Arterial Hypertension, Atrial Fibrillation
Conditions
Keywords
clinical practice guidelines, Clinical Decision Support Systems, adherence to guidelines, evidence-based medicine
Brief summary
The Clinical Decision Support Systems (CDSS) based on real clinical data and its own algorithms can help to make the right choice according to guidelines. The goal of the INTELLECT II study is to investigate treatment adherence to guidelines/science-based medicine and its impact on patient outcomes into two groups of doctors, clinical centers with standard care of treatment (control), and clinical centers using CDSS (active).
Detailed description
Hypertension and atrial fibrillation are 2 important public health priorities. There is a gap between evidence-based best management and actual clinical practice. To decrease this gap, clinical practice guidelines (CPGs), based on available evidence are employed. Clinical decision support system ("MedicBK") is a computer-based program that analyzes published evidence and provides prompts and reminders to assist health care providers in implementing clinical guidelines and science-based medicine at the point of care. The INTELLECT II trial is designed as a multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment. Approximately 10 centers from Russia will be enrolled. Centers managing patients with symptomatic atrial fibrillation and/or hypertension will be randomized to either patient management with aid of CDSS ("MedicBK") or standard care.
Interventions
OTHERCDSS ("MedicBK")
Clinical decision support system ("MedicBK") is a computer-based program that analyzes published evidence and provides prompts and reminders to assist health care providers in implementing clinical guidelines and science-based medicine at the point of care.
Sponsors
Samara Regional Cardiology Dispensary
Medicbook LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years old * Patients diagnosed with nonvalvular atrial fibrillation and hypertension and indications for therapy according to European guidelines.
Exclusion criteria
* Inability to adhere to study procedures * Severe heart-valve disorder * Stroke within 14 days or severe stroke within 6 months before screening * Active bleedings * Thyroid dysfunction * Pregnancy * Secondary hypertension
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance with AF/hypertension clinical practice guidelines | 1 month | number of patients treated in accordance with current ESC clinical guidelines for management atrial fibrillation evaluated by independent professionals compared with Clinical decision support system MedicBK |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total cardiovascular events | 6 months | total stroke or systemic embolism, total coronary heart disease, major bleeding, recurrence of atrial fibrillation, hospitalization or death from congestive heart failure and other significant vascular deaths |
| Total mortality | 6 months | death from all causes |
| total number of non-planing visits and hospitalization | 6 months | non-planing hospitalizations, non-planning visits, urgent visits |
Countries
Russia
Outcome results
None listed