Stroke, AcuteTelestrokeNCT01582620
Telestroke in Nordland Hospital. A Study of a Telemedicine Network in Rural Hospitals
A study testing Telestroke in people with Stroke, Acute, run by University Hospital of North Norway at 2 sites in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Telestroke
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesNorway
- Study dates
- Aug 2011to 24 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted to the two local hospitals diagnosed with acute cerebral stroke
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Nordlandssykehuset HF Lofoten
Gravdal, Nordland, 8372
Nordlandssykehuset HF Vesterålen
Stokmarknes
About this study
Official title: 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.
Read more
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
Read the 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.
- Conditions
- Stroke, Acute
- Being tested
- Telestroke
- Keywords
- Cerebrovascular disorders, Telemedicine, remote consultation, rural, thrombolysis therapy, plasminogen activators, stroke care, stroke management
- Medical subject headings
- Stroke, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelestrokeProcedure or surgery
remote videoconference consultations
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the proportion of stroke patients receiving thrombolysis treatment after the introduction of a telestroke service
Measured: Approx. 30 months
Secondary outcomes (4)
Door-to-(thrombolysis)needle-time
Measured: 18 months
Scores for functional outcomes at admission and discharge
Measured: 18 months
Proportion of patient transfers from Lofoten and Vesterålen in the acute phase to secondary level
Measured: 18 months
Proportion of stroke patients receiving "telestroke" examination
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startAug 2011
- Primary completionDec 2012
- Study completion24 Mar 2020
Why it stopped: Principal investigator moved, and the study should have been taken out of UNN Clincaltrial.gov account 5-6 years back in time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Nordlandssykehuset HF
- Responsible party
- Sponsor
- Investigators
- Heidi Jacobsen, Study director, Norwegian center for integrated care and telemedicine, Tromsø NorwayRolf Salvesen, PhD professor, Principal investigator, Neurological department, Nordlandssykehuset HFStein Roald Bolle, PhD, Study chair, Norwegian center for integrated care and telemedicine, University Hospital North Norway, Tromsø
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582620
- Sponsor's protocol ID
- 2010/2277(REK)
- Other IDs
- 2277/2010 (REK)
- Acronym
- Telestroke
- Status last verified
- Apr 2012
- First submitted
- 26 May 2011
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telestroke in Nordland Hospital: Improved Treatment of Cerebral Stroke in Small Hospitals
- ClinicalTrials.gov ID
- NCT01582620
- Acronym / sponsor ID
- Telestroke / 2010/2277(REK)
- Conditions
- Stroke, Acute
- Keywords
- Cerebrovascular disorders, Telemedicine, remote consultation, rural, thrombolysis therapy, plasminogen activators, stroke care, stroke management
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator moved, and the study should have been taken out of UNN Clincaltrial.gov account 5-6 years back in time.
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Nordlandssykehuset HF
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted to the two local hospitals diagnosed with acute cerebral stroke
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telestrokeremote videoconference consultations | Procedure or surgery | – |
Primary outcome
Change in the proportion of stroke patients receiving thrombolysis treatment after the introduction of a telestroke service
Time frame: Approx. 30 months
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Principal investigator moved, and the study should have been taken out of UNN Clincaltrial.gov account 5-6 years back in time.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heidi Jacobsen study director
Norwegian center for integrated care and telemedicine, Tromsø Norway
Rolf Salvesen, PhD professor principal investigator
Neurological department, Nordlandssykehuset HF
Stein Roald Bolle, PhD study chair
Norwegian center for integrated care and telemedicine, University Hospital North Norway, Tromsø
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telestroke in people with Stroke, Acute, run by University Hospital of North Norway at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal investigator moved, and the study should have been taken out of UNN Clincaltrial.gov account 5-6 years back in time.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the proportion of stroke patients receiving thrombolysis treatment after the introduction of a telestroke service (time frame: Approx. 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.