Improving screening strategies for migrants in primary care
| ISRCTN | ISRCTN14795012 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14795012 |
| Secondary identifying numbers | 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
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
Scientific
Rosello 132, 4º
Barcelona
08036
Spain
| Phone | +34 (0)652870779 |
|---|---|
| ana.requena@isglobal.org |
Study information
| Study design | Cluster randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | GP practice |
| Study type | Screening |
| 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 | 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 study start date | 01/03/2017 |
| Completion date | 31/12/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | 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 |
| 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
Barcelona
08036
Spain
Lleida
25007
Spain
Manresa
08241
Spain
Manresa
08243
Spain
Barcelona
08025
Spain
Tortosa
43500
Spain
Tortosa
43500
Spain
Lleida
25003
Spain
Sponsor information
Research organisation
Rosello 132, 7º
Barcelona
08036
Spain
| Phone | +34 (0)9322754001802 |
|---|---|
| ana.requena@isglobal.org | |
| Website | www.isglobal.org |
"ROR" |
https://ror.org/03hjgt059 |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Government of Catalonia
- Location
- Spain
Results and Publications
| Intention to publish date | 06/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Two articles in peer-reviewed journals |
| 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.
