Clinical trial NCT03302572: Effectiveness Brief Information Advanced Directives Primary Care
Official title: Effectiveness of a Brief Information About Advanced Directives in Primary Care: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Care
Advance Directives
Randomized Controlled Trial
Keywords: primary care
advance directives
randomized controlled trial
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
First posted: 2017-10-05
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Interest in or performance of advance directives
timeFrame: In 3 months
Secondary outcomes:
measure: Baseline characteristics of those who perform or are interested in Advanced Directives
timeFrame: In 3 months
measure: Baseline characteristics of those performing Advanced directives in intervention group
timeFrame: In 3 months
measure: Reasons to performance Advanced directives
timeFrame: In 3 months
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Institu Català de la Salut
state: Barcelona
Study officials:
affiliation: Institut Català de la Salut
name: Yolanda Rando
role: PRINCIPAL_INVESTIGATOR
References: