Improving screening strategies for migrants in primary care

ISRCTN	ISRCTN14795012
DOI	https://doi.org/10.1186/ISRCTN14795012
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	SLT002/16/00455
Sponsor	Barcelona Institute for Global Health
Funder	Generalitat de Catalunya - Departament de Salut (PERIS SLT002/16/00455)

Submission date: 11/06/2019
Registration date: 26/06/2019
Last edited: 08/07/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Ana Requena-Méndez
Scientific

Rosello 132, 4º
Barcelona
08036
Spain

Phone	+34 (0)652870779
Email	ana.requena@isglobal.org

Study information

Primary study design	Interventional
Study design	Cluster randomized study
Secondary study design	Cluster randomised trial
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
Study acronym	CRIBMI
Study objectives	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(s)	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)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Number of diagnoses of all aggregated conditions included in the study, extracted from medical records between March and December 2018:
Key secondary outcome measure(s)	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
Completion date	31/12/2019

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	7481
Total final enrolment	14598
Key inclusion criteria	Migrant patients coming from endemic countries for any of the conditions included in the study
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/03/2018
Date of final enrolment	31/12/2018

Locations

Countries of recruitment

Spain

Study participating centres

CAPBSE

Carrer Roselló 161
Barcelona
08036
Spain

EAP Lleida 1

Rambla Ferran
Lleida
25007
Spain

EAP Manresa 2

Plaça Catalunya
Manresa
08241
Spain

EAP Manresa IV

Sagrada Familia
Manresa
08243
Spain

CAP Sagrada Familia

Carrer Corsega 643
Barcelona
08025
Spain

EAP Tortosa 1 (Est)

Plaça Carrilet s/n
Tortosa
43500
Spain

CAP Tortosa Oest (Baix Ebre)

Avenida Colom 16-20
Tortosa
43500
Spain

CAP Primer de Maig

C/ De la Mercè, 5
Lleida
25003
Spain

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	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).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		25/04/2019		Yes	No
Results article		06/07/2021	08/07/2021	Yes	No

Editorial Notes

08/07/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
13/06/2019: Trial's existence confirmed by ethics committee.