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一项多地点实用型混合 3 型整群随机试验的结果,比较了在医疗补助豁免计划中对社区居住的残疾和老年人实施干预时的促进程度。

Results of a multi-site pragmatic hybrid type 3 cluster randomized trial comparing level of facilitation while implementing an intervention in community-dwelling disabled and older adults in a Medicaid waiver.

机构信息

Kirkhof College of Nursing, Grand Valley State University, 301 Michigan St, Room C352, Grand Rapids, MI, 49504, USA.

Statistics Department, Grand Valley State University, Grand Rapids, USA.

出版信息

Implement Sci. 2022 Aug 26;17(1):57. doi: 10.1186/s13012-022-01232-5.

Abstract

BACKGROUND

Evidence-based interventions that optimize physical function for disabled and older adults living in the community who have difficulty with daily living tasks are available. However, uptake has been limited, particularly in resource-constrained (Medicaid) settings. Facilitation may be an effective implementation strategy. This study's aim was to compare internal facilitation (IF) versus IF and external facilitation (EF) on adoption and sustainability of an intervention in a Medicaid home and community-based waiver.

METHODS

In a hybrid type 3 trial, waiver sites (N = 18) were randomly assigned to implement the intervention using a bundle of strategies with either IF or IF and EF. Adoption and sustainability were assessed via Stages of Implementation Completion (SIC) for each site. Clinician attitudes toward evidence-based practice and self-efficacy were evaluated among 539 registered nurses, social workers, and occupational therapists. Medicaid beneficiary outcomes of activities of daily living, depression, pain, falls, emergency department visits, and hospitalizations were evaluated in a sample of N = 7030 as reflected by electronic health records data of the Medicaid waiver program. Linear mixed-effects models were used to compare outcomes between trial arms while accounting for cluster-randomized design.

RESULTS

The mean SIC scores were 72.22 (standard deviation [SD] = 16.98) in the IF arm (9 sites) and 61.33 (SD = 19.29) in the IF + EF arm (9 sites). The difference was not statistically significant but corresponded to the medium clinically important effect size Cohen's d = 0.60. Clinician implementation outcomes of attitudes and self-efficacy did not differ by trial arm. Beneficiary depression was reduced significantly in the IF + EF arm compared to the IF arm (p = .04, 95% confidence interval for the difference [0.01, 0.24]). No differences between trial arms were found for other beneficiary outcomes.

CONCLUSIONS

Level of facilitation did not enhance capacity for adoption and sustainability of an evidence-based intervention in a Medicaid setting that cares for disabled and older adults. Improved beneficiary depression favored use of IF and EF compared to IF alone, and no differences were found for other outcomes. These findings also suggest level of facilitation may not have impacted beneficiary outcomes.

TRIAL REGISTRATION

ClinicalTrials.gov , NCT03634033 ; date registered August 16, 2018.

摘要

背景

为有日常生活活动困难的社区内失能和老年残疾人提供了优化身体功能的循证干预措施。然而,其使用率一直受到限制,特别是在资源有限的(医疗补助)环境中。促进可能是一种有效的实施策略。本研究的目的是比较内部促进(IF)与 IF 和外部促进(EF)对医疗补助家庭和社区豁免中的干预措施的采用和可持续性的影响。

方法

在混合 3 期试验中,豁免站点(N=18)被随机分配使用包含 IF 或 IF 和 EF 的一组策略来实施干预措施。通过每个站点的实施完成阶段(SIC)评估采用和可持续性。在 539 名注册护士、社会工作者和职业治疗师中评估了临床医生对循证实践的态度和自我效能感。通过医疗补助豁免计划的电子健康记录数据评估了 N=7030 名医疗补助受益人的日常生活活动、抑郁、疼痛、跌倒、急诊就诊和住院等结果。线性混合效应模型用于在考虑到集群随机设计的情况下比较试验臂之间的结果。

结果

IF 臂(9 个站点)的平均 SIC 评分为 72.22(标准差[SD]=16.98),IF+EF 臂(9 个站点)的平均 SIC 评分为 61.33(SD=19.29)。差异不具有统计学意义,但对应于中等临床重要效应大小 Cohen's d=0.60。试验臂的临床医生实施结果的态度和自我效能感没有差异。与 IF 臂相比,IF+EF 臂中受益人的抑郁明显降低(p=0.04,差异的 95%置信区间[0.01,0.24])。在其他受益人的结果方面,两个试验臂之间没有差异。

结论

在为残疾和老年人提供护理的医疗补助环境中,促进水平并没有提高循证干预措施的采用和可持续性。与单独使用 IF 相比,IF 和 EF 的使用更有利于受益人的抑郁改善,而其他结果则没有差异。这些发现还表明,促进水平可能没有影响受益人的结果。

试验注册

ClinicalTrials.gov,NCT03634033;注册日期 2018 年 8 月 16 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/341b/9419328/505770b9d85b/13012_2022_1232_Fig1_HTML.jpg

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