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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01942031
Other study ID # EPN2010/1158-31/2
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2013
Est. completion date October 2019

Study information

Verified date September 2020
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 204
Est. completion date October 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Primary care center in Stockholm county

Exclusion Criteria:

- localisation outside Stockholm County

Study Design


Intervention

Behavioral:
structured collegial feed back
Collegial feed back to primary care physicians at randomized primary care centers

Locations

Country Name City State
Sweden Karolinska Institutet Stroke Research Network at Södersjukhuset Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Geary L, Hasselström 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. — View Citation

Geary L, Hasselström 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.2020.0 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Outcome meassures will be followed during two years
Secondary 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 baseline 2010 and 2012, followed for one year after intervention
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