Palliative CareNCT03913390
Decision Making With Bioethical Perspective in Palliative Care en Mexico
An observational study of Palliative Care, run by University of Guadalajara at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Palliative Care
- How many people
- 72 participants
- Where
- 1 siteMexico
- Study dates
- 12 Apr 2019to 5 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older 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.
Who may be able to join
- 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:
Show all 11Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Descriptive Study on Decision Making With a Bioethical Perspective in Some Cities of Mexico
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.
Read more
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.
Read the 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.
- Conditions
- Palliative Care
- Keywords
- Guideline, Decision Making, Bioethics, Palliative Care, Terminal Care
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative results
Demographic data, Bioethics training, Experience with clinical situations with bioethical implication.
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start12 Apr 2019
- Primary completion20 Aug 2019
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosa Margarita Alvarez Alvarez, University of Guadalajara
- Investigators
- Rodrigo Ramos-Zuñiga, MD PhD, Study director, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913390
- Sponsor's protocol ID
- 218901374
- Status last verified
- Dec 2020
- First submitted
- 7 Apr 2019
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptive Study on Decision Making With a Bioethical Perspective in Some Cities of Mexico
- ClinicalTrials.gov ID
- NCT03913390
- Acronym / sponsor ID
- 218901374
- Conditions
- Palliative Care
- Keywords
- Guideline, Decision Making, Bioethics, Palliative Care, Terminal Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of GuadalajaraUniversity, hospital or other
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (11 listed)
- Agree to participate in the study.
- Health personnel engaged in palliative care
- Work in the public and/or private sector.
- Incomplete survey.
- The participants who answered questions 19 and 20 of the survey sent by Google Forms were chosen.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quantitative results
Time frame: 1 year
Demographic data, Bioethics training, Experience with clinical situations with bioethical implication.
Qualitative results
Time frame: 1 year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo Ramos-Zuñiga, MD PhD study director
University of Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Palliative Care, run by University of Guadalajara at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative results (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2020.