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Effectiveness of the "7H" Intervention to Reduce Frequent Attendance in Primary Care ("7H")

26 mars 2015 mis à jour par: Juan Ángel Bellón Saameño, The Mediterranean Institute for the Advance of Biotechnology and Health Research

Effectiveness of the "7H" Intervention to Reduce Frequent Attendance in Primary Care: Cluster Randomised Controlled Trial. The "7H" Study

The main objective is to measure the effectiveness of a new intervention to decrease use of services of primary care frequent attenders (FA).Among the secondary objectives are to evaluate the cost-effectiveness and cost utility of the new intervention compared with usual care.

METHODS: There will be a randomized controlled trial with cluster assignment. It will take place in the field of primary care in the city of Malaga.It will be evaluated a new multicomponent intervention called "7H" (7 Hypothesis). This intervention will be applied on the FA by their family doctors in the intervention group. In the control group will be developed usual cares.

The main outcome is the total of visits of FA at 12 months of the follow-up. The secondary outcomes include changes happened in biopsychosocial health, satisfaction, and quality of life measurements. The investigators will assess the dependent and independents (from FA, general practitioner [GP] and health centres) variables at baseline, and 12 months. At baseline it will be include a random sample of 450 FA (225 for each arm), belonging to 30 family doctors of 10 health centres. It will be performed linear regression multilevel models with 4 levels (time, patient, doctor and health centre) to evaluate the effectiveness of the intervention. . Moreover will be undertaken multivariate gamma and quantile regressions to assess the cost-effectiveness and cost-utility respectively of the new intervention versus usual cares, estimating their standard errors by bootstrap calculations.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

The "7H" intervention

  1. Hypothesis generation: analysis of available informationGPs analyze all the available information about possible reasons for frequent attendance from clinical charts using a standardized questionnaire designed to facilitate analysis of this information. This questionnaire prompts analysis of the following: (1) category of visits and their frequencies; (2) type of frequent attender according to the first point; (3) family and personal history, and biopsychosocial problem list that needed follow-up; (4) searching for common factors for frequent attendance from the previous points; (5) feelings and thoughts questionnaires, 'In most interviews with this patient I think ...' (11 items), 'I feel ...' (13 items); (6) rethinking issues of GP capacity (and processes) to resolve the frequent attendance in this patient; and (7) analyzing the different professionals who intervened in patient care and their contribution to resolving or continuing frequent attendance.Finally, GPs indicate the type of hypothesis from a list of seven that they believe made the patient a frequent attender: biological, psychological, social, family, cultural, administrative-organizational, or related to the doctor-patient relationship.
  2. Hypothesis confirmation: the decision to accept or refute each hypothesis is based on the GP's interpretation of the data (cognitive component) and the self-perception about feeling sure (emotional component). When necessary, the GPs can try out the hypothesis with one or more of the following strategies: another interview with the patient,biological and psychosocial tests, and/or asking for the opinion of other professionals.
  3. Planning: the GP makes plans for each frequent attender based on the confirmed hypothesis and available resources. There are many possible plans, examples of which include: making longer intervals between medical revisits for stable chronic patients, and asking for collaboration with nurses; looking for possible causes of the unstable physical chronic illness and intervening accordingly; scheduling an interview to search for a psychological, family or/and, social diagnosis; suppressing unnecessary face-to-face medical revisits for repeat prescriptions in stable chronic patients, and asking the health centre administrative staff for collaboration; asking the social worker at the health centre for help; referring to community resources if necessary; and being more realistic about the type of doctor-patient relationship expected. These plans are then commented on at the group meeting, after which the GP negotiates the plan with the frequent attender. The GP should never suggest to the patient: 'You have to attend less frequently'. This would be too aggressive and the patient might react with anger or guilt. It is better to offer a search for solutions to the patient's health problem from both points of view.

Type d'étude

Interventionnel

Inscription (Réel)

527

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

      • Málaga, Espagne, 29009
        • Servicio Andaluz de Salud. Distrito Sanitario Málaga

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

14 ans et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Frequent Attenders: 90th percentile of number of visits of the previous year, stratified by age and sex.

Exclusion Criteria:

  • < 14 years.
  • Unable to understand or speak Spanish.
  • Cognitive impairment.
  • Terminal illness.
  • Planning to be outside of the the city 3 or more months during the next 12 months.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune intervention: Soins habituels
Expérimental: New multicomponent intervention
The GPs in the intervention group will undertake an interactive workshop training session (15 hours) on the '7 hypotheses' (7H) intervention. In short, this intervention encourages GPs to select from a list of seven possible hypotheses for why the patient is a frequent attender: biological, psychological, social, family, cultural, administrative-organisational, or related to the doctor-patient relationship.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Délai
Effectiveness of the intervention "7H"
Délai: 12 months
12 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Cost-effectiveness and cost-utility
Délai: 12 months
To evaluate the cost-effectiveness and cost-utility of the intervention "7H" versus usual care.
12 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 janvier 2010

Achèvement primaire (Réel)

1 février 2013

Achèvement de l'étude (Réel)

1 juin 2013

Dates d'inscription aux études

Première soumission

28 juin 2010

Première soumission répondant aux critères de contrôle qualité

28 juin 2010

Première publication (Estimation)

29 juin 2010

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

27 mars 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

26 mars 2015

Dernière vérification

1 mars 2015

Plus d'information

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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