The Effect of a Multicomponent Intervention on Quality of Life in Residents of Nursing Homes: A Randomized Controlled Trial (COSMOS)

Objectives: 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. Design: Multicenter, cluster-randomized, single-blinded, controlled trial. Setting: Thirty-three nursing homes with 67 units (clusters) from 8 Norwegian municipalities. Participants: 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. Measurements: 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). Results: 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. Conclusion and implications: 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.The COSMOS trial and EF, IA, CG, and DDS were supported by the Research Council of Norway (sponsor's protocol code 222113/H10); TH and TE were financed by the University of Bergen . BSH would like to thank the G.C. Rieber Foundation and the Norwegian government for supporting our work at the Centre for elderly and nursing home medicine, University of Bergen, Norway. The Rebekka Ege Hegermann’s foundation funded costs incurred in executing the study. Parts of the work (DDS) were carried out at the Biostatistics and data analysis core facility (BIOS), University of Bergen. Professor Stein Emil Vollset, University of Bergen, gave scientific advice to improve the manuscript. DA is a Royal society Wolfson research merit award holder and would like to thank the Wolfson foundation and the Royal society for their support.published version, accepted version (12 month embargo