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Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Care provided by AF expert program
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Atrial Fibrillation focused on measuring nurse, expert program, primary care, implementation, interdisciplinary, effectiveness, disease management system

Eligibility Criteria

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

Inclusion Criteria:

  • Every newly diagnosed AF patient.
  • Every AF patient who is not seen by a cardiologist or electrophysiologist in the past 2 years before inclusion.
  • AF must be confirmed on electrocardiogram.
  • Capable of providing written informed consent.
  • Dutch speaking and verbally testable, without cognitive impairment.

Exclusion Criteria:

  • AF patients who once received an arrhythmologic consult about AF prior to the start of the study.
  • AF patients who have a systematic follow-up at a cardiologist prior to the start of the study.
  • Terminally ill AF patients
  • Participation in another clinical trial

Sites / Locations

  • UZ Leuven

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AF expert program

Usual care

Arm Description

Care provided by the interdisciplinary, nurse-coordinated AF expert program

Outcomes

Primary Outcome Measures

cardiovascular events
Combined endpoint of cardiovascular hospitalizations, cardiovascular deaths and unplanned cardiovascular visits. Cardiac death: Cardiac arrhythmic, Cardiac non-arrhythmic, Vascular non cardiac Cardiovascular hospitalization: Arrhythmic events (AF, syncope, sustained ventricular tachycardia, cardiac arrest), Heart Failure, Acute myocardial infarction, Stroke, Systemic embolism, Major bleeding, Life-threatening effects of drugs Unplanned cardiovascular visits

Secondary Outcome Measures

Guideline adherence
Does the medical record report a formal CHA2DS2-VASc score, HAS-BLED bleeding risk score and EHRA score? Does the medical record report an appropriate prescription of antithrombotic treatment. Does the medical record report an appropriate application of rate and rhythm (not if asymptomatic, if contraindicated and not in patients with permanent AF) Does the medical record report an appropriate upstream therapy? (For example in heart failure patients, is the heart failure treated)
Hospitalization days and clinic visits
Number of outpatient (internal or neurological) clinic visits per year Number of emergency room visits per year due to AF Number of hospitalization days due to AF Number of hospitalization days for cardiovascular reasons Number of hospitalization days on intensive care due to AF
Perceived health
Perceived health will be measured by the EuroQol Five Dimensional Questionnaire (EQ-5D-3L)
AF related symptoms and symptom burden
AF related symptoms and symptom burden will be measured by the Leuven Arrhythmia Questionnaire (LARQ)
Patient satisfaction
Patient satisfaction about information provided, about therapy and about follow-up, will be measured with a 10-point visual analog scale (VAS).
Patient knowledge
The Atrial Fibrillation Knowledge Scale (AF knowledge scale) will be used.
Patient adherence with medication
This will be assessed by self-report using the Dutch version of the 8-item Morisky Medication Adherence Scale (MMAS-8 scale).
Time to establishment of a management plan by electrophysiologist or cardiologist
This outcome will be searched for by reviewing medical records of, or by interviewing, all participating patients at 1, 3, 6 months and 1 year.

Full Information

First Posted
August 19, 2013
Last Updated
August 23, 2013
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01928121
Brief Title
Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients
Official Title
Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients - A Clustered Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to assess the effectiveness of a newly developed interdisciplinary nurse-coordinated AF expert program for primary care patients. Therefore a prospective, pragmatic clustered randomized controlled trial will be performed in general practices.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
nurse, expert program, primary care, implementation, interdisciplinary, effectiveness, disease management system

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AF expert program
Arm Type
Experimental
Arm Description
Care provided by the interdisciplinary, nurse-coordinated AF expert program
Arm Title
Usual care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Care provided by AF expert program
Primary Outcome Measure Information:
Title
cardiovascular events
Description
Combined endpoint of cardiovascular hospitalizations, cardiovascular deaths and unplanned cardiovascular visits. Cardiac death: Cardiac arrhythmic, Cardiac non-arrhythmic, Vascular non cardiac Cardiovascular hospitalization: Arrhythmic events (AF, syncope, sustained ventricular tachycardia, cardiac arrest), Heart Failure, Acute myocardial infarction, Stroke, Systemic embolism, Major bleeding, Life-threatening effects of drugs Unplanned cardiovascular visits
Time Frame
after 1 year
Secondary Outcome Measure Information:
Title
Guideline adherence
Description
Does the medical record report a formal CHA2DS2-VASc score, HAS-BLED bleeding risk score and EHRA score? Does the medical record report an appropriate prescription of antithrombotic treatment. Does the medical record report an appropriate application of rate and rhythm (not if asymptomatic, if contraindicated and not in patients with permanent AF) Does the medical record report an appropriate upstream therapy? (For example in heart failure patients, is the heart failure treated)
Time Frame
after 1 year
Title
Hospitalization days and clinic visits
Description
Number of outpatient (internal or neurological) clinic visits per year Number of emergency room visits per year due to AF Number of hospitalization days due to AF Number of hospitalization days for cardiovascular reasons Number of hospitalization days on intensive care due to AF
Time Frame
after 1 year
Title
Perceived health
Description
Perceived health will be measured by the EuroQol Five Dimensional Questionnaire (EQ-5D-3L)
Time Frame
After 1 year
Title
AF related symptoms and symptom burden
Description
AF related symptoms and symptom burden will be measured by the Leuven Arrhythmia Questionnaire (LARQ)
Time Frame
After 1 year
Title
Patient satisfaction
Description
Patient satisfaction about information provided, about therapy and about follow-up, will be measured with a 10-point visual analog scale (VAS).
Time Frame
After year
Title
Patient knowledge
Description
The Atrial Fibrillation Knowledge Scale (AF knowledge scale) will be used.
Time Frame
After 1 year
Title
Patient adherence with medication
Description
This will be assessed by self-report using the Dutch version of the 8-item Morisky Medication Adherence Scale (MMAS-8 scale).
Time Frame
After 1 year
Title
Time to establishment of a management plan by electrophysiologist or cardiologist
Description
This outcome will be searched for by reviewing medical records of, or by interviewing, all participating patients at 1, 3, 6 months and 1 year.
Time Frame
After 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Every newly diagnosed AF patient. Every AF patient who is not seen by a cardiologist or electrophysiologist in the past 2 years before inclusion. AF must be confirmed on electrocardiogram. Capable of providing written informed consent. Dutch speaking and verbally testable, without cognitive impairment. Exclusion Criteria: AF patients who once received an arrhythmologic consult about AF prior to the start of the study. AF patients who have a systematic follow-up at a cardiologist prior to the start of the study. Terminally ill AF patients Participation in another clinical trial
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Berti
Phone
0032-479-845016
Email
dana.berti@uzleuven.be
First Name & Middle Initial & Last Name or Official Title & Degree
Hein Heidbuchel
Phone
0032-16-344248
Email
hein.heidbuchel@uzleuven.be
Facility Information:
Facility Name
UZ Leuven
City
Leuven
State/Province
Vlaams Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dana Berti
Phone
0032-16-341848
Email
dana.berti@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Hein Heidbuchel
Phone
0032-16-344248
Email
hein.heidbuchel@uzleuven.be
First Name & Middle Initial & Last Name & Degree
Dana Berti
First Name & Middle Initial & Last Name & Degree
Hein Heidbuchel

12. IPD Sharing Statement

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Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients

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