The impact of patient education in preventing patient falls
Design
This is a quasi-experimental study that will be performed before and after the intervention. The study population will be including inpatients of one of the selected hospital in Tabriz's in the year 2020. The sample size will be 173 based on a similar study and sampling formula. Samples will be randomly selected based on inclusion criteria.
Prior to the study, participants will complete informed consent and a questionnaire will be provided to patients.
Settings and conduct
The intervention will be conducted for approximately 6 months. Patients (according to the inclusion criteria) will be educated and their knowledge and self-efficacy before and after the education will be calculated, and finally, the fall rate (as a final outcome) will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria included:
Being at least 18 years old,
having a minimum hospital stay of at least 4 days,
and having a Morse risk score above 25.
Exclusion criteria include Being unwilling to participate in the study, being unconscious and having a Morse risk score lower than 25.
Intervention groups
In this study, patients will be trained based on an educational program aimed at increasing their knowledge and self-efficacy about falling patients. Educational content is formulated through a review of the literature and clinical experience of specialists. A trained nurse will educate patients throughout the study. Face to face and pamphlets will be used for this purpose. Patients' knowledge and self-efficacy will be measured by valid questionnaires before and after education.
Main outcome variables
Knowledge and self-efficacy and rates of patient fall
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200109046067N1
Registration date:2020-03-29, 1399/01/10
Registration timing:prospective
Last update:2020-03-29, 1399/01/10
Update count:0
Registration date
2020-03-29, 1399/01/10
Registrant information
Name
Zahra Chegini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 1048
Email address
cheginiz@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of educational intervention on the self-efficacy and patient falls of hospitalized patients: A quasi-experimental, before-after trial
Public title
The impact of patient education in preventing patient falls
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Hospital stay of at least 4 days
Morse risk score above 25
Exclusion criteria:
Morse risk score lower than 25
Patients' unconsciousness
Patients' Unwillingness
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
170
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
School of Management and Medical Informatics, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz 5165665811, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Approval date
2018-10-22, 1397/07/30
Ethics committee reference number
IR.TBZMED.REC.1397.617
Health conditions studied
1
Description of health condition studied
Fall involving bed
ICD-10 code
W06
ICD-10 code description
Fall from bed
2
Description of health condition studied
Fall involving wheelchair, Fall involving chair
ICD-10 code
W05
ICD-10 code description
Fall from non-moving wheelchair, nonmotorized scooter and motorized mobility scooter
3
Description of health condition studied
other fall on same level
ICD-10 code
W01
ICD-10 code description
Fall on same level from slipping, tripping and stumbling
Primary outcomes
1
Description
Patients' knowledge about patient falls
Timepoint
Before patient education and 7 days after training
Method of measurement
Using a valid questionnaire consisting of 20 items with three options of correct, false and do not know about patient knowledge to prevent falls
2
Description
Self-efficacy of patients to prevent patient falls
Timepoint
Before patient education and 7 days after training
Method of measurement
A validated 15-item questionnaire on self-efficacy for preventive falls with a four-choice Likert scale
3
Description
Number of patient falls in six months
Timepoint
At the end of intervention (end of September)
Method of measurement
Based on the patient fall data recorded in the hospital information system
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with high risk of falls as intervention group before and after intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital at Tabriz
Full name of responsible person
Zahra Chegini
Street address
School of Management and Medical Informatics, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz 5165665811, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3325 1378
Email
Z.cheginy@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Khosro Asibkia
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz, PO Box: 5165665931, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3334 4280
Email
z.cheginy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
zahra chegini
Position
phd candidate
Latest degree
Master
Other areas of specialty/work
Health Service Management
Street address
School of Management and Medical Informatics, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz 5165665811, Iran
City
tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3325 1378
Email
Z.cheginy@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Chegini
Position
P.h.D. Candidate
Latest degree
Master
Other areas of specialty/work
Health Service Management
Street address
Daneshgah
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3335 1048
Fax
+98 41 3335 9680
Email
cheginiz@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Chegini
Position
Phd Candidate
Latest degree
Master
Other areas of specialty/work
Health Service Management
Street address
Daneshgah St‐ Tabriz‐ East Azerbaijan, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5165665811
Phone
+98 41 3325 1379
Email
z.cheginy@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data from the questionnaire information will be presented in tables.
When the data will become available and for how long
Start of access period 6 months after printing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Patient data at the request of the responsible author
From where data/document is obtainable
Email to Corresponding Author: Zahra Chegini
Z.cheginy@gmail.com
What processes are involved for a request to access data/document
About a week after emailing the request to the announced address