NCT03913390

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

April 12, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2020

Completed
Last Updated

December 11, 2020

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

April 7, 2019

Last Update Submit

December 8, 2020

Conditions

Keywords

GuidelineDecision MakingBioethicsPalliative CareTerminal Care

Outcome Measures

Primary Outcomes (2)

  • Quantitative results

    Demographic data, Bioethics training, Experience with clinical situations with bioethical implication.

    1 year

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Quantitative sampling: Non-probabilistic sampling for convenience, of an open nature. Aimed at a specific professional profile according to the theme, the study identified the characteristics of decision-making of the health personnel working in the context of palliative care in different cities of Mexico, the result was not considered generalizable. The Statistical Package for the Social Sciences 21® (SPSS) software was used for statistical analysis. Qualitative sampling: A sampling called critical case was followed, according to which cases are chosen based on characteristics that can provide different perspectives on the phenomenon, this choice was based on the profession of the participant, the years of seniority in palliative care and that the cases reflected a bioethical conflict or dilemma. Qualitative Data Analysis Atlas Ti version 6.0® software was used for statistical analysis.

You may qualify if:

  • Agree to participate in the study.
  • Health personnel engaged in palliative care
  • Work in the public and/or private sector.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rosa Margarita Alvarez Alvarez

Zapopan, Jalisco, 45170, Mexico

Location

Study Officials

  • Rodrigo Ramos-Zuñiga, MD PhD

    University of Guadalajara

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 7, 2019

First Posted

April 12, 2019

Study Start

April 12, 2019

Primary Completion

August 20, 2019

Study Completion

November 5, 2020

Last Updated

December 11, 2020

Record last verified: 2020-12

Locations