Introduction: The majority of nursing home (NH) patients suffer from complex diseases, including dementia. This makes advance care planning (ACP) particularly important.Objectives: The aim was to investigate the effect of an ACP intervention on communication among NH staff, patient, and family. We further investigated whether the intervention affected nursing staff distress.Methods: The ACP intervention was a part of the 4-month cluster randomized controlled COSMOS trial with a 9-month follow-up. Norwegian NH units (n = 72), with 765 patients were invited, and eligible units were cluster randomized to usual care or the intervention group. The ACP intervention consisted of an education program targeting all NH staff (nurses and physicians) and managers. Implementation was supported by a train-the-trainer approach, with regular phone calls from the researchers. The effect of the intervention was assessed by a data collection form and questionnaires. Nursing staff distress was assessed by the Neuropsychiatric Inventory -Nursing Home version.Results: Five hundred and forty five patients from 67 NH units were included and randomized to the intervention (N = 297; 36 units) and control group (N = 248; 31 units). Organized meetings between the family, patient, and nurses were conducted more frequently in the intervention compared to the control group at month 4 (OR = 3.9, 95% CI = 1.6 to 9.4, p = 0.002). Monthly contact between family and nurses was also more frequent in the intervention group (OR = 6.5, 95% CI = 1.6 to 3.5, p = 0.010). Nurses and families were more satisfied with their communication in the intervention compared to the control group. Staff distress was reduced in the intervention group at month 4 (B = -1.8, 95% CI = -3.1 to -0.4, p = 0.012). The intervention effect at month 4 did not persist during follow-up at month 9.Conclusion: Compared to control, the ACP intervention improved the communication, and family and staff satisfaction as well as reduced staff distress. However, during the follow-up period these positive effects were not persistent. Indicating the necessity for ongoing staff support regarding ACP.Trial Registration: www.ClinicalTrials.gov (NCT02238652).

BackgroundAdvance Care Planning (ACP) is the repeated communication and decision-making process between the patient, family, and healthcare professionals. This study describes an ACP intervention in nursing homes and evaluates the outcomes of the implementation process.MethodsThe ACP intervention was part of a 4-month complex, cluster randomized controlled trial (COSMOS). 37 Norwegian nursing homes with 72 units (1 cluster = 1 unit) and 765 patients were invited to participate and eligible units were randomised to the intervention group or control. Nursing home staff in the intervention group was offered a standardized education programme to learn early and repeated communication with patients and families and to implement ACP in their units. We used a train-the-trainer approach to educate staff in the units, supported by regular telephone calls and a midway seminar after two months. Individual patient logs consisting of different communication deliverables were used to evaluate the implementation process. Supported by Qualitative Content Analyses, we identified facilitators and barriers of the ACP implementation based on feedback during midway seminars and individual patient logs.ResultsThe ACP intervention was conducted in 36 NH units (n = 297); 105 healthcare providers participated at the education seminar prior to the study, and 3–4 employees from each unit participated in the midway seminar. NH staff reported the educational material relevant for the implementation strategy. The patient logs showed that ACP was successfully implemented in 62% (n = 183) of the patients using our predefined implementation criteria. The staff emphasized the clear communication of the relevance of ACP addressed to leaders and staff as important facilitators, along with the clearly defined routines, roles and responsibilities. Identified barriers included lack of competence, perceived lack of time, and conflicting culture and staff opinions.ConclusionMonthly communication with the family was the most frequently conducted communication, and the predefined criteria of successfully implemented ACP were largely achieved. Nursing home routines and engagement of leaders and staff were crucial facilitators, whereas lack of time and competence reduced the implementation success.Trial registrationThe COSMOS-trial was registered in the ClinicalTrials.gov (NCT02238652) July 7th, 2014Electronic supplementary materialThe online version of this article (10.1186/s12877-018-0713-7) contains supplementary material, which is available to authorized users.

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 QoLevisual 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 ¼ .04; QUALIDEM P ¼ .002). However, follow-up analysis from month 4 to 9 showed an intervention effect for EQ-VAS (P ¼ .003) and QUALIDEM total score (P ¼ .01; care relationship P ¼ .02; positive affect P ¼ .04, social relations P ¼ .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 ¼ .023) and 9 (P ¼ .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 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.

BackgroundNursing home patients have complex mental and physical health problems, disabilities and social needs, combined with widespread prescription of psychotropic drugs. Preservation of their quality of life is an important goal. This can only be achieved within nursing homes that offer competent clinical conditions of treatment and care. COmmunication, Systematic assessment and treatment of pain, Medication review, Occupational therapy, Safety (COSMOS) is an effectiveness-implementation hybrid trial that combines and implements organization of activities evidence-based interventions to improve staff competence and thereby the patients’ quality of life, mental health and safety. The aim of this paper is to describe the development, content and implementation process of the COSMOS trial.Methods/DesignCOSMOS includes a 2-month pilot study with 128 participants distributed among nine Norwegian nursing homes, and a 4-month multicenter, cluster randomized effectiveness-implementation clinical hybrid trial with follow-up at month 9, including 571 patients from 67 nursing home units (one unit defined as one cluster). Clusters are randomized to COSMOS intervention or current best practice (control group). The intervention group will receive a 2-day education program including written guidelines, repeated theoretical and practical training (credited education of caregivers, physicians and nursing home managers), case discussions and role play. The 1-day midway evaluation, information and interviews of nursing staff and a telephone hotline all support the implementation process. Outcome measures include quality of life in late-stage dementia, neuropsychiatric symptoms, activities of daily living, pain, depression, sleep, medication, cost-utility analysis, hospital admission and mortality.DiscussionDespite complex medical and psychosocial challenges, nursing home patients are often treated by staff possessing low level skills, lacking education and in facilities with a high staff turnover. Implementation of a research-based multicomponent intervention may improve staff’s knowledge and competence and consequently the quality of life of nursing home patients in general and people with dementia in particular.Trial registrationClinicalTrials.gov NCT02238652

Individual pain treatment reduced staff distress in the intervention group compared to control group especially in regard to agitation-related symptoms and apathy. Furthermore, our results indicated a multifactorial model of staff distress, in which enhanced knowledge and understanding of NPSs and pain in people with advanced dementia may play an important role.