Cerebral AneurysmNCT02503553
Decision Aids in Cerebral Aneurysm Treatment
A study testing Option grid for cerebral aneurysm treatment in people with Cerebral Aneurysm, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Aneurysm
- What is being tested?
- Option grid for cerebral aneurysm treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients for whom a decision is made to undergo cerebral aneurysm treatment
Who cannot join
- patients presenting with ruptured aneurysms/subarachnoid hemorrhage
- pediatric patients
- emergency operations with no preoperative clinic visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Cerebral Aneurysm
- Being tested
- Option grid for cerebral aneurysm treatment, Control
- Keywords
- option grid, neurosurgery, cerebral aneurysm
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Option grid for cerebral aneurysm treatmentBehavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Decision aid | Experimental | 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. Receives: Behavioral: Option grid for cerebral aneurysm treatment |
| Control | Placebo comparator | 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. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Checked once: a) in the preoperative clinic visit
Secondary outcomes (3)
EVAN-G
A patient satisfaction score with 6 domains. The score ranges from 0-100 with higher scores representing higher satisfaction.
Measured: Checked once: a) within 24 hours of the operation
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.
Measured: Checked twice: a) in the preoperative clinic visit, b) immediately preoperatively on the day of the surgery
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.
Measured: Checked twice: a) in the preoperative clinic visit, b) immediately preoperatively on the day of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Primary completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral AneurysmStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kimon Bekelis, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503553
- Sponsor's protocol ID
- STUDY00028774
- Status last verified
- Feb 2016
- First submitted
- 17 Jul 2015
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decision Aids in Cerebral Aneurysm Treatment
- ClinicalTrials.gov ID
- NCT02503553
- Acronym / sponsor ID
- STUDY00028774
- Conditions
- Cerebral Aneurysm
- Keywords
- option grid, neurosurgery, cerebral aneurysm
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Primary completion
- Aug 2015 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision aid | Experimental | Behavioral: Option grid for cerebral aneurysm treatmentOption 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 comparator | Behavioral: ControlPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients for whom a decision is made to undergo cerebral aneurysm treatment
Key exclusion criteria (3 listed)
- patients presenting with ruptured aneurysms/subarachnoid hemorrhage
- pediatric patients
- emergency operations with no preoperative clinic visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Option grid for cerebral aneurysm treatmentPatients 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. | Behavioural | Decision aid |
| ControlPatients 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. | Behavioural | Control |
Primary outcome
OPTION score
Time frame: Checked once: a) in the preoperative clinic visit
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.
3 secondary outcomes
EVAN-G
Time frame: Checked once: a) within 24 hours of the operation
Change in stress level
Time frame: Checked twice: a) in the preoperative clinic visit, b) immediately preoperatively on the day of the surgery
Change in patient satisfaction level
Time frame: Checked twice: a) in the preoperative clinic visit, b) immediately preoperatively on the day of the surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimon Bekelis, MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Option grid for cerebral aneurysm treatment in people with Cerebral Aneurysm, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OPTION score (time frame: Checked once: a) in the preoperative clinic visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.