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.
研究概览
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Barcelona
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L'Hospitalet de Llobregat、Barcelona、西班牙、08905
- 招聘中
- Institu Català de la Salut
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接触：
- Yolanda Rando
- 电话号码：+34616678030
- 邮箱：yolanrando@gmail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
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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.
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无干预：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."
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Interest in or performance of advance directives
大体时间：In 3 months
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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
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In 3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Baseline characteristics of those who perform or are interested in Advanced Directives
大体时间：In 3 months
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Evaluate the baseline characteristics of those who perform or are interested in Advanced Directives (whether they are in the control or intervention group).
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In 3 months
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Baseline characteristics of those performing Advanced directives in intervention group
大体时间：In 3 months
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To assess the baseline characteristics of those performing the Advanced Directives and those not within the intervention group
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In 3 months
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Reasons to performance Advanced directives
大体时间：In 3 months
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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).
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In 3 months
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合作者和调查者
调查人员
- 首席研究员：Yolanda Rando、Institut Català de la Salut
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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