Development and pilot testing of LIMIT: a multicomponent tool to support opioid tapering

从VHA提供者那里接受阿片类药物的退伍军人人数从2001年的651，000人增加到2002年的1，101，346人。 2013年，有相当大的比例接受长期阿片类药物治疗（LTOT）。对以下方面的关切日益增加： LTOT的适度或无益处以及显著的短期和长期副作用导致 广泛努力减少VHA中阿片类药物的使用。然而，支持退伍军人的资源 锥度是不够的。初级保健，其中大多数LTOT在VHA规定，是负担过重，紧张 来应对照顾慢性疼痛患者的挑战。药剂师管理和其他资源密集型 临床方案是有效的，但可能太耗费时间或资源，对许多机构来说不可行。 此外，即使是资源充足的中心医疗中心通常也难以满足社区的需求， 门诊部。一种可扩展的、相对便宜的减量干预措施，以支持初级保健和/或 扩大资源密集型专科诊所的覆盖范围将对那些没有 从LTOT中获得足够的好处。 因此，该提案的目标是开发LIMIT（阿片类药物治疗中的少即是多），一个互动的， 理论知情，多组件移动的网站程序，使退伍军人安全地减少阿片类药物。我们将 使用干预映射（IM）框架开发LIMIT，这是一个严格的协议，用于开发有效的 行为改变干预。为了实现我们的目标，我们提出以下具体目标： 目标1.按照IM协议的前四个迭代步骤开发LIMIT。我们将开发一个 基于需求评估、变更目标和 提出了基于理论的行为改变技术。关键线人（包括退伍军人和主要 护理提供者）已经并将继续参与LIMIT的开发，以提高 可用性、未来传播和实施。 目标二。对LIMIT原型进行预测试。我们将执行一轮又一轮的可用性测试 每轮LTOT上有四到六名老手的LIMIT原型，然后现场测试改进的移动的网站 在现实世界的设置程序。可用性将使用定性和定量方法进行测试， 将根据需要作出改进。 目标3：评价LIMIT全面疗效RCT的可行性。我们将进行为期9个月， 随机、双组、平行、开放标签、可行性试验。合格受试者将随机分配至LIMIT 与疼痛监测应用程序相比。将在9个月内收集结局指标。 为了确保严格和成功的未来实施，我们将：1）制定一个基于证据的计划， 经证明可最大限度地提高参与度和保留率的功能; 2）确保该计划包括以下机制： 解决退伍军人在考虑阿片类药物减量时报告的各种障碍（例如，害怕疼痛发作， 系统放弃）; 3）采用以用户为中心的设计-退伍军人的有意义的输入， 初级保健提供者在整个开发和测试阶段;和4）坚持最近公布的 移动的卫生干预指导方针。

The number of veterans receiving opioids from VHA providers increased from 651,000 in 2001 to 1,101,346 in 2013, with a substantial proportion receiving long-term opioid therapy (LTOT). Rising concerns regarding modest or absent benefit with LTOT as well as significant short- and long-term side effects have resulted in widespread efforts to curtail the use of opioids in the VHA. However, resources to support veterans who wish to taper are inadequate. Primary care, where most LTOT in VHA is prescribed, is overburdened and straining to meet the challenge of caring for patients with chronic pain. Pharmacist-run and other resource intensive clinical programs are effective, but may be too time or resource intensive to be feasible for many facilities. Furthermore, even well-resourced hub medical centers typically struggle to meet the needs of community- based outpatient clinics. A scalable, relatively inexpensive tapering intervention to support primary care and/or to extend the reach of resource-intensive specialty clinics would be of great benefit to veterans who are not deriving sufficient benefit from LTOT. As such, the goal of this proposal is to develop LIMIT (Less Is More In Opioid Treatment), an interactive, theory-informed, multi-component mobile website program to enable veterans to safely taper opioids. We will develop LIMIT using the Intervention Mapping (IM) framework, a rigorous protocol for developing effective behavior change interventions. To meet our objective, we propose the following specific aims: Aim 1. To develop LIMIT following the first four iterative steps of the IM protocol. We will develop a functional prototype based on the data generated from a needs assessment, change objectives, and proposed theory-based behavior change techniques. Key informants (including veterans and primary care providers) have and will continue to will be involved in the development of LIMIT to enhance usability, future dissemination and implementation. Aim 2. To pre-test the initial LIMIT prototype. We will perform iterative rounds of usability testing of the LIMIT prototype with four to six veterans on LTOT per round and then field test the refined mobile website program in a real-world setting. Usability will be tested using both qualitative and quantitative approaches and refinements will be made as required. Aim 3. To evaluate feasibility of a full-scale efficacy RCT of LIMIT. We will conduct a 9-month, randomized, two-arm, parallel, open-label, feasibility trial. Eligible participants will be randomized to LIMIT versus a pain monitoring app. Outcome measures will be collected over 9 months. To ensure rigor and successful future implementation, we will: 1) develop an evidence based program with features proven to maximize engagement and retention; 2) ensure that the program includes mechanisms to address the diverse obstacles veterans report when consider opioid tapering (e.g. fear of pain flares and abandonment by the system); 3) employ a User Centered Design – with meaningful input from veterans and primary care providers throughout the development and testing phases; and 4) adhere to recently published guidelines for mobile health interventions.