 months
18 months
Proportion of patient transfers from Lofoten and Vesterålen in the acute phase to secondary level
Time Frame: 18 months
18 months
Proportion of stroke patients receiving "telestroke" examination
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Heidi Jacobsen, Norwegian center for integrated care and telemedicine, Tromsø Norway
  • Principal Investigator: Rolf Salvesen, PhD professor, Neurological department, Nordlandssykehuset HF
  • Study Chair: Stein Roald Bolle, PhD, Norwegian center for integrated care and telemedicine, University Hospital North Norway, Tromsø

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

March 24, 2020

Study Registration Dates

First Submitted

May 26, 2011

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimate)

April 20, 2012

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

April 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 2010/2277(REK)
  • 2277/2010 (REK) (Other Identifier: The National Committees for research ethics in Norway)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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