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临床试验/NCT06108817
NCT06108817已完成不适用

Low-value Chronic Prescription of Acid Reducing Medication Among Dutch General Practitioners: Impact of a Patient Education Intervention

Radboud University Medical Center2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
2
主要终点
patients receiving a low-value chronic ARM prescription

研究概览

简要总结

Dyspepsia is a commonly encountered clinical condition in Dutch general practice, which is often treated through the prescription of acid-reducing medication (ARM). However, recent studies indicate that the majority of chronic ARM users lack an indication for their use and that their long-term use is associated with adverse outcomes. A patient-focussed educational intervention was developed aiming to reduce low-value (chronic) use of ARM. This study is a randomized controlled study, evaluating its effect on the low-value chronic prescription of ARM using data from a subset of practices from the Nivel Primary Care Database. The intervention involves distributing an educational waiting room posters and flyers informing both patients and general practitioners (GPs) regarding the appropriate indications for prescription of an ARM for dyspepsia, which also referred to an online decision aid. The interventions' effect is evaluated through calculation of the odds ratio of a patient receiving a low-value chronic ARM prescription over the second half of 2021 and 2022 (i.e. pre-intervention vs. post-intervention).

详细描述

A randomized controlled interventional study was conducted and evaluated using data derived from a subset of practices participating in the Nivel Primary Care Database (Nivel-PCD). The Nivel-PCD contains care data routinely collected from the electronic medical records from 529 GP practices throughout the Netherlands, representing approximately 2 million registered patients. Furthermore, the database contains longitudinal information regarding patient characteristics such as age, sex, GP consultations, diagnoses, and drug prescriptions. Socioeconomic status (SES) scores (on the level of Dutch postal codes) were obtained from the Central Statistical Office (CBS). Patients were assigned to one of five categories (lowest, below average, average, above average, highest) based on quintiles. Age categories were defined based on the available GP guidelines. Diagnoses are recorded using the International Classification of Primary Care version 1 (ICPC-1). Prescriptions are recorded using the Anatomical Therapeutic Chemical classification system (ATC). This study was approved by the relevant governance bodies of the Nivel-PCD (nr. NZR00322.017) and by the Research Ethics Committee of the Radboud University Medical Centre (dossier number 2022-13579).

Intervention and recruitment The intervention consisted of the distribution of a poster for the waiting room and flyers to be given to patients aiming to inform both patients and GPs with respect to the correct indications for treatment of dyspepsia. After signing up, practices assigned to the intervention group received a package containing 60 flyers and one waiting room poster to use during consultations. The flyer and poster provide a short description of the correct indications for treatment of dyspepsia. Additionally, both the flyers and posters contained a QR-code linking to a decision aid explaining the correct indications and causes of dyspepsia.

Recruitment of the practices took place from July until October of 2022. Practices were recruited from the pool of practices that provide their registration data to the Nivel. The recruitment involved sending several e-mails asking for their participation. The responding practices were randomly assigned to either the intervention or control group. Throughout the recruitment process, no information regarding the exact research topic or the intervention was provided, ensuring the blind participation of the practices.

Sample size calculation Based on a z-test sample size calculation using the proportion of patients that received an inappropriate chronic ARM prescription observed in an earlier assessment in the Netherlands (88% of chronic ARMs users do not have an indication), an alpha of 0.05, power of 0.80 and an expected reduction of 10%, a minimum number of 28 GP practices (with a mean of 328 patients that are inappropriately using a chronic ARM) were required to achieve significance.

Randomisation The participating general practitioners were recruited in a blinded manner from the Nivel-PCD. Meaning that the GPs were approached by the Nivel-PCD without receiving information regarding the purpose of the study. After having consented to participation, GPs were randomly assigned to either the intervention or control group. When a GP was assigned to the intervention group, the entire practice was seen as being exposed. GPs assigned to the intervention group received the poster and flyers, to be shared with the patients suffering from dyspepsia. GPs assigned to the control group received nothing. However, it is important to note that the access to the decision aid was not limited to the GPs of the intervention group and their patients, it was freely accessible to anyone through the website Thuisarts.nl.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • the pool of practices that provide their registration data to the Nivel

排除标准

  • 未提供

结局指标

主要结局

patients receiving a low-value chronic ARM prescription

时间窗: 4 months

the incidence rate of (inappropriate) chronic ARM prescriptions in the same 6 months before and after the intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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