Nursing Home Pain Management Algorithm Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 396
- 试验地点
- 2
- 主要终点
- Change from Baseline in Pain at 3 months
研究概览
简要总结
Pain assessment and management deficiencies in nursing homes (NHs) are well documented. Unrelieved pain in this setting results in poorer resident outcomes, including depression, decreased mobility, sleep disturbance, and impaired physical and social functioning. This randomized controlled trial will evaluate the efficacy of a pain management algorithm coupled with intense diffusion strategies in improving pain, physical function and depression among NH residents. Specific aims of the study are to: 1) Evaluate the effectiveness of a pain management algorithm (ALG) coupled with intense diffusion strategies, as compared with pain education (EDU) and weak diffusion strategies, in improving pain, mobility, and depression among NH residents; 2) Determine the extent to which adherence to the ALG and organizational factors are associated with changes in resident outcomes and the extent to which changes in these variables are associated with changes in outcomes; 3) Evaluate the persistence of changes in process and outcome variables at long-term follow-up and 4) Evaluate the relationships among behavioral problems and pain in severely cognitively impaired residents who are unable to provide self-report.
详细描述
Inadequate pain management in nursing homes (NHs) is well documented. Unrelieved pain in this setting results in depression, decreased mobility, sleep disturbance, and impaired physical and social functioning. This randomized controlled trial will evaluate the efficacy of a pain management algorithm delivered using intense diffusion strategies. Outcomes are facility pain practices and residents' pain, physical function and depression. Specific aims of the study are to: 1) Evaluate the effectiveness of a pain management algorithm (ALG) coupled with intense diffusion strategies, as compared with pain education (EDU) and weak diffusion strategies, in improving pain, mobility, and depression among NH residents; 2) Determine the extent to which adherence to the ALG and organizational factors are associated with changes in resident outcomes and the extent to which changes in these variables are associated with changes in outcomes; 3) Evaluate the persistence of changes in process and outcome variables at long-term follow-up and 4) Evaluate the relationships among behavioral problems and pain in severely cognitively impaired residents who are unable to provide self-report.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •long-term nursing home residents,
- •65 years and older,
- •with moderate or greater pain in the week prior to screening,
- •residing in a participating facility,
- •who consent to participate (or whose surrogate decisionmaker consents to participation)
排除标准
- •short-term stay patients,
- •persons less than 65 years,
- •residents on hospice
结局指标
主要结局
Change from Baseline in Pain at 3 months
时间窗: 3 months
Brief Pain Inventory (self-reporting participants) Nursing Assistant Surrogate Report
Change from Baseline in Pain at 6 months
时间窗: 6 months post intervention
Brief Pain Inventory (self-reporting participants) Nursing Assistant Surrogate Report
次要结局
- Change from Baseline in Mobility at 3 months(3 months)
- Change from Baseline in Agitation at 6 months(6 months)
- Change from Baseline in Depression at 6 months(6 months post intervention)
- Change from Baseline in Mobility at 6 months(6 months post-intervention)
- Change from Baseline in Depression at 3 months(3 months)
- Change from Baseline in Adherence to Best Practices at 6 months(6 months post-intervention)
- Change from Baseline Adherence to Best Practices at 3 months(3 months)