Apps to Reduce the Impact That Adverse Events Among Health Professionals

NCT ID: NCT02410408

Last Updated: 2016-01-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

Occupational Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Control

Information package about patient safety certification or how to conduct Root Cause Analysis

Group Type: ACTIVE_COMPARATOR

information package

Intervention Type: OTHER

Information on PSC and RCA

Experimental

Apps: Root Cause Analysis or patient safety ISO certification

Group Type: EXPERIMENTAL

Apps Root Cause Analysis or patient safety ISO certification

Intervention Type: DEVICE

Apps for conducting RCA or PSC

Interventions

Apps Root Cause Analysis or patient safety ISO certification

Apps for conducting RCA or PSC

Intervention Type: DEVICE

information package

Information on PSC and RCA

Intervention Type: OTHER

Other Intervention Names

Root Cause Analysis or patient safety certification Apps

Eligibility Criteria

Inclusion Criteria

• staff

Exclusion Criteria

• a experience in health institutions of less than 3 years

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osakidetza

OTHER

Sponsor Role: collaborator

Andaluz Health Service

OTHER_GOV

Sponsor Role: collaborator

Servicio Madrileño de Salud, Madrid, Spain

OTHER

Sponsor Role: collaborator

Servicio Valenciano de Salud

UNKNOWN

Sponsor Role: collaborator

Institut Català de la Salut

OTHER

Sponsor Role: collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role: lead

Responsible Party

José Joaquín Mira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José Mira, PhD

Role: PRINCIPAL_INVESTIGATOR

FISABIO/Universidad Miguel Hernández

Locations

FISABIO

Elche, Alicante, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 25192876 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22976126 (View on PubMed)

Other Identifiers

15/310

Identifier Type: -

Identifier Source: org_study_id