Assessment of the SmartJournal Intervention for Improved Oral Care in Nursing Homes: Protocol for a Cluster Randomized Controlled Trial
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SUBMITTER: Melbye E
PROVIDER: S-EPMC10589829 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundDementia-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.MethodsDementia 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.Results34 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).ConclusionsDCM 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 registrationDutch Trials Registry NTR2314.
| S-EPMC3904939 | biostudies-literature
Project description:BackgroundResidents living in nursing homes usually have complex healthcare needs and require a comprehensive care approach to identifying and meeting their care needs. Suboptimal quality of care is reported in nursing homes and is associated with the poor health and well-being of the residents, the burden on acute care hospitals and the high costs of healthcare for the government. The aim of this study is to test the hypothesis that an Aged Care Clinical Mentoring Model will create and sustain evidence-based quality improvement in priority areas and will be cost-effective in nursing homes in Hunan Province, China.MethodsA cluster randomized controlled trial will be applied to the study. Fourteen nursing homes will be randomly allocated to either the intervention group (n = 7) or the control group (n = 7). Forty staff will be recruited from each nursing home and the estimated sample size will be 280 staff in each group. The intervention includes a structured, evidence-based quality improvement education program for staff to facilitate knowledge translation in evidence-based quality improvement targeting urinary incontinence, pressure injury and falls prevention. The primary outcomes are nursing homes' capacity to create and sustain quality improvement, staff perceptions of person-centered care, self-reported quality of care by residents and selected quality indicators at 12 months follow-up adjusted for baseline value. Secondary outcomes are residents' quality of life, residents' unplanned admissions to acute care hospitals, quality of care reported by staff, staff job satisfaction and staff intention to leave adjusted for baseline value. A mixed linear regression model will be adopted to compare the significant differences between groups over a 12-month period.DiscussionAlthough the Aged Care Clinical Mentoring Model has been tested as an effective model to bring positive changes in nursing homes in a high-income country, factors affecting the adaptation of the model in nursing homes in low- and middle-income countries are unknown. The carefully planned intervention protocol enables the project team to consider enablers and barriers when adapting the Model. Therefore, strategies and resources will be in place to manage challenges while demonstrating best practice in this study.Trial registrationProspectively registered via Chinese Clinical Trial Registry (ChiCTR), ChiCTR-IOC-17013109 , Registered on 25 October 2017.
| S-EPMC6203281 | biostudies-literature
Project description:BackgroundClose to half of all deaths in Norway occur in nursing homes, which signals a need for good communication on end-of-life care. Advance care planning (ACP) is one means to that end, but in Norwegian nursing homes, ACP is not common. This paper describes the protocol of a project evaluating an ACP-intervention in Norwegian nursing homes. The aims of this research project were to promote the possibility for conversations about the end of life with patients and relatives; promote patient autonomy; create a better foundation for important decisions in the case of medical emergencies and at the end of life; and gain experiences in order to find out what characterizes good ACP and good implementation strategies.Methods/designThis study was a mixed method study including a cluster-randomized clinical trial. Eight nursing home wards or "clusters" were pair-matched, and one ward from each pair was randomly selected for a 12-month intervention. The intervention consisted of implementing an ACP-guideline. Implementation strategies were training and supervision of project teams and staff in using the guideline, written information to patients and next of kin, and information meetings with nursing home staff. The project was evaluated using both quantitative and qualitative data, and both outcome and process evaluation. Quantitative data included patient chart reviews of ACP, diagnoses, patient preferences for decision-making and treatment, values and wishes that are more general, documented life-prolonging treatment and hospitalizations, and concordance between patient wishes and treatment. The primary outcome was documented ACP. Qualitative data included observations of conversations, interviews with patients, next of kin and health care personnel, logs from project coordinators and conversations, and transcripts from meetings with project teams in the intervention group.DiscussionThis project attempted to increase the quality and use of ACP in Norwegian nursing homes (NH). A mixed methods approach, inclusion of patients with dementia, attempts to involve, as many patients as possible, and a sustainable implementation plan adapted to real life in nursing homes were strengths of the project.
| S-EPMC6090595 | biostudies-literature
Project description:BACKGROUND:Urinary tract infection (UTI) is the most common reason for antibiotic prescription in nursing homes. Overprescription causes antibiotic-related harms in those who are treated and others residing within the nursing home. The diagnostic process in nursing homes is complicated with both challenging issues related to the elderly population and the nursing home setting. A physician rarely visits a nursing home for suspected UTI. Consequently, the knowledge of UTI and communication skills of staff influence the diagnosis. OBJECTIVE:The objective of this study is to describe a cluster randomized controlled trial with a tailored complex intervention for improving the knowledge of UTI and communication skills of nursing home staff in order to decrease the number of antibiotic prescriptions for UTI in nursing home residents, without changing hospitalization and mortality. METHODS:The study describes an open-label cluster randomized controlled trial with two parallel groups and a 1:1 allocation ratio. Twenty-two eligible nursing homes are sampled from the Capital Region of Denmark, corresponding to 1274 nursing home residents. The intervention group receives a dialogue tool, and all nursing home staff attend a workshop on UTI. The main outcomes of the study are the antibiotic prescription rate for UTI, all-cause hospitalization, all-cause mortality, and suspected UTI during the trial period. RESULTS:The trial ended in April 2019. Data have been collected and are being analyzed. We expect the results of the trial to be published in a peer-reviewed journal in the fall of 2020. CONCLUSIONS:The greatest strengths of this study are the randomized design, tailored development of the intervention, and access to medical records. The potential limitations are the hierarchy in the prescription process, Hawthorne effect, and biased access to data on signs and symptoms through a UTI diary. The results of this trial could offer a strategy to overcome some of the challenges of increased antibiotic resistance and could have implications in terms of how to handle cases of suspected UTI. TRIAL REGISTRATION:ClinicalTrials.gov NCT03715062; https://clinicaltrials.gov/ct2/show/NCT03715062. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/17710.
| S-EPMC7244999 | biostudies-literature
Project description:BackgroundThe majority of nursing home residents with dementia experience behavioural and psychological symptoms like apathy, agitation, and anxiety. According to analyses of prescription prevalence in Germany, antipsychotic drugs are regularly prescribed as first-line treatment of neuropsychiatric symptoms in persons with dementia, although guidelines clearly prioritise non-pharmacological interventions. Frequently, antipsychotic drugs are prescribed for inappropriate reasons and for too long without regular reviewing. The use of antipsychotics is associated with adverse events like increased risk of falling, stroke, and mortality. The aim of the study is to investigate whether a person-centred care approach, successfully evaluated in nursing homes in the United Kingdom, can be implemented in German nursing homes and, in comparison with a control group, can result in a clinically relevant reduction of the proportion of residents with antipsychotic prescriptions.Methods/designThe study is a cluster-randomised controlled trial comparing an intervention group (two-day initial training on person-centred care and ongoing training and support programme) with a control group. Both study groups will receive, as optimised usual care, a medication review by an experienced psychiatrist/geriatrician providing feedback to the prescribing physician. Overall, 36 nursing homes in East, North, and West Germany will be randomised. The primary outcome is the proportion of residents receiving at least one antipsychotic prescription (long-term medication) after 12 months of follow-up. Secondary outcomes are residents' quality of life, agitated behaviour, as well as safety parameters like falls and fall-related medical attention. A health economic evaluation and a process evaluation will be performed alongside the study.DiscussionTo improve care, a reduction of the current high prescription rate of antipsychotics in nursing homes by the intervention programme is expected.Trial registrationClinicalTrials.gov: NCT02295462.
| S-EPMC4464611 | biostudies-literature
Project description:IntroductionDespite several calls to deprescribe benzodiazepine receptor agonists (BZRA) in older adults, their use among nursing home residents (NHRs) remains high. Therefore, we developed an intervention targeting general practitioners' and healthcare professionals' behaviours regarding BZRA deprescribing in nursing homes (NHs): The END-IT NH (bENzodiazepines Deprescribing InTerventions Nursing homes) 6-component intervention. Before moving on to a large-scale effectiveness and cost-effectiveness evaluation, this feasibility study aims at: (1) assessing the feasibility of the intervention implementation in NHs, (2) assessing the feasibility of conducting a larger-scale evaluation, in terms of recruitment and data collection and (3) conducting an exploratory cost-effectiveness evaluation.Methods and analysisWe will conduct a cluster-randomised controlled trial in a sample of 6 NHs, with 10-15 NHRs included per NHs. Four NHs will be randomised into the intervention group, and two NHs will deliver usual care (control group). Data collection will occur at baseline, 3, and 6 months (study end). We will collect information to explore implementation fidelity, mechanisms of impact and contextual factors at patient-level, NH-level and healthcare professional-level, using both quantitative and qualitative measures. The feasibility of the study conduction will be assessed by measuring recruitment and attrition rates and completeness of data collection. An exploratory cost-effectiveness evaluation will be conducted based on quality of life and healthcare use and cost data.Ethics and disseminationThis study protocol received approval from the ethical committee of CHU UCL Namur on the 20 June 2023. All data are confidential and will be anonymised prior to analysis. De-identified data will be shared on a data depository with a 2-year embargo. The results of the study will be disseminated through a scientific paper and will be communicated to local stakeholders and policymakers through a local symposium.Trial registration numberNCT05929443.
| S-EPMC11499836 | biostudies-literature
Project description:BackgroundQuality improvement (QI) programs focused on mastery of content by individual staff members are the current standard to improve resident outcomes in nursing homes. However, complexity science suggests that learning is a social process that occurs within the context of relationships and interactions among individuals. Thus, QI programs will not result in optimal changes in staff behavior unless the context for social learning is present. Accordingly, we developed CONNECT, an intervention to foster systematic use of management practices, which we propose will enhance effectiveness of a nursing home Falls QI program by strengthening the staff-to-staff interactions necessary for clinical problem-solving about complex problems such as falls. The study aims are to compare the impact of the CONNECT intervention, plus a falls reduction QI intervention (CONNECT + FALLS), to the falls reduction QI intervention alone (FALLS), on fall-related process measures, fall rates, and staff interaction measures.Methods/designSixteen nursing homes will be randomized to one of two study arms, CONNECT + FALLS or FALLS alone. Subjects (staff and residents) are clustered within nursing homes because the intervention addresses social processes and thus must be delivered within the social context, rather than to individuals. Nursing homes randomized to CONNECT + FALLS will receive three months of CONNECT first, followed by three months of FALLS. Nursing homes randomized to FALLS alone receive three months of FALLs QI and are offered CONNECT after data collection is completed. Complexity science measures, which reflect staff perceptions of communication, safety climate, and care quality, will be collected from staff at baseline, three months after, and six months after baseline to evaluate immediate and sustained impacts. FALLS measures including quality indicators (process measures) and fall rates will be collected for the six months prior to baseline and the six months after the end of the intervention. Analysis will use a three-level mixed model.DiscussionBy focusing on improving local interactions, CONNECT is expected to maximize staff's ability to implement content learned in a falls QI program and integrate it into knowledge and action. Our previous pilot work shows that CONNECT is feasible, acceptable and appropriate.Trial registrationClinicalTrials.gov: NCT00636675.
| S-EPMC3310735 | biostudies-literature
Project description:Ageing has become a worldwide reality and presents new challenges for the health-care system. Research has shown that potentially inappropriate prescribing, both potentially inappropriate medications and potentially prescribing omissions, is highly prevalent in older people, especially in the nursing home setting. The presence of potentially inappropriate medications/potentially prescribing omissions is associated with adverse drug events, hospitalisations, mortality and health-care costs. The Collaborative approach to Optimise MEdication use for Older people in Nursing homes (COME-ON) study aims to evaluate the effect of a complex, multifaceted intervention, including interdisciplinary case conferences, on the appropriateness of prescribing of medicines for older people in Belgian nursing homes.A multicentre cluster-controlled trial is set up in 63 Belgian nursing homes (30 intervention; 33 control). In each of these nursing homes, 35 residents (≥65 years) are selected for participation. The complex, multifaceted intervention comprises (i) health-care professional education and training, (ii) local concertation (discussion on the appropriate use of at least one medication class at the level of the nursing home) and (iii) repeated interdisciplinary case conferences between general practitioner, nurse and pharmacist to perform medication review for each included nursing home resident. The control group works as usual. The study period lasts 15 months. The primary outcome measures relate to the appropriateness of prescribing and are defined as (1) among residents who had at least one potentially inappropriate medication/potentially prescribing omission at baseline, the proportion of them for whom there is a decrease of at least one of these potentially inappropriate medications/potentially prescribing omissions at the end of study, and (2) among all residents, the proportion of them for whom at least one new potentially inappropriate medication/potentially prescribing omission is present at the end of the study, compared to baseline. The secondary outcome measures include individual components of appropriateness of prescribing, medication use, outcomes of the case conferences, clinical outcomes and costs. A process evaluation (focusing on implementation, causal mechanisms and contextual factors) will be conducted alongside the study.The COME-ON study will contribute to a growing body of knowledge concerning the effect of complex interventions on the use of medicines in the nursing home setting, and on factors influencing their effect. The results will inform policymakers on strategies to implement in the near future.Current Controlled Trials ISRCTN66138978.
| S-EPMC4788941 | biostudies-other
Project description:BACKGROUND:Research has highlighted the need for improving the implementation of advance care planning (ACP) in nursing homes. We developed a theory-based multicomponent ACP intervention (the ACP+ programme) aimed at supporting nursing home staff with the implementation of ACP into routine nursing home care. We describe here the protocol of a cluster randomised controlled trial (RCT) that aims to evaluate the effects of ACP+ on nursing home staff and volunteer level outcomes and its underlying processes of change. METHODS:We will conduct a cluster RCT in Flanders, Belgium. Fourteen eligible nursing homes will be pair-matched and one from each pair will be randomised to either continue care and education as usual or to receive the ACP+ programme (a multicomponent programme which is delivered stepwise over an eight-month period with the help of an external trainer). Primary outcomes are: nursing home care staff's knowledge of, and self-efficacy regarding ACP. Secondary outcomes are: 1) nursing home care staff's attitudes towards ACP and ACP practices; 2) support staff's and volunteer's ACP practices and 3) support staff's and volunteers' self-efficacy. Measurements will be performed at baseline and eight months post-measurement, using structured self-reported questionnaires. A process evaluation will accompany the outcome evaluation in the intervention group, with measurements throughout and post-intervention to assess implementation, mechanisms of impact and context and will be carried out using a mixed-methods design. DISCUSSION:There is little high-quality evidence regarding the effectiveness and underlying processes of change of ACP in nursing homes. This combined outcome and process evaluation of the ACP+ programme aims to contribute to building the necessary evidence to improve ACP and its uptake for nursing home residents and their family. TRIAL REGISTRATION:The study is registered at ClinicalTrials.gov (no. NCT03521206). Registration date: May 10, 2018. Inclusion of nursing homes started March, 2018. Hence, the trial was retrospectively registered but before end of data collection and analyses.
| S-EPMC6950862 | biostudies-literature
Project description:IntroductionMany people living with advanced dementia live and die in nursing care homes. The quality of life, care and dying experienced by these people is variable. Namaste Care is a multisensory programme of care developed for people with advanced dementia. While there is emerging evidence that Namaste Care may be beneficial for people with dementia, there is a need to conduct a feasibility study to establish the optimum way of delivering this complex intervention and whether benefits can be demonstrated in end-of-life care, for individuals and service delivery. The aim of the study is to ascertain the feasibility of conducting a full trial of the Namaste Care intervention.Methods and analysisA feasibility study, comprising a parallel, two-arm, multicentre cluster controlled randomised trial with embedded process and economic evaluation. Nursing care homes (total of eight) who deliver care to those with advanced dementia will be randomly allocated to intervention (delivered at nursing care home level) or control. Three participant groups will be recruited: residents with advanced dementia, informal carers of a participating resident and nursing care home staff. Data will be collected for 6 months. Feasibility objectives concern the recruitment and sampling of nursing homes, residents, informal carers and staff; the selection and timing of primary (quality of dying and quality of life) and secondary clinical outcome measures (person centredness, symptom presence, agitation, quality of life, resource use and costs and residents' activity monitored using actigraphy). Acceptability, fidelity and sustainability of the intervention will be assessed using semistructured interviews with staff and informal carers.Ethics and disseminationThis protocol has been approved by NHS Wales Research Ethics Committee 5 (ref: 17/WA0378). Dissemination plans include working with a public involvement panel, through a website (http://www.namastetrial.org.uk), social media, academic and practice conferences and via peer reviewed publications.Trial registration numberISRCTN14948133; Pre-results.
| S-EPMC6254402 | biostudies-literature