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

Primary Purpose

Stroke, Acute

Status
Terminated
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Telestroke
Sponsored by
University Hospital of North Norway
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke, Acute focused on measuring Cerebrovascular disorders, Telemedicine, remote consultation, rural, thrombolysis therapy, plasminogen activators, stroke care, stroke management

Eligibility Criteria

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

Inclusion Criteria:

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

Sites / Locations

  • Nordlandssykehuset HF Lofoten
  • Nordlandssykehuset HF Vesterålen

Outcomes

Primary Outcome Measures

Change in the proportion of stroke patients receiving thrombolysis treatment after the introduction of a telestroke service

Secondary Outcome Measures

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

Full Information

First Posted
May 26, 2011
Last Updated
March 24, 2020
Sponsor
University Hospital of North Norway
Collaborators
Nordlandssykehuset HF
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1. Study Identification

Unique Protocol Identification Number
NCT01582620
Brief Title
Telestroke in Nordland Hospital. A Study of a Telemedicine Network in Rural Hospitals
Acronym
Telestroke
Official Title
Telestroke in Nordland Hospital: Improved Treatment of Cerebral Stroke in Small Hospitals
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Why Stopped
Principal investigator moved, and the study should have been taken out of UNN Clincaltrial.gov account 5-6 years back in time.
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
March 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital of North Norway
Collaborators
Nordlandssykehuset HF

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute
Keywords
Cerebrovascular disorders, Telemedicine, remote consultation, rural, thrombolysis therapy, plasminogen activators, stroke care, stroke management

7. Study Design

Primary Purpose
Health Services Research
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

Intervention Type
Procedure
Intervention Name(s)
Telestroke
Intervention Description
remote videoconference consultations
Primary Outcome Measure Information:
Title
Change in the proportion of stroke patients receiving thrombolysis treatment after the introduction of a telestroke service
Time Frame
Approx. 30 months
Secondary Outcome Measure Information:
Title
Door-to-(thrombolysis)needle-time
Time Frame
18 months
Title
Scores for functional outcomes at admission and discharge
Time Frame
18 months
Title
Proportion of patient transfers from Lofoten and Vesterålen in the acute phase to secondary level
Time Frame
18 months
Title
Proportion of stroke patients receiving "telestroke" examination
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients admitted to the two local hospitals diagnosed with acute cerebral stroke
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi Jacobsen
Organizational Affiliation
Norwegian center for integrated care and telemedicine, Tromsø Norway
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rolf Salvesen, PhD professor
Organizational Affiliation
Neurological department, Nordlandssykehuset HF
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stein Roald Bolle, PhD
Organizational Affiliation
Norwegian center for integrated care and telemedicine, University Hospital North Norway, Tromsø
Official's Role
Study Chair
Facility Information:
Facility Name
Nordlandssykehuset HF Lofoten
City
Gravdal
State/Province
Nordland
ZIP/Postal Code
8372
Country
Norway
Facility Name
Nordlandssykehuset HF Vesterålen
City
Stokmarknes
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

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

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