BACKGROUND Guidelines on urinary incontinence recommend that absorbent products are only used as a coping strategy pending definitive treatment, as an adjunct to ongoing therapy, or for long-term management after all treatment options have been explored. However, these criteria are rarely met and a significant share of long-term product users could still benefit from therapeutic interventions recommended in guidelines for urinary incontinence. Better implementation of these guidelines can potentially result in both health benefits for women and long-term cost savings for society. The aim of the COCON study is to evaluate the (cost-)effectiveness of a nurse-led intervention to optimise implementation of guideline-concordant continence care in comparison with usual care for urinary incontinent women aged 55 years and over who use absorbent products. METHODS This randomised clinical trial compares usual care with a nurse-led intervention to optimise implementation of guideline-concordant continence care. Women (anticipated N = 160) are recruited in 12 community pharmacies in three Dutch regions, and are eligible for trial entry when they are 55 years and over, community-dwelling and long-term users of absorbent products (≥4 months) reimbursed by health insurance. Measurements are administered at baseline, 3, 6 and 12 months. Primary outcome is severity of urinary incontinence (ICIQ-UI SF); other outcomes include health related quality of life (EQ-5D-5 L), use of absorbent products (in accordance with the recommended criteria in guidelines) (yes/no), and societal costs. Mixed model analysis will be performed to compare (the course) of outcomes between groups. The economic evaluation will be performed from a societal perspective. The implementation process is investigated using the Tailored Implementation for Chronic Diseases (TICD) framework. DISCUSSION Results will add to current knowledge of the (cost-)effectiveness of nurse-led primary healthcare to improve guideline-concordant care for older women with urinary incontinence. In addition, the results will provide more insight into care needs and health service utilization of this group of women, as well as into use of absorbent products in accordance with the recommended criteria in guidelines. Finally, results will increase our understanding of the intervention's uptake and could provide useful insights for future dissemination and sustenance. TRIAL REGISTRATION Dutch Trial Register NTR4396, registered 13-January-2014.

中文翻译：

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由护士主导的干预措施的成本效益，以优化实施指南一致的节制性护理：COCON研究的研究方案。

背景技术关于尿失禁的指南建议吸收性产品仅用作最终治疗之前的应对策略，作为正在进行的治疗的辅助手段，或在探索了所有治疗方案之后用于长期治疗。但是，这些标准很少得到满足，长期使用该产品的用户中仍有很大一部分仍可以从尿失禁指南中推荐的治疗性干预中受益。更好地执行这些准则可能会给妇女带来健康益处，并为社会带来长期的成本节省。COCON研究的目的是评估与55岁及以上使用吸收性产品的尿失禁妇女的常规护理相比，以护士为主导的干预措施的（成本）效果，以优化实施准则一致的尿失禁护理。方法这项随机临床试验将常规护理与护士主导的干预进行了比较，以优化准则一致的节制性便秘护理的实施。妇女（预计N = 160）在荷兰三个地区的12家社区药房招募，有资格在55岁及以上，社区居住和长期使用吸收性产品（≥4个月）的使用者报销，报销费用为健康保险。在基线，3、6和12个月时进行测量。主要结果是尿失禁的严重程度（ICIQ-UI SF）；其他结果包括与健康相关的生活质量（EQ-5D-5 L），使用吸收性产品（根据准则中的建议标准）（是/否）和社会成本。将执行混合模型分析以比较（过程）各组之间的结果。经济评估将从社会角度进行。使用针对慢性病的量身定制实施（TICD）框架对实施过程进行了调查。讨论结果将增加对护士主导的初级保健的（成本）效果的当前了解，以改善患有尿失禁的老年妇女的指南一致护理。此外，结果将提供更多有关该组妇女的护理需求和卫生服务利用的见解，以及根据准则中建议的标准使用吸收性产品的见解。最后，结果将增加我们对干预措施采用的了解，并可以为将来的传播和维持提供有用的见解。试用注册荷兰试用注册号NTR4396，于2014年1月13日注册。