Intervention for Fall Prevention Clinical Trial
Official title:
A Pilot Fall Prevention Program Using "STRATIFY" at Triage of Emergency Department in Hong Kong
A fall is an event which results in a person coming to rest unwittingly on the floor or
ground or other lower level. Those who have fall history have significantly more
hospitalizations and clinical visits as well as emergency department visits than those who do
not. Loss of confidence in walking, fear of falling, social isolation and depression can also
occur in those patients. Fall is a predictor for decreased functional status and risk factor
for the whole institution Approximately 30% to 40% of people aged 65 years and older who
lived in the community fall each year. Multiple studies related to falls have shown a close
relation between sex and age. As a result, Elderlies who are prone to falling consume more
health care resources than non-fallers.
STRATIFY proved to be more accurate and more frequently utilized. STRATIFY was originally
derived in mixed acute/rehabilitation geriatric wards of UK urban teaching hospital using a
'case control' design and multi-variate regression to identify predictors of falls in
hospital inpatients. This resulted in a simple five-point score (each item scoring 1 or 0),
with predictive "cut-offs" as 2 or 3 used in the original validation studies which followed.
STRATIFY was not designed or validated for continuous modelling of risk but for use in
categorical prediction 'high' versus 'low risk'. Sensitivity and specificity were both found
to be in excess of 80% in the two UK cohort of the original paper, leading to wide spread
adoption of the tool in clinical practice. It is now ten years since the publication of the
original STRATIFY paper and a number of prospective studies in several cohort of patients
have been published.
Objective and Propose
1. To assess the effectiveness of the fall preventing intervention after targeted group is
screened by the tool "STRATIFY" in triage
2. To look at the discrepancy of fall perception of patient/caregiver and the assessment
result using "STRATIFY".
3. To compare the fall rate after applying the screening tool "STRATIFY" and with
intervention given in their AEDs.
Hypothesis
1. It is hypothesized that the effectiveness score collected from patient and/or caregivers
via questionnaires within data collection period shows positive result and these
measures are worth to execute in A&E.
2. It is hypothesized that there may not be a big discrepancy of fall perception of
caregivers with the result of assessment tool and there is a discrepancy of fall
perception of fall perception of patients as they may over-estimate their ability
3. It is hypothesized that the fall rate of intervention group will be lower than that of
control group.
Rate of fall incident which is properly documented and reported to AIRS after using fall
screening tool "STRATIFY" and intervention given will be the intervention group.
Rate of fall incident of usual practice in a designated period will be the control group.
Methodology:
Design: Prospective two-center observational study Data collection Frequency: Cross-sectional
Sampling Design: convenience sampling Sampling Tool: Assessment forms & Questionnaires
Data collection Time:
Subject recruitment started from 1/2020 to 3/2020. Geriatric Attendance were extracted from
the Clinical Data Analysis and Reporting System (CDARS) in the period of 1/2019 to 3/2019 and
1/2020 to 3/2020 Numbers of fall cases were extracted from AIRS system. Setting: KWH A&E and
PWH A&E (different cluster)
Population and sample size For a 95% confidence interval with width=0.3, the expected sample
size is at least 267 subjects needed to be recruited based on the rule of thumb that SD =
range/4. In this study, approximately 300 subjects will be recruited (~150 from Kwong Wah
Hospital and ~150 from Prince of Wales Hospital) .
Subject recruitment:
Nurse investigators will be assigned to different duty by Duty in-charge in each shift. First
of all, the research nurse will screen the case with inclusion and exclusion criteria. After
that, investigators will approach to the target group, 10mins will be given to the target
group to consider whether to participate in the study or not. Once the target group decided
to participate in the research, fall risk of targeted patients will be screened by using
"STRATIFY" fall risk assessment tool at triage by investigators. Patient will be screened
into 2 groups, either at risk (score≥2) or not at risk (score<2). Nursing intervention
includes fall signage, fall bracelet, instruction card will be provided to high risk group
(score≥2). Questionnaires will be distributed to the target groups to collect their opinions
towards the screening tool and the intervention upon they were discharged or admitted.
Content Validity The content validity of patient/caregiver effectiveness score questionnaire
and instruction card will be established by a panel of eight including one geriatric nursing
consultant, one emergency nursing consultant, two emergency medicine specialists and four
advanced practice nurses from two A&Es. They will review the questionnaire and all
suggestions will be incorporated into the final version of the questionnaire. Ten lay persons
will be invited to complete the questionnaire to examine the readability to general public.
Selection and Withdrawal of subjects Nurse investigator will be assigned to different duty by
Duty in-charge in each shift. First of all, the research nurse will screen the case with
inclusion and exclusion criteria. After that, investigators will approach to the target
group, 20mins will be given to the target group to consider whether to participate in the
study or not. Once the target group decided to participate in the research, fall risk of
targeted patients will be screened by using STRATIFY at triage by investigators. Patient will
be screened into 2 groups, either at risk (score≥2) or not at risk (score<2).
Nursing interventions Fall signage, fall bracelet, instruction card will be provided to high
risk group. Patients of high risk group will be positioned close to the nurse's station. For
high risk patients, nurse should ensure that the bed is at the lowest height, the brakes are
locked and the patient's belongings are within reach. Questionnaires will be distributed to
the target groups to collect their opinions towards the screening tool and the interventions.
Inclusion criteria:
Patient aged 65years old or above Caregiver aged 18years old or above and has cared patient
for at least 1month Able to read and listen Cantonese/English Able to consent Triage category
3, 4, 5 Using Hong Kong Identity Card for registration
Exclusion criteria Patient who has done the fall assessment using Morse Fall Scale (i.e.
patient in Observation Ward in KWH and patient who admitted to EM Ward in PWH) Caregivers of
patient who has done the fall assessment using Morse Fall Scale Unable to consent Unable to
read and listen Cantonese/English Triage category 1&2 cases
Primary Outcome:
The effectiveness score of the fall preventing intervention collected from patient and/or
caregivers via questionnaires within data collection period (Questionnaire Q2 & Q4).
Secondary Outcome:
The discrepancy of fall perception of patient/caregiver to STRATIFY screening tool
(Questionnaire Q1).
Number of fall cases in A&E of PWH and KWH which are properly documented and reported to
AIRS.
Method of Data Analysis The effectiveness score collected from patient and/or caregivers via
questionnaires within data collection period (Questionnaire Q1-3) will be presented using
descriptive method. The confidence intervals, correlation will be calculated.
The discrepancy of fall perception of patient/caregiver to STRATIFY screening tool
(Questionnaire Q4) is analyzed by constructing CI which estimates the proportion of subjects
who do not know they are high risk but they actually are.
Number of fall cases in A&E of PWH and KWH which are properly documented and reported to AIRS
will be analyzed and presented with descriptive method.
Direct Access to Source Data and Documents The principal investigator and other investigators
of the research team are responsible for data collection and they will be permitted to access
to source data and study record.
Quality Control and Quality Assurance Daily logs will be recorded by the research nurse to
monitor the study progress including the number of respondents approached, interviews
completed or refused and incomplete interviews. All data entered in the database will be
verified and cleaned. After completion of data entry, computer logic checks will be run for
consistency of related code. Questionable data will be reviewed against the hard copy of
questionnaire. Necessary corrections will be made to the database.
Ethical approval The protocol will be submitted to the Research Ethics Committee (Kowloon
Central/Kowloon East and NTEC). The conduct of the study will be complied with the
"declaration of Helsinki". Participation in the study is voluntary and withdrawal is allowed
at any moment during data collection. An information sheet is provided and a written consent
is required from the participant.
Data Handling, Record Keeping, Publication and Disposal All identifiable personal data will
be anonymized and will follow the HA policy on handling of patient data privacy. The
completed questionnaires and records will be kept in a locked cabinet for 3 years. The
computerized research and personal data will be kept by encryption with restricted use to
authorized person only. All data are used for research only.
The completed questionnaires will be destroyed by cross-cut shredding and disposed to
confidential disposal container. The computerized research and personal data will be
destroyed by data erasure software to ensure the data cannot be recovered. The data disposing
procedure will be held at the end of 3 years storage period.
Financing and Insurance Not applicable
Publication Policy The dissemination of research findings will be presented in post
registered core course.
Supplements Written consent form, questionnaires and patient information sheet.
Indemnity and Insurance N/A
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