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实施映射在混合型1实用临床试验规划中的应用:犹他州BeatPain研究

Use of implementation mapping in the planning of a hybrid type 1 pragmatic clinical trial: the BeatPain Utah study.

作者信息

Fritz Julie M, Gibson Bryan, Wetter David W, Del Fiol Guilherme, Solis Victor, Ford Isaac, Lundberg Kelly, Thackeray Anne

机构信息

Department of Physical Therapy & Athletic Training, University of Utah, 383 Colorow Dr., Room 391, Salt Lake City, UT, 84108, USA.

Department of Biomedical Informatics, University of Utah, Salt Lake City, UT, USA.

出版信息

Implement Sci Commun. 2024 Jan 5;5(1):3. doi: 10.1186/s43058-023-00542-z.

Abstract

BACKGROUND

Considerable disparities in chronic pain management have been identified. Persons in rural, lower income, and minoritized communities are less likely to receive evidence-based, nonpharmacologic care. Telehealth delivery of nonpharmacologic, evidence-based interventions for persons with chronic pain is a promising strategy to lessen disparities, but implementation comes with many challenges. The BeatPain Utah study is a hybrid type 1 effectiveness-implementation pragmatic clinical trial investigating telehealth strategies to provide nonpharmacologic care from physical therapists to persons with chronic back pain receiving care in ommunity health centers (CHCs). CHCs provide primary care to all persons regardless of ability to pay. This paper outlines the use of implementation mapping to develop a multifaceted implementation plan for the BeatPain study.

METHODS

During a planning year for the BeatPain trial, we developed a comprehensive logic model including the five-step implementation mapping process informed by additional frameworks and theories. The five iterative implementation mapping steps were addressed in the planning year: (1) conduct needs assessments for involved groups; (2) identify implementation outcomes, performance objectives, and determinants; (3) select implementation strategies; (4) produce implementation protocols and materials; and (5) evaluate implementation outcomes.

RESULTS

CHC leadership/providers, patients, and physical therapists were identified as involved groups. Barriers and assets were identified across groups which informed identification of performance objectives necessary to implement two key processes: (1) electronic referral of patients with back pain in CHC clinics to the BeatPain team and (2) connecting patients with physical therapists providing telehealth. Determinants of the performance objectives for each group informed our choice of implementation strategies which focused on training, education, clinician support, and tailoring physical therapy interventions for telehealth delivery and cultural competency. We selected implementation outcomes for the BeatPain trial to evaluate the success of our implementation strategies.

CONCLUSIONS

Implementation mapping provided a comprehensive and systematic approach to develop an implementation plan during the planning phase for our ongoing hybrid effectiveness-implementation trial. We will be able to evaluate the implementation strategies used in the BeatPain Utah study to inform future efforts to implement telehealth delivery of evidence-based pain care in CHCs and other settings.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT04923334 . Registered June 11, 2021.

摘要

背景

已发现慢性疼痛管理存在显著差异。农村、低收入和少数族裔社区的人群接受循证非药物治疗的可能性较小。为慢性疼痛患者提供循证非药物干预的远程医疗是减少差异的一项有前景的策略,但实施过程面临诸多挑战。犹他州战胜疼痛研究是一项1型混合有效性-实施务实临床试验,旨在研究远程医疗策略,以便为在社区卫生中心(CHC)接受治疗的慢性背痛患者提供来自物理治疗师的非药物治疗。CHC为所有患者提供初级保健,无论其支付能力如何。本文概述了如何使用实施映射为战胜疼痛研究制定多方面的实施计划。

方法

在战胜疼痛试验的规划年期间,我们开发了一个全面的逻辑模型,包括由其他框架和理论提供信息的五步实施映射过程。在规划年中涉及了五个迭代的实施映射步骤:(1)对相关群体进行需求评估;(2)确定实施结果、绩效目标和决定因素;(3)选择实施策略;(4)制定实施协议和材料;(5)评估实施结果。

结果

CHC领导/提供者、患者和物理治疗师被确定为相关群体。在各群体中识别出了障碍和资产,这些为确定实施两个关键流程所需的绩效目标提供了信息:(1)将CHC诊所中背痛患者电子转诊至战胜疼痛团队;(2)将患者与提供远程医疗的物理治疗师联系起来。每个群体绩效目标的决定因素为我们选择实施策略提供了依据,这些策略侧重于培训、教育、临床医生支持,以及为远程医疗服务和文化能力量身定制物理治疗干预措施。我们为战胜疼痛试验选择了实施结果,以评估我们实施策略的成功程度。

结论

实施映射为我们正在进行的混合有效性-实施试验的规划阶段制定实施计划提供了一种全面且系统的方法。我们将能够评估犹他州战胜疼痛研究中使用的实施策略,为未来在CHC和其他环境中实施循证疼痛护理的远程医疗服务提供参考。

试验注册

ClinicalTrials.gov标识符:NCT04923334。于2021年6月11日注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9478/10768478/2e2e3c0bc534/43058_2023_542_Fig1_HTML.jpg

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