• Bettina S Husebø, Clive Ballard, Dag Aarsland, Geir Selbaek, Dagrun D Slettebo, Christine Gulla, Irene Aasmul, Torstein Habiger, Tony Elvegaard, Ingelin Testad, and Elisabeth Flo.
• 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. Electronic address: Bettina.Husebo@uib.no.
• J Am Med Dir Assoc. 2019 Mar 1; 20 (3): 330-339.

ObjectivesTo 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.DesignMulticenter, cluster-randomized, single-blinded, controlled trial.SettingThirty-three nursing homes with 67 units (clusters) from 8 Norwegian municipalities.ParticipantsSeven 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.MeasurementsPrimary 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).ResultsDuring 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 ImplicationsTemporarily, 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.Copyright © 2018 AMDA – The Society for Post-Acute and Long-Term Care Medicine. All rights reserved.

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