Protocol summary

Summary
This study is a cluster randomized controlled trial using stepped wedge method for examining effectiveness of multiple intervention strategy in reducing patients’ fall and fall-related injuries for 38 weeks in a general hospital. The units (clusters) are determined by random allocation before the start of the trial for entrancing to the intervention phase at specific period of times (2 weeks). All clusters start the trial in a control phase with no intervention being delivered in any of them and then sequentially cross over from the control group to the intervention group, until all units are receiving the intervention. Inclusion criteria: All patients admitted to 18 units with a Morse risk score more than 45; patients with a history of fall and exclusion criteria: Patients with a Morse risk score less than 45. The primary and secondary outcome measures will be patient fall during hospitalization and fall-related injuries, their treatments respectively. The number of patient admissions to the unit and the number of patient bed days (LOS for each patient) will be collected routinely at each unit. The sample size used in this study is calculated based on Woertman’s study formula . Our hypothesis is that the interventions will a reduction of 30 percent on the incidence in fall rate. The required sample size was calculated to be 2100, using an alpha of 0.05 and desired power level of 0.90. Interventions of the study are as follows: patient education, staff training, training patients for not leaving the bed and the bathroom without asking for help, placement of nursing-call bells, Provide adequate lighting, supervise high risk patients during transmission and handovers, allocate mobility devices, placement of call bell and safe guard in bathrooms, placement of a ‘Fall alert’ sign above the patient’s bed, detection and treatment of postoperative complications such as Hypoxia, using yellow wristband, encourage appropriate use of eyeglasses, hearing aids and footwear, reassessment of patients after their fall, placing side rails on bed and encourage patients to empty their bladder and bowel prior to bedtime.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015052022333N1
Registration date: 2015-10-20, 1394/07/28
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-10-20, 1394/07/28
Registrant information
Name
zhila Najafpour
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2117
Email address
zh-najafpour@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-11-11, 1394/08/20
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect patient and staff education programs to decrease falls and fall-related injuries in a general hospital: cluster randomized controlled trail
Public title
prevention of patient fall
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: All patients admitted in 18 wards with a MORSE risk score more than 45; patients with a history of falls Exclusion criteria: Patients with a MORSE risk score less than 45
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 2100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committe in Resarech afiilated of Tehran Univercity of Medical Sciences
Street address
8th floor,center buliding of Tehran Univercity of Medical Sciences, GHods street, Keshavarz boulevard, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-08-01, 1394/05/10
Ethics committee reference number
IR.TUMS.REC.1394.496

Health conditions studied

1

Description of health condition studied
fall from bed, fall from wheelchair, fall from chair, fall from or off toilet
ICD-10 code
w05-w06-w0
ICD-10 code description
Fall involving bed, Fall involving wheelchair, Fall involving chair, other fall on same level

Primary outcomes

1

Description
Patient fall during hospitalization
Timepoint
38 weeks
Method of measurement
patient interview, screening of medical record

Secondary outcomes

1

Description
Fall-related injuries, their treatments and LOS (Length of stay)
Timepoint
38 weeks
Method of measurement
Observation, patient interview, physician assessment of patient's clinical condition and screening of medical record

Intervention groups

1

Description
patient education, staff training, training patients for not leaving the bed and the bathroom without asking for help, placement of nursing-call bells, Provide adequate lighting, supervise high risk patients during transmission and handovers, allocate mobility devices, placement of call bell and safe guard in bathrooms, placement of a ‘Fall alert’ sign above the patient’s bed, detection and treatment of postoperative complications such as Hypoxia, using yellow wristband, encourage appropriate use of eyeglasses, hearing aids and footwear, reassessment of patients after their fall, placing side rails on bed and encourage patients to empty their bladder and bowel prior to bedtime.
Category
Prevention

2

Description
Participants in the control phase receive usual care of hospital that consists of assessment of patients and having specific identification wristband.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Shariati hospital
Full name of responsible person
Dr. Ali Movafegh
Street address
Shariati hospital, at the begining of Jalale Al Ahmad avenue, Kargar's north street, Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohamad Arab
Street address
Economic And Health Managment group, Public Health Faculty, Tehran university of medical sciences, Pour Sina street, 16 Azar street,Tehra, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran Univercity of Medical Sciences
Full name of responsible person
Dr.Mohammad Arab
Position
PHD health care managment
Other areas of specialty/work
Street address
Economic And Health Management group, Public Health Faculty, Tehran University of Medical Sciences, Pour Sina street, Keshavarz boulevard, Tehran, Iran
City
Tehran
Postal code
Phone
+98 218898129
Fax
Email
arabmoha@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Arash Rashidiyan
Position
PHD Public Health
Other areas of specialty/work
Street address
Economic And Health Management group, Public Health Faculty, Tehran University of Medical Sciences, Pour Sina street, Keshavarz boulevard, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8898 9129
Fax
Email
arash.rashidian@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Jila Najafpour
Position
PHD Health Care Managment
Other areas of specialty/work
Street address
Economic And Health Management group, Public Health Faculty, Tehran University of Medical Sciences, Pour Sina street, Keshavarz boulevard, Tehran, Iran
City
Tehran
Postal code
Phone
00
Fax
Email
zh-najafpour@razi.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...