NCT02410408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 5, 2016

Status Verified

December 1, 2015

Enrollment Period

Same day

First QC Date

March 29, 2015

Last Update Submit

January 2, 2016

Conditions

Occupational Diseases

Keywords

Patient SafetyAppRoot Cause AnalysisPatient Safety Certification

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Other: information package

Experimental

EXPERIMENTAL

Apps: Root Cause Analysis or patient safety ISO certification

Device: Apps Root Cause Analysis or patient safety ISO certification

Interventions

Apps Root Cause Analysis or patient safety ISO certificationDEVICE

Apps for conducting RCA or PSC

Also known as: Root Cause Analysis or patient safety certification Apps
Experimental
information packageOTHER

Information on PSC and RCA

Control

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • staff

You may not qualify if:

  • a experience in health institutions of less than 3 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FISABIO

Elche, Alicante, 03202, Spain

Location

Related 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.

    PMID: 25192876BACKGROUND

  • 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.

    PMID: 22976126BACKGROUND

MeSH Terms

Conditions

Occupational DiseasesAlzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • José Mira, PhD

    FISABIO/Universidad Miguel Hernández

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 29, 2015

First Posted

April 7, 2015

Study Start

January 1, 2016

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 5, 2016

Record last verified: 2015-12

Locations

ES(1)