Decision Aids in Cerebral Aneurysm Treatment
| Status: | Withdrawn |
|---|---|
| Conditions: | Cardiology, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
Identifying and making a decision about the best health treatment or screening option can be
difficult for patients. Decision aids can be used when there is more than one reasonable
option, when no option has a clear advantage in terms of health outcomes, and when each
option has benefits and harms that patients may value differently.
Decision aids may be pamphlets, videos, or web-based tools. They make the decision explicit,
describe the options available, and help people to understand these options as well as their
possible benefits and harms. This helps patients to consider the options from a personal
view (e.g., how important the possible benefits and harms are to them) and helps them to
participate with their health practitioner in making a decision.
Cerebral aneurysms are common and potentially very dangerous. However, there are important
treatment choices that may prevent bleeding and stroke before aneurysm rupture.Current
procedural options are clipping and endovascular coiling. The anatomy of most aneurysms is
amenable to either treatment.
The treatment decisions are not simple, since each choice has its own trade-offs. How the
benefits and trade-offs are valued varies across different patients, and, therefore, the
right treatment decision needs to include greater patient participation. This starts with
better communication of the probabilities associated with the outcomes of each option in
terms that can be understood by patients. Equally important is helping the patients clarify
their own treatment goals, as well as legitimizing patients' partnership in the
decision-making process. Tools (e.g., decision aids) to achieve shared decision-making, are
lacking in this area of medicine. We propose to investigate the impact of such decision aids
on patient satisfaction and the outcomes of cerebral aneurysm coiling and clipping.
Aim 1. To determine whether structured decision aids offered to cerebral aneurysm patients
are associated with increased patient participation in the decision making process as
indicated by the OPTION score
Aim 2. To determine whether structured decision aids offered to cerebral aneurysm patients
are associated with improved quality of life and patient satisfaction outcomes immediately
preoperatively, and 30 days postoperatively.
difficult for patients. Decision aids can be used when there is more than one reasonable
option, when no option has a clear advantage in terms of health outcomes, and when each
option has benefits and harms that patients may value differently.
Decision aids may be pamphlets, videos, or web-based tools. They make the decision explicit,
describe the options available, and help people to understand these options as well as their
possible benefits and harms. This helps patients to consider the options from a personal
view (e.g., how important the possible benefits and harms are to them) and helps them to
participate with their health practitioner in making a decision.
Cerebral aneurysms are common and potentially very dangerous. However, there are important
treatment choices that may prevent bleeding and stroke before aneurysm rupture.Current
procedural options are clipping and endovascular coiling. The anatomy of most aneurysms is
amenable to either treatment.
The treatment decisions are not simple, since each choice has its own trade-offs. How the
benefits and trade-offs are valued varies across different patients, and, therefore, the
right treatment decision needs to include greater patient participation. This starts with
better communication of the probabilities associated with the outcomes of each option in
terms that can be understood by patients. Equally important is helping the patients clarify
their own treatment goals, as well as legitimizing patients' partnership in the
decision-making process. Tools (e.g., decision aids) to achieve shared decision-making, are
lacking in this area of medicine. We propose to investigate the impact of such decision aids
on patient satisfaction and the outcomes of cerebral aneurysm coiling and clipping.
Aim 1. To determine whether structured decision aids offered to cerebral aneurysm patients
are associated with increased patient participation in the decision making process as
indicated by the OPTION score
Aim 2. To determine whether structured decision aids offered to cerebral aneurysm patients
are associated with improved quality of life and patient satisfaction outcomes immediately
preoperatively, and 30 days postoperatively.
Our study will include patients presenting in the clinic with a diagnosis of cerebral
aneurysm. Patients for whom surgical intervention is deemed necessary will be approached for
participation in the study. After signing informed consent, they will be randomized to
receive a document that will serve as a decision aid (option grid). If they are randomized
as controls they will receive a standard information booklet. Patients will be given a few
minutes to read through the option grid choices, and will have the chance to ask questions
about the two possible treatments (cerebral aneurysm clipping, cerebral aneurysm coiling).
The remainder of the interaction between patient and provider will not be affected in any
other way. The physician is free to make any recommendations based on their best judgment,
and the patient is free to choose based on their preferences. The visit with the patient
will be voice recorded and (immediately after the completion of the encounter) will be
scored based on the OPTION score, which assesses patient participation in the shared
decision making process.
Patients will be interviewed again preoperatively on the day of the operation, immediately
postoperatively, and 30-days postoperatively (via telephone). Performance on secondary
outcome measures will be recorded.
Variables will be analyzed using Fisher exact test for categorical variables and the
nonparametric Wilcoxon rank-sum test for continuous variables. Logistic regression will be
performed, for each binary outcome. Linear regression will be performed for each continuous
outcome.
aneurysm. Patients for whom surgical intervention is deemed necessary will be approached for
participation in the study. After signing informed consent, they will be randomized to
receive a document that will serve as a decision aid (option grid). If they are randomized
as controls they will receive a standard information booklet. Patients will be given a few
minutes to read through the option grid choices, and will have the chance to ask questions
about the two possible treatments (cerebral aneurysm clipping, cerebral aneurysm coiling).
The remainder of the interaction between patient and provider will not be affected in any
other way. The physician is free to make any recommendations based on their best judgment,
and the patient is free to choose based on their preferences. The visit with the patient
will be voice recorded and (immediately after the completion of the encounter) will be
scored based on the OPTION score, which assesses patient participation in the shared
decision making process.
Patients will be interviewed again preoperatively on the day of the operation, immediately
postoperatively, and 30-days postoperatively (via telephone). Performance on secondary
outcome measures will be recorded.
Variables will be analyzed using Fisher exact test for categorical variables and the
nonparametric Wilcoxon rank-sum test for continuous variables. Logistic regression will be
performed, for each binary outcome. Linear regression will be performed for each continuous
outcome.
Inclusion Criteria:
- All patients for whom a decision is made to undergo cerebral aneurysm treatment
Exclusion Criteria:
- patients presenting with ruptured aneurysms/subarachnoid hemorrhage
- pediatric patients
- emergency operations with no preoperative clinic visit
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