Effectiveness Brief Information Advanced Directives Primary Care

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.

Study Overview

• Status: Unknown
• Conditions: Randomized Controlled Trial; Primary Care; Advance Directives
• Intervention / Treatment: Other: Brief information group

• Study Type: Interventional
• Enrollment (Anticipated): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08905
      • Recruiting
      • Institu Català de la Salut
      • Contact: Yolanda Rando; Phone Number: +34616678030; Email: yolanrando@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
No 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."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	In 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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	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).	In 3 months

Collaborators and Investigators

• Sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
• Investigators: Principal Investigator: Yolanda Rando, Institut Català de la Salut

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2016
• Primary Completion (Anticipated): March 31, 2018
• Study Completion (Anticipated): March 31, 2018

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 4, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: randomized controlled trial; primary care; advance directives
• Other Study ID Numbers: 15/101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: For confidentiality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No