Addressing Opioid Use Disorder in the Elderly Through Primary Care Innovation: Pain and Opioid Management in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,035
- 试验地点
- 2
- 主要终点
- Health-Related Quality of Life and Functioning: Mental Health Summary Score
研究概览
简要总结
The extent and depth of the ongoing opioid crisis are well known and many interventions are under way in the United States and other countries to alleviate its devastating impact on individuals and the society. To address specific challenges of pain and opioid management (POM) in older and vulnerable adults, the investigators will design and implement a multi-faceted, person-centered, and scalable opioid use disorder (OUD) management program in Oklahoma primary care practices. The investigators expect that the rigorously designed and evidence-based program will establish and disseminate innovative solutions for pain and opioid management in high-risk, older and vulnerable populations living with chronic pain. The proposed initiative will help primary care practices optimize pain management approaches in older adults through an integrated and trans-disciplinary application of innovations in multi-modal pain management, pain mechanism-based pharmacotherapy, patient goal-oriented care, implementation science, evidence-based quality improvement methodology, and community-engaged design.
详细描述
The project's specific aims are:
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Building upon existing guidelines and tools that the investigators' collaborative has developed and implemented for pain and opioid management (POM), refine and tailor care processes, implementation support strategies, and shared decision support resources to the specific needs of older adults in primary care settings, using a systematic approach, including:
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Conduct a rapid, iterative process, through which a diverse healthcare professional expert panel adapts and enhances existing POM approaches and tools to older adult patients (POMOA);
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Implement a subsequent formative process, through which a patient and caregiver community advisory board ensures that the tailored POM approach and resources are acceptable, usable, context-sensitive and value-added for older adults and their caregivers; and
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Assemble tailored resources to create a POMOA Toolkit from which primary care practices can select sets of resources based on their specific needs, guided by academic detailers and practice facilitators.
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Over a 2-year period, help a minimum of 36 Oklahoma primary care practices implement a person-centered, goal-oriented, and community-linked approach to pain management, tailored to older adults. The implementation approach will include the following:
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Using benchmarking and performance feedback, academic detailing, practice facilitation, and technology support, help practices integrate the tailored POMOA approach and resources into their workflows, focusing on improving patient functioning, self-efficacy, and the optimization of pain management; and
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Through ongoing observation and analysis, identify facilitators and barriers to program implementation to accelerate convergence on effective and replicable methods.
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Conduct a multi-dimensional and comprehensive evaluation of the impact of the RISE-OK program, including the measurement of the following outcomes:
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Patient-Centered Outcomes: Patient health-related quality of life and functioning (PROMIS-29), self- efficacy for pain management using a modified Arthritis Self-Efficacy scale (ASES), pain interference (Pain-Enjoyment-General Activity), and functional goal attainment (Goal Attainment Scaling);
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Care Quality Outcomes: Patient utilization of opioid medications (morphine milligram equivalents) and alternative therapies in older adults, change in prescribing patterns, and diversification of pharmacological and non-pharmacological pain therapies;
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Care Process Outcomes: Impact of the program on practice-level care process outcomes (chronic opioid therapy registry use; systematic chronic opioid therapy visits; pain impact/interference measurement, pain management and risk/benefit conversations; naloxone prescription; tapering practices; patient/caregiver education; shared decision-making; referrals/community service linkages; medication assisted therapy utilization); and
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Qualitative Outcomes: Healthcare professional, health system leadership, patient, and caregiver perceptions of the utility, effectiveness and generalizability of the RISE-OK program, explored via semi-structured interviews, exit surveys, and in-depth program implementation process observations.
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Disseminate innovative approaches and products developed by the RISE-OK project in several ways:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 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
- 否
入选标准
- •For the Practice: Deliver primary care services to older adults. Be located in Oklahoma. Be willing to complete a pre- and post-practice characteristic and building blocks of primary care survey. Use an electronic health record.
- •For Practice Clinicians: Be an MD, DO, PA, or APRN licensed to practice in Oklahoma. Be willing to complete a pre- and post- practice member survey. Be willing to work with the OPHIC external support personnel to use the performance measures.
- •For Practice Staff: Be employed by the practice. Be willing to complete a pre- and post- practice member survey. Be willing to work with the OPHIC external support personnel to use performance measures to optimize pain management approaches in older adults.
- •For Practice Patients: Be chronic pain patients aged 60 or older, or may be younger, but vulnerable due to disability, significant functional limitation or social deprivation. Be willing to complete PROMIS-29 surveys, participate in RISE-OK Project activities, and provide feedback on the RISE-OK program.
排除标准
- •Practices: Does not provide primary care. Provides only urgent care and does not provide continuity of care or long-term follow-up care. Does not use an electronic health record.
- •Clinicians: Do not provide primary care with continuity and chronic care follow-up. Planning to leave practice within the next 12 months, including if the clinician is planning to retire within the next 12 months.
- •Practice Staff: Under 18 years of age.
- •Patients: Not older adult chronic pain patients.
研究组 & 干预措施
Primary Care Practices
Dissemination and Implementation Research
干预措施: Dissemination and Implementation Research (Other)
结局指标
主要结局
Health-Related Quality of Life and Functioning: Mental Health Summary Score
时间窗: Baseline to 17 months
Change in Patient-Reported Outcomes Measurement Information System Survey (PROMIS-29) Mental Health Summary Score
Morphine Milligram Equivalent (MME)
时间窗: Baseline to 17 months
Change in mean opioid Morphine Milligram Equivalent (MMEs) at the practice level
Health-Related Quality of Life and Functioning: Physical Health Summary Score
时间窗: Baseline to 17 months
Change in Patient-Reported Outcomes Measurement Information System Survey (PROMIS-29) Physical Health Summary Score
次要结局
- Self-Efficacy(17 months)
- Chronic Opioid Therapy Statistics: Eligible Patients(Month 17)
- Chronic Opioid Therapy Statistics: Chronic Pain Diagnosis(Month 17)
- Chronic Opioid Therapy Statistics: High Risk Patients(Month 17)
- Polypharmacy Risk(Month 17)
- Chronic Opioid Therapy Statistics: Visit Addressing Pain Management(Month 17)
- Pain-Related Goal Attainment(Month 17)
- Diversification of Pain Therapy(Month 17)
- Pain-Function Interference(Month 17)