Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project.
Designing a valid randomized pragmatic primary care implementation trial: the my own health report (MOHR) project.
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DOI：
10.1186/1748-5908-8-73
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发表时间：
2013-06-25
期刊：
影响因子：
--
通讯作者：
MOHR Study Group
中科院分区：
文献类型：
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作者：
Krist AH;Glenn BA;Glasgow RE;Balasubramanian BA;Chambers DA;Fernandez ME;Heurtin-Roberts S;Kessler R;Ory MG;Phillips SM;Ritzwoller DP;Roby DH;Rodriguez HP;Sabo RT;Sheinfeld Gorin SN;Stange KC;MOHR Study Group
迫切需要更多地关注初级保健中以病人为中心的健康行为和社会心理问题，并需要实用的工具、研究设计和与临床和政策相关的结果。我们的目标是设计一项科学严谨、有效实用的试验，以测试初级保健实践是否能够系统地收集患者报告的信息，并为患者提供所需的建议、目标设定和咨询。本文报道了“我自己的健康报告”（MOHR）研究的迭代设计，这是一项随机延迟干预试验。9对不同的初级保健实践将在4个月后随机进行早期或延迟干预。干预措施包括实地开展卫生部的评估——涉及卫生行为和心理社会问题的10个领域——并随后为前来保健或慢性病治疗的患者提供所需的咨询和支持。作为一项务实的参与性试验，在整个研究设计过程中，包括执业合伙人和患者在内的利益相关者团体都参与其中，以考虑当地的资源和特点。参与性任务包括确定卫生部的评估内容，改进研究设计，提供结果测量的输入，以及设计实施工作流程。研究结果包括干预范围（提供并完成MOHR评估的患者百分比），有效性（患者报告被问及主题，设定改变目标，并在早期与延迟干预实践中获得帮助），影响结果的背景因素和干预成本。卫生部的研究表明，参与式设计可以在广泛的初级保健环境中促进一致地收集和使用患者报告的健康行为和心理社会评估。虽然本质上是实用的，但研究设计将允许有效的比较来回答提出的研究问题，并且研究结果将广泛地推广到一系列初级保健环境。根据实用解释连续指标总结（PRECIS）框架，该研究设计比其他已发表的试验更实用。研究人员、从业者和政策制定者试图使医疗保健更加以患者为中心和相关，这些方法和发现应该引起他们的兴趣。Clinicaltrials.gov: NCT01825746
There is a pressing need for greater attention to patient-centered health behavior and psychosocial issues in primary care, and for practical tools, study designs and results of clinical and policy relevance. Our goal is to design a scientifically rigorous and valid pragmatic trial to test whether primary care practices can systematically implement the collection of patient-reported information and provide patients needed advice, goal setting, and counseling in response. This manuscript reports on the iterative design of the My Own Health Report (MOHR) study, a cluster randomized delayed intervention trial. Nine pairs of diverse primary care practices will be randomized to early or delayed intervention four months later. The intervention consists of fielding the MOHR assessment – addresses 10 domains of health behaviors and psychosocial issues – and subsequent provision of needed counseling and support for patients presenting for wellness or chronic care. As a pragmatic participatory trial, stakeholder groups including practice partners and patients have been engaged throughout the study design to account for local resources and characteristics. Participatory tasks include identifying MOHR assessment content, refining the study design, providing input on outcomes measures, and designing the implementation workflow. Study outcomes include the intervention reach (percent of patients offered and completing the MOHR assessment), effectiveness (patients reporting being asked about topics, setting change goals, and receiving assistance in early versus delayed intervention practices), contextual factors influencing outcomes, and intervention costs. The MOHR study shows how a participatory design can be used to promote the consistent collection and use of patient-reported health behavior and psychosocial assessments in a broad range of primary care settings. While pragmatic in nature, the study design will allow valid comparisons to answer the posed research question, and findings will be broadly generalizable to a range of primary care settings. Per the pragmatic explanatory continuum indicator summary (PRECIS) framework, the study design is substantially more pragmatic than other published trials. The methods and findings should be of interest to researchers, practitioners, and policy makers attempting to make healthcare more patient-centered and relevant. Clinicaltrials.gov: NCT01825746
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DOI：
10.1186/1748-5908-4-50
发表时间：
2009-08-07
期刊：
Implementation science : IS
影响因子：
--
作者：
Damschroder LJ;Aron DC;Keith RE;Kirsh SR;Alexander JA;Lowery JC
通讯作者：
Lowery JC
影响因子：
3
作者：
Chin, Marshall H.;Drum, Melinda L.;Schaefer, Cynthia T.
通讯作者：
Schaefer, Cynthia T.
影响因子：
12.7
作者：
Glasgow, Russell E.;Vinson, Cynthia;Hunter, Christine
通讯作者：
Hunter, Christine
影响因子：
158.5
作者：
AVORN, J;SOUMERAI, SB
通讯作者：
SOUMERAI, SB
影响因子：
--
作者：
Bush, K;Kivlahan, DR;Bradley, KA
通讯作者：
Bradley, KA