scholarly journals INFORMED CONSENT IN CLINICAL TRIALS FOR PERSONS WITH DEMENTIA

2019 ◽  
Vol 3 (Supplement_1) ◽  
pp. S28-S28 ◽  
Author(s):  
Joan G Carpenter
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Nursing Homes ◽  
Decision Maker ◽  
Surrogate Decision Maker ◽  
Decision Making Capacity ◽  
Consent Document ◽  
Surrogate Decision

Abstract Informed consent is one of the most important processes during the implementation of a clinical trial; special attention must be given to meeting the needs of persons with dementia in nursing homes who have impaired decision making capacity. We overcame several challenges during enrollment and consent of potential participants in a pilot clinical trial including: (1) the consent document was designed for legally authorized representatives however some potential participants were capable of making their own decisions; (2) the written document was lengthy yet all seven pages were required by the IRB; (3) the required legal wording was difficult to understand and deterred potential participants; and (4) the primary mode of communication was via phone. We tailored assent and informed consent procedures to persons with dementia and their legally authorized representative/surrogate decision maker to avoid risking an incomplete trial and to improve generalizability of trial results to all persons with dementia.

Advance Care Planning and Surrogate Decision-Making (DRAFT)

2018 ◽  
Author(s):  
Robert C. Macauley
Keyword(s):  
Decision Making ◽  
Decision Maker ◽  
Patient Autonomy ◽  
Best Interests ◽  
Evidence Based ◽  
Surrogate Decision Maker ◽  
Substituted Judgment ◽  
Decision Making Capacity ◽  
Advance Care ◽  
Surrogate Decision

Adult patients are presumed to possess decision-making capacity, but when they are unable to make their own decisions—which is especially frequent in the context of serious illness—ideally a surrogate decision-maker will be able to determine what the patient would have wanted (i.e., substituted judgment). Only when this is not possible is it necessary to fall back on what seems to be in the patient’s best interests. To foster patient autonomy, goals and values should be identified and documented in advance, such as in an advance directive, as well as a surrogate decision-maker named. This helps guide the medical team in critical and often uncertain times, given the challenges in accurate prognostication (which are lessening with the advent of evidence-based tools).

Increasing Health Literacy to Improve Clinical Trial Recruitment

2018 ◽  
pp. 94-108
Author(s):  
Saliha Akhtar
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Health Literacy ◽  
Trial Recruitment ◽  
Negative Perception ◽  
Consent Forms ◽  
Clinical Trial Recruitment ◽  
And Training

Health literacy has been found to be linked to healthcare understanding and decision making. Therefore, it makes sense why individuals who do not understand clinical trials will be less likely to want to enroll in one. In fact, three major barriers found in the literature that prevent potential participants from enrolling in clinical trials include a distrust or negative perception, lack of understanding, and lack of accessible and affordable healthcare. Hence, there is a need to increase potential participants' healthcare understanding so that they can make the best healthcare decisions for themselves. Strategies suggested to help increase potential participants' health literacy include revising informed consent forms, utilizing culturally targeted statements, using a variety of material, and training investigative site personnel. These proposed strategies may help increase health literacy, which in turn could improve clinical trial recruitment. Furthermore, these strategies focus on different elements of health literacy and coupled together may bring the most improvement.

scholarly journals POLST Signature Requirements: Responding With Compassion While Ensuring Informed Consent

2020 ◽  
pp. 104990912095308
Author(s):  
Robert Macauley ◽  
Susan Tolle
Keyword(s):  
Health Care ◽  
Informed Consent ◽  
Decision Maker ◽  
Health Care Professional ◽  
Patient Autonomy ◽  
Necessary Condition ◽  
Surrogate Decision Maker ◽  
Decisional Capacity ◽  
Spiritual Distress ◽  
Surrogate Decision

The majority of states require the signature of a surrogate decision maker on a POLST form for a patient who lacks decisional capacity. While commendable in its intention to ensure informed consent, in some cases this may lead the surrogate to feel that they are signing their loved one’s “death warrant,” adding to their emotional and spiritual distress. In this paper we argue that such a signature should be recommended rather than required, as it is neither a sufficient nor necessary condition of informed consent. Additional steps—such as requiring the attestation and documentation of the signing health care professional that verbal consent was fully informed and voluntary—can achieve the ultimate goal of respecting patient autonomy without adding to the surrogate’s burden.

Entering a Clinical Trial: Is It Right For You?–A randomized study of the Clinical Trials Video and its impact on the informed consent process

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9072-9072
Author(s):  
S. Hitchcock-Bryan ◽  
B. Hoffner ◽  
S. Joffe ◽  
M. Powell ◽  
C. Parker ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Randomized Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Provider Communication ◽  
Patient Provider Communication ◽  
Source Of Information

9072 Background: In an effort to improve the informed consent process for subjects considering participation in a clinical trial, we created an educational video: “Entering a Clinical Trial: Is it Right for You?” In this randomized study, we assessed the effect of the video on patients’ understanding and perceptions of clinical trials. We also assessed patient satisfaction with the video and how the video impacted decision-making and patient-provider communication. Methods: We recruited 90 adults considering cancer clinical trials of whom 77 participated. After discussing the trial with the physician and reading the trial consent form, patients were randomized to receive (n=38) or not receive (n=39) the study video. Using a validated questionnaire, we interviewed subjects to assess objective understanding of the trial, our primary endpoint, and self-reported understanding of clinical trials. All subjects completed a second interview assessing secondary endpoints, including patient-provider communication, satisfaction with video, and decision-making. We used linear regression (two-sided tests) to conduct the primary analysis and the Wilcoxon rank-sum test and descriptive statistics to analyze the secondary aims. Results: Neither objective nor self-reported understanding of clinical trials differed between the two groups (Mean 86.5 vs. 87, p=0.75). 85% (61/72) indicated the video was an important source of information about clinical trials; 89% of those who watched the video with their family/friends (n=37) said the video helped loved ones better understand clinical trials; 73% indicated it helped their family accept their decision about participation. 81% (58/72) felt better prepared to discuss the trial with their physician after watching the video. Of those who found the video helpful with decision- making, 80% (21/26) were considering a trial for the first time compared with 19% (5/26) veterans who had previously participated in a clinical trial. Conclusions: The video did not measurably improve subjects’ understanding of their clinical trials. However, subjects reported that the video was an important source of information, helped them educate their families, and enhanced patient-provider communication. No significant financial relationships to disclose.

Ethics

Oncology ◽  
2017 ◽  
pp. 728-738
Author(s):  
Natalia S. Ivascu ◽  
Sheida Tabaie ◽  
Ellen C. Meltzer
Keyword(s):  
Decision Making ◽  
Critical Care ◽  
Informed Consent ◽  
Ethical Issues ◽  
Surrogate Decision Making ◽  
Ethical Problems ◽  
Decision Making Capacity ◽  
Surgical Critical Care ◽  
Surrogate Decision ◽  
Special Circumstances

In all areas of medicine physicians are confronted with a myriad ethical problems. It is important that intensivists are well versed on ethical issues that commonly arise in the critical care setting. This chapter will serve to provide a review of common topics, including informed consent, decision-making capacity, and surrogate decision-making. It will also highlight special circumstances related to cardiac surgical critical care, including ethical concerns associated with emerging technologies in cardiac care.

scholarly journals Lay persons’ perception of the requirements for research in emergency obstetric and newborn care

2020 ◽  
Author(s):  
Daniel Kabonge Kaye
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Newborn Care ◽  
Obstetric Complications ◽  
Trial Participation ◽  
Related Information ◽  
Lay Persons ◽  
Newborn Complications

Abstract Background: Factors that could potentially act as facilitators and barriers to successful recruitment strategies in perinatal clinical trials are not well documented. The objective was to assess lay persons’ understanding of the informed consent for randomized clinical trial in emergency obstetric and newborn care.Methods: This was a qualitative study conducted among survivors of severe obstetric complications who were attending the post-natal clinic of Kawempe National Referral Hospital, Uganda, 6-8 weeks after surviving severe obstetric complications during pregnancy or childbirth. The study that involved 18 in-depth interviews was conducted from June 1, 2019 to July 6, 2019. The issues explored included perceptions of the purpose and necessity to conduct such research how research-related information would be disclosed, and what could be the potential benefits and risks of participation. The data was analyzed by thematic analysis.Results: Respondents felt that research was necessary to investigate the cause, prevention or complications of an illness, especially as much was known about some pregnancy and newborn complications. Most believed that the emergency contexts affects whether and what prospective participants may understand if information about research was disclosed. Whereas they did not see the value of procedures like randomization, they felt that if these and any other procedures necessary should be done transparently and fairly. The decisions to participate would significantly be influenced by possibility of risk to the unborn baby or the newborn. Solidarity was an important influence on decision-making.Conclusions: Respondents valued participation in RCTs in emergency obstetric and newborn care. However, they expressed concerns and valued openness, transparency and accountability with regard to how clinical trials information is disclosed and the decision-making process for clinical trial participation. While autonomy and solidarity are contradictory values, they complement each other during decision-making for informed consent.

Ethics

2017 ◽  
pp. 1-11
Author(s):  
Natalia S. Ivascu ◽  
Sheida Tabaie ◽  
Ellen C. Meltzer
Keyword(s):  
Decision Making ◽  
Critical Care ◽  
Informed Consent ◽  
Ethical Issues ◽  
Surrogate Decision Making ◽  
Ethical Problems ◽  
Decision Making Capacity ◽  
Surgical Critical Care ◽  
Surrogate Decision ◽  
Special Circumstances

In all areas of medicine physicians are confronted with a myriad ethical problems. It is important that intensivists are well versed on ethical issues that commonly arise in the critical care setting. This chapter will serve to provide a review of common topics, including informed consent, decision-making capacity, and surrogate decision-making. It will also highlight special circumstances related to cardiac surgical critical care, including ethical concerns associated with emerging technologies in cardiac care.

Ethics

2015 ◽  
pp. 124-134
Author(s):  
Natalia S. Ivascu ◽  
Sheida Tabaie ◽  
Ellen C. Meltzer
Keyword(s):  
Decision Making ◽  
Critical Care ◽  
Informed Consent ◽  
Ethical Issues ◽  
Surrogate Decision Making ◽  
Ethical Problems ◽  
Decision Making Capacity ◽  
Surgical Critical Care ◽  
Surrogate Decision ◽  
Special Circumstances

In all areas of medicine physicians are confronted with a myriad ethical problems. It is important that intensivists are well versed on ethical issues that commonly arise in the critical care setting. This chapter will serve to provide a review of common topics, including informed consent, decision-making capacity, and surrogate decision-making. It will also highlight special circumstances related to cardiac surgical critical care, including ethical concerns associated with emerging technologies in cardiac care.

Autism and Advance Directives: Determining Capability and the Use of Health-Care Tools to Aid in Effective Communication and Decision-Making

2019 ◽  
Vol 37 (5) ◽  
pp. 354-363
Author(s):  
Valerie Satkoske ◽  
Joann M. Migyanka ◽  
David Kappel
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Decision Maker ◽  
Advance Directives ◽  
Health Care Providers ◽  
Surrogate Decision Maker ◽  
Care Providers ◽  
Surrogate Decision ◽  
End Of Life Decision ◽  
Life Decision

With the growing number of individuals with Autism Spectrum Disorder (ASD) reaching the age of consent, health-care providers must be prepared to bridge gaps in their knowledge of ASD. This is especially true for clinicians who may have to determine if a person with ASD has the capacity to engage in end-of-life decision making, complete advance directives, or act as a surrogate decision maker for someone else. This paper provides an overview of the unique characteristics of autism as related to the communication, cognitive processing, and the capability to participate in advance care planning and, when acting as a surrogate decision maker, to consider the values and preferences of others. In addition, we examine the roles and responsibilities of clinician as facilitator of shared health-care decision making communication with the individual who has autism. Consideration is given to determining capacity, planning for atypical responses, the impact or lack of influence of the framing effect, and strategies for presenting information. Finally, we will offer health-care providers information and examples for adapting their existing end-of-life decision-making tools and conversation guides to meet the communication needs of persons with ASD.

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