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PICANT Cluster RCT

Cite as:

Siebenhofer, Prof. Dr. A. (Goethe-University Frankfurt am Main, Institute for General Practice, Germany) (): PICANT Cluster RCT. DANS. https://doi.org/10.17026/dans-2z5-pbz6

2016-11-01 Siebenhofer, Prof. Dr. A. (Goethe-University Frankfurt am Main, Institute for General Practice, Germany) 10.17026/dans-2z5-pbz6

To examine whether applying case management in general practices reduces thromboembolic events requiring hospitalization and major bleeding events (combined primary outcome), as well as mortality, frequency and duration of hospitalization, severe treatment interactions, adverse events, quality of anticoagulation, health-related quality of life, and intervention costs, patients’ assessment of chronic illness care, self-reported adherence to medication, GP and HCA knowledge, patient knowledge , and satisfaction with shared decision-making.
Cluster-randomized controlled trial undertaken at 52 general practices in Germany with adult patients with a long-term indication for oral anticoagulation. The complex intervention included training for healthcare assistants, information and quality circles for general practitioners, and 24 months of case management for patients. Assessment was after 12 and 24 months. The intention-to-treat population included all randomized practices and patients, the per-protocol analysis included only those that received treatment without major protocol violations.
The mean (SD) age of the 736 patients was 73.5 (9.4) years and 597 (81.1%) had atrial fibrillation. After 24 months, the primary endpoint had occurred in 40 (11.0%) intervention and 48 (12.9%) control patients (hazard ratio 0.83, 95% CI 0.55 to 1.25; P=.37). Patients’ perceived quality of care, patients’ knowledge and HCAs’ knowledge improved significantly at 24 months. The other secondary endpoints did not differ between groups. For patients obtaining treatment without major protocol deviations, hospital admissions were significantly reduced in the intervention group.
Even though the main outcomes did not differ significantly, the intervention appears to have positively influenced some process parameters under ‘real-world conditions’