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
4º
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
7º
Barcelona
08036
Spain
+34 (0)9322754001802
ana.requena@isglobal.org
Sponsor type
Research organisation
Website
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
unknown
Funding Body Subtype
Location
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.