在初级保健中，针对血糖控制不佳的 2 型糖尿病患者的共同决策和以患者为中心-DEBATE 试验的集群随机对照结果。

Shared decision making and patient-centeredness for patients with poorly controlled type 2 diabetes mellitus in primary care-results of the cluster-randomised controlled DEBATE trial.

机构信息

Institute of General Practice, Rostock University Medical Centre, Doberaner Str. 142, 18057, Rostock, Germany.

Institute of Medical Biometry and Epidemiology, Medical Centre Hamburg-Eppendorf, Martinistraße 52, 20246, Hamburg, Germany.

出版信息

BMC Fam Pract. 2021 May 15;22(1):93. doi: 10.1186/s12875-021-01436-6.

DOI:10.1186/s12875-021-01436-6

PMID:33992088

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8126132/

Abstract

BACKGROUND

We investigate whether an educational intervention of GPs increases patient-centeredness and perceived shared decision making in the treatment of patients with poorly controlled type 2 diabetes mellitus?

METHODS

We performed a cluster-randomized controlled trial in German primary care. Patients with type 2 diabetes mellitus defined as HbA1c levels ≥ 8.0% (64 mmol/mol) at the time of recruitment (n = 833) from general practitioners (n = 108) were included. Outcome measures included subjective shared decision making (SDM-Q-9; scale from 0 to 45 (high)) and patient-centeredness (PACIC-D; scale from 1 to 5 (high)) as secondary outcomes. Data collection was performed before intervention (baseline, T0), at 6 months (T1), at 12 months (T2), at 18 months (T3), and at 24 months (T4) after baseline.

RESULTS

Subjective shared decision making decreased in both groups during the course of the study (intervention group: -3.17 between T0 and T4 (95% CI: -4.66, -1.69; p < 0.0001) control group: -2.80 (95% CI: -4.30, -1.30; p = 0.0003)). There were no significant differences between the two groups (-0.37; 95% CI: -2.20, 1.45; p = 0.6847). The intervention's impact on patient-centeredness was minor. Values increased in both groups, but the increase was not statistically significant, nor was the difference between the groups.

CONCLUSIONS

The intervention did not increase patient perceived subjective shared decision making and patient-centeredness in the intervention group as compared to the control group. Effects in both groups might be partially attributed to the Hawthorne-effect. Future trials should focus on patient-based intervention elements to investigate effects on shared decision making and patient-centeredness.

TRIAL REGISTRATION

The trial was registered on March 10, 2011 at ISRCTN registry under the reference ISRCTN70713571 .

摘要

背景

我们研究了对全科医生进行教育干预是否会增加治疗控制不佳的 2 型糖尿病患者的以患者为中心和共同决策感知。

方法

我们在德国初级保健中进行了一项群组随机对照试验。招募时患有 2 型糖尿病的患者（定义为 HbA1c 水平≥8.0%（64mmol/mol））（n=833）来自全科医生（n=108）。主要结局包括主观共同决策（SDM-Q-9；0 至 45 分（高分）的评分）和以患者为中心（PACIC-D；1 至 5 分（高分）的评分）。数据采集在干预前（基线，T0）、6 个月（T1）、12 个月（T2）、18 个月（T3）和 24 个月（T4）进行。

结果

在研究过程中，两组的主观共同决策均下降（干预组：T0 至 T4 期间下降 3.17 分（95%CI：-4.66，-1.69；p<0.0001），对照组：-2.80 分（95%CI：-4.30，-1.30；p=0.0003））。两组之间无显著差异（-0.37；95%CI：-2.20，1.45；p=0.6847）。该干预对以患者为中心的影响较小。两组的数值均增加，但增加不具有统计学意义，组间差异也无统计学意义。