Decision Making With Bioethical Perspective in Palliative... | NCT03913390

Studies
Decision Making With Bioethical Perspective in Palliative Care en Mexico

NCT03913390

Sponsor

University of Guadalajara

Status

Completed

Last Update Posted

Dec 11, 2020Actual

Enrollment

72Actual

Phase

Not provided

Conditions

Palliative Care

Interventions

Not provided

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 12, 2019Actual

Primary Completion Date

Aug 20, 2019Actual

Completion Date

Nov 5, 2020Actual

First Submitted Date

Apr 7, 2019

First Submission Date that Met QC Criteria

Apr 9, 2019

First Posted Date

Apr 12, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2020

Last Update Posted Date

Dec 11, 2020Actual

Description Module

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.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample