Nonpharmacologic Pain Management in FQHC Primary Care Clinics
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- PEG-3
研究概览
简要总结
The goal of this study is to improve pain management and reduce opioid reliance for patients with chronic back pain in Utah Federally-Qualified Health Centers (FQHCs). The study compares the effectiveness of nonpharmacologic pain treatments using telehealth to overcome access barriers. We will use automated EHR reminders for electronic referral to teleconsult services. Our project tests adaptive treatments and uses a hybrid type I design - focused on effectiveness outcomes while gathering implementation data to inform future efforts to scale effective strategies.
详细描述
This randomized clinical trial compares the effectiveness of different strategies to provide efficacious nonpharmacologic interventions to patients with back pain seeking care in FQHCs throughout the state of Utah. The strategies evaluated are designed to overcome the barriers specific to rural and low income communities served by FQHC clinics through innovative use of telehealth resources. The randomized trial will randomize individual participants to one of two interventions strategies, one providing both a brief pain teleconsult with a 10-week telehealth physical therapy, the other uses an adaptive strategy - providing the brief pain teleconsult first, followed by the 10-week telehealth physical therapy only among those non-responsive to the brief teleconsult treatment. We will also evaluate outcomes related to the efforts to implement strategies in FQHC clinics in order to provide valuable information for future efforts to scale effective strategies into other low resource health care settings. Assessments will occur at baseline and after 12-, 26- and 52-weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The study is outcome assessor and investigator blinded. Blinding will only be broken in emergency situations for reasons of participant safety such as a serious adverse event. If blinding is broken, either intentionally or unintentionally, the reason will be fully documented and entered on an electronic case report form. Every effort will be made to discuss the decision to break blinding with the Data Safety Monitoring Board in advance.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to communicate in English or Spanish
- •Age between 18-80
- •Visit with an FQHC provider (in-person or via telehealth) in past 90 days
- •Back pain has been an ongoing problem for at least the past 3 months, and has been a problem on at least half the days in the past 6 months
- •Access to resources necessary to receive telehealth sessions (phone or 2-way video)
排除标准
- •Currently pregnant
- •Currently involved in active substance use disorder treatment (other than peer support groups, AA, etc.)
- •History of spine surgery in past 6 months
- •Has a condition restricting participation in physical activity (i.e., unable to ambulate independently (with or without assistive device) for at least 5 minutes.
- •Reason for back pain is a fracture or non-musculoskeletal condition (i.e., spinal tumor, inflammatory disorder, etc.)
结局指标
主要结局
PEG-3
时间窗: 12 weeks
The PEG-3 measure includes 3 items evaluating 1) pain severity, and interference of pain with 2) enjoyment and 3) general activity. Item response options range from 0-10. The PEG-3 score is expressed as the mean of all item scores with higher scores indicating greater pain impact
次要结局
- PEG-3(baseline, 26- and 52-weeks)
- Physical Function(baseline, 12-, 26- and 52-weeks)
- Sleep Disturbance(baseline, 12-, 26- and 52-weeks)
- opioid use(across 52 week follow-up)
- Pain Catastrophizing(baseline, 12-, 26- and 52-weeks)
- Pain Self-Efficacy(baseline, 12-, 26- and 52-weeks)
- Global Impression of Change(baseline, 12-, 26- and 52-weeks)
研究者
Julie Fritz
Distinguished Professor
University of Utah