Feasibility of Risk Sign Displays to Prevent Falls, Dehydration and Pulmonary Aspiration in Nursing Homes: a Clinical Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Patients' adherence trough the number of times and reasons to taken off the risk display or refused to use during the period of the study and/or withdrawing from the study
研究概览
简要总结
BACKGROUND: Prior research has shown a relationship between dehydration, falls and pulmonary aspiration among older adults in nursing and health care facilities, which contributes to its loss of independence and quality-of-life. Is believed that improving communication among health professional decreases the number of adverse events in institutionalized patients. This study will evaluate the feasibility of a set of sign displays designed to communicate fall, dehydration and pulmonary aspiration risks and will reflect on tailored interventions to manage these events in nursing homes.
METHODS AND ANALYSIS: This will be a national, single-center, feasibility study. All patients, with chronic neurologic diseases selected from a nursing home, will be invited to participate. At baseline patients will undertake a screening risk assessment and it will be attributed a correspondent risk display. Study duration will be a minimum of 3 months per participant, including daily record of events and monthly interview assessments. Events data will be compared with historical data extracted retrospectively from medical and nursing charts.
详细描述
- Preparation phase - teaching session for health professionals An initial teaching session will be held to train and familiarize health professionals with the usage of the sign displays and corresponding intervention procedures. The training will also consist of memorizing/training the definition given to falls, dehydration and pulmonary aspiration and redefining registration of such events in the software. During the training session, any queries from the professionals will be explained. The investigators expect the training will last 60 minutes. This training will be accompanied by written information with the definition of a fall, pulmonary aspiration and dehydration, and specific instructions on what procedures to undertake for each risk sign display. Additionally, the researcher will exemplify the procedure practically, if needed.
- Screening All patients will be invited to participate if they fulfil inclusion criteria. The nurse team from CNS nursing home will propose patients for recruitment and a multidisciplinary team will discuss and decided their study inclusion. In case of incapacity for the patients to give informed consent, family members will then be asked for consent and authorization of screening visit. Informed consent containing comprehensive information about objectives, duration, procedures, voluntariness and possible risks of study participation, will be obtained from patients before any study related proceedings. During the screening visit, an explanation of the objective and compliance needed for the study will be given to the participants and caregivers and all questions will be considered and answered.
Demographics data, clinical manifestations and disease management, co-morbidities and past medical conditions will be obtained using a structured questionnaire. Also a brief clinical assessment of risk of falling, pulmonary aspiration and dehydration will be done.
In the end of screening and risk assessment, the correspond risk displays will be given to patient by the investigator.
2.1) Clinical Scales
Mini Mental State Examination (MMSE) The Mini Mental State Examination is a brief 30-point questionnaire that is used to quantitatively assess cognition. The MMSE test includes simple questions and problems in a number of areas: the time and place of the test, repeating list of words, arithmetic, language use and comprehension, and copying a drawing. It can be used to screen for cognition impairment, to estimate the severity of cognitive impairment at a given point in time, to follow the course of cognitive changes in an individual over time, and to document an individual's response to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female staying at CNS nursing home for long term care;
- •Risk of falling and/or dysphagia and/or dehydration defined by brief screening assessment;
- •Being interested in participating in this study;
- •Signing an informed consent form;
- •Willing to comply with the monthly interviews required
- •Eligibility validated by CNS health professionals in the multidisciplinary clinical meeting
排除标准
- •Having significant active psychiatric problems (example: hallucinations, confusion, psychosis) that aggravates patient´s symptoms when dealing with the use of sign displays;
- •Inability participate according to the CNS health professionals' judgement
研究组 & 干预措施
Risk sign displays
At baseline patients will undertake a screening risk assessment and it will be attributed a correspondent risk display. Study duration will be a minimum of 3 months per participant, including daily record of events and monthly interview assessments. Events data will be compared with historical data extracted retrospectively from medical and nursing charts.
干预措施: Risk sign displays (Device)
结局指标
主要结局
Patients' adherence trough the number of times and reasons to taken off the risk display or refused to use during the period of the study and/or withdrawing from the study
时间窗: Minimum of 3 months
次要结局
- Health professionals' satisfaction measured with sign displays through 7-point likert scale and open-ended questions regarding the overall benefits of using the displays and overall perception of its impact on decreasing risk.(Minimum of 3 months)
- Comparison to historical medical and nursing charts data review of the relative frequency of number of events per number of days of hospitalization registered during the period of the study, with in an equal period of time, one year before.(Minimum of 3 months)
- Type and frequency of adverse events recorded during the period of the study(Minimum of 3 months)
- Patients' satisfaction with the sign displays measured with a 7-point likert scale and open-ended questions.(Minimum of 3 months)