Improving patient self-reporting of antihypertensive adverse drug events in primary care: a stepped wedge cluster randomised trial

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).

Patient and family engagement interventions in primary care patient safety: a systematic review and meta-analysis

“…Of the eight completed RCTs, improvements were reported in all of those focusing on adverse drug events (all at Level 1 engagement; 40,44,48). Among completed RCTs focusing on medication appropriateness, only one out of four found a significant positive effect (Level 2 engagement; 38), whereas three other RCTs, all at Level 1 engagement, did not find significant effects (41,43,50).…”

“…All of the selected studies were published between 2001 and 2021 (Table 2). Five studies were cluster Randomized Controlled Trials (RCTs) (45, 48, 50, 51, 54), three were standard RCTs (46, 49, 58), and six consisted of RCT protocols, (43, 44, 47, 55–57) and two were trial registration records (52, 53).…”

“…Geographically, the selected records were distributed across regions, with seven (43, 44, 46–49, 52) were sourced from the United States, the remaining ten originating from various countries, including Germany (50, 51),France (45, 55)), Spain ((53, 57) both from the same project), Canada (56), the United Kingdom (58), and Australia (54). The authors’ country of affiliation matched where projects were carried out for all RCTs.…”

Expanding Family Health History to Include Family Medication History

“…Discrepancies between self-reported medication history and prescription history in the medical record have been demonstrated [ 63 , 64 ], highlighting patient unawareness, confusion, and poor recollection [ 65 ]. Additionally, patient reporting of adverse events has been reported to be low [ 66 ]. Reconstruction of a patient’s medication history from the medical record, if feasible, is likely to be time-consuming and incomplete [ 67 ].…”

“…Lastly, the collection and review of additional information will likely add to the provider’s consultation time per patient, and potentially the need for more healthcare professionals, especially pharmacists and multidisciplinary teams [ 66 , 79 , 80 ]. Digital tools to facilitate documentation of medication (e.g., medication tracking apps) and adverse events may improve accuracy and timely reporting [ 81 ] and avoid inaccuracies associated with patient recall.…”