Mobile application for the proper use of head and neck diagnostic imaging tests

ISRCTN ISRCTN12300306
DOI https://doi.org/10.1186/ISRCTN12300306
Secondary identifying numbers PIN-0365-2016
Submission date
16/09/2020
Registration date
01/10/2020
Last edited
08/10/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Although of enormous potential utility, Decision Support Tools (DSTs) connected with computerized medical history systems are still at a very early stage of development. No public system in Spain has these types of tools incorporated into their digital medical records. Mobile Health Applications (e-Health) can also be conceived as a DST, both of an active nature (that is, the professional resorting to them proactively to obtain information at the moment) and of a passive type, since they are capable of being integrated into Corporate Information Systems. Based on the data contained from the medical history, these DSTs would provide information directly and passively, without the need to request it.
On the other hand, despite the enormous amount of scientific information that is generated every day, available in real-time thanks to the internet, clinicians have many difficulties with efficiently accessing the best information filtered by quality and relevance. The need for continuous updating in an extraordinarily changing scientific reality makes mobile applications very useful tools to keep us updated, with quick access in real-time through a device that can accompany us at all times (smartphone, tablet).
The main aim of this study is to demonstrate that the appropriate use of head and neck imaging tests can be improved with an app as a DST.

Who can participate?
Requests made by the doctors of the Puerta del Mar Hospital for head and neck imaging tests in the field of emergencies, outpatient consultations and hospitalization, in a given period of time.

What does the study involve?
After a period of dissemination and learning, the mobile application will be offered to the hospital physicians involved in the study. The percentage of requests for inappropriate diagnostic imaging tests will be analyzed in a period before and another after the implementation of the app.

What are the possible benefits and risks of participating?
The expected benefits are better use of imaging tests, avoiding useless imaging tests and/or recommending the best.

Where is the study run from?
Puerta del Mar University Hospital (Spain)

When is the study starting and how long is it expected to run for?
January 2017 to March 2021

Who is funding the study?
Council of Andalusian Health Services (Consejería de Salud, Junta de Andalucia) (Spain)

Who is the main contact?
Javier Jaén-Olasolo, MD, PhD
javier.jaen.sspa@juntadeandalucia.es

Contact information

Dr Javier Jaén-Olasolo
Public

Avenida Ana de Viya 21
Cádiz
11019
Spain

ORCiD logoORCID ID 0000-0002-6691-2120
Phone +34 (0)956 002 698
Email javier.jaen.sspa@juntadeandalucia.es

Study information

Study designComparative study before-and-after the intervention
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Hospital
Study typeDiagnostic
Participant information sheet No participant information sheet available
Scientific titleEvaluation of the impact of a mobile application for the proper use of head and neck diagnostic imaging tests
Study acronymHANDIT (Head And Neck Diagnostic Imaging Tests)
Study objectivesA mobile application can improve the proper use of head and neck diagnostic imaging tests leading to decrease variability in medical practice, incorporate evidence-based diagnostic procedures and possibly at lower costs.
Ethics approval(s)Submission pending, Research Ethics Committee of Cádiz (Comité de Ética de la Investigación de Cádiz, Office 817. 8ª Floor, Hospital Universitario Puerta del Mar, Ana de Viya, 21,Cádiz, Spain, 11009; +34 (0)956002005; ceic.hpm.sspa@juntadeandalucia.es), ref: N/A
Health condition(s) or problem(s) studiedHead and neck pathology
InterventionUse of a mobile application as a decision-making aid tool for head and neck pathology imaging by physicians who request them.

After a period of dissemination and learning, the mobile application will be offered to the hospital physicians involved in the study. The degree of adequacy of requests for imaging tests to the best available scientific evidence will be analyzed in a period prior to and another after the implementation of the APP to compare.

For the analysis, the study consists of a period of 3 months prior to the intervention (use of the app) from June to August 2010 and a second phase after the intervention, from September to December 2020.
Intervention typeOther
Primary outcome measurePercentage of requests for inappropriate diagnostic imaging tests, evaluated by clinicians and/or radiologists belonging to the research group. First, a radiologist makes an initial evaluation and then another clinician or radiologist different from the previous one makes a second evaluation, without knowing the previous result. In case of discrepancy, a third party is called in. The degree of suitability of the application is established according to the criteria of the American College of Radiology: a) appropriate, b) may be appropriate or doubtful, c) not appropriate. The application recruitment period is 3 months before and 3 months after the intervention.
Secondary outcome measures1. Evaluation of the economic impact: the researchers will perform a conservative analysis by minimizing costs, assuming that the effects on health and well-being are identical. They will calculate the economic benefit only in relation to the number of scans avoided or modified, without taking into account the time lost by patients or caregivers or the possible health consequences. Evaluated 3 months after the intervention.
2. Degree of satisfaction and usability by the professionals using the mobile application, measured by a survey and a Likert-type scale with five levels of response: 1) totally disagree, 2) disagree, 3) neither agree nor disagree, 4) agree, 5) totally agree. Measured 3 months after the intervention.
Overall study start date01/01/2017
Completion date31/03/2021

Eligibility

Participant type(s)Patient
Age groupAll
SexBoth
Target number of participants364 requests for head and neck imaging tests
Key inclusion criteriaRequests made by the doctors of the Puerta del Mar Hospital for head and neck imaging tests, in the field of emergencies, outpatient consultations and hospitalization
Key exclusion criteriaPathology different to head and neck and/or outside to the field of emergencies, outpatient consultations and hospitalization
Date of first enrolment01/06/2020
Date of final enrolment31/12/2020

Locations

Countries of recruitment

  • Spain

Study participating centre

Puerta del Mar University Hospital
Ana de Viya Avenue, 21
Cádiz
11009
Spain

Sponsor information

Fundación para la Gestión de la Investigación Biomedica de Cádiz
Research organisation

Ana de Viya Avenue
Cádiz
11009
Spain

Phone +34 (0)956 245 018 / +34 (0)956 245 019
Email fundacion.cadiz@juntadeandalucia.es
Website http://www.juntadeandalucia.es/index.html

Funders

Funder type

Government

Council of Andalusian Health Services (Consejería de Salud, Junta de Andalucia) (Spain)

No information available

Results and Publications

Intention to publish date31/03/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planDissemination of the research results within the clinical and scientific community, through papers published in clinical journals and presentations at conferences. The research team must provide the Andalusian government's Health Department with a final report before the end of 2021. The intention is to publish the results of the study before and, in any case, about 1 year after the overall trial end date.
IPD sharing planThe data that will appear in the data collection sheet are the following: diagnostic suspicion, requested test, checklist of signs and symptoms, clinical unit or service requestor and care setting. Personal data will not be recorded. Each patient will be assigned a code, which only the researcher collecting the data will be able to connect with his/her name. Only the researcher will have access to the table where codes and names are linked. This table will be destroyed when the data collection is finished. For other types of data, available upon request, the contact person is the principal investigator of the study: Javier Jaén-Olasolo, MD, PhD (javier.jaen.sspa@juntadeandalucia.es).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file 08/10/2020 No No

Additional files

ISRCTN12300306_PROTOCOL.pdf
Uploaded 08/10/2020

Editorial Notes

08/10/2020: Uploaded protocol (not peer reviewed).
29/09/2020: Trial's existence confirmed by Research Ethics Committee of Cádiz.