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.

项目概要 服用阿片类药物导致慢性疼痛的患者经常会感到孤独，这与贫困有关 健康结果以及阿片类药物滥用和阿片类药物使用障碍的更高风险。鉴于几乎一半的阿片类药物 是在初级保健中规定的，迫切需要开发和测试干预措施以减少 有阿片类药物滥用风险的初级保健患者的孤独感。我们研究的长期目标是减少阿片类药物 通过解决长期使用阿片类药物的初级保健患者的孤独感来解决滥用和阿片类药物使用障碍。 通过认知行为治疗和改善来解决适应不良的社会认知的干预措施 通过社交导航进行的社会支持已被证明可以有效减少孤独感并改善 其他领域的结果，但尚未在有物质使用障碍风险的患者中进行测试。 在我们的研究中，该研究回应了 RFA-DA-23-010（增强社会联系和改善 孤独症预防和治疗 SUD 并支持康复），我们提出了一项试点 3 组随机临床试验 有效性试验将调整并测试实施两种有效干预措施的可行性：(1) 使用认知行为疗法进行心理干预来解决周围适应不良的思维模式 社交联系；(2) 社交导航干预，将参与者与社交机会联系起来； 发展支持性的社交网络。我们提议的研究将在初级保健实践中进行 华盛顿、怀俄明、阿拉斯加、蒙大拿和爱达荷地区实践和研究网络，一个以实践为基础的网络 超过 100 个实践的研究网络。我们的具体目标是：（1）完善和适应社会 通过参与对长期阿片类药物的初级保健患者进行导航和心理孤独干预 患者和临床医生参加一系列利益相关者小组会议，(2) 评估实施 使用 RE-AIM 框架对 102 名患者进行的 3 组随机临床有效性试验，以及 (3) 确定中介结果（孤独感）、主要结果（阿片类药物）的分布和变异性 误用）和次要结果，包括阿片类药物剂量、功能状态和患者报告的三岁疼痛 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，因为我们正在测试针对患者孤独感的循证干预措施 在已经接受护理且大多数患有慢性疼痛的患者的情况下，阿片类药物滥用的风险很高 接受与疼痛相关的护理。我们期望，与 R34 机制的目的一致，该项目 将为我们进行更大规模的实用试验做好准备，我们可以利用嵌入式或远程行为健康 各种初级保健实践中的专业人员，测试患者的结果、临床水平的可行性、 和可持续性。该项目预计将对减少阿片类药物滥用产生积极影响，并有可能 药物滥用障碍的发展，以及改善健康结果、功能和生活质量。