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

Effectiveness of an Interdisciplinary, Nurse-coordinated Atrial Fibrillation Expert Program for Primary Care Patients - A Clustered Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Care provided by AF expert program

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dana Berti; Phone Number: 0032-479-845016; Email: dana.berti@uzleuven.be
• Study Contact Backup: Name: Hein Heidbuchel; Phone Number: 0032-16-344248; Email: hein.heidbuchel@uzleuven.be

Study Locations

• Belgium
  • Vlaams Brabant
    • Leuven, Vlaams Brabant, Belgium, 3000
      • UZ Leuven
      • Contact: Hein Heidbuchel; Phone Number: 0032-16-344248; Email: hein.heidbuchel@uzleuven.be
      • Contact: Dana Berti; Phone Number: 0032-16-341848; Email: dana.berti@uzleuven.be
      • Sub-Investigator: Dana Berti
      • Principal Investigator: Hein Heidbuchel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: AF expert program; Care provided by the interdisciplinary, nurse-coordinated AF expert program	Other: Care provided by AF expert program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	after 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	after 1 year
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	after 1 year
Perceived health	Perceived health will be measured by the EuroQol Five Dimensional Questionnaire (EQ-5D-3L)	After 1 year
AF related symptoms and symptom burden	AF related symptoms and symptom burden will be measured by the Leuven Arrhythmia Questionnaire (LARQ)	After 1 year
Patient satisfaction	Patient satisfaction about information provided, about therapy and about follow-up, will be measured with a 10-point visual analog scale (VAS).	After year
Patient knowledge	The Atrial Fibrillation Knowledge Scale (AF knowledge scale) will be used.	After 1 year
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).	After 1 year
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.	After 1 year

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): August 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: August 19, 2013
• First Submitted That Met QC Criteria: August 19, 2013
• First Posted (Estimate): August 23, 2013

Study Record Updates

• Last Update Posted (Estimate): August 26, 2013
• Last Update Submitted That Met QC Criteria: August 23, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: primary care; effectiveness; nurse; implementation; interdisciplinary; expert program; disease management system
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: not yet applicable