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Trial registered on ANZCTR


Registration number
ACTRN12616000035426
Ethics application status
Approved
Date submitted
26/10/2015
Date registered
18/01/2016
Date last updated
18/01/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A nurse led educational intervention to enhance nurses’ knowledge and compliance in fall risk assessment in acute medical wards.
Scientific title
A nurse led educational intervention to enhance nurses’ knowledge and compliance in fall risk assessment in acute medical wards.
Secondary ID [1] 287730 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fall risk in hospital 296568 0
Condition category
Condition code
Injuries and Accidents 296831 296831 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A structured education intervention was conducted after the completion of pre-test and pre-compliance audits. A total of eight sessions were conducted over a period of 2 weeks to ensure all nurses in the intervention group had chance to attend, so each nurse can attend more than one sessions but at least they had to attend one sessions. The session was held every afternoon from 2.30-4.30. after the nurses had handed over the nursing report. This was to enable more nurses to attend the teaching session. The teaching material provides information on fall prevalence, fall burdens and fall standard precaution. The following is the detail description of the teaching intervention:
1. Introduction
1.1. Definition of fall
1.2. Prevalence and consequence of fall
1.3. Fall burden and cost
2. Assessment of falls in the hospital
2.1. Patient age
2.2. History of fall
2.3. Extrinsic factors
2.4. Intrinsic factors
3. Staff Responsibilities
3.1 Lying and standing / standing blood pressure at least once
3.2 Assist in patient’s elimination needs
3.3 No restraining of patient
3.4 Ensure safe environment: lighting, assistive device, furniture, alarm system (ice cream bell), keep patient rooms and hallway free of clutter, keeping object within reach of patient, cot sides down and properly fitted shoes and clothing.
Following the teaching session, a fall prevention support group was set up to provide guidance and discussions on problems while implementing fall precautions in a hand phone application ‘Whatsapp group’.This is a convenient platform in view that every medical nurse has a smart phone and easy to set up.

Data collection method / procedure
Phase I
After successfully obtained ethical approval from MREC on 25th January, 2015, sixty-five nurses from control group and 60 nurses from the intervention group were recruited to participate in the study which was conducted in March 2015. The nurses were randomized into control and intervention groups using computerized randomization software. Intervention group were randomized as wards 1 and control group as ward 2. Assistance was sought from the ward sisters in arranging the pretest sessions. Four consecutive pretest sessions were conducted from 1st March, 2015 to 15th March, 2015 to assess their knowledge. The knowledge of the nurses was assessed before and after intervention to both groups. Concurrently, the demographic data of the nurses were collected.
Consent for participating in the pretest was obtained from each participant. The nurses were informed that their participation was on a voluntary basis and there would be no repercussion should they decline to participate. Additionally, the participants were also instructed to maintain confidential of the questions from other participants who had yet to sit for the pretest. This is important to ensure validity of the results.
Meanwhile, the pre compliance audits were carried out by a fall nurse and a physiotherapist from the fall team during the first two weeks of March, 2015. A total of 125 audits performed where 60 were from intervention wards and 65 were from control wards. The nurses were given unique identification numbers as C1 to C65 for control group and T1 to T60 for intervention group. This identification were made with assistance from the ward sisters who provided the ward staff nurses’ name list from each ward involved in this study. Audit was used as data collection method because it is important to determine the nurses’ current practices in fall risk assessment.

Phase II
A structured education intervention was conducted after the completion the pretest to the intervention group. A total of 8 teaching sessions were conducted over a period of 2 weeks were conducted to ensure all nurses in the intervention group had chance to attend. A total of 60 nurses attended the teaching session. The teaching sessions were held in the afternoon with assistance from the ward sisters. The teaching sessions were conducted in the geriatric seminar room in the geriatric ward. The teaching was conducted by using power point presentation over 2 hours. The purpose of the education was to provide information and prevention strategies on in patient fall. Refreshments were served after the session in appreciation of their participant. The nurses were instructed to practice the fall prevention practices in their wards.

Phase III
One week after the teaching session, post-tests were conducted. The post-test questions were exactly the same as the pre-test questions but administered at different time. This was not disclosed to the participants to prevent contamination. A total of 5 post-test were conducted over one week from in the 1st week of April. 60 nurses from intervention group and 65 nurses from intervention group completed the test with the assistance from the ward sisters. The same measures were adopted to ensure confidentiality of the participants. To avoid contamination the participants were instructed not to expose the questions to other participant who are to attend the test later. The tests were conducted in the geriatric seminar room in the geriatric ward.
Post intervention audits were carried out over a period of 2 weeks in April by the same fall nurse and physiotherapist from fall team using the same audit tool. The audits on the nurses were matched with the pre- intervention audits as the nurses were identified as C1 to C65 for control group and T1 to T60 for intervention group. A total of 125 audits were completed with 60 audits from intervention group and 65 from control group. Registration of attendance at each session was used to monitor adherence of participant. This was done so to facilitate analysis to match with their pre and post knowledge.
Intervention code [1] 293123 0
Prevention
Comparator / control treatment
The nurses in the control group receive no educational intervention and continue care as per usual.
Control group
Active

Outcomes
Primary outcome [1] 296435 0
To investigate the effect of education on nurses’ knowledge in fall risk assessment in acute medical wards in a general hospital.

The nurses' knowledge was assess by using a test questionnaire designed specifically for this study.
Timepoint [1] 296435 0
Baseline before intervention, then 6 weeks post intervention completion.
Primary outcome [2] 296521 0
To investigate the effect of education on nurses’ compliance in fall risk assessment in acute medical wards in a general hospital.

The nurses' compliance was assess by using a test questionnaire designed specifically for this study.
Timepoint [2] 296521 0
Baseline before intervention, then 6 weeks post intervention completion.
Secondary outcome [1] 318449 0
To determine the level of compliance in fall assessment among staff nurses in the medical wards before and after implementation of a nurse-led education intervention.

The the level of compliance in fall assessment among staff nurses was assess by using hospital records.
Timepoint [1] 318449 0
Baseline before intervention, then 6 weeks post intervention completion.

Eligibility
Key inclusion criteria
- Registered nurses who had undergone 3 years nursing training and obtained Diploma in Nursing and registered with the Nursing Board of Malaysia.
- Registered nurses currently working in the designated ward during study period.
Minimum age
25 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Registered nurses who were on confinement leave, no pay leave or study leave for more than 1 month during the study period.
- Registered nurses who were undergoing post basic training during the study period.
- Registered nurses who had previously attended a fall workshop.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/03/2015
Date of last participant enrolment
Anticipated
Actual
13/03/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
130
Accrual to date
Final
125
Recruitment outside Australia
Country [1] 7272 0
Malaysia
State/province [1] 7272 0
Klang Valley

Funding & Sponsors
Funding source category [1] 292273 0
University
Name [1] 292273 0
University of Malaya Research Grant
Country [1] 292273 0
Malaysia
Primary sponsor type
University
Name
University of Malaya
Address
Nursing Science Department
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 290951 0
Individual
Name [1] 290951 0
TAN SEEW GEEK
Address [1] 290951 0
Nursing Science Department
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur, Malaysia
Country [1] 290951 0
Malaysia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293748 0
Medical Research and Ethics Committee (MREC), Malaysia
Ethics committee address [1] 293748 0
Ethics committee country [1] 293748 0
Malaysia
Date submitted for ethics approval [1] 293748 0
Approval date [1] 293748 0
25/01/2015
Ethics approval number [1] 293748 0
(5) KKM/NIHSEC/P15-122

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61150 0
Mrs TAN SEEW GEEK
Address 61150 0
Department of Nursing Sciences
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur, Malaysia
Country 61150 0
Malaysia
Phone 61150 0
+603-79493675
Fax 61150 0
Email 61150 0
mcchong@um.edu.my
Contact person for public queries
Name 61151 0
Abdulaziz Mansoor
Address 61151 0
Department of Nursing Sciences
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur, Malaysia
Country 61151 0
Malaysia
Phone 61151 0
+60182127207
Fax 61151 0
Email 61151 0
aziz-mansoor@hotmail.com
Contact person for scientific queries
Name 61152 0
Chong Mei Chan
Address 61152 0
Department of Nursing Sciences
Faculty of Medicine
University of Malaya
50603 Kuala Lumpur, Malaysia
Country 61152 0
Malaysia
Phone 61152 0
+603-79493675
Fax 61152 0
Email 61152 0
mcchong@um.edu.my

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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