Karine Buchet-Poyau1, Pauline Occelli2,3, Sandrine Touzet2,3, Carole Langlois-Jacques4, Sophie Figon5, Jean-Pierre Dubois5, Antoine Duclos3,6, Marc Chanelière2,3,5, Cyrille Colin3,7, Muriel Rabilloud4,8, Maud Keriel-Gascou2,5. 1. Hospices Civils de Lyon, Pôle de santé publique, Service Recherche et Epidémiologie Clinique, F-69003, Lyon, France. karine.poyau@chu-lyon.fr. 2. Hospices Civils de Lyon, Pôle de santé publique, Service Recherche et Epidémiologie Clinique, F-69003, Lyon, France. 3. Laboratoire Research on Healthcare Performance RESHAPE, INSERM U1290, Université Lyon 1, F-69622, Villeurbanne, France. 4. Hospices Civils de Lyon, Pôle de santé publique, Service de Biostatistique, F-69002, Lyon, France. 5. Collège universitaire de Médecine Générale, Université Lyon 1, F-69622, Villeurbanne, France. 6. Hospices Civils de Lyon, Pôle de santé publique, Service des Données de Santé, F-69003, Lyon, France. 7. Hospices Civils de Lyon, Pôle de santé publique, Service d'Evaluation Economique en Santé, F-69003, Lyon, France. 8. CNRS, UMR 5558, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique Santé, Université Lyon 1, F-69622, Villeurbanne, France.
Abstract
BACKGROUND: About 25% of patients experience adverse drug events (ADE) in primary care, but few events are reported by the patients themselves. One solution to improve the detection and management of ADEs in primary care is for patients to report them to their general practitioner. The study aimed to assess the effect of a booklet designed to improve communication and interaction between patients treated with anti-hypertensive drugs and general practitioners on the reporting of ADEs. METHODS: A cluster randomized controlled cross-sectional stepped wedge open trial (five periods of 3 months) was conducted. A cluster was a group of general practitioners working in ambulatory offices in France. Adults consulting their general practitioner to initiate, modify, or renew an antihypertensive prescription were included. A booklet including information on cardiovascular risks, antihypertensive treatments, and ADE report forms was delivered by the general practitioner to the patient in the intervention group. The primary outcome was the reporting of at least one ADE by the patient to his general practitioner during the three-month period after enrolment. Two clusters were randomised by sequence for a total of 8 to receive the intervention. An intention-to-treat analysis was conducted. A logistic mixed model with random intercept was used. RESULTS:Sixty general practitioners included 1095 patients (median: 14 per general practitioner; range: 1-103). More patients reported at least one ADE to their general practitioner in the intervention condition compared to the control condition (aOR = 3.5, IC95 [1.2-10.1], p = 0.02). The modification and initiation of an antihypertensive treatment were also significantly associated with the reporting of ADEs (aOR = 4.4, CI95 [1.9-10.0], p < 0.001 and aOR = 11.0, CI95 [4.6-26.4], p < 0.001, respectively). The booklet delivery also improved patient satisfaction on general practitioner communication and high blood pressure management. CONCLUSION: A booklet can improve patient self-reporting of ADEs to their general practitioners. Future research should assess whether it can improve general practitioner management of ADEs and patient's health status. TRIAL REGISTRATION: Trial registry identifier NCT01610817 (2012/05/30).
RCT Entities:
BACKGROUND: About 25% of patients experience adverse drug events (ADE) in primary care, but few events are reported by the patients themselves. One solution to improve the detection and management of ADEs in primary care is for patients to report them to their general practitioner. The study aimed to assess the effect of a booklet designed to improve communication and interaction between patients treated with anti-hypertensive drugs and general practitioners on the reporting of ADEs. METHODS: A cluster randomized controlled cross-sectional stepped wedge open trial (five periods of 3 months) was conducted. A cluster was a group of general practitioners working in ambulatory offices in France. Adults consulting their general practitioner to initiate, modify, or renew an antihypertensive prescription were included. A booklet including information on cardiovascular risks, antihypertensive treatments, and ADE report forms was delivered by the general practitioner to the patient in the intervention group. The primary outcome was the reporting of at least one ADE by the patient to his general practitioner during the three-month period after enrolment. Two clusters were randomised by sequence for a total of 8 to receive the intervention. An intention-to-treat analysis was conducted. A logistic mixed model with random intercept was used. RESULTS: Sixty general practitioners included 1095 patients (median: 14 per general practitioner; range: 1-103). More patients reported at least one ADE to their general practitioner in the intervention condition compared to the control condition (aOR = 3.5, IC95 [1.2-10.1], p = 0.02). The modification and initiation of an antihypertensive treatment were also significantly associated with the reporting of ADEs (aOR = 4.4, CI95 [1.9-10.0], p < 0.001 and aOR = 11.0, CI95 [4.6-26.4], p < 0.001, respectively). The booklet delivery also improved patient satisfaction on general practitioner communication and high blood pressure management. CONCLUSION: A booklet can improve patient self-reporting of ADEs to their general practitioners. Future research should assess whether it can improve general practitioner management of ADEs and patient's health status. TRIAL REGISTRATION: Trial registry identifier NCT01610817 (2012/05/30).
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