Condition category
Not Applicable
Date applied
11/06/2019
Date assigned
26/06/2019
Last edited
18/06/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Migrant health status may be improved if certain health conditions are identified early through a screening program. This is a study conducted in eight primary care centers (PCCs) located in four areas of Catalonia that evaluates the feasibility and cost-effectiveness of a screening program through a digital tool used by medical doctors during their daily consultation. The tool based on origin, age and sex, generates an alarm in the medical record system indicating the specific recommendations for each individual. The seven infectious diseases selected are HIV, hepatitis B, hepatitis C, tuberculosis, strongyloidiasis, schistosomiasis and Chagas disease. Female genital mutilation (FGM) and mental health are also included as they are associated with migration.

Who can participate?
Migrant patients coming from endemic countries for any of the conditions included in the study

What does the study involve?
Participating PCCs are randomly allocated to either use the digital tool or not. A training session concerning migrant screening strategies for each condition is done in all PCCs. The number of diagnoses of all the conditions are extracted from medical records.

What are the possible benefits and risks of participating?
The expected benefits are to increase the number of screened migrants and to improve their health and to increase the awareness of the primary care health professionals about the health needs of the migrant populations.

Where is the study run from?
Eight primary care centers (PCCs) located in four areas of Catalonia (Spain)

When is the study starting and how long is it expected to run for?
March 2017 to December 2019

Who is funding the study?
Generalitat de Catalunya - Departament de Salut (Spain)

Who is the main contact?
Dr Ana Requena-Méndez
ana.requena@isglobal.org

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ana Requena-Méndez

ORCID ID

Contact details

Rosello 132

Barcelona
08036
Spain
+34 (0)652870779
ana.requena@isglobal.org

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

SLT002/16/00455

Study information

Scientific title

Cost-effectiveness of an alert software tool implemented in the medical record system of primary care centres to improve the screening procedure in migrants

Acronym

CRIBMI

Study hypothesis

The implementation of a decision support system (DSS) of primary care health professionals concerning disease-specific screening in migrant populations may improve the diagnostic yield of health professional and avoid potential complications of the diseases.

Ethics approval

Approved 16/12/2016, Ethics committee of the Hospital Clínic of Barcelona (HCB/2016/0858) and the Jordi Gol i Gurina Foundation (SLT002/16/00455) (Hospital Clínic de Barcelona, Villarroel, 170 – 08036 Barcelona, Spain; Tel: +34 (0)93 227 54 00)

Study design

Cluster randomized study

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Condition

HIV, hepatitis B and C, tuberculosis, strongyloidiasis, schistosomiasis, Chagas disease, female genital mutilation and mental health assessment

Intervention

The study takes place in 8 primary care centers (PCCs) located in four areas of Catalonia. In each area, a digital tool (providing recommendations for migrant screening purpose based on an individual risk assessment) will be randomly allocated to the medical record system of one PPC, and will be compared with other PPCs (control) where no digital tool will be implemented.

Intervention: Implementation of DSS tool in PCC providing individual risk assessment for 9 conditions that should be screened in each individual migrant based upon 3 variables (country of origin, sex and age)
Control: PCC without implementation of DSS

Intervention: 01/03/2018 - 31/12/2018
No follow-up

Intervention type

Other

Phase

Drug names

Primary outcome measure

Number of diagnoses of all aggregated conditions included in the study, extracted from medical records between March and December 2018:

Secondary outcome measures

Extracted from medical records between March and December 2018:
1. Number of HIV diagnoses
2. Number of strongyloidiasis diagnoses
3. Number of schistosomiasis diagnoses
4. Number of tuberculosis diagnoses
5. Number of Chagas disease diagnoses
6. Number of Hepatitis C diagnoses
7. Number of Hepatitis B diagnoses
8. Number of mental health diagnoses
9. Number of female genital mutilation diagnoses
10. Number of early diagnoses of HIV
11. Number of early diagnoses of hepatitis B and C and HIV

Overall trial start date

01/03/2017

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Migrant patients coming from endemic countries for any of the conditions included in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

There are a total of 8 centres distributed in 4 areas (2 centres in each area). The targeted population are the migrants being attended in that primary care. The number of individuals varies in each area but are similar between PPCs from the same area. It varies between 2034 and 7481

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/03/2018

Recruitment end date

31/12/2018

Locations

Countries of recruitment

Spain

Trial participating centre

CAPBSE
Carrer Roselló 161
Barcelona
08036
Spain

Trial participating centre

EAP Lleida 1
Rambla Ferran
Lleida
25007
Spain

Trial participating centre

EAP Manresa 2
Plaça Catalunya
Manresa
08241
Spain

Trial participating centre

EAP Manresa IV
Sagrada Familia
Manresa
08243
Spain

Trial participating centre

CAP Sagrada Familia
Carrer Corsega 643
Barcelona
08025
Spain

Trial participating centre

EAP Tortosa 1 (Est)
Plaça Carrilet s/n
Tortosa
43500
Spain

Trial participating centre

CAP Tortosa Oest (Baix Ebre)
Avenida Colom 16-20
Tortosa
43500
Spain

Trial participating centre

CAP Primer de Maig
C/ De la Mercè, 5
Lleida
25003
Spain

Sponsor information

Organisation

Barcelona Institute for Global Health

Sponsor details

Rosello 132

Barcelona
08036
Spain
+34 (0)9322754001802
ana.requena@isglobal.org

Sponsor type

Research organisation

Website

www.isglobal.org

Funders

Funder type

Government

Funder name

Generalitat de Catalunya - Departament de Salut (PERIS SLT002/16/00455)

Alternative name(s)

Government of Catalonia

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Spain

Results and Publications

Publication and dissemination plan

Two articles in peer-reviewed journals

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Ana Requena-Méndez (ana.requena@isglobal.org).

Intention to publish date

06/06/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Sequeira-Aymar E, diLollo X, Osorio-Lopez Y, Gonçalves AQ, Subirà C, Requena-Méndez A [Recommendations for the screening for infectious diseases, mental health, and female genital mutilation in immigrant patients seen in Primary Care]. Aten Primaria. 2019 Apr 24. pii: S0212-6567(19)30043-5.

Publication citations

Additional files

Editorial Notes

13/06/2019: Trial's existence confirmed by ethics committee.