- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02212171
TRIAP: Is Triage by Healthcare Mini-teams Effective to Improve Efficiency in Primary Health Care? (TRIAP)
Background: With new challenges for healthcare, there is a clear consensus among experts on the need to introduce changes in the organization of care in health centres to address the problems of over-attendance, bureaucratization and other emerging issues that require growing amounts of attention. However, there has been insufficient research into possible models and the impact of their adoption.
The objective is to assess the feasibility and effectiveness of the TRIAP intervention, a new organizational model based on triage and healthcare mini-teams (two general practitioners/pediatricians, two nurses and one member of the administrative staff) compared to the current model, aiming to achieve a correct classification of the healthcare needs of the primary care population and direct them to the most suitable professional.
In addition, the implementation research objective is to identify the facilitators for and barriers to the implementation of the intervention in the context of primary care.
Methods/ design: This is a quasi-experimental controlled clinical trial to be performed in 14 healthcare mini-teams (7 intervention and 7 control groups) from 8 health centres in the Basque Healthcare Service (Osakidetza) Interior Health Region.
The results will be assessed using the data on morbidity-adjusted attendance of users to their family doctor, number of referral, addition of new activities to the portfolio of services, and patient perception and professional satisfaction. All the variables will be measured at baseline and at the end of the intervention, 24 months later.
Using covariance analysis models, the investigators will estimate the effect attributable to the intervention by analyzing differences in changes between the two groups, and calculating the 95% confidence interval, adjusting the comparisons for baseline values. The investigators will also adjust for potential confounding and effect-modifying variables.
Nominal groups will be held at the end of the intervention with the participation of all the agents involved in intervention centres to identify the facilitators for and barriers to the implementation of the intervention.
Discussion: There is a need to develop new forms of organization in primary care services to respond to new healthcare demands. To pursue this aim, changes have to be introduced in the organization of healthcare within health centres, redefining the roles of primary care professionals and refocusing their activity towards population health needs, seeking greater efficiency in health services.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
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Vitoria, Espagne
- Basque Healthcare Service
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- The study populations are patients of the seven mini-teams established, these professionals being responsible for the GP lists in the health centres of San Miguel in Basauri, Miraballes and Ondarroa, and the paediatric list in Etxebarri health centre. The control units are from the health centres of Basauri-Ariz, Arratia, Amorebieta and Bermeo, all located in the Interior Health Region.
Exclusion Criteria:
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Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: TRIAP intervention
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The primary healthcare professionals organised in healthcare mini-teams, composed of 2 doctors, 2 nurses and 1 member of the administrative staff.
They will develop the new portfolio of services: health promotion, joint review of patient medical records by doctors and nurses to improve the management of certain groups of patients, and organization of minor surgery services, etc. |
Aucune intervention: Usual care
Usual care: Patients in the control group will be treated according to Osakidetza recommendations.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Patients attendance
Délai: Baseline and at 24 months
|
Number of visits of the patients to their GP and paediatricians in accordance to the Adjusted Clinical Groups [ACG] Case-Mix System. The patients will be classified using the ACG system, on the basis of their age, sex and ICD-9-CM codes of health problems diagnosed over a year in visits to their GP/paediatrician. The ACG case-mix system was designed by researchers at Johns Hopkins University, originally for care on an outpatient basis, and classifies the population into around 100 self-excluding categories. Regardless of the number of contacts with the healthcare services, each person is classified every year into a single ACG depending on their age, sex, and combination of diagnoses they were assigned over the previous 12 months. For this study, we will use the ACG Assignment Software version 7.00. All the tasks performed will be recorded in the Osabide computer system of the Basque Health Service. |
Baseline and at 24 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Patients referral: number of patient referrals by GPs and paediatricians in accordance to the Adjusted Clinical Groups [ACG] Case-Mix System.
Délai: Baseline and at 24 months
|
Baseline and at 24 months
|
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New activities added to the current portfolio of services
Délai: Baseline and at 24 months
|
Number of programmed activities of health promotion, joint review of medical records by the doctors and nurses to improve the management of certain groups of patients, minor surgery services in PC, activities for achieving a comprehensive approach to managing non-surgical osteomuscular disorders and the use of ultrasound scans.
|
Baseline and at 24 months
|
Patient satisfaction
Délai: Baseline and at 24 months
|
Measured using the Primary Care Assessment Tool (PCAT) Pasarín MI et al.
Evaluation of primary care: The "Primary Care Assessment Tools - Facility version" for the Spanish health system.
Gac Sanit.
2013 Jan-Feb;27(1):12-8.
|
Baseline and at 24 months
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Satisfaction of health professionals
Délai: Baseline and at 24 months
|
In terms of professional quality of life measured using the Professional Quality of Life questionnaire (PQL-35). Cabezas, C. La calidad de vida de los profesionales. FMC. 2000;7 (Supl 7):53-68. |
Baseline and at 24 months
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- TRIAP
- 2011111131 (Autre subvention/numéro de financement: Basque Health Goverment)
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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Essais cliniques sur Organization of Health Service
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Queens College, The City University of New YorkRecrutementPublication d'articles soumis à l'American Journal of Public HealthÉtats-Unis