Apps to Reduce the Impact That Adverse Events Among Health Professionals (ASV)
Primary Purpose
Occupational Diseases
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Apps Root Cause Analysis or patient safety ISO certification
information package
Sponsored by
About this trial
This is an interventional health services research trial for Occupational Diseases focused on measuring Patient Safety, App, Root Cause Analysis, Patient Safety Certification
Eligibility Criteria
Inclusion Criteria:
- staff
Exclusion Criteria:
- a experience in health institutions of less than 3 years
Sites / Locations
- FISABIO
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control
Experimental
Arm Description
Information package about patient safety certification or how to conduct Root Cause Analysis
Apps: Root Cause Analysis or patient safety ISO certification
Outcomes
Primary Outcome Measures
Number of participants improving their capacity to conduct Root Cause Analysis
Effectiveness of the App to improve knowledge and skills to conduct RCA
Number of participants improving their capacity to lead patient safety ISO certification review
Effectiveness of the App to improve knowledge and skills to assure necessary task to achieve patient safety ISO certification
Secondary Outcome Measures
Full Information
NCT ID
NCT02410408
First Posted
March 29, 2015
Last Updated
January 2, 2016
Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Osakidetza, Andaluz Health Service, Servicio Madrileño de Salud, Madrid, Spain, Servicio Valenciano de Salud, Institut Català de la Salut
1. Study Identification
Unique Protocol Identification Number
NCT02410408
Brief Title
Apps to Reduce the Impact That Adverse Events Among Health Professionals
Acronym
ASV
Official Title
Designing Guides and Tools to Reduce the Impact That Adverse Events Also Have Among Professionals and Health Institutions
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Miguel Hernandez de Elche
Collaborators
Osakidetza, Andaluz Health Service, Servicio Madrileño de Salud, Madrid, Spain, Servicio Valenciano de Salud, Institut Català de la Salut
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Adverse events are also the cause of suffering in health professionals involved (second victims). This study has the aim of design and evaluates two applications for staff of hospital and primary care settings with the intention of improving their capacity to conduct Root Cause Analysis (RCA) and to help them introducing patient safety certification (PSC).
A single-blind randomized controlled trial shall conduct with a control and an experimental group (N=84) in both cases. The characteristics of both apps shall specify based on the suggestions of health professionals and shall design for Android and IOS (for iPhone or Ipad).
The randomly subjects in the control group shall receive oral and written information and the experimental group used App for two months. Pre- and post- measures shall include: patient safety knowledge and culture and self-perceived capacity to enhance RCA or follow-up PSC. In the experimental group, data shall also collect on their previous experience with information and communication technologies, their rating of each App. The inter-group intervention effects shall calculate by univariate linear models and ANOVA, with the pre- to post-intervention differences as the dependent variables.
Detailed Description
Adverse events (AEs) are the cause of harm and suffering in patients and may also markedly affect the work, family and personal life of health professionals involved, second victims, as well as damaging the reputation of affected health organizations (third victims), by undermining people's trust in these institutions. Between 28 and 57% of physicians (79-89% in the case of residents) recognize having being involved in medical error with serious consequences for one or more patients at some point in their career, while 90% believe that in their hospital there is insufficient help and support for professionals following an AE. In Spain, extrapolating from national AE data in hospitals and primary care, it has been estimated that 15% of healthcare professionals are involved in this type of event per year.
Guidelines and recommendations of the role of staff directive of health institutions in the field of the safety of patients have been developed with the aim to reduce the impact of adverse events in the second and third victims. The root causes analysis (RCA) and the patient safety certification (PSC) systems following the International Organization for Standardization (ISO) rules are two examples of these interventions in which staff has direct responsibility.
In this study the investigators design and assess two apps designed for Android and IOS (for iPhone or Ipad) to help staff conducting RCA or implementing PSC. To evaluate these Apps the investigators opted for a single-blind experimental design with two groups (control and experimental) and pre- and- post assessments. Subjects shall be randomly assigned to the control or experimental group. The control group shall compose of subjects who did not use experimental devices, and the experimental group of people used this tool for two months. To maintain the single-blind and be able to link the pre- and post- measurements, subjects shall assign codes as a function of their date of birth and initials. The investigators randomly select 84 subjects from health districts in Spain who develop directive function. Exclusion criteria: less than 3 years of professional experience. The sample size was calculated to detect a difference between means of at least of 10 points with a statistical power of 90% at a level of significance of α = 0.05 (in a two-tailed test). The investigators requested the informed consent of patients from both control and experimental groups. All the participating shall complete a questionnaire to assess patient safety knowledge and culture as well as self-efficacy.
Those in the control group received oral and written information regarding patient safety certification or Root Cause Analysis. Participants in the experimental group were given the apps installed and personalized according to their institution. Two months later, the measurements made pre-intervention shall repeat. Additionally, subjects from the experimental group also shall ask to evaluate apps (its performance, functionality, usability, reliability, acceptability, usefulness, design, simplicity, accessibility, and problem-solving power as well as overall satisfaction with the tool). In order to assess the effectiveness of the apps, we shall build various univariate linear models and, where there were inter-group differences in pre-intervention measurements, performed univariate linear models and ANOVA, using as the dependent variables the differences between the pre- and post-intervention measurements.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occupational Diseases
Keywords
Patient Safety, App, Root Cause Analysis, Patient Safety Certification
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Information package about patient safety certification or how to conduct Root Cause Analysis
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Apps: Root Cause Analysis or patient safety ISO certification
Intervention Type
Device
Intervention Name(s)
Apps Root Cause Analysis or patient safety ISO certification
Other Intervention Name(s)
Root Cause Analysis or patient safety certification Apps
Intervention Description
Apps for conducting RCA or PSC
Intervention Type
Other
Intervention Name(s)
information package
Intervention Description
Information on PSC and RCA
Primary Outcome Measure Information:
Title
Number of participants improving their capacity to conduct Root Cause Analysis
Description
Effectiveness of the App to improve knowledge and skills to conduct RCA
Time Frame
two months
Title
Number of participants improving their capacity to lead patient safety ISO certification review
Description
Effectiveness of the App to improve knowledge and skills to assure necessary task to achieve patient safety ISO certification
Time Frame
two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
staff
Exclusion Criteria:
a experience in health institutions of less than 3 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José Mira, PhD
Organizational Affiliation
FISABIO/Universidad Miguel Hernández
Official's Role
Principal Investigator
Facility Information:
Facility Name
FISABIO
City
Elche
State/Province
Alicante
ZIP/Postal Code
03202
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
25192876
Citation
Parand A, Dopson S, Renz A, Vincent C. The role of hospital managers in quality and patient safety: a systematic review. BMJ Open. 2014 Sep 5;4(9):e005055. doi: 10.1136/bmjopen-2014-005055.
Results Reference
background
PubMed Identifier
22976126
Citation
Seys D, Wu AW, Van Gerven E, Vleugels A, Euwema M, Panella M, Scott SD, Conway J, Sermeus W, Vanhaecht K. Health care professionals as second victims after adverse events: a systematic review. Eval Health Prof. 2013 Jun;36(2):135-62. doi: 10.1177/0163278712458918. Epub 2012 Sep 12.
Results Reference
background
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Apps to Reduce the Impact That Adverse Events Among Health Professionals
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