COSMOS—improving the quality of life in nursing home patients: protocol for an effectiveness-implementation cluster randomized clinical hybrid trial

Background: Nursing 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/Design: COSMOS 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. Discussion: Despite 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

Staff distress improves by treating pain in nursing home patients with dementia: results from a cluster-randomized controlled trial

Context. Most people with dementia develop neuropsychiatric symptoms (NPSs), which are distressing for their carers. Untreated pain may increase the prevalence and severity of NPSs and thereby staff burden. Objectives. We investigated the association between NPSs and the impact of individual pain treatment on distress in nursing home staff. Methods. Nursing home (NH) units were cluster-randomized to an intervention group (33 NH units; n ¼ 175) or control group (27 NH units; n ¼ 177). Patients in the intervention group received individual pain treatment for eight weeks, followed by a four-week washout period; control groups received care as usual. Staff informants (n ¼ 138) used the Neuropsychiatric InventoryeNH version (including caregiver distress) as primary outcome to assess their own distress. Other outcomes were pain (Mobilization-Observation-Behavior-Intensity-Dementia-2 Pain Scale) and cognitive functioning (MinieMental State Examination). Results. Using hierarchical regression analysis, all NPS items at baseline were associated with staff distress (P < 0.01) apart from euphoria; agitation had the largest contribution (b ¼ 0.24). Using mixed models, we found significantly lower staff distress in the intervention group compared to the control group. Moreover, we also found significantly reduced distress in the control group, and there were still effects in both groups throughout the washout period. Conclusion. 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.publishedVersio

”HLR minus, med rett til å la dø”. Et møte med sykepleiers erfaring og opplevelse av forhåndsvurdering av HLR minus (Hjerte-lungeredning minus)

Background: DNR order means that cardiopulmonary resuscitation should not be implemented in cases of acute cardiac or respiratory arrest. In a case like this a physician has to make a journal note with a DNR order, with justification for the decision. It is because of the increasing amount of old people hospitalized in Norway that this has been a topic of high relevance for practice in health institutions. The study purpose: The goal is to increase understanding of nurses' experience of being in situations where DNR has not been ordered, and how they feel this should have been taken into consideration. Method: This is a qualitative study, using the method of in-depth interviews. 7 nurses were interviewed with a view to their experience of being in the previously mentioned situation. Decontextualizing and recontextualizing has been part of the analysis of the transcribed interviews. Nurses' descriptions are presented in a condensed form. Quotations are used to illustrate the informants` experiences. Selected perspectives for discussion of nurses experience are theories concerning; ethics, professional discretion, morality, and suffering. Findings: Nurses see it as their duty to initiate resuscitation unless a physician has made a decision and ordered DNR. Communication both with colleagues, patients and their families involves many challenges and especially challenging is that this is a topic that is rarely considered before the patient's condition is very poor. Conclusion: The nurses find it problematic to relate to an established procedure for how to handle situations when they believe it should have been ordered DNR; they express the need for an academic forum in their working environment, for discussion and reflections on the theme

Implementierung von Advance Care Planning in Norwegen

Advance Care Planning has a relatively short history in the Norwegian health care services. This article gives an overview of advance care planning research and its implementation in the health care services in Norway. Advance care planning has received increased attention from policymakers and the health care services. Research projects have been performed, and several are on-going. Implementation has largely treated advance care planning as a complex intervention, with a whole-system approach that puts emphasis on the conversation and patient activation. Advance directives have a peripheral role in this context.publishedVersionPaid open acces

Advance Care Planning in Nursing Homes – Improving the Communication Among Patient, Family, and Staff: Results From a Cluster Randomized Controlled Trial (COSMOS)

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)

Advance Care Planning and the staff perspective: The development, implementation, and investigation of a complex intervention in the nursing home :

Abstract Background Nursing home patients represent a heterogeneous, complex, and clinically challenging population. A crucial concern is that most of the patients lack the capacity to provide informed consent, as approximately 80% have dementia along with multimorbidity and polypharmacy. Once admitted, most patients die in the nursing home, which puts significant demands on the staff to provide adequate end-of-life care. Ideally, the end-of-life process in the nursing home, be it acute or chronic, should be characterised by trust and understanding shared by the patient, family, and staff and by high awareness of the patient’s values and wishes. However, for many patients and family members difficult question arise. We know that it is essential to involve patients in medical decision-making, but this is increasingly difficult when the patient does not understand the situation or is not able to form an opinion and communicate it. In these instances, family members are often asked to become guardians. Making decisions on a person’s behalf is demanding, and the family might not know what their loved ones would have thought about treatment and end-of-life care. The staff might also experience this uncertainty as distressing because they do not know what the patient and family need. This uncertainty increases the risk of unwanted treatments and disagreements within the family and between family and staff. This necessitates a systematic approach that is developed, implemented, and tested in the nursing home setting. Advance Care Planning (ACP) aims to address the patients’ preferences, values, and potential concerns about treatment and care. Providing ACP represents an important tool that can help the patient, family, and staff to achieve a common understanding of “what matters” and to be better prepared for the end-of-life process and medical emergencies by creating a common understanding and trust. ACP can help the staff understand the patients’ values, wishes, and needs and make them more confident in their patient care. In turn, this might also affect the staff in terms of reduced distress. The complexity of the situation becomes even more evident by the fact that most nursing home patients with dementia have neuropsychiatric symptoms such as agitation and depression, which are distressing for both the patients and the staff. The lack of competence and knowledge to deal with difficult symptoms can also be distressing for the staff, leading to increased risk of burnout, sick leave, and turnover. Increasing the staff’s knowledge and competence along with providing effective interventions that improve challenging symptoms are central for the patients’ wellbeing and might also reduce staff distress. Aims The overarching aim of this thesis was twofold. First it sought to develop, implement, and test the effects of ACP, and second it sought to address the staff perspective in the nursing home setting. Specifically, it was a key to explore how staff received the ACP intervention and implementation and if staff distress was affected by improved patient treatment and routines in the nursing home. Methods Two studies provided the data for this thesis. In paper 1, we used data from a cluster randomised controlled trial (cRCT) called “The Impact of Pain on Behavioural Disturbances in Patients with Moderate and Severe Dementia” (PAIN-BPSD). Papers 2 and 3 used data from the cRCT called the COSMOS trial (COmmunication in the form of ACP, Systematic pain assessment and management, Medication review, Organisation of activities, and Safety). All of the included patients were 65 years or older and received long-term care in Norway. Paper 1: Staff distress was investigated by secondary analyses from the PAIN-BPSD study, which was originally designed to test the effects of pain treatment on neuropsychiatric symptoms in nursing home patients with dementia. Nursing home units were allocated to the intervention group (33 units; n = 175) or control group (27 units; n = 177). Patients in the intervention group received a stepwise protocol for treating pain for eight weeks, followed by a four-week washout period. The control group received care as usual. Staff informants (n = 138) reported neuropsychiatric symptoms in patients and their own distress in relation to these using the Neuropsychiatric Inventory–Nursing Home version (NPI-NH). Additional outcomes were pain as measured by the Mobilisation-Observation-Behaviour-Intensity-Dementia-2 Pain Scale (MOBID-2) and cognitive functioning as measured by the Mini Mental Status Examination (MMSE). Paper 2: The development and implementation of the ACP component in the COSMOS trial was investigated, and facilitators and barriers were identified. The COSMOS trial lasted for four months with a nine-month follow-up. Paper 2 used data from the intervention group (297 patients from 36 nursing home units) focusing on the four-month intervention period. The participating staff (COSMOS ambassadors) received a standardised education programme on ACP. The implementation was ensured using a train-the-trainer approach involving the whole nursing home unit. The implementation process was assessed using individual patient logs and structured staff feedback. Facilitators and barriers were identified by qualitative analysis of the feedback from the patient logs and from a midway evaluation seminar. Paper 3: A cRCT using secondary analyses from the COSMOS trial was performed to investigate the effects of ACP on frequency of communication and satisfaction with communication as perceived by nursing home staff and families. Data included 36 intervention clusters (n = 297) and 31 control clusters (n = 248) using data from baseline, month four, and month nine. Communication was evaluated using a data collection form and questionnaires answered by the patients’ family and by the staff. Results Paper 1: We found that agitation had the largest contribution (β = 0.24) to staff distress at baseline, and we found significantly lower total staff distress in the pain treatment group compared to the control group at the eight-week assessment (B = −3.53, 95% CI = −5.47 to −1.58). Still, staff distress was also significantly reduced in the control group (B = −2.98, 95% CI = −4.38 to −1.59). The effect remained significant within both the intervention group (B = −6.24, 95% CI = −8.01 to −4.48) and the control group (B = −2.53, 95% CI = −4.34 to −0.71) throughout the four-week washout period. Paper 2: The ACP component was well received, and 105 healthcare providers participated at the education seminar. The staff reported that the educational material was relevant for their efforts to implement ACP. According to the patient logs, ACP was successfully implemented in 62% (n = 183) of the patients. Important facilitators included a clear communication to nursing home managers and staff that ACP was an essential part of adequate care and having clearly defined routines, roles, and responsibilities when implementing ACP. Lack of competence and time and conflicting cultures and staff opinions were identified as barriers. Paper 3: ACP had a positive effect on communication; meetings between the families, patients, and nurses were organised more frequently in the intervention group compared to the control group at month four (OR = 3.9, 95% CI = 1.6 to 9.4, p = 0.002). There were also more monthly contacts between families and nurses in the intervention group compared to the control group (OR = 6.5, 95% CI = 1.6 to 3.5, p = 0.010). Nursing home staff (B = 1.9, 95% CI = 0.80 to 2.91, p = 0.001) and the patients’ families (B = 0.4, 95% CI = 0.02 to 0.85, p = 0.040) were more satisfied with the communication in the intervention group compared to the control group. We also detected reduced staff distress in the intervention group compared to the control group (B = −1.8, 95% CI = −3.1 to −0.4, p = 0.012). These effects did not remain significant at the nine-month follow-up, suggesting that a closer follow-up is needed to ensure sustainability of the communication process. Conclusion This thesis describes the development, implementation, and testing of ACP in the nursing home, involving the staff perspective as a prerequisite for optimal communication between patients, families, and staff. ACP was successfully implemented leading to improved frequency of and satisfaction with the communication between the staff and family. We also found reduced staff distress, both in the PAIN-BPSD study and in the COSMOS trial. The need to involve the nursing home management and to clearly define roles and responsibilities is important so that ACP is prioritised and adopted in the nursing home setting. The focus on education and staff competence is suggested as crucial for a sustainable ACP intervention that lasts beyond the active implementation phase of a research project

Description of an advance care planning intervention in nursing homes: outcomes of the process evaluation

Abstract Background Advance 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. Methods The 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. Results The 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. Conclusion Monthly 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 registration The COSMOS-trial was registered in the ClinicalTrials.gov (NCT02238652) July 7th, 201

Staff Distress Improves by Treating Pain in Nursing Home Patients With Dementia: Results From a Cluster-Randomized Controlled Trial

AbstractContextMost people with dementia develop neuropsychiatric symptoms (NPSs), which are distressing for their carers. Untreated pain may increase the prevalence and severity of NPSs and thereby staff burden.ObjectivesWe investigated the association between NPSs and the impact of individual pain treatment on distress in nursing home staff.MethodsNursing home (NH) units were cluster-randomized to an intervention group (33 NH units; n = 175) or control group (27 NH units; n = 177). Patients in the intervention group received individual pain treatment for eight weeks, followed by a four-week washout period; control groups received care as usual. Staff informants (n = 138) used the Neuropsychiatric Inventory–NH version (including caregiver distress) as primary outcome to assess their own distress. Other outcomes were pain (Mobilization-Observation-Behavior-Intensity-Dementia-2 Pain Scale) and cognitive functioning (Mini–Mental State Examination).ResultsUsing hierarchical regression analysis, all NPS items at baseline were associated with staff distress (P < 0.01) apart from euphoria; agitation had the largest contribution (β = 0.24). Using mixed models, we found significantly lower staff distress in the intervention group compared to the control group. Moreover, we also found significantly reduced distress in the control group, and there were still effects in both groups throughout the washout period.ConclusionIndividual 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