Ischemic StrokeNCT01942031
Improved Prevention of Stroke in Primary Care in Stockholm, Sweden (Förbättrad Prevention av Stroke)
A study testing structured collegial feed back in people with Ischemic Stroke and Hemorrhagic Stroke, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Stroke is a devastating disease. The acute mortality in Sweden is 20 % and 25 % of all patients relapse. Secondary prevention is proven efficient but observational studies have shown that a number of patients are lost to follow up and do not receive recommended prevention. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Stroke, Hemorrhagic Stroke, TIA
- What is being tested?
- structured collegial feed back
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2013to Oct 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary care center in Stockholm county
Who cannot join
- localisation outside Stockholm County
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet Stroke Research Network at Södersjukhuset
Stockholm
About this study
Official title: An Interventional Study of How Collegial Feed Back to Primary Care Physicians on Detection of Diagnosis and Dispensation of Prescribed Secondary Preventive Drugs Affect Stroke Prevention.
Stroke is a devastating disease. The acute mortality in Sweden is 20 % and 25 % of all patients relapse. Secondary prevention is proven efficient but observational studies have shown that a number of patients are lost to follow up and do not receive recommended prevention. The aim of the study is to 1) describe, by analyzing register data, the detection rate of patients with hospital diagnosis of stroke, TIA, and atrial fibrillation in the primary care center where they are listed. The analysis is done by sex, age, and socioeconomic status. Furthermore, rate of dispensed prescriptions of secondary preventive drugs are analysed for the identified population. 2) in a randomized controlled study evaluate if collegial feed back and targeted information of secondary prevention to the intervention group can improve the detection rate and the medication of the patients listed at the participating primary care centers.
Read the detailed description
All primary care centers in Stockholm County (approximately 200) are randomised to control or intervention (receiving structured feed back on detection rate of stroke/transient ischemic attacks in comparison to hospital discharge registry data. The randomisation is done group wise based on training areas. A data set is presented by different means; 1) in written reports, directly to the head of each primary care center in the intervention group 2)in oral presentation on training sessions for the physicians in each training ares. Measures of detection rates of diagnosis and dispensed prescriptions of secondary preventive drugs are made before start of the project and after one year. The control group, ie the primary care centers not receiving feed back, are measured in the same way and thus provide a control group. The hypothesis being that with visibility of the problem, it is easier to improve care wich is what all health providers aim to do.
Outcome measures is percentage of patients with stroke (ICD code I60, I 61, I63, I64) and transitory ischemic attacks(G45) who are dispensed prescribed secondary preventive medication and death.
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke, TIA, Atrial Fibrillation
- Being tested
- structured collegial feed back
- Keywords
- Ischemic stroke, Hemorrhagic stroke, TIA, Atrial fibrillation, prevention, primary care
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
structured collegial feed backBehavioural
Collegial feed back to primary care physicians at randomized primary care centers
| Study group | Role | What they receive |
|---|---|---|
| structured collegial feed back | Experimental | Structured feed back and information about stroke to the primary care center, to physicians and head of the center Receives: Behavioral: structured collegial feed back |
| Control group | No intervention | No structured feed back on stroke prevention. Ordinary educational activities only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of identified patients with stroke/TIA in primary care and analysis of dispensed prescriptions in each group
percentage of patients identified with hospital discharge diagnosis of stroke/TIA in primary care diagnosis register. Analysis of changes in outcome before intervention and after. the intervention will take place during one year and collection of data before start of intervention and one year after ended intervention will be performed
Measured: Outcome meassures will be followed during two years
Secondary outcomes (1)
dispensed prescriptions of secondary preventives drugs in patients with stroke/TIA
dispensed prescriptions of recommended secondary preventive drugs in patients detected and not detected at each primary care center
Measured: baseline 2010 and 2012, followed for one year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionMar 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mia von Euler, Karolinska Institutet
- Investigators
- Mia von Euler, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942031
- Sponsor's protocol ID
- EPN2010/1158-31/2
- Status last verified
- Sep 2020
- First submitted
- 15 Apr 2013
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Geary L, Hasselstrom J, Carlsson AC, Eriksson I, von Euler M. Secondary prevention after stroke/transient ischemic attack: A randomized audit and feedback trial. Acta Neurol Scand. 2019 Aug;140(2):107-115. doi: 10.1111/ane.13109. Epub 2019 May 9.
PubMed 31017305Geary L, Hasselstrom J, Carlsson AC, Schenck-Gustafsson K, von Euler M. An audit & feedback intervention for improved anticoagulant use in patients with atrial fibrillation in primary care. Int J Cardiol. 2020 Jul 1;310:67-72. doi: 10.1016/j.ijcard.2020.04.027. Epub 2020 Apr 12. No abstract available.
PubMed 32327203
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study of How Collegial Feed Back to Primary Care Physicians on Detection of Diagnosis and Dispensation of Prescribed Secondary Preventive Drugs Affect Stroke Prevention.
- ClinicalTrials.gov ID
- NCT01942031
- Acronym / sponsor ID
- EPN2010/1158-31/2
- Conditions
- Ischemic Stroke, Hemorrhagic Stroke, TIA, Atrial Fibrillation
- Keywords
- Ischemic stroke, Hemorrhagic stroke, TIA, Atrial fibrillation, prevention, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Mar 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 13 Sep 2013 (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.
Stroke is a devastating disease. The acute mortality in Sweden is 20 % and 25 % of all patients relapse. Secondary prevention is proven efficient but observational studies have shown that a number of patients are lost to follow up and do not receive recommended prevention. The aim of the study is to 1) describe, by analyzing register data, the detection rate of patients with hospital diagnosis of stroke, TIA, and atrial fibrillation in the primary care center where they are listed. The analysis is done by sex, age, and socioeconomic status. Furthermore, rate of dispensed prescriptions of secondary preventive drugs are analysed for the identified population. 2) in a randomized controlled study evaluate if collegial feed back and targeted information of secondary prevention to the intervention group can improve the detection rate and the medication of the patients listed at the participating primary care centers.
Detailed description
All primary care centers in Stockholm County (approximately 200) are randomised to control or intervention (receiving structured feed back on detection rate of stroke/transient ischemic attacks in comparison to hospital discharge registry data. The randomisation is done group wise based on training areas. A data set is presented by different means; 1) in written reports, directly to the head of each primary care center in the intervention group 2)in oral presentation on training sessions for the physicians in each training ares. Measures of detection rates of diagnosis and dispensed prescriptions of secondary preventive drugs are made before start of the project and after one year. The control group, ie the primary care centers not receiving feed back, are measured in the same way and thus provide a control group. The hypothesis being that with visibility of the problem, it is easier to improve care wich is what all health providers aim to do.
Outcome measures is percentage of patients with stroke (ICD code I60, I 61, I63, I64) and transitory ischemic attacks(G45) who are dispensed prescribed secondary preventive medication and death.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| structured collegial feed back | Experimental | Behavioral: structured collegial feed backStructured feed back and information about stroke to the primary care center, to physicians and head of the center |
| Control group | No intervention | –No structured feed back on stroke prevention. Ordinary educational activities only. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Primary care center in Stockholm county
Key exclusion criteria (1 listed)
- localisation outside Stockholm County
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 |
|---|---|---|
| structured collegial feed backCollegial feed back to primary care physicians at randomized primary care centers | Behavioural | structured collegial feed back |
Primary outcome
percentage of identified patients with stroke/TIA in primary care and analysis of dispensed prescriptions in each group
Time frame: Outcome meassures will be followed during two years
percentage of patients identified with hospital discharge diagnosis of stroke/TIA in primary care diagnosis register. Analysis of changes in outcome before intervention and after. the intervention will take place during one year and collection of data before start of intervention and one year after ended intervention will be performed
1 secondary outcome
dispensed prescriptions of secondary preventives drugs in patients with stroke/TIA
Time frame: baseline 2010 and 2012, followed for one year after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Results publication: PubMed 31017305Geary L, Hasselstrom J, Carlsson AC, Eriksson I, von Euler M. Secondary prevention after stroke/transient ischemic attack: A randomized audit and feedback trial. Acta Neurol Scand. 2019 Aug;140(2):107-115. doi: 10.1111/ane.13109. Epub 2019 May 9.
- Results publication: PubMed 32327203Geary L, Hasselstrom J, Carlsson AC, Schenck-Gustafsson K, von Euler M. An audit & feedback intervention for improved anticoagulant use in patients with atrial fibrillation in primary care. Int J Cardiol. 2020 Jul 1;310:67-72. doi: 10.1016/j.ijcard.2020.04.027. Epub 2020 Apr 12. No abstract available.
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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.
Mia von Euler, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing structured collegial feed back in people with Ischemic Stroke and Hemorrhagic Stroke, run by Karolinska Institutet at 1 site in Sweden.
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 1 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: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
percentage of identified patients with stroke/TIA in primary care and analysis of dispensed prescriptions in each group (time frame: Outcome meassures will be followed during two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01942031, which also lists 2 linked publications.
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 16 Sep 2020.