BETTER WISE 方案:利用现有工具改善初级保健中的癌症和慢性病预防与筛查,提高癌症幸存者和患者的健康水平 - 一项混合方法设计中的整群随机对照试验。
The BETTER WISE protocol: building on existing tools to improve cancer and chronic disease prevention and screening in primary care for wellness of cancer survivors and patients - a cluster randomized controlled trial embedded in a mixed methods design.
机构信息
Department of Family Medicine, University of Alberta, 6-10 University Terrace, Edmonton, AB, T6G 2T4, Canada.
Covenant Health, Grey Nuns Community Hospital, 1100 Youville Drive Northwest, Edmonton, AB, T6L 5X8, Canada.
出版信息
BMC Cancer. 2018 Sep 26;18(1):927. doi: 10.1186/s12885-018-4839-y.
BACKGROUND
There is a pressing need to reduce the burden of chronic disease and improve healthcare system sustainability through improved cancer and chronic disease prevention and screening (CCDPS) in primary care. We aim to create an integrated approach that addresses the needs of the general population and the special concerns of cancer survivors. Building on previous research, we will develop, implement, and test the effectiveness of an approach that proactively targets patients to attend an individualized CCDPS intervention delivered by a Prevention Practitioner (PP). The objective is to determine if patients randomized to receive an individualized PP visit (vs standard care) have improved cancer surveillance and CCDPS outcomes. Implementation frameworks will help identify and address facilitators and barriers to the approach and inform future dissemination and uptake.
METHODS/DESIGN: The BETTER WISE project is a pragmatic two-arm cluster randomized controlled trial embedded in a mixed methods design, including a qualitative evaluation and an economic assessment. The intervention, informed by the expanded chronic care model and previous research, will be refined by engaging researchers, practitioners, policy makers, and patients. The BETTER WISE tool kit includes blended care pathways for cancer survivors (breast, colorectal, prostate) and CCDPS including lifestyle risk factors and screening for poverty. Patients aged 40-65, including both cancer survivors and general population patients, will be randomized at the physician level to an intervention group or to a wait-list control group. Once the intervention is completed, patients randomized to wait-list control will be invited to receive a prevention visit. The main outcome, calculated at 12-months follow-up, will be an individual patient-level summary composite index, defined as the proportion of CCDPS actions achieved relative to those for which the patient was eligible at baseline. A qualitative evaluation will capture information related to program outcome, implementation (facilitators and barriers), and sustainability. An economic assessment will examine the projected cost-benefit impact of investing in the BETTER WISE approach.
DISCUSSION
This project builds on existing work and engages end users throughout the process to develop, implement, and determine the effectiveness of a multi-faceted intervention that addresses CCDPS and cancer survivorship in primary care settings.
TRIAL REGISTRATION
ISRCTN21333761 . Registered on December 19, 2016.
背景
通过在基层医疗中加强癌症和慢性病的预防与筛查(CCDPS),来减轻慢性病负担并提高医疗体系的可持续性,这是当务之急。我们旨在创建一种综合方法,以满足普通人群的需求,并解决癌症幸存者的特殊问题。在此前研究的基础上,我们将开发、实施并测试一种主动针对患者的方法的有效性,该方法旨在促使患者接受预防从业者(PP)提供的个性化 CCDPS 干预。其目的是确定随机分配到接受个性化 PP 访问(与标准护理相比)的患者是否在癌症监测和 CCDPS 结果方面有所改善。实施框架将有助于确定并解决该方法的促进因素和障碍,并为未来的传播和采用提供信息。
方法/设计:BETTER WISE 项目是一项实用的两臂集群随机对照试验,嵌入混合方法设计中,包括定性评估和经济评估。该干预措施以扩展的慢性病护理模型和先前的研究为基础,并通过让研究人员、从业者、政策制定者和患者参与进来进行完善。BETTER WISE 工具包包括针对癌症幸存者(乳腺癌、结直肠癌、前列腺癌)和 CCDPS 的混合照护途径,包括生活方式风险因素和贫困筛查。将年龄在 40-65 岁之间的患者(包括癌症幸存者和一般人群患者)按医生级别随机分配到干预组或候补名单对照组。一旦干预完成,随机分配到候补名单对照组的患者将被邀请接受预防访问。主要结果将在 12 个月的随访时计算,是一个个体患者水平的综合指数,定义为相对于基线时患者符合条件的 CCDPS 行动的比例。定性评估将收集与项目结果、实施(促进因素和障碍)和可持续性相关的信息。经济评估将检查投资 BETTER WISE 方法的预期成本效益影响。
讨论
该项目基于现有工作,并在整个过程中让最终用户参与,以开发、实施并确定一种多方面干预措施的有效性,该措施可解决基层医疗环境中的 CCDPS 和癌症生存问题。
试验注册
ISRCTN21333761。于 2016 年 12 月 19 日注册。