Decision Aids in Cerebral Aneurysm Treatment

NCT02503553 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-02-03

No results posted yet for this study

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.

Conditions

  • Cerebral Aneurysm

Interventions

BEHAVIORAL

Option grid for cerebral aneurysm treatment

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.

BEHAVIORAL

Control

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.

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Kimon Bekelis, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Primary Completion
2015-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02503553 on ClinicalTrials.gov