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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University Hospital of North Norway.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Nordlandssykehuset HF
Information provided by (Responsible Party):
University Hospital of North Norway
ClinicalTrials.gov Identifier:
NCT01582620
First received: May 26, 2011
Last updated: April 19, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention
Stroke, Acute
Procedure: Telestroke

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Telestroke in Nordland Hospital: Improved Treatment of Cerebral Stroke in Small Hospitals

Resource links provided by NLM:


Further study details as provided by University Hospital of North Norway:

Primary Outcome Measures:
  • Change in the proportion of stroke patients receiving thrombolysis treatment after the introduction of a telestroke service [ Time Frame: Approx. 30 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Door-to-(thrombolysis)needle-time [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Scores for functional outcomes at admission and discharge [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Proportion of patient transfers from Lofoten and Vesterålen in the acute phase to secondary level [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Proportion of stroke patients receiving "telestroke" examination [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: August 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Telestroke
    remote videoconference consultations
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted to the two local hospitals diagnosed with acute cerebral stroke
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582620

Locations
Norway
Nordlandssykehuset HF Lofoten Recruiting
Gravdal, Nordland, Norway, 8372
Contact: Bettina Heermann, MD       Bettina.Heermann@nordlandssykehuset.no   
Nordlandssykehuset HF Vesterålen Recruiting
Stokmarknes, Norway
Contact: Finn Larssen-Aas, MD       Finn.Larssen-Aas@nordlandssykehuset.no   
Sponsors and Collaborators
University Hospital of North Norway
Nordlandssykehuset HF
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
  More Information

No publications provided

Responsible Party: University Hospital of North Norway
ClinicalTrials.gov Identifier: NCT01582620     History of Changes
Other Study ID Numbers: 2010/2277(REK), 2277/2010 (REK)
Study First Received: May 26, 2011
Last Updated: April 19, 2012
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by University Hospital of North Norway:
Cerebrovascular disorders
Telemedicine
remote consultation
rural
thrombolysis therapy
plasminogen activators
stroke care
stroke management

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 18, 2014