Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00352573 |
| Other study ID # |
020247 |
| Secondary ID |
02-CC-0247 |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2002 |
| Est. completion date |
July 14, 2014 |
Study information
| Verified date |
December 2021 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study will survey a random sample of 2,100 general medicine physicians in Europe and in
the U.S. about ethical difficulties they face in their practice of medicine. The participants
will complete a questionnaire designed to meet the following study objectives:
- Identify the types of ethical dilemmas physicians report that they face in their
practice and approaches they find helpful in responding to these situations
- Determine what ethical support physicians would find useful in dealing with ethically
problematic situations
- Explore physicians experience with 'bedside rationing', due to economic or societal
constraints, what procedures they forgo as a result, and what criteria they use in their
rationing decisions
- Explore physicians perceptions of the equity of the health care system they work in
- Determine what interventions directed at limiting health care costs physicians would
find acceptable.
Physicians in Italy, Norway, Switzerland and the United Kingdom who practice direct patient
care for at least 20 percent of their time may enroll in this study.
The practice of medicine sometimes involves situations where important values come into
conflict. The refusal of life-saving treatment, the concern that telling the truth could have
problematic consequences, acceptable ways of facing a request to die all are examples of
dilemmas that can arise in the practice of medicine. The absence of clear-cut 'right answers'
to questions raised by these situations have led to the development of support services, such
as ethics consultations, to help in decision-making concerning ethical problems that arise in
clinical settings. Information from this survey can provide input into the continuing
development of ethics support services by establishing an evidence base regarding the ethical
difficulties encountered by physicians and the type of support they would consider useful in
resolving these dilemmas.
Description:
Ethics support services are being developed in many European countries, but the evidence base
concerning the types of ethical dilemmas faced by physicians in these countries is small. The
ways in which physicians respond to ethically difficult situations and the types of ethical
support they would consider useful in such cases are also largely unexplored. In this study,
we aim to explore the experience of physicians regarding ethical issues at the bedside in
Italy, Norway, Switzerland, the UK, and the US. These are countries with very different
cultural contexts, where ethics support services are in various stages of development. A
better understanding of the ethical difficulties encountered by physicians in these different
settings and the ways in which they respond to them would be useful locally to assist the
development of support services. It would also permit intercultural comparison of the
practical answers given to difficult questions for which there cannot be said that there is
one right answer.
One of the ethical dilemmas faced by physicians at the bedside is the allocation of scarce
resources. This is of particular interest, as it has implications that go beyond the
physician-patient encounter. The choices made by physicians in situations of scarce resources
not only reflect their values, but also the constraints they must work with. Knowing more
about the role of those factors could be an important contribution to an evidence base for
health policy.
This is an exploratory cross-sectional self-administered mailed survey of physicians in
primary care in Italy, Switzerland, and the UK. The part of the survey instrument exploring
physicians' experience and attitudes regarding resource allocation at the bedside will also
be conducted in the U.S. The questionnaire will address the type and frequency of ethical
dilemmas faced by physicians, how they approach such dilemmas, the type of ethical support
they would find useful in such situations, as well as their attitudes and practices in
situations of scarce resources. Data will be analyzed using descriptive statistics, factorial
analysis of variance to determine factors associated with the type and frequency of ethical
difficulties encountered, and logistic regression to determine factors associated with
reported rationing behavior and with perception of the equity of the health care system.
Independent variables used in the analysis of the last two points will also include health
care systems characteristics collected from the literature. Participants will be selected on
the basis of national listings. To ensure sufficient exposure to direct clinical practice,
inclusion criteria will include direct patient care for at least a year and at least 20% of
the participants time.
