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Occupational DiseasesASVNCT02410408

Apps to Reduce the Impact That Adverse Events Among Health Professionals

A study testing Apps Root Cause Analysis or patient safety ISO certification and information package in people with Occupational Diseases, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 25 to 65 years
Conditions the study is for
Occupational Diseases
What is being tested?
Apps Root Cause Analysis or patient safety ISO certification and information package
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteSpain
Study dates
Jan 2016to Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • staff

Who cannot join

  • a experience in health institutions of less than 3 years

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • FISABIO

    Elche, Alicante, 03202

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
Apps Root Cause Analysis or patient safety ISO certification, information package
Keywords
Patient Safety, App, Root Cause Analysis, Patient Safety Certification
Medical subject headings
Occupational Diseases, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apps Root Cause Analysis or patient safety ISO certificationDevice

    Also called Root Cause Analysis or patient safety certification Apps

    Apps for conducting RCA or PSC

  • information packageOther

    Information on PSC and RCA

Study groups in NCT02410408
Study groupRoleWhat they receive
ControlActive comparatorInformation package about patient safety certification or how to conduct Root Cause Analysis
Receives: Other: information package
ExperimentalExperimentalApps: Root Cause Analysis or patient safety ISO certification
Receives: Device: Apps Root Cause Analysis or patient safety ISO certification

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants improving their capacity to conduct Root Cause Analysis

    Effectiveness of the App to improve knowledge and skills to conduct RCA

    Measured: two months

  2. 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

    Measured: two months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02410408
Sponsor's protocol ID
15/310
Acronym
ASV
Status last verified
Dec 2015
First submitted
29 Mar 2015
Last updated
5 Jan 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 25192876
  • 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.

    PubMed 22976126

Questions about this trial

What is this clinical trial studying?

A study testing Apps Root Cause Analysis or patient safety ISO certification and information package in people with Occupational Diseases, run by Universidad Miguel Hernandez de Elche at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants improving their capacity to conduct Root Cause Analysis (time frame: two months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02410408, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016.

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