IMPACCT Centre-Improving Palliative, Aged and Chronic Care through Clinical Research and Translation, Faculty of Health, University of Technology Sydney (UTS), Building 10, 235 Jones St, Ultimo, Sydney, NSW, 2007, Australia.
School of Nursing and Centre for Healthcare Transformation, Queensland University of Technology (QUT), Brisbane, QLD, Australia.
BMC Health Serv Res. 2024 Aug 22;24(1):969. doi: 10.1186/s12913-024-11243-1.
The Stop Cancer PAIN Trial was a phase III pragmatic stepped wedge cluster randomised controlled trial which compared effectiveness of screening and guidelines with or without implementation strategies for improving pain in adults with cancer attending six Australian outpatient comprehensive cancer centres (n = 688). A system for pain screening was introduced before observation of a 'control' phase. Implementation strategies introduced in the 'intervention' phase included: (1) audit of adherence to guideline recommendations, with feedback to clinical teams; (2) health professional education via an email-administered 'spaced education' module; and (3) a patient education booklet and self-management resource. Selection of strategies was informed by the Capability, Opportunity and Motivation Behaviour (COM-B) Model (Michie et al., 2011) and evidence for each strategy's stand-alone effectiveness. A consultant physician at each centre supported the intervention as a 'clinical champion'. However, fidelity to the intervention was limited, and the Trial did not demonstrate effectiveness. This paper reports a sub-study of the Trial which aimed to identify factors inhibiting or enabling fidelity to inform future guideline implementation initiatives.
The qualitative sub-study enabled in-depth exploration of factors from the perspectives of personnel at each centre. Clinical champions, clinicians and clinic receptionists were invited to participate in semi-structured interviews. Analysis used a framework method and a largely deductive approach based on the COM-B Model.
Twenty-four people participated, including 15 physicians, 8 nurses and 1 clinic receptionist. Coding against the COM-B Model identified 'capability' to be the most influential component, with 'opportunity' and 'motivation' playing largely subsidiary roles. Findings suggest that fidelity could have been improved by: considering the readiness for change of each clinical setting; better articulating the intervention's value proposition; defining clinician roles and responsibilities, addressing perceptions that pain care falls beyond oncology clinicians' scopes of practice; integrating the intervention within existing systems and processes; promoting patient-clinician partnerships; investing in clinical champions among senior nursing and junior medical personnel, supported by medical leaders; and planning for slow incremental change rather than rapid uptake.
Future guideline implementation interventions may require a 'meta-implementation' approach based on complex systems theory to successfully integrate multiple strategies.
Registry: Australian New Zealand Clinical Trials Registry; number: ACTRN 12615000064505; data: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspxid=367236&isReview=true .
Stop Cancer PAIN 试验是一项 III 期实用阶梯式楔形聚类随机对照试验，比较了在澳大利亚六家综合癌症中心就诊的成年癌症患者中进行疼痛筛查和指南（有或没有实施策略）的有效性（n=688）。在观察“对照”阶段之前引入了疼痛筛查系统。在“干预”阶段引入的实施策略包括：（1）对遵守指南建议进行审核，并向临床团队提供反馈；（2）通过电子邮件管理的“间隔教育”模块对卫生专业人员进行教育；（3）患者教育手册和自我管理资源。策略的选择是根据能力、机会和动机行为（COM-B）模型（Michie 等人，2011 年）和每个策略独立有效性的证据来确定的。每个中心的顾问医师都支持该干预措施作为“临床冠军”。然而，对干预措施的遵从性有限，并且试验并未显示出有效性。本文报告了该试验的一项子研究，旨在确定影响遵从性的因素，以为未来的指南实施计划提供信息。
该定性子研究使我们能够从每个中心人员的角度深入探讨因素。邀请临床冠军、临床医生和诊所接待员参加半结构化访谈。分析采用了框架方法和基于 COM-B 模型的主要演绎方法。
共有 24 人参加，包括 15 名医生、8 名护士和 1 名诊所接待员。根据 COM-B 模型进行编码，确定“能力”是最具影响力的因素，而“机会”和“动机”则起着次要作用。研究结果表明，可以通过以下方式提高一致性：考虑每个临床环境的变革准备情况；更好地阐明干预措施的价值主张；定义临床医生的角色和责任，解决疼痛护理超出肿瘤临床医生工作范围的看法；将干预措施纳入现有系统和流程；促进医患合作关系；在高级护理和初级医疗人员中投资于临床冠军，由医学领导者提供支持；并计划进行缓慢的渐进式变革，而不是快速采用。
未来的指南实施干预措施可能需要基于复杂系统理论的“元实施”方法，以成功整合多种策略。
澳大利亚新西兰临床试验注册处；注册号：ACTRN 12615000064505；数据：https://www.anzctr.org.au/Trial/Registration/TrialReview.aspxid=367236&isReview=true 。
