Delivering an Innovative Multi-disease Screening Tool to High-risk Migrant Populations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 980
- 试验地点
- 2
- 主要终点
- Comparison of the detection rate per month of all aggregated infections (HIV, HBV, HCV, TB, T.cruzi, S.stercoralis and Schistosoma spp. infections) between the intervention and control centres
研究概览
简要总结
Migrants' overall health status may be improved by increasing the detection of certain infectious diseases and other conditions for which effective care is available. This can be achieved through a systematic screening of these conditions using innovative and digital solutions implemented in routine health care.
This study aims to evaluate the implementation of a screening programme for migrants at primary care level in two different settings of Spain (Catalonia and Andalusia) using an innovative digital and user-friendly software tool (ISMiHealth). In Catalonia, the ISMiHealth tool has already been integrated into the Electronic Patient Record (EPR) system (eCAP) as part of a pilot study in 2018; currently, the research team aims to validate the tool in a higher number of primary care centres in this area. Therefore, a pragmatic cluster randomised controlled trial will be conducted with two parallel groups, in which selected centres using the novel software ISMiHealth will be compared to others that follow the current routine practice. On the other hand, in Andalusia a pilot cluster randomised controlled trial will be carried out, where the ISMiHealth tool will be implemented in the EPR system (DIRAYA) to evaluate the preliminary effectiveness of the tool in other settings.
The ISMiHealth software is a clinical decision support system that provides recommendations for primary healthcare professionals on screening for targeted conditions. It currently includes: 7 communicable diseases (Human immunodeficiency virus, Hepatitis B and C virus, Tuberculosis, Chagas diseases, strongyloidiasis and schistosomiasis) and one key health condition (female genital mutilation). Through routinely collected variables (country of birth, age, and sex), the software performs an individualised risk assessment and provides real-time prompts to healthcare professionals on screening for the selected health conditions. In any case, health professionals will be responsible for requesting screening tests and/or referrals to specialists.
详细描述
- Objectives
General objective: To develop an integrated and primary care based, communicable diseases and female genital mutilation (FGM) screening programme for migrant populations in Spain in order to promote better health and integration.
Specific objectives:
- Aim 1: To develop a Spanish consensus guidance on migrant screening recommendations based on existing European examination/screening programmes and on a consensus of a country-expert transdisciplinary national collaborative network.
- Aim 2: To scale-up and validate a simple and user-friendly innovative digital tool that will be integrated into the local electronic patient record (EPR) system of primary care in two different settings (Catalonia and Andalusia), and that aims to facilitate targeted screening to migrants presenting for a routine appointment. This digital tool will support health professionals to follow best-practice recommendations, while considering patients' individual characteristics (country of birth, age, sex) and therefore specific risk factors.
- Study design
This study will be developed into two sub-studies in order to accomplish the specific objectives.
2.1 Study 1 related to aim 1. Spanish consensus guidance on migrant screening recommendations.
- A comparative review and analysis of existing screening programmes at regional, national and international level will be performed.
- A report with the reviewed results will be developed and presented in the consensus workshops.
- A consensus workshop with national experts will be carried out by study site to establish which diseases will be included in the final screening algorithm and what will be defined as the screening criteria for each condition. The tentative elements to include are Human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), Tuberculosis (TB), selected parasitic infections and FGM. For most of the communicable diseases, the screening criteria will be fully aligned with the current European Centre for Disease Prevention and Control (ECDC) screening guidelines and recommendations.
- To measure the level of agreement with the recommendations, a questionnaire based on a Likert Scale of 5 points (1- Strongly disagree, 2- Disagree, 3- Neutral, 4- Agree and 5- Strongly agree) will be sent to the different experts invited to the workshops.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria:
- •Centres with a migration density higher than 7%.
- •II) Primary care professionals
- •Inclusion criteria:
- •Aged >18 years old working at the selected PCCs.
- •III) Migrant populations
- •Inclusion criteria:
- •Individuals assigned to a PCC.
- •Patients attending the PCCs for any reason.
- •Aged >15 years old in the Catalonian site.
- •Aged >14 years old in the Andalusian site.
- •Coming from countries in the geographic areas of Africa, Latin-America, Asia and Eastern Europe following the categorization of the United Nations Statistical Commission.
排除标准
- •For the active TB recommendation, migrants residing in the host country for more than five years.
- •For FGM recommendation, being a male.
研究组 & 干预措施
Primary care centres with the ISMiHealth software tool.
Primary care centres implementing the screening programme through the ISMiHealth software (tool-based arm).
干预措施: Clinical decision support system for screening of migrants using the ISMiHealth software tool. (Other)
Primary care centres that follow current routine care.
Primary care centres that follow the current practices in routine care (non tool-based arm).
结局指标
主要结局
Comparison of the detection rate per month of all aggregated infections (HIV, HBV, HCV, TB, T.cruzi, S.stercoralis and Schistosoma spp. infections) between the intervention and control centres
时间窗: Over at least 5 years until the end of the intervention (1 year).
In the Andalusian site, syphilis, latent TB and intestinal parasites will also be included. The monthly detection rate will be based on positive serologies, chest radiographies, the ICD-9 (for Andalusia) or ICD-10 (for Catalonia) of FGM and/or gynaecologist referrals, within the migrant patients who visited their assigned centre during the intervention period. Also, positive tuberculin skin test (TST) and/or Interferon Gamma Release Assay (IGRA) and stool samples will be considered for the Andalusian site. Control and intervention PCCs will be compared before and after the implementation.
次要结局
- Number of diagnosed individuals with follow-up visits in the hospital of reference(Through study completion, 1 year.)
- Comparison of the detection rate per month of each individual condition, the infections and FGM cases, between the intervention and control centres(Over at least 5 years until the end of the intervention (1 year).)
- Associations between the screening performance of all aggregated infections (yes/no) and patients' sex (female/male) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of all aggregated infections (yes/no) and patients' immunosuppression status (yes/no) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of each individual condition (yes/no), including FGM, and patients' sex (female/male) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of each individual condition (yes/no), including FGM, and the type of region where the PCC is located in Catalonia, Spain (urban/rural) will be analysed using the data collected in the SISAP database(Through study completion, 1 year.)
- Associations between the screening performance of all aggregated infections (yes/no) and patients' age (in years) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of all aggregated infections (yes/no) and the time that patients have been registered in the Spanish National Health System (in years) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of each individual condition (yes/no), including FGM, and patients' area of birth (Africa/Latin America/Asia/Eastern Europe) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Number of diagnosed individuals under treatment(Through study completion, 1 year.)
- Comparison of the number of early HBV and HCV diagnoses(Over at least 5 years until the end of the intervention (1 year).)
- Associations between the screening performance of all aggregated infections (yes/no) and if the patient fulfilled the criteria of the screening recommendation (yes/no) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of all aggregated infections (yes/no) and the arm of the study (Intervention/Control) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of all aggregated infections (yes/no) and the presence of another condition (yes/no) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Comparison of the number of screening tests performed for all aggregated infections(Over at least 5 years until the end of the intervention (1 year).)
- Comparison of the the number of screening tests performed for each individual condition(Over at least 5 years until the end of the intervention (1 year).)
- Associations between the screening performance of all aggregated infections (yes/no) and patients' area of birth (Africa/Latin America/Asia/Eastern Europe) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of each individual condition (yes/no), including FGM, and the time that patients have been registered in the Spanish Health System (in years) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance each individual condition (yes/no), including FGM, and if the patient fulfilled the criteria of the screening recommendation (yes/no) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Comparison of the number of early HIV diagnoses(Over at least 5 years until the end of the intervention (1 year).)
- Associations between the screening performance of all aggregated infections (yes/no) and the region where the PCC is located (Terres de l'Ebre/Lleida/Tarragona/Costa de Ponent) will be analysed using the data collected in the SISAP database(Through study completion, 1 year.)
- Associations between the screening performance of all aggregated infections (yes/no) and the type of region where the PCC is located in Catalonia, Spain (urban/rural) will be analysed using the data collected in the SISAP database(Through study completion, 1 year.)
- Associations between the screening performance of each individual condition (yes/no), including FGM, and patients' age (in years) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of HBV and/or HCV (yes/no) and the levels of bilirubin (mg/dL) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of each individual condition (yes/no), including FGM, and the region where the PCC is located (Terres de l'Ebre/Lleida/Tarragona/Costa de Ponent) will be analysed using data collected in the SISAP database(Through study completion, 1 year.)
- Associations between the screening performance of each individual condition (yes/no), including FGM, and the arm of the study (Intervention/Control) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of each individual condition (yes/no), including FGM, and the presence of another condition (yes/no) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of HIV (yes/no) and the viral load (copies/mL) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of HBV and/or HCV (yes/no) and the levels of transaminases (U/L) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of HBV and/or HCV (yes/no) and the levels of clotting parameters [such as prothrombin (seconds), fibrinogen (mg/dL), among others] will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of HBV and/or HCV (yes/no) and the levels of platelets (U/µL) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of each individual condition (yes/no), including FGM, and patients' immunosuppression status (yes/no) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)
- Associations between the screening performance of HIV (yes/no) and the CD4 cell count (cell/µL) will be analysed using the data collected from the EPR system(Through study completion, 1 year.)