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Rationale, design, and implementation protocol of the Dutch clinical practice guideline Pain in patients with cancer: a cluster randomised controlled trial with short message service (SMS) and interactive voice response (IVR)
Nienke te Boveldt, Yvonne Engels, Kees Besse, Kris Vissers, Myrra Vernooij-Dassen
Implementation Science , 2011, DOI: 10.1186/1748-5908-6-126
Abstract: A cluster randomised controlled trial with two arms will be performed in six oncology outpatient clinics of hospitals in the Southeastern region of the Netherlands, with three hospitals in the intervention and three in the control condition. Follow-up measurements will be conducted in all hospitals to study the long-term effect of the intervention. The intervention includes training of professionals (medical oncologists, nurses, and general practitioners) and SMS-IVR to report pain in patients with cancer to improve pain reporting by patients, pain management by medical oncologists, nurses, and general practitioners, and decrease pain intensity.This innovative implementation strategy with technical tools and the involvement of patients, may enhance the use of the guideline 'pain in patients with cancer' for pain management. Short Message Service alerts may serve as a tool to support self-management of patients. Therefore, the SMS-IVR intervention may increase the feeling of having control over one's life.Netherlands Trial Register (NTR): NTR2739Pain is a major healthcare problem for patients with cancer [1] and is one of the most frequently feared symptoms [2,3]. In 2007, in a Dutch study 64% of patients with metastatic, advanced, or terminal disease [4], 59% of those on anti-cancer treatment and 33% of patients after curative treatment experienced pain [4]. Often, pain control is inadequate [2-9]. In 2007, Deandrea et al. demonstrated that pain in nearly one-half patients with cancer is undertreated [10]. As illustrated by the high prevalence of pain, for most patients acceptable pain reduction has not yet been reached. Up to now, no hospital-wide intervention has yet improved the treatment of pain in general [11].A key barrier to adequate treatment of pain is ineffective communication between patients and healthcare providers about their pain [12,13]. Patients often consider information they receive from providers to be unclear [14,15]. Generally, patients lack kn
Systematic care for caregivers of people with dementia in the ambulatory mental health service: designing a multicentre, cluster, randomized, controlled trial
Anouk Spijker, Frans Verhey, Maud Graff, Richard Grol, Eddy Adang, Hub Wollersheim, Myrra Vernooij-Dassen
BMC Geriatrics , 2009, DOI: 10.1186/1471-2318-9-21
Abstract: In our ongoing, cluster, randomized, single-blind, controlled trial, the participants in six mental health services in four regions of the Netherlands have been randomized per service. Professionals of the ambulatory mental health services (psychologists and social psychiatric nurses) have been randomly allocated to either the intervention group or the control group. The study population consists of community-dwelling people with dementia and their informal caregivers (patient-caregiver dyads) coming into the health service. The dyads have been clustered to the professionals. The primary outcome measure is the patient's admission to a nursing home or home for the elderly at 12 months of follow-up. This measure is the most important variable for estimating cost differences between the intervention group and the control group. The secondary outcome measure is the quality of the patient's and caregiver's lives.A novelty in the SCPD is the pro-active and systematic approach. The focus on the caregiver's sense of competence is relevant to economical healthcare, since this sense of competence is an important determinant of delay of institutionalization of people with dementia. The SCPD might be able to facilitate this with a relatively small cost investment for caregivers' support, which could result in a major decrease in costs in the management of dementia. Implementation on a national level will be started if the SCPD proves to be efficient.NCT00147693Estimates state that the rapidly aging western European population will peak at about 2040 [1]. An aging population demands more healthcare and challenges the healthcare budget. Two-thirds of the people with dementia (also referred to as "patients" in this study protocol) are cared for at home [2]. Care at home is often intensive and burdensome. Informal caregivers of these patients carry a greater burden than informal caregivers of other chronically ill people [3], and they are at a greater risk of depression [4-6]. The
WHEDA study: Effectiveness of occupational therapy at home for older people with dementia and their caregivers - the design of a pragmatic randomised controlled trial evaluating a Dutch programme in seven German centres
Sebastian Voigt-Radloff, Maud Graff, Rainer Leonhart, Katrin Schornstein, Myrra Vernooij-Dassen, Marcel Olde-Rikkert, Michael Huell
BMC Geriatrics , 2009, DOI: 10.1186/1471-2318-9-44
Abstract: A multi-centre single blind randomised controlled trial design is being used in seven health care centres (neurological, psychiatric and for older people) in urban regions. Patients are 1:1 randomised to treatment or control group. Assessors are blind to group assignment and perform measurements on both groups at baseline, directly after intervention at 6 weeks and at 16, 26 and 52 weeks follow-up. A sample of 140 community dwelling older people (aged >65 years) with mild or moderate dementia and their primary caregivers is planned. The experimental intervention consists of an evidence-based community occupational therapy programme including 10 sessions occupational therapy at home. The control intervention consists of one community occupational therapy consultation based on information material of the Alzheimer Society. Providers of both interventions are occupational therapists experienced in treatment of cognitively impaired older people and trained in both programmes. 'Community' indicates that occupational therapy intervention occurs in the person's own home. The primary outcome is patients' daily functioning assessed with the performance scale of the Interview for Deterioration in Daily Living Activities in Dementia and video tapes of daily activities rated by external raters blind to group assignment using the Perceive, Recall, Plan and Perform System of Task Analysis. Secondary outcomes are patients' and caregivers' quality of life, mood and satisfaction with treatment; the caregiver's sense of competence, caregiver's diary (medication, resource utilisation, time of informal care); and the incidence of long-term institutionalisation. Process evaluation is performed by questionnaires and focus group discussion.The transfer from the Dutch mono-centre design to the pragmatic multi-site trial in a German context implicates several changes in design issues including differences in recruitment time, training of interventionists and active control group treatment.T
Research protocol of the NeedYD-study (Needs in Young onset Dementia): a prospective cohort study on the needs and course of early onset dementia
Deliane van Vliet, Christian Bakker, Raymond TCM Koopmans, Myrra JFJ Vernooij-Dassen, Frans RJ Verhey, Marjolein E de Vugt
BMC Geriatrics , 2010, DOI: 10.1186/1471-2318-10-13
Abstract: The NeedYD-study (Needs in Young Onset Dementia) is a longitudinal observational study investigating early onset dementia patients and their caregivers (n = 217). Assessments are performed every six months over two years and consist of interviews and questionnaires with patients and caregivers. The main outcomes are (1) the needs of patients and caregivers, as measured by the Camberwell Assessment of Needs for the Elderly (CANE) and (2) neuropsychiatric symptoms, as measured by the NeuroPsychiatric Inventory (NPI). Qualitative analyses will be performed in order to obtain more in-depth information on the experiences of EOD patients and their family members. The results of this study will be compared with comparable data on late onset dementia from a historical cohort.The study protocol of the NeedYD-study is presented here. To our knowledge, this study is the first prospective cohort study in this research area. Although some limitations exist, these do not outweigh the strong points of this study design.Dementia is often regarded as a disease of old age. However, there is also a group in which the symptoms of the disease develop before the age of 65. Prevalence rates of early onset dementia (EOD) have been reported to range between 54 and 260 cases per 100,000 in the 30-64 age group [1-3].EOD is recognized as an important psychosocial and medical health problem with serious consequences for patients and their families [4,5]. EOD is more difficult to recognize than late onset dementia (LOD) in the early stages of the disease because of the lower prevalence rate, the wider range of etiologies [6,7] and the use of other mental health services (e.g., community mental health teams). These factors cause an important delay before an accurate diagnosis can be established, commonly resulting in feelings of insecurity and frustration for both patients and their families [8]. A proper diagnosis is an important prerequisite for receiving adequate (in)formal support and health
Act In case of Depression: The evaluation of a care program to improve the detection and treatment of depression in nursing homes. Study Protocol
Debby L Gerritsen, Martin Smalbrugge, Steven Teerenstra, Ruslan Leontjevas, Eddy M Adang, Myrra JFJ Vernooij-Dassen, Els Derksen, Raymond TCM Koopmans
BMC Psychiatry , 2011, DOI: 10.1186/1471-244x-11-91
Abstract: In a 19-month longitudinal controlled study using a stepped wedge design, 14 somatic and 14 dementia special care units will implement the care program. All residents who give informed consent on the participating units will be included. Primary outcomes are the frequency of depression on the units and quality of life of residents on the units. The effect of the care program will be estimated using multilevel regression analysis. Secondary outcomes include accuracy of depression-detection in usual care, prevalence of depression-diagnosis in the intervention group, and response to treatment of depressed residents. An economic evaluation from a health care perspective will also be carried out.The care program is expected to be effective in reducing the frequency of depression and in increasing the quality of life of residents. The study will further provide insight in the cost-effectiveness of the care program.Netherlands Trial Register (NTR): NTR1477Depression is a common health problem in nursing home (NH) residents: prevalence rates vary from 6 to even 50% [1-3]. Depression is strongly related to quality of life of NH residents [4], it seriously impacts wellbeing and daily functioning, and increases use of health care services and even mortality [5-7]. The association between depression and quality of life highlights the importance of identifying and treating depression in NH residents with and those without dementia [8,4]. Unfortunately, although depression is a treatable disorder [9], various studies have shown poor detection and undertreatment of depression in NH residents [2,10-12].Several studies have demonstrated effects of pharmacological and psychosocial interventions for depression in nursing homes [13,14]. The review of Bharucha et al. [15] of 'talk therapies' for depression in long-term care presents evidence for an improvement in depressive symptoms after reminiscence/life review therapy. Moreover, there is evidence for the effectiveness of multifaceted
(Cost)-effectiveness of family meetings on indicated prevention of anxiety and depressive symptoms and disorders of primary family caregivers of patients with dementia: design of a randomized controlled trial
Karlijn J Joling, Hein PJ van Hout, Philip Scheltens, Myrra Vernooij-Dassen, Bernard van den Berg, Judith Bosmans, Freek Gillissen, Mary Mittelman, Harm WJ van Marwijk
BMC Geriatrics , 2008, DOI: 10.1186/1471-2318-8-2
Abstract: An American landmark study reported substantial beneficial effects of a multifaceted intervention where family meetings had a central place on depression in family caregivers as well as on delay of institutionalization of patients. These effects were not replicated in other countries yet. We perform the first trial comparing only structured family meetings with significant others versus usual care among primary family caregivers of community dwelling demented patients and measure the effectiveness on both depression and anxiety in the primary caregiver, both on disorder and symptom levels.In this randomized controlled trial effectiveness as well as cost-effectiveness of family meetings is evaluated. The intervention group receives four family meetings with family and close friends of the primary family caregiver of a community dwelling patient with a clinical diagnosis of dementia. Dyads of patients and their primary caregiver are followed up to one year after baseline assessment. The main outcome measures are the incidence of anxiety and depressive disorders assessed with the Mini-International Neuropsychiatric Interview (MINI) and the severity of anxiety and depressive symptoms in caregivers is measured by validated self report instruments: the Centre for Epidemiologic Studies Depression Scale (CES-D) for depression and the anxiety scales of the Hospital Anxiety and Depression scales (HADS) for anxiety. The economic evaluation is performed from a societal perspective.By evaluating the effectiveness of only structured family meetings organized in the Netherlands, this study will contribute to the existing literature about the value of psychosocial interventions for dementia caregivers.Dutch Trial Registry ISRCTN90163486Dementia is a major public health problem. The estimated prevalence rate of dementia among community dwelling elderly aged 65 to 95 is 6.6% [1]. A recent paper reported that approximately 5.1 million people in the European Union live with dementia. W
A new combined strategy to implement a community occupational therapy intervention: designing a cluster randomized controlled trial
Carola ME D?pp, Maud JL Graff, Steven Teerenstra, Eddy Adang, Ria WG Nijhuis - van der Sanden, Marcel GM OldeRikkert, Myrra JFJ Vernooij-Dassen
BMC Geriatrics , 2011, DOI: 10.1186/1471-2318-11-13
Abstract: In this cluster randomized, single-blinded, controlled trial, each cluster consists of at least two occupational therapists, a manager, and a physician working at Dutch healthcare organizations that deliver community occupational therapy. Forty-five clusters, stratified by healthcare setting (nursing home, hospital, mental health service), have been allocated randomly to either the intervention group (CI strategy) or the control group (ED strategy). The study population consists of the professionals included in each cluster and community-dwelling people with dementia and their caregivers. The primary outcome measures are the use of community OT, the adherence of OTs to the COTiD program, and the cost effectiveness of implementing the COTiD program in outpatient care. Secondary outcome measures are patient and caregiver outcomes and knowledge of managers, physicians and OTs about the COTiD program.Implementation research is fairly new in the field of occupational therapy, making this a unique study. This study does not only evaluate the effects of the CI-strategy on professionals, but also the effects of professionals' degree of implementation on client and caregiver outcomes.NCT01117285Dementia is associated with a major decrease in quality of life of clients and their caregivers due to a loss of independence, autonomy, and social participation [1]. In addition, dementia is a major driver of costs in health care [2]. These costs increased by 34% between 2005 and 2009 [3]. In the Netherlands, nearly 1% of people aged 65 years old suffer from dementia and 40% of people aged 90 and over [4]. The number of dementia patients will increase substantially in the years to come [5]. This stresses the importance of effective interventions which aim at increasing quality of life of people with dementia and their caregivers [6] and implementation of these interventions in practice.Two recent pilot studies showed that strategies currently used to implement the COTiD program are n
Improving person-centred care in nursing homes through dementia-care mapping: design of a cluster-randomised controlled trial
Geertje van de Ven, Irena Draskovic, Eddy MM Adang, Rogier ART Donders, Aukje Post, Sytse U Zuidema, Raymond TCM Koopmans, Myrra JFJ Vernooij-Dassen
BMC Geriatrics , 2012, DOI: 10.1186/1471-2318-12-1
Abstract: The study is a cluster-randomised controlled trial, with nursing homes grouped in clusters. Studywise minimisation is the allocation method. Nursing homes in the intervention group will receive a dementia-care-mapping intervention, while the control group will receive usual care. The primary outcome measure is resident agitation, to be assessed with the Cohen-Mansfield Agitation Inventory. The secondary outcomes are resident neuropsychiatric symptoms, assessed with the Neuropsychiatric Inventory - Nursing Homes and quality of life, assessed with Qualidem and the EQ-5D. The staff outcomes are stress reactions, job satisfaction and job-stress-related absenteeism, and staff turnover rate, assessed with the Questionnaire about Experience and Assessment of Work, the General Health Questionnaire-12, and the Maastricht Job Satisfaction Scale for Health Care, respectively. We will collect the data from the questionnaires and electronic registration systems. We will employ linear mixed-effect models and cost-effectiveness analyses to evaluate the outcomes. We will use structural equation modelling in the secondary analysis to evaluate the plausibility of a theoretical model regarding the effectiveness of the dementia-care mapping intervention. We will set up process analyses, including focus groups with staff, to determine the relevant facilitators of and barriers to implementing dementia-care mapping broadly.A novelty of dementia-care mapping is that it offers an integral person-centred approach to dementia care in nursing homes. The major strengths of the study design are the large sample size, the cluster-randomisation, and the one-year follow-up. The generalisability of the implementation strategies may be questionable because the motivation for person-centred care in both the intervention and control nursing homes is above average. The results of this study may be useful in improving the quality of care and are relevant for policymakers.The trial is registered in the Ne
Effects of Dementia-Care Mapping on Residents and Staff of Care Homes: A Pragmatic Cluster-Randomised Controlled Trial
Geertje van de Ven, Irena Draskovic, Eddy M. M. Adang, Rogier Donders, Sytse U. Zuidema, Raymond T. C. M. Koopmans, Myrra J. F. J. Vernooij-Dassen
PLOS ONE , 2013, DOI: 10.1371/journal.pone.0067325
Abstract: Background The effectiveness of dementia-care mapping (DCM) for institutionalised people with dementia has been demonstrated in an explanatory cluster-randomised controlled trial (cRCT) with two DCM researchers carrying out the DCM intervention. In order to be able to inform daily practice, we studied DCM effectiveness in a pragmatic cRCT involving a wide range of care homes with trained nursing staff carrying out the intervention. Methods Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training and conducted the 4-months DCM-intervention twice during the study. The primary outcome was agitation, measured with the Cohen-Mansfield agitation inventory (CMAI). The secondary outcomes included residents’ neuropsychiatric symptoms (NPSs) and quality of life, and staff stress and job satisfaction. The nursing staff made all measurements at baseline and two follow-ups at 4-month intervals. We used linear mixed-effect models to test treatment and time effects. Results 34 units from 11 care homes, including 434 residents and 382 nursing staff members, were randomly assigned. Ten nurses from the intervention units completed the basic and advanced DCM training. Intention-to-treat analysis showed no statistically significant effect on the CMAI (mean difference between groups 2·4, 95% CI ?2·7 to 7·6; p = 0·34). More NPSs were reported in the intervention group than in usual care (p = 0·02). Intervention staff reported fewer negative and more positive emotional reactions during work (p = 0·02). There were no other significant effects. Conclusions Our pragmatic findings did not confirm the effect on the primary outcome of agitation in the explanatory study. Perhaps the variability of the extent of implementation of DCM may explain the lack of effect. Trial Registration Dutch Trials Registry NTR2314.
The Economics of Dementia-Care Mapping in Nursing Homes: A Cluster-Randomised Controlled Trial
Geertje van de Ven, Irena Draskovic, Elke van Herpen, Raymond T. C. M. Koopmans, Rogier Donders, Sytse U. Zuidema, Eddy M. M. Adang, Myrra J. F. J. Vernooij-Dassen
PLOS ONE , 2014, DOI: 10.1371/journal.pone.0086662
Abstract: Background Dementia-care mapping (DCM) is a cyclic intervention aiming at reducing neuropsychiatric symptoms in people with dementia in nursing homes. Alongside an 18-month cluster-randomized controlled trial in which we studied the effectiveness of DCM on residents and staff outcomes, we investigated differences in costs of care between DCM and usual care in nursing homes. Methods Dementia special care units were randomly assigned to DCM or usual care. Nurses from the intervention care homes received DCM training, a DCM organizational briefing day and conducted the 4-months DCM-intervention twice during the study. A single DCM cycle consists of observation, feedback to the staff, and action plans for the residents. We measured costs related to health care consumption, falls and psychotropic drug use at the resident level and absenteeism at the staff level. Data were extracted from resident files and the nursing home records. Prizes were determined using the Dutch manual of health care cost and the cost prices delivered by a pharmacy and a nursing home. Total costs were evaluated by means of linear mixed-effect models for longitudinal data, with the unit as a random effect to correct for dependencies within units. Results 34 units from 11 nursing homes, including 318 residents and 376 nursing staff members participated in the cost analyses. Analyses showed no difference in total costs. However certain changes within costs could be noticed. The intervention group showed lower costs associated with outpatient hospital appointments over time (p = 0.05) than the control group. In both groups, the number of falls, costs associated with the elderly-care physician and nurse practitioner increased equally during the study (p<0.02). Conclusions DCM is a cost-neutral intervention. It effectively reduces outpatient hospital appointments compared to usual care. Other considerations than costs, such as nursing homes’ preferences, may determine whether they adopt the DCM method. Trial Registration Dutch Trials Registry NTR2314
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