Decision Aids in Cerebral Aneurysm Treatment
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2015
CompletedFirst Posted
Study publicly available on registry
July 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedFebruary 3, 2016
February 1, 2016
July 17, 2015
February 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
OPTION score
A scale on which physician-patient interactions will be graded by an independent blinded observer (based on the voice recording) to assess patient participation in the shared-decision making process.
Checked once: a) in the preoperative clinic visit
Secondary Outcomes (3)
EVAN-G
Checked once: a) within 24 hours of the operation
Change in stress level
Checked twice: a) in the preoperative clinic visit, b) immediately preoperatively on the day of the surgery
Change in patient satisfaction level
Checked twice: a) in the preoperative clinic visit, b) immediately preoperatively on the day of the surgery
Study Arms (2)
Decision aid
EXPERIMENTALOption grid for cerebral aneurysm treatment Patients will receive an option grid during the preoperative visit. They will be given the chance to ask questions. The interaction with the aneurysm surgeon will be voice recorded.
Control
PLACEBO COMPARATORPatients will receive the standard information booklet for cerebral aneurysms during the preoperative visit. They will be given the chance to ask questions. The interaction with the aneurysm surgeon will be voice recorded.
Interventions
Patients will receive an option grid during the preoperative visit. They will be given the chance to read it and ask questions. The option grid will include head to head comparative answers for the two interventions available for cerebral aneurysms (surgical clipping and endovascular coiling). The interaction with the aneurysm surgeon will be voice recorded.
Patients will receive the standard information booklet for cerebral aneurysms during the preoperative visit. They will be given the chance to ask questions. The interaction with the aneurysm surgeon will be voice recorded.
Eligibility Criteria
You may qualify if:
- All patients for whom a decision is made to undergo cerebral aneurysm treatment
You may not qualify if:
- patients presenting with ruptured aneurysms/subarachnoid hemorrhage
- pediatric patients
- emergency operations with no preoperative clinic visit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kimon Bekelis, MD
Dartmouth-Hitchcock Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2015
First Posted
July 21, 2015
Primary Completion
August 1, 2015
Last Updated
February 3, 2016
Record last verified: 2016-02