Decision Aids in Cerebral Aneurysm Treatment

Cerebral Aneurysm Clinical Trial

Official title:

Decision Aids in Cerebral Aneurysm Treatment

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02503553
• Other study ID #: STUDY00028774
• Status: Withdrawn
• Phase: N/A
• First received: July 17, 2015
• Last updated: February 2, 2016

Study information

• Verified date: February 2016
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Aneurysm
• Cerebral Aneurysm
• Intracranial Aneurysm

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	EVAN-G	A patient satisfaction score with 6 domains. The score ranges from 0-100 with higher scores representing higher satisfaction.	Checked once: a) within 24 hours of the operation	No
Secondary	Change in stress level	On a scale of 0-10 with 0 being no stress and 10 being the worst stress in the patient's life.	Checked twice: a) in the preoperative clinic visit, b) immediately preoperatively on the day of the surgery	No
Secondary	Change in patient satisfaction level	On a scale of 0-10 with 0 being not satisfied and 10 being completely satisfied with the preoperative experience.	Checked twice: a) in the preoperative clinic visit, b) immediately preoperatively on the day of the surgery	No