Clinical Trial: Apps to Reduce the Impact That Adverse Events Among Health Professionals

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Designing Guides and Tools to Reduce the Impact That Adverse Events Also Have Among Professionals and Health Institutions

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 Summary:

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
Sponsor: Universidad Miguel Hernandez de Elche

Current Primary Outcome:

• Number of participants improving their capacity to conduct Root Cause Analysis [ Time Frame: two months ]
  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 [ Time Frame: two months ]
  Effectiveness of the App to improve knowledge and skills to assure necessary task to achieve patient safety ISO certification

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Universidad Miguel Hernandez de Elche

Dates:
Date Received: March 29, 2015
Date Started: January 2016
Date Completion:
Last Updated: January 2, 2016
Last Verified: December 2015