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

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Abstract

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.

Section snippets

Participants and Settings

COSMOS was a multicenter, cluster-randomized, single-blind controlled trial. We chose this design to control for contamination, because the implementation of the multicomponent intervention was based on an educational program for NH staff.16 The intervention lasted 4 months, with data collection at baseline and months 4 and 9. The researchers' networking and promotional work ensured NH recruitment located in 8 small and large, wealthy and less prosperous municipalities in western and southeast

Results

Between May 2014 and December 2015, a total of 723 patients from 33 NHs were cluster randomized to the intervention group (36 units; N = 394) or control (31 units; N = 329); 97 patients were excluded from the intervention group and 81 from control (Figure 1). A total of 461 (85%) participants completed the assessment at month 4, and 397 (73%) follow-up assessment at month 9. Dropout rates were similar in the intervention (83 [28%] participants) and control (65 [26%] participants) (P = .65);

Discussion

Our study showed that the COSMOS intervention did not improve QoL in NH patients during the active intervention from baseline to month 4. However, follow-up analyses between months 4 and 9 demonstrated significant effects on QoL in the intervention group compared to controls, as measured by EQ-VAS and QUALIDEM. Improvements were especially related to care relationship, positive affect, and social relations. The trial offered significant enhancements for some of the secondary outcomes (CGIC;

Conclusion and Implications

COSMOS provides a nonpharmacologic multicomponent intervention to manage multimorbid NH patients and to support health care staff who are incorporated in a standardized education program. Temporarily, the QoL decreased in the intervention group, leading to our hypothesis that staff may be overwhelmed by the work-intensive intervention period. However, the decrease reversed significantly during follow-up, indicating a potential learning effect. Further, the intervention group improved in ADL

Acknowledgments

We thank the patients, their relatives, and the NH staff for their willingness and motivation that made this work possible.

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

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    Declaration of Interest: BSH, EF, IA, CG, TH, TE, GS, IT, and DDS declare that they have no competing interests.

    CB reports grants and personal fees from Lundbeck, grants and personal fees from Acadia, personal fees from Roche, personal fees from Orion, personal fees from GSK, personal fees from Otusaka, personal fees from Heptares, personal fees from Lilly, outside the submitted work. DA has received research support and/or honoraria from AstraZeneca, H. Lundbeck, Novartis Pharmaceuticals and GE Health, and serves as paid consultant for H. Lundbeck, Eisai, and Axovant.

    Role of the funding source: The funding source had no role in study design, data collection, data analyses, data interpretation or writing of the report.

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