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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01582620
Recruitment Status : Unknown
Verified April 2012 by University Hospital of North Norway.
Recruitment status was:  Recruiting
First Posted : April 20, 2012
Last Update Posted : April 20, 2012
Nordlandssykehuset HF
Information provided by (Responsible Party):
University Hospital of North Norway

Tracking Information
First Submitted Date  ICMJE May 26, 2011
First Posted Date  ICMJE April 20, 2012
Last Update Posted Date April 20, 2012
Study Start Date  ICMJE August 2011
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
Change in the proportion of stroke patients receiving thrombolysis treatment after the introduction of a telestroke service [ Time Frame: Approx. 30 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
  • Door-to-(thrombolysis)needle-time [ Time Frame: 18 months ]
  • Scores for functional outcomes at admission and discharge [ Time Frame: 18 months ]
  • Proportion of patient transfers from Lofoten and Vesterålen in the acute phase to secondary level [ Time Frame: 18 months ]
  • Proportion of stroke patients receiving "telestroke" examination [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Telestroke in Nordland Hospital. A Study of a Telemedicine Network in Rural Hospitals
Official Title  ICMJE Telestroke in Nordland Hospital: Improved Treatment of Cerebral Stroke in Small Hospitals
Brief Summary

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

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Stroke, Acute
Intervention  ICMJE Procedure: Telestroke
remote videoconference consultations
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 19, 2012)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients admitted to the two local hospitals diagnosed with acute cerebral stroke
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01582620
Other Study ID Numbers  ICMJE 2010/2277(REK)
2277/2010 (REK) ( Other Identifier: The National Committees for research ethics in Norway )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital of North Norway
Study Sponsor  ICMJE University Hospital of North Norway
Collaborators  ICMJE Nordlandssykehuset HF
Investigators  ICMJE
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
PRS Account University Hospital of North Norway
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP