Differences in the quality of oral anticoagulation therapy with vitamin K antagonists in German GP practices - results of the cluster-randomized PICANT trial (Primary Care Management for Optimized Antithrombotic Treatment).

BACKGROUND: In Germany, patients receiving oral anticoagulation (OAC) are often treated by general practitioners (GPs), and large proportions of patients receive vitamin K antagonists (VKAs). The quality of OAC in German GP practices, differences between various practices, and improvement potential through implementation of case management, have not yet been investigated satisfactorily. Based on results of a cluster-randomized controlled trial, we aimed to assess whether OAC quality can be improved, any variations between practices exist and determine practice- and patient-level factors. METHODS: The PICANT trial (2012-2015) was performed in 52 GP practices in Hesse, Germany. Adult patients with long-term indication for OAC received best practice case management in the intervention group. International normalized ratio (INR) values were recorded from anticoagulation passes. The Rosendaal method was used to calculate Time in Therapeutic Range (TTR) at patient level, and mean pooling to obtain center-specific TTR (cTTR) at practice level. The quality of OAC was assessed by TTR and cTTR. Linear model analyses were used to investigate associations between practice-/ patient-level factors and TTR. RESULTS: Inclusion of 736 patients (49.6% intervention and 50.4% control patients); 690 (93.8%) received phenprocoumon. Within 24 months, the TTR was 75.1% (SD 17.6) in the intervention versus 74.3% (SD 17.8) in the control group (p = 0.670). The cTTR averaged 75.1% (SD 6.5, range: 60.4 to 86.7%) in the intervention versus 74.3% (SD 7.2, range: 52.7 to 85.7%) in the control group (p = 0.668). At practice level, the TTR was significantly lower in practices with a male physician and certification in quality management. At patient level, the TTR was significantly higher in patients with moderate to high compliance, in men, and in patients that performed self-management. The TTR was significantly lower in patients with certain comorbidities, and who were hospitalized. CONCLUSIONS: The intervention did not effectively improve OAC quality compared to routine care. Quality of INR control was generally good, but considerable variation existed between GP practices. The variability indicates optimization potential in some practices. The demonstrated association between patient-level factors and TTR highlights the importance of considering patient characteristics that may impede achieving high quality therapeutic outcomes. TRIAL REGISTRATION: ISRCTN registry, ISRCTN41847489 , registered 27 February 2012.

Fast-track intubation for accelerated interventional stroke treatment.

BACKGROUND: As intravenous thrombolysis frequently fails to recanalize occluded proximal intracerebral arteries, interventional recanalization therapy is increasingly being considered as treatment option in acute ischemic stroke patients. The optimal periprocedural patient management for these interventions is currently unknown. The aim of this study was to identify factors delaying door-to-treatment times, and to evaluate the effect of a fast-track intubation standard operating procedure (I-SOP) on door-to-angiography time. METHODS: First, we retrospectively reviewed records of 48 acute stroke patients who were treated by interventional recanalization of intracranial occlusions between 2006 and 2009 at our institution. Time to angiography was defined as time from hospital admission to the beginning of the angiographic procedure. Second, an I-SOP for fast-track intubation was implemented and effects on door-to-angiography time were prospectively analyzed in 23 consecutive patients. RESULTS: In the retrospective dataset (n = 48), the mean door-to-angiography time was 2.2 ± 0.1 h (mean ± SEM). A clinically relevant time loss attributable to the intubation procedure was suggested by a 51 ± 21 min shorter door-to-angiography time for patients already intubated prior to admission (P = 0.0189). Additional factors associated with a prolonged door-to-angiography time were: door-to-diagnosis time (P < 0.001), onset-to-door time (P = 0.0117), and male gender (mean difference +27 ± 15 min, P = 0.0822). In the prospective dataset (n = 23), I-SOP implementation reduced mean door-to-angiography time by 25 ± 10 min (P = 0.0164). CONCLUSIONS: In acute stroke patients, intubation prior to interventional recanalization therapy can delay treatment initiation. The implementation of an I-SOP accelerates interventional treatment initiation.

Primary care management for patients receiving long-term antithrombotic treatment: A cluster-randomized controlled trial.

PURPOSE: To examine whether applying case management in general practices reduces thromboembolic events requiring hospitalization and major bleeding events (combined primary outcome). Secondary endpoints were 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. METHODS: 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, while the per-protocol analysis included only those that received treatment without major protocol violations. RESULTS: 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, their knowledge, and HCAs' knowledge, had improved significantly at 24 months. The other secondary endpoints did not differ between groups. In the intervention group, hospital admissions were significantly reduced in patients that received treatment without major protocol deviations. CONCLUSIONS: Even though the main outcomes did not differ significantly, the intervention appears to have positively influenced several process parameters under 'real-world conditions'.