Assessment of the SmartJournal Intervention for Improved Oral Care in Nursing Homes: an Evaluation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 322
- 试验地点
- 2
- 主要终点
- Mucosal-plaque index (MPS)
研究概览
简要总结
Poor oral health is common in care-dependent older adults, and healthcare professionals report numerous barriers when it comes to provision of oral care for elderly patients. Frequently reported barriers are lack of oral health knowledge/skills and care resistant behaviors (CRB) in patients suffering from dementia. Other barriers include lack of adequate oral care routines and satisfactory systems for documentation of issues related to oral health, a high workload and unclear responsibilities. To overcome these barriers, an easy-to-use digital tool named SmartJournal has been developed to assist health personnel in preserving the older patient's oral health. SmartJournal has three components: one for documentation of oral hygiene routines, one for monthly oral health assessment and one for e-learning (a digital knowledge base with information on geriatric oral health and handling of CRB). The objectives of the present study are to assess: 1) the effectiveness of SmartJournal in enhancing nursing home caregivers' capability, opportunity, motivation and routines related to oral care, 2) whether SmartJournal usage may result in improved oral health for nursing home residents and 3) whether SmartJournal usage may result in changes in documentation of oral health related issues in patient journals.
A cluster randomized controlled trial (C-RCT) will be employed to assess effects of SmartJournal usage as specified in the study objectives. Nursing homes located in Rogaland, Norway, will be recruited and randomly assigned to an intervention- and a control group. The intervention group will be provided with tablets containing SmartJournal, while the control group will continue with existing oral care routines. The intervention will last for 12 weeks. Measurements will be performed in both groups at baseline, immediately post-intervention (3 months) and at follow-up (9 months) and include: 1) a survey assessing caregivers' capability, opportunity, motivation and routines related to oral care, 2) oral examinations in residents using mucosal-plaque score (MPS) as a primary outcome variable for assessing oral health status, and 3) examination of patient journals to assess the frequency and quality of reported oral health related issues. We hypothesize that SmartJournal usage will have a positive effect as measured by favorable changes in study variable scores.
详细描述
INTRODUCTION
Poor oral health is common in frail and care-dependent older adults and includes tooth loss, poor oral hygiene, high prevalence of dental caries and periodontal disease, defective dental prostheses, hyposalivation and various oral lesions caused by misfitting dentures and/or precancerous or cancerous states. Alarmingly, oral health is shown to be the most neglected area in Norwegian nursing homes and oral healthcare is the first task to be downgraded due to lack of resources. Neglect of oral health, resulting in poor oral hygiene, may cause infections and inflammation both locally and systemically. Oral infections have been associated with systemic conditions such as atherosclerosis, diabetes and aspiration pneumonia. Moreover, chewing difficulties as a result of poor dental status have been associated with altered dietary habits, malnutrition and cognitive decline. According to the World Health Organization, this is a worldwide problem as oral health is an often neglected area of healthy ageing. A few decades ago, most older adults were denture wearers. Today, an increasing number of elderly keep their natural teeth - often in combination with complex and expensive fixed and/or removable prosthesis. While dentures are easy to manage, the more complex prosthetic devices can represent a challenge with regard to handling and cleaning. Thus, care-dependent elderly have to rely on caregivers to maintain satisfactory oral health. Research from Sweden and Denmark has shown that about 80% of nursing home residents need assistance with daily oral hygiene practices. Thus, it is disturbing that healthcare professionals report numerous barriers when it comes to provision of adequate oral care. The most frequently reported barriers are lack of knowledge and skills and care resistant behaviors (CRB), in particular among patients suffering from dementia. Research has indicated that more than 50% of Norwegian nursing home residents with dementia refuse oral care assistance. In cases of frequent CRB, daily oral care may be postponed repeatedly, resulting in poor oral hygiene and increased risk of oral and systemic infections. Other reported barriers include lack of adequate oral care routines, lack of systems for documentation of issues related to oral health, a high workload and unclear responsibilities. To overcome the reported barriers for provision of adequate oral care in the elderly, an interactive and easy-to-use digital tool named SmartJournal has been developed to assist health personnel in preserving nursing home residents' oral health. SmartJournal, which is an application for tablet, is created by researchers at the Oral Health Centre of Expertise in Rogaland, Norway, in close collaboration with dental professionals, nursing home caregivers and innovative research- and development environments. The objectives of the current research are: to assess 1) the effectiveness of SmartJournal in enhancing nursing home caregivers' capability, opportunity, motivation and routines related to oral care, 2) whether SmartJournal usage may result in improved oral health for nursing home residents and 3) whether SmartJournal usage may result in changes in the documentation of oral health related issues in patient journals.
METHODS
Design and procedures
A pragmatic cluster randomized controlled trial (C-RCT) will be employed to assess effects of SmartJournal usage as specified in the study objectives. Nursing homes located in Rogaland, Norway, will be recruited and randomly assigned to an intervention group and a control group. Nursing homes in the intervention group will be provided with tablets containing SmartJournal, while nursing homes in the control group will continue with existing oral care routines. The intervention will last for 12 weeks. Following recruitment of participants and baseline measurements, nursing homes in the intervention group will be provided with SmartJournal toolboxes and packages with oral hygiene equipment, while nursing homes in the control group will receive oral hygiene equipment packages only. Training, follow-up and technical support for SmartJournal users will be provided by project staff employed at the Oral Health Centre of Expertise Rogaland.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
Participants will not receive information about who is included in the intervention- and control group, respectively. They will only receive information that is relevant for their participation. The chosen study design (C-RCT) facilitates this masking by reducing the possibility of contamination between the groups.
入排标准
- 年龄范围
- 60 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nursing homes:
- •Located in Rogaland county, Norway
- •Long-term facilities
- •Residents (patients):
- •Long-term residents (i.e., residents with the nursing home as their permanent address)
- •Residents with and without dementia, who can undergo oral examination
- •Nursing staff:
- •All types of nursing staff (nurses, auxiliary nurses, students)
- •Full- and parttime staff
排除标准
- •Nursing homes:
- •Specialized nursing homes (e.g., psychiatry, substance abuse)
- •Short-term facilities (e.g., rehabilitation, respite care)
- •Nursing homes already following a specific protocol for oral care and/or participate in other comprehensive interventions
- •Residents (patients):
- •Short-term residents
- •Critically ill and terminal patients receiving palliative care
- •Nursing staff:
- •Staff with purely administrative tasks (e.g., heads of institutions)
结局指标
主要结局
Mucosal-plaque index (MPS)
时间窗: Change in MPS from baseline at 3 months and 9 at months.
The primary outcome measure is MPS. MPS is comprised of a four-point plaque score (PS) and a four-point mucosal score (MS). PS = 1: no visible plaque, PS = 2: plaque is barely visible, PS = 3: moderate amount of plaque, PS = 4: large amount of plaque almost covering the whole surface of teeth. MS = 1: normal mucosa, MS = 2: mild inflammation, MS = 3: medium inflammation, MS = 4: strong inflammation. For both scores, if in doubt between 1 and 2, dental personnel are instructed to score 1. If in doubt between 3 and 4, they are instructed to score 4. The index is designed to evaluate oral health and oral hygiene in groups of individuals. This makes it a suitable index to be used when conditions are not optimal to assess the patient's oral health. In a nursing home setting, dental personnel have limited equipment and poor light compared to an ordinary dental clinic setting. Therefore, using an index designed to be applied outside a dental clinic setting is feasible in this research.
次要结局
- Survey data(Change in variable scores for capability, opportunity, motivation and routines (measured in questionnaire) from baseline at 3 months and at 9 months.)