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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03913390
Other study ID # 218901374
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 12, 2019
Est. completion date November 5, 2020

Study information

Verified date December 2020
Source University of Guadalajara
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

All clinical practice includes decision making, and sometimes you are ethically challenging because of the consequences it will bring to the patient, the health professional or society in general. Ethics seeks the best solution to a better treatment and seeks to increase the quality of life of the patient with correct decision making. Ethical / bioethical considerations are of a generic nature, and do not apply to specific situations. Therefore, it is suggested that there should be guidelines or recommendations in the field of palliative care in Mexico that may be an adjunct to decision making. The relevance of knowledge, application and management of ethical / bioethical recommendations is unknown as part of decision-making by professionals dedicated to palliative care in our country, taking into consideration the principles of autonomy, beneficence, non-malfeasance and Justice. It is necessary to consider the participation of patients, caregivers and health personnel in this decision making process of decisions. This study intends to identify the current situation of this issue in Mexico. To analyze the characteristics of decision-making with bioethical involvement in palliative care in a representative sample of care professionals in some regions of the country. Quantitative method: - Describe the current situation in decision-making with bioethical involvement in palliative care. - Identify if the personnel dedicated to palliative care know guidelines or recommendations related to decision-making in palliative care and the current legal framework. - Know the strategies that palliative care personnel follow in situations in which the decision to make is difficult or problematic. Qualitative method: - Know the particular situations that signify a conflict or situation with bioethical implications for health professionals in palliative care. - Analyze the variables that influence decision-making around the application of bioethics in palliative care.


Description:

Mixed study, for the quantitative part, it was prospective, descriptive, and cross-sectional investigation; on the qualitative part it was a case study. A sample of 72 health professionals was considered for the quantitative part and 8 for the qualitative part. The sampling strategy was for convenience. Data collection was achieved through a semi-structured survey applied in a virtual environment with the Google Forms platform. The quantitative data analysis was with descriptive measures of central tendency using the Statistical Package for the Social Sciences 21® (SPSS) software, and the qualitative ones with thematic content analysis techinique through the Qualitative Data Analysis Atlas Ti version 6.0® software. Informed consent was obtained from the participants for the use of the data.


Recruitment information / eligibility

Status Completed
Enrollment 72
Est. completion date November 5, 2020
Est. primary completion date August 20, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion criteria for the quantitative sample: - Agree to participate in the study. - Health personnel engaged in palliative care - Work in the public and/or private sector. Non- inclusion criteria: - Incomplete survey. Elegibility criteria for the qualitative sample: - The participants who answered questions 19 and 20 of the survey sent by Google Forms were chosen. - Of these, the profession of origin was identified to select those that belonged to professions that are from the disciplines that make up the multidisciplinary teams in palliative care, additionally; The time of work experience in this area was considered, they were included with more than 10 years of experience and less than 10. - Likewise, the variability of cases and those that reflected an ethical conflict were looked for. Ineligibility criteria for the qualitative sample: - Those cases where similar situations or scenarios were described were discarded.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Mexico Rosa Margarita Alvarez Alvarez Zapopan Jalisco

Sponsors (1)

Lead Sponsor Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quantitative results Demographic data, Bioethics training, Experience with clinical situations with bioethical implication. 1 year
Primary Qualitative results The last two questions with a qualitative approach, the objective is to obtain a broader view of the characteristics of decision-making, considering that palliative care by definition is an approach to care from different disciplines 1 year
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