Open AccessPrimary care management for patients receiving long-term antithrombotic treatment: A cluster-randomized controlled trial
Author(s) -
Andrea Siebenhofer,
Lisa-Rebekka Ulrich,
Karola Mergenthal,
Andrea Berghold,
Gudrun Pregartner,
Birgit Kemperdick,
Sylvia Schulz-Rothe,
Sandra Rauck,
Sebastian Harder,
Ferdinand M. Gerlach,
Juliana J. Petersen
Publication year - 2019
Publication title -
plos one
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.99
H-Index - 332
ISSN - 1932-6203
DOI - 10.1371/journal.pone.0209366
Subject(s) - medicine , randomized controlled trial , quality of life (healthcare) , clinical endpoint , adverse effect , cluster randomised controlled trial , hazard ratio , population , atrial fibrillation , emergency medicine , intention to treat analysis , cluster (spacecraft) , intervention (counseling) , patient satisfaction , physical therapy , pediatrics , confidence interval , surgery , nursing , environmental health , computer science , programming language
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’.