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Decision Aids in Cerebral Aneurysm Treatment

Primary Purpose

Cerebral Aneurysm

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Option grid for cerebral aneurysm treatment
Control
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cerebral Aneurysm focused on measuring option grid, neurosurgery, cerebral aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Decision aid

Control

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

EVAN-G
A patient satisfaction score with 6 domains. The score ranges from 0-100 with higher scores representing higher satisfaction.
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.
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.

Full Information

First Posted
July 17, 2015
Last Updated
February 2, 2016
Sponsor
Dartmouth-Hitchcock Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02503553
Brief Title
Decision Aids in Cerebral Aneurysm Treatment
Official Title
Decision Aids in Cerebral Aneurysm Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dartmouth-Hitchcock Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Aneurysm
Keywords
option grid, neurosurgery, cerebral aneurysm

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Decision aid
Arm Type
Experimental
Arm 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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Option grid for cerebral aneurysm treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
OPTION score
Description
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.
Time Frame
Checked once: a) in the preoperative clinic visit
Secondary Outcome Measure Information:
Title
EVAN-G
Description
A patient satisfaction score with 6 domains. The score ranges from 0-100 with higher scores representing higher satisfaction.
Time Frame
Checked once: a) within 24 hours of the operation
Title
Change in stress level
Description
On a scale of 0-10 with 0 being no stress and 10 being the worst stress in the patient's life.
Time Frame
Checked twice: a) in the preoperative clinic visit, b) immediately preoperatively on the day of the surgery
Title
Change in patient satisfaction level
Description
On a scale of 0-10 with 0 being not satisfied and 10 being completely satisfied with the preoperative experience.
Time Frame
Checked twice: a) in the preoperative clinic visit, b) immediately preoperatively on the day of the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimon Bekelis, MD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

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Decision Aids in Cerebral Aneurysm Treatment

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