Patient and Provider Interventions for Managing Osteoarthritis in Primary Care

描述（由申请人提供）：循证指南强调骨关节炎（OA）的充分管理需要医学和行为模式的结合。然而，许多推荐的指南并没有定期纳入临床实践，并且推荐的行为策略（例如运动和体重管理）并没有被大多数患者实践。本研究的目的是比较以患者为基础的行为干预，以提供者为基础的干预，以及两种干预的组合，以改善OA患者的预后。这项研究将提供新颖的、有价值的信息，比较这三种干预措施在现实世界初级保健环境中的影响和成本效益。这将是一项随机对照试验，纳入n=560例有症状的膝关节或髋关节OA患者，采用2 × 2因子设计。患者将被分配到四个研究组之一：1。仅针对OA的患者行为干预，2。3.仅针对OA的提供者干预3 . OA患者行为干预+提供者干预；常规护理控制。患者行为干预将是一个为期12个月的项目，包括以下内容：书面教育材料（重点是运动、体重管理和认知行为疼痛管理），为下肢OA患者量身定制的运动视频，以及咨询师每月打电话支持行为改变。提供者干预将包括提供有关患者OA症状和治疗的信息，以及针对患者的循证护理建议。提供者将在临床护理点获得这些信息。结果评估的主要时间点为12个月。我们还将在6个月、18个月和24个月时通过电话评估一组有限的结果。主要结果将是西安大略省和麦克马斯特大学骨关节炎指数（WOMAC）。次要结果包括客观身体机能（短体能测试）和抑郁症状（贝克抑郁量表）。主要研究分析将比较每个干预组与常规护理对照组的结果。我们还将评估每项干预措施的成本效益。

DESCRIPTION (provided by applicant): Evidence-based guidelines emphasize that adequate management of osteoarthritis (OA) requires a combination of medical and behavioral modalities. However, many of the recommended guidelines are not regularly incorporated into clinical practice, and the recommended behavioral strategies (e.g. exercise and weight management) are not practiced by most patients. The objective of this study is to compare a patient- based behavioral intervention, a provider-based intervention, and a combination of the two interventions, for improving outcomes among patients with OA. This study will provide novel, valuable information comparing the impact and cost-effectiveness of these three interventions in the context of real-world primary care settings. This will be a randomized controlled trial of n=560 patients with symptomatic knee or hip OA, using a 2 x 2 factorial design. Patients will be assigned to one of four study arms: 1.) Patient Behavioral Intervention for OA Only, 2.) Provider Intervention for OA Only, 3.) Patient Behavioral Intervention + Provider Intervention for OA, and 4.) Usual Care Control. The Patient Behavioral Intervention will be a twelve-month program that includes the following elements: written educational materials (focused on exercise, weight management, and cognitive behavioral pain management), an exercise video tailored for patients with lower extremity OA, and monthly telephone calls by a counselor to support behavior change. The Provider Intervention will involve giving information on patients' OA symptoms and treatment, as well as patient-specific evidence-based recommendations for care. Providers will have access to this information at the point of clinical care. The primary time point for outcome assessment will be at 12-months. We will also assess a limited set of outcomes via telephone at 6-months, 18-months, and 24-months. The primary outcome will be the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC). Secondary outcomes will include objective physical function (Short Physical Performance Test) and depressive symptoms (Beck Depression Inventory). The main study analyses will compare outcomes in each intervention group to the usual care control group. We will also assess the cost-effectiveness of each intervention. PUBLIC HEALTH RELEVANCE: Osteoarthritis (OA) is one of the most common chronic conditions and a leading cause of disability among adults. Many patients with OA have significant pain and functional limitations, even though they receive some medical care for their OA. This study will compare an intervention for patients, an intervention for health care providers, and a combination of both interventions for improving pain and function among patients with OA.