Chair of Health Economics, TUM School of Medicine and Health, Technical University of Munich, Georg-Brauchle-Ring 60/62, Munich, 80992, Germany.
Vivantes - Netzwerk für Gesundheit GmbH, Berlin, Germany.
BMC Med. 2024 Oct 21;22(1):480. doi: 10.1186/s12916-024-03691-7.
We conducted a prospective, randomized, controlled, two-group parallel trial investigating the effectiveness of a care management program employing cardiac care navigators providing post-discharge support to patients compared to standard care.
The intervention commenced in 2019/2020 for 2862 patients hospitalized with heart failure, coronary heart disease, or cardiac arrhythmias in departments of cardiology across eight participating sites of a hospital group in Berlin, Germany. We analyzed the results using an intention-to-treat approach. The primary outcome was the all-cause rehospitalization rate after 12 months. Secondary outcomes included rehospitalizations due to one of the qualifying cardiac diagnoses, duration of rehospitalization, mortality, health-related quality of life, and several process indicators. Trial data were collected from a combination of face-to-face and phone interviews conducted by hospital staff throughout the 12-month follow-up period using standardized questionnaires. Administrative claims data were provided by a large statutory health insurer. Outcomes for the intervention and control groups were compared using logistic regression, generalized linear models (GLMs) with a negative binomial distribution, ordinary least squares, and Cox proportional hazards regression.
Compared to the control group (N = 1294), the intervention group (N = 1256) had a lower rate of all-cause rehospitalizations (62.6% vs. 66.4%, p = 0.05) and shorter lengths of stay (14.49 vs. 16.89 days, p = 0.02) during the 12-month follow-up period. These differences were also present for rehospitalizations due to the cardiac diseases qualifying for study recruitment, with rehospitalization rates for the intervention and control groups being 58.0% vs. 61.4% (p = 0.08) and particularly pronounced for lengths of rehospitalization stay of 12.97 vs. 15.40 days (p = 0.01), respectively. Subgroup analyses indicated positive effects of the intervention for patients 70 years and older (p = 0.05), females (p = 0.06), and those with little or no German language proficiency (p = 0.03). Furthermore, we found positive effects on patients' adherence to health-related behavioral recommendations (81.91% vs. 73.95%, p = 0.000).
This study adds to the body of evidence indicating that care management interventions supporting patients as they transition from the inpatient to the outpatient sector can lower rehospitalizations, decrease length of rehospitalization stays, and improve adherence to post-discharge recommendations.
German Clinical Trial Register, DRKS00020424 . Registered 2020-06-18. (retrospectively registered).
我们进行了一项前瞻性、随机、对照、两臂平行试验，旨在研究心脏护理导航员提供出院后支持的护理管理方案对患者的有效性，与标准护理相比。
该干预措施于 2019/2020 年在德国柏林一家医院集团的 8 个参与站点的心脏病学部门开始，对因心力衰竭、冠心病或心律失常住院的 2862 名患者进行。我们采用意向治疗方法分析结果。主要结局是 12 个月后全因再入院率。次要结局包括因符合纳入标准的心脏诊断之一再入院、再入院持续时间、死亡率、健康相关生活质量和几个过程指标。试验数据通过医院工作人员在整个 12 个月随访期间进行的面对面和电话访谈收集，使用标准化问卷。行政索赔数据由一家大型法定健康保险公司提供。使用逻辑回归、具有负二项分布的广义线性模型 (GLM)、普通最小二乘法和 Cox 比例风险回归比较干预组和对照组的结局。
与对照组（N=1294）相比，干预组（N=1256）的全因再入院率较低（62.6% vs. 66.4%，p=0.05），住院时间较短（14.49 天 vs. 16.89 天，p=0.02）在 12 个月的随访期间。对于因符合研究招募标准的心脏疾病而导致的再入院，也存在这些差异，干预组和对照组的再入院率分别为 58.0%和 61.4%（p=0.08），特别是再入院时间分别为 12.97 天和 15.40 天（p=0.01）。亚组分析表明，该干预措施对 70 岁及以上患者（p=0.05）、女性（p=0.06）和德语水平较低或几乎没有德语水平的患者（p=0.03）有积极影响。此外，我们发现该干预措施对患者健康相关行为建议的依从性有积极影响（81.91% vs. 73.95%，p=0.000）。
本研究进一步证实了护理管理干预措施支持患者从住院到门诊过渡可以降低再入院率、缩短再入院时间并提高出院后建议的依从性。
德国临床试验注册处，DRKS00020424。注册日期：2020 年 6 月 18 日（回顾性注册）。
