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自我管理支持干预对老年人哮喘结局的影响:SAMBA研究随机临床试验

Effect of a Self-management Support Intervention on Asthma Outcomes in Older Adults: The SAMBA Study Randomized Clinical Trial.

作者信息

Federman Alex D, O'Conor Rachel, Mindlis Irina, Hoy-Rosas Jamillah, Hauser Diane, Lurio Joseph, Shroff Nandini, Lopez Ray, Erblich Joel, Wolf Michael S, Wisnivesky Juan P

机构信息

Division of General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.

Division of General Internal Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.

出版信息

JAMA Intern Med. 2019 Aug 1;179(8):1113-1121. doi: 10.1001/jamainternmed.2019.1201.

DOI:10.1001/jamainternmed.2019.1201
PMID:31180474
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6563560/
Abstract

IMPORTANCE

Older adults with asthma have worse control and outcomes than younger adults. Interventions to address suboptimal self-management among older adults with asthma are typically not tailored to the specific needs of the patient.

OBJECTIVE

To test the effect of a comprehensive, patient-tailored asthma self-management support intervention for older adults on clinical and self-management outcomes.

DESIGN, SETTING, AND PARTICIPANTS: Three-arm randomized clinical trial conducted between February 2014 and December 2017 at primary care practices and personal residences in New York City. Adults 60 years and older with persistent, uncontrolled asthma were identified from electronic medical records at an academic medical center and a federally qualified health center. Of 1349 patients assessed for eligibility, 406 met eligibility criteria, consented to participate, and were randomized to 1 of 3 groups: home-based intervention, clinic-based intervention, or control (usual care). A total of 391 patients received the allocated treatment.

INTERVENTIONS

Screening for psychosocial, physical, cognitive, and environmental barriers to asthma control and self-management with actions to address identified barriers. The intervention was delivered in the home or primary care practices by asthma care coaches.

MAIN OUTCOMES AND MEASURES

Primary outcomes were the Asthma Control Test, Mini Asthma Quality of Life Questionnaire, Medication Adherence Rating Scale, metered dose inhaler technique, and emergency department visits for asthma care. Primary analyses compared intervention (home or clinic based) with usual care.

RESULTS

Of the 391 patients who received treatment, 58 (15.1%) were men, and the mean (SD) age was 67.8 (7.4) years. After accounting for baseline scores, scores on the asthma control test were better in the intervention groups vs the control group (difference-in-differences at 3 months, 1.2; 95% CI, 0.2-2.2; P = .02; 6 months, 1.0; 95% CI, 0.0-2.1; P = .049; 12 months, 0.6; 95% CI, -0.5 to 1.8; P = .28; and overall, χ2 = 13.4, with 4 degrees of freedom; P = .01). Emergency department visits were lower at 12 months for the intervention groups vs the control group (16 [6.2%] vs 17 [12.7%]; P = .03; adjusted odds ratio, 0.8; 95% CI, 0.6-0.99; P = .03). Statistically significant improvements were observed for the intervention vs control patients in quality of life (overall effect: χ2 = 10.5, with 4 degrees of freedom; P = .01), medication adherence (overall effect: χ2 = 9.5, with 4 degrees of freedom; P = .049), and inhaler technique (metered-dose inhaler technique, correctly completed steps at 12 months, median [range]: 75% [0%-100%] vs 58% [0%-100%]). No significant differences in outcomes were observed between patients receiving the intervention in home vs practice settings.

CONCLUSIONS AND RELEVANCE

An intervention directed by patients' needs and barriers improved asthma outcomes and self-management behaviors among older adults.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT02316223.

摘要

重要性

患有哮喘的老年人比年轻人的病情控制和预后更差。针对哮喘老年患者自我管理欠佳的干预措施通常未针对患者的具体需求进行定制。

目的

测试一项针对老年人的全面、根据患者需求量身定制的哮喘自我管理支持干预措施对临床和自我管理结果的影响。

设计、地点和参与者:2014年2月至2017年12月在纽约市的初级保健机构和个人住所进行的三臂随机临床试验。从一家学术医疗中心和一家联邦合格健康中心的电子病历中识别出60岁及以上患有持续性、未得到控制的哮喘的成年人。在1349名接受资格评估的患者中,406名符合资格标准,同意参与,并被随机分为3组中的1组:居家干预组、门诊干预组或对照组(常规护理)。共有391名患者接受了分配的治疗。

干预措施

筛查影响哮喘控制和自我管理的心理社会、身体、认知和环境障碍,并采取行动解决已识别的障碍。该干预由哮喘护理教练在患者家中或初级保健机构实施。

主要结局和指标

主要结局包括哮喘控制测试、哮喘生活质量小问卷、药物依从性评定量表、定量吸入器使用技术以及因哮喘护理而前往急诊科就诊的次数。主要分析将干预组(居家或门诊)与常规护理进行比较。

结果

在接受治疗的391名患者中,58名(15.1%)为男性,平均(标准差)年龄为67.8(7.4)岁。在考虑基线分数后,干预组在哮喘控制测试中的得分高于对照组(3个月时的差异差值为1.2;95%置信区间为0.2 - 2.2;P = 0.02;6个月时为1.0;95%置信区间为0.0 - 2.1;P = 0.049;12个月时为0.6;95%置信区间为 - 0.5至1.8;P = 0.28;总体而言,χ2 = 13.4,自由度为4;P = 0.01)。干预组在12个月时因哮喘前往急诊科就诊的次数低于对照组(16例[6.2%]对17例[12.7%];P = 0.03;调整后的优势比为0.8;95%置信区间为0.6 - 0.99;P = 0.03)。与对照组患者相比,干预组患者在生活质量(总体效应:χ2 = 10.5,自由度为4;P = 0.01)、药物依从性(总体效应:χ2 = 9.5,自由度为4;P = 0.049)和吸入器技术(定量吸入器技术,12个月时正确完成步骤的中位数[范围]:75%[0% - 100%]对58%[0% - 100%])方面有统计学上的显著改善。在居家接受干预的患者和在门诊接受干预的患者之间,结局未观察到显著差异。

结论与意义

一项根据患者需求和障碍指导的干预措施改善了老年患者的哮喘结局和自我管理行为。

试验注册

ClinicalTrials.gov标识符:NCT02316223。

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