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

Primary Purpose

Ischemic Stroke, Hemorrhagic Stroke, TIA

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
structured collegial feed back
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Stroke focused on measuring Ischemic stroke, Hemorrhagic stroke, TIA, Atrial fibrillation, prevention, primary care

Eligibility Criteria

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

Inclusion Criteria:

  • Primary care center in Stockholm county

Exclusion Criteria:

  • localisation outside Stockholm County

Sites / Locations

  • Karolinska Institutet Stroke Research Network at Södersjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

structured collegial feed back

Control group

Arm Description

Structured feed back and information about stroke to the primary care center, to physicians and head of the center

No structured feed back on stroke prevention. Ordinary educational activities only.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 15, 2013
Last Updated
September 14, 2020
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01942031
Brief Title
Improved Prevention of Stroke in Primary Care in Stockholm, Sweden (Förbättrad Prevention av Stroke)
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.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
October 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Hemorrhagic Stroke, TIA, Atrial Fibrillation
Keywords
Ischemic stroke, Hemorrhagic stroke, TIA, Atrial fibrillation, prevention, primary care

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
204 (Actual)

8. Arms, Groups, and Interventions

Arm Title
structured collegial feed back
Arm Type
Experimental
Arm Description
Structured feed back and information about stroke to the primary care center, to physicians and head of the center
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No structured feed back on stroke prevention. Ordinary educational activities only.
Intervention Type
Behavioral
Intervention Name(s)
structured collegial feed back
Intervention Description
Collegial feed back to primary care physicians at randomized primary care centers
Primary Outcome Measure Information:
Title
percentage of identified patients with stroke/TIA in primary care and analysis of dispensed prescriptions in each group
Description
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
Time Frame
Outcome meassures will be followed during two years
Secondary Outcome Measure Information:
Title
dispensed prescriptions of secondary preventives drugs in patients with stroke/TIA
Description
dispensed prescriptions of recommended secondary preventive drugs in patients detected and not detected at each primary care center
Time Frame
baseline 2010 and 2012, followed for one year after intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary care center in Stockholm county Exclusion Criteria: localisation outside Stockholm County
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mia von Euler, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet Stroke Research Network at Södersjukhuset
City
Stockholm
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
31017305
Citation
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. Erratum In: Acta Neurol Scand. 2021 Mar;143(3):336.
Results Reference
result
PubMed Identifier
32327203
Citation
Geary 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.
Results Reference
result

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

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