Development and Pilot Testing of LIMIT: a Multicomponent Tool to Support Opioid Tapering
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 8
- 主要终点
- Daily Morphine Milligram Equivalents (MME)
研究概览
简要总结
There are nearly one million veterans being treated with long-term opioid therapy (LTOT) for chronic pain. Numerous short and long-term harms associated with LTOT and mounting evidence suggest they have modest or no benefit. Yet, currently available resources to support veterans 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. 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 study is to develop and test an interactive, theory-informed, multi-component mobile website to enable veterans to safely taper opioids while managing their pain.
详细描述
The investigators will conduct a 9-month, randomized, two-arm, parallel, open-label, feasibility trial of the multicomponent mobile website called SUMMIT. Eligible participants will be randomized to SUMMIT versus a pain monitoring app. Outcome measures will be collected over 9 months.
To ensure rigor and successful future implementation, the investigators 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for Veterans will be primary care patients who are dispensed 84 consecutive days of a stable dose of opioids (reflecting three consecutive 28-day prescriptions) through primary care and who report stable levels of pain intensity over the past month.
排除标准
- •Exclusion criteria will be Veterans on liquid methadone or buprenorphine for opioid use disorder (OUD) and those who have transitioned to buprenorphine (transdermal or sublingual) for chronic pain, have hearing or visual impairments (not corrected with hearing aids or glasses), psychiatric conditions, cognitive impairments, or participating in a concurrent pain or opioid-related research study.
研究组 & 干预措施
SUMMIT
Participants randomized to the experimental intervention will participate in a Motivational Interviewing (MI) session lasting between 30 and 60 minutes with study psychologist. All MI sessions will be audiotaped using a VA-approved digital recorder and transcribed verbatim. Participants will subsequently be shown how to access SUMMIT via a set of unique anonymized login credentials and to navigate the components of SUMMIT on one or more devices, depending on their preference. They will then be trained on how to complete the outcome surveys.
干预措施: SUMMIT (Behavioral)
control
Participants randomized to the control intervention will use an eHealth comparator: My Pain Diary: Chronic Pain Management (iPhone, Android). This app includes a pain monitoring functioning only, and thus will only minimally overlap, if at all, with SUMMIT's components. Control participants will not participate in a MI session. Participants will download the app and be shown how to use the My Pain Diary app and trained how to complete the outcome surveys
干预措施: control (Behavioral)
结局指标
主要结局
Daily Morphine Milligram Equivalents (MME)
时间窗: 9-months
Morphine milligram equivalents per day based on participant self report.
Minutes of Summit App Use
时间窗: 6 months
Total number of minutes of use of the Summit app over the 6 month intervention
Daily Morphine Milligram Equivalents (MME)
时间窗: 9-months
Morphine milligram equivalents per day based on participant self report.
Minutes of Summit App Use
时间窗: 6 months
Total number of minutes of use of the Summit app over the 6 month intervention
次要结局
- Behavior Intervention Rating Scale (BIRS)(six months)
- Behavior Intervention Rating Scale (BIRS)(six months)