Systematic Pain Assessment in Nursing Home Residents With Advanced Dementia; Effect on Pain Management and Patient Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Change in analgesic intake measured in Defined Daily Dose (DDD) or a similar measure from baseline to 12 weeks. Will be assessed in both the Intervention and Control group.
研究概览
简要总结
It is estimated that 45-80 % of nursing home residents have substantial pain at any given time. Residents with impaired cognition have been found to report chronic pain more often, more frequent and more severe, compared to residents with normal cognition. Approximately 3/4 of permanent residents in nursing homes in Norway have developed dementia. The burden of dementia is often compounded by painful conditions. Despite over a decade of research on the subject, inadequate pain assessment and management remain significant problems among institutionalized older adults, with and without dementia. The poor pain management in patients with dementia has been attributed, at least in part, to difficulties with, and lack of, pain assessment in this population. Therefore, this study seek to determine the effect of regular pain assessment.
详细描述
The aim of the study is to determine the effect of regular pain assessment on pain management interventions applied and patient outcomes among patient with severe dementia.
A cluster randomized controlled trial will be conducted. A cluster is defined as a single independent nursing home. The clusters will be randomly assigned to either the experimental or control condition. Appropriate information will be given to both the intervention and the control group. All nurses in the experimental conditions will be taught how to administer the DOLOPLUS-2. The study will start after the initial education session. During the 3-month study period, the participating nursing staff will be asked to complete the DOLOPLUS-2 regularly. The control groups will receive standard methods of care. Data collection at baseline and at 4, 8 and 12 months.
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
- Single (Participant)
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
- •≥ 65 years old
- •Dementia diagnosis
- •Severe language impairment/non-communicative
- •Clinically significant pain and/or behavioral symptoms: a score of at least 44 on the Norwegian version of the Cohen-Mansfield Agitation Inventory (CMAI),
- •or a score of at least 4 (frequency × severity) on items of the Neuropsychiatric Inventory - Nursing Home Version (NPI-NH),
- •or an indication of clinically significant pain (≥ 5) according to the DOLOPLUS-2 at baseline
排除标准
- •Short term stay, < 4 weeks
- •Primary psychiatric diagnosis
研究组 & 干预措施
ITreatment arm: Pain Assessment
Pain assessment by Doloplus-2 pain scale regularly and additional pain assessment in situations where pain is suspected.
干预措施: Pain assessment (Other)
Control arm: No treatment
Treatment us usual
结局指标
主要结局
Change in analgesic intake measured in Defined Daily Dose (DDD) or a similar measure from baseline to 12 weeks. Will be assessed in both the Intervention and Control group.
时间窗: 12 weeks
Change in pain score on the Dolplus-2 pain scale, and change in proportion scoring ≥ 5 on the Doloplus-2 scale from baseline to 12 week. Will be assessed in both the Intervention and Control group.
时间窗: 12 weeks
次要结局
- Validity and reliability of the Doloplus-2 pain scale.(12 weeks)
- Change in psychotropic drug use from baseline to 12 weeks. Will be assessed in both the Intervention and Control group(12 weeks)
- Change in NPS from baseline to 4, 8, 12 weeks. Will be assessed in both the Intervention and Control group(4, 8, 12 weeks)
- Nurses evaluation of systematic pain assessment tools by using a questionnaire developed for this study. Will be assessed in both the Intervention and Control group(12 weeks)
- Change in agitation measured with Brief Agitation Rating Scale (BARS) from baseline to 4 to 8 to 12 weeks. Will be assessed in both the Intervention and Control group.(4, 8, 12 weeks)
- Change in QoL measured with QUALID from baseline to 12 weeks. Will be assessed in both the Intervention and Control group.(12 weeks)
- Change in personal activity of daily living measured with the Physical Self Management Scale from baseline to 12 weeks. Will be assessed in both the Intervention and Control group.(12 weeks)
- Convergent validity of three pain scales: the Doloplus-2, the Mobid-2 and the Checklist for non-verbal pain behavior.(Baseline - 12 weeks)
- Association between variables; pain, agitation, NPS, depression, ADL, QoL, analgesic use, psychotropic use Will be assessed in both the Intervention and Control group.(Baseline and 12 weeks)
- Pain management intervention applied when pain is detected with pain assessment tool Doloplus-2. Will be assessed for the Intervention group(12 weeks)
研究者
Liv Halvorsrud
Associate Professor, PhD
Oslo Metropolitan University