Nursing Home Residents Clinical Trial
Official title:
Feasibility of Risk Sign Displays to Prevent Falls, Dehydration and Pulmonary Aspiration in Nursing Homes: a Clinical Study Protocol
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.
1. 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.
2. 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.
Time Up and Go (TUG) Time Up and Go is a quick capacity measure to for functional
mobility and a good predictor of subject's ability to independently walk outside safely.
This clinical test is recommended by MDS review of measurement Instruments to assess
posture, gait, and balance in Parkinson's disease and in the latest physiotherapy
guidelines to Parkinson's disease. In this test is asked to participant to get up from a
standard chair, walk 3m at a comfortable and safe speed and then turn walk to back to
sit in the chair.
Morse Falls Scale The Morse fall scale assesses the risk of falling for hospital
in-patients or those in long-term care, in particular evaluates: falls history, the
presence of comorbidities, the use of walking aids, mental status and whether or not
patients are on intravenous therapy.
Swallowing Disturbance Questionnaire (SDQ) The Swallowing Disturbance Questionnaire
(SDQ) for PD patients is a validated self-reporting 15-item questionnaire on swallowing
disturbances that appear in the oral and pharyngeal phases of swallowing. Fourteen
questions rated by a four-point scale (0 for no disturbance and 3 for severe
disturbance), and one ''yes/no'' question (yes was scored 2.5 and no was scored 0.5).
GULP Dehydration Risk Screening Tool The GULP is a screening tool to assess geriatric
dehydration risk. It includes a score from 0 to 7 points for three categories (24 h
fluid intake; urine colour; clinical risk factors for dehydration). Based on results,
the GULP tool recommends an hydration management plan, engaging like this the patient in
self-monitoring of urine and verbal prompts.
3. Diary Record In the end of each nursing shift all events of falls, near falls,
dehydration and pulmonary aspiration will be recorded in documents specifically created
for that purpose by the working staff of CNS.
4. Monthly Visits At the end of each month, an interview will be performed to patients and
a self-completed questionnaire will be handed to health professionals. Both will be
questioned regarding overall acceptability levels and asked for any encountered problems
regarding the use of the displays. Additionally, these moments will include questions on
clarity of the instructions, reminder of the event definitions and the registration
procedures.
Importantly, investigators recognize that the visit interview is not flawless, because
participants may have forgotten some of their complaints by the time of the visit
interview. To their knowledge, there is no study that has previously studied whether
recall interviews must be made weekly or whether more-frequent visits would be
sufficient to obtain a reliable estimate of information. For this study, a monthly
period was considered reasonable and particularly more helpful and feasible in future
large trials with long follow-up periods.
All visit interviews will be performed by the investigator and will take no more than 10
minutes.
5. Monthly reports In the end of each month, as strategy to keep health professionals
informed and to remember the importance of registering, a newsletter will be sent to all
CNS staff. This will contain information about the study duration and will present a
summary of the number of participants in the study (number of patients recruited and
number of drop-outs) and of the event recorded in that month.
6. Data collection of events It will also collect, in relation to all CNS residents,
historical data related to falls, dehydration and pulmonary aspiration events
retrospectively from medical and nursing chats within the period of the study and the
same period, one year before.
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