Efficiency of an interactive program for enhancing patient reporting of adverse drug events in primary care

Introduction Adverse drug events (ADE) are frequents in primary care. They could often be prevented and their complications avoided. One of the main causes is that patients rarely know how to detect ADE. Another cause is inadequate communication between patients and physicians. If patients were effectively trained in identifying and reporting ADE, this should enhance ADE management (and avoid consequences on patient's health). The aim of the InPAct study was to assess an interactive programpromoting patients to be active in ADE identification and their reporting to their general practitioners (GP), in order to enhance ADE management in primary care. We focused on patients treated by anti-hypertensive drugs, mainly prescribed in primary care and known to be often responsible for ADE. Methods/design We conducted a cluster randomized controlled stepped wedge trial, with eight clusters of GP. The InPAct program was implemented in the clusters in random order along five successive three-month periods. The program featured: – a patient booklet including information on cardiovascular risks and management of antihypertensive drugs, care plans and patient ADE report forms; – standardized training of physicians in how to present the booklet to the patient. The primary outcome was the active reporting of ADE by patients to their GP within three months of inclusion, after the identification of the ADE by the patients themselves. Total ADE identification (i.e. ADE identified by physician or patient, independently of patient active reporting to their practitioner), knowledge of patient about cardiovascular risks and management of antihypertensive treatments and patient satisfaction about their care management by their general practitioner were evaluated as secondary outcomes. The effect of the intervention was quantified and tested using a mixed logistic model to integrate cluster and time effects. Results We analyzed data for 1095 patients included by 60 different GP belonging to the 8 clusters. Multivariate analyses showed that InPAct program efficiently enhanced active reporting of ADE by patients to their GP (OR = 3.5, 95 CI [1.2–10.1], P = 0.02), but also total ADE identification (OR = 2.6, 95 CI [1.3–5.1], P = 0.01). The anti-hypertensive prescription status (initiation, modification or renewal) was strongly associated with patient active ADE reporting and total ADE identification. Moreover, patient satisfaction about their care management by their GP was higher in the intervention group, as the communication or the given information by the practitioner were concerned. Conclusion The InPAct intervention constituted an original program that was intended to improve ADE management in primary care by enhancing patient involvement in their own care. Finally, the InPAct intervention was efficient not only to enhance patient ADE identification associated with an active reporting, but also total ADE identification and communication between patients and their practitioners. Our study suggests that a better communication between patients and GP could improve patient safety in primary care.