Investigating the impact of using a health assessment mobile application on medical errors in the assessment of trauma patients
Design
The study will be conducted as a clinical trial with a control group, with parallel groups, one-sided blind, with the participation of 80 patients hospitalized due to trauma. Randomization will be done using white and black colored cards.
Settings and conduct
Trauma patients referring to the medical education centers of Shahid Beheshti University of Medical Sciences, if they are eligible, will be included in the study and will be randomly assigned to intervention and control groups using colored cards. This study will be performed in a blind way. In this way, researcher A will do the evaluation and error checking will be done by researcher B, who will be unaware of the allocation of groups. Also, the data analyst will not know about the grouping of the participants
Participants/Inclusion and exclusion criteria
Inclusion criteria: hospitalization due to trauma, Exclusion criteria: not having a smart phone
Intervention groups
In the intervention group, the patient's assessment is checked with the help of the status assessment software. In this software, the assessment steps are done in order and step by step, and it guides the evaluator like a guide and reminds the evaluator of points at each step, and in the control group, the evaluation will be done without the help of the software and in the usual way.
Main outcome variables
Increasing accuracy in the evaluation of trauma patients and reducing the occurrence of medical errors in the evaluation of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210131050189N7
Registration date:2023-12-14, 1402/09/23
Registration timing:prospective
Last update:2023-12-14, 1402/09/23
Update count:0
Registration date
2023-12-14, 1402/09/23
Registrant information
Name
Raziyeh Ghafouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 4520
Email address
ghafouri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-21, 1402/09/30
Expected recruitment end date
2024-02-19, 1402/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the impact of using a health assessment mobile application on clinical judgment and medical errors in trauma patient assessment
Public title
Impact of using a health assessment mobile app on medical errors
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Having a smart phone
Hospitalized due to trauma
Exclusion criteria:
Reluctance to use mobile application for initial assessment after hospitalization
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Before starting the research, 40 white color cards and 40 black cards will be prepared. All the cards will be placed in an envelope, then the cards will be taken out randomly and numbered from 1 to 80 in order of exit. Each card will then be placed in a sealed envelope and its number will be written on the envelope. As each patient enters the study, a special envelope from number 1 to 80 will be opened for him. If the card is white, the participant will be assigned to the intervention group, and if the card is black, the participant will be assigned to the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The evaluation of patients is done by researcher A, and the evaluation of errors that occurred in the evaluation is checked by the researcher. Also, the data analyst will not know the type of intervention
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Shahid Beheshti University of Medical Sciences
Reducing the occurrence of medical errors in the evaluation of patients
Timepoint
Upon arrival to a month after discharge
Method of measurement
Re-hospitalization and error in evaluation based on 28 errors
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, the patient's assessment is checked with the help of the status assessment software. In this software, the evaluation steps are done in order and step by step, and it guides the evaluator like a guide and reminds the evaluator of points at each step.
Category
Diagnosis
2
Description
Control group: In the control group, the evaluation is done in the usual way
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital, Tehran
Full name of responsible person
Raziyeh Ghafouri
Street address
Shahid Madani Street, Imam Hossein Square, Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 3000
Email
info@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
(Ayatollah) Taleghani Educational Hospital
Full name of responsible person
Raziyeh Ghafouri
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2303 1100
Email
taleghani@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zergi
Street address
Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
19839-63113
Phone
+98 21 2243 9770
Email
Intl_office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh Ghafouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 912 783 8896
Email
raziehghafouri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh ghafouri
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2520
Email
raziehghafouri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Raziyeh Ghafouri
Position
َAssistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
SBMU School of Nursing & Midwifery, Vali-Asr Avenue, Cross of Vali-Asr Avenue and Hashemi Rafsanjani (Neiaiesh) Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
0982188202520
Email
raziehghafouri@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
By email to the corresponding author
raziehghafouri@gmail.com
When the data will become available and for how long
After the publication of the article
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
More research
From where data/document is obtainable
By email to the corresponding author
raziehghafouri@gmail.com
What processes are involved for a request to access data/document
By email to the corresponding author
raziehghafouri@gmail.com