Systems analysis and improvement approach to optimize outpatient mental health treatment cascades in Mozambique (SAIA-MH): study protocol for a cluster randomized trial.

Systems analysis and improvement approach to optimize outpatient mental health treatment cascades in Mozambique (SAIA-MH): study protocol for a cluster randomized trial.
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系统分析和改进的方法,以优化门诊心理健康治疗级联在莫桑比克(SAIA-MH):研究方案的集群随机试验。

DOI:
10.1186/s13012-022-01213-8
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发表时间:
2022-06-06
影响因子:
7.2
通讯作者:
Wagenaar, Bradley H.
Wagenaar, Bradley H.
中科院分区:
医学1区
文献类型:
--
作者:
Cumbe, Vasco F. J.;Muanido, Alberto Gabriel;Turner, Morgan;Ramiro, Isaias;Sherr, Kenneth;Weiner, Bryan J.;Flaherty, Brian P.;Sharma, Monisha;Faduque, Flavia;Xerinda, Ernesto Rodrigo;Wagenaar, Bradley H.

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正在进行大量投资以缩小心理健康(MH)治疗差距,在许多低收入和中等收入国家(LMIC)中,这一差距通常超过90%。然而,有限的注意力已经支付给病人的护理质量在新生和不断发展的LMIC MH系统。在撒哈拉以南非洲的系统评估中,MH失访率通常超过50%,次优药物依从性通常超过60%。本研究旨在填补空白的循证实施战略,针对优化的MH治疗级联在LMICs通过测试低成本的多组分实施战略纳入常规政府MH护理在莫桑比克。采用整群随机试验设计,16家提供初级MH护理的诊所(8家干预和8家对照)将被随机分配到心理健康系统分析和改善方法(SAIA-MH)或注意力安慰剂对照组。SAIA-MH是一个多成分的实施策略,在整体持续质量改进框架中融合了外部促进,临床咨询和提供者团队会议与系统工程工具。在6个月的基线期之后,干预设施将在2年的密集实施期内实施SAIA-MH战略,然后是1年的维持阶段。主要结局将是所有诊断为MH疾病并接受基于药物的治疗的患者的比例,这些患者实现了功能改善,药物依从性和MH护理的保留。执行情况研究综合框架将用于评估执行工作成功的决定因素。具体目标1b将包括利用纵向结构方程模型评估SAIA-MH战略的机制,以及具体目标2,估计将SAIA-MH在莫桑比克推广到省和国家一级的成本和成本效益。据我们所知,这项研究是第一个创新的,以测试一个多组分的实施策略,在低收入国家的MH护理级联优化。从设计上看,SAIA-MH是一种低成本策略,可以针对有效的初级MH护理障碍制定与背景相关的解决方案,因此重点关注可以长期持续的系统改进。由于SAIA-MH已被纳入常规的政府MH服务提供中,这一务实的试验有可能为莫桑比克和其他类似的LMIC的SAIA-MH规模扩大提供信息。ClinicalTrials.gov; NCT 05103033; 2021年11月2日。
Significant investments are being made to close the mental health (MH) treatment gap, which often exceeds 90% in many low- and middle-income countries (LMICs). However, limited attention has been paid to patient quality of care in nascent and evolving LMIC MH systems. In system assessments across sub-Saharan Africa, MH loss-to-follow-up often exceeds 50% and sub-optimal medication adherence often exceeds 60%. This study aims to fill a gap of evidence-based implementation strategies targeting the optimization of MH treatment cascades in LMICs by testing a low-cost multicomponent implementation strategy integrated into routine government MH care in Mozambique. Using a cluster-randomized trial design, 16 clinics (8 intervention and 8 control) providing primary MH care will be randomized to the Systems Analysis and Improvement Approach for Mental Health (SAIA-MH) or an attentional placebo control. SAIA-MH is a multicomponent implementation strategy blending external facilitation, clinical consultation, and provider team meetings with system-engineering tools in an overall continuous quality improvement framework. Following a 6-month baseline period, intervention facilities will implement the SAIA-MH strategy for a 2-year intensive implementation period, followed by a 1-year sustainment phase. Primary outcomes will be the proportion of all patients diagnosed with a MH condition and receiving pharmaceutical-based treatment who achieve functional improvement, adherence to medication, and retention in MH care. The Consolidated Framework for Implementation Research (CFIR) will be used to assess determinants of implementation success. Specific Aim 1b will include the evaluation of mechanisms of the SAIA-MH strategy using longitudinal structural equation modeling as well as specific aim 2 estimating cost and cost-effectiveness of scaling-up SAIA-MH in Mozambique to provincial and national levels. This study is innovative in being the first, to our knowledge, to test a multicomponent implementation strategy for MH care cascade optimization in LMICs. By design, SAIA-MH is a low-cost strategy to generate contextually relevant solutions to barriers to effective primary MH care, and thus focuses on system improvements that can be sustained over the long term. Since SAIA-MH is integrated into routine government MH service delivery, this pragmatic trial has the potential to inform potential SAIA-MH scale-up in Mozambique and other similar LMICs. ClinicalTrials.gov; NCT05103033; 11/2/2021.
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