Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02410408
Other study ID # 15/310
Secondary ID
Status Completed
Phase N/A
First received March 29, 2015
Last updated January 2, 2016
Start date January 2016
Est. completion date January 2016

Study information

Verified date December 2015
Source Universidad Miguel Hernandez de Elche
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 84
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 65 Years
Eligibility Inclusion Criteria:

- staff

Exclusion Criteria:

- a experience in health institutions of less than 3 years

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Device:
Apps Root Cause Analysis or patient safety ISO certification
Apps for conducting RCA or PSC
Other:
information package
Information on PSC and RCA

Locations

Country Name City State
Spain FISABIO Elche Alicante

Sponsors (6)

Lead Sponsor Collaborator
Universidad Miguel Hernandez de Elche Andaluz Health Service, Institut Català de la Salut, Osakidetza, Servicio Madrileño de Salud, Madrid, Spain, Servicio Valenciano de Salud

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. Review. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants improving their capacity to conduct Root Cause Analysis Effectiveness of the App to improve knowledge and skills to conduct RCA two months No
Primary 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 two months No
See also
  Status Clinical Trial Phase
Completed NCT06006481 - Musculoskeletal Problems and Strategies Developed by Physiotherapists to Cope With Them
Completed NCT06003842 - The Effect of Kinesio® Tex Application on Pain, Functionality, Sleep Quality and Work Performance in Drivers N/A
Completed NCT06004284 - Effect of Exercise Given to Factory Workers With Ergonomics Training on Pain and Functionality N/A
Completed NCT05019781 - The Effectiveness of Kinesio Taping in Violin Players N/A
Recruiting NCT04255498 - Understanding GWI: Integrative Modeling Phase 1
Completed NCT04075279 - Heart at Work Study
Terminated NCT05508893 - Screening for Coronary Artery Disease USing Primary Evaluation With Coronary CTA in Aviation Medicine (SUSPECT) N/A
Active, not recruiting NCT05357365 - Establishing a Cohort for Occupational Disease of Emergency Medical Workers
Completed NCT05047497 - Ventilatory Functions, Oxygen Saturation, and Quality of Life Response to Long Time Cement Dust Exposure
Not yet recruiting NCT06149364 - Cost-effectiveness, Impact of a Workplace-based Intervention to Reduce Occupational Sitting Time in Office-based Workers N/A
Completed NCT03559153 - Effect of Passive and Active Rest Break in Musculoskeletal Complains N/A
Completed NCT03738202 - Multifaceted Intervention for Protection Against Cotton Dust Exposure Among Textile Workers N/A
Recruiting NCT05039398 - 'Dialogue and Guidance' - a Policy Intervention for Improved OHS Among Workplaces With WEA Violations N/A
Not yet recruiting NCT05416723 - Occupational and Environmental Origins of ANCA Vasculitis: Contribution of Data From the National Network for Vigilance and Prevention of Occupational Pathologies (RNV3P)
Completed NCT02093936 - Lymphocytes Cut Off Values of Induced Sputum Samples in Healthy and Non-healthy Patients- A Cross Sectional Study N/A
Not yet recruiting NCT05571995 - RCT of TRIMOSH Module in Improving Knowledge, Attitude, and Practice Among Food Industries Workers N/A
Completed NCT00871637 - Airway Macrophages and Sputum Milieu in Adult Subjects With Airflow Obstruction
Completed NCT00012844 - Redesigning Patient Handling Tasks to Prevent Nursing Back Injuries N/A