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Improved Prevention of Stroke in Primary Care in Stockholm, Sweden (Förbättrad Prevention av Stroke)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Mia von Euler, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01942031
First received: April 15, 2013
Last updated: September 10, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Ischemic Stroke
Hemorrhagic Stroke
TIA
Atrial Fibrillation
Behavioral: structured collegial feed back

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • dispensed prescriptions of secondary preventives drugs in patients with stroke/TIA [ Time Frame: baseline 2010 and 2012, followed for one year after intervention ] [ Designated as safety issue: No ]
    dispensed prescriptions of recommended secondary preventive drugs in patients detected and not detected at each primary care center


Estimated Enrollment: 200
Study Start Date: October 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: structured collegial feed back
Structured feed back and information about stroke to the primary care center, to physicians and head of the center
Behavioral: structured collegial feed back
Collegial feed back to primary care physicians at randomized primary care centers
No Intervention: Control group
No structured feed back on stroke prevention. Ordinary educational activities only.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary care center in Stockholm county

Exclusion Criteria:

  • localisation outside Stockholm County
  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: NCT01942031

Locations
Sweden
Karolinska Institutet Stroke Research Network at Södersjukhuset
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Mia von Euler, MD, PhD Karolinska Institutet
  More Information

No publications provided

Responsible Party: Mia von Euler, Associate Professor, Head Karolinska Institutet Stroke Research Network at Södersjukhuset, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01942031     History of Changes
Other Study ID Numbers: EPN2010/1158-31/2
Study First Received: April 15, 2013
Last Updated: September 10, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Karolinska Institutet:
Ischemic stroke
Hemorrhagic stroke
TIA
Atrial fibrillation
prevention
primary care

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Atrial Fibrillation
Intracranial Hemorrhages
Arrhythmias, Cardiac
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Heart Diseases
Hemorrhage
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014