SMS text message-delivered pain self-management intervention for patients undergoing total knee replacement surgery: protocol for a randomised controlled type 1 hybrid effectiveness-implementation trial

针对接受全膝关节置换术患者的短信疼痛自我管理干预:一项随机对照I型混合效果-实施试验方案

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Abstract

INTRODUCTION: The efficacy and safety of SMS text message-delivered interventions for providing pain self-management education and improving clinical pain outcomes have been demonstrated in several randomised controlled trials. However, little is known about the feasibility and effectiveness of these interventions within Australian hospital settings. The current protocol describes a trial designed to evaluate the effectiveness and implementation of an SMS text message-delivered intervention designed to support patients' engagement with pain self-management strategies and improve clinical pain outcomes after total knee replacement surgery. METHODS AND ANALYSIS: A hybrid, type 1 effectiveness-implementation trial will be conducted at a private hospital in Australia. Participants (n=130) will be randomised to either the intervention group (receiving a pain self-management educational video prior to surgery, plus daily SMS text message reminders for 3 weeks after surgery) or an active control group (receiving the pre-surgery video alone, without text message reminders) in addition to usual care. Effectiveness outcomes will be pain intensity (primary), opioid dose, knee function and pain-related distress and will be recorded at baseline, 3 days, 3 weeks, 6 weeks, 3 months and 6 months after surgery using self-reported surveys. Pain self-efficacy and health-related quality of life will be measured at 6 weeks, 3 months and 6 months post-surgery. Implementation outcomes (Reach, Experience, Adoption, Implementation, Maintenance) will be evaluated using mixed (qualitative and quantitative) methods. This trial represents a first step towards the translation of digitally delivered postoperative support for engaging with pain self-management in the Australian healthcare system. ETHICS AND DISSEMINATION: The study protocol was reviewed and approved by the Austin Health Human Ethics Research Committee (Australia, HREC/110142/Austin-2024). Study results will be published in a peer-reviewed journal and presented at scientific and professional meetings. TRIAL REGISTRATION NUMBER: ACTRN12624001060538.

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