Decision Aids in Cerebral Aneurysm Treatment

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Brief Title

Decision Aids in Cerebral Aneurysm Treatment

Official Title

Decision Aids in Cerebral Aneurysm Treatment

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.
    

Detailed Description

      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.
    


Study Type

Interventional


Primary Outcome

OPTION score

Secondary Outcome

 EVAN-G

Condition

Cerebral Aneurysm

Intervention

Option grid for cerebral aneurysm treatment

Study Arms / Comparison Groups

 Decision aid
Description:  Option 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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

0



Primary Completion Date

August 2015

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Kimon Bekelis, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02503553

Organization ID

STUDY00028774


Responsible Party

Sponsor

Study Sponsor

Dartmouth-Hitchcock Medical Center


Study Sponsor

Kimon Bekelis, MD, Principal Investigator, Dartmouth-Hitchcock Medical Center


Verification Date

February 2016