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针对高需求、高成本商业保险患者的护理协调:一项随机临床试验。

Care Coordination for High-Need, High-Cost Commercially Insured Patients: A Randomized Clinical Trial.

作者信息

Duru O Kenrik, Harwood Jessica, Moin Tannaz, Takada Sae, Tseng Chi-Hong, Saju Rintu, Lee Ella, Fatehpuria Anusha, Mangione Carol M

机构信息

Division of General Internal Medicine and Health Services Research, David Geffen School of Medicine at UCLA, Los Angeles, California.

Health Services Research and Development, Center for Healthcare Innovation, Implementation, and Policy, VA Greater Los Angeles Health Care System, Los Angeles, California.

出版信息

JAMA Netw Open. 2025 Jun 2;8(6):e2511804. doi: 10.1001/jamanetworkopen.2025.11804.

Abstract

IMPORTANCE

High-need, high-cost (HNHC) patients account for 5% of the US population yet represent nearly half of health care spending.

OBJECTIVE

To evaluate whether national care coordination could reduce health care cost and utilization in a commercially insured HNHC population.

DESIGN, SETTING, AND PARTICIPANTS: This national, 2-arm randomized clinical trial with intention-to-treat and instrumental variable analyses included patients aged 18 years or older who were defined as HNHC according to a proprietary model (in the top 5% of spend within a rolling 12-month claims utilization window and projected to remain in the top 5% over the subsequent 12 months). Patients were randomized from January 2018 to October 2019. Data were analyzed from January 1 to December 31, 2024.

INTERVENTION

Participants were randomized monthly 60:40 to telephonic care coordination from a registered nurse, including medication review, a barriers-to-care survey, addressing urgent coordination needs (eg, patient unable to fill prescriptions), development of a case management plan addressing identified clinical risk factors, and establishing an outreach time frame, or to the control group with usual care. The nurse contacted patients over the 60 days after enrollment until all risk factors included in the management plan were addressed.

MAIN OUTCOMES AND MEASURES

The main outcomes were mean monthly emergency department visits, inpatient hospitalizations, and total plan cost (medical and pharmacy) over 12 months following the index date, defined as the enrollment date for intervention participants or the randomly generated synthetic enrollment date for nonparticipants. Outcomes were examined separately among patients with diabetes.

RESULTS

The analytic sample included 93 379 HNHC patients with a mean (SD) age of 46 (12) years (54% female). In intention-to-treat analyses, there were no differences between groups in mean (SE) monthly emergency department visits (0.033 [0.001] for control vs 0.033 [0.001] for treatment; mean difference [SE], 0 [0]; 95% CI, -0.001 to 0.002; P = .69), inpatient hospitalizations (0.009 [0] for control vs 0.010 [0] for treatment; mean difference [SE], 0.001 [0]; 95% CI, 0-0.002; P = .06), or cost (total: $2507 [$32] for control vs $2568 [$26] for treatment; mean difference [SE], $60 [$41]; 95% CI, -$20 to $140; P = .14). In the instrumental variable analyses and in the subsample with diabetes, no evidence of statistically significant reductions in these outcomes were found.

CONCLUSIONS AND RELEVANCE

In this randomized clinical trial of a national care coordination intervention, neither health care cost nor acute care utilization was reduced in the intervention group compared with the control group. The results emphasize the challenges of improving efficiency of care in a complex HNHC population with escalating health care costs.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04415515.

摘要

重要性

高需求、高成本(HNHC)患者占美国人口的5%,但却占医疗保健支出的近一半。

目的

评估全国性护理协调能否降低商业保险的HNHC人群的医疗保健成本和利用率。

设计、设置和参与者:这项全国性的双臂随机临床试验采用意向性分析和工具变量分析,纳入了18岁及以上的患者,这些患者根据一种专有模型被定义为HNHC(在滚动的12个月索赔使用窗口内支出处于前5%,并预计在随后的12个月内仍处于前5%)。患者于2018年1月至2019年10月被随机分组。数据于2024年1月1日至12月31日进行分析。

干预措施

参与者每月以60:40的比例随机分配接受注册护士的电话护理协调,包括药物审查、护理障碍调查、解决紧急协调需求(如患者无法取药)、制定针对已识别临床风险因素的病例管理计划以及确定外联时间框架,或分配至接受常规护理的对照组。护士在入组后的60天内联系患者,直至管理计划中包含的所有风险因素都得到解决。

主要结局和指标

主要结局为索引日期(定义为干预参与者的入组日期或非参与者随机生成的模拟入组日期)后12个月内的平均每月急诊就诊次数、住院次数以及总计划成本(医疗和药房)。结局在糖尿病患者中分别进行检查。

结果

分析样本包括93379名HNHC患者,平均(标准差)年龄为46(12)岁(54%为女性)。在意向性分析中,两组在平均(标准误)每月急诊就诊次数(对照组为0.033[0.001],治疗组为0.033[0.001];平均差值[标准误],0[0];95%置信区间,-0.001至0.002;P = 0.69)、住院次数(对照组为0.009[0],治疗组为0.010[0];平均差值[标准误],0.001[0];95%置信区间,0至0.002;P = 0.06)或成本(总计:对照组为2507美元[32美元],治疗组为2568美元[26美元];平均差值[标准误],60美元[41美元];95%置信区间,-20美元至140美元;P = 0.14)方面均无差异。在工具变量分析以及糖尿病亚组中,未发现这些结局有统计学显著降低的证据。

结论及相关性

在这项全国性护理协调干预的随机临床试验中,与对照组相比,干预组的医疗保健成本和急性护理利用率均未降低。结果强调了在医疗保健成本不断上升的复杂HNHC人群中提高护理效率所面临的挑战。

试验注册

ClinicalTrials.gov标识符:NCT04415515。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a061/12188368/116d7cde7e7f/jamanetwopen-e2511804-g001.jpg

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