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Effectiveness Brief Information Advanced Directives Primary Care

4 octobre 2017 mis à jour par: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Effectiveness of a Brief Information About Advanced Directives in Primary Care: A Randomized Clinical Trial

The knowledge and completion of advanced directives (ADs) by the population is generally low. Primary care could develop a very important role to inform and assist in the preparation of this document because of its accessibility.

Objective: To evaluate the effectiveness of an oral brief information and a brochure administered in primary care to improve the proportion of ADs records.

Design: Randomized clinical trial. Ambit: 7 offices from a urban health center which serves about 25,000 users older than 18 years.

Material and methods It will be administered randomly triptych and oral brief information about the existence of advance directives for people over 18 to attend the appointment of their family doctor for any reason (intervention group). It will be given the possibility of more extensive information if they wish and collaboration will be offered for the advance directive according to patient preferences. The control group will not receive any information. Follow-up: 3 months. Variables will be: number of people interested in ADs, number of ADs made and demographic data (gender, age, education level, race, comorbidities, religion, testament) in both groups. Statistical analysis: multiple linear regression, Poisson and Cox as response analyzed, with the intervention/control group as the main variable adjusting for potential confounders. Bivariate comparison using Student t test or Mann-Whitney test (continuous variables) and chi-square or Fisher's exact test (categorical variables). 165 subjects were required in the control group and 165 in the intervention group.

Conclusion: positive results of this study will bring out the brief information managed by family physicians increases the number of ADs thus facilitating the right to autonomy of the patient.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Anticipé)

330

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.

Coordonnées de l'étude

Lieux d'étude

  • Espagne
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Espagne, 08905
        • Recrutement
        • Institu Català de la Salut
        • Contact:

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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Patients older than 18 years old who go to their family doctor by appointment.

Exclusion Criteria:

  • - Patients with language barrier
  • Patients younger than 18 years (advanced directives not provided for by law)
  • Patients with altered decision-making ability according to computerized clinical history by coding in health problems or mentioned in a clinical course of computerized medical history : cognitive impairment, dementia, mental retardation diagnosed. Although there are studies on attitudes towards advanced directives of people with early cognitive impairment (Minimental> 18), it was decided to discard because the intervention should be brief. The cited study also concludes that this type of patients prefer to delegate decisions to the family.
  • Patients who come spontaneously to their family doctor.
  • Patients who have already been recruited previously in the study. Patients who may visit by appointment only on more than one occasion will only participate once and subsequent visits for recruitment will be excluded. In addition, there will be no reinforcement of the study intervention in these visits.
  • Patients who have already formalized the advanced directives.
  • Patients who do not wish to participate in the study.

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: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Brief information group
Patients will be given brief information about the existence of advance directives after resolving the reason for the visit for which they had come. This information will not last more than 3 minutes and will not be repeated on successive visits within the recruitment period. Also, an informative triptych will be given to the patient so that he can read it at home. These leaflets have been made by the regional Department of Health. They will be advised that we can extend the information or help them to do the document in the near future if they want, we will inform that we would wait for the answer 3 months. In case of interest, they can leave their information in the User Service by specifying name, telephone number and reference doctor or ask for an appointment again.
Autre: Brief information group
Patients will be given oral brief information about the existence of advance directives after resolving the reason for the visit for which they had come. This information will not last more than 3 minutes and will not be repeated on successive visits within the recruitment period. Also, an informative triptych will be given to the patient so that he can read it at home. These leaflets have been made by the regional Department of Health. They will be advised that we can extend the information or help them to do the document in the near future if they want, we will inform that we would wait for the answer 3 months. In case of interest, they can leave their information in the User Service by specifying name, telephone number and reference doctor or ask for an appointment again.
Aucune intervention: Control group
Patients who fall into a control group will only be attended to their reason for visiting and will be asked for the necessary data to obtain the independent variables if they do not appear in their history. If the patient in this group wants the information, he will be excluded from the study because he "refuses to participate."

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Interest in or performance of advance directives
Délai: In 3 months
Proportion of people interested in or performance of Advance Directives in 3 months in the adult population. They will be obtained at the moment that the patient shows interest in the intervention of when they performance the Advance Directives, or if not, by asking by appointment or by telephone within 3 months of their recruitment
In 3 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Baseline characteristics of those who perform or are interested in Advanced Directives
Délai: In 3 months
Evaluate the baseline characteristics of those who perform or are interested in Advanced Directives (whether they are in the control or intervention group).
In 3 months
Baseline characteristics of those performing Advanced directives in intervention group
Délai: In 3 months
To assess the baseline characteristics of those performing the Advanced Directives and those not within the intervention group
In 3 months
Reasons to performance Advanced directives
Délai: In 3 months
Evaluate the reasons why patients finally formalize the document by open question (will be categorized if there is a limited number of responses, otherwise the reasons will be described qualitatively).
In 3 months

Collaborateurs et enquêteurs

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

Parrainer

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Les enquêteurs

  • Chercheur principal: Yolanda Rando, Institut Català de la Salut

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 (Réel)

3 novembre 2016

Achèvement primaire (Anticipé)

31 mars 2018

Achèvement de l'étude (Anticipé)

31 mars 2018

Dates d'inscription aux études

Première soumission

18 septembre 2017

Première soumission répondant aux critères de contrôle qualité

4 octobre 2017

Première publication (Réel)

5 octobre 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 octobre 2017

Dernière mise à jour soumise répondant aux critères de contrôle qualité

4 octobre 2017

Dernière vérification

1 septembre 2017

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • 15/101

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

For confidentiality

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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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