Addressing Loneliness in Primary Care Patients on Chronic Opioids to Prevent Opioid Misuse

解决长期使用阿片类药物的初级保健患者的孤独感，以防止阿片类药物滥用

• 批准号: 10678256
• 负责人: Sebastian Tong
• 金额: $ 23.33万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-15 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10678256
• 关键词: Address; Alaska; Behavior; COVID-19 pandemic; Caring; Chronic; Clinic; Cognitive Therapy; Data; Development; Dose; Ethnic Origin; Evidence based intervention; Feeling; Future; Gender; Geographic Locations; Goals; Group Meetings; Health; Health Professional; Idaho; Intervention; Loneliness; Measures; Mediating; Montana; Opioid; Outcome; Pain; Pain interference; Participant; Patient-Focused Outcomes; Patients; Pattern; Perception; Population; Primary Care; Quality of life; Race; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recovery Support; Reporting; Research; Risk; Series; Social Network; Social support; Substance Use Disorder; System; Testing; Therapeutic Intervention; Time; Washington; Wyoming; arm; behavioral health; care seeking; caregiving; chronic pain patient; effectiveness clinical trial; efficacious intervention; evidence base; experience; feasibility testing; functional status; high risk; implementation outcomes; improved; improved outcome; innovation; opioid misuse; opioid use; opioid use disorder; pain outcome; patient engagement; patient population; pilot test; pilot trial; poor health outcome; post intervention; practice-based research network; pragmatic trial; prescription opioid; prevent; primary care clinician; primary care patient; primary care practice; primary care setting; primary outcome; psychologic; secondary outcome; social; social cognition; social skills; treatment as usual

PROJECT SUMMARY Patients with chronic pain on opioids frequently experience loneliness, which is associated with poorer health outcomes and higher risks for opioid misuse and opioid use disorder. Given that almost half of opioids are prescribed in primary care, a critical need exists for the development and testing of interventions to reduce loneliness in primary care patients at risk for opioid misuse. The long-term goal of our study is to reduce opioid misuse and opioid use disorder by addressing loneliness in primary care patients on chronic opioids. Interventions addressing maladaptive social cognition through cognitive behavioral therapy and improving social support through social navigation have been shown to be effective in reducing loneliness and improving outcomes in other fields but have not been tested in patients at risk for substance use disorder. In our study, which responds to RFA-DA-23-010 (Enhancing Social Connectedness and Ameliorating Loneliness to Prevent and Treat SUD and Support Recovery), we propose a pilot 3-arm randomized clinical effectiveness trial that will adapt and test the feasibility of implementing two efficacious interventions: (1) a psychological intervention using cognitive behavioral therapy to address maladaptive thought patterns around social connection and (2) a social navigation intervention to connect participants with social opportunities and develop supportive social networks. Our proposed study would take place in primary care practices from the Washington, Wyoming, Alaska, Montana and Idaho region Practice and Research Network, a practice-based research network of over 100 practices. Our specific aims are: (1) to refine and adapt both the social navigation and psychological loneliness interventions for primary care patients on chronic opioids by engaging patients and clinicians in a series of stakeholder group meetings, (2) to assess the feasibility of implementing a 3-arm randomized clinical effectiveness trial with 102 patients using the RE-AIM framework, and (3) to determine the distribution and variability in the mediating outcome (loneliness), the primary outcome (opioid misuse) and secondary outcomes including opioid dose, functional status and patient-reported pain at three time points -- baseline, post-intervention and 3 months post-intervention. Our study is innovative because we are testing evidence-based interventions for loneliness in patients at high risk for opioid misuse where they are already receiving care and where most patients with chronic pain receive their pain related care. We expect that, consistent with the purpose of the R34 mechanism, this project will prepare us for larger scale pragmatic trial, where we can leverage embedded or remote behavioral health professionals within a diverse set of primary care practices, that tests patient outcomes, clinic-level feasibility, and sustainability. The project is expected to have a positive impact in reducing opioid misuse and potentially development of substance use disorder, as well as improve health outcomes, functionality, and quality of life.

项目摘要 阿片类药物慢性疼痛的患者经常感到孤独，这与较差有关 健康结果和阿片类药物滥用和阿片类药物使用障碍的较高风险。鉴于几乎一半的阿片类药物 在初级保健中规定了开发和测试干预措施的关键需求以减少 初级保健患者的孤独感，面临阿片类药物滥用的风险。我们研究的长期目标是减少阿片类药物 通过解决慢性阿片类药物的初级保健患者的孤独感，滥用和阿片类药物使用障碍。 通过认知行为疗法解决不良适应性社会认知的干预措施并改善 通过社会导航的社会支持已被证明可以有效地减少孤独和改善 在其他领域的结果，但尚未在有药物使用障碍风险的患者中进行测试。 在我们的研究中，对RFA-DA-23-010做出反应（增强社会联系和改善 防止和治疗SUD和支持恢复的孤独感），我们提出了一个飞行员3臂随机临床 有效试验将适应和测试实施两种有效干预措施的可行性：（1）A 使用认知行为疗法的心理干预措施解决适应不良的思维模式 社会联系和（2）社会导航干预措施，将参与者与社会机会联系起来 建立支持性的社交网络。我们提出的研究将在初级保健实践中进行 华盛顿，怀俄明州，阿拉斯加，蒙大拿州和爱达荷州地区实践与研究网络，一个基于实践的 超过100种实践的研究网络。我们的具体目的是：（1）完善和适应社会 通过参与慢性阿片类药物的初级保健患者的导航和心理孤独干预措施 一系列利益相关者组会议中的患者和临床医生（2）评估实施的可行性 使用RE-AIM框架对102名患者进行3臂随机临床有效性试验，（3） 确定介导结果的分布和变异性（孤独感），主要结果（阿片类药物 滥用）和次要结果，包括阿片类药物剂量，功能状态和患者报告的疼痛 时间点 - 基线，干预后和干预后3个月。 我们的研究具有创新性，因为我们正在测试患者孤独的基于证据的干预措施 阿片类药物滥用的高风险，他们已经在接受护理以及大多数患有慢性疼痛的患者 接受与疼痛有关的护理。我们希望，与R34机制的目的一致，该项目 将为我们做好大规模务实试验的准备，我们可以利用嵌入式或远程行为健康 在各种初级保健实践中的专业人员，测试患者的结果，诊所级别的可行性， 和可持续性。预计该项目将对减少阿片类药物的滥用和潜在的潜在影响产生积极影响 培养物质使用障碍的发展，并改善健康结果，功能和生活质量。