Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Impact of Ethical/Bioethical Recommendations in Decision-making in Palliative Care in Mexico

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03913390
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Rosa Margarita Alvarez Alvarez, University of Guadalajara

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 assess the impact of knowledge of ethical / bioethical recommendations in decision making with ethical / bioethical involvement in palliative care in Mexico.

  • Diagnose the current situation in decision making with ethical / bioethical involvement in palliative care in Mexico.
  • Identify if the personnel dedicated to palliative care know guidelines or recommendations related to the 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.
  • Analyze the strategies used by professionals that result in an improvement in the quality (impact) of decision making in palliative care.

Condition or disease
Palliative Care

Detailed Description:
Descriptive, prospective, through surveys, with quantitative and qualitative analysis. The questionnaire proposal is elaborated, which was designed by the authors, based partially on the literature. This questionnaire was sent to palliative care experts for validation. The questionnaire will be sent through google forms (www.google.com/forms) to health personnel who work in palliative care such as doctors, nurses, social workers and psychologists in Mexico. It consists of 20 questions with four conceptual categories, demographic data, professional training, ethics / bioethics training and experience with clinical situations involving ethics / bioethics. The questionnaire will focus on the analysis they carry out to make decisions that they consider to have ethical / bioethical implications. The form will be sent up to 2 times to the selected group of health professionals

Layout table for study information
Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Impact of Ethical/Bioethical Recommendations in Decision-making in Palliative Care in Mexico
Actual Study Start Date : April 12, 2019
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care




Primary Outcome Measures :
  1. Number of Participants who responds questionnaire [ Time Frame: Baseline ]
    Percentage

  2. Frequency of situations with implications ethical or bioethical for decision making in palliative care [ Time Frame: Baseline ]

    Experiences in clinical situations in palliative care with ethic/bioethics implications.

    Likert scale: Never- almost never- sometimes- almost every day - every day


  3. Training in ethics or bioethics [ Time Frame: Baseline ]

    Previous training in ethics or bioethics

    • Course: %
    • Seminar: %
    • Diplomate: %
    • Other: %



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Health workers in palliative cares services (home based, hospital setting and primary care) in Mexico, like doctors, nurses, psychologist and social workers.
Criteria

Inclusion Criteria:

  • Health workers in palliative care (nurses, doctors, psychologists, social workers)

Exclusion Criteria:

  • Incomplete survey

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913390


Contacts
Layout table for location contacts
Contact: Rosa Margarita A Alvarez, MD 013314403942 alvarezrosamargarita@gmail.com
Contact: Rodrigo Ramos-Zuñiga, MD PhD 52 1058-5200 ext 33675 rodrigorz13@gmail.com

Locations
Layout table for location information
Mexico
Rosa Margarita Alvarez Alvarez Recruiting
Zapopan, Jalissco, Mexico, 45170
Contact: Rosa Margarita A Alvarez Alvarez, MD    52 33 1440 3942    alvarezrosamargarita@gmail.com   
Contact: Rodrigo Ramos-Zuñiga, MD PhD    52 33 1058 5200 ext 33675    rodrigorz13@gmail.com   
Sponsors and Collaborators
University of Guadalajara

Layout table for additonal information
Responsible Party: Rosa Margarita Alvarez Alvarez, Principal investigator, University of Guadalajara
ClinicalTrials.gov Identifier: NCT03913390    
Other Study ID Numbers: 218901374
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rosa Margarita Alvarez Alvarez, University of Guadalajara:
guidelines
decision making
bioethics
palliative care
end of life