Abbott Allan, Schröder Karin, Enthoven Paul, Nilsen Per, Öberg Birgitta
Department of Medical and Health Sciences, Division of Physiotherapy, Faculty of Health Sciences, Linköping University, Linköping, Sweden.
Department of Medical and Health Sciences, Division of Community Medicine, Faculty of Health Sciences, Linköping University, Linköping, Sweden.
BMJ Open. 2018 Apr 24;8(4):e019906. doi: 10.1136/bmjopen-2017-019906.
Low back pain (LBP) is a major health problem commonly requiring healthcare. In Sweden, there is a call from healthcare practitioners (HCPs) for the development, implementation and evaluation of a best practice primary healthcare model for LBP.
(1) To improve and understand the mechanisms underlying changes in HCP confidence, attitudes and beliefs for providing best practice coherent primary healthcare for patients with LBP; (2) to improve and understand the mechanisms underlying illness beliefs, self-care enablement, pain, disability and quality of life in patients with LBP; and (3) to evaluate a multifaceted and sustained implementation strategy and the cost-effectiveness of the BetterBack☺ model of care (MOC) for LBP from the perspective of the Swedish primary healthcare context.
This study is an effectiveness-implementation hybrid type 2 trial testing the hypothesised superiority of the BetterBack☺ MOC compared with current routine care. The trial involves simultaneous testing of MOC effects at the HCP, patient and implementation process levels. This involves a prospective cohort study investigating implementation at the HCP level and a patient-blinded, pragmatic, cluster, randomised controlled trial with longitudinal follow-up at 3, 6 and 12 months post baseline for effectiveness at the patient level. A parallel process and economic analysis from a healthcare sector perspective will also be performed. Patients will be allocated to routine care (control group) or the BetterBack☺ MOC (intervention group) according to a stepped cluster dogleg structure with two assessments in routine care. Experimental conditions will be compared and causal mediation analysis investigated. Qualitative HCP and patient experiences of the BetterBack☺ MOC will also be investigated.
The findings will be published in peer-reviewed journals and presented at national and international conferences. Further national dissemination and implementation in Sweden and associated national quality register data collection are potential future developments of the project.
13 December 2017, protocol version 3.
NCT03147300; Pre-results.
腰痛是一个常见的重大健康问题，通常需要医疗保健服务。在瑞典，医疗从业者呼吁开发、实施和评估一种针对腰痛的最佳实践初级医疗保健模式。
（1）改善并理解医疗从业者为腰痛患者提供最佳实践连贯初级医疗保健时，其信心、态度和信念改变的潜在机制；（2）改善并理解腰痛患者疾病信念、自我护理能力、疼痛、残疾和生活质量改变的潜在机制；（3）从瑞典初级医疗保健背景的角度，评估一种多方面且持续的实施策略以及BetterBack☺护理模式（MOC）对腰痛的成本效益。
本研究是一项有效性-实施混合型2期试验，测试BetterBack☺ MOC相较于当前常规护理的假设优越性。该试验涉及在医疗从业者、患者和实施过程层面同时测试MOC的效果。这包括一项前瞻性队列研究，调查医疗从业者层面的实施情况，以及一项患者盲法、实用、整群、随机对照试验，在基线后3个月、6个月和12个月进行纵向随访，以评估患者层面的有效性。还将从医疗保健部门的角度进行平行的过程和经济分析。患者将根据具有常规护理两次评估的阶梯式整群折线结构，被分配到常规护理（对照组）或BetterBack☺ MOC（干预组）。将比较实验条件并进行因果中介分析。还将调查医疗从业者和患者对BetterBack☺ MOC的定性体验。
研究结果将发表在同行评审期刊上，并在国内和国际会议上展示。该项目未来可能的发展方向包括在瑞典进一步进行全国性传播和实施，以及相关国家质量登记数据收集。
2017年12月13日，方案版本3。
NCT03147300；预结果。
