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Open Access 01-12-2021 | Care | Research

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

Authors: Karine Buchet-Poyau, Pauline Occelli, Sandrine Touzet, Carole Langlois-Jacques, Sophie Figon, Jean-Pierre Dubois, Antoine Duclos, Marc Chanelière, Cyrille Colin, Muriel Rabilloud, Maud Keriel-Gascou

Published in: BMC Primary Care | Issue 1/2021

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).

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Title: Improving patient self-reporting of antihypertensive adverse drug events in primary care: a stepped wedge cluster randomised trial
Authors: Karine Buchet-Poyau
Pauline Occelli
Sandrine Touzet
Carole Langlois-Jacques
Sophie Figon
Jean-Pierre Dubois
Antoine Duclos
Marc Chanelière
Cyrille Colin
Muriel Rabilloud
Maud Keriel-Gascou
Publication date: 01-12-2021
Publisher: BioMed Central
Keyword: Care
Published in: BMC Primary Care / Issue 1/2021
Electronic ISSN: 2731-4553
DOI: https://doi.org/10.1186/s12875-021-01478-w

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

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

Abstract

Background

Methods

Results

Conclusion

Trial registration

At a glance: The ONWARDS insulin icodec trials

Springer Medicine

Abstract

Background

Methods

Results

Conclusion

Trial registration

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