An interventional study of Brief information group in Primary Care, Advance Directives and Randomized Controlled Trial, sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-05.
Sponsored by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
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.
Other: Brief information 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."
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.
Interest in or performance of advance directives
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
Time frame: In 3 months
Baseline characteristics of those who perform or are interested in Advanced Directives
Evaluate the baseline characteristics of those who perform or are interested in Advanced Directives (whether they are in the control or intervention group).
Time frame: In 3 months
Baseline characteristics of those performing Advanced directives in intervention group
To assess the baseline characteristics of those performing the Advanced Directives and those not within the intervention group
Time frame: In 3 months
Reasons to performance Advanced directives
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).
Time frame: In 3 months
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Plan to share: No — For confidentiality
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina