以资源为导向的病例管理，用于在全科医疗中实施针对慢性疼痛和频繁使用镇痛药患者的建议（缓解项目）：单臂探索性可行性研究方案

Resource-Oriented Case Management to Implement Recommendations for Patients With Chronic Pain and Frequent Use of Analgesics in General Practices (Project RELIEF): Protocol for a Single-Arm Exploratory Feasibility Study.

作者信息

Poß-Doering Regina, Brinkmöller Sabrina, Balzer Alexandra, Wurmbach Viktoria Sophie, Paul Cinara, Stolz Regina, Zugaj Marco Richard, Tesarz Jonas, Wensing Michel, Straßner Cornelia

机构信息

Department of Primary Care and Health Services Research, Medical Faculty, Heidelberg University, University Hospital Heidelberg, Heidelberg, Germany.

Institute of Medical Biometrics, Medical Faculty, University Heidelberg, University Hospital Heidelberg, Heidelberg, Germany.

出版信息

JMIR Res Protoc. 2025 Apr 15;14:e66335. doi: 10.2196/66335.

DOI:10.2196/66335

PMID:40233357

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12041818/

Abstract

BACKGROUND

Chronic noncancer pain (CNCP) is a frequent reason for counseling in general practice. Current German guidelines emphasize its biopsychosocial etiology and the importance of self-care and nonpharmacological treatment strategies such as education, physical and social activity, and psychological approaches. Comprehensive assessments are necessary to individualize treatment maximally and monitor appropriate use of pain medication. General practitioners face many challenges in implementing holistic pain management, which considers biological, psychological, and social aspects. In project RELIEF (resource-oriented case management to implement recommendations for patients with chronic pain and frequent use of analgesics in general practices), a case management program was developed to facilitate implementation of guideline recommendations on pain management regarding medical assessment and monitoring, patient and practice team education, promotion of self-care strategies, and rational pharmacotherapy.

OBJECTIVE

We evaluated the feasibility of the intervention and study procedures before applying them in a larger cluster randomized controlled trial. Our secondary objective is to estimate potential effects of the complex intervention.

METHODS

A single-arm trial with general practices and patients with CNCP and analgesics use will be conducted, accompanied by a mixed methods process evaluation. The intervention comprises 5 components, including software-supported medical pain history, 3 scheduled structured appointments, e-learning on CNCP for general practitioners and medical assistants, educational material for patients, toolbox with information on (regional) resources for patients and practice teams. Participating practices will be located in the federal state of Baden-Württemberg, Germany, and will recruit eligible patients (adults with CNCP for more than 3 months, with at least moderate pain-related disability, permanent or on-demand use of analgesics or co-analgesics in the previous 4 weeks, and practice team assessed ability to participate actively in the trial). A questionnaire given to the first 150 adult patients entering the practice in February 2025 will help screen eligible patients. The primary objective will be measured by a set of predefined indicators. The key secondary outcome is pain-related disability measured by the Pain Disability Index German version. All participants will be asked to participate in the process evaluation. Outcome evaluation data will be gathered by paper-based and digitally provided questionnaires to be completed by participants. Process evaluation data will be gathered in surveys and a qualitative study. Descriptive analyses will be performed.

RESULTS

Recruitment occurred between October and December 2024. Targeted sample size was 6 practices and 50 patients. The intervention period will be February-June 2025. It is expected that eligible patients will benefit from the intervention and that improved medication management and intensified use of nonpharmacological treatment strategies will reduce pain-related disabilities and other patient-reported outcomes.

CONCLUSIONS

This study will provide valuable information regarding feasibility and potential effects before testing the intervention in a confirmatory cluster randomized controlled trial.

TRIAL REGISTRATION

German Clinical Trials Register DRKS00034831; https://www.drks.de/search/de/trial/DRKS00034831.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/66335.

摘要

背景

慢性非癌性疼痛（CNCP）是全科医疗中常见的咨询原因。当前德国指南强调其生物心理社会病因以及自我护理和非药物治疗策略（如教育、体育和社交活动以及心理方法）的重要性。全面评估对于最大程度地实现治疗个体化以及监测止痛药物的合理使用至关重要。全科医生在实施考虑生物、心理和社会方面的整体疼痛管理时面临诸多挑战。在“缓解”项目（以资源为导向的病例管理，用于在全科医疗中为慢性疼痛患者和频繁使用镇痛药的患者实施建议）中，制定了一个病例管理项目，以促进关于疼痛管理的指南建议在医学评估与监测、患者及医疗团队教育、自我护理策略推广以及合理药物治疗方面的实施。

目的

在将干预措施和研究程序应用于更大规模的整群随机对照试验之前，我们评估了它们的可行性。我们的次要目的是估计这种复杂干预的潜在效果。

方法

将开展一项针对全科医疗和患有CNCP且使用镇痛药的患者的单臂试验，并伴有混合方法的过程评估。干预包括5个组成部分，包括软件支持下的医学疼痛史、3次预定的结构化预约、面向全科医生和医疗助理的关于CNCP的电子学习、患者教育材料、为患者和医疗团队提供（区域）资源信息的工具箱。参与的医疗机构将位于德国巴登 - 符腾堡州，并将招募符合条件的患者（患有CNCP超过3个月的成年人，至少有中度疼痛相关残疾，在过去4周内持续或按需使用镇痛药或辅助镇痛药，且医疗团队评估有能力积极参与试验）。向2025年2月进入该医疗机构的前150名成年患者发放的问卷将有助于筛选符合条件的患者。主要目的将通过一组预定义指标来衡量。关键的次要结局是用德文版疼痛残疾指数测量的疼痛相关残疾。将要求所有参与者参与过程评估。结局评估数据将通过纸质和数字形式提供的问卷由参与者完成收集。过程评估数据将通过调查和定性研究收集。将进行描述性分析。