Department of Global Public Health and Primary Care, Centre for Elderly and Nursing Home Medicine, Faculty of Medicine, University of Bergen, Norway; Municipality of Bergen, Bergen, Norway.
University of Exeter Medical School, Exeter, United Kingdom; Centre for Age-Related Medicine, Stavanger University Hospital, Stavanger, Norway.
J Am Med Dir Assoc. 2019 Mar;20(3):330-339. doi: 10.1016/j.jamda.2018.11.006. Epub 2019 Jan 7.
To investigate if the multicomponent intervention of the COSMOS trial, combining communication, systematic pain management, medication review, and activities, improved quality of life (QoL) in nursing home patients with complex needs.
Multicenter, cluster-randomized, single-blinded, controlled trial.
Thirty-three nursing homes with 67 units (clusters) from 8 Norwegian municipalities.
Seven hundred twenty-three patients with and without dementia (≥65 years) were cluster randomized to usual care or intervention in which health care staff received standardized education and on-site training for 4 months with follow-up at month 9.
Primary outcome was change in QoL as measured by QUALIDEM (QoL dementia scale); QUALID (QoL late-stage dementia scale), and EQ-VAS (European QoL-visual analog scale) from baseline to month 4. Secondary outcomes were activities of daily living (ADL), total medication, staff distress, and clinical global impressions of change (CGIC).
During the active intervention, all 3 QoL measures worsened, 2 significantly (QUALID P = .04; QUALIDEM P = .002). However, follow-up analysis from month 4 to 9 showed an intervention effect for EQ-VAS (P = .003) and QUALIDEM total score (P = .01; care relationship P = .02; positive affect P = .04, social relations P = .01). The secondary outcomes of ADL function, reduction of medication (including psychotropics) and staff distress, improved significantly from baseline to month 4. Intervention effects were also demonstrated for CGIC at month 4 (P = .023) and 9 (P = .009), mainly because of deterioration in the control group.
Temporarily, the QoL decreased in the intervention group, leading to our hypothesis that health care staff may be overwhelmed by the work-intensive COSMOS intervention period. However, the decrease reversed significantly during follow-up, indicating a potential learning effect. Further, the intervention group improved in ADL function and received less medication, and staff reported less distress and judged COSMOS as able to bring about clinically relevant change. This suggests that nonpharmacologic multicomponent interventions require long follow-up to ensure uptake and beneficial effects.
研究 COSMOS 试验的多组分干预措施（包括沟通、系统疼痛管理、药物审查和活动）是否能提高有复杂需求的养老院患者的生活质量（QoL）。
多中心、聚类随机、单盲、对照试验。
来自挪威 8 个城市的 33 家养老院的 67 个单元（聚类）。
723 名有或没有痴呆症（≥65 岁）的患者被聚类随机分配到常规护理或干预组，其中医护人员接受了为期 4 个月的标准化教育和现场培训，并在第 9 个月进行随访。
主要结局是通过 QUALIDEM（痴呆症 QoL 量表）、QUALID（晚期痴呆症 QoL 量表）和 EQ-VAS（欧洲 QoL-视觉模拟量表）从基线到第 4 个月测量的 QoL 变化。次要结局是日常生活活动（ADL）、总用药量、员工压力和临床总体印象变化（CGIC）。
在积极干预期间，所有 3 项 QoL 测量指标均恶化，其中 2 项指标有显著差异（QUALID P=0.04；QUALIDEM P=0.002）。然而，从第 4 个月到第 9 个月的随访分析显示，EQ-VAS（P=0.003）和 QUALIDEM 总分（P=0.01；护理关系 P=0.02；积极影响 P=0.04，社会关系 P=0.01）有干预效果。ADL 功能、药物（包括精神药物）用量减少和员工压力的次要结局从基线到第 4 个月显著改善。第 4 个月和第 9 个月 CGIC 的干预效果也得到了证明（P=0.023 和 P=0.009），主要是因为对照组的恶化。
暂时，干预组的 QoL 下降，导致我们的假设，即医护人员可能会被工作量大的 COSMOS 干预期压垮。然而，在随访过程中，这种下降有了显著的改善，表明可能存在学习效应。此外，干预组的日常生活活动功能得到改善，用药量减少，员工压力减轻，并且认为 COSMOS 能够带来临床相关的变化。这表明，非药物多组分干预措施需要长期随访，以确保其被接受并产生有益效果。
