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法国首次 COVID-19 封锁期间全科医生电话随访 6 个月的结果(COVIQuest):使用医疗管理数据库的集群随机试验。

Six-month outcomes after a GP phone call during the first French COVID-19 lockdown (COVIQuest): a cluster randomised trial using medico-administrative databases.

机构信息

Epidemiology Unit for Clinical Data in Centre-Val de Loire (EpiDcliC), CHRU de Tours, Tours, Centre-Val de Loire, France

University of Tours, Tours, Centre-Val de Loire, France.

出版信息

BMJ Open. 2024 Nov 24;14(11):e085094. doi: 10.1136/bmjopen-2024-085094.

Abstract

OBJECTIVES

The first COVID-19 lockdown raised concerns about reduced access to primary care, especially for people with chronic diseases particularly at risk in the absence of follow-up. However, the COVIQuest trial, evaluating the impact of a general practitioner (GP) phone call (intervention) to chronic patients with cardiovascular disease (CVD) or mental health disorder (MHD) concluded that the intervention had no effect at 1 month on the rate of self-reported hospitalisations in the CVD subtrial, whereas the intervention group in MHD subtrial might have a higher rate. This second part of the study aimed to describe the 6 month hospitalisation and specialised consultation rates, using the French health data system (). The secondary objective was to describe these rates during the same period in 2019.

DESIGN

A cluster randomised controlled trial, with clusters being GPs.

SETTING

Primary care, 149 GPs from eight French regions.

PARTICIPANTS

Patients ≥70 years old with chronic CVD or ≥18 years old with MHD.

INTERVENTIONS

A standardised GP-initiated phone call aiming to evaluate patient's need for urgent care (vs usual care for control groups).

PRIMARY AND SECONDARY OUTCOME MEASURES

The occurrence of at least one hospitalisation at end point 31 October 2020 (randomisation 30 April 2020), excluding those starting on 30 April 2020, was measured as planned. Another main outcome was the occurrence of at least one specialised consultation during the same period. These 6 month effects were studied, using a logistic regression model within a generalised estimating equation framework, for each subtrial.

RESULTS

4640 patients were included: 3274 cardiovascular (mean age 79.9±7.0 years; 57.8% male) and 1366 psychiatric (53.2±7.0; 36.5%). For both subtrials, the intervention patients were significantly more hospitalised than the control patients, respectively, 17.3% versus 14.9% of CVD patients (OR=1.26 (1.05 to 1.52)); 14.4% versus 10.7% of MHD patients (OR=1.40 (1.00 to 1.96)). During the same period in 2019, the hospitalisation rates were, respectively, 16.3%, 18.2%, 15.8% and 14.8%. The proportions of patients with at least one specialised consultation were not different between the intervention and control groups, respectively, 24.6% versus 24.3% for CVD patients (OR=1.06 (0.85 to 1.32)); 26.5% versus 24.4% for MHD patients (OR=1.15 (0.84 to 1.57)). During the same period in 2019, these rates were, respectively, 22.7%, 24.6%, 28.0% and 25.5%.

CONCLUSIONS

The intervention was associated with higher rates of hospitalisation at 6 months in patients with MHD or CVD. No intervention impact was found in outpatient care. These results are difficult to interpret because of a potential artefact induced by national campaigns promoting medical use during lockdown, overlapping the study inclusion period. This study showed that medico-administrative databases could represent a complementary cost-effective tool to clinical research for long-term and healthcare consumption outcomes.

TRIAL REGISTRATION NUMBER

NCT04359875.

摘要

目的

第一次 COVID-19 封锁引起了人们对初级保健服务获取减少的担忧,特别是对于那些在没有后续治疗的情况下处于高风险的慢性疾病患者。然而,COVIQuest 试验评估了全科医生(GP)对心血管疾病(CVD)或精神健康障碍(MHD)慢性患者的电话(干预)的影响,得出的结论是,在 CVD 子试验中,干预在 1 个月时对自我报告的住院率没有影响,而 MHD 子试验中的干预组可能有更高的住院率。本研究的第二部分旨在使用法国健康数据系统()描述 6 个月的住院和专科咨询率。次要目标是描述 2019 年同期的这些比率。

设计

一项集群随机对照试验,集群为全科医生。

设置

初级保健,来自法国八个地区的 149 名全科医生。

参与者

≥70 岁的慢性 CVD 患者或≥18 岁的 MHD 患者。

干预措施

由全科医生发起的标准化电话,旨在评估患者是否需要紧急护理(对照组为常规护理)。

主要和次要结果

测量截至 2020 年 10 月 31 日(随机分组 2020 年 4 月 30 日)的至少一次住院的发生情况,不包括从 2020 年 4 月 30 日开始的住院情况。另一个主要结果是在同一时期内至少进行一次专科咨询。使用广义估计方程框架内的逻辑回归模型,针对每个子试验研究了 6 个月的效果。

结果

共纳入 4640 名患者:3274 名心血管患者(平均年龄 79.9±7.0 岁;57.8%为男性)和 1366 名精神科患者(53.2±7.0;36.5%)。对于两个子试验,干预组患者的住院率明显高于对照组患者,CVD 患者分别为 17.3%和 14.9%(OR=1.26(1.05 至 1.52));MHD 患者分别为 14.4%和 10.7%(OR=1.40(1.00 至 1.96))。在 2019 年同期,住院率分别为 16.3%、18.2%、15.8%和 14.8%。干预组和对照组之间至少有一次专科咨询的患者比例没有差异,CVD 患者分别为 24.6%和 24.3%(OR=1.06(0.85 至 1.32));MHD 患者分别为 26.5%和 24.4%(OR=1.15(0.84 至 1.57))。在 2019 年同期,这些比率分别为 22.7%、24.6%、28.0%和 25.5%。

结论

该干预措施与 MHD 或 CVD 患者 6 个月的住院率升高有关。在门诊护理方面没有发现干预的影响。由于在研究纳入期间全国范围内开展了促进封锁期间医疗使用的宣传活动,可能会产生潜在的人为因素,导致这些结果难以解释。本研究表明,医疗管理数据库可能是临床研究的一种补充、具有成本效益的工具,可用于长期和医疗保健消费结果。

试验注册

NCT04359875。

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